Please forgive me if this reads a little frenetic. I wanted to give you an immediate read on some news that's come to seem more confusing than it is.
I spent the whole day watching the very high-stakes, very low-energy meeting of the FDA advisory committee that was reviewing the evidence on Pfizer vaccine boosters.
I hope you had more fun today than I did. By which I mean, you did anything else at all.
No no, truly it’s reassuring to see how much scrutiny goes into this process. Today panel of 18 vaccine experts convened, per traditional FDA protocol (except via Zoom, with someone almost always, humanizingly, forgetting to mute). They went through all the clinical data on boosters in granular detail, evaluating safety and effectiveness. And they grilled the Pfizer execs on all the gaps in their case for boosters.
The entire meeting was open to the public, and you can watch it if you want. It's not good entertainment, but it's less frustrating than Ted Lasso. And might be eye-opening for anyone who genuinely believes the vaccine approval process was "rushed" and wants to see how slowly and deliberately people can read powerpoint slides that surely took far longer to create. Only about 5,000 of us were actually watching live, despite millions of people having very strong takes on it. (In fairness, it’s boring.)
As you probably heard right away, the BREAKING NEWS was that the group voted 16-2 against Pfizer’s request for approval of boosters for all people 16 and older.
That vote was entirely unsurprising. Pfizer basically just ... didn’t have evidence that young people need boosters. It was almost like they were bluffing.
And it was strange to watch the company argue that their product was going to stop working probably, even though it’s still working really well right now.
It was the inverse of the approval meeting last December (which I also lamentably watched in full). At that point, Pfizer came before the committee to make the case that their vaccines are extremely effective. The FDA experts tried to punch holes in the argument and make sure the evidence was rock solid. It was.
And since then, the vaccines have continued to prove extremely effective, overall. Effectiveness at preventing hospitalization is still 80-90 percent after six months. Pfizer was trying to argue that it wasn’t clear that this effectiveness would continue to hold up after that. Anyway, it was weird, but that’s not why you’re here.
So the committee voted against approval. And millions of people got a push alert / headline / tweet saying that the FDA didn't approve the boosters.
But ... that was, dear reader, not the end!
There’s very clearly a subset of people who do benefit from boosters, everyone agreed.
So in the final 30-ish minutes of this very long day, the committee debated how to define that group. They spent a while discussing whether the age cutoff should be 60 or 65, and which medical conditions should be included, etc. And ultimately they left it kind of vague, authorizing booster shots for people 65 and older or who are “at high risk of severe COVID-19.”
That made sense. (Given that the group had agreed not to consider issues like global equity of vaccine distribution in the discussion. Because if they did that, they’d immediately adjourn. No one needs a third dose more than someone else needs their first.) But there is clearly evidence that immunity does fade with time, and high-risk groups can benefit from boosters.
That would've been a mostly satisfactory end to the story.
Except that there's also some very legitimate concern about health-care workers. Even though they may be younger than 65, and not necessarily "at high risk of severe disease" because of medical conditions, they are at higher risk of exposure than most people. And when hospitals are overwhelmed and systems are stretched thin, every otherwise-healthy respiratory therapist who calls into work sick—even if they ultimately recover and are fine–can mean that someone high risk goes without care and doesn't recover. Many ICUs are already short staffed and need all hands on deck.
So, just before adjourning, the committee added a clause to include health-care workers in the authorization. Then they expanded that to include other high-risk jobs. And that, minutes before the Zoom ended, was probably the biggest news of the day: The group voted 18-0 to include among the authorization “individuals at high risk of occupational exposure.” Which could include, depending how you interpret it … a ton of people.
This guidance can still be tweaked and interpreted by FDA, given that this was just a meeting of an advisory committee. But usually the agency's rulings hew very closely to what the advisory committee recommends.
Everyone may need boosters eventually. But not yet. Until then, we have to grapple with the fundamental conundrum that has beset humanity since day one: Some things are good for some people but not for others.
Also, yes, false alarm with the whole “everyone can get boosters in September” thing, which was ill-informed and premature. The FDA approval process may be slow and laborious and frustrating and boring, but it’s the best we have. As Fauci said this week—possibly my favorite paragraph in recent memory—in an article for Kaiser Health News:
Maybe I’m just delirious from 8 hours of half-watching scientists far smarter than I quibble over the mechanics of multivariate regression analyses, but I love the notion that decisions are made like …
This is fictional, obviously. That's how we authorize acts of war, not how we authorize medications.
Also we … don’t have an FDA commissioner.
(I’m not sure if people don’t know that or don’t care or both, but it’s September, and still no one has been nominated to lead the U.S. Food and Drug Administration. Which would be odd in any moment, but especially during a pandemic. I’ve inquired as to why, and answers amount to: It's a very tough job to fill, because everything is so politicized, and candidates have to know so much about biostatistics and medicine and the pharmaceutical industry in order to be qualified to lead FDA that they probably already have much more stable, lucrative, lower-stress jobs in the private sector. Everyone criticizes the FDA and it's a totally thankless position. Also you have to move to DC.)
SPONSORED: Would you like to serve as commissioner of the Food and Drug Administration? Please send a current CV to Joseph R. Biden. Your cover letter can just be “It was written I should be loyal to the nightmare of my choice.”
This isn’t to say I don’t trust this process. The agency still has an acting commissioner and remains functional. It's still the closest thing we have to an independent review process to protect consumers. The review I witnessed at such length was reassuring and transparent enough that even if I missed something, and if FDA did authorize (or reject) a medication that clearly went against the available evidence, there would be an outcry. I think in this case, the system held.
Take care, have a good weekend,
P. S. If you missed the longer thing I wrote this week about how the pandemic ends, please check it out if you get a second.