WASHINGTON (AP) — An influential federal advisory panel overwhelmingly rejected a plan Friday to give Pfizer COVID-19 booster shots to most Americans, but it endorsed the extra shots for those who are 65 or older or run a high risk of severe disease.
The twin votes represented a heavy blow to the Biden administration’s sweeping effort to shore up nearly all Americans’ protection amid the spread of the highly contagious delta variant.
The decision was made by a committee of outside experts who advise the Food and Drug Administration.
14 thoughts on “From the AP: US panel backs COVID-19 boosters only for elderly, high-risk”
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Fridays.Report
THERE MAY BE A LOOPHOLE!
“High-risk” includes “obesity”… which is defined as, what? 25 BMI or higher?Report
30. If they’re going to be honest and confine it to “severe” obesity, 40.Report
I’m too slow.Report
We all have days like that.Report
I have no problem with telling the pharmacist “Seriously, I’m totally a 30.”Report
Looks like > 30 BMI per Pfizer’s FDA briefing document. But Pfizer didn’t seek permission for a specific subset, so there may be other data that has not been made public that would define the eligible group.Report
This sounds like the panel rejected the “waning” efficacy argument presented by Pfizer (one panel member was quoted as telling Pfizer they’ve looked at their data and don’t see it, per CNN), but agreed that some portion of the population is not as likely to have gotten a good immune response from primary vaccination. That was known at the time of the initial emergency authorization.Report
To be honest, I’m not really surprised.
The one part of the whole process the rush due to the pandemic would stress would be the dose timing.
Safety, short-term efficacy? Those were going to be solid. But I wouldn’t be surprised to find that that the optimal dose timing will be adjusted in the future. What we have is “good enough” given the stress the system is under.
But perhaps they’ll end up with a three-dose setup like Hep A, or a larger or smaller gap between two doses, etc.Report
That committee is going to care hugely about medical ethics. That means it’s a committee of people who didn’t want to say FU to the world’s unvaccinated.
You see this issue pop up whenever we’re compared against the world’s HC system and always one of the metrics is equality.
Pity. I have school age kids. The odds of them being exposed is very high. I was looking forward to reducing the impact of a break through.Report
Yep. Called it.
Then, in an 18-0 vote, it endorsed extra shots for people 65 and older and those at risk of serious disease. Panel members also agreed that health workers and others who run a high risk of being exposed to the virus on the job should get boosters, too.
Read between the lines and it works for people who might face exposure but “major ethical concerns” (i.e. for us hogging the vaccine) wins out.
https://www.sbsun.com/2021/09/17/us-panel-backs-covid-19-boosters-only-for-seniors-high-risk/Report
The take on NPR on Friday was that Pfizer didn’t prove their case with the data presented. Interestingly it was followed by a story about the high vaccination rates India has achieved while supplying the world with huge percentages of the vaccines.Report
Pfizer has been fully authorized and is no longer under an EUA. Which your friend would also know. So either he’s trolling you, or you are trolling us. Nice try.Report
There are conflicting questions.
One is individual HC and answering the question: “Does a booster help individuals”. The answer is pretty clearly yes. The panel wants to give a third shot to people with high exposure. That presumably means in terms of reducing the impact of breakthrough cases, a booster helps enough to be worthwhile for the people who are already vaccinated.
The other question is how to fight the pandemic as a whole. The panel pretty clearly got focused on “controlling the pandemic” (worldwide, and that’s a quote from them), and not what would be useful for individuals. Thus we get weird counter-arguments like Israel’s situation and experience may not apply to the US.
I buy the argument that Pfizer didn’t prove that immunity wains, but that’s irrelevant on whether a 3rd shot would be useful.
Big picture the panel is run by people who buy into the problem that: “The Biden plan has also raised major ethical concerns about impoverished parts of the world still clamoring for vaccine.” (quote from previous link).
What is best for the world and fighting the pandemic is vaccinating everyone who hasn’t been vaccinated reguardless of country. What is best for the US is reducing the impact of the virus, even if that means giving everyone a 3rd shot while three fourths of the world hasn’t had one.Report