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WASHINGTON – The director of the US Centers for Disease Control and Prevention on Thursday signed off on using new vaccines by Pfizer and GSK to prevent severe respiratory syncytial virus infection in older people.
CDC Director Rochelle Walensky endorsed agency advisories last week for adults age 60 or older to get the vaccine, but stopped short of saying the entire population should get one of the vaccines.
The vaccines are the first approved to prevent RSV, which causes about 14,000 deaths in adults 65 and older in the U.S. each year, according to government estimates. Walensky’s signoff is the last key regulatory step before the shooting release.
Both Pfizer and GSK said they expect to begin offering the shot this fall, ahead of the RSV season.
Seniors can receive the vaccine once after talking with a health care provider about whether the RSV vaccine is right for them, the CDC said in a statement Thursday.
“With this CCC recommendation, the administration is making sure Americans have stronger protection against respiratory viruses,” Health and Human Services Secretary Xavier Becerra said in a statement. Becerra said the vaccines should protect “the most vulnerable elderly, those living in nursing or long-term care facilities, and those with weakened immune systems.”
At a meeting of CDC advisers last week, some committee members wanted a broader recommendation, but others expressed concern about insufficient data on how effective vaccines are in people over age 75 and other high-risk groups. The disease usually causes mild and cold-like symptoms, but for severe pain and hospitalization, especially in the elderly and children.
Both Pfizer and GSK presented information at the meeting, that the vaccines can be protective for at least two years, but the additional protection may indicate a higher price because it will provide additional benefits to the health system. Americans over age 65 covered by Medicare are not required to pay out-of-pocket for the vaccine.
GSK said during the conference that it expects the shot to cost between $200 and $295 per dose. The company previously said that the price will be at least 120 dollars per dose.
At the meeting, Pfizer estimated a price range of $180 to $270 per dose, but did not guarantee that the final price would fall within that range, saying it was amid competitive price negotiations over the shot.
The US Food and Drug Administration in May approved the first RSV vaccines from GSK and ArexV, and later Pfizer’s Abrisvo, for people age 60 and older.
Pfizer is awaiting FDA approval for an RSV vaccine for pregnant women to protect their infants. The regulatory process for that vaccine is behind vaccines for adults, and CDC advisors haven’t considered it yet.
Contribute: Leroy Leo and Raghav Mahobe
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