RSV vaccines, which have drastically lowered infant hospitalisations, have come under review by the Food & Drug Administration (FDA) despite no previously published reports of safety issues.
The Guardian reports that regulatory officials are re-examining the safety of the respiratory syncytial virus (RSV) shots, stirring fears that this could lead to the removal or limitation of jabs that have dramatically lowered hospital admissions among babies.
FDA officials told three manufacturers of RSV preventative treatments for babies last week that their products are being reviewed because of safety concerns raised by anti-vaccine activists, Reuters reported.
The FDA routinely evaluates safety information about approved drugs, said the Department of Health and Human Services (HHS) press secretary Emily Hilliard.
A team at the Centre for Drug Evaluation and Research was “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”, she said.
“The RSV shots were the first time we had any kind of tools to prevent these complications,” said Elias Kass, a naturopathic physician specialising in paediatrics in Washington.
RSV was the most common cause of hospitalisation 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 Immunisation Practices (ACIP) to the Centres 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 all 17 previous advisers were fired and replaced by HHS Secretary John F Kennedy Jr’s own hand-picked advisers.
Kevin Ault, a former ACIP adviser and an obstetrician/gynaecologist 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, he 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 show 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,” he noted.
Even so, in their meeting last week the new vaccine advisers 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 hospital admissions.
Vaccinating during pregnancy was 55% to 68% effective in keeping newborns from being hospitalised 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 vaccines were 79% to 83% less likely to land up in hospital, the study found.
Before they were widely available, 2% to 3% of all infants in America were hospitalised for RSV. The respiratory illness has also been associated with developing asthma.
See more from MedicalBrief archives:
Jab could slash RSV babies’ hospital admissions by 80% – global study
Respiratory virus killing 100,000 children a year – systemic analysis
UK approves one-shot RSV vaccine for babies