GOP pressures FDA committee to buck agency on COVID vax for kids under five

Days ahead of meetings to consider recommending emergency use authorization (EUA) of COVID-19 vaccines for the youngest children yet, the FDA's external advisors are the target of congressional Republican pressure.

Sens. Ted Cruz of Texas and Ron Johnson of Wisconsin joined with Reps. Bill Posey of Florida, Louis Gohmert of Texas, and 18 other House members to seek basic statistics from FDA Commissioner Robert Califf and the Vaccines and Related Biological Products Advisory Committee (VRBPAC).

The lawmakers want to know how children under five have fared against COVID, divided between those who are healthy and those with preexisting conditions. Specifically, the lawmakers seek data on deaths "from," hospitalizations "due to" COVID, and how many "required treatment." Lawmakers sought "a list of medical emergencies" for this group that gives the FDA authority to use EUA for a COVID vaccine as well.

The Republicans asked why the FDA has been "so slow to release the hundreds of thousands of pages of data from pre-approval manufacturer studies" and post-approval data, when they can expect full release, and when it would release the data behind this expected EUA.

The letter seeks FDA estimates for cardiac risk of young kids, given the unexpectedly high rates of myocarditis among vaccinated adolescents and young adults, and why it pledged to lower the efficacy threshold below 50% for symptomatic infection. Lawmakers noted EUA for recipients 16 and up required 90% efficacy "preventing confirmed COVID infection."

Other questions concerned the FDA's metric of measuring "neutralizing antibodies to the original SARS-CoV2 spike protein," whether vaccinating young kids could increase their risk for "future novel COVID variants," and what research it consulted on the risk of "antibody-dependent enhancement" in any age group.

"The broad approach of the CDC and FDA to date has been a one-size fits all policy — get the vaccine regardless of age, risk factors, the underlying health of the individual, or previous infection," they wrote Wednesday.

The FDA would "respond to the letter directly" but not share its response with Just the News, press officer Abby Capobianco said. She didn't answer how it sees the lawmakers' request for granular data and the FDA's definition of "herd immunity" for kids. According to CDC seroprevalence data, about 75% of children ages 0-17 had natural immunity in December.

MedPage Today reported the FDA is likely to authorize both Moderna's vaccine for ages 6 months to 5 years and Pfizer's for 6 months to 4 years, and the White House is already treating approval as a foregone conclusion, buying 10 million doses between the two makers.

"Realistically, it means we could see shots in arms of kids under 5 as early as the week of June 20," COVID response coordinator Ashish Jha, said at a Thursday press conference. Jha was recently accused of "scare-mongering" and "misinformation" about COVID exceeding flu deaths in kids.

Posey spokesperson George Cecala told Just the News this was the first time the Republicans reached out directly to VRBPAC members, because it's not clear they're asking for basic data from the agency. VRBPAC members didn't respond to queries.

"We're the only country that's considering this" approval at such a young age, "and there's probably some good reasons for that," Chief of Staff Stuart Burns said. Once Pfizer and Moderna get U.S. approval "they can market it across the world" for the same age range, since "many other countries defer to U.S. FDA approval," Cecala said.

An April review by Insider found only seven countries vaccinating children under 5: China, Hong Kong, Bahrain, Chile and Argentina (3), and Cuba and Venezuela (2). When Europe's regulator approved Pfizer's Comirnaty for ages 5-11, its CDC emphasized prioritizing those "at risk of severe COVID-19" while saying "consideration could be given" to others.

House Republicans previously demanded vaccine safety and efficacy data in April, while a May letter to Califf and CDC Director Rochelle Walensky, joined by Cruz, asked specifically about EUA for young kids. 

"This generation is the population at least risk for serious adverse complications, therefore we should take caution when promoting a vaccine for their developing bodies," they wrote in May. They also asked why the FDA trusted a safety-and-efficacy study of the BioNTech-Pfizer vaccine for ages 5-11 that the drug makers funded.

The FDA has not always seen eye-to-eye with VRBPAC, overruling the committee's rejection of a booster for ages 16 and up in November and not seeking its counsel before authorizing a fourth dose for ages 50 and up. 

Those actions followed the resignation of its top two vaccines officials, reportedly in protest of the Biden administration unilaterally promising boosters for all adults in September.

VRBPAC member Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia, has tried to walk a middle ground. In an American Medical Association podcast last month, he emphasized vaccines designed for kids are still using "the original recipe" that preceded the "immune evasive" Omicron and its subvariants.

While Moderna's protection against mild illness topped out at 37% in its kids trial, "those original vaccines have always been protective against serious illness, which is really the goal of these vaccines," he said, even while estimating "population immunity" between natural infection and vaccination was 95%.

Boosters have not been a panacea for COVID transmission either. Good Morning America shared anecdotes of boosted people who were crestfallen to get infected again and reported 1.6 million reinfections across 24 states, though Tufts Medical Center epidemiologist Shira Doron said the "frequency of false positive test results" makes accurate measurement difficult. 

McClatchy News Service reported the boosted appear to have a higher infection rate than the merely vaccinated, though the unvaccinated have the highest rate, citing CDC numbers through April 23.

While experts said unreported at-home testing for the merely vaccinated may explain the gap with the boosted, that explanation would seemingly apply to unvaccinated people who are subject to mandatory ongoing testing by employers as a condition of exemption.