Medical experts question feds' evidence for second COVID booster, refusal to consult advisers

The federal government's enthusiasm for COVID-19 vaccine boosters is not matched by some of its outside advisers and other medical professionals, including the head of a leading medical journal who questions the evidence behind the decisions in the past several months.

The Food and Drug Administration on Tuesday authorized a fourth mRNA dose for ages 50 and older, expanding its availability beyond immunocompromised people, without input from its Vaccines and Related Biological Products Advisory Committee.

The Centers for Disease Control and Prevention followed hours later without consulting its Advisory Committee on Immunization Practices.

The FDA previously overruled VRBPAC in November by authorizing a third mRNA dose for ages 16 and older. The agency's top two vaccine officials, Marion Gruber and Philip Krause, resigned earlier in the fall when the Biden administration promoted boosters for all adults before the agency could weigh in.

Johns Hopkins University medical professor Marty Makary, a member of the National Academy of Medicine, asked sarcastically whether "bypassing the typical voting process" of the VRBPAC was "following the science."

Instead, the agency plans to convene its outside experts to "discuss" the FDA's decision, which is like "a judge issuing a verdict and then having lawyers make their arguments," Makary wrote in a tweet thread.

"There is zero clinical data that a 4th dose reduces hospitalization risk," he said. "There isn't even any evidence that a 3rd dose reduces hospitalization risk in young people."

VRBPAC member Eric Rubin, editor in chief of The New England Journal of Medicine, told CNN he has only seen fourth-dose data "for participants followed for just a few weeks." The committee needs to know how well it protects "highly vulnerable people against serious disease and death."

Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia and another VRBPAC member, said the committee has seen evidence only for "the possibility" that a fourth dose benefits those over 65. Without evidence for those over 50, "there shouldn't be this recommendation," he told CNN.

Former FDA Associate Commissioner Peter Pitts correctly predicted the FDA wouldn't "recommend" the second booster for ages 50 and up. The agency announcement Tuesday said the fourth dose "may be administered" to that age group, while the CDC said it was updating "recommendations to allow" the fourth dose.

Pitts told Just the News the FDA didn't have enough data to justify the "recommend" language. But "the data is crystal clear" that the second booster produces higher antibodies and thus "the benefit outweighs the risk" for that age group, which is why Pitts is fine with VRBPAC and ACIP being sidelined.

Authorizing a fourth dose would "cement a dangerous precedent: inadequate evidence being used to justify widespread vaccination for years to come," University of California San Francisco epidemiologist Vinay Prasad wrote last week in City Journal. "Pfizer and Moderna will get rich, our arms will ache, and no one will know if we made the right decision."

The agency is relying on "two observational studies comparing people who rushed to be boosted with those who didn’t," one of which showed an implausibly large benefit the day after boosting, while the other "relied on actively testing people with no symptoms," said Prasad, who once reported the FDA to Twitter for misinformation.

Former Harvard Medical School Dean Jeffrey Flier approvingly shared Prasad's longer review of one of those studies. "Until recently, nearly all scientists" would have demanded evidence from a randomized trial, Flier wrote. "Not clear how this changed."

Asked to respond to VRBPAC members' claims and criticisms from other doctors, FDA spokesperson Abby Capobianco told Just the News that the authorization "does not raise new scientific questions that would benefit from additional discussion" by VRBPAC.

She pointed to a press call with the FDA's Peter Marks, director of the Center for Biologics Evaluation and Research, who appeared in the agency video Prasad reported for misinformation.

Marks told reporters "this was a relatively straightforward decision made based on data ... such as the survival benefit [and] the reduction of hospitalization." While he admitted the agency only had data on ages 60 and up, Marks said the FDA set the floor at 50 because "a significant enough group of people in that range that would be at high risk, and this reduces confusion for people with a very good [second booster] safety profile."

The CDC didn't answer whether the FDA's action prompted it to authorize the second booster as well, or respond directly to criticism from outside doctors.

Spokesperson Kate Grusich told Just the News the CDC "values" ACIP and the "voluntary service of its members," but to "ensure the best use of resources both internally and externally, some incremental changes to vaccine policy do not need to go before the full committee."

Its vaccine experts and ACIP's Vaccines Work Group "reviewed the available data and the CDC Director approved these updates" for the benefit of "those at highest risk for severe outcomes," Grusich said, but did not answer what feedback the ACIP work group provided and how Walensky responded to it.

Prasad also warned that vaccine mandates in "ultra-low-risk populations" were certain to stiffen when the feds authorize fourth doses for younger populations. Many colleges already require third mRNA shots for students, and the University of California's booster policy also applies to a school it runs with students as young as 12, he said.

A new study by University of Washington pediatrics researchers casts doubt on claims that the post-mRNA vaccination heart inflammation observed at higher rates in young people is mild or short-lived.

Accepted for publication in the Journal of Pediatrics, the Seattle Children's Hospital study tracked 35 patients diagnosed with myopericarditis within a week of receiving a second Pfizer dose. The final cohort was composed of 16 patients who had "acute phase and follow-up CMR [cardiac magnetic resonance studies] available for review."

All but one were male, and all but two were non-Hispanic white, with a median age of 15.

They all had chest pain, and 10 of the 16 had an "abnormal electrocardiogram." The median time between vaccination and treatment with nonsteroidal anti-inflammatory drugs was 2.5 days.

At their followup CMR 3-8 months later, 11 of the 16 had "persistent" late gadolinium enhancement (LGE), or scarring, "although there was a significant decrease in the quantifiable" percentage of LGE.

Philadelphia cardiologist Anish Koka said this scarring had not been observed in studies of multi-system inflammatory syndrome in children (MIS-C) myocarditis, which results from COVID infection.

"Vaxx myocarditis is worse than MIS-C myocarditis," he tweeted.

University of Pittsburgh medical professor Walid Gellad, director of its Center for Pharmaceutical Policy & Prescribing, responded that he wouldn't call it "worse." But the research undermines the claim that children "fully recover" from vaccine-associated heart inflammation – talking points that some doctors "casually parroted."

The CDC "has a civic duty to ... rigorously study the long-term effects of vaccine-induced myocarditis" given this study, Makary of Johns Hopkins tweeted. A week earlier, other medical experts pointed to a small Israeli study of boosted adults, ages 18-44, that also found LGE in patients referred for CMR within 21 days of the booster.