FDA Approves Boosters for Over 65
Roll up your sleeves again…but only if you’re 65 or older:
A key advisory panel to the Food and Drug Administration overwhelmingly rejected recommending Pfizer booster shots for most recipients of the company’s coronavirus vaccine, instead endorsing them only for people who are 65 or older or at high risk of severe Covid-19.
The vote — the first on boosters in the United States — was a blow to the Biden administration’s strategy to make extra shots available to most fully vaccinated adults in the United States eight months after they received a second dose. The broader rollout was to start next week.
Committee members appeared dismissive of the argument that the general population needed booster shots, saying the data from Pfizer and elsewhere still seemed to show two shots protected against severe disease or hospitalization and did not prove a third shot would stem the spread of infection. Some also criticized a lack of data that an additional injection would be safe for younger people.
Based on the data we have at this point, this recommendation appears to be a reasonable. As I noted on Thursday, the vaccines seem to be holding up well for most adults but fading a bit for those over 65. Those over 65 are also the most at risk for death and serious illness. While boosters for younger adults would improve their immunity a bit, it’s nowhere near the gain that can be made be vaccinated the presently unvaccinated, whether in this country or around the world. Boosters mean that those already vaccinated are slightly safer. New vaccinations means fewer paths for the disease to spread, fewer chances for it to mutate. And, as noted by the FDA, the risk reduction for most people is so small, it means that side effects might actually factor into the decision.
There will be some nuance here as to who, exactly, qualifies as “at-risk”. But I think those decisions are probably best left to the doctor and patients, rather than dictated from on high.
Ultimately, the FDA will make the final decision. But I wonder if the panel is thinking ahead. The big worry is not fading immunity but a variant that bypasses existing immunity. If such a variant occurs, we will a need an updated version of the vaccine, possibly one with the delta spike. It might be better to keep our powder dry until that moment comes, if it comes. You can’t tell people the need a booster in September and then turn around and say they need a completely new vaccine in October.
I do think, in the future, booster vaccines will be needed. Maybe every year, maybe every three years, maybe in combination with changes to better deal with variants. But today’s news is not a “setback” for anyone. It’s a sign that the vaccines are mostly doing their job.
Let’s hope it stays that way.
Chubsters are at risk.
I get a booster.
All y’all skinny people of good repute can enjoy your two shots and your assurance from the gummint that you’re doin’ fine without a third.Report
Hm. Yesterday when I heard the news I was like “okay then I guess I don’t have to plan a day to get one and then another day to lie around the house” but yeah, I am (technically) JUST in the “obese” category. But I don’t know? My metabolic panels are always good (my doctor sighs “your blood numbers are better than mine”) and I am generally in good health.
and of course I live in Vaccine-Refusal Central, so there are more potential sources of infection than some places.
The thing I have loathed most in all of this is how on my own I have been to figure out what to do. All of adulthood is making it up as you go along, but here, making it up wrong could possibly kill you.
I guess I’ll continue to sit at home and do very little, and wait and see what my doctor says in January when I have a checkup 🙁Report
This advice is very Pfizer-cetric. It’s not clear what those of us who got J&J, which seems to be the least effective of the vaccines (though still much better than nothing) should do.Report
Sorry, as a member of the Moderna Master Race, I can’t hear you over the sound of all the antibodies coursing through my veins.Report
This past Wednesday Moderna released preliminary data they say suggests effectiveness against mild cases declines over time.
Full disclosure: My wife and I both received the Moderna shots.Report
That was pretty much expected, wasn’t it? Obviously the antibody response wasn’t going to last forever. I assume the general shape of the curve looks like Pfizer’s, but starting from a higher point.Report
But the B and T cells provide long-lasting immunity and Pfizer only presented evidence on antibodies. Apparently Pfizer (nor Moderna) have that kind of data.Report
The White House has put the FDA in a bind. They have basically said there will be a booster program later this year, at least for the oldsters and other at risk groups. Now it’s up to the FDA to figure out the terms under which such a program will operate.
Yesterday’s panel provided cover for the FDA to approve a booster for people who are Pfizer-vaccinated. Moderna has provided enough data to provide cover for extending that EUA to cover a booster for people who got the Moderna shots. The J&J people may be left out.Report
I don’t understand the plan and wasn’t even sure there was one until I googled around Friday. But the first issue is that this is a company-driven process. I believe J&J conducted simultaneous trials for single dose and two dose vaccination and only submitted one dose presumably because at that point the one-dose had a comparative advantage over the mRNA vaccines. But if J&J doesn’t ask for approval, that’s that.
The other issue is that the studies get harder and harder as we are now left with observational studies in a population that is highly infected and vaccinated, with heterogenous human responses to each, and a wide variation of socialization.Report
I can’t remember where, but I saw some data on this, and T cells don’t last much longer than antibodies. It’s only the B cells that stick around long-term.Report
It appears that memory T cells may decline, but I don’t think they would decline like antibodies. Memory cells are the source of long-term protective immunity.
This paper found more memory B cells at 6 months than at 1 month post symptom onset, with no apparent half-life. For T cells, they found the half-life to be about 3-6 months, but comparable T Cells immunity from small pox and SARs would predict that T Cell levels would stabilize btw/ 6-12 months. (SARS T-Cell response has been shown 17 years after the outbreak)
Immunological memory to SARS-CoV-2 assessed for up to 8 months after infection
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I think the FDA, with some help from the CDC and White House, have dug themselves a nasty procedural hole. There’s going to be a lot of pressure on them to at least extend EUAs to cover boosters for Moderna for the same groups they approved for Pfizer, mix-and-match vaccines in a number of situations, and cover kids. And most of it will have to be done to a political schedule, not a technical one.
I got an e-mail from Kaiser yesterday, much more weasel-worded than they usually are, about boosters. At least here in Colorado, they seem to be (justifiably, IMO) concerned about having to treat members who got the Moderna vaccine differently than they treat the members who got the Pfizer shots.Report
Go get a real vaccine.
I strongly expect that sort of mixing and matching is good for you.
I also strongly expect we won’t get advise suggesting that until after the “vaccine equity world wide” issue has been solved. That panel suggested you need a booster if your health profile is poor or if your exposure profile is high (i.e. you work in HC).
Some of the arguments coming out of that panel suggest their reasoning was more “equity” based than “this would help an individual” based.Report
I suspect that’s good advice.Report
Latest word is that two-dose J&J is looking pretty good:
https://www.cnn.com/cnn/2021/09/21/health/johnson-vaccine-two-doses-booster/index.htmlReport