FDA Shut Out Its Own Experts in Approving Another Booster Shot

The Food and Drug Administration bypassed its own experts in approving a fourth dose of vaccine for Americans 50 years and older last week, despite many of its vaccine experts being skeptical about the need for another booster shot and unsure about its safety.

The Wall Street Journal reports that the FDA’s advisory committee on vaccines never met prior to the approval of another booster shot. The Journal’s Dr. Marty Makary says the advisory committee meeting this week is “like having lawyers present arguments to a judge who’s already issued a verdict.”

Several members of the FDA’s vaccine advisory committee made their thoughts known to different media outlets.

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.

The evidence suggests that the risk of side effects would cause almost anyone — immunocompromised or not — to hesitate. In fact, the data gathered to date is insufficient for anyone who might need a fourth booster to make an informed decision.

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.

The CDC approved the fourth dose hours after the FDA gave its go-ahead. They didn’t convene their vaccine advisory panel either.

Whatever happened to “follow the science”?

I wasn’t planning on getting a fourth dose of the vaccine after seeing the data from Israel showing that the extra shot did nothing as far as immunity is concerned. At some point, the law of diminishing returns must apply and the risk/reward balance will tilt decisively toward “risk.”

But for two agencies who scold Americans about not “following the science,” they certainly have a lot of gumption to lecture us about safety when they refuse to follow their own procedures to keep all of us safe.