Federal officials revise recommendations for RSV vaccine

In an unusual move, federal health officials have revised their recommendations on who should get the respiratory syncytial virus vaccine.

The Centers for Disease Control and Prevention recommended last year that adults age 60 or older could receive a single lifetime dose of an RSV vaccine, in consultation with their health care providers.

On Wednesday, the agency’s scientific advisors restated that guidance. Based on recent safety and effectiveness data, they unanimously recommended that all Americans age 75 and older receive one dose of an RSV vaccine.

For adults aged 60 to 74, the panel recommended vaccination only for people with certain serious conditions, such as chronic heart or lung disease, advanced kidney disease and diabetes with organ damage.

The advisors have decided not to recommend the vaccine for other adults in this age group, but people can still consult their healthcare provider to assess the risk of infection for them.

Paradoxically, the new criteria could open up eligibility for the shot, some advisers say. Not everyone at high risk — some older Black Americans, for example — has access to a health care provider who can make that decision.

Writing out the conditions could help clarify who needs the RSV vaccine most, the advisers said. The director of the CDC, Dr. Mandy Cohen, accepted the panel’s recommendations on Wednesday afternoon.

The Food and Drug Administration has approved three RSV vaccines. Two of them, GSK’s Arexvy and Pfizer’s Abrysvo, were approved in May last year and were administered during the autumn and winter. The third, an mRNA vaccine called mRESVIA, made by Moderna, was only approved in May.

Officials said in February that the vaccines may have caused some cases of Guillain-Barré syndrome, a rare neurological disorder. Data analyses presented to the panel on Wednesday did little to clarify concerns about the vaccine.

The uncertainty fueled much of the hesitation among advisers weighing the relative benefits and harms of the vaccines. GBS “is not a minor consequence,” said Dr. Jamie Loehr, one of the consultants and a general practitioner in Ithaca, NY

“Patients who have it often end up in the hospital for three to four months, possibly intubated and possibly die,” he said.

Concerns about side effects played a particularly large role when the panel considered expanding the eligibility criteria for GSK’s Arexvy to adults ages 50 to 59. The FDA approved Arexvy for use in that age group in June.

But at Wednesday’s meeting, the CDC advisers concluded that for most Americans in that age group, the risk of RSV is not high enough to justify the potential harm or cost of vaccination.

“I don’t want to see even one person who is not at risk get GBS from an unnecessary vaccine,” Dr. Camille Kotton, one of the advisers, said in an interview.

The panelists will continue to evaluate their recommendations as more data becomes available. For now, Dr. Kotton said, “we just don’t want to rush into making a recommendation for a lower-risk population.”

Some panelists also noted that it is important to administer the vaccines when adults are most at risk.

The vaccines are meant to be given only once, because clinical trials have shown that a second dose does not really improve immunity.

Some advisers say immunity to the virus may have waned by the time Americans who are not at high risk get vaccinated at younger ages.

As with other respiratory diseases, the risk of RSV infection increases sharply with age. From 2016 to 2020, the virus was linked to as many as 140,000 hospitalizations annually among Americans 65 and older, compared with fewer than 20,000 among those 60-64.

Among unvaccinated adults who are hospitalized, RSV is similar in severity to COVID and the flu. Chronic conditions increase the risk. Among adults 65 and older, hospitalization rates are more than three times higher among people with heart failure, according to data presented at the CDC meeting.

Several advisers expressed concern that reducing the number of Americans eligible for RSV vaccination from 60 to 74 could send “the wrong message” about the safety of the vaccines. But ultimately, all voted to approve the new criteria.