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All COVID-19 Updates

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 vaccine

12.14.20
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 BioNTech

11.09.20
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. B

09.08.20
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 pandemic

05.05.20
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 Medicine

04.22.20
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-2

04.01.20
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 Plan

03.24.20
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 peer-reviewed data publications from the Pfizer-BioNTech COVID-19 vaccine program.

* 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.