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INDIANAPOLIS (WISH) – A U.S. Food and Drug Administration committee met virtually for the first time this week to discuss the safety of moving forward and fully approving the booster injections of Pfizer against COVID-19.
So what does it take for a vaccine to be approved by the FDA?
The business, to say the least, is rigorous. The independent review board recruits the best scientists in each of their areas of expertise to assess different sectors. The goal is to make an informed, evidence-based decision about whether to move forward.
Full approval is very different from emergency use authorization, according to Dr. Aaron Lottes, professor of engineering at Purdue University. The standards are higher and the process is much longer. If granted, the public, he says, should have full confidence in the agency’s decision, whether it is a yes or a no.
“It really is a different bar. Approval has a higher bar. This is a full standard review process that any vaccine would go through, ”Lottes said. “And once the FDA looks at all the data, it’s really comprehensive data. Long-term follow-up data are now available…. They determine that the vaccine is safe and effective against COVID-19. “
Full approval depends on a number of factors. There are different sectors and scientists in each category who are responsible for evaluating the data presented under the microscope. Some of them include:
- Evidence: There are tens of thousands of studies around the world that researchers will evaluate to determine if the evidence is strong enough to support the vaccine.
- Manufacturing: Is the establishment responsible for sterility and compliance with the vaccination code? Labeling: Are the labels clear and systematic on all packaging and vials of vaccine?
- Dosage: Are some diluted? Are some more powerful? Each dose should be consistent in terms of concentration to avoid complications.
The risks versus the benefits are then weighed, meaning what the potential side effects are and is there more to be gained by getting the vaccine than not.
After this long process, the committee decides whether the vaccine is safe and effective enough to warrant full FDA approval.
While the initial two-dose series of Pfizer is FDA approved, the Moderna shot is not. However, says Lottes, we can expect a final decision in the coming weeks.
Below, the full interview with Lottes. Users of the app can go online to find it with this story.
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