Vaccine Testing and Development Timeline and Myths

New vaccines must go through a long journey before they are finally approved by the FDA and get added to the recommended immunization schedule.

Vaccine Testing and Development Myths

There are many myths and much misinformation surrounding vaccine testing and development that is used to scare parents away from vaccinating their kids.

Have you heard that vaccines aren’t tested together?

Or that flu vaccines or Tdap were never tested on pregnant women?

Then there are the myths about fast-tracking, and that important steps are skipped when a vaccine is on fast track for FDA approval, or that the whole vaccine testing and development process happens very quickly.

Vaccine Testing and Development Timeline

The vaccine development process is anything but quick.

“Vaccine development is a long, complex process, often lasting 10-15 years and involving a combination of public and private involvement.”

The History of Vaccines on Vaccine Development, Testing, and Regulation

During this time of the exploratory and pre-clinical stage research and then phase 1,2, and 3 trails, vaccines are:

• tested on animals
• tested on small groups of people
• tested on larger groups of people
• tested alone
• tested together with other vaccines
• tested for safety
• tested for efficacy (to make sure they work)

This often includes double-blind, placebo controlled vaccine trials.

Fast tracking does speed the process up, but not because any of the testing is skipped. The researchers just get more frequent meetings and communication with the FDA and “Eligibility for Accelerated Approval and Priority Review, if relevant criteria are met.”

“Vaccine development is a complex multidisciplinary activity, combining understanding of host-pathogen interactions at the molecular level, with clinical science, population-level epidemiology and the biomechanical requirements of production.”

Anthony L. Cunningham, et al on Vaccine development: From concept to early clinical testing

Testing doesn’t stop once a vaccine is approved by the FDA and is added to the immunization schedule either. We often continue to see testing for vaccine safety and efficacy using phase 4 trials and with our post-licensure vaccine safety system, including VAERS and the Vaccine Safety Datalink.

And of course testing continues long after we begin using vaccines to see how long their protection will last. For example, because of continued testing, we now know that Gardasil and Cervarix are providing protection that lasts at least 8 and 9 years.

What To Know About Vaccine Testing and Development

From pre-clinical studies and years of phase 1, 2, and 3 trials to continued monitoring after a vaccine is approved and added to the immunization schedule, the vaccine testing and development process helps make sure that vaccines are safe and that they work.

More About Vaccine Testing and Development

• Vaccine Development, Testing, and Regulation
• CDC – Vaccine Testing and the Approval Process
• The Science Behind Vaccine Research and Testing
• FDA – Background on Viral Vaccine Development
• Debunking myths about vaccine testing and safety
• Vaccines aren’t tested – myth vs. science
• Safety of Flu and Pertussis Vaccines in Pregnancy Assessed
• Vaccine Development, Testing, and Regulation
• Placebo use in vaccine trials: Recommendations of a WHO expert panel
• Making Vaccines: Process of Vaccine Development
• FDA – Fast Track
• Vaccine Trials: Methods and Best Practices
• Report – Current topics in research ethics in vaccine studies
• WHO – Guidelines on clinical evaluation of vaccines: regulatory expectations
• WHO – Ethical considerations arising from vaccine trials conducted in paediatric populations with high disease burden in developing countries
• Was the Gardasil vaccine ever compared with a placebo?
• Debunking myths about vaccine testing and safety
• Study – Vaccine development: From concept to early clinical testing