The Pfizer vaccine could receive full approval before Labor Day.
ATLANTA – Among the millions of Americans who are yet to be vaccinated, there are those who note that current vaccines have yet to receive full approval from the U.S. Food and Drug Administration.
11Live viewer Chris Hancock is vaccinated, but she has friends and family who are not.
âI myself have been vaccinated for several months,â Hancock explains. “One of their biggest hesitations as to why they don’t want to receive the vaccine is that it hasn’t been approved by the FDA.”
The FDA has granted emergency use authorization for the Pfizer, Moderna, and Johnson and Johnson vaccines. The clearance came after a series of clinical trials, and the FDA continues to monitor the safety of the vaccines Americans are currently receiving.
Dr Anthony Fauci said he hopes the FDA will fully approve COVID vaccines before the end of the month. He predicts that when that happens, it will trigger a wave of vaccination warrants.
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Here’s why the FDA has yet to give final approval for the vaccines.
For months, while operating under the emergency use authorization, vaccine manufacturers collected data. Dr Grace Gowda of the College of Pharmacy at the University of Georgia said the FDA will carefully review all of this data before granting full approval.
âWe’re talking millions of pages,â says Dr Gowda. âThat’s pretty much everyone on deck, a whole bunch of people looking at millions of pages of documents. The FDA’s review process is the most robust in the world.
Before granting emergency use authorization, the FDA conducted a scientific evaluation. Based on this, the agency says it “can assure the public and the medical community that vaccines meet rigorous FDA standards for safety, efficacy and build quality.”
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The agency can withdraw an emergency use authorization and stop the use of a vaccine if there is a problem.
Dr Gowda says that once the FDA gives its final approval, it is very difficult to remove this distinction.
âThere is a big burden on the FDA when it uses the term ‘approve’,â says Dr. Gowda. âThis has legal implications. Once they approve it, the only way to get it back is to take legal action. They can go to court. They have to show a gap and it’s a big process, so approval is a big step.
Dr Gowda says the data review process alone typically takes up to two years for the FDA.