US health officials re-examine RSV shots despite documented safety and efficacy

US regulatory officials are re-examining the safety of RSV shots despite no published reports of safety issues – a move that could lead to the removal or limitation of shots that have dramatically lowered hospitalizations among babies.

It’s the latest move from US health officials under Robert F Kennedy Jr, the secretary of the US Department of Health and Human Services (HHS) and a longtime anti-vaccine activist, to limit access to shots and to undermine public trust in the safe and effective products.

Officials at the US Food and Drug Administration (FDA) told three manufacturers of RSV preventative treatments for babies last week their products are being reviewed because of safety concerns raised by anti-vaccine activists, Reuters reported on Tuesday.

When asked by the Guardian if the FDA was reviewing the preventative shots and maternal RSV shots, a spokesperson confirmed the news.

The FDA routinely evaluates safety information about approved drugs, HHS press secretary Emily Hilliard said. A team at the FDA’s Center for Drug Evaluation and Research “is rigorously reviewing the available data, as it does for all products, to ensure decisions remain rooted in evidence-based science and in the best interest of patients”, Hilliard said.

The spokesperson did not respond to questions about whether the review was prompted by safety signals or anti-vaccine activists, and did not respond by press time to a question clarifying whether the review applies to shots for both babies and pregnant people.

“The RSV shots were the first time we had any kind of tools to prevent these complications,” said Elias Kass, a naturopathic physician specializing in pediatrics in Seattle, Washington.

RSV was the most common cause of hospitalization among US infants, he added: “To have a tool to prevent that is incredible.”

There were two working groups assessing evidence on RSV for the Advisory Committee on Immunization Practices (ACIP) to the US Centers for Disease Control and Prevention (CDC). One group focused on the vaccines given during pregnancy and the other on the preventative shots given to babies.

Neither group appears to have met since Kennedy fired all 17 previous advisers and replaced them with his own hand-picked advisers.

Kevin Ault, a former ACIP adviser and an obstetrician/gynecologist who has remained a liaison for the committee, was on the RSV working group for maternal vaccination until it stopped meeting. No new safety information about RSV shots has been released, Ault said.

In fact, news from the group was positive.

“There were concerns about pre-term delivery as a safety signal in the original maternal trials, but there have been subsequent safety data that shows that’s not an increased risk,” Ault said. That evidence was publicly discussed by the previous ACIP advisers.

“The efficacy and the safety signals have both been very reassuring,” Ault said.

Even so, the new vaccine advisers in their meeting last week made several comments about re-evaluating the vaccines given during pregnancy, saying they have “a new way of looking at pregnancy and vaccines,” Ault said. But no information about this new approach has been given to the public.

The shots to prevent RSV are one of the greatest public health breakthroughs in recent years, with dramatic declines in hospitalization, Ault said.

Vaccinating during pregnancy was 55% to 68% effective in keeping newborns from being hospitalized in the first six months of their lives, according to a survey of studies published in the New England Journal of Medicine in October.

Babies who were given the preventative antibody shots were 79% to 83% less likely to be hospitalized, the study found.

Decisions from the FDA could limit access to the shots, and public health experts worry that the announcements, without evidence, undermining the shots could affect public trust and confidence in vaccine safety.

Before the shots were widely available, 2% to 3% of all infants in the US were hospitalized for RSV. The respiratory illness has also been associated with developing asthma.

“Almost every parent has some experience with RSV,” Ault said. “So I think it’s going to be a lot easier to talk about the risk and benefits of these interventions to parents, just because they realize what a devastating disease it is.”