In a video posted to social media on Tuesday, HHS Secretary Robert F. Kennedy, Jr. claimed that there is a lack of clinical data to support the repeat COVID-19 booster strategy in children.
The Centers for Disease Control and Prevention will remove routine COVID-19 vaccination for healthy children and healthy pregnant women from its guidelines, according to HHS Secretary Robert F. Kennedy, Jr.
Kennedy, who has a long history of opposition to vaccines, announced the change in a social media video on Tuesday, alongside NIH Director Jay Bhattacharya and FDA Commissioner Marty Makary.
“There’s no evidence healthy kids need [repeat COVID-19 vaccination] today, and most countries have stopped recommending it for children,” Makary said on the video.
“It makes sense and it’s good science,” Bhattacharya stated, referring to the decision to discontinue repeat boosters in healthy children and pregnant women.
Tuesday’s announcement comes a month after Politico first reported that Kennedy was considering removing routine COVID-19 shots from the CDC’s immunization guidelines. While doing so puts the U.S. in line with other countries—the U.K. and Canada, for instance, do not recommend yearly boosters for healthy younger individuals—BMO Capital Markets analysts at the time warned that such a move “would be a meaningful negative step, reflecting RKF Jr.’s broader comfort making unilateral decisions.”
Indeed, STAT notes that Kennedy’s decision contravenes the normal process around vaccine recommendations, as it was made without consulting the CDC or the Advisory Committee on Immunization Practices.
“It seems like an end run around the normal process, around the normal transparency where you get outside expert input, and perhaps also around the scientists and the agency as we don’t hear anything of what the reasoning was for this decision,” Jesse Goodman, a former FDA chief scientist who now leads Georgetown University’s Center on Medical Product Access, Safety and Stewardship, told STAT.
Last week, Makary, alongside Vinay Prasad, the new director of the Center for Biologics Evaluation and Research, unveiled a new risk-based strategy for approving new COVID-19 vaccines. Writing for the New England Journal of Medicine, the two health officials said that new approval guidelines will focus on seniors 65 years and up and patients aged 6 months and above who are at risk of severe outcomes. “Pregnancy or recent pregnancy” was included in the article’s list of conditions that raise the risk of severe COVID-19.
“Insofar as possible, when approving a Covid-19 vaccine for high-risk groups, the FDA will encourage manufacturers to conduct randomized, controlled trials in the population of healthy adults as part of their postmarketing commitment,” according to the NEJM editorial.
Notably, the CDC’s Advisory Committee on Immunization Practices during a meeting last month indicated its support for such a risk-based strategy.
Since taking over at the start of the year, the Trump administration has shaken up the COVID-19 status quo in the U.S., which in turn has left a handful of biotechs in the lurch. Vaxart, for instance, had its $453 million contract with the government, which was meant to fund the development of its oral COVID-19 vaccine, frozen in February. The HHS has since lifted its stop-work order.
GeoVax and CastleVax likewise ran into similar roadblocks, with their respective government funding being frozen.
Arguably the most high-profile case of COVID-19 vaccine disruption, however, is that of Novavax’s vaccine Nuvaxovid, for which the FDA missed a target decision date in April. The approval finally came on May 16—some six weeks later—but included notable restrictions on use. Unlike other coronavirus shots, which are indicated for all people 12 years and older, Nuvaxovid can only be used in seniors aged 65 and up and in individuals 12 through 64 years of age with “at least one underlying condition that puts them at high risk for severe outcomes from COVID-19.”
