FDA Shuts Out Its Own Experts in Authorizing Another Vaccine Booster

Covid Global

By Marty Makary
As originally published in the Wall Street Journal

The Food and Drug Administration last week authorized Americans 50 and over to get a fourth Covid vaccine dose. Some of the FDA’s own experts disagree with the decision, but the agency simply ignored them. It will convene its advisory committee this Wednesday to discuss future vaccine needs. That’s like having lawyers present arguments to a judge who’s already issued a verdict.

Eric Rubin, editor in chief of the New England Journal of Medicine, sits on the advisory committee. He told CNN last month that he hadn’t seen enough data to determine whether anyone needs a fourth dose whose immune system isn’t seriously deficient.

Another committee member, Cody Meissner, agrees. Dr. Meissner, chief of pediatric infectious diseases at Tufts Children’s Hospital, told me last week that the fourth dose is “an unanswered scientific question for people with a normal immune system.”

A third member of the committee, Paul Offit of the Children’s Hospital of Philadelphia, told the Atlantic that he advised his 20-something son to forgo the third shot, which the FDA recommends for everyone 12 and over.

At the crux of the broad opposition to second boosters is the recognition of B- and T-cells, which public-health officials have long ignored. They talk only about antibody levels, which tend to decline in the months after vaccination. B- and T-cells, activated by the primary vaccine series or an infection (and augmented by a single booster in older patients), are highly and durably effective at preventing serious illness from Covid.

An additional vaccine dose induces a fleeting high in antibody levels, offering only mild and short-lived protection against infection.

Two top FDA officials quit the agency in September complaining of undue pressure to authorize boosters. Marion Gruber, former director of the Office of Vaccine Research and Review, and her deputy, Philip Krause, later wrote about the lack of data to support a broad booster authorization.

Hours after the FDA authorized the fourth dose, the Centers for Disease Control and Prevention gave its formal approval to the move—also without convening its external vaccine experts. Director Rochelle Walensky asserted that the additional doses are safe.

But the jury is still out on vaccine-related complications. One of the most common reported adverse events is tinnitus, or ringing in the ears. Gregory Poland, director of the Mayo Clinic Vaccine Research Group, developed a severe case while driving home after his second vaccine dose. He told MedPage Today he believes tens of thousands of people may be affected in the U.S. and he thinks more research is needed.

But neither the CDC nor the National Institutes of Health has made a priority of studying vaccine complications. The CDC isn’t even transparent about its investigations into young people who have died after Covid vaccination. A Seattle Children’s Hospitals study published in the Journal of Pediatrics March 25 found that 69% of children who presented with myocarditis after the vaccine had late gadolinium enhancement, a related abnormality, in an MRI three to eight months later.

Instead of investigating these complications further, health agencies rely on messy and incomplete data from their clunky website called Vaers, or Vaccine Adverse Event Reporting System, where some patients report their own possible vaccination complications. When citizens inquire about vaccine complication rates, public-health officials point to the significant limitations of their own method of tracking them.

While the FDA has approved fourth doses quickly and with little supporting data, it’s also been sitting for months on ample data supporting two new Covid vaccines. Novavax and Covaxin use traditional vaccine technology, in contrast with the mRNA shots from Pfizer and Moderna.

Covaxin, developed by Bharat Biotech and Ocugen, could yield broader protection against variants, and both shots could overcome some Americans’ hesitancy about a novel technology.

But the FDA hasn’t acted on Novavax’s Jan. 31 application for emergency use, and it rejected Covaxin twice, once for adults and once for children. Both have been approved by the World Health Organization and other countries. “We don’t need another vaccine,” Anthony Fauci, President Biden’s chief medical adviser, told India’s News Nation in December. “We have enough vaccines.”

Trust in public health is at an all-time low. When agencies bypass their own experts, it only reinforces the perception that health policy is driven by groupthink and politics.

Dr. Makary is a professor at the Johns Hopkins School of Medicine and author of “The Price We Pay: What Broke American Health Care and How to Fix It.”

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