All COVID-19 Updates
09.19.2025
ACIP COVID-19 Public Statement
Over the past five years, Pfizer and BioNTech's COVID-19 vaccine efforts reflect a continuous commitment to address a public health challenge.09.19.2025
Pfizer-BioNTech Statement to ACIP Meeting 19th September 2025
Pfizer and BioNTech remain deeply committed to making safe and effective vaccines that help protect lives in the U.S. and around the world. The Pfizer-BioNTech COVID-19 vaccine has been reviewed by multiple regulatory authorities, including the FDA, and has met all safety and quality control guidelines.09.16.2025
Pfizer Reaffirms Safety and Efficacy of COVID-19 Vaccines
Pfizer Inc. today reaffirmed the safety and efficacy of the COVID-19 vaccine and posted resources supporting its impact on global health.09.15.2025
Pfizer Shares Available Analyses of Myocarditis and COVID-19 Vaccines
Pfizer Inc. today posted publicly available COVID-19 data from global analyses of myocarditis, further representing its dedication to transparency.09.09.2025
Pfizer Upholds Commitment to Transparency and Shares Analysis of COVID-19 Vaccination in Pregnant Women
Pfizer Inc. today posted COVID-19 vaccine data in pregnant women, continuing to deliver on President Trump’s call for transparency of our findings in an open and accessible manner.09.08.2025
Pfizer and BioNTech Announce Topline Data Demonstrating Robust Immune Response With Their LP.8.1-Adapted COVID-19 Vaccine 2025-2026 Formula
Pfizer Inc. and BioNTech SE today announced positive topline results from an ongoing Phase 3 clinical trial cohort evaluating the safety, tolerability, and immunogenicity of a 30-µg dose of the LP.8.1-adapted monovalent COMIRNATY® (COVID-19 Vaccine, mRNA) 2025-2026 Formula in adults aged 65 and older and in adults aged 18 through 64 with at least one underlying risk condition for severe COVID-19.09.03.2025
Pfizer Responds to Success of Operation Warp Speed and Reaffirms Transparency of COVID Vaccine Data
Pfizer Inc. today reaffirmed its commitment to transparently and consistently disclosing its research findings regarding its COVID-19 vaccine and to maintaining the integrity of those ongoing studies for all those we serve.08.27.2025
Pfizer and BioNTech’s COMIRNATY® Receives U.S. FDA Approval for Adults 65 and Older and Individuals Ages 5 through 64 at Increased Risk for Severe COVID-19
Pfizer and BioNTech SE announced the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for the companies’ LP.8.1-adapted monovalent COVID-19 vaccine.07.25.2025
Pfizer and BioNTech Receive Positive CHMP Opinion for LP.8.1-adapted COVID-19 Vaccine in the European Union
Pfizer and BioNTech SE announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended marketing authorization for the companies’ LP.8.1-adapted monovalent COVID-19 vaccine (COMIRNATY® LP.8.1) for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 6 months of age and older.05.28.2025
Pfizer and BioNTech Submit EMA Application for COVID-19 Vaccine Targeting LP.8.1 for 2025-2026 Season
Pfizer and BioNTech SE announced that they have submitted a regulatory application to the European Medicines Agency (EMA) for approval of COMIRNATY® for the 2025-2026 season, targeting the LP.8.1 strain.09.20.2024
Pfizer and BioNTech Receive Positive CHMP Opinion for Omicron KP.2-adapted COVID-19 Vaccine in the European Union
Pfizer Inc. and BioNTech SE today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended marketing authorization for the companies’ Omicron KP.2-adapted monovalent COVID-19 vaccine (COMIRNATY® KP.2) for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 6 months of age and older.08.27.2024
Pfizer Launches PfizerForAll™, a Digital Platform that Helps Simplify Access to Healthcare
Pfizer Inc. today introduced PfizerForAll, a user-friendly digital platform designed to make access to healthcare and managing health and wellness more seamless for people across the U.S. The new, end-to-end experience will support the millions of Americans affected annually by common illnesses like migraine, COVID-19 or flu, and those seeking to protect themselves with adult vaccinations.08.22.2024
Pfizer and BioNTech Receive U.S. FDA Approval & Authorization for Omicron KP.2-adapted COVID-19 Vaccine
Pfizer Inc. and BioNTech SE today announced that the U.S. Food and Drug Administration (“FDA”) has approved the supplemental Biologics License Application for individuals 12 years of age and older (COMIRNATY® (COVID-19 Vaccine, mRNA), and granted emergency use authorization for individuals 6 months through 11 years of age (Pfizer-BioNTech COVID-19 Vaccine) of the companies’ Omicron KP.2-adapted 2024-2025 Formula COVID-19 vaccine.08.16.2024
Pfizer and BioNTech Provide Update on mRNA-based Combination Vaccine Program Against Influenza and COVID-19 in Individuals 18-64 Years of Age
Pfizer Inc. and BioNTech SE today announced top-line results from their Phase 3 clinical trial to evaluate the companies’ combined mRNA vaccine candidate against influenza and COVID-19 in healthy individuals 18-64 years of age.06.27.2024
Pfizer and BioNTech Receive Positive CHMP Opinion for Omicron JN.1-adapted COVID-19 Vaccine in the European Union
Pfizer Inc. and BioNTech SE today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended marketing authorization for the companies’ Omicron JN.1-adapted monovalent COVID-19 vaccine (COMIRNATY® JN.1) for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 6 months of age and older.10.26.2023
Pfizer and BioNTech Announce Positive Topline Data for mRNA-based Combination Vaccine Program Against Influenza and COVID-19
Pfizer Inc. and BioNTech SE today announced positive topline results from a Phase 1/2 study (NCT05596734) evaluating the safety, tolerability and immunogenicity of mRNA-based combination vaccine candidates for influenza and COVID-19 among healthy adults 18 to 64 years of age.10.13.2023
Pfizer Amends U.S. Government Paxlovid Supply Agreement and Updates Full-Year 2023 Guidance
Pfizer Inc. today announced that it has amended its supply agreement with the U.S. government for Paxlovid, the first oral antiviral pill approved by the U.S. Food and Drug Administration (FDA) and is updating its Full-Year 2023 Guidance.09.11.2023
Pfizer and BioNTech Receive U.S. FDA Approval for 2023-2024 COVID-19 Vaccine
Pfizer Inc. and BioNTech SE today announced that the U.S. Food and Drug Administration (FDA) approved the supplemental Biologics License Application (COMIRNATY 2023-2024 Formulation) for individuals 12 years and older and granted emergency use authorization for individuals 6 months through 11 years of age for the companies’ Omicron XBB.1.5-adapted monovalent COVID-19 vaccine.08.30.2023
Pfizer and BioNTech Receive Positive CHMP Opinion for Omicron XBB.1.5-adapted COVID-19 Vaccine in the European Union
Pfizer Inc. and BioNTech SE today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended marketing authorization for the companies’ Omicron XBB.1.5-adapted monovalent COVID-19 vaccine (COMIRNATY® Omicron XBB.1.5) administered as a single dose for individuals 5 years of age and older, regardless of prior COVID-19 vaccination history.06.23.2023
Pfizer and BioNTech Submit Applications to U.S. FDA for Omicron XBB.1.5-Adapted Monovalent COVID-19 Vaccine
Pfizer Inc. and BioNTech SE today announced the companies have submitted regulatory applications to the U.S. Food and Drug Administration (FDA) for their Omicron XBB.1.5-adapted monovalent COVID-19 vaccine for individuals 6 months of age and older.06.23.2023
Pfizer and BioNTech Initiate Application to European Medicines Agency for Omicron XBB.1.5-Adapted Monovalent COVID-19 Vaccine
Pfizer Inc. and BioNTech SE today announced they have initiated the submission of a variation to the European Medicines Agency (EMA) for their Omicron XBB.1.5-adapted monovalent COVID-19 vaccine for the 2023-2024 fall and winter season.05.26.2023
Pfizer and BioNTech Provide Update on COVID-19 Vaccine Supply Agreement with the European Commission
Pfizer Inc. and BioNTech SE today announced they have reached an agreement with the European Commission (EC) to amend their existing contract to deliver COVID-19 vaccines to the European Union.05.25.2023
Pfizer’s PAXLOVID™ Receives FDA Approval for Adult Patients at High Risk of Progression to Severe COVID-19
Pfizer Inc. announced today that the U.S. Food and Drug Administration (FDA) approved PAXLOVID™ (nirmatrelvir tablets and ritonavir tablets) for the treatment of mild-to-moderate COVID-19 in adults who are at high risk for progression to severe COVID-19, including hospitalization or death.05.11.23
Global and U.S. Agencies Declare End of COVID-19 Emergency
On May 5, more than three years since COVID-19 was designated as a pandemic, the World Health Organization (WHO) declared an end to the global Public Health Emergency (PHE) for COVID-19. Following an initial announcement earlier this year, the U.S. Department of Health and Human Services (HHS) declared the same for the United States, effective on May 11.03.16.23
FDA Advisory Committee Votes in Support of Favorable Benefit-Risk Profile for Pfizer’s PAXLOVID™
Pfizer Inc. announced today that the U.S. Food and Drug Administration’s (FDA) Antimicrobial Drugs Advisory Committee (AMDAC) voted 16 to 1 that available data support the safety and effectiveness of PAXLOVID™ (nirmatrelvir tablets and ritonavir tablets) for the treatment of mild-to-moderate COVID-19 in adult patients who are at high risk for progression to severe illness.03.14.23
Pfizer and BioNTech Receive U.S. Emergency Use Authorization of Omicron BA.4/BA.5-Adapted Bivalent COVID-19 Booster in Children Under 5 Years
Pfizer Inc. and BioNTech SE announced today that the U.S. Food and Drug Administration (FDA) granted emergency use authorization (EUA) to provide a single booster dose of the companies’ Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine in children 6 months through 4 years of age (also referred to as under 5 years of age) at least 2 months after completion of primary vaccination with three doses of the Pfizer-BioNTech COVID-19 Original Vaccine.03.01.23
Pfizer and BioNTech Submit for U.S. Emergency Use Authorization of Omicron BA.4/BA.5-Adapted Bivalent COVID-19 Booster in Children Under 5 Years
Pfizer Inc. and BioNTech SE today submitted an application to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) of a booster (fourth) dose of the companies’ Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine in children 6 months through 4 years of age (also referred to as under 5 years).02.24.23
Pfizer and BioNTech Submit Supplemental Biologics License Application for U.S. FDA Approval of Omicron BA.4/BA.5-Adapted Bivalent COVID-19 Vaccine for Ages 12 Years and Older as Primary Series or Booster
Pfizer Inc. and BioNTech SE today announced they have submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for approval of their Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine as a primary series and booster dose(s) for individuals 12 years of age and older.01.27.23
Pfizer Receives Positive CHMP Opinion for Conversion of PAXLOVID™ Conditional Marketing Authorization to Full Marketing Authorization in the European Union
Pfizer Inc. today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended converting the conditional Marketing Authorization (cMA) for PAXLOVID™ (nirmatrelvir tablets and ritonavir tablets) to standard (also referred to as “full”) Marketing Authorization (MA) for the treatment of COVID-19 in adults who do not require supplemental oxygen and who are at increased risk of the disease becoming severe.12.20.22
U.S. FDA Extends Review of Pfizer’s New Drug Application for PAXLOVID™
Pfizer Inc. announced today that the U.S. Food and Drug Administration (FDA) has extended the review period for the New Drug Application (NDA) for its COVID-19 oral treatment, PAXLOVID™ (nirmatrelvir tablets and ritonavir tablets).12.13.22
Pfizer to Provide U.S. Government with an Additional 3.7 Million Treatment Courses of PAXLOVID™ to Help Combat COVID-19
Pfizer Inc. has reached an agreement with the U.S. Government for the purchase of an additional 3.7 million treatment courses of its authorized COVID-19 oral treatment, PAXLOVID™ (nirmatrelvir [PF-07321332] tablets and ritonavir tablets).12.09.22
Pfizer and BioNTech Receive U.S. FDA Fast Track Designation for Single-Dose mRNA-Based Vaccine Candidate Against COVID-19 and Influenza
Pfizer Inc. and BioNTech SE today announced the companies have received Fast Track Designation from the U.S. Food and Drug Administration (FDA) for their mRNA-based combination vaccine candidate for influenza and COVID-19, which aims to help prevent two respiratory diseases with a single injection.12.08.22
Pfizer and BioNTech Receive U.S. FDA Emergency Use Authorization for Omicron BA.4/BA.5-Adapted Bivalent COVID-19 Vaccine in Children Under 5 Years
Pfizer Inc. and BioNTech SE today announced the U.S. Food and Drug Administration (FDA) granted Emergency Use Authorization (EUA) of their Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine as the third 3-µg dose in the three-dose primary series for children 6 months through 4 years of age.12.05.22
Pfizer and BioNTech Submit Application to U.S. FDA for Emergency Use Authorization of Omicron BA.4/BA.5-Adapted Bivalent COVID-19 Vaccine in Children Under 5 Years
Pfizer Inc. and BioNTech SE today announced that the companies have submitted an application to the U.S. Food and Drug Administration (FDA) for emergency use authorization (EUA) of their Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine as the third 3-µg dose in the three-dose primary series for children 6 months through 4 years of age.11.18.22
Pfizer and BioNTech Report New Data on Omicron BA.4/BA.5-Adapted Bivalent Booster Demonstrating Improved Immune Response Against Emerging Omicron Sublineages
Pfizer Inc. and BioNTech SE today announced results from an analysis examining the immune response induced by their Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine [Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5)] against newer Omicron sublineages, including BA.4.6, BA.2.75.2, BQ.1.1 and XBB.1.11.16.22
Pfizer and BioNTech Advance Next-Generation COVID-19 Vaccine Strategy with Study Start of Candidate Aimed at Enhancing Breadth of T cell Responses and Duration of Protection
Pfizer Inc. and BioNTech SE today announced that the companies have initiated a Phase 1 study to evaluate the safety, tolerability and immunogenicity of a next generation COVID-19 vaccine candidate that aims to enhance SARS-CoV-2 T cell responses and potentially broaden protection against COVID-19.11.10.22
Pfizer and BioNTech Receive Positive CHMP Opinion for Omicron BA.4/BA.5-Adapted Bivalent COVID-19 Vaccine Booster for Children 5 Through 11 Years of Age in European Union
Pfizer Inc. and BioNTech SE today announced a booster dose of their Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine (COMIRNATY® Original/Omicron BA.4/BA.5 5/5 µg) has been recommended for marketing authorization by the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) for children 5 through 11 years of age.11.04.22
Pfizer and BioNTech Announce Updated Clinical Data for Omicron BA.4/BA.5-Adapted Bivalent Booster Demonstrating Substantially Higher Immune Response in Adults Compared to the Original COVID-19 Vaccine
Pfizer Inc. and BioNTech SE today announced updated data from a Phase 2/3 clinical trial demonstrating a robust neutralizing immune response one-month after a 30-µg booster dose of the companies’ Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine (Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5)).11.03.22
Pfizer and BioNTech Initiate Phase 1 Study of Single Dose mRNA-Based Combination Vaccine Candidate for Influenza and COVID-19
Pfizer Inc. and BioNTech SE today announced the advancement of an mRNA-based combination vaccine candidate for influenza and COVID-19 to a Phase 1 trial with the aim to address two severe respiratory diseases with one vaccine.10.19.22
Pfizer and BioNTech Receive Positive CHMP Opinion for COMIRNATY® in Children 6 Months to less than 5 Years in the European Union
Pfizer Inc. and BioNTech SE today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended marketing authorization (MA) for a 3-µg dose of COMIRNATY® (COVID-19 vaccine, mRNA), which is based on the wild-type spike protein of SARS-CoV-2, as a three-dose series for children ages 6 months to less than 5 years (also referred to as 6 months through 4 years of age).10.13.22
Pfizer and BioNTech Announce Positive Early Data From Clinical Trial of Omicron BA.4/BA.5-Adapted Bivalent Booster in Individuals 18 Years and Older
Pfizer Inc. and BioNTech SE today announced early data from a Phase 2/3 clinical trial (NCT05472038) evaluating the safety, tolerability, and immunogenicity of the companies’ Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine (Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5)).10.12.22
Pfizer and BioNTech Receive U.S. FDA Emergency Use Authorization for Omicron BA.4/BA.5-Adapted Bivalent COVID-19 Vaccine Booster in Children 5 Through 11 Years of Age
Pfizer Inc. and BioNTech SE today announced that the U.S. Food and Drug Administration (FDA) granted Emergency Use Authorization (EUA) for a 10-µg booster dose of their Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine in children 5 through 11 years of age.09.26.22
Pfizer and BioNTech Submit Application to U.S. FDA for Emergency Use Authorization of Omicron BA.4/BA.5-Adapted Bivalent Vaccine Booster in Children 5 Through 11 Years of Age
Pfizer Inc. and BioNTech SE today announced they have completed a submission to the U.S. Food and Drug Administration (FDA) requesting Emergency Use Authorization (EUA) of a 10-µg booster dose of the companies’ Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine for children ages 5 through 11 years of age.09.24.22
Statement from Pfizer Chairman and CEO Albert Bourla on Testing Positive for COVID-19
I wanted to let you know that I have tested positive for COVID. I’m feeling well and symptom free.09.22.22
Pfizer to Supply Global Fund Up to 6 Million PAXLOVID™ Treatment Courses for Low-and-Middle-Income Countries
Pfizer Inc. announced today an agreement to supply up to six million treatment courses of its COVID-19 oral treatment, PAXLOVID™ (nirmatrelvir [PF-07321332] tablets and ritonavir tablets) to Global Fund as part of its COVID-19 Response Mechanism (C19RM).09.16.22
Pfizer and BioNTech Receive Positive CHMP Opinion for Conversion of COMIRNATY® Conditional Marketing Authorization to Full Marketing Authorization in the European Union
Pfizer Inc. and BioNTech SE today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended converting the conditional Marketing Authorization (cMA) for COMIRNATY® [COVID-19 Vaccine (nucleoside modified)] to standard (also referred to as “full”) Marketing Authorization (MA) for all authorized indications and formulations.09.12.22
Pfizer and BioNTech Receive Positive CHMP Opinion for Omicron BA.4/BA.5-Adapted Bivalent COVID-19 Vaccine Booster in European Union
Pfizer Inc. and BioNTech SE today announced a 30-µg booster dose of their Omicron BA.4/BA.5 bivalent-adapted COVID-19 Vaccine (COMIRNATY® Original/Omicron BA.4/BA.5 15/15 µg) has been recommended for conditional marketing authorization (cMA) by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) for individuals ages 12 years and older.09.01.22
Pfizer and BioNTech Receive Positive CHMP Opinion for Omicron BA.1-Adapted Bivalent COVID-19 Vaccine Booster in European Union
Pfizer Inc. and BioNTech SE today announced a 30-µg booster dose of their Omicron BA.1 Bivalent COVID-19 Vaccine (COMIRNATY® Original/Omicron BA.1 15/15 µg) has been recommended for conditional marketing authorization (cMA) by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) for individuals 12 years and older.08.31.22
Pfizer and BioNTech Granted FDA Emergency Use Authorization of Omicron BA.4/BA.5-Adapted Bivalent COVID-19 Vaccine Booster for Ages 12 Years and Older
Pfizer Inc. and BioNTech SE today announced that the U.S. Food and Drug Administration (FDA) granted Emergency Use Authorization (EUA) of a 30-µg booster dose of the Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original [15 µg] and Omicron BA.4/BA.5 [15 µg]) for individuals ages 12 years and older.08.26.22
Pfizer and BioNTech Complete Submission to European Medicines Agency for Omicron BA.4/BA.5 Adapted Bivalent Vaccine
Pfizer Inc. and BioNTech SE today announced they have completed a submission to the European Medicines Agency (EMA) for a booster dose of an Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine for individuals 12 years of age and older.08.23.22
Pfizer and BioNTech Announce Updated COVID-19 Vaccine Data Supporting Efficacy in Children 6 Months through 4 Years of Age
Pfizer Inc. and BioNTech SE today announced updated efficacy results from a Phase 2/3 trial evaluating a three 3-µg dose series of the Pfizer-BioNTech COVID-19 Vaccine in children 6 months through 4 years of age, reinforcing previously reported interim vaccine efficacy data collected in March and April 2022.08.22.22
Pfizer and BioNTech Submit Application to U.S. FDA for Emergency Use Authorization of Omicron BA.4/BA.5-Adapted Bivalent COVID-19 Vaccine
Pfizer Inc. and BioNTech SE today announced they have completed a submission to the U.S. Food and Drug Administration (FDA) requesting Emergency Use Authorization (EUA) of a booster dose of an Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine for individuals 12 years of age and older.08.15.22
Statement from Pfizer Chairman and CEO Albert Bourla on Testing Positive for COVID-19
Pfizer Inc. – I would like to inform the public that I have tested positive for COVID-19. I am grateful to have received four doses of the Pfizer-BioNTech vaccine and I am feeling well while experiencing very mild symptoms.07.27.22
Pfizer and BioNTech Advance COVID-19 Vaccine Strategy With Study Start of Next-Generation Vaccine Candidate Based on Enhanced Spike Protein Design
Pfizer Inc. and BioNTech SE today announced that the companies have initiated a randomized, active-controlled, observer-blind, Phase 2 study to evaluate the safety, tolerability, and immune response of an enhanced COVID-19 mRNA-based vaccine candidate at a 30 µg dose level.07.19.22
Pfizer and BioNTech Complete Submission to European Medicines Agency for Omicron BA.1 Adapted Bivalent Vaccine Candidate
Pfizer Inc. and BioNTech SE today announced they have completed a submission to the European Medicines Agency (EMA) for an Omicron-adapted bivalent COVID-19 vaccine candidate, based on the BA.1 sub-lineage, for individuals 12 years of age and older.07.08.22
Pfizer and BioNTech Announce U.S. FDA Approval of their COVID-19 Vaccine COMIRNATY® For Adolescents 12 through 15 Years of Age
Pfizer Inc. and BioNTech SE today announced the U.S. Food and Drug Administration (FDA) approved the companies’ supplemental Biologics License Application (sBLA) for their COVID-19 vaccine, known as COMIRNATY® (COVID-19 Vaccine, mRNA), to include individuals 12 through 15 years of age.07.08.22
Pfizer and BioNTech Submit a Variation to EMA for the Vaccination of Children 6 Months to less than 5 Years with COMIRNATY®
Pfizer Inc. and BioNTech SE today announced that the companies have submitted a variation to the European Medicines Agency (EMA) requesting to update the Conditional Marketing Authorization (CMA) in the European Union (EU) with data supporting the vaccination of children ages 6 months to less than 5 years with the 3-µg dose of COMIRNATY® (COVID-19 vaccine, mRNA) as a three dose series.06.30.22
Pfizer Announces Submission of New Drug Application to the U.S. FDA for PAXLOVID™
Pfizer Inc. today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for approval of PAXLOVID™ (nirmatrelvir [PF-07321332] tablets and ritonavir tablets) for patients who are at high risk for progression to severe illness from COVID-19.06.29.22
Pfizer and BioNTech Announce New Agreement with U.S. Government to Provide Additional Doses of COVID-19 Vaccine
Pfizer Inc. and BioNTech SE today announced a new vaccine supply agreement with the U.S. government to support the continued fight against COVID-19.06.25.22
Pfizer and BioNTech Announce Omicron-Adapted COVID-19 Vaccine Candidates Demonstrate High Immune Response Against Omicron
Pfizer Inc. and BioNTech SE today announced positive data evaluating the safety, tolerability, and immunogenicity of two Omicron-adapted COVID-19 vaccine candidates: one monovalent and the other bivalent, a combination of the Pfizer-BioNTech COVID-19 Vaccine and a vaccine candidate targeting the spike protein of the Omicron BA.1 variant of concern.06.17.22
Pfizer-BioNTech COVID-19 Vaccine Receives FDA Emergency Use Authorization for Children 6 Months through 4 Years of Age
Pfizer Inc. and BioNTech SE today announced the U.S. Food and Drug Administration (FDA) granted emergency use authorization (EUA) of the Pfizer-BioNTech COVID-19 Vaccine as a three 3-µg dose series for children 6 months through 4 years of age (also referred to as 6 months to less than 5 years of age).06.15.22
Pfizer and BioNTech Provide Update on Rolling Submission to European Medicines Agency for a Potential Variant-Adapted Vaccine
Pfizer Inc. and BioNTech SE today announced the European Medicines Agency (EMA) has initiated a rolling review for a variant-adapted version of the companies’ COVID-19 vaccine.06.14.22
Pfizer Reports Additional Data on PAXLOVID™ Supporting Upcoming New Drug Application Submission to U.S. FDA
Pfizer Inc. today shared data from the Phase 2/3 EPIC-SR (Evaluation of Protease Inhibition for COVID-19 in Standard-Risk Patients) study evaluating the use of PAXLOVID™ (nirmatrelvir [PF-07321332] tablets and ritonavir tablets) in patients who are at standard risk for developing severe COVID-19.06.06.22
Pfizer to Invest $120 Million to Produce COVID-19 Oral Treatment in the U.S.
Pfizer Inc. announced today that it will further strengthen its commitment to United States manufacturing with a $120 million investment at its Kalamazoo, Michigan, facility, enabling U.S.-based production in support of its COVID-19 oral treatment, PAXLOVIDTM (nirmatrelvir [PF-07321332] tablets and ritonavir tablets).05.23.22
Pfizer-BioNTech COVID-19 Vaccine Demonstrates Strong Immune Response, High Efficacy and Favorable Safety in Children 6 Months to Under 5 Years of Age Following Third Dose
Pfizer Inc. and BioNTech SE today announced topline safety, immunogenicity and vaccine efficacy data from a Phase 2/3 trial evaluating a third 3-µg dose of the Pfizer-BioNTech COVID-19 Vaccine in children 6 months to under 5 years of age.05.17.22
Pfizer and BioNTech Granted U.S. Emergency Use Authorization for Booster Dose of Their COVID-19 Vaccine in Children 5 Through 11 Years of Age
Pfizer Inc. and BioNTech SE today announced the U.S. Food and Drug Administration (FDA) expanded emergency use authorization (EUA) to include a booster dose after completion of the primary series of the Pfizer-BioNTech COVID-19 Vaccine in children 5 through 11 years of age.05.13.22
Pfizer and BioNTech Provide Update on COVID-19 Vaccine Supply Agreement with European Commission
Pfizer Inc. and BioNTech SE today announced they have reached an agreement with the European Commission (EC) to amend their originally agreed contractual delivery schedules for the Pfizer-BioNTech COVID-19 Vaccine.04.29.22
Pfizer Shares Top-Line Results from Phase 2/3 EPIC-PEP Study of PAXLOVID™ for Post-Exposure Prophylactic Use
Pfizer Inc. today shared top-line results from the Phase 2/3 EPIC-PEP (Evaluation of Protease Inhibition for COVID-19 in Post-Exposure Prophylaxis) study evaluating PAXLOVID™ (nirmatrelvir [PF-07321332] tablets and ritonavir tablets) for post-exposure prophylactic use.04.26.22
Pfizer and BioNTech Submit Application for U.S. Emergency Use Authorization for a COVID-19 Vaccine Booster Dose in Children 5 Through 11 Years of Age
Pfizer Inc. and BioNTech SE today submitted an application to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) of a 10-µg booster dose of the Pfizer-BioNTech COVID-19 Vaccine for children 5 through 11 years of age (also referred to as children ages 5 through <12).04.14.22
Pfizer and BioNTech Announce Data Demonstrating High Immune Response Following a Booster Dose of their COVID-19 Vaccine in Children 5 Through 11 Years of Age
Pfizer Inc. and BioNTech SE today announced positive results from a Phase 2/3 clinical trial evaluating the safety, tolerability and immunogenicity of a 10-µg booster (third) dose of the Pfizer-BioNTech COVID-19 vaccine in healthy children 5 through 11 years of age.03.29.22
Pfizer and BioNTech Receive Expanded U.S. Emergency Use Authorization for an Additional COVID-19 Vaccine Booster in Individuals Aged 50 Years and Older
Pfizer Inc. and BioNTech SE today announced that the U.S. Food and Drug Administration (FDA) has expanded the emergency use of their COVID-19 vaccine to include a second booster dose in adults ages 50 years and older who have previously received a first booster of any authorized COVID-19 vaccine.03.22.22
Pfizer to Supply UNICEF up to 4 Million Treatment Courses of Novel COVID-19 Oral Treatment for Low- and Middle-Income Countries
Pfizer Inc. announced today an agreement with UNICEF to supply up to 4 million treatment courses of its COVID-19 oral treatment, PAXLOVID™ (nirmatrelvir [PF-07321332] tablets and ritonavir tablets), to 95 low- and middle-income countries, pending authorization or approval.03.15.22
Pfizer and BioNTech Submit for U.S. Emergency Use Authorization of an Additional Booster Dose of their COVID-19 Vaccine for Older Adults
Pfizer Inc. and BioNTech SE today announced the companies have submitted an application to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) of an additional booster dose for adults 65 years of age and older who have received an initial booster of any of the authorized or approved COVID-19 vaccines.03.09.22
Pfizer Initiates Phase 2/3 Study of Novel COVID-19 Oral Treatment in Pediatric Participants
Pfizer Inc. announced today that it has initiated a Phase 2/3 study, EPIC-PEDS (Evaluation of Protease Inhibition for COVID-19 in Pediatric Patients), to evaluate the safety, pharmacokinetics, and efficacy of Pfizer’s PAXLOVID™ (nirmatrelvir [PF-07321332] tablets and ritonavir tablets) in non-hospitalized, symptomatic, pediatric participants with a confirmed diagnosis of COVID-19 who are at risk of progression to severe disease.02.24.22
Pfizer and BioNTech Receive Positive CHMP Opinion for COVID-19 Vaccine Booster in Adolescents 12 through 17 Years of Age in the European Union
Pfizer Inc. and BioNTech SE today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion on the administration of the companies’ COVID-19 vaccine COMIRNATY® as a booster dose (30ug) at least six months after the second dose in adolescents 12 through 17 years of age.02.11.22
Pfizer and BioNTech Provide Update on Rolling Submission for Emergency Use Authorization of Their COVID-19 Vaccine in Children 6 Months Through 4 Years of Age
Pfizer Inc. and BioNTech SE today announced plans to extend their rolling submission to the U.S. Food and Drug Administration (FDA) seeking to amend the Emergency Use Authorization of the Pfizer-BioNTech COVID-19 Vaccine to include children 6 months through 4 years of age, which had been requested by FDA.02.01.22
Pfizer and BioNTech Initiate Rolling Submission for Emergency Use Authorization of Their COVID-19 Vaccine in Children 6 Months Through 4 Years of Age Following Request From U.S. FDA
Pfizer Inc. and BioNTech SE today announced that following a request from the U.S. Food and Drug Administration (FDA) the companies have initiated a rolling submission seeking to amend the Emergency Use Authorization (EUA) of the Pfizer-BioNTech COVID-19 Vaccine to include children 6 months through 4 years of age (6 months to <5 years of age), in response to the urgent public health need in this population.01.27.22
Pfizer Receives CHMP Positive Opinion for Novel COVID-19 Oral Treatment
Pfizer Inc. announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion recommending the conditional marketing authorization (CMA) of Pfizer’s PAXLOVID™ (nirmatrelvir [PF-07321332] tablets and ritonavir tablets) for the treatment of COVID-19 in adults who do not require supplemental oxygen and who are at increased risk for progressing to severe COVID-19.01.25.22
Pfizer and BioNTech Initiate Study to Evaluate Omicron-Based COVID-19 Vaccine in Adults 18 to 55 Years of Age
Pfizer Inc. and BioNTech SE today announced the initiation of a clinical study to evaluate the safety, tolerability and immunogenicity of an Omicron-based vaccine candidate in healthy adults 18 through 55 years of age.01.24.22
Pfizer and BioNTech Publish Data from Two Laboratory Studies on COVID-19 Vaccine-induced Antibodies Ability to Neutralize SARS-CoV-2 Omicron Variant
Pfizer Inc. and BioNTech SE today announced the publication of new results from two laboratory studies demonstrating that three doses of the Pfizer-BioNTech COVID-19 Vaccine (BNT162b2) elicited antibodies that neutralize the Omicron variant (B.1.1.529).01.18.22
Pfizer Shares In Vitro Efficacy of Novel COVID-19 Oral Treatment Against Omicron Variant
Pfizer Inc. today shared results from multiple studies demonstrating that the in vitro efficacy of nirmatrelvir, the active main protease (Mpro) inhibitor of PAXLOVID™ (nirmatrelvir [PF-07321332] tablets and ritonavir tablets), is maintained against the SARS-CoV-2 variant Omicron.01.12.22
Positive Top-Line Results of Pfizer’s Phase 3 Study Exploring Coadministration of PREVNAR 20™ With Pfizer-BioNTech COVID-19 Vaccine in Older Adults Released
Pfizer Inc. today announced positive top-line results from a Phase 3 study (B74710126) describing the safety and immunogenicity of PREVNAR 20™ (Pneumococcal 20-valent Conjugate Vaccine) in 570 adults in the United States 65 years of age or older when administered at the same time as the Pfizer-BioNTech COVID-19 Vaccine or when each vaccine was given with placebo.01.04.22
Pfizer to Provide U.S. Government with an Additional 10 Million Treatment Courses of its Oral Therapy to Help Combat COVID-19
Pfizer Inc. announced that the U.S. government has committed to purchasing an additional 10 million treatment courses of its COVID-19 oral therapy, PAXLOVID™ (nirmatrelvir [PF-07321332] tablets and ritonavir tablets).01.03.22
Pfizer and BioNTech Receive U.S. FDA Emergency Use Authorization of COVID-19 Vaccine Booster for Individuals 12 Years of Age and Older
Pfizer Inc. and BioNTech SE today announced that the U.S. Food and Drug Administration (FDA) has expanded the Emergency Use Authorization (EUA) of a booster dose of the Pfizer-BioNTech COVID-19 Vaccine to include individuals 12 years of age and older.12.23.21
Pfizer and BioNTech Submit Updated Longer-Term Follow-Up Data of COMIRNATY® in Adolescents 12 Through 15 Years of Age to EMA
Pfizer Inc. and BioNTech SE today announced that they have submitted longer-term follow-up data from the companies’ pivotal Phase 3 clinical trial in 2,228 individuals 12 through 15 years of age to the European Medicines Agency (EMA) to further support the favorable safety and efficacy profile of COMIRNATY® (COVID-19 mRNA vaccine) in this age group.12.22.21
Pfizer Receives U.S. FDA Emergency Use Authorization for Novel COVID-19 Oral Antiviral Treatment
Pfizer Inc. announced today that the U.S. Food and Drug Administration (FDA) has authorized the emergency use of PAXLOVID™ (nirmatrelvir [PF-07321332] tablets and ritonavir tablets) for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg [88 lbs]) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death.12.22.21
Pfizer to Provide the United Kingdom an Additional 2.5 Million Treatment Courses of Investigational Oral Antiviral Candidate to Help Combat COVID-19
Pfizer Inc. announced an additional agreement with the United Kingdom (UK) government to supply an additional 2.5 million treatment courses of its investigational candidate PAXLOVID™ (nirmatrelvir [PF-07321332] tablets and ritonavir tablets), subject to local authorization.12.20.21
Pfizer and BioNTech to Provide European Union More Than 200 Million Additional Doses of COMIRNATY® to Help Meet Continued Need for Vaccine Supply
Pfizer Inc. and BioNTech SE today announced an agreement has been reached with the European Commission (EC) and its member states to exercise an option to purchase more than 200 million additional doses of COMIRNATY®, the companies’ COVID-19 vaccine.12.17.21
Pfizer and BioNTech Provide Update on Ongoing Studies of COVID-19 Vaccine
Pfizer Inc. and BioNTech SE today shared that following a routine review by the external independent Data Monitoring Committee (DMC), the companies will amend the clinical study evaluating the safety, tolerability, and immunogenicity of the Pfizer-BioNTech COVID-19 Vaccine in children 6 months to under 5 years of age.12.16.21
Pfizer and BioNTech Submit Supplemental Biologics License Application for U.S. FDA Approval of COMIRNATY® in Adolescents 12 Through 15 Years of Age
Pfizer Inc. and BioNTech SE today announced they have submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) to expand the approval of COMIRNATY® (COVID-19 Vaccine, mRNA) to include individuals ages 12 through 15 years.12.16.21
EMA Issues Advice for Potential Early Use of Pfizer’s Novel COVID-19 Oral Antiviral Candidate
Pfizer Inc. announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued advice on the use of PAXLOVID™ (nirmatrelvir [PF-07321332] tablets and ritonavir tablets), stating that PAXLOVID can be used to treat adults with COVID-19 who do not require supplemental oxygen and who are at increased risk of progressing to severe disease.12.14.21
Pfizer Announces Additional Phase 2/3 Study Results Confirming Robust Efficacy of Novel COVID-19 Oral Antiviral Treatment Candidate in Reducing Risk of Hospitalization or Death
Pfizer Inc. today announced final results from an analysis of all 2,246 adults enrolled in its Phase 2/3 EPIC-HR (Evaluation of Protease Inhibition for COVID-19 in High-Risk Patients) trial of its novel COVID-19 oral antiviral candidate PAXLOVID™ (nirmatrelvir [PF-07321332] tablets and ritonavir tablets).12.09.21
Pfizer and BioNTech Receive U.S. FDA Emergency Use Authorization of COVID-19 Vaccine Booster for Individuals 16 Years and Older
Pfizer Inc. and BioNTech SE today announced that the U.S. Food and Drug Administration (FDA) has expanded the Emergency Use Authorization (EUA) of a booster dose of the Pfizer-BioNTech COVID-19 Vaccine to include individuals 16 years of age and older.12.08.21
Pfizer and BioNTech Provide Update on Omicron Variant
Pfizer Inc. and BioNTech SE today announced results from an initial laboratory study demonstrating that serum antibodies induced by the Pfizer-BioNTech COVID-19 Vaccine (BNT162b2) neutralize the SARS-CoV-2 Omicron variant after three doses.12.07.21
Pfizer Invites Public to Register for Webcast of Analyst and Investor Call to Discuss Pfizer-BioNTech COVID-19 Vaccine and Pfizer’s Novel COVID-19 Oral Antiviral Treatment Candidate
Pfizer Inc. invites investors and the general public to access a live webcast of a presentation and conference call with investment analysts at 8:30 a.m. EST on Friday, December 17, 2021.11.25.21
Pfizer And BioNTech Receive Positive CHMP Opinion For COMIRNATY® In Children 5 To <12 Years Of Age In The European Union
Pfizer Inc. and BioNTech SE today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion on the administration of the companies’ COVID-19 vaccine COMIRNATY® in children 5 to under 12 years of age.11.22.21
Follow-Up Data From Phase 3 Trial of Pfizer-BioNTech COVID-19 Vaccine Support Safety and High Efficacy in Adolescents 12 Through 15 Years of Age
Pfizer Inc. and BioNTech SE today announced topline results from a longer-term analysis of the safety and efficacy of their COVID-19 vaccine in individuals 12 through 15 years of age.11.19.21
Pfizer And BioNTech To Provide Support As A COVID-19 Vaccine Donor To Olympic And Paralympic Athletes And Delegations
Together, Pfizer and BioNTech have pledged to donate doses of the Pfizer-BioNTech COVID-19 Vaccine for the benefit of interested Games participants from National Olympic and Paralympic Committees around the world, as well as other stakeholders of the Olympic Movement with key responsibilities for the delivery of the Games.11.19.21
Pfizer and BioNTech Receive Expanded U.S. FDA Emergency Use Authorization of COVID-19 Vaccine Booster to Include Individuals 18 and Older
Pfizer Inc. and BioNTech SE today announced that the U.S. Food and Drug Administration (FDA) has expanded the emergency use authorization (EUA) of a booster dose of the Pfizer-BioNTech COVID-19 Vaccine to include individuals 18 years of age and older.11.18.21
Pfizer to Provide U.S. Government with 10 Million Treatment Courses of Investigational Oral Antiviral Candidate to Help Combat COVID-19
Pfizer Inc. today announced an agreement with the U.S. government to supply 10 million treatment courses of its investigational COVID-19 oral antiviral candidate, PAXLOVID™ (PF-07321332; ritonavir), subject to regulatory authorization from the U.S. Food and Drug Administration (FDA).11.16.21
Pfizer Seeks Emergency Use Authorization for Novel COVID-19 Oral Antiviral Candidate
Pfizer Inc. today announced it is seeking Emergency Use Authorization (EUA) of its investigational oral antiviral candidate, PAXLOVID™ (PF-07321332; ritonavir), for the treatment of mild to moderate COVID-19 in patients at increased risk of hospitalizations or death.11.16.21
Pfizer and The Medicines Patent Pool (MPP) Sign Licensing Agreement for COVID-19 Oral Antiviral Treatment Candidate to Expand Access in Low- and Middle-Income Countries
Pfizer Inc. and the Medicines Patent Pool (MPP), a United Nations-backed public health organization working to increase access to life-saving medicines for low- and middle-income countries, today announced the signing of a voluntary license agreement for Pfizer’s COVID-19 oral antiviral treatment candidate PF-07321332, which is administered in combination with low dose ritonavir (PF-07321332; ritonavir).11.11.21
Zipline, Pfizer and BioNTech Collaboration Paves the Way for Automated, On-Demand Delivery of First mRNA COVID-19 Vaccines in Ghana
Zipline, the global leader in instant logistics, Pfizer Inc. and BioNTech SE today announced that Zipline has successfully completed the first long-range drone delivery of both authorized mRNA COVID-19 vaccines requiring ultra-cold-chain in Ghana.11.05.21
Pfizer’s Novel COVID-19 Oral Antiviral Treatment Candidate Reduced Risk of Hospitalization or Death by 89% in Interim Analysis of Phase 2/3 EPIC-HR Study
Pfizer Inc. today announced its investigational novel COVID-19 oral antiviral candidate,PAXLOVID™, significantly reduced hospitalization and death, based on an interim analysis of the Phase 2/3 EPIC-HR (Evaluation of Protease Inhibition for COVID-19 in High-Risk Patients) randomized, double-blind study of non-hospitalized adult patients with COVID-19, who are at high risk of progressing to severe illness.10.29.21
Pfizer and BioNTech Receive First U.S. FDA Emergency Use Authorization of a COVID-19 Vaccine in Children Ages 5 Through 11 Years
Pfizer Inc. and BioNTech SE today announced that the U.S. Food and Drug Administration (FDA) has authorized for emergency use the Pfizer-BioNTech COVID-19 Vaccine for children 5 through 11 years of age (also referred to as 5 to <12 years).10.28.21
Pfizer and BioNTech to Provide U.S. Government an Additional 50 Million Pediatric Doses of COVID-19 Vaccine to Support Further Preparedness for Future Needs
Pfizer Inc. and BioNTech SE today announced that the U.S. government has purchased 50 million more doses of the companies’ COVID-19 vaccine.10.26.21
FDA Advisory Committee Votes in Favor of Granting Emergency Use Authorization for the Pfizer-BioNTech COVID-19 Vaccine in Children 5 to <12 Years
Pfizer Inc. and BioNTech SE today announced that the U.S. Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted 17 to 0, with 1 abstention, to recommend the FDA grant Emergency Use Authorization (EUA) for the companies’ COVID-19 vaccine in children 5 to <12 years of age.10.21.21
Pfizer and BioNTech Announce Phase 3 Trial Data Showing High Efficacy of a Booster Dose of Their COVID-19 Vaccine
Pfizer Inc. and BioNTech SE today announced topline results from a Phase 3 randomized, controlled trial evaluating the efficacy and safety of a 30-µg booster dose of the Pfizer-BioNTech COVID-19 Vaccine in more than 10,000 individuals 16 years of age and older.10.18.21
New Formulation of COMIRNATY® Receives Positive Opinion from CHMP
Pfizer Inc. and BioNTech SE today announced that the European Medicines Agency’s (EMA) Committee for Human Medicinal Products (CHMP) issued a positive opinion for a new formulation of COMIRNATY® (COVID-19 vaccine, mRNA).10.15.21
Pfizer and BioNTech Submit Data to EMA for the Vaccination of Children 5 to <12 Years of Age with COMIRNATY®
Pfizer Inc. and BioNTech SE today announced that they submitted data supporting the vaccination of children 5 to <12 years of age with COMIRNATY® (COVID-19 mRNA vaccine) to the European Medicines Agency (EMA) for a variation of the EU Conditional Marketing Authorization (CMA).10.04.21
Pfizer and BioNTech Receive CHMP Positive Opinion for COVID-19 Vaccine Booster in the European Union
Pfizer Inc. and BioNTech SE today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion on the administration of the companies’ COVID-19 vaccine as a booster dose at least six months after the second dose in individuals 18 years of age and older.09.28.21
Pfizer and BioNTech Submit Initial Data to U.S. FDA From Pivotal Trial of COVID-19 Vaccine in Children 5 to <12 Years of Age
Pfizer Inc. and BioNTech SE announced they have submitted data to the U.S. Food and Drug Administration (FDA) from the Phase 2/3 trial of their COVID-19 vaccine in children 5 to <12 years of age.09.27.21
Pfizer Starts Global Phase 2/3 EPIC-PEP Study of Novel COVID-19 Oral Antiviral Candidate for Post-Exposure Prophylaxis in Adults
Pfizer Inc. today announced the start of the Phase 2/3 EPIC-PEP (Evaluation of Protease Inhibition for COVID-19 in Post-Exposure Prophylaxis) study to evaluate the investigational novel oral antiviral candidate PF-07321332, co-administered with a low dose of ritonavir, for the prevention of COVID-19 infection.09.22.21
Pfizer and BioNTech Receive First U.S. FDA Emergency Use Authorization of a COVID-19 Vaccine Booster
Pfizer Inc. and BioNTech SE today announced that the U.S. Food and Drug Administration (FDA) has authorized for emergency use a booster dose of the Pfizer-BioNTech COVID-19 Vaccine for individuals 65 years of age and older, individuals 18 through 64 years of age at high risk of severe COVID-19, and individuals 18 through 64 years of age whose frequent institutional or occupational exposure to SARS-CoV-2 puts them at high risk of serious complications of COVID-19 including severe COVID-19.09.22.21
Pfizer and BioNTech Expand Collaboration with U.S. to Provide 500 Million Additional COVID-19 Vaccine Doses at Not-for-Profit Price for Donation to Poorest Countries
Pfizer Inc. and BioNTech SE today announced plans to expand their agreement with the U.S. government by providing an additional 500 million doses of the companies’ COVID-19 vaccine at a not-for-profit price for donation to low- and lower-middle-income countries and the organizations that support them.09.20.21
Pfizer and BioNTech Announce Positive Topline Results From Pivotal Trial of COVID-19 Vaccine in Children 5 to 11 Years
Pfizer Inc. and BioNTech SE today announced results from a Phase 2/3 trial showing a favorable safety profile and robust neutralizing antibody responses in children 5 to 11 years of age using a two-dose regimen of 10 µg administered 21 days apart, a smaller dose than the 30 µg dose used for people 12 and older.09.17.21
FDA Advisory Committee Votes Unanimously in Favor Of COMIRNATY® Booster for Emergency Use in People 65 and Older and Certain High-risk Populations
Pfizer Inc. and BioNTech SE announced today that the U.S. Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted unanimously to recommend the FDA grant Emergency Use Authorization (EUA) for a booster dose of COMIRNATY® (COVID-19 Vaccine, mRNA) in individuals 65 years of age and older and individuals at high risk of severe COVID-19.09.08.21
Our Firsts: Marking the Milestones in The Relentless Fight Against COVID-19 (PDF)
From the beginning of the global COVID-19 pandemic, Pfizer and BioNTech have been relentless in our mission to fight this deadly disease. As we continue to achieve critical milestones with our COVID-19 vaccine, we thank the colleagues, researchers, clinical trial partners, participants, and their families, who have made each of these significant moments possible.09.06.21
Pfizer and BioNTech Submit a Variation to EMA with the Data in Support of a Booster Dose of COMIRNATY®
Pfizer Inc. and BioNTech SE today announced that they submitted a variation to the European Medicines Agency (EMA) requesting to update the Conditional Marketing Authorization (CMA) with data supporting a booster (third) dose of COMIRNATY® (COVID-19 vaccine, mRNA) to prevent COVID-19 in individuals 16 years of age and older.09.01.21
First Participant Dosed in Phase 2/3 Study of Oral Antiviral Candidate in Non-Hospitalized Adults with COVID-19 Who Are at Low Risk of Severe Illness
Pfizer Inc. today shared that the first participant has been dosed in a pivotal Phase 2/3 clinical trial to evaluate the safety and efficacy of PF-07321332 – an investigational orally administered protease inhibitor antiviral therapy designed specifically to combat COVID-19 – in non-hospitalized, symptomatic adult participants who have a confirmed diagnosis of SARS-CoV-2 infection and are not at increased risk of progressing to severe illness, which may lead to hospitalization or death.08.26.21
Pfizer and BioNTech Announce Collaboration With Brazil’s Eurofarma to Manufacture COVID-19 Vaccine Doses for Latin America
Pfizer Inc. and BioNTech SE today announced the signing of a letter of intent with Eurofarma Laboratórios SA, a Brazilian biopharmaceutical company, to manufacture COMIRNATY® (COVID-19 Vaccine, mRNA) for distribution within Latin America.08.25.21
Pfizer and BioNTech Initiate Rolling Submission of Supplemental Biologics License Application to U.S. FDA for Booster Dose of COMIRNATY® in Individuals 16 and Older
Pfizer Inc. and BioNTech SE today announced the initiation of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for the approval of a booster (third) dose of COMIRNATY® (COVID-19 Vaccine, mRNA) to prevent COVID-19 in individuals 16 years of age and older.08.23.21
Pfizer-BioNTech COVID-19 Vaccine COMIRNATY® Receives Full U.S. FDA Approval for Individuals 16 Years and Older
Pfizer Inc. and BioNTech SE today announced that the U.S. Food and Drug Administration (FDA) approved the Biologics License Application (BLA) for COMIRNATY® (COVID-19 Vaccine, mRNA) to prevent COVID-19 in individuals 16 years of age and older.08.16.21
Pfizer and BioNTech Announce Submission of Initial Data to U.S. FDA to Support Booster Dose of COVID-19 Vaccine
Pfizer Inc. and BioNTech SE today announced that they have submitted Phase 1 data to the U.S. Food and Drug Administration (FDA) to support the evaluation of a third, or booster, dose of the companies’ COVID-19 vaccine (BNT162b2) for future licensure.07.28.21
Pfizer and BioNTech Share Detailed Update to the Results from 6 Month Safety and Efficacy Data Analysis of Landmark COVID-19 Vaccine Study
Pfizer Inc. and BioNTech SE today shared the detailed six-month follow-up results from the Landmark Phase 3 study of the safety and efficacy of the Pfizer-BioNTech COVID-19 vaccine (BNT162b2) on the preprint server medRxiv and have submitted the manuscript to a peer-reviewed publication.07.23.21
Pfizer and BioNTech to Provide U.S. Government with an Additional 200 Million Doses of COVID-19 Vaccine to Help Meet Continued Need for Vaccine Supply in the U.S.
Pfizer Inc. and BioNTech SE today announced that the U.S. government has purchased an additional 200 million doses of the Pfizer-BioNTech COVID-19 Vaccine.07.21.21
Pfizer and BioNTech Announce Collaboration With Biovac to Manufacture and Distribute COVID-19 Vaccine Doses Within Africa
Pfizer Inc. and BioNTech SE today announced the signing of a letter of intent with The Biovac Institute (Pty) Ltd, known as “Biovac,” a Cape Town-based, South African biopharmaceutical company, to manufacture the Pfizer-BioNTech COVID-19 Vaccine for distribution within the African Union.07.16.21
U.S. FDA Grants Priority Review for the Biologics License Application for Pfizer-BioNTech COVID-19 Vaccine
Pfizer Inc. and BioNTech SE today announced that the U.S. Food and Drug Administration (FDA) granted Priority Review designation for the Biologics License Application (BLA) for their mRNA vaccine to prevent COVID-19 in individuals 16 years of age and older.07.08.21
Pfizer and BioNTech Provide Update on Booster Program in Light of the Delta-Variant
As part of Pfizer’s and BioNTech’s continued efforts to stay ahead of the virus causing COVID-19 and circulating mutations, the companies are providing an update on their comprehensive booster strategy.06.16.21
Data Published in New England Journal of Medicine Shows Pfizer’s Tofacitinib Meets Primary Endpoint in Brazilian Study in Patients Hospitalized with COVID-19 Pneumonia
Pfizer Inc. and The Academic Research Organization (ARO) from the Hospital Israelita Albert Einstein today announced that the New England Journal of Medicine has published positive findings from the STOP-COVID study (NCT04469114) evaluating the efficacy and safety of oral Janus kinase (JAK) inhibitor tofacitinib in 289 hospitalized adult patients with COVID-19 pneumonia who were not on ventilation.06.10.21
Pfizer and BioNTech to Provide 500 Million Doses of COVID-19 Vaccine to U.S. Government for Donation to Poorest Nations
Pfizer Inc. and BioNTech SE today announced plans to provide the U.S. government at a not-for-profit price 500 million doses of the companies’ COVID-19 vaccine, 200 million doses in 2021 and 300 million doses in the first half of 2022, to further support the multilateral efforts to address the surge of infection in many parts of the world and to help end the pandemic.05.28.21
Pfizer and BioNTech Receive First Authorization in European Union for COVID-19 Vaccine in Adolescents
Pfizer Inc. and BioNTech SE today announced that the Conditional Marketing Authorization (CMA) for COMIRNATY® in the European Union (EU) has been expanded to include individuals 12 to 15 years of age.05.24.21
Pfizer Initiates Study Exploring Coadministration of Its 20-valent Pneumococcal Conjugate Vaccine Candidate Along With a Third Dose of the Pfizer-BioNTech COVID-19 Vaccine in Older Adults
Pfizer Inc. today announced that the first enrolled subjects have received their immunizations as part of a new study in adults ages 65 or older exploring the coadministration of the company’s 20-valent pneumococcal conjugate vaccine (20vPnC) candidate following a booster dose of the Pfizer-BioNTech COVID-19 Vaccine, currently authorized by the Food and Drug Administration (FDA) under an Emergency Use Authorization (EUA).05.20.21
Pfizer and BioNTech to Supply the European Union With up to 1.8 Billion Additional Doses of COMIRNATY®
Pfizer Inc. and BioNTech SE today announced a new agreement with the European Commission (EC) to supply 900 million doses of COMIRNATY®, the companies’ COVID-19 vaccine, to the European Union (EU), with an option for the EC to request up to an additional 900 million doses.05.10.21
Pfizer and BioNTech Receive First U.S. Authorization for Emergency Use of COVID-19 Vaccine in Adolescents
Pfizer Inc. and BioNTech SE announced today that the U.S. Food and Drug Administration (FDA) has expanded the Emergency Use Authorization (EUA) for their COVID-19 vaccine to include individuals 12 to 15 years of age.05.07.21
Pfizer and BioNTech Initiate Rolling Submission of Biologics License Application for U.S. FDA Approval of Their COVID 19 Vaccine
Pfizer Inc. and BioNTech SE today announced the initiation of a Biologics License Application (BLA) with the U.S. Food and Drug Administration (FDA) for approval of their mRNA vaccine to prevent COVID-19 in individuals 16 years of age and older.05.06.21
Pfizer and BioNTech to Provide COVID-19 Vaccine Doses for Olympic Athletes at the 2020 Tokyo Games
Pfizer Inc. and BioNTech SE today announced the signing of a Memorandum of Understanding (MoU) with the International Olympic Committee (IOC) to donate doses of the companies’ COVID-19 Vaccine to help vaccinate athletes, and their delegations, participating in the Olympic and Paralympic Games Tokyo 2020, which are scheduled to begin on July 23, 2021.04.19.21
Pfizer and BioNTech to Supply the European Union with 100 Million Additional Doses of COMIRNATY®
Pfizer Inc. and BioNTech SE today announced they will supply an additional 100 million doses of COMIRNATY®, the companies’ COVID-19 vaccine, to the 27 European Union (EU) member states in 2021.04.09.21
Pfizer and BioNTech Request Regulatory Agencies Expand Emergency Use of Their COVID-19 Vaccine to Adolescents
Pfizer Inc. and BioNTech SE today requested amendments to the U.S. Emergency Use Authorization (EUA) of the Pfizer-BioNTech Vaccine (BNT162b2) to expand the use in adolescents 12 to 15 years of age.04.01.21
Pfizer and BioNTech Confirm High Efficacy and No Serious Safety Concerns Through Up to Six Months Following Second Dose in Updated Topline Analysis of Landmark COVID-19 Vaccine Study
Pfizer Inc. and BioNTech SE today announced updated topline results from analysis of 927 confirmed symptomatic cases of COVID-19 observed in their pivotal Phase 3 study through March 13, 2021, showing the Pfizer-BioNTech COVID-19 vaccine, BNT162b2, was 91.3% effective against COVID-19, measured seven days through up to six months after the second dose.03.31.21
Pfizer-BioNTech Announce Positive Topline Results of Pivotal COVID-19 Vaccine Study in Adolescents
Pfizer Inc. and BioNTech SE today announced that, in a Phase 3 trial in adolescents 12 to 15 years of age with or without prior evidence of SARS-CoV-2 infection, the Pfizer-BioNTech COVID-19 vaccine BNT162b2 demonstrated 100% efficacy and robust antibody responses, exceeding those recorded earlier in vaccinated participants aged 16 to 25 years old, and was well tolerated.03.26.21
EMA Approves New Storage Option for Pfizer-BioNTech Vaccine, Easing Distribution and Storage of Doses Across European Union
Pfizer Inc. and BioNTech SE announced today that the European Medicines Agency (EMA) approved storage of COMIRNATY® at -25°C to -15°C for a total of two weeks based on data showing the stability at these temperatures in standard pharmaceutical freezers.03.23.21
Pfizer Initiates Phase 1 Study of Novel Oral Antiviral Therapeutic Agent Against SARS-CoV-2
Pfizer Inc. announced today that it is progressing to multiple ascending doses after completing the dosing of single ascending doses in a Phase 1 study in healthy adults to evaluate the safety and tolerability of an investigational, novel oral antiviral therapeutic for SARS-CoV-2, the virus that causes COVID-19.03.11.21
Real-World Evidence Confirms High Effectiveness of Pfizer-BioNTech COVID-19 Vaccine and Profound Public Health Impact of Vaccination One Year After Pandemic Declared
Pfizer Inc. and BioNTech SE today announced real-world evidence demonstrating dramatically lower incidence rates of COVID-19 disease in individuals fully vaccinated with the Pfizer-BioNTech COVID-19 Vaccine (BNT162b2), underscoring the observed substantial public health impact of Israel’s nationwide immunization program.03.03.21
Pfizer-BioNTech’s COVID-19 Vaccine Arrives in Rwanda
Pfizer and BioNTech, in partnership with UNICEF, today announced the arrival of the first doses of their COVID19 Vaccine in Rwanda through the COVAX Facility.02.25.21
Pfizer and BioNTech Initiate a Study as Part of Broad Development Plan to Evaluate COVID-19 Booster and New Vaccine Variants
Pfizer Inc. and BioNTech SE announced today they have begun an evaluation of the safety and immunogenicity of a third dose of the Pfizer-BioNTech COVID-19 vaccine (BNT162b2) to understand the effect of a booster on immunity against COVID-19 caused by the circulating and potential newly emerging SARS-CoV-2 variants.02.19.21
Pfizer and BioNTech Submit COVID-19 Vaccine Stability Data at Standard Freezer Temperature to the U.S. FDA
Pfizer Inc. and BioNTech SE today announced the submission of new data to the U.S. Food and Drug Administration (FDA) demonstrating the stability of their COVID-19 vaccine when stored at -25°C to -15°C (-13°F to 5°F), temperatures more commonly found in pharmaceutical freezers and refrigerators.02.19.21
President Biden Visits Pfizer’s Kalamazoo Manufacturing Facility
Today President Biden visited Pfizer’s Kalamazoo, MI facility, the largest manufacturing site in Pfizer’s network and the largest employer in the city of Kalamazoo.02.18.21
Pfizer and BioNTech Commence Global Clinical Trial to Evaluate COVID-19 Vaccine in Pregnant Women
Pfizer Inc. and BioNTech SE announced today that the first participants have been dosed in a global Phase 2/3 study to further evaluate the safety, tolerability, and immunogenicity of the Pfizer-BioNTech COVID-19 vaccine(BNT162b2) in preventing COVID-19 in healthy pregnant women 18 years of age and older.02.17.21
Pfizer and BioNTech to Supply the European Union with 200 Million Additional Doses of COMIRNATY®
Pfizer Inc. and BioNTech SE today announced an agreement with the European Commission (EC) to supply an additional 200 million doses of COMIRNATY®, the companies’ COVID-19 Vaccine, to the 27 European Union (EU) member states. The EC has the option to request supply of an additional 100 million doses.02.17.21
In Vitro Study Published in The New England Journal of Medicine Demonstrates Sera from Individuals Immunized with the Pfizer- BioNTech COVID-19 Vaccine Neutralize SARS-CoV-2 with South African Variant Spike Mutations
Pfizer Inc. and BioNTech SE today announced results from an in vitro study that provides additional data on the capability of sera from individuals immunized with the Pfizer-BioNTech COVID-19 vaccine (BNT162b2) to neutralize SARS-CoV-2 with the South African variant spike protein.02.12.21
Pfizer and BioNTech to Supply the United States with 100 Million Additional Doses of COVID-19 Vaccine
Pfizer Inc. and BioNTech SE today announced that the U.S. government has exercised its option for an additional 100 million doses of the Pfizer-BioNTech COVID-19 Vaccine. This brings the total number of doses to be supplied by the companies to the U.S. government to 300 million.02.08.21
Pfizer and BioNTech Publish Data from In Vitro Studies in Nature Medicine Demonstrating COVID-19 Vaccine Elicits Antibodies that Neutralize SARS-CoV-2 with Key Mutations Present in U.K. and South African Variants
Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced the publication in Nature Medicine of data from in vitro studies that demonstrate that sera from individuals vaccinated with the PfizerBioNTech COVID-19 vaccine neutralize SARS-CoV-2 with key mutations present in the United Kingdom (U.K.) and South African variants.02.01.21
Pfizer and BioNTech Publish Preclinical Data from Investigational COVID-19 Vaccine Program in Nature
Pfizer Inc. and BioNTech SE today announced that preclinical data in non-human primate and mouse models from Pfizer and BioNTech’s mRNA-based vaccine candidates, BNT162b1 and BNT162b2, for the prevention of COVID-19 were published in the journal Nature. Some of these data were initially made available to the public on September 9, 2020 via the online preprint server, bioRxiv.01.29.21
Pfizer and BioNTech Publish Data on COVID-19 Vaccine-Induced Antibodies’ Ability to Neutralize SARS-CoV-2 U.K.Strain Pseudovirus in Cell Culture in Science
Pfizer Inc. and BioNTech SE today announced that data from an in vitro study on the capability of sera from individuals immunized with the Pfizer-BioNTech COVID-19 vaccine BNT162b2 to neutralize a pseudovirus bearing the SARS-CoV-2 U.K. variant, also known as B.1.1.7 lineage, were published in the journal Science.01.27.21
In Vitro Studies Demonstrate Pfizer and BioNTech COVID-19 Vaccine Elicits Antibodies that Neutralize SARS-CoV-2 with Key Mutations Present in U.K. and South African Variants
Pfizer Inc. and BioNTech SE announced results from in vitro neutralization studies of sera from individuals vaccinated with the Pfizer-BioNTech COVID-19 vaccine.01.22.21
Pfizer and BioNTech Reach Agreement with COVAX for Advance Purchase of Vaccine to Help Combat COVID-19
Pfizer and BioNTech SE today announced an advance purchase agreement with COVAX for up to 40 million doses of the Pfizer-BioNTech COVID-19 Vaccine.01.20.21
Pfizer and BioNTech Publish Results of Study Showing COVID-19 Vaccine Elicits Antibodies that Neutralize Pseudovirus Bearing the SARS-CoV-2 U.K. Strain Spike Protein in Cell Culture
Today, Pfizer Inc. and BioNTech SE announced results f rom an in vitro study that provides additional data on the capability of sera from individuals immunized with the Pfizer-BioNTech COVID-19 vaccine, BNT162b2, to neutralize the SARS-CoV-2 U.K. strain, also known as B.1.1.7 lineage or VOC 202012/01.01.08.21
An In Vitro Study Shows Pfizer-BioNTech COVID-19 Vaccine Elicits Antibodies that Neutralize SARS-CoV-2 with a Mutation Associated with Rapid Transmission
Pfizer Inc. and BioNTech SE today announced results from an in vitro study conducted by Pfizer and the University of Texas Medical Branch (UTMB) that shows the antibodies from people who have received the Pfizer-BioNTech COVID-19 vaccine effectively neutralize SARS-CoV-2 with a key mutation that is also found in two highly transmissible strains.12.29.20
Pfizer and BioNTech to Supply the European Union with 100 Million Additional Doses of COMIRNATY®
Pfizer Inc. and BioNTech SE today announced they will supply an additional 100 million doses of COMIRNATY®, the companies’ COVID-19 Vaccine, to the 27 European Union (EU) member states in 2021.12.23.20
Pfizer and BioNTech to Supply the U.S. with 100 Million Additional Doses of COVID-19 Vaccine
Pfizer Inc. and BioNTech SE today announced a second agreement with the U.S. government to supply an additional 100 million doses of the companies’ COVID-19 Vaccine from production facilities in the U.S.12.21.20
Pfizer and BioNTech Receive Authorization in the European Union for COVID-19 Vaccine
Pfizer Inc. and BioNTech SE announced today that the European Commission (EC) has granted a conditional marketing authorization (CMA) to Pfizer and BioNTech for COMIRNATY® (also known as BNT162b2), for active immunization to prevent COVID-19 caused by SARS-CoV-2 virus, in individuals 16 years of age and older.12.21.20
Pfizer and BioNTech Receive CHMP Positive Opinion for their COVID-19 Vaccine
Pfizer Inc. and BioNTech SE announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion to recommend the conditional marketing authorization (CMA) of the Pfizer-BioNTech COVID-19 Vaccine (also known as BNT162b2), for active immunization to prevent COVID-19 caused by SARS-CoV-2 virus, in individuals 16 years of age and older.12.17.20
Pfizer Update on COVID-19 Vaccine Distribution
Pfizer Inc. (NYSE: PFE) today released the following statement to address public comments that allege there are issues in the production and distribution of the company’s COVID-19 vaccine12.14.20
Pfizer and BioNTech Provide Data from German Phase 1/2 Study Further Characterizing Immune Response Following Immunization with Lead COVID-19 Vaccine Candidate BNT162b2
Pfizer Inc. and BioNTech SE today announced additional data on neutralizing antibody and T cell responses from the Phase 1/2 trial with BNT162b2 conducted in Germany.12.12.20
U.S. CDC Committee of Independent Health Experts Recommends Vaccination with Pfizer and BioNTech COVID-19 Vaccine for Persons Ages 16 Years and Older
Pfizer and BioNTech announced today that the U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) voted today to recommend the use of the Pfizer-BioNTech COVID-19 vaccine in people 16 years of age and older under the Emergency Use Authorization (EUA) issued by the U.S. Food and Drug Administration (FDA).12.11.20
Pfizer and BioNTech Celebrate Historic First Authorization in the U.S. of Vaccine to Prevent COVID-19
Pfizer and BioNTech announced today that the U.S. Food and Drug Administration (FDA) has authorized the emergency use of the mRNA vaccine, BNT162b2, against COVID-19 in individuals 16 years of age or older.12.10.20
Pfizer and BioNTech Receive FDA Advisory Committee Vote Supporting Potential First Emergency Use Authorization for Vaccine to Combat COVID-19 in the U.S.
Pfizer Inc. and BioNTech SE announced today that the U.S. Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted 17 to 4 in support of the FDA granting Emergency Use Authorization (EUA) for the companies’ COVID-19 mRNA vaccine (BNT162b2).12.10.20
Pfizer and BioNTech Announce Publication of Results from Landmark Phase 3 Trial of BNT162b2 COVID-19 Vaccine Candidate in The New England Journal of Medicine
Pfizer Inc. and BioNTech SE today announced that the New England Journal of Medicine has published safety and final efficacy results from the pivotal Phase 3 trial of BNT162b2, their mRNA-based COVID-19 vaccine candidate.12.02.20
Pfizer and BioNTech Achieve First Authorization in the World for a Vaccine to Combat COVID-19
Pfizer Inc. and BioNTech SE announced today that the Medicines & Healthcare Products Regulatory Agency (MHRA) in the U.K. has granted a temporary authorization for emergency use for their COVID-19 mRNA vaccine (BNT162b2), against COVID-19.11.20.20
Pfizer and BioNTech to Submit Emergency Use Authorization Request Today to the U.S. FDA for COVID-19 Vaccine
Pfizer Inc. and BioNTech SE announced they will submit a request today to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) of their mRNA vaccine candidate, BNT162b2 against SARS-CoV-2, which will potentially enable use of the vaccine in high-risk populations in the U.S. by the middle to end of December 2020.11.18.20
Pfizer and BioNTech Conclude Phase 3 Study of COVID-19 Vaccine Candidate, Meeting All Primary and Secondary Efficacy Endpoints
Pfizer Inc. and BioNTech SE today announced that, after conducting the final efficacy analysis in their ongoing Phase 3 study, their mRNA-based COVID-19 vaccine candidate, BNT162b2, met all of the study’s primary efficacy endpoints.11.16.20
Pfizer Update On Our U.S. COVID-19 Vaccine Candidate Distribution Preparedness
Pfizer (NYSE: PFE) today announced the U.S. COVID-19 Immunization Pilot Program with four states, to help refine the plan for the delivery and deployment of the company’s COVID-19 vaccine candidate that is being co-developed with BioNTech11.09.20
Pfizer and BioNTech Announce Vaccine Candidate Against COVID-19 Achieved Success in First Interim Analysis from Phase 3 Study
Pfizer Inc. and BioNTech SE today announced their mRNA-based vaccine candidate, BNT162b2, against SARS-CoV-2 has demonstrated evidence of efficacy against COVID-19 in participants without prior evidence of SARS-CoV-2 infection, based on the first interim efficacy analysis conducted on November 8, 2020 by an external, independent Data Monitoring Committee (DMC) from the Phase 3 clinical study.10.14.20
Pfizer and BioNTech Announce New England Journal of Medicine Publication of Phase 1 Data on Lead mRNA Vaccine Candidate vBNT162b2 Against COVID-19
Pfizer Inc. and BioNTech SE today announced that preliminary, peer-reviewed data from the Phase 1 portion of their ongoing U.S. study of BNT162b2 were published online in the New England Journal of Medicine (NEJM). BNT162b2, which has advanced into a global Phase 3 study, is part of the companies’ mRNA-based vaccine development program against COVID-19.09.30.20
BioNTech and Pfizer Announce Nature Publication of German Phase 1/2 Study Data from mRNA-based Vaccine Candidate BNT162b1 Against SARS-CoV-2
BioNTech SE and Pfizer Inc. today announced that preliminary, peer-reviewed data from their ongoing German Phase 1/2 Study of BNT162b1 were published online in the journal Nature. B09.12.20
Pfizer and BioNTech Propose Expansion of Pivotal COVID-19 Vaccine Trial09.08.20
Biopharma Leaders Unite To Stand With Science
Nine CEOs sign historic pledge to continue to make the safety and well-being of vaccinated individuals the top priority in development of the first COVID-19 vaccines.08.20.20
Pfizer and BioNTech Share Positive Early Data on Lead mRNA Vaccine Candidate BNT162b2 Against COVID-19
Pfizer Inc. and BioNTech SE today shared additional Phase 1 safety and immunogenicity data from their ongoing U.S. study of the BNT162 mRNA-based vaccine program against SARS-CoV-2, which has advanced into Phase 2/3 evaluation.08.12.20
Pfizer and BioNTech Announce Publication of Peer-Reviewed Data from Ongoing Phase 1/2 study of mRNA-based Vaccine Candidate, BNT162b1, Against SARSCoV-2 in Nature
Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced that preliminary, peer-reviewed data from their BNT162 mRNA-based vaccine development program, Project Lightspeed, against SARS-CoV-2, were published online in the journal Nature.08.07.20
Pfizer Announces Agreement with Gilead to Manufacture Remdesivir for Treatment of COVID-19
Pfizer today announced a multi-year agreement with Gilead Sciences, Inc. to manufacture and supply Gilead’s investigational antiviral remdesivir, as one of multiple external manufacturing organizations supporting efforts to scale up supply of the investigational treatment for COVID-19.08.05.20
Pfizer and BioNTech to Supply Canada with their BNT162 mRNA- Based Vaccine Candidate
Pfizer Canada and BioNTech SE today announced an agreement with the Government of Canada to supply their BNT162 mRNA-based vaccine candidate against SARS-CoV2, subject to clinical success and Health Canada approval.07.31.20
Pfizer and BioNTech to Supply Japan with 120 Million Doses of their BNT162 mRNA-based Vaccine Candidate
Pfizer Inc. and BioNTech SE today announced an agreement with the Ministry of Health, Labour and Welfare (MHLW) in Japan to supply 120 million doses of BNT162 mRNA-based vaccine candidate against SARS-CoV2, subject to clinical success and regulatory approval, beginning in 2021.07.27.20
Pfizer and BioNTech Choose Lead mRNA Vaccine Candidate Against COVID-19 and Commence Pivotal Phase 2/3 Global Study
Pfizer Inc. and BioNTech SE today announced the start of a global (except for China) Phase 2/3 safety and efficacy clinical study to evaluate a single nucleoside-modified messenger RNA (modRNA) candidate from their BNT162 mRNA-based vaccine program against SARS-CoV-2.07.22.20
Pfizer and BioNTech Announce an Agreement with U.S. Government for up to 600 Million Doses of mRNA-based Vaccine Candidate Against SARS-CoV-2
Pfizer Inc. and BioNTech SE today announced the execution of an agreement with the U.S. Department of Health and Human Services and the Department of Defense to meet the U.S. government’s Operation Warp Speed program goal to begin delivering 300 million doses of a vaccine for COVID-19 in 2021.07.20.20
Pfizer and BioNTech Announce Early Positive Update from German Phase 1/2 COVID-19 Vaccine Study, Including First T Cell Response Data
BioNTech SE and Pfizer Inc. today announced initial data from their ongoing German Phase 1/2, open-label, non-randomized, non-placebo-controlled, dose-escalation trial, that is part of the global mRNA-based vaccine program against SARS-CoV-2.07.20.20
Pfizer and BioNTech Announce Agreement with the United Kingdom for 30 Million Doses of mRNA-based Vaccine Candidate against SARS-CoV-2
Pfizer Inc. and BioNTech SE today announced an agreement with the United Kingdom to supply 30 million doses of their BNT162 mRNA-based vaccine candidate against SARS-CoV-2, currently in development, subject to clinical success and regulatory approval.07.13.20
Pfizer and BioNTech Granted FDA Fast Track Designation for Two Investigational mRNA-based Vaccine Candidates Against SARS-CoV-2
Pfizer and BioNTech today announced that two of the companies’ four investigational vaccine candidates from their BNT162 mRNA-based vaccine program (BNT162b1 and BNT162b2) being developed to help protect against SARS-CoV-2 (the virus that causes COVID-19), received Fast Track designation from the U.S. Food and Drug Administration (FDA).07.01.20
Pfizer and BioNTech Announce Early Positive Data from an Ongoing Phase 1/2 study of mRNA-based Vaccine Candidate Against SARS-CoV-2
Pfizer and BioNTech today announced preliminary data from the most advanced of four investigational vaccine candidates from their BNT162 mRNA-based vaccine program, Project Lightspeed, against SARS-CoV-2, the virus causing the current global pandemic05.05.20
Pfizer and BioNTech Dose First Participants in the U.S. as Part of Global COVID-19 mRNA Vaccine Development Program
First participants dosed at NYU Grossman School of Medicine and University of Maryland School of Medicine04.22.20
BioNTech and Pfizer announce regulatory approval from German authority Paul-Ehrlich-Institut to commence first clinical trial of COVID-19 vaccine candidates
The trial is the first clinical trial of a COVID-19 vaccine candidate to start in Germany, and is part of a global development program. Pfizer and BioNTech will also conduct trials for BNT162 in the United States upon regulatory approval, which is expected shortly.04.13.20
COVID-19 Information Update for U.S. Health Care Professionals
We are committed to ensuring public health and safety. You and the patients you serve are critically important to us.04.09.20
Pfizer Advances Battle Against COVID-19 on Multiple Fronts
Researchers and scientists have been relentlessly working to develop an investigational antiviral compound to treat SARS-CoV-2, which causes the current pandemic of coronavirus infections (COVID-19), a vaccine to prevent infection as well as evaluating other therapies that have scientific potential to help infected patients fight the virus.04.09.20
Pfizer and BioNTech Announce Further Details on Collaboration to Accelerate Global COVID-19 Vaccine Development
Pfizer and BioNTech to jointly develop COVID-19 vaccine, initially in the United States and Europe, and scale-up manufacturing capacity to support global supply Potential to supply millions of vaccine doses by the end of 2020 subject to technical success of the development program and approval by regulatory authorities, and then rapidly scale up capacity to produce hundreds of millions of doses in 2021.04.09.20
From Breakthroughs.com: "All Hands on Deck as Scientists Revive SARS Protease Inhibitor to Attempt to Fight COVID-19"
As scientists around the globe race to find ways to treat COVID-19, the fastest approach to finding a treatment may be to repurpose existing drugs in the hopes of avoiding having to start from “square one” on the drug development pathway.04.06.20
Pfizer and The Pfizer Foundation Donate $40 Million in Charitable Grants, Expand Product Access and Mobilize Colleagues to Combat COVID-19 Pandemic
The donation addresses the urgent needs of partners who are working to slow the spread of the virus within communities and strengthen vulnerable healthcare systems against future public health threats.04.03.20
From Breakthroughs.com: "4 Things to Know About the Science of Coronavirus"
Visit Breakthroughs.com to learn more about the basic science of coronaviruses and SARS-CoV-204.01.20
Medical Professionals Across Merck & Co., Inc., Pfizer Inc., and Eli Lilly and Company Activate to Support Health Systems, First Responders and Patients Amid COVID-19 Pandemic
Three leading biopharmaceutical companies have announced programs enabling employees with medical and laboratory expertise to volunteer their services to local healthcare systems and those hardest hit by COVID-19.03.25.20
Pfizer Shares Safety Data on Azithromycin-Hydroxychloroquine Combination
Company Follows Up on Recently Made Commitment as Part of Five-Point Plan03.24.20
From Breakthroughs.com: "Racing to Develop a Potential COVID-19 Vaccine with Unprecedented Partnership"
Visit Breakthroughs.com to read the article.03.24.20
From The Antigen Podcast: "What's Next? Coronavirus, Disease X, Maternal & Adult Immunization"
Visit our "The Antigen" podcast page to listen in.03.18.20
Pfizer Postpones Investor Day Scheduled for March 31, 2020 Due to Coronavirus Concerns
At this point, there isn’t a timetable for rescheduling the event and Pfizer will work within the context of appropriate guidance from health authorities to determine a future date.03.17.20
Pfizer and BioNTech to Co-Develop Potential COVID-19 Vaccine
Companies will jointly develop BioNTech’s mRNA-based vaccine candidate BNT162 to prevent COVID-19 infection.03.14.20
Pfizer's R&D Chief on Why the Healthcare Industry Must Collaborate to Beat COVID-19 Coronavirus
Chief Scientific Officer Mikael Dolsten on why coordination is needed to address the coronavirus outbreak.03.13.20
Pfizer Outlines Five-Point Plan to Battle COVID-19
Chairman and CEO calls on biopharma industry to collaborate on combatting the global pandemic.For additional information about Pfizer, please see our filings with the U.S. Securities and Exchange Commission, including the information provided in the sections captioned “Risk Factors” and “Forward-Looking Information and Factors That May Affect Future Results”.
Peer Reviewed Publications
Below are links to Pfizer-sponsored, peer-reviewed COVID-19 publications.
- Vaccine (Journal):
Risk of adverse events after Omicron XBB-adapted BNT162b2 COVID-19 vaccination in the United States (January 25, 2025)
In this analysis of individuals who received the BNT162b2 XBB COVID-19 vaccine, researchers evaluated the association between the BNT162b2 XBB COVID-19 vaccine and the risk of 20 pre-specified adverse events of special interest (AESIs) between September 11, 2023 and January 15, 2024. - Vaccine (Journal):
2024-2025 BNT162b2 COVID-19 vaccine effectiveness in non-immunocompromised adults: mid-season estimates from vaccine registries in two states linked to administrative claims(July 24, 2025)
In this retrospective cohort study conducted between August 22, 2024, and December 31, 2024, among nearly 7 million non-immunocompromised adults in California and Louisiana, receipt of the BNT162b2 2024–2025 COVID-19 vaccine provided significant protection against serious COVID-19-associated hospitalization compared to those who did not receive a 2024–2025 season COVID-19 vaccine of any brand in this period. - Infectious Diseases and Therapy (Journal):
Extended Nirmatrelvir/Ritonavir Treatment Durations for Immunocompromised Patients With COVID-19 (EPIC-IC): A randomized, double-blind, phase 2 trial(July 14, 2025)
This phase 2, randomised, double-blind, placebo-controlled study was conducted at 73 outpatient clinics, including hospital-based, community, or dedicated research facilities, across nine countries (Spain, the USA, Slovakia, Mexico, Canada, Australia, Brazil, Hungary, and Bulgaria). Scarce clinical data exist to support nirmatrelvir–ritonavir dosing recommendations for immunocompromised patients with COVID-19, who represent a heterogeneous population with clinically significant underlying diseases and comorbidities. In our study, similar percentages of participants had a sustained viral load below LLOQ from days 15 to 44 across all treatment regimens, and within similar numbers of days. This result indicates that the currently recommended 5-day course of nirmatrelvir–ritonavir is adequate for most patients who are immunocompromised. - Infectious Diseases and Therapy (Journal):
Safety and Immunogenicity of Monovalent Omicron KP.2-Adapted BNT162b2 COVID-19 Vaccine in Adults: Single-Arm Substudy from a Phase 2/3 Trial(July 1, 2025)
One month after vaccination, KP.2-adapted BNT162b2-elicited neutralizing titers against Omicron KP.2, JN.1, and KP.3 were numerically higher than those induced by JN.1-adapted BNT162b2. Geometric mean fold rises from before to 1 month after vaccination were numerically higher in those who received KP.2-adapted BNT162b2 compared with those who received JN.1-adapted BNT162b2 - Microbiology Spectrum (Journal):
Association between nirmatrelvir/ritonavir treatment and antibiotic prescribing in the outpatient setting among patients with COVID-19 (March 5, 2025)
Study suggests that the availability of effective SARS-CoV-2 antiviral treatment, specifically Nirmatrelvir/ritonavir (NMV/r), may influence outpatient antibiotic prescribing patterns. NMV/r-eligible patients with COVID-19 who received NMV/r were 35% less likely to be prescribed outpatient antibiotics compared to NMV/r-eligible patients who did not receive NMV/r. - Journal of Medicinal Chemistry (Journal):
Discovery of Nirmatrelvir (PF-07321332): A Potent, Orally Active Inhibitor of the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS CoV-2) Main Protease(February 28, 2025)
The article details Pfizer’s preclinical development of nirmatrelvir (PF-07321332), the antiviral component of PAXLOVID, designed to inhibit the main protease (Mpro) of SARS-CoV-2. This enzyme is essential for viral replication, making it a prime target for therapeutic intervention. - Vaccine (Journal):
A phase 2/3 trial to investigate the safety and immunogenicity of monovalent Omicron JN.1-adapted BNT162b2 COVID-19 vaccine in adults ≥18 years old (February 25, 2025)
These safety and immunogenicity data support administration of JN.1 lineage-adapted BNT162b2 in adults. It is likely that safe and effective variant-adapted COVID-19 vaccines, regularly updated to closely match circulating SARS-CoV-2 strains, will continue to be important to help protect against COVID-19, especially among vulnerable populations. - Vaccine (Journal):
Effectiveness of BNT162b2 XBB.1.5 vaccine in immunocompetent adults using tokenization in two U.S. States (February 22, 2025)
BNT162b2 XBB.1.5 vaccine provided significant additional protection for immunocompetent adults against COVID-19-associated hospital admission and emergency department visits during the 2023–2024 fall and winter respiratory virus season. - Vaccines (Journal):
Safety and Immunogenicity of Concomitant and Combined Administration of Bivalent BNT162b2 COVID-19 Vaccine and Bivalent RSVpreF Respiratory Syncytial Virus Vaccine with Quadrivalent Influenza Vaccine in Adults ≥65 Years of Age(February 5, 2025)
This study met all immunogenicity endpoints, demonstrating that immune responses of concomitantly administered RSVpreF and BNT162b2 and combined RSVpreF and BNT162b2 vaccines, given with or without QIV, were noninferior to the administration of separate vaccines. Concomitantly administered vaccines and the combined vaccine, alone or with QIV, were also safe and well tolerated. Collectively, these results support administration of these vaccine regimens in older adults to help protect against these important respiratory pathogens in this vulnerable population. - Biomedical Informatics Insights (Journal):
Development and Validation of a Machine Learning Model Elucidating Clinical Risk Factors in Severe COVID-19(January 1, 2025)
Study authors used machine learning (ML) to figure out which health factors at the start of a COVID-19 infection could predict whether someone might get seriously ill. This study shows that machine learning can help doctors identify patients at high risk of severe COVID-19 early on. It also confirms that PAXLOVID is effective in reducing that risk. These insights can help guide treatment decisions and improve future clinical trials. - JAMA: Journal of the American Medical Association (Journal):
Pfizer BioNTech XBB1.5 effectiveness (durability and JN.1 sub-lineage)(December 12, 2024)
BNT162b2 XBB vaccine provided protection against COVID-19–associated hospitalization and emergency department or urgent care visits among children 5 to 17 years of age during the 2023-2024 season with estimated vaccine effectiveness point estimates ranging from 63% to 73%. - EClinicalMedicine (Journal):
Effectiveness of the BNT162b2 XBB.1.5-adapted vaccine against COVID-19 hospitalization related to the JN.1 variant in Europe: A test-negative case control study using the id.DRIVE platform (December 9, 2024)
BNT162b2 XBB.1.5-adapted vaccine provided protection against JN.1-related hospitalization, regardless of prior vaccination history, with no evidence of waning through five months. These data support yearly vaccination against COVID-19 to prevent severe illness during the respiratory virus season. - Clinical Infectious Diseases (Journal):
ALLEVIATION OF COVID-19 SYMPTOMS AND REDUCTION IN HEALTHCARE UTILIZATION AMONG HIGH-RISK PATIENTS TREATED WITH NIRMATRELVIR/RITONAVIR (NMV/R): A PHASE 3 RANDOMIZED TRIAL(November 11, 2024)
Nirmatrelvir/ritonavir (NMV/r) is an oral antiviral treatment for mild to moderate coronavirus disease 2019 (COVID-19). This phase 2/3, double-blind, randomized (1:1) study assessed oral NMV/r 300 mg/100 mg versus placebo every 12 hours for 5 days in high-risk, unvaccinated, nonhospitalized, symptomatic adults with COVID-19 from 343 sites across 21 countries. In addition to reducing COVID-19‒related hospitalization or death from any cause through day 28, NMV/r was found to also reduce duration of COVID-19 symptoms and utilization of healthcare resources versus placebo in patients at high risk of progressing to severe disease. - Clinical Infectious Diseases (Journal):
Virologic Response and Safety of Ibuzatrelvir, a Novel SARS-CoV-2 Antiviral, in Adults With COVID-19 (November 2, 2024)
Despite effective vaccines and treatments for COVID-19, clinical burden persists. An unmet need exists for additional effective agents with safety profiles allowing use across a broad population. Ibuzatrelvir is an orally bioavailable SARS-CoV-2 Mpro inhibitor with demonstrated in vitro antiviral activity and low potential for safety concerns, including drug–drug interactions. All 3 ibuzatrelvir doses were associated with robust antiviral activity and an acceptable safety profile, supporting continued clinical development. - Infectious Diseases and Therapy (Journal):
Pharmacovigilance of Drug-Drug Interactions with Nirmatrelvir/Ritonavir (October 26, 2024)
Low reporting rates of drug-drug interactions support the potential for nirmatrelvir/ritonavir treatment to be safely managed with careful use of available drug interaction resources to aid in risk mitigation. - Journal of Pharmaceutical Innovation (Journal):
Development and implementation of a comprehensive initiative to educate healthcare providers and patients in the United States about the risk of drug-drug interactions associated with nirmatrelvir/ritonavir during the COVID-19 pandemic (September 28, 2024)
This case study describes the development of a comprehensive drug-drug interaction (DDI) education initiative for nirmatrelvir/ritonavir during the COVID-19 pandemic. Following Emergency Use Authorization in December of 2021, the rapid dissemination of information on identification and management of DDIs was needed to ensure appropriate use of nirmatrelvir/ritonavir when treating patients with COVID-19 who were at an increased risk of progression to severe illness. The initiative included comprehensive outreach activities to compliantly inform healthcare providers and patients through the development of various educational materials and omnichannel engagement strategies. - Kansenshogaku Zasshi (Journal of Infectious Diseases) (Journal):
General use outcome survey of the Pfizer COVID-19 vaccine targeting recipients aged 20 years or older (healthcare workers) soon after approval (follow-up survey up to 12 months after first immunization) (September 20 ,2024) - BMJ Global Health (Journal):
The global health and economic value of COVID-19 vaccination (September 7, 2024)
We provide the first estimates of the broad value of COVID-19 vaccination (CV) incorporating GDP, QALY and direct and indirect cost impacts. Through December 2021, CV produced significant health and economic value, represented strong value for money and produced significant macroeconomic benefits that should be considered in vaccine evaluation. - Vaccines (Journal):
THE ROLE OF COVID-19 VACCINATION IN CHILDREN (August 29, 2024)
Children remain at risk of severe outcomes of COVID-19 in the current endemic setting, particularly when other respiratory pathogens are circulating, increasing the likelihood of co-infection. Vaccination of children has been shown to be effective against SARS CoV-2 infection and severe COVID-19. It is also likely to help prevent long-term consequences of COVID-19 in children. - Current Therapeutic Research (Journal):
US Real-World Effectiveness Study of Nirmatrelvir/Ritonavir in Preventing Hospitalization of High-Risk COVID-19 Patients (August 24, 2024)
Authors describe nirmatrelvir/ritonavir (NMV/r) effectiveness in preventing hospitalization among COVID-19 patients at high risk of severe disease. - Infectious Diseases and Therapy (Journal):
What proportion of nirmatrelvir/ritonavir prescriptions are filled in the United States?(August 3, 2024)
This retrospective cohort study included individuals aged ≥ 12 years with a nirmatrelvir/ritonavir prescription ordered at a large national retail pharmacy. Most patients filled their nirmatrelvir/ritonavir prescriptions. Interventions to improve uptake should focus on increasing patient and provider awareness, reducing nirmatrelvir/ritonavir prescribing disparities, and ensuring treatment initiation within 5 days. - New England Journal of Medicine (Journal):
Oral Nirmatrelvir–Ritonavir as Postexposure Prophylaxis for Covid-19(July 17, 2024)
In this placebo-controlled trial, postexposure prophylaxis with nirmatrelvir–ritonavir for 5 or 10 days did not significantly reduce the risk of symptomatic SARS-CoV-2 infection. - Open Forum Infectious Diseases (Journal):
Effectiveness of BNT162b2 XBB Vaccine against XBB and JN.1 Sub-lineages(July 7, 2024)
The Pfizer BNT162b2 XBB vaccine worked better against XBB than against JN.1, especially in the first two months after vaccination. Since JN.1 became the dominant strain globally, the study supports updating the vaccine to better target JN.1 and related variants—aligning with recommendations from the FDA, EMA, and WHO. - Vaccines (Journal):
Immunogenicity of the Monovalent Omicron XBB.1.5-Adapted BNT162b2 COVID-19 Vaccine Against XBB.1.5, BA.2.86, and JN.1 Sublineages: A Phase 2/3 Trial(July 2, 2024)
This was an additional exploratory analysis from a phase 2/3 study of the monovalent Omicron XBB.1.5-adapted BNT162b2 vaccine in baseline-seropositive, vaccine-experienced adults ≥18 years of age. The immunogenicity data presented in the publication supported the administration of the then recommended XBB.1.5-adapted BNT162b2 vaccine while also highlighting the potential need to periodically update COVID-19 vaccines to match circulating SARS-CoV-2 strains. - Viruses (Journal):
Severe COVID-19 outcomes in five Latin American countries in the postvaccination era(June 26, 2024)
This study analyzed the clinical profiles, rates of hospitalization, ICU admission, ventilatory support utilization, and mortality of COVID-19 cases in five LATAM countries following the implementation of national COVID-19 vaccination programs. We observed a decrease in hospitalization rates from 2021 to 2022, but our findings reinforce that severe outcomes of COVID-19 persist with a considerable burden in the region. - JAMA: Journal of the American Medical Association (Journal):
Estimated effectiveness of the BNT162b2 XBB Vaccine against COVID-19(June 24, 2024)
In this case-control study, individuals who did not receive an XBB vaccine and had received only older versions of COVID-19 vaccines had little, if any, additional protection compared with unvaccinated individuals against COVID-19 end points, including hospital admission, regardless of the number or type of prior doses received. Receipt of a BNT162b2 XBB vaccine, however, was associated with statistically significant reduced risk of developing a range of COVID-19 outcomes during the early part of the 2023 to 2024 viral respiratory season—with the strongest protective effects seen against hospital admission. - Infectious Diseases and Therapy (Journal):
Perceived Risk for Severe COVID-19 and Oral Antiviral Use Among Antiviral-Eligible US Adults (June 23, 2024)
This study aims to assess the management of high-risk COVID-19 patients in the Middle East, Africa, and Eastern Europe, with a focus on understanding current practices, challenges, and potential strategies for improvement. - Infectious Diseases and Therapy (Journal):
Cross-Sectional Survey of Factors Contributing to COVID-19 Testing Hesitancy Among US Adults at Risk of Severe Outcomes From COVID-19 (June 13, 2024)
Understanding the demographic factors of individuals who experience COVID-19 testing hesitancy will help guide strategies to improve US testing rates. - Vaccines (Journal):
Effectiveness of BNT162b2 Vaccine for Preventing COVID-19-Related Hospitalizations: a Test-Negative Case-Control Study(June 13, 2024)
Study demosrated BNT162b2 vaccine to be effective in preventing COVID-19-related acute respiratory illness hospitalizations in a unique population of predominantly African American adults. Reporting vaccine efficacy (VE) in racially diverse populations may provide additional reassurance on the protective effects of vaccination and improve equity. VE was greatest following ≥1 booster dose and was durable but decreased during Omicron variant predominance. There is an ongoing need to conduct real-world VE studies as new variants emerge and as population immunity evolves over time to inform public policy decisions. - Journal of the Pediatric Infectious Diseases Society (JPIDS) (Journal):
Bivalent Omicron BA.4/BA.5 BNT162b2 Vaccine in 6-Month- to < 12-Year-Olds(June 11, 2024)
In this analysis, bivalent BNT162b2 as a fourth dose elicited a robust immune response in infants and children 6 months to < 12 years old, with a safety and tolerability profile immediately and in the month following vaccination similar to that seen with original BNT162b2 in infants, toddlers, and children - Cureus (Journal):
Management of Patients at High Risk of Serious COVID-19 Disease: Optimising the Patient Pathway in the Middle East, Africa, and Eastern Europe(May 20, 2024)
Collaboration among stakeholders is essential to optimize COVID-19 management for high-risk patients - New England Journal of Medicine (Journal):
Nirmatrelvir for Vaccinated/Unvaccinated, Outpatient Adults with Covid-19 (April 3, 2024)
Authors assessed the safety and efficacy of nirmatrelvir–ritonavir as an antiviral agent against SARS-CoV-2 in symptomatic, nonhospitalized, vaccinated or unvaccinated adults. Nirmatrelvir–ritonavir was not associated with a significantly shorter time to sustained alleviation of Covid-19 symptoms than placebo, and the usefulness of nirmatrelvir–ritonavir in patients who are not at high risk for severe Covid-19 has not been established. - Scientific Reports (Journal):
Predictors of nirmatrelvir-ritonavir receipt among COVID-19 patients: a real-world analysis in a large US health system (March 29, 2024)
This study represents a detailed analysis of nirmatrelvir–ritonavir dispensing patterns across COVID-19 patient characteristics using real-world data from a large and diverse US population. - Frontiers in Pediatrics (Journal):
Pediatric COVID-19 in Argentina: A Comprehensive Analysis of Disease and Economic Burden through Official Data and a Systematic Literature Review(March 13, 2024)
This study looked at how COVID-19 affected children and teens (ages 0–18) in Argentina between March 2020 and August 2021, before vaccines were available for this age group. It combined official health data with a review of published studies to understand both the health impact and economic cost of the disease. - Vaccines (Journal):
Effectiveness of BNT162b2 BA.4/5 bivalent COVID-19 vaccine against long COVID symptoms: a US nationwide study (February 11, 2024)
This longitudinal prospective survey-based study, conducted among symptomatic adult outpatients with laboratory-confirmed SARS-CoV-2 infections, found that, compared with the unvaccinated group, the cohort of patients that were vaccinated with the BNT162b2 BA.4/5 bivalent COVID-19 vaccine was associated with lower prevalence rates, odds and burden of long COVID. - JAMA Pediatrics (Journal):
Effectiveness of BNT162b2 against COVID-19-related emergency department, urgent care, and outpatient encounters among US children < 5 years of age in a large integrated US health system (September 15, 2023)
This study examines the association of the receipt of wild-type BNT162b2 vaccine with medically attended COVID-19 outcomes among children younger than 5 years in the US. Receiving at least 2 doses of wild-type BNT162b2 vaccine was associated with a reduced risk of COVID-19 emergency department or urgent care and outpatient visits in children younger than 5 years. - Infectious Diseases and Therapy (Journal):
Safety and Immunogenicity of the BNT162b2 Vaccine Coadministered With Seasonal Inactivated Influenza Vaccine in Adults (September 12, 2023)
BNT162b2 coadministered with Seasonal Inactivated Influenza Vaccine (SIIV) elicited immune responses that were non inferior to those elicited by BNT162b2 alone and SIIV alone, and BNT162b2 had an acceptable safety profile when coadministered with SIIV. The results of this study support the coadministration of BNT162b2 and SIIV in adults. - Open Forum Infectious Diseases (Journal):
Safety, Tolerability,and Pharmacokinetics of Single and Multiple Ascending Intravenous Infusions of PF-07304814 (Lufotrelvir) in Participants Hospitalized With COVID-19(July 10, 2023)
These safety and pharmacokinetic findings support the continued evaluation of lufotrelvir in clinical studies. - The New England Journal of Medicine:
Bivalent Omicron BA.1–Adapted BNT162b2 Booster in Adults Older than 55 Years(January 19, 2023)
Data from an ongoing phase 3 trial in adults older than 55 years demonstrated that the candidate monovalent or bivalent omicron BA.1–adapted vaccines had a safety profile similar to that of BNT162b2 (30 μg), induced substantial neutralizing responses against ancestral and omicron BA.1 strains, and, to a lesser extent, neutralized BA.4, BA.5, and BA.2.75 strains. - The New England Journal of Medicine:
Oral Nirmatrelvir for High-Risk, Nonhospitalized Adults with COVID-19(February 16, 2022)
Results from this Phase 2/3 trial found that Pfizer’s oral COVID-19 treatment reduced the risk of hospitalization or death from any cause by 89% and 88% for patients treated within 3 days and 5 days, respectively, compared to placebo in nonhospitalized, high-risk adult patients. - Science:
Neutralization of SARS-CoV-2 Omicron by BNT162b2 mRNA vaccine–elicited human sera(January 18, 2022)
This lab study tested Wuhan, Beta, Delta, or Omicron pseudoviruses with sera of 51 participants that received two or three doses of the mRNA-based COVID-19 vaccine, BNT162b2, and support that three doses of BNT162b2 may protect against Omicron-mediated COVID-19. - The New England Journal of Medicine:
Evaluation of the BNT162b2 Covid-19 Vaccine in Children 5 to 11 Years of Age (November 9, 2021)
Data from a Phase 2/3 study found that a Covid-19 vaccination regimen consisting of two 10-μg doses of BNT162b2 administered 21 days apart was found immunogenic and efficacious, with no serious side effects observed in children 5 to 11 years of age. - Science:
An oral SARS-CoV-2Mpro inhibitor clinical candidate for the treatment of COVID-19(November 2, 2021)
This study found PF-07321332 demonstrated oral activity in a mouse-adapted SARS-CoV-2 model and achieved oral plasma concentrations exceeding the in vitro antiviral cell potency in a Phase 1 clinical trial in healthy human participants. - The New England Journal of Medicine:
SARS-CoV-2 Neutralization with BNT162b2 Vaccine Dose 3(September 15, 2021)
This study found that the third dose of the Pfizer-BioNTech COVID-19 vaccine, BNT162b2, elicited much higher neutralizing titers against the initial SARS-CoV-2 virus (wild type), the Beta variant, and the highly infectious Delta variant, than the first two doses. - The New England Journal of Medicine:
Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine through 6 Months(September 15, 2021)
Data from the Pivotal Phase 3 study found that the Pfizer-BioNTech COVID-19 vaccine, BNT162b2, continues to be safe, well tolerated, and remains highly efficacious in preventing COVID-19, including disease caused by new SARS-CoV-2 variants, through up to six months after the second dose. - Nature:
Preclinical characterization of an intravenous coronavirus 3CL protease inhibitor for the potential treatment of COVID19(October 18, 2021)
This study presents the ADME, safety, in vitro, and in vivo antiviral activity data to support the clinical evaluation of PF-07304814 as a potential COVID-19 treatment. - Journal of Medical Chemistry:
Discovery of Ketone-Based Covalent Inhibitors of Coronavirus 3CL Proteases for the Potential Therapeutic Treatment of COVID-19(October 15, 2021)
This study focused on the discovery of reversible and irreversible ketone-based inhibitors of SARS CoV-1 3CLpro employing ligand-protease structures which led to the identification of PF-00835231 as a potent inhibitor of CoV-2 3CLpro with suitable pharmaceutical properties to warrant further development as a potential intravenous treatment for COVID-19. - Reproductive Toxicology (Journal):
Lack of effects on female fertility and prenatal and postnatal offspring development in rats with BNT162b2, a mRNA-based COVID-19 vaccine (August 2021) - The New England Journal of Medicine:
Tofacitinib in Patients Hospitalized with Covid-19 Pneumonia(June 16, 2021)*
Among patients hospitalized with Covid-19 pneumonia, tofacitinib led to a lower risk of death or respiratory failure through day 28 than placebo. - Nature:
BNT162b2-elicited neutralization of B.1.617 and other SARS-CoV-2 variants(June 10, 2021)
This study found that sera from individuals immunized with the Pfizer-BioNTech COVID-19 vaccine (BNT162b2) neutralized SARS-CoV-2 with spike protein mutations present in the B.1.617.1, B.1.617.2, B.1.618 (all first identified in India) or B.1.525 (first identified in Nigeria) lineages. - Reproductive Toxicology:
Lack of effects on female fertility and prenatal and postnatal offspring development in rats with BNT162b2, a mRNA-based COVID-19 vaccine(May 28, 2021)
This developmental and reproductive toxicity (DART) study conducted in rats found that the Pfizer-BioNTech COVID-19 vaccine (BNT162b2) was well-tolerated, had no effects on female mating performance, fertility, or any ovarian or uterine parameters nor on embryo-fetal or postnatal survival, growth, physical development or neurofunctional development in the offspring through the end of lactation. - The New England Journal of Medicine:
Safety, Immunogenicity, and Efficacy of the BNT162b2 COVID-19 Vaccine in Adolescents(May 27, 2021)
This placebo-controlled, observer-blinded trial found that in individuals 12-15 years of age, the Pfizer-BioNTech COVID-19 vaccine (BNT162b2) was well-tolerated, had a statistically greater immune response than in 16-25-year-olds and was 100% effective against COVID-19. - Nature:
BNT162b2 vaccine induces neutralizing antibodies and poly-specific T cells in humans(May 27, 2021)
This study found that the Pfizer-BioNTech COVID-19 vaccine (BNT162b2) elicited a strong immune response during our Phase 1/2 trial with BNT162b2 prime–boost vaccination in healthy adults conducted in Germany. - The New England Journal of Medicine:
BNT162b2-Elicited Neutralization Against New SARS-CoV-2 Spike Variants(May 12, 2021)
This study found that sera from individuals immunized with the Pfizer-BioNTech COVID-19 vaccine (BNT162b2) neutralized SARS-CoV-2 with spike protein mutations present in the California and New York virus variants, as well as the U.K. virus variant with an E484K substitution. - The Lancet:
Impact and effectiveness of mRNA BNT162b2 vaccine against SARS-CoV-2 infections and COVID-19 cases, hospitalizations, and deaths following a nationwide vaccination campaign in Israel: an observational study using national surveillance data(May 5, 2021)
This is an analysis of real-world surveillance data from a period of observation following the launch of the Ministry of Health nationwide vaccine campaign. The analysis found that two doses of BNT162b2 are highly effective across all age groups (≥16 years) in preventing SARS-CoV-2 infections and COVID-19-related hospitalizations, severe disease, and death, including those caused by SARS-CoV-2 variant Alpha (B.1.1.7). - Journal of Virology:
A Comparative Analysis of SARS-CoV-2 Antivirals Characterizes 3CLpro Inhibitor PF-00835231 as a Potential New Treatment for COVID-19(April 26, 2021)
This study validated the early time of action of PF-00835231, the active component of the first-in-class 3CLpro-targeting regimen, providing in vitro evidence for the drug’s potential as a possible SARS-CoV-2 antiviral treatment. - Nature:
The effect of SARS-CoV-2 D614G mutation on BNT162b2 vaccine-elicited neutralization(March 25, 2021)
This study found that the D614G spike protein mutation modestly reduced SARS-CoV-2 neutralization by BNT162b2 vaccine-elicited mouse, rhesus, and human sera. - The New England Journal of Medicine:
Neutralizing Activity of BNT162b2-Elicited Serum(Mar. 8, 2021)
This in vitro study provided data that demonstrated sera from individuals immunized with the Pfizer-BioNTech COVID-19 vaccine (BNT162b2) neutralized SARS-CoV-2 with spike protein mutations found in the Brazil, U.K. and South African virus variants. - Nature Medicine:
Neutralization of SARS-CoV-2 spike 69/70 deletion, E484K and N501Y variants by BNT162b2 vaccine-elicited sera(Feb. 8, 2021)
These in vitro studies found that sera from individuals vaccinated with the Pfizer- BioNTech COVID-19 vaccine neutralized SARS-CoV-2 with key mutations present in the U.K. and South African variants. - Nature:
Immunogenic BNT162b vaccines protect rhesus macaques from SARS-CoV-2(Feb. 1, 2021)
This in vitro study found that the Pfizer-BioNTech vaccine candidates, BNT162b1 and BNT162b2, induced strong immune responses in mice and rhesus macaques. - Science:
Neutralization of SARS-CoV-2 lineage B.1.1.7 pseudovirus by BNT162b2 vaccine–elicited human sera(Jan. 29, 2021)
This in vitro study found that sera from individuals vaccinated with the Pfizer-BioNTech COVID-19 vaccine, BNT162b2, neutralized a pseudovirus bearing the SARS-CoV-2 U.K. variant, also known as B.1.1.7 lineage. - The New England Journal of Medicine:
Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine(Dec. 31, 2020)
This landmark Phase 3 trial of BNT162b2 found that the vaccine candidate was well tolerated and demonstrated 95% efficacy in preventing COVID-19 in those without prior infection 7 days or more after the second dose. - Nature:
COVID-19 vaccine BNT162b1 elicits human antibody and TH1 T cell responses(Sept. 30, 2020)
Data from this Phase 1/2 study in Germany found that immunization with BNT162B1, a nucleoside-modified messenger RNA (modRNA) candidate which encodes an optimized SARS-CoV-2 receptor binding domain (RBD) antigen, elicited robust RBD-specific antibody, T cell and favorable cytokine responses. - Nature:
Phase I/II study of COVID-19 RNA vaccine BNT162b1 in adults(Aug. 12, 2020)
This study provided an overview of preliminary data from the U.S. Phase 1/2 clinical trial of BNT162b1, which demonstrated that BNT162b1 could be administered in a dose that was well tolerated and generated dose dependent immunogenicity.
* Tofacitinib is not approved or authorized for use in patients with COVID-19 pneumonia. The tofacitinib trial was a research collaboration between Pfizer and the Academic Research Organization from the Hospital Israelita Albert Einstein, which was the regulatory sponsor and clinical trial coordinating center.
- Vaccine (Journal):
Links to Citations Contained in Pfizer’s 9/16/2025 Press Statement
- International Vaccine Access Center:
Results of COVID-19 Vaccine Effectiveness Studies: An Ongoing Systematic Review. Forest Plots: Vaccine Effectiveness against Delta and Omicron Variants of Concern (May 12, 2022) - Life (Journal):
COVID-19 Vaccine and Long COVID: A Scoping Review (July 16, 2022) - International Journal of Environmental Research and Public Health (Journal):
Effect of COVID-19 Vaccines on Reducing the Risk of Long COVID in the Real World: A Systematic Review and Meta-Analysis (September 29, 2022) - eClinical Medicine – Part of The Lancet Discovery Science (Journal):
Impact of COVID-19 vaccination on the risk of developing long-COVID and on existing long-COVID symptoms: A systematic review (November 2022) - Vaccine (Journal):
Protective effect of COVID-19 vaccination against long COVID syndrome: A systematic review and meta-analysis (March 10, 2023) - Pediatric Rheumatology (Journal):
The protective effect of COVID-19 vaccines on developing multisystem inflammatory syndrome in children (MIS-C): a systematic literature review and meta-analysis (August 7, 2023) - Antimicrobial Stewardship & Healthcare Epidemiology (Journal):
The effectiveness of COVID-19 vaccine in the prevention of post-COVID conditions: a systematic literature review and meta-analysis of the latest research (October 13, 2023) - Vaccine (Journal):
Impact of Pre-Infection COVID-19 Vaccination on the Incidence and Severity of Post-COVID Syndrome: A Systematic Review and Meta-Analysis (February 12, 2024) - Centers for Disease Control and Prevention:
Preliminary Estimates of COVID-19 Burden for 2024-2025 (December 6, 2024) - Journal of Infection (Journal):
The effect of pre-COVID and post-COVID vaccination on long COVID: A systematic review and meta-analysis (December 2024) - Vaccine (Journal):
Estimating COVID-19 associated hospitalizations, ICU admissions, and in-hospital deaths averted in the United States by 2023-2024 COVID-19 vaccination: A conditional probability, causal inference, and multiplier-based approach (March 7, 2025) - Human Vaccines & Immunotherapies (Journal):
Factors affecting the impact of COVID-19 vaccination on post COVID-19 conditions among adults: A systematic literature review (March 13, 2025) - European Centre for Disease Prevention and Control:
Does COVID-19 vaccination reduce the risk and duration of post COVID-19 condition? (March 25, 2025) - Nature Communications (Open-Access Journal):
Early effectiveness of the BNT162b2 KP.2 vaccine against COVID-19 in the US Veterans Affairs Healthcare System (April 29, 2025) - Centers for Disease Control and Prevention:
COVID-19 Vaccination Coverage and Intent for Vaccination, Children 6 months through 17 years, United States (May 7, 2025) - Centers for Disease Control and Prevention:
COVID-19 Vaccination Coverage and Intent for Vaccination, Adults 18 Years and Older, United States (May 7, 2025) - Centers for Disease Control and Prevention:
COVID-NET (June 5, 2025) - Centers for Disease Control and Prevention:
Staying Up to Date with COVID-19 Vaccines (June 6, 2025) - Centers for Disease Control and Prevention:
Long COVID Basics (July 24, 2025) - The Lancet Infectious Diseases (Journal):
Effectiveness of the BNT162b2 and mRNA-1273 JN.1-adapted vaccines against COVID-19-associated hospitalisation and death: a Danish, nationwide, register-based, cohort study (July 29, 2025) - International Vaccine Access Center:
Results of COVID-19 Vaccine Effectiveness Studies: An Ongoing Systematic Review. Forest Plots: Vaccine Effectiveness against Omicron Variant of Concern (August 29, 2025) - Centers for Disease Control and Prevention:
Antibody Seroprevalence (September 5, 2025) - Centers for Disease Control and Prevention:
COVID-19 Surveillance Data in the United States (September 5, 2025) - Vaccine (Journal):
BNT162b2 COVID-19 vaccine effectiveness in non-immunocompromised adults: mid-season estimates from vaccine registries in two states linked to administrative claims (August 30, 2025)
Analysis of COVID-19 Vaccination in Pregnant Women, including Clinical Study Report Synopsis
Links to Citations Contained in Pfizer’s 9/15/2025 Press Statement
- New England Journal of Medicine (Journal):
Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine (December 31, 2020) - Centers for Disease Control and Prevention -- Morbidity and Mortality Weekly Report (MMWR):
Cardiac Complications After SARS-CoV-2 Infection and mRNA COVID-19 Vaccination - PCORnet, United States, January 2021-January 2022 (April 8, 2022) - Lancet Respiratory Medicine (Journal):
Myopericarditis following COVID-19 vaccination and non-COVID-19 vaccination: a systematic review and meta-analysis (April 11, 2022) - Journal of the American Medical Association (Journal):
Myocarditis Adverse Event Less Common After COVID-19 Vaccine Booster (April 12, 2022) - JAMA Cardiology (Journal):
SARS-CoV-2 Vaccination and Myocarditis in a Nordic Cohort Study of 23 Million Residents (June 1, 2022) - Nature Communications (Journal):
Age and sex-specific risks of myocarditis and pericarditis following Covid-19 messenger RNA vaccines (June 25, 2022) - Circulation (Journal):
Risk of Myocarditis After Sequential Doses of COVID-19 Vaccine and SARS-CoV-2 Infection by Age and Sex (August 22, 2022) - NPJ Vaccines (Journal):
Myocarditis associated with COVID-19 vaccination (June 28, 2024) - Journal of the American Medical Association (Journal):
Long-Term Prognosis of Patients With Myocarditis Attributed to COVID-19 mRNA Vaccination, SARS-CoV-2 Infection, or Conventional Etiologies (August 26 ,2024) - E Clinical Medicine (Journal):
Cardiac manifestations and outcomes of COVID-19 vaccine-associated myocarditis in the young in the USA: longitudinal results from the Myocarditis After COVID Vaccination (MACiV) multicenter study (September 6, 2024) - Pediatric Cardiology (Journal):
Myocarditis and Pericarditis are Temporally Associated with BNT162b2 COVID-19 Vaccine in Adolescents: A Systematic Review and Meta-analysis (October 15, 2024) - Centers for Disease Control and Prevention:
Updates to COVID-19 Vaccine Effectiveness (June 25,2025) - NPJ Vaccines (Journal):
Surveillance and follow up outcomes of myocarditis after mRNA COVID-19 vaccination in Australia (July 16, 2025)
Links to Citations Contained in Pfizer’s 9/9/2025 Press Statement
- Centers for Disease Control and Prevention:
CDC issues urgent health advisory recommending COVID-19 vaccination during pregnancy. (September 29, 2021) - Nature Communications (Open Access Journal):
Systematic review and meta-analysis of the effectiveness and perinatal outcomes of COVID-19 vaccination in pregnancy (May 10, 2022) - Obstetrics and Gynecology Clinics of North America (Journal):
Safety and Effectiveness of Maternal COVID-19 Vaccines Among Pregnant People and Infants (June 2023) - Drug Safety (Journal):
Safety and Effectiveness of COVID-19 Vaccines During Pregnancy: A Living Systematic Review and Meta-analysis. (July 15, 2024) - British Medical Journal (Journal):
COVID-19 infection and vaccination during the first trimester and risk of congenital anomalies: Nordic registry-based study (July 17, 2024) - Centers for Disease Control and Prevention:
COVID-19 vaccination for women who are pregnant or breastfeeding. - Centers for Disease Control:
About Birth Defects (February 25, 2025)
- International Vaccine Access Center: