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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

 

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

 

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.

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Emergency uses of the Pfizer-BioNTech COVID-19 Vaccine have not been approved or licensed by the FDA, but have been authorized by the FDA, under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) in individuals 5 years of age and older. COMIRNATY is licensed by the FDA for individuals 16 years of age and older. In addition, COMIRNATY is under EUA for individuals ages 12 through 15, a third dose for certain immunocompromised individuals 12 years of age and older, and a booster dose for certain individuals 18 years of age and older. The emergency uses are 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 Sheets at www.cvdvaccine-us.com.

M
Meghna Rao