The Story
Drop the ‘emergency use’ part. Pfizer’s vaccine just got FDA approval.
Do tell.
There are three COVID-19 vaccines on the US market: Pfizer's, Johnson & Johnson's, and Moderna's. All three have been greenlighted for emergency use. Meaning, they showed enough efficacy early on to get the provisional go-ahead. Now, after reviewing 340,000 pages of data, the FDA is patting itself on the back for the call.
Go on.
Pfizer’s clinical trial followed thousands of subjects for at least six months – up from the two months needed for emergency use authorization. The FDA found that serious side effects like heart inflammation were still extremely rare. Also, that efficacy at preventing COVID-19 six months out was 91%. Worth noting: that six-month period wrapped up before the delta variant hit. Delta is believed to have taken a big hit on efficacy.
Which means...boosters?
Correct. Pfizer plans to ask the FDA to give it the full approval for boosters, too – something the Biden admin wants to start rolling out for people soon. Meanwhile, Moderna is waiting for its turn to get the FDA’s full approval. J&J says it will file later this year. But heads up: the full approval for Pfizer is only for people 16 and up. Kids ages 12-15 can still get vaccinated under the FDA’s emergency use authorization.
So...what now?
There are about 85 million unvaccinated Americans eligible to get shots. The Biden admin is hoping the FDA’s endorsement for Pfizer will ease some of their concerns. One poll found that 31% of unvaccinated adults said that the FDA’s full approval would make them more likely to get it. The move could also open the door wider for mandates. Following the announcement, the Pentagon said it’s moving ahead with vaccine requirements for service members. It comes as NYC requires all public school staff to get at least one dose over the next month.
theSkimm
Never before in the history of the FDA has the agency reportedly had this much data to look at when approving a vaccine. Now, as delta wreaks havoc on the country, health officials are hoping the FDA’s stamp of approval will give a boost of confidence to those still hesitant of rolling up their sleeves.
PS: The FDA’s approval could mean your workplace will require a COVID-19 vaccine. Wondering if it’s legal? The short answer: yes.
