What if I told you that one in 50 people who took a new drug had a “medically assisted adverse event” and the manufacturer refused to disclose exactly what the complication was: would you take it?
What if the theoretical benefit was only transient, lasting about three months, after which your susceptibility returns to baseline?
What if we told you that the Food and Drug Administration approved it without any human outcome data and European regulators don’t universally recommend it like the Centers for Disease Control and Prevention do?
Here’s what we know about the new COVID vaccine the Biden administration is strongly recommending for all Americans 6 months and older.
The push is so hard that former White House COVID coordinator Dr. Ashish Jha and CDC chief Mandy Cohen are making unsupported claims that the new vaccine reduces hospitalizations. Long COVID and the likelihood of spreading COVID.
None of these claims have an iota of scientific support.
In fact, if manufacturers said so, they could be fined for making false marketing claims beyond an FDA-approved indication.
Questions surrounding Moderna’s new COVID vaccine approved this week still loom.
Pfizer’s version, also approved this week, also has zero efficacy data and has not been tested in humans at all. We only have data on antibody production from 10 mice.
The FDA, or Moderna (frankly, sometimes it’s hard to tell the difference), 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 new bivalent COVID booster, last fall, without human outcome data, it was an epic failure.
Only 17% of Americans took it (and some of them were forced to do so by their employer or school).
Not anticipating such weak public support for the boost last year, the Biden administration had prepaid pharmaceuticals $4.9 billion for 171 million doses, many of which were thrown in the trash.
Now he makes the same mistake.
Two weeks ago, the Biden administration increased its orders for the pediatric version of the new COVID vaccines from 14.5 million doses at $1.3 billion to 20 million doses at $1.7 billion, which that’s more than four times the pediatric doses that were used last year.
It clearly seems that this time there is a special push to give it to children – the same group that European regulators do not support.
In fact, the original Moderna vaccine was banned in some parts of Europe for people under the age of 30.
European doctors are not alone.
Dr. Paul Offit, a vaccine mandate supporter and FDA advisor at the University of Pennsylvania, he said The Atlantic this week that it will not take the new vaccine against COVID.
He also did not take the bivalent booster last fall, despite being 72 years old.
Although I disagreed with Jha about the reinforcement, recently he confessed“Yeah, he was wrong, but you know you can’t say 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 stuck their heads in the sand and repeated what public health officials said.
Pfizer made $100 billion during the pandemic. It can afford to fund a randomized trial to prove to the American people that the new booster is effective.
This is the scientific process.
Unlike the flu, COVID-19 circulates constantly, so there are many opportunities to get a trial; in fact, Moderna already did a randomized trial.
His trial of just 50 people began four months ago and, oddly, reported only 14 days of side effects.
Why didn’t you enroll more people in your trial? Why didn’t you report three months effectiveness and not do a proper test?
Conducting a placebo-controlled trial in people during this time would not only provide useful information; it would allow for further study of these issues three and six months from now, when a winter surge may occur.
Let’s face it: follow-up studies of COVID vaccines have generally revealed a disappointing truth: mild efficacy against the infection is transient and lasts only a few months.
Maybe Pfizer and Moderna knew the FDA regulatory process was oiled for them and they didn’t have to.
It is time for the FDA to resume its role as a regulator and not the marketing department of Pfizer and Moderna.
It is possible that a new booster could help lower the severity of COVID infection for selected high-risk populations, but this requires an adequate clinical trial.
It’s also worth noting that the CDC’s new recommendation ignores natural immunity, which means many schools will do the same.
A February Lancet review of the 65 studies concluded that 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 vaccine anyway, but the correct scientific answer is that the risks are expected to outweigh the benefit.
Proponents of pushing for new COVID boosters point to the annual flu vaccine approval process, which does not require a randomized trial.
But COVID vaccines are very different from flu vaccines.
COVID vaccines have higher rates of complications, including serious and life-threatening cardiac reactions. Flu vaccines have a safety record of more than 50 years, while COVID vaccines have been associated with a rate of serious adverse events of one in 5,000 doses, according to a German study by the Paul-Ehrlich-Institut.
Another to studypublished last year in the medical journal Vaccine, estimated the rate of serious adverse events to be as high as one in 556 recipients of the COVID vaccine.
And for young people, the incidence of myocarditis is six to 28 times higher after the vaccine than after infection, even for women, according to a 2022 JAMA Cardiology. to study.
This is one of the reasons a to study that we and several national colleagues published last year found that college booster mandates appeared to have resulted in net harm to public health.
Finally, at the molecular level, some scientists are concerned about what’s called immune imprinting and the additional ways that multiple booster doses can weaken the immune system.
A to study published last year in the journal Science described a reduced immune response among infected people who then received three doses of the COVID vaccine.
If public health officials have their way, a healthy 5-year-old will receive 72 COVID vaccinations in his lifetime, if he lives an average life, with a risk of myocarditis after each one.
Inexplicably and in defiance of science, the CDC says that even if a child had COVID three weeks ago, they should still get the new COVID vaccine.
Two of the FDA’s top vaccine experts are gone. Dr. Marion Gruber, who was director of the FDA’s office of vaccines, and her deputy director, Dr. Philip Krause, left the agency in 2021 in protest of political pressure to authorize booster shots for youth .
Since the loss of these two vaccine experts, the agency’s vaccine authorizations have been consistent with an overly cozy relationship between the pharmaceutical industry and the White House.
Pushing a new COVID vaccine without human outcome data makes a mockery of the scientific method and our regulatory process.
Indeed, why have an FDA if White House doctors can simply declare a drug safe after discussing secret data in private meetings with the pharmacy?
If public health officials do not want repeated disappointing participation of Americans receiving the COVID booster vaccine, they should require a proper clinical trial to show the benefit to the American people.
Public health leaders cannot afford to waste more credibility and money on interventions without 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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