July 2, 2023 Source: drugdu 110
The Centers for Disease Control and Prevention on Thursday recommended that adults ages 60 and above receive a single dose of RSV vaccines from Pfizer and GSK after consulting their doctors.
Outgoing CDC Director Rochelle Walensky signed off on the recommendation, which an advisory panel of outside experts made last week. That endorsement says seniors should work with their health-care providers to decide if taking a shot is right for them.
The CDC said the shots are expected to be available to the public this fall, when respiratory syncytial virus – along with Covid and the flu – typically begins to spread at higher levels.
“These vaccines provide an opportunity to help protect older adults against severe RSV illness at a time when multiple respiratory infections are likely to circulate,” the CDC said in a statement.
The virus is a common respiratory infection that usually causes mild, cold-like symptoms, but more severe cases in older adults and children. Each year, RSV kills 6,000 to 10,000 seniors and a few hundred children younger than 5, according to CDC data.
Walensky’s decision comes a month after the U.S. Food and Drug Administration approved the vaccines, making them the world’s first authorized jabs against RSV.
Spokespeople for Pfizer and GSK did not immediately respond to requests for comment.
Both companies last week unveiled late-stage clinical data suggesting that their respective vaccines generally maintain protection against RSV after one season of the virus, which in the U.S. typically lasts from October to March.
But the panel raised concerns about the lack of efficacy data on subgroups of the elderly population at the highest risk of severe RSV.
Dr. Michael Melgar, a CDC medical officer who evaluated data on both shots, said during an advisory panel meeting that adults ages 75 and older and those with an underlying medical condition are underrepresented in phase 3 clinical trials from both companies.
He said seniors with weak immune systems were excluded from the trials altogether.
Both companies said studies on those populations are ongoing.
The CDC panel also raised concerns about the price of the shots, which could limit their accessibility to some Americans.
GSK said it will price its vaccine between $200 and $295. Pfizer said it will price its shot between $180 and $270.
The companies declined to guarantee the pricing.
Pfizer has also developed a vaccine to protect newborns from RSV.
An FDA advisory panel last month backed that shot, but raised safety concerns over premature births that may be tied to the jab. The FDA is expected to make a final decision on that vaccine in August.
Reference:
https://www.cnbc.com/2023/06/29/rsv-vaccine-cdc-recommends-pfizer-gsk-shots-for-older-adults.html
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