BRAZOS COUNTY, TX — A U.S. government advisory panel has endorsed Pfizer’s coronavirus vaccine, opening the door for the FDA to provide emergency use authorization in the coming days.
”One of the things that the FDA advisory panel today [Thursday] is going to look at are those potentials for those vaccine reactions,” said Jason McKnight, primary care and population health expert with Texas A&M.
Data collected through Pfizer's clinical trials was thoroughly reviewed by the selected FDA advisory committee in order to come up with a recommendation for the FDA.
”It is a group of scientist and physicians and vaccine researchers and really all interested parties who look at all the data,” said McKnight.
After reviewing the data, the committee voted 17-4 with one abstention that the FDA should grant emergency use authorization.
”Very early on before any vaccine candidates were even introduced, the FDA set forth criteria that they were going to be required to be shown in studies before something could even receive that emergency use authorization,” McKnight added.
The FDA has set four main criteria points that must be met in order to acquire the emergency use authorization. Those points include the effectiveness and potential benefit of the vaccine, if the danger to the public is life threatening, and that there should be no other alternatively approved product.
”Before emergency use authorization would be granted, they had to study these populations getting the vaccine for at least two months. The majority of patients who received this vaccine in the Phase 1, Phase 2 and Phase 3 trials, they have now been evaluated for over six months,” McKnight said.
Now that the committee has made its recommendation, it's up to the FDA to officially give its approval. Once that happens, the vaccine can be distributed.
”Once the approval is in place, I should say, they will then send the vaccines to Texas. They already have 109 hospitals that have been chosen for their allocated vaccines,” said Daniel Owens, a members of the Texas Infectious Disease Preparedness Task Force.
”Once approval or emergency use authorization is granted, these vaccine companies will continue to follow patients both in the studies and outside the studies to ensure that there are no long-term adverse reactions,” McKnight added.