Makary and Prasad have a sounding board piece written in NEJM about the future of COVID-19 vaccine regulation at the FDA. Some thoughts: - ThreadSky

enirenberg.bsky.social • 12 days ago

Makary and Prasad have a sounding board piece written in NEJM about the future of COVID-19 vaccine regulation at the FDA.

Some thoughts:

Comments

djjakej.bsky.social•12 days ago

Insanity! They want to let it rip!
8 shots in arms! 6 Pfizer left and 2 Moderna Right! They will be studying me! Lol! 😂 55 and caught it in 10/2021 mild due to 2nd Pfizer was months before!
But crazy 18 months of long hauler! Diabetes got worse! Heart rate dropped! 42 Resting now! 110 maxes out.

djjakej.bsky.social•12 days ago

I will get a Covid shot again. No placebo’s I trust Science! Maybe Novavax next? All 3 covid vaccines? Why not.

ckb67.bsky.social•12 days ago

That list of increased risk is pretty limited. „Neurological conditions limited to dementia and Parkinson’s?“ What about ALS? What about some of the rare diseases? Will they let providers determine their patients‘ risks? Or should they just say they are physically inactive, since that’s on the list?

djjakej.bsky.social•12 days ago

Still recommended for many to get the real shot! They will kill more and sicken more to study it for 10 years. The country with the most dead and sick from covid! With only 4% of the population! 18% Of Covid Dead! Lies are still killing from Covid! Unvaccinated with the 2024 shot die more often!

halibut.bsky.social•12 days ago

This confuses me because unless something has changed since last fall, everyone here in BC, Canada is encouraged to get COVID boosters? The province texts me to set up appointments for me and my kids.

enirenberg.bsky.social•12 days ago

Yeah I didn’t have time to go through the table country by country but it did look suspicious to me

halibut.bsky.social•12 days ago

We do run our *spring* program like this. So people at risk get two boosters a year. But everybody gets one in the fall, typically with a flu shot.

martinhope.bsky.social•11 days ago

📌

ericmeyerowitz.bsky.social•12 days ago

Figure 1 is also wildly misleading

In most countries you are eligible for annual boosters from 18-64 regardless of comorbidities or immune compromise, and the vaccines are specifically recommended for all over age 65

See Australia:

https://www.health.gov.au/our-work/covid-19-vaccines/getting-your-vaccination

enirenberg.bsky.social•12 days ago

Yeah it did look hinky to me but I didn’t have the time to look into it more closely when I was writing the thread

larksandkatydids.bsky.social•12 days ago

Canada also offers covid boosters to everyone? I can't find ANYTHING where it's even a recommendation that only older people or people with health conditions? See here: https://www.canada.ca/en/public-health/services/publications/healthy-living/canadian-immunization-guide-part-4-active-vaccines/page-26-covid-19-vaccine.html#a15

ericmeyerowitz.bsky.social•12 days ago

Thanks for sharing that!

christophersdad.bsky.social•12 days ago

In Austria, infants from 6 months of age can receive a free vaccination against Covid, and the national vaccination plan for 2024/25 says everyone aged 12 and over can get the annual booster, see p. 13–14

ericmeyerowitz.bsky.social•12 days ago

Thank you for sharing!

pidringer.bsky.social•11 days ago

With nary a word about Long COVID and protection for those who desire it....

dj1au.bsky.social•12 days ago

Once upon a time the US was a world leader and better than other countries but now looking at inferior countries to justify making the US weaker.

doxy-cycling.bsky.social•12 days ago

I kinda think it should factor in that in the US the vaccines can be cheap, but a hospitalization for a few days can financial devastate someone. In those other countries, you can be hospitalized without going bankrupt. Any hospitalization is not ideal of course.

beware1984.bsky.social•12 days ago

https://bsky.app/profile/sabivm.bsky.social/post/3lpnijlmmvk2g

quantumtessera.bsky.social•12 days ago

Can we get them if we pay out of pocket?

enirenberg.bsky.social•12 days ago

Provided they are licensed under a BLA I believe so

danielwilliams965.bsky.social•12 days ago

@ [at] the FDA sounds spicy. I don't rate your chances.

zpgs2025.bsky.social•12 days ago

Does this likely mean we’ll need an RX for vaccines, or do you think we’ll be able to self attest at a pharmacy?

calyps09.bsky.social•12 days ago

That’s been the case for a while now. CVS, etc ask about high risk status and if you say yes they give it to you.

zolascola.bsky.social•12 days ago

I had to get a Rx this year for booster. Pharmacy (Costco) said they couldn’t go against CDC guidance, even if I paid out of pocket.

danaaddydesigns.bsky.social•12 days ago

📌

enirenberg.bsky.social•12 days ago

Before getting into this, it's worth noting that there is an upcoming ACIP meeting that was going to discuss COVID-19 vaccine recommendations and a VRBPAC meeting on Thursday for strain selection. The timing here seems to intentionally undermine those proceedings.

enirenberg.bsky.social•12 days ago

This is a straw man and not in fact how the policy has been justified. People are fully capable of understanding age- and risk-based recommendations. However, accessibility to care and health disparities are a much more serious problem in the US than in other higher income countries.

ericmeyerowitz.bsky.social•12 days ago

Wild that the citation for that ridiculous statement is a news article written by Makary where he inserts some out of context quotations from a public ACIP meeting

radiantvimes.bsky.social•12 days ago

This sounds like another case of the MAGA crowd saying the quiet part out loud. They truly want to believe that the American people literally really are just that dumb.

radiantvimes.bsky.social•12 days ago

And they want the American people to believe that about themselves, too

enirenberg.bsky.social•12 days ago

With this in mind, minimizing barriers to accessing vaccines is likely to achieve the best possible health outcomes. Furthermore, we are persistently disregarding the fact that COVID-19 vaccines do reduce transmission. High-risk individuals are frequently high-risk for reasons that...

geneticsmike7.bsky.social•12 days ago

Well, they haven't reduced symptomatic infection by any reasonable amount since 2021, so I'm very skeptical of any notable reduction in transmission, particularly 1-2 months post-vaccination.

angelaisms.bsky.social•12 days ago

Vaccinating my kids protects them *and* me. And protecting me helps them. Because despite what the covid minimalists have been declaring for years now, kids *are* better off when their parents are able to, you know, function.

enirenberg.bsky.social•12 days ago

compromise their ability to mount a protective immune response. Placing the burden of their protection entirely on them is the antithesis of public health.

geneticsmike7.bsky.social•11 days ago

I do think there is no evidence to suggest that additional Covid vaccines are a net health benefit to most relatively healthy, <65yo individuals, and that is very much relevant for proper public health decisions. This has been true for 2-3 yrs now.

mdaware.org•12 days ago

"we should protect the vulnerable"

enirenberg.bsky.social•12 days ago

I don't think I can adequately put into words how infuriating this is coming from these two who actively worked to undermine confidence in childhood vaccination, particularly Vinay Prasad. However, their own reference doesn't even support the insinuation behind their claim.
https://archive.ph/kT8wg

merz.bsky.social•12 days ago

And Prasad’s wild lies in the Indian press likely led to thousands of avoidable deaths.

enirenberg.bsky.social•12 days ago

Rates declined rapidly with the pandemic onset, before any vaccines were available, which appears to be the clear result of political polarization around vaccines in general and pandemic-related disruptions to accessibility of care. That their boss managed to catapult this into some form of...

melodyschreiber.com•12 days ago

This is a constant refrain of Prasad's and there's absolutely no evidence for it

agathedemarais.bsky.social•11 days ago

For France this is misleading. Recommendation is:
- All aged 65+ (not 80 as table states); all at high risk; and all who live with high-risk folks get annual shot in Fall
- Those aged 80+ or at very high risk should also get Spring booster
- Anyone can get an annual shot for free, no questions asked

agathedemarais.bsky.social•11 days ago

Source: https://www.ameli.fr/assure/sante/themes/covid-19/vaccination-contre-le-covid-19/vaccination-covid19

andrewtanyongyi.bsky.social•12 days ago

Prasad & Makary appear reasonable by mimicking UK JCVI, but cannot hide their anti-vax pandering as they write "these studies alone can provide reassurance that the American repeat-boosters-in-perpetuity strategy is evidence-based", referring to methods very different from studies valued by UK JCVI.

greyson.bsky.social•12 days ago

This is an egregious misrepresentation of comparator country policies.

In Canada, for ex, NACI's most recent statement summary is here: https://www.canada.ca/en/public-health/services/publications/vaccines-immunization/national-advisory-committee-immunization-summary-guidance-covid-19-vaccines-2025-summer-2026.html

greyson.bsky.social•12 days ago

Since we don't currently expect updated vaccine, people who *should* get another dose: 65y+, unvaccinated 6m+, pregnant, ppl w underlying conditions, residents in congregate living or Indigenous communities, HCW, members of equity-denied communities.

All others 6m+ *may* receive another dose.

greyson.bsky.social•12 days ago

People who *should* get 2 doses per year: 80y+, adults in longterm care homes/other senior congregate care, anyone moderate or severely immunocompromised who is 6m+, age 65-79 with risk factors for severe C19 disease.

If mutations mean updated vaccines become available, this will be revisited.

mmorgenschoen.bsky.social•12 days ago

in other countries “recommendation” means “recommendation”. it doesn’t mean “limiting access to these groups and denying it to others”.

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