FDA claims about boosters and kids branded 'misinformation,' research questions youth vaccination

The FDA is doubling down on its confident pronouncements about bivalent COVID-19 boosters and vaccinating low-risk children, even as mainstream media warn readers that more jabs could actually make them more vulnerable to infection and highlight Pfizer's secrecy with trial data.

Research from abroad on COVID vaccine efficacy is also putting U.S. regulators between a rock and a hard place. The White House has driven booster policy for more than a year, overriding objections by top vaccines officials who reportedly resigned in protest.

The rising scrutiny of the jab-first ask-questions-later approach — which did not protect CDC Director Rochelle Walensky or FDA Commissioner Robert Califf from COVID infections shortly after their bivalent boosters — coincides with a possible electoral backlash against the agencies' most fervent political supporters.

FDA vaccines chief Peter Marks, who directs the Center for Biologics Evaluation and Research, told parents Monday in his "Just a Minute" video series to inoculate their children with boosters targeting Omicron and Wuhan strains, which were authorized without human trial data.

Boosting children as young as 5 is "still the best way to avoid the worst outcomes" of the virus, he claimed. The bivalents will "provide better protection against the Omicron variant causing the most disease" as children attend school in person and their families resume "pre-pandemic activities."

Marks' claims are "misinformation," according to University of California San Francisco epidemiologist Vinay Prasad, a vocal critic of one-size-fits-all vaccine policy who has called on President Biden to fire all his COVID advisers.

The official has no data to back his "better protection" claim or insinuation that the boosters will reduce childhood severe COVID outcomes, Prasad tweeted. "He's spending the FDA's credibility like Monopoly money."

The basis for Marks' statements isn't clear, and the FDA didn't respond when asked for clarification.

Pfizer CEO Albert Bourla said early human trial data showed its bivalent prompted "increased neutralizing antibodies" that could "potentially provide better protection" against Omicron subvariants BA.4/5. But a Pfizer official admitted to the FDA's Vaccines and Related Biological Products Advisory Committee that "there is no established correlate" between antibody levels and protection from disease. 

Pfizer's press release last week on its bivalent trial also emphasized increased antibody levels, but the results were limited to a month after boosting, and the drugmaker didn't mention its effect for adults 55 and under, The New York Times noted. Pfizer shared further data under wraps with the White House, but the FDA refused to tell Just the News if Marks had seen it.

Pfizer's vaccine effectiveness (VE) against Omicron may dip into negative territory for younger children as early as two months after completion of a two-dose mRNA primary series, according to the Qatar research team that has been studying both vaccines and natural immunity in national cohorts.

Their new study in the New England Journal of Medicine, which excluded children with a record of previous infection and predates the bivalent boosters, shows "overall effectiveness" of 26% in ages 5-17, peaking at 50% right after the second dose but "negligible after 3 months." 

VE varied widely in the 5-11 cohort, studied during Omicron's prevalence: nearly three times higher for 5-7 than for 8-11. The 12-17 group, which started in February 2021 and had "many" vaccinated participants, saw nearly double the effectiveness for 12-14 as for 15-17. Pre-Omicron performance, by contrast, was 88% "and waned relatively slowly."

Danish-American epidemiologist Tracy Beth Hoeg, who advises Florida's Department of Health, highlighted the VE confidence intervals in the study, which "shows why there is no international consensus on need to vax non high-risk kids during omicron."

For ages 5-11, the lower CI boundary after 2 months and median after 4 months are both about -10, meaning infection is more likely for vaccinated children. For 12-17 pre-Omicron, the lower boundary hit -30 at 4 months. The 12-17 median VE was nearly -2 for those vaccinated as late as June 30, 2021.

"Our findings suggest the need to reconsider the value and strategies of vaccinating healthy children in the omicron era with the use of currently available vaccines," the Qatar team wrote.

The Miami Herald and Fortune explained "immune imprinting" to readers in response to research that suggests the new boosters actually worsen immune response compared to the primary series.

Also known as "original antigenic sin," immune imprinting theoretically trains an immune system to develop a robust response only to the variant it first encounters through infection or vaccination, not subsequent variants.

A University of Melbourne research team warned in the journal Trends in Immunology a year ago, before the Omicron wave, that immune imprinting would explain why then-newer variants such as Beta and Delta were "efficiently escap[ing] the neutralizing antibody response."

Pisa University Hospital hematologist Daniele Focosi tweeted that the "most disturbing" finding from one of the studies, by the same Qatar research team, "is that reinfection rate in unvaccinated is similar to the rate in triple vaccinated."

In a worrying sign for rising Omicron subvariants, University of Texas researchers found the BA.5 bivalent "does not produce robust neutralization" against BA.2.75.2, BQ.1.1, and XBB.1, though the research has not been peer-reviewed.

The feds have tried to counter the pessimistic research by promoting their own research. Last month, acting National Institutes of Health Director Lawrence Tabak shared an NIH-funded study in the Journal of the American Medical Association. 

While he said it found "remarkably low incidence" of severe COVID in boosted veterans from last fall, winter and spring, and "quite low" severe illness in those without "immune-compromising conditions," the study had no control group and included infections from the Delta variant, which is genetically closer to the Wuhan strain used in original vaccines and boosters.

The research team, which included a UCSF epidemiology colleague of Prasad's, said it excluded unboosted or unvaccinated populations "because a robust body of evidence has demonstrated the effectiveness of vaccine boosters."

Tabak cited "hope," not evidence, that bivalents "will offer even broader protection."