(Reuters) – The director of the U.S. Centers for Disease Control and Prevention on Thursday signed off on the use of new vaccines from Pfizer and GSK to prevent severe respiratory syncytial virus (RSV) infections in older adults.
CDC Director Rochelle Walensky endorsed agency advisers’ recommendation last week that adults aged 60 or older get the shots, but stopped short of saying all of that population should get one of the vaccines.
The vaccines are the first approved to prevent RSV, which causes around 14,000 deaths in adults aged 65 and older in the U.S. annually, according to government estimates. Walensky’s signoff is the final key regulatory step ahead of the shots’ rollout.
Both Pfizer and GSK have said they expect to start supplying the shots this fall ahead of the RSV season.
Older adults may receive a single dose of the vaccine after discussions with a healthcare provider about whether RSV vaccination is right for them, the CDC said in a statement on Thursday.
At the CDC advisers’ meeting last week, some committee members wanted a broader recommendation, but others expressed concerns that there wasn’t enough data on how effective the vaccines are in people over age 75 and other high-risk groups. The disease usually causes mild, cold-like symptoms, but can lead to serious illness and hospitalization, especially among older adults and children.
Both Pfizer and GSK presented data at the meeting suggesting the shots could be protective for at least two years, but the additional protection could mean higher prices because of the additional benefit to the health system. Americans over the age of 65 covered by the Medicare program are not expected to pay out of pocket for the vaccines.
GSK said during the meeting that it expects to price its shot at between $200 and $295 a dose. The company had previously said the price would be at least $120 per dose.
At the meeting, Pfizer estimated the price range of $180 to $270 per dose, but did not guarantee that final price would fall within that range, saying it was in the middle of competitive price negotiations on the shots.
The U.S. Food and Drug Administration in May approved the first of the RSV vaccines, from GSK and branded as Arexvy, and later Pfizer’s Abrysvo, for people aged 60 and older.
Pfizer is awaiting FDA approval of an RSV vaccine for pregnant women aimed at protecting infants. The regulatory process for that shot is behind the vaccines for older adults, and the CDC’s advisers have not considered it yet.
(This story has been corrected to say that Pfizer is still awaiting FDA approval of it’s maternal shot in paragraph 11)
Source: Read Full Article
