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I don't recommend FDA's infinity vaccine booster strategy

The FDA is about to authorize a second round of bivalent COVID booster shots for older Americans who got their previous bivalent booster just 4 months ago. This after the Biden administration purchased 171 million doses of the vaccine, of which approximately 116 million doses are unused.

“Those doses are going to be expiring and will be thrown out. So it makes sense to have those shots in arms instead of being tossed in the waste basket,” Dr. Peter Hotez, of Baylor College of Medicine, told NPR.

But where’s the clinical data to support a never-ending booster strategy? For some high-profile public health experts, the need for clinical data doesn’t seem to matter.

Dr. Michael Osterholm, of the University of Minnesota, told CNN that he recently tried to get a second bivalent booster for himself six months after his previous bivalent vaccine to “top off his protection,” but said, “I was turned down.”

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.

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New research by Joseph Fraiman and his team found that as many as 1 in 662 people developed a “serious adverse event” after the COVID vaccine. In addition, a study of Americans over age 65, the first group in which the FDA plans to authorize the second bivalent booster, showed a clear increase in the risk of pulmonary embolus from the vaccine.

I’m in agreement with Dr. Paul Offit who recently addressed boosters in young people in the New England Journal of Medicine writing, “I believe we should stop trying to prevent all symptomatic infections in healthy, young people by boosting them with vaccines containing mRNA from strains that might disappear a few months later.” While Dr. Offit has said he supports boosters for older and high-risk Americans, he is one of few doctors who has challenged the medical establishment groupthink that promotes an all-or-nothing vaccine with repeated boosters recommendation for everyone.

A growing group of physicians in the U.S. are concerned about the lack of data transparency with COVID vaccine complications and newly revealed censorship by big tech of any “vaccine hesitancy content.” But when vaccine complications are downplayed, it makes the vaccine seem safer than it really is, and when COVID deaths are overcounted, it makes the virus look more dangerous than it really is.

As a result, people have distorted perception of risk and a myopic view of preventing COVID death that downplays therapeutics such as Paxlovid, monoclonal antibodies, and Vitamin D.

Lack of consensus on COVID boosters for younger patients raises questions Video

Sadly, the FDA’s two best vaccine regulators 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 protest over political pressure to authorize vaccine boosters in young people in 2021. After their departure announcements, both wrote scathing commentaries explaining why the data did not support a broad booster authorization. Ever since the loss of these two vaccine experts at the FDA, the agency’s authorizations have been erratic and seemingly political.

The Biden administration drew strong criticism two months ago when the Department of Health and Human Services tweeted: “The more often you get COVID, the higher your risk of complications.” That’s the exact opposite of what’s true. In fact, throughout the pandemic, one of the greatest sources of COVID misinformation has been the U.S. government. This particular false claim was in a tweet that went on to encourage people to get another dose of the COVID vaccine if it’s been 3 months or more since one recovered from COVID.

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Sign is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., on Aug. 29, 2020.

Sign is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., on Aug. 29, 2020. (Reuters/Andrew Kelly/File Photo)

Ignoring natural immunity has been one of the greatest pieces of misinformation spread during the pandemic. The tragedy is that it was spread by public health officials. A recent Lancet review of 65 studies concluded that natural immunity is at least as good as vaccinated immunity, and probably better.

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The FDA has since routinely bypassed its customary external advisory committee vote before controversial vaccine decisions. It’s the new norm at the agency. If the external advisors are hinting that they are going to vote against something, the agency doesn’t bring it before them to vote. It just authorizes it without them.

For those who have a weakened immune system, a repeat vaccine strategy may be appropriate. But if the FDA wants to rebuild public trust, it should bring the second bivalent vaccine authorization before a vote of its external advisory committee. In the meantime, I will not be recommending an infinity vaccine booster strategy to my parents.

CLICK HERE TO READ MORE FROM DR. MARTY MAKARY

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