FDA advisers support approval of RSV vaccine to protect infants

VPM | By Scott Hensley and Rob Stein

Published May 18, 2023 at 8:58 PM EDT

The first vaccine to protect infants from respiratory syncytial virus, or RSV, moved a step toward approval by the Food and Drug Administration with a positive vote Thursday from a panel of experts.

Advisers to the Food and Drug Administration recommended that the agency should approve the first vaccine to protect infants from RSV, or respiratory syncytial virus. But some of the experts expressed reservations about the adequacy of data in support of the vaccine’s safety.

In a two-part vote, the experts voted unanimously, 14-0, that the available data support the effectiveness of the Pfizer vaccine in preventing severe RSV-related respiratory illness. They then voted 10-4 that the data supports the vaccine’s safety.

RSV is a leading cause of infant hospitalization in the U.S. From 58,000 to 80,000 children younger than 5 years old are hospitalized each year with RSV infections, according to the Centers for Disease Control and Prevention. Infants 6 months old and younger are at elevated risk for severe RSV illness.

The votes came after a day of testimony and discussion during a public meeting of the agency’s expert panel on vaccines. The FDA isn’t bound to follow the advice of its expert panels, but it usually does. A decision on the vaccine for infants is expected by late August.

The vaccine isn’t given to babies. Instead, pregnant people are immunized during the late second to third trimester of pregnancy. The antibodies they develop against RSV pass to the fetus in the womb and later protect the newborn.

A clinical study involving 7,400 people found the vaccine had 81.8% efficacy in preventing severe respiratory illness caused by RSV within three months after birth and 69.4% in the first six months.

There was some evidence that those who got vaccinated might have been more likely to give birth prematurely. And committee members worried about pregnant people getting the vaccine at the same time as some other vaccines, such as TDAP (tetanus-diphtheria-pertussis), because it could interfere with their effectiveness.

“I worry that if preterm births are in any way a consequence of this vaccine, that would be tragic,” said Dr. Paul Offit, professor of pediatrics at The Children’s Hospital of Philadelphia. He voted no on the adequacy of safety data.

The same Pfizer vaccine is under FDA review to protect people 60 and older people from RSV. Advisers voted to support approval of the vaccine at February meeting.

Separately, in a first, the agency approved an RSV vaccine from drugmaker GSK in early May for people 60 and older.

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Scott Hensley

Scott Hensley edits stories about health, biomedical research and pharmaceuticals for NPR's Science desk. During the COVID-19 pandemic, he has led the desk's reporting on the development of vaccines against the coronavirus.

Hensley has worked on award-winning investigations in collaboration with journalistic partners.

He was the lead NPR editor on an investigation with the Center for Public Integrity in 2018 that exposed drug industry influence on the choices of preferred medicines by Medicaid programs. The work won the 2019 Gerald Loeb Award for audio reporting.

In 2017, Hensley was the lead NPR editor on an investigation with Kaiser Health News that showed how the pharmaceutical industry exploits government incentives intended to encourage the development of treatments for rare diseases. The stories won the 2019 digital award from the National Institute for Health Care Management.

Hensley has been editing in his current role since 2019. He joined NPR in 2009 to launch Shots, a blog that expanded to become a digital destination for NPR health coverage.

Before NPR, Hensley was a reporter and editor at The Wall Street Journal. He was the founding editor of The Wall Street Journal Health Blog, which focused on the intersection of health and business. As a reporter, he covered the drug industry and the Human Genome Project.

Hensley served on the board of the Association of Health Care Journalists from 2012 to 2020.

He has a bachelor's degree in natural sciences from Johns Hopkins University and a master's in journalism from Columbia University.

Before becoming a journalist, Hensley worked in the medical device industry. He remains, now and forever, a lover of Dobermans, lacrosse and Callinectes sapidus.

See stories by Scott Hensley