FDA review and long-term safety monitoring
Once data from Phase 3 is compiled, vaccine developers send all safety and efficacy data to the FDA for review. At the same time, the proposed manufacturing site must pass a pre-approval inspection visit where officials ensure the vaccine can be produced safely.
With the clinical trial and manufacturing data in hand, experts at the FDA determine whether the data show the vaccine is safe, effective, and can be manufactured at a high quality and on a consistent basis. Only after these criteria are met, the FDA will provide its stamp of approval for the vaccine.
But the journey doesn’t end there. The FDA, Centers for Disease Control and Prevention (CDC), and vaccine developers continue monitoring the vaccine’s safety and efficacy as long as the vaccine is used. Moreover, your local health care provider serves as yet another line of protection in an already heavily guarded process. They are legally obligated to report any adverse or negative outcomes to the FDA and CDC.
The vaccine development process is designed to ensure any vaccines used by the public have undergone rigorous testing to prove they are safe and effective. Ultimately, the vaccine development process helps make sure we are best equipped to protect our families and communities.
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