Vaccines

FDA Finally Recommends COVID-19 Booster Shots for All Adults

After months of inconsistent messaging and a chaotic track record, will anybody trust it?

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On Friday, the Food and Drug Administration (FDA) officially announced its recommendation for COVID-19 booster shots for all American adults. This is great news, as the U.S. faces not only the continued spread of the delta variant, but also potential outbreaks over the winter. Unfortunately, the agency's track record up to this point could seriously jeopardize the rollout.

The new guidelines recommend single-dose boosters of either the Pfizer or Moderna vaccines for any American adult who has received either two doses of the Pfizer or Moderna shots, or one dose of the Johnson & Johnson vaccine. As the FDA's announcement explains, "Prior to today's authorizations," single-dose vaccine boosters "[were only] authorized for administration to individuals 65 years of age and older, individuals 18 through 64 years of age at high risk of severe COVID-19 and individuals 18 through 64 years of age with frequent institutional or occupational exposure to SARS-CoV-2."

What this news leaves out, however, is the fraught process in between. In August, President Joe Biden recommended authorizing boosters to all adults no later than September 20. The FDA acting commissioner and White House COVID-19 czar both endorsed the plan, but internally the FDA disagreed, feeling it was more important to prioritize shots for children under 13—despite the fact that it was already known by then that unvaccinated children were about as safe from COVID-19 as vaccinated adults. While Biden stuck to his original deadline, making the recommendation himself, the FDA waited two full months before authorizing booster shots for anyone but the most vulnerable.

Of course, in those two months, plenty of evidence emerged for the boosters' safety, effectiveness, and necessity. For example, Moderna first submitted data on the effectiveness of its vaccine as a third-dose booster on September 1. Two weeks later, on September 15, it released updated information on long-term effectiveness, demonstrating that while still highly effective long after receiving the two initial doses, "The increased risk of breakthrough infections…illustrates the impact of waning immunity and supports the need for a booster to maintain high levels of protection."

By mid-October, Israel was seeing widespread success in containing outbreaks, in part based on authorizing Pfizer boosters for people ages 12 and up. Severe breakthrough cases have been increasingly rare and there has been no increase in rare yet serious side effects, like myocarditis, among teens and young adults.

And yet, the FDA's inconsistent messaging on the subject rarely matched the seriousness of the moment. Scott Gottlieb, a former FDA commissioner, told CBS's Face the Nation that "the confusing message around the boosters may end up being one of the biggest missed opportunities in this pandemic." Even in the initial authorization for vulnerable populations, when the Centers for Disease Control and Prevention (CDC) chose not to include those in high-risk occupations, the agency's director Rochelle Walensky simply overruled the recommendation and included them anyway. Regardless of whether her decision was correct, the shambolic way in which it was carried out undermines the message.

In recent days, the most straightforward and authoritative direction on boosters came not from the public health agencies, but from Ashish Jha, dean of Brown University's School of Public Health. Writing in The Atlantic, in an article candidly titled "You Should Get a Booster Now," Jha plainly conveys the reality of the current situation: While the Pfizer/Moderna vaccines generate high levels of immunity, their effectiveness wanes over time. The unvaccinated are still several times more likely to become infected, and to die, than the vaccinated. Breakthrough infections are still possible, and with large enough spread, the disease can still pose a threat to the vaccinated. Boosters are extremely effective and are the least onerous way to protect not only the vulnerable, but the greater public as well. Why the FDA was unable to convey those plain facts clearly and unambiguously up to this point boggles the mind.

By all accounts, it seems clear that most adults who were vaccinated at least six months ago should receive a booster as soon as possible. And yet, the FDA and CDC have done such a poor job up to now that it is unsurprising that they enjoy such low levels of trust among the public. To the extent that messaging about boosters can reach the general population, it will be in spite of our public health agencies, not because of them.

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  1. I'll wait for the test data dump in 2076, thanks.

    1. My thoughts exactly. I got my shots in March. Now they have boosters. They took 108 days to review the test data but want over 20,000 days to release the data? I'll wait and see.

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  2. "will anybody trust it?"

    Of course not. The apparatus of government and experts stopped working in May of 2020 when the same people wagging their fingers about staying home made the bold argument that public health REQUIRED allowing demonstrations in the street.

    Even if you believe that COVID was an existential threat requiring lockdowns. Even if you believe that Racism is a massive public health crisis. As soon as the Public Health experts- the SCIENTISTS- decided that the latter outweighed the former, they admitted to political goals being part of their judgement.

    I'm sorry, you cannot put that genie back in the lamp.

    1. +10

  3. In August, President Joe Biden recommended authorizing boosters to all adults no later than September 20.

    I used to doubt the vaccines but once I found out Joe Biden was recommending them it totally changed my mind. It's hard to argue with his expertise in science and medicine and epidemiology, just as hard as it is to argue with Joe Namath over what medication is best for my arthritis pain or Shaquille O'Neal over what the best pizza is.

    1. Those Shaq-a-Roni's were pretty good though.

    2. Oh, sure, a white man tells you what arthritis medication to use and you take his advice. A black man suggests you use Icy Hot and you reply "Aren't you the pizza guy?"

      Racist.

  4. September 20. The FDA acting commissioner and White House COVID-19 czar both endorsed the plan, but internally the FDA disagreed, feeling it was more important to prioritize shots for children under 13

    We don't need no vaccination
    We don't need no fed control
    No masks are needed in the classroom
    Brandon leave them kids alone

    Hey! Brandon! Leave them kids alone...

    1. If you don't eat beyond meat, you can't have any pudding! How can you have any pudding if you don't eat beyond meat?!

  5. So now all the people who have been bragging they are "fully vaccinated" suddenly find out they are not. So, now they have to go for a booster shot. While there, I would suggest you go ahead and make your appointment for your February 2022 booster.

  6. Have they announced yet how many boosters you're going to need and for how many years you're going to need them or are they still going with the usual answer to these sorts of questions, "More" ?

    1. One at least every six months for the rest of your life.

      1. But don’t worry, those boosters will be “free”; only your taxes will have to be increased to pay for it.

    2. You can rest assured that all the longitudinal studies have been completed and the data is clear and irrefutable. This "We know the answers, but it'll be more fun if you just guess." game is just how federally managed healthcare is supposed to work.

      About half of 6 yr. old boys would've rightly punched their older brother in the stomach and taken back whatever was taken from them at this point but... girls will be girls.

  7. “This is great news”

    No. It isn’t.

  8. Did I accidentally navigate to CNN.com? How much of the sweet sweet vaccine cash is Reason getting?

  9. Boosters are extremely effective and are the least onerous way to protect not only the vulnerable, but the greater public as well. Why the FDA was unable to convey those plain facts clearly and unambiguously up to this point boggles the mind.

    The reason they are unable to convey those plain facts is because a)they are incompetent and b)those facts just ain't true.

    The only people who need boosters are the over-65 and the immunocompromised. Nothing has changed since August re that.

    If they had simply stuck with the facts about the virus and the vaccine, then it would remain a simple set of facts. Only the 65+ and immuno need the booster - but the booster is not 'unsafe' for any age group - and the ONLY action that can help hospitals and med workers who are about to drop dead is for the unvax to get vax.

    But no one is listening to that because it is all politicized. And the FDA/CDC already went down their path of politicizing messages.

    1. Idiots like you didn’t help.

    2. Or perhaps everyone got all rosy and never bothered to question the glowing outlook promised solely by manufacturer data?

    3. the ONLY action that can help hospitals and med workers who are about to drop dead is for the unvax to get vax

      You mean like these hospital and med workers?

  10. Bullshit.

    1. But it's the official bullshit, so you are expected to find it delicious.

  11. By all accounts, it seems clear that most adults who were vaccinated at least six months ago should receive a booster as soon as possible.

    Well not by ALL accounts. Moderna's own data showed barely any difference between people vaccinated early in the year and people vaccinated recently.

    https://www.cnbc.com/2021/10/12/moderna-covid-booster-fda-staff-doesnt-take-stance-says-two-doses-protect-against-severe-disease.html

    1. The study they submitted to the FDA in Sept (with 10,000 early recipients and 10,000 recent recipients) apparently wasn't convincing enough, so they resubmitted recently with data from 300 people.

      1. If you test 10000 people, you can easily select a subset of 300 where the differences seem statistically significant…

      2. This is amusing... "long-term effectiveness"

  12. Or maybe you need 4:

    https://chicago.suntimes.com/covid-vaccine/2021/10/27/22749557/4th-covid-vaccine-shot-america-seniors-immunocompromised-health-coronavirus-cdc-boosters

    The fourth shot should be received at least six months after the third, the CDC said. The CDC does not consider the third shots now being approved for Moderna and Pfizer vaccines as boosters.

    1. Are we going to redefine the word booster?

      1. Immunological supplement. FDA approved.

        1. "The vaccine has always been three shots."

  13. It's a rapidly mutating flu virus. Vaccine attempts are inherently a shot in the dark. Previous mRNA vaccine attempts have not gone well.
    Put down the Starbucks, pick up an orange and walk.

  14. Every major COVID projection and prediction by government officials has turned out to be wrong so far.

    When it comes to the vaccines, they were promised to end the epidemic, but they have done nothing of the sort: fully vaccinated individuals have high rates of infection and spread the disease, and it appears that vaccinations are actually driving the evolution of new COVID variants.

    The COVID vaccine seems to prevent more serious disease with existing variants and that is all it does. There is no reason to believe at this point that a booster is beneficial to any individual, or that it will have any effect on the spread of the disease.

    1. that unvaccinated children were about as safe from COVID-19 as vaccinated adults

      "In order to combat the spread of hyperprecautious, mealy-mouthed, medical-ish disinformation, I will now say that there is data out there that maybe shows something that I think is about true."

      Every set of County School District data shows unvaccinated children dying in absolute numbers less than vaccinated administrators. This is despite the unvaccinated children outnumbering the administrators by several fold. Even the best claims of efficacy of the vaccine don't approach the numbers children incur naturally.

      The CDC is only part of the problem. You're the rest. Fuck you.

    2. Sorry, the above was not meant in reply.

  15. No, to libertarians, this is terrible news. The way the recommendation/authorization was structured before made a booster mandate practically impossible to implement, but didn't actually prevent anyone from getting a booster who wanted one.

    To a humanitarian, this is also terrible news, because it will encourage more low-risk people to get a booster, when the developing world can't even get supplies to give the primary series to their high risk populations.

    The only reason why this is considered to be a good plan at all is because of a weird obsession with case counts. Post-vaccination, COVID puts fewer people in the hospital than the flu. If every single person who was hospitalized after vaccination was boosted with a perfect booster, it would cut COVID hospitalizations by less than 15%, despite the fact that the high risk population is overwhelmingly vaccinated. Not only that, but if you boost the high risk population, you are already getting 95+% of the benefit of boosting everyone.

    We need to break ourselves of the idea that we can prevent people from getting exposed to COVID, as opposed to just delaying it. Sure, some policy might prevent you from getting COVID at work, but eventually you'll go grocery shopping and the person next to you reaching for the pretzels will turn out to be asymptomatic with it. Everything the government has done is a delaying rather than prevention tactic. At this point, we have delayed so long that people can get vaccinated prior to exposure, which is good, but doesn't mean they won't get exposed, just that the consequence of such exposure will be sharply reduced.

    1. The only reason why this is considered to be a good plan at all is because of a weird obsession with case counts...We need to break ourselves of the idea that we can prevent people from getting exposed to COVID

      Agree 100%. I think a big part of the problem is that we conflate 'exposure' to the virus and 'testing positive to that exposure' with 'infected'/'seriously infected'/hospitalized/dead. That this is just a continuum - where the vaccine itself has an impact along that entire continuum.

      Unfortunately it is clear however that we will never break ourselves of any of the delusions that have now turned into gang colors. One gang wants to stop all exposure. The other wants to ignore all deaths.

      1. where the vaccine itself has an impact along that entire continuum.

        *May* have an impact. An 8 yr. old gets exposed to COVID, the vaccine has no impact on their risk of contracting it and an insignificant effect, especially relative to their own immune system, across the rest of the spectrum.

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