RSV shots for babies under FDA review despite evidence of safety : NPR

An electron microscope image provided by the National Institutes of Health shows human respiratory syncytial virus virions, colored blue, and antibodies against an RSV protein, colored yellow.

AP/National Institute of Allergy and Infectious Diseases, NIH

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AP/National Institute of Allergy and Infectious Diseases, NIH

Health and Human Services Secretary Robert F. Kennedy Jr.’s campaign to rethink how doctors use vaccines recently took a big legal hit. A federal judge in Boston has blocked, at least temporarily, Kennedy’s cut in federally supported childhood vaccines, as well as Kennedy’s other controversial new vaccine policies.

The decision came as Kennedy publicly focused more on nutrition due to the White House’s concern that his unpopular vaccine restrictions could hurt Republicans politically. As a result, uncertainty over the Trump administration’s already tumultuous federal vaccine policy has only intensified, as questions swirl around how the administration will respond to this legal setback.

One step Kennedy could take would be to vaccinate babies to protect them against respiratory syncytial virus. RSV is very contagious and can be very dangerous for babies. In fact, RSV is the most common reason babies end up in the hospital during their first year of life.

“Some of these kids are sometimes on a ventilator. And they may be on oxygen because they really can’t breathe because of this virus,” says Dr. Yvonne Maldonado, a pediatric infectious disease specialist at Stanford University. “So it’s quite serious in the very young. Some of these babies develop chronic lung disease from this infection and can develop asthma.”

But two new shots have been a game-changer for protecting babies against RSV, she says. These laboratory-made “monoclonal antibodies” fight infections like natural antibodies. More than half of U.S. infants have received one of these shots, according to a February survey by the Centers for Disease Control and Prevention. Vaccines are about 80% effective in preventing babies from ending up in intensive care because of RSV, according to the CDC.

“They are very new but they have already had a lot of success. Monoclonal antibodies have led to a significant reduction in baby hospitalizations for RSV infections,” says Maldonado. “It’s quite remarkable.”

So Maldonado and other infectious disease experts were surprised and alarmed when the Food and Drug Administration announced a review of the safety of these monoclonal antibodies in December.

“The safety of these products has already been thoroughly reviewed, including by the FDA. The science and the facts will support that these are very safe products,” says Dr. Sean O’Leary, an assistant professor of pediatrics at the University of Colorado who chairs the American Academy of Pediatrics’ committee on infectious diseases.

O’Leary suspects the investigation could be another example of Kennedy trying to undermine vaccinations.

“It’s pretty much the same thing. It’s falsely promoting these security risks that aren’t real in the name of continuing attempts to dismantle the U.S. vaccination program,” O’Leary says.

The FDA has not said when its review might be completed.

Others welcome the study, pointing to adverse effects reported in vaccinated babies, including fever, seizures and even some deaths.

“I’m concerned about the safety of these products,” says Brian Hooker, chief medical officer of Children’s Health Defense, a group critical of vaccine safety and mandates. “I think the whole safety profile, especially for this very vulnerable population, is worth looking at.”

The companies that make the vaccines, Sanofi and Merck, say they are cooperating with the FDA review. They emphasize that the shots are very safe and that there is no evidence that deaths or other serious reactions after vaccination were caused by the shots.

“As a father myself and as the leader of our medical affairs group, the death of a child is a tragedy,” says Ayman Chit, who leads Sanofi’s medical affairs department for North America. “But no deaths in our clinical studies were linked to vaccination. And that’s not just our conclusion, the FDA itself, analyzing all of our data, came to the same conclusion.”

Still, many public health experts worry that the FDA’s safety review could lead to restrictions that would make it harder for babies to access vaccines and discourage doctors or parents from protecting babies from RSV.

“I think it would be a real shame if infants in the United States were no longer protected against RSV,” said Dr. Paula Annunziata, senior vice president of infectious diseases and vaccines at Merck. “I think it would be horrible.”

Beyond RSV, another measure that could act as a deterrent to vaccination would involve significantly expanding the conditions that would be eligible for compensation through the Federal Vaccine Injury Compensation Program, which compensates families for complications associated with vaccines.

Vaccine advocates fear the change could threaten the solvency of the program, which is vital to maintaining the viability of the vaccine market by limiting the legal liability of manufacturers. Aaron Siri, a lawyer who has challenged vaccine mandates and filed vaccine injury lawsuits, is close to Kennedy and just asked him to add more than 300 conditions that could qualify for compensation.