What if I told you one in 50 people who took a new medication had a “medically attended adverse event” and the manufacturer refused to disclose what exactly the complication was — would you take it?
And what if the theoretical benefit was only transient, lasting about three months, after which your susceptibility goes back to baseline?
And what if we told you the Food and Drug Administration cleared it without any human-outcomes data and European regulators are not universally recommending it as the Centers for Disease Control and Prevention is?
That’s what we know about the new COVID vaccine the Biden administration is firmly recommending for every American 6 months old and up.
The push is so hard that former White House COVID coordinator Ashish Jha and CDC head Mandy Cohen are making unsupported claims the new vaccine reduces hospitalizations. long COVID and the likelihood you will spread COVID.
None of those claims has a shred of scientific support.
In fact, if the manufacturers said that, they could be fined for making false marketing claims beyond an FDA-approved indication.
The questions surrounding Moderna’s new COVID vaccine approved this week are still looming.
Pfizer’s version, approved this week as well, also has zero efficacy data and has not been tested on humans at all. We only have data about antibody production from 10 mice.
The FDA, or Moderna (frankly it’s hard to tell the difference sometimes), should disclose what happened to the patient who took the new vaccine and had a complication that required medical attention.
The public has a right to know.
The last time the Biden administration approved and recommended a novel COVID bivalent booster, last fall, with no human outcomes data, it was an epic fail.
Only 17% of Americans took it (and some of those were forced to do so by their employer or school).
Not foreseeing such weak public support for the booster last year, the Biden administration had prepaid pharma $4.9 billion for 171 million doses — many of which were tossed in the wastebasket.
Now it is making the same mistake.
Two weeks ago, the Biden administration upped its orders for the pediatric version of the new COVID vaccines from 14.5 million doses at $1.3 billion to 20 million doses for $1.7 billion, which is more than four times as many pediatric doses used last year.
There clearly seems to be a special push this time to give it to children — the same group European regulators are not supporting.
In fact, the original Moderna vaccine was banned in parts of Europe for people under age 30.
European doctors are not alone.
Dr. Paul Offit, a vaccine-mandate supporter and FDA adviser from the University of Pennsylvania, told The Atlantic this week that he’s not going to take the new COVID vaccine.
He didn’t take the bivalent booster last fall either, despite being 72 years old.
While he disagreed with White House adviser Dr. Ashish Jha on the booster, he recently confessed, “Yes, he was wrong, but you know you can’t say that exactly.”
Yes, you can.
America is tired of political apologists as medical experts. They want the truth.
Offit is at least more honest than most experts who put their heads in the sand and parroted whatever public-health officials said.
Pfizer made $100 billion during the pandemic. It can afford to fund a randomized trial to demonstrate to the American people the new booster is effective.
That’s the scientific process.
Unlike influenza, COVID-19 is constantly circulating so there is ample opportunity to run a trial; indeed Moderna already ran a randomized trial.
Its trial of just 50 people began four months ago and oddly only reported 14-day side effects.
Why didn’t it enroll more people in its trial? Why didn’t it report three-month effectiveness and do a proper trial?
Conducting a placebo-controlled trial in people during this time would not only yield useful information; it would enable further study of those subjects three and six months from now, when a winter surge may occur.
Let’s be honest: Follow-up studies of COVID vaccines in general have revealed a disappointing truth — mild efficacy against infection is transient, lasting just a few months.
Perhaps Pfizer and Moderna knew the FDA regulatory process was greased for them and they didn’t have to.
It’s time for the FDA to resume its role as a regulator and not the marketing department for Pfizer and Moderna.
It is possible a new booster may help downgrade the severity of COVID infection for select high-risk populations, but that’s all the more reason a proper clinical trial is needed.
It’s also worth noting the CDC’s new recommendation ignores natural immunity, which means many schools will do the same.
A February Lancet review of 65 studies concluded natural immunity is at least as good as vaccinated immunity and probably better.
So if a college student had COVID a few months ago, the CDC wants him or her to get the new shot anyway, but the correct scientific answer is the risks are expected to outweigh the benefit.
Supporters of pushing the novel COVID boosters point to the annual flu-shot approval process, which does not require a randomized trial.
But COVID vaccines are very different from flu vaccines.
COVID vaccines have higher complication rates, including severe and life-threatening cardiac reactions. Flu shots have a 50-plus-year safety record whereas COVID vaccines have been associated with a serious adverse event rate of one in 5,000 doses according to a German study by the Paul-Ehrlich-Institut.
Another study, published last year in the medical journal Vaccine, estimated the rate of serious adverse events to be as high as one in 556 COVID-vaccine recipients.
And for young people, the incidence of myocarditis is six to 28 times higher after the vaccine than after infection, even for females, according to a 2022 JAMA Cardiology study.
That’s one of the reasons a study we and several national colleagues published last year found that college booster mandates appear to have resulted in a net public-health harm.
Finally, at a molecular level, some scientists are concerned about what is called immune imprinting and additional ways multiple booster doses can weaken the immune system.
A study published last year in the journal Science described a reduced immune response among people infected who then received three COVID-vaccine doses.
If public health officials get their way, a healthy 5-year-old boy will get 72 COVID-vaccine shots over the course of his lifetime, if he has an average lifespan, with a risk of myocarditis after each one.
Inexplicably and defying science, the CDC is saying even if a child had COVID three months ago, he or she should still get the new COVID shot.
Two of the FDA’s two best vaccine experts are gone. Dr. Marion Gruber, who was director of the FDA’s vaccine office, and her deputy director, Dr. Philip Krause, both quit the agency in 2021 in protest over political pressure to authorize vaccine boosters in young people.
Ever since the loss of these two vaccine experts, the agency’s vaccine authorizations have been consistent with an overly cozy relationship between pharma and the White House.
Pushing a new COVID vaccine without human-outcomes data makes a mockery of the scientific method and our regulatory process.
In fact, why have an FDA if White House doctors can simply declare a drug to be safe after discussing secret data in private meetings with pharma?
If public-health officials don’t want a repeat disappointing turnout of Americans who get the COVID booster shot, they should require a proper clinical trial to show the American people the benefit.
Public-health leaders cannot afford to squander any more credibility and money on interventions with no scientific support.
Marty Makary, MD, MPH, is a professor at the Johns Hopkins School of Medicine and author of “The Price We Pay.” Tracy Beth Høeg, MD, PhD, is an epidemiologist at the University of California, San Francisco.
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