COVID-19 vaccine news has been heating up in recent weeks with perhaps the biggest story to date dropping Thursday morning. Apparently, the U.S. Food and Drug Administration (FDA) is set to convene and vote on the approval of the Pfizer-BioNTech vaccine, making it the first to hit the market in the United States. And it would mean that effective immediately following that vote, the vaccine would be available under an emergency use authorization.
The vote for the COVID-19 vaccine is apparently a foregone conclusion with little doubt it is unanimously approved by the FDA. This would then set up for the beginning stages of distribution. The key group determining the vote is the FDA’s Vaccines and Related Biological Products Advisory Committee whose board apparently holds the final sway in the process.
Regarding this new COVID-19 vaccine, former FDA chief Dr. Margaret Hamburg has said the side effects from those to whom it’s been administered are showing up more and more. But apparently, that’s a good thing in the vaccine world, signaling that it’s growing in strength in the fight against the virus. The body’s growing response to the vaccine, among test patients, means higher rates of effectiveness. This, among other things, will probably be key discussions on Thursday from the FDA committee.
On Wednesday, it was reported that pending FDA authorization, the Pfizer-BioNTech COVID-19 vaccine would begin a government distribution rollout. That first batch would be for up to 3 million doses of the vaccine to be made available. The emergency use authorization by the FDA is a way to speed along the approval process outside of the group’s typical way of approving new and experimental drugs. It allows a fast track policy in times of what’s deemed great public need. Apparently, the COVID-19 crisis meets that criteria.
The first recipients of the COVID-19 vaccine will likely be the nation’s healthcare workers who are in the most contact with those already infected with the virus. Additionally, those residing and working in residential care nursing facilities would also be among the first group to see the doses. The federal government has also said they would be stockpiling additional doses of the vaccine in coming weeks, up to 500 million total, as it begins a larger-scale rollout for other populations that aren’t deemed as high risk.
News of the FDA approval comes at a time when more and more institutions are signaling they’ll require proof of the COVID-19 vaccine among citizens. Ticketmaster has said they will want to see proof of the vaccine before attending concert events. Meanwhile, Australia’s largest airline Qantas has said it will require passengers to be vaccinated before taking any flights. These aren’t likely to be the last companies deciding to go this route with documented proof of the vaccine. It stands to reason we see much more of this in short order when the vaccine is in wider distribution.
Again, the FDA’s committee resolution on fast-tracking the vaccine isn’t likely to be a long or drawn-out meeting. There’s great confidence it’s merely a formality and by the end of the week, the COVID-19 vaccine will begin to make its initial rounds.