Sorry, you need to enable JavaScript to visit this website.
Skip to main content
Home

Header Top Menu

  • Careers
  • Investors
  • News
    • Press Release Archive
    • Press Statements
    • Podcasts
      • The Antigen Podcast
      • Get Science Podcast
      • Diverse Perspectives Podcast
      • menopause: unmuted
      • Hemcast
    • Contact Media Relations
    • Press Kits & Downloads
      • Company Press Kit
      • Pfizer Oncology Press Kit
      • PSA Narrative
      • RA NarRAtive
      • Rare Disease Gene Therapy Press Kit
      • ATTR-Amyloidosis Press Kit
      • UC Narrative
      • Eczema Inside Out Press Kit
  • Partners
    • Discovery to Pre-candidate
      • Focus Areas
        • Therapeutic Areas
          • Internal Medicine
          • Inflammation and Immunology
          • Oncology
          • Rare Disease
          • Vaccines
        • Therapeutic Modalities and Technology Platforms
          • Drug Safety
          • Gene Therapy
          • Target Sciences
          • Precision Medicine
          • Medicinal Sciences
            • Biologics Product & Process Development
            • Biotherapeutics Discovery
            • Medicine Design
            • Small Molecule Product & Process Development
        • Emerging Science
          • DNA Damage Response
          • Microsatellite Repeat Expansions
          • Senescence
      • Partnering Models
    • Candidate Through Commercialization
      • Focus Areas
        • Internal Medicine
        • Inflammation and Immunology
        • Oncology
        • Rare Disease
        • Vaccines
        • Hospital
    • Pfizer CentreOne
    • Pfizer Ventures
      • Our portfolio

Healthcare Professionals

  • Healthcare Professionals

Connect with Us

  • Connect with Us
    • Email
    • FAQ
    • Privacy Policy (NEW)
    • YouTube
    • Twitter
    • Facebook
    • LinkedIn
    • Instagram
  • Your Health

    • Healthy Living
      • Brain & Nervous System
      • Cardiovascular Health
      • Cold & Flu
      • Digestive Health
      • Healthier Aging
      • Living Tobacco Free
      • Men’s Health
      • Mental Health
      • Nutrition & Fitness
      • Pediatric Health
      • Respiratory Health
      • Skin Health
      • Vaccines & Prevention
      • Women’s Health

    • Disease & Condition
      • Cancer
      • Cardiovascular Diseases & Conditions
      • Diabetes & Metabolic Disorders
      • Immune System Diseases & Conditions
      • Infections & Infectious Diseases
      • Neurological Diseases & Conditions
      • Menopause
      • Rare Disease
      • Vaccine-Related Conditions
      • Skin Diseases & Conditions
      • Atopic Dermatitis
      • Cardiovascular Disease
      • Severe Hypertriglyceridemia

    • Coronavirus disease (COVID-19)

    • Managing your health
      • Caregiving
      • Evaluating Health Information
      • Tracking Your Health
      • Your Medicines
      • Health Literacy

    • Wellness
    Hot Topics

    Maintaining Emotional Well-Being During COVID-19

    Emotional Well-Being Tips for People Living with Chronic Inflammatory Conditions During COVID-19
  • Our Science

    • Driven to Discover the cure

    • Focus Areas
      • Internal Medicine
      • Inflammation & Immunology
      • Oncology
      • Rare Disease
      • Vaccines
      • Anti Infectives

    • Product Pipeline

    • Clinical Trials
      • Guide to Clinical Trials
      • Find a Trial
      • Expanded Access & Compassionate Use
      • Clinical Trials in Children
      • Partnering with Pfizer
      • Trial Data & Results
      • Research Integrity & Transparency
      • Diversity in Clinical Trials

    • R&D Platforms
      • Biosimilars
      • Gene Therapy
      • Medicinal Sciences
      • Precision Medicine
      • Maternal Immunization

    • Collaboration
      • Partner with Pfizer

    • Research sites

    • Coronavirus disease (COVID-19) Scientific Resources
    HOT TOPICS

    MRNA VS. CONVENTIONAL VACCINES

    What Makes an RNA Vaccine Different From a Conventional Vaccine?
  • Our People

    • Meet The Experts
      • Scientists
      • Internal Medicine – Metabolic Disease
      • Inflammation & Immunology
      • Oncology
      • Rare Disease
      • Vaccines
      • Medical Professionals

    • The Journey

    • Leadership
      • Executives
      • Board Members
      • Company Fact Sheet

    • Diverse Perspectives
      • Diversity & Inclusion
      • Supplier Diversity
    HOT TOPICS

    Meet our new Chief Patient Officer, Dr. Dara Richardson-Heron

    dr_richardson_300x170.jpg

    Working Together to Empower Women

    VizagWomen_300x170.jpg

    • Hot Topics
  • Our Purpose

    • Commitment to Global Health
      • Expanding Access
      • Strengthening Health Systems
      • Providing Disaster & Humanitarian Relief
      • Unleashing the Power of Our Colleagues
      • Highlighting Individual Voices

    • Protecting People and the Environment
      • Pfizer's Green Journey
      • Product Stewardship
      • EHS Governance
      • EHS Supply Chain
      • Key Performance Indicators
      • Health & Safety
      • Human Rights

    • Positions on Health Policies
      • Ready for Cures
      • How does Pfizer price medicines?
      • Value of Medicines
      • Policy Positions
      • Creating Cures Through Facility Investments

    • Transparency
      • Working with Health Care Professionals
      • Transparency in Grants
      • Code of Conduct
      • Corporate Compliance
      • Sales and Marketing Compliance

    • Independent Grants
      • Competitive Grants Program
      • Independent Medical Education
      • Investigator Sponsored Research
      • Quality Improvement
      • COVID-19 Vaccine Grants

    • Contributions & Partnerships
      • Healthcare Charitable Contributions
      • Lobbying & Political Contributions
    HOT TOPICS

    Pfizer Women’s Resource Group

    Media Name: IWD_Pull_up_Banner_300x170.jpg

    • Hot Topics
  • Our Products

    • Product listing

    • How drugs are made
      • Branded vs. Generic
      • Biologics & Biosimilars
      • Commitment to Quality

    • Distributors
      • Pfizer Distributors
      • Greenstone Distributors

    • Medicine Safety
      • Reporting Adverse Events
      • Making Good Treatment Choices
      • Partnering With Patients
      • Health Literacy
      • Medicine Safety Tips for Patients
      • Counterfeiting
      • Unused Medicines

    • Safety Data Sheets

    • Medical Information Contacts

    • Pfizer Global Supply
    HOT TOPICS

    Universal vs. Single Payer Healthcare

    Media Name: universal_healthcare300x170.jpg
  • Careers

    • Working Here
      • Mission & Purpose
      • Culture
      • Diversity & Inclusion
      • Career Growth & Colleague Development
      • Compensation & Benefits
      • Ensuring Corporate Responsibility
    • Search Jobs
    • Student & Early Career
      • Postdoctoral Program
      • US Summer Student Worker Program
      • Opportunities for Veterans
    • Pfizer365.com
    • Our Hiring & Recruiting Process
      • Frequently Asked Questions
      • Tips for Interviewing at Pfizer
    • Connect With Us
  • Investors

    • Investors Overview
      • Why Invest / Our Story
      • Prospective Investors
      • Fact Sheet
    • Events & Presentations
    • Financials
      • Quarterly Reports
      • Annual Reports
      • SEC Filings
      • Interactive Data Filings
    • Investor News
    • Stock Information
      • Historical Price Lookup
      • Investment Calculator
      • Historical Stock Chart & Data
      • Dividend & Split History
      • Stock FAQs
    • Governance
      • Board Committees and Charters
      • The Pfizer Board Policies
      • Corporate Governance FAQs
      • Contact Our Directors
    • Shareholder Services
      • Stock FAQs
      • Advisory Information
      • Cost Basis Calculator
  • News

    • Contact Media Relations
    • Podcasts
    • Press Kits & Downloads
    • Press Release Archive
    • Press Statements
  • Partners
  • Footer links

    • Footer Aside Section1
      • CAREER-SEEKERS
      • INVESTORS
      • News & Media
      • Partners
    • Footer Aside Section 2
      • Healthcare Professionals
      • Business To Business
      • Change Region
      • Sitemap
    • Footer Aside Section3
      • Twitter
      • Facebook
      • Linkedin
      • Instagram
      • Youtube
    • Footer Aside Section4
      • Contact Us
      • Terms of Use
      • Privacy Policy

How Are Vaccines Developed?

How Are Vaccines Developed?
OUR SCIENCE/ How Are Vaccines Developed?
April 27, 2020

Vaccines have revolutionized our ability to improve health and save lives, resulting in the control, elimination, or near-elimination of many life-threatening diseases. The path to disease prevention – the development of a novel vaccine – is a complex and lengthy process that generally takes 10 to 15 years.1 Every step of the way, our team is committed to pursuing research and forming partnerships that facilitate the rapid development and delivery of a vaccine. To help protect against the COVID-19 pandemic, one such partnership is already underway with the goal of bringing forward a safe and effective vaccine with unprecedented urgency.

 

A Typical Vaccine Roadmap

 

Step 1: Exploratory – Research

Usually, laboratory research is conducted for 2 to 5 years to identify antigens to include in a vaccine.1

 

 

Step 2: Preclinical – Safety & Efficacy

Researchers conduct testing to assess vaccine candidates’ immunogenicity, their ability to elicit the desired immune response. Other areas of focus include short-term toxicology, formulation, and development of a scalable, efficient, and reproducible manufacturing process. This data collection and analysis can take around 2 years. 1

 

Step 3: Clinical – Safety & Efficacy in Humans

In the United States, an application for an Investigational New Drug (IND) is submitted to the U.S. Food and Drug Administration (FDA). Only with an approval of the IND by the FDA does the potential vaccine proceed through 3 phases of testing in humans.2,4

  • Phase 1 (2 years) – Typically, less than 100 volunteers are administered the candidate vaccine in a non-blinded study to determine whether it is safe to proceed to Phase 2, and to determine whether a sufficient immune response is provoked.1,2
     
  • Phase 2 (2 to 3 years) – A larger group of subjects receive the vaccine candidate; the safety, immunogenicity, doses, immunization schedules, and delivery methods are studied.1
     
  • Phase 3 (5 to 10 years) – This randomized, placebo-controlled, blinded pivotal study generally involves thousands of people in whom vaccine safety and efficacy are tested. This trial generally includes monitoring potential side effects in subjects, determining whether the vaccine candidate can help to prevent disease, and testing whether it leads to the production of antibodies against the specific pathogen.1,2

 

Step 4: Regulatory Review & Approval – Licensure

If the candidate vaccine is determined to be safe and effective, a Biologics License Application (BLA) is submitted to the FDA, which may conduct its own testing. The FDA also inspects the production of the vaccine candidate and monitors its potency, safety, and purity; this entire process could take up to 2 years.2,4

 

 

Step 5: Production – Scaling Up

Manufacturing scales up production of large quantities of the vaccine, ensuring all product meets the necessary regulatory requirements, including current Good Manufacturing Processes (cGMP).2

 

 

Step 6: Quality Control – Performance Review, Post-Marketing

The vaccine is continuously tracked and monitored for its performance, safety, and effectiveness through pharmacovigilance conducted after the product is released into the market.2,4

 

 

Vaccine Development Infographic (3).png

 

 

References

  1. International Federation of Pharmaceutical Manufacturers & Associations. The complex journey of a vaccine: the steps behind developing a new vaccine. Accessed April 15, 2020. https://www.ifpma.org/wp-content/uploads/2019/07/IFPMA-ComplexJourney-2019_FINAL.pdf
  2. Milken Institute of Public Health: George Washington Public Health Online. Producing prevention: the complex development of vaccines. Published March 6, 2019. Accessed April 16, 2020. https://publichealthonline.gwu.edu/blog/producing-prevention-the-complex-development-of-vaccines/
  3. Centers for Disease Control and Prevention. Vaccines and Immunization: vaccine testing and the approval process. Updated May 1, 2014. Accessed April 15, 2020. https://www.cdc.gov/vaccines/basics/test-approve.html
  4. The College of Physicians of Philadelphia: The History of Vaccines. Vaccine development, testing, and regulation. Updated January 17, 2018. Accessed April 16, 2020. https://www.historyofvaccines.org/content/articles/vaccine-development-testing-and-regulation

 

MORE ON COVID-19
How to stay safe and prevent the spread.

The Pfizer-BioNTech COVID-19 vaccine has not been approved or licensed by the U.S. Food and Drug Administration (FDA), but has been authorized for emergency use by FDA under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) for use in individuals 16 years of age and older. The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564(b)(1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner. Please see EUA Fact Sheet at www.cvdvaccine.com.

Every step of the way, our team is committed to pursuing research and forming partnerships that facilitate the rapid development and delivery of a vaccine.

Related Hot Topics
Albert Bourla On Ensuring Equitable Access to COVID-19 Vaccines
Albert Bourla On Ensuring Equitable Access to COVID-19 Vaccines
The Facts About Pfizer and BioNTech’s COVID-19 Vaccine
The Facts About Pfizer and BioNTech’s COVID-19 Vaccine
Sandy Focuses on Diversity in Our Clinical Trials
Sandy Focuses on Diversity in Our Clinical Trials
An Early Passion for Science and Public Health Inspires Adriana’s Work
An Early Passion for Science and Public Health Inspires Adriana’s Work
“The Ice Man” - The Pfizer Colleague & Dad Who Keeps Our Medicines and Vaccines on Ice
“The Ice Man” - The Pfizer Colleague & Dad Who Keeps Our Medicines and…
KZOO-Vials-in-Tray-2-(1)_380X220.jpg
Distributing Our COVID-19 Vaccine to the World
KZOO_Filling_Line_10_380X300.jpg
COVID-19 Vaccine U.S. Distribution Fact Sheet
Scientists_Image_380X220.jpg
Albert Bourla Discusses Our FDA Submission
Tags
Clinical Trials
COVID-19
COVID-19 Vaccine Efforts
Global Product Development
science
Vaccines
Show
Hide

Footer menu

  • Your Health
    • Healthy Living
    • Disease Conditions
    • Manage Your Health
  • Our Science
    • Therapeutic Areas
    • Product Pipeline
    • Clinical Trials
    • R&D Platforms
    • Collaboration
    • Research SItes
  • Our People
    • Meet the Experts
    • The Journey
    • Leadership
    • Diverse Perspectives
  • Our Purpose
    • Commitment To Global Health
    • Positions on Health Policies
    • Transparency
    • Contributions & Partnerships
  • Our Products
    • Product Listing
    • How Drugs are Made
    • Distributors
    • Global Product Information Contacts

Footer aside

  • Footer Aside Section1
    • CAREER-SEEKERS
    • INVESTORS
    • News & Media
    • Partners
  • Footer Aside Section 2
    • Healthcare Professionals
    • Business To Business
    • Change Region
    • Sitemap
  • Footer Aside Section3
    • Twitter
    • Facebook
    • Linkedin
    • Instagram
    • Youtube
  • Footer Aside Section4
    • Contact Us
    • Terms of Use
    • Privacy Policy
Pfizer Logo Footer

Copyright © 2002-2021 Pfizer Inc. All rights reserved. This information—including product information—is intended only for residents of the United States.
The products discussed herein may have different labeling in different countries.