COVID Shots Now Optional for Healthy Americans*

*All seventeen of them seen celebrating bigly

I’m baaaaaaaaaack, babies! Thanks for your patience while I flew across the country to sit weepily in a 35-degree arena waiting to hear my daughter’s name and watch her smiley, 1.5-second sprint across the jumbotron! All snark aside, it was a magical and meaningful celebration for us all (and also shockingly, blisteringly cold—California, you’re psychotic) and I’m super proud of my brilliant, diligent, blessedly unwoke graduate. Now, back to it!

In a shocking display of sanity and reason, the same federal health agencies who once insisted we needed a vax card to get a bang trim or attend a backyard wedding are now suggesting that “healthy people” might not need a COVID shot every year.

After years of encouraging/coercing/bribing/mandating everyone from toddlers to triathletes to roll up their sleeves for the latest useless booster, the FDA published revised COVID vaccine guidance this week in the New England Journal of I Guess We’re Back to Covering Medicine. According to the freshly retooled agency [*now with twice the science!], only people 65 and older and those with “one or more risk factors that put them at high risk for severe Covid-19 outcomes” will continue to qualify for fast-tracked annual pokes. The Associated Press called it a “major new policy shift by the Trump administration.”

If you’re under 65 and your biggest medical complaint is a gluten sensitivity you self-diagnosed on TikTok, you’ll now have to wait for randomized clinical trials (that involve actual placebo controls and show meaningful symptom reduction as well as fewer—not more—hospitalizations and deaths) before being given the glorious opportunity to inject yourself with a potentially fatal turbo cancer-promoter. Dr. Vinay Prasad, the newly appointed head of the Center for Biologics Evaluation and Research at the FDA, said interim results from some such studies could be ready by next year.

Raise your hand if you’re not signing up as a trial participant.🙋‍♀️

“Is the pharmacist going to determine if you're in a high-risk group?” demanded rabid jabvocate Dr. Paul Offit. “The only thing that can come of this will make vaccines less insurable and less available.” Offit also hilariously argued that placebo-controlled trials would be unethical by denying half of the study participants the lifesaving spike protein juice.

“We simply don’t know whether a healthy 52-year-old woman with a normal BMI who has had Covid-19 three times and has received six previous doses of a Covid-19 vaccine will benefit from the seventh dose,” wrote Prasad and FDA Commissioner Marty Makary.

That sound you just heard? Oh, just over half of the national populace shouting, “We DON’T?”

Prasad and Makary went on to slam the U.S.’s “one-size-fits-all” approach to COVID boosters and stated that they reject the view that “the American people are not sophisticated enough to understand age- and risk-based recommendations.” The authors also called our country’s vaccine policies the most aggressive in the world—an observation that, until now, would get you labeled an anti-science nutjob or a Russian bot.

The roach in the risotto? Per the very same NEJM piece, nearly 3 out of 4 U.S. adults have one or more risk factors that put them at high risk for severe Covid-19 outcomes, which include but are not limited to asthma, diabetes, cardiovascular disease, depression, some neurological conditions, cancer, COPD, cirrhosis, cystic fibrosis, tuberculosis, obesity, physical inactivity, and pregnancy. “Top FDA leaders estimate more than 100 million Americans would be eligible for the shots under the new framework,” WaPo reported, barely concealing its relief before lamenting the good old days when literally anyone and everyone could volunteer to become a human pincushion as often and enthusiastically as they would like.

One could argue that the FDA still called this round for Pharma, but at least this time they mumbled something about evidence on their way out of the ring. It was less knockout punch, more broken nose. Nevertheless, the odds are a lot better than they used to be that your barista won’t be demanding to see your antibody titers before handing over your cold brew.

For the past several years, Americans were told annual COVID boosters were “just like flu shots,” except the part where flu shots were overwhelmingly less deadly and had never been required to enter kindergarten classrooms, concerts, or your cousin’s birthday party. But now, the new FDA wants rigorous clinical trials before approving them for low-risk people, trials they were decidedly not demanding when compulsory chemical cocktails were being forced on millions of otherwise healthy Americans under the former administration.

“The FDA’s new Covid-19 philosophy represents a balance of regulatory flexibility and a commitment to gold-standard science,” Prasad and Makary wrote. “The FDA will approve vaccines for high-risk persons and, at the same time, demand robust, gold-standard data on persons at low risk. These clinical trials will inform future directions for the FDA, but more important [sic], they will provide information that is desperately craved by health care providers and the American people.”

It’s not quite the Nuremberg-level reckoning many of us were hoping for; it’s more like the regulatory equivalent of your gaslighting ex finally texting “ok maybe I was kind of a jerk.” But at least our health agencies are, for the first time, admitting that maybe—just maybe—we should study whether injecting an experimental product into millions of the walking well every year might warrant actual data first. And honestly? That’s progress.

As always, tell the class why you voted the way you did in the comments. :)

VERY MUCH WORTH NOTING: The public has until 11:59 p.m. Eastern Time this Friday, May 23, to submit comments to the FDA Vaccine Advisory Committee regarding authorizing/approving the continuation of Covid-19 injections. Pfizer whistleblower Karen Kingston, who calls the shots “a dangerous gene-editing biomedical experiment that should have never been in injected in any child (or adult for that matter),” posted a free article with sample verbiage and tips for submitting. It takes literally less than two minutes to post a comment, and as of yesterday fewer than 8,000 people had taken the time to do so—and an alarming number of them are in enthusiastic, demented support of continued, unfettered access to the poison jabs.

Please, take the time to do this. Don’t wait until Friday or tomorrow or even this afternoon. Do it now. Share your story. Make a fuss. Be loud. You don’t get to whine about the state of the world if you do nothing to try to change it. ;)

Signed books make lovely graduation/Father’s Day/just-because gifts.