At long last, the FDA fully approved Pfizer's COVID vaccine this week, upgrading it from "emergency use authorization" status. This outcome felt like a long time coming, considering that more than 200 million doses of this particular vaccine have already been injected into Americans (Moderna clocks in at approximately 142 million, with Johnson & Johnson at 14 million). In case you missed the news on Monday, here are a few details of yesterday's approval, which will likely have an immediate impact:
TODAY: The FDA granted full approval to the Pfizer-BioNTech CoV2 vaccine in people 16 years and older.
— Nicole Saphier, MD (@NBSaphierMD) August 23, 2021
The Food and Drug Administration on Monday granted full approval to Pfizer-BioNTech’s coronavirus vaccine for people 16 and older, making it the first to move beyond emergency use status in the United States...Pfizer said it presented the F.D.A. with data from 44,000 clinical trial participants in United States, the European Union, Turkey, South Africa and South America. The company said the data showed the vaccine was 91 percent effective in preventing infection — a slight drop from the 95 percent efficacy rate that the data showed when the F.D.A. decided to authorize the vaccine for emergency use in December. Pfizer said the decrease reflected the fact that researchers had more time to catch people who became infected...The Pfizer-BioNTech vaccine will continue to be authorized for emergency use for children ages 12 to 15 while Pfizer collects the necessary data required for full approval. A decision on whether to authorize the vaccine for children younger than 12 could be at least several months away...Some experts have estimated that full approval might convince just five percent of those who are unvaccinated to get shots. Even if that’s so, “that’s still a huge slice of people,” Dr. Thomas Dobbs, the chief health officer for Mississippi, a state that is particularly hard hit by the Delta variant. He said licensure will help “shake loose this false assertion that the vaccines are an ‘experimental’ thing.”
The clinical trials have been robust, but the far, far wider body of evidence lies with the hundreds of millions of doses that have been administered, demonstrating the safety and effectiveness of the vaccine. It's true that its protection against infection appears to be waning amid the Delta surge – this is most concerning among vulnerable groups who got vaxxed earliest, and who are beginning to get recommended boosters – but prevention of serious outcomes like hospitalization or death remains very strong. The doctor quoted in the Times piece is right that some vaccine skeptics have been dissuaded by the notion that the emergency-use-only vaccines are "experimental," a questionably-described distinction that is vitiated by full FDA approval. Some anti-vaccine individuals who've relied on the "experimental" line will inevitably shift to a new rationale to reject the life-saving shots, but some data has indicated that at least some of the hesitant would genuinely be moved by the FDA bestowing its final and formal blessing, which it now has. A new poll from NBC (showing Joe Biden taking on water) suggests that amid this nasty Delta wave hospitalizing and killing scores of unvaccinated Americans, the ranks of the "hard no" contingent may be dwindling:
Of note: Only 13 percent of Americans in new NBC poll say they will never take the COVID vaccine, as cases spike across the South.
— Josh Kraushaar (@HotlineJosh) August 22, 2021
Lower than in other surveys. https://t.co/CGR5kcTDwS
Delta worries and spikes in very serious cases were already moving the needle significantly before the FDA officially green-lit Pfizer for final approval. This is from just before the FDA announcement:
The U.S. administered more than 1 million vaccine doses Friday, marking the third day in a row more than a million shots were distributed, according to a White House official. Cyrus Shahpar, the White House’s COVID-19 data director, said more than 1.05 million doses were given Friday, including 526,000 first shots. Shahpar noted that 200 million Americans have now received at least one dose of a COVID-19 vaccine.
It's been weeks since the US was last vaccinating at this clip. Hopefully, the FDA development will convince some unsure Americans to jump off the fence. Then there are the people who may soon get shoved off the fence by their employers, a much likelier scenario now that the shots have been officially approved:
The [FDA] decision will set off a cascade of vaccine requirements by hospitals, colleges, corporations and other organizations. United Airlines recently announced that its employees will be required to show proof of vaccination within five weeks of regulatory approval. Oregon has adopted a similar requirement for all state workers, as have a host of universities in states from Louisiana to Minnesota. The Pentagon has said it would mandate the shots for the country’s 1.3 million active-duty troops once the Pfizer approval came through.
Mandating vaccines for active-duty troops, or students at various levels is hardly groundbreaking. I continue to prefer non-mandates, but make no mistake: They're coming. I'll leave you with two points: First, remember the flurry of claims a few weeks back, amplified by public health officials, that viral loads among the vaccinated were as strong as among the unvaccinated? New data suggests the reality is more optimistic:
Good summary of the data here by @sailorrooscout. Yes, symptomatic delta breakthroughs may transmit but likely LESS likely to transmit and you are less likely to be infected in first place if you are vaccinated. https://t.co/TO4eqZvV63
— Monica Gandhi MD, MPH (@MonicaGandhi9) August 23, 2021
And finally, we know the vaccines work incredibly well. Masking in schools? We've been through that, and I won't beat that drum again, at least in this post. Masking in general? This is interesting:
Actual data! How about that? https://t.co/k9O4ej2rCI
— Pradheep J. Shanker (@Neoavatara) August 23, 2021
