A health worker prepares a flu vaccine before administering it to a local resident in Los Angeles, US, on December 3. 17, 2022.
Xinhua News Agency | Getty Images
An advisory panel for the Centers for Disease Control and Prevention recommended Wednesday that adults 60 and older, after consultation with their physicians, receive a single dose of RSV vaccines from Pfizer And GSK.
The panel said older people should use “joint clinical decision making,” which involves working with their healthcare provider to determine how much they can benefit from a shot.
Outgoing CDC Director Rochelle Walensky will decide whether to finalize the recommendation.
The committee’s decision brings one step closer to making punches against respiratory syncytial virus available to the public this fall, when the disease usually begins to spread at higher levels.
The recommendation also comes weeks after the Food and Drug Administration approved both vaccines, making them the world’s first authorized shots against respiratory syncytial virus.
The virus is a common respiratory infection that usually causes mild cold-like symptoms, but causes more severe cases in the elderly and children. Each year, RSV kills between 6,000 and 10,000 older adults and a few hundred children under 5 years old, according to the CDC.
Pfizer and GSK on Wednesday submitted new clinical trial data to the panel, which provided the first glimpse of the picks’ durability after one season of RSV. The season usually lasts from October to March in the northern hemisphere.
A single dose of Pfizer’s shot was 78.6% effective in preventing lower respiratory tract infections with three or more symptoms during the middle of the second RSV season, according to new clinical trial results presented Wednesday. This is down from over 85% at the end of the first season in seniors.
Pfizer said efficacy dropped to 48.9% in the “mid-season 2” for less severe forms of the disease in that age group, down from about 66%.
The company said Wednesday that a single dose of the GSK shot was 78.8% effective against severe RSV disease after two seasons, compared to 94% after one season. Severe illness refers to conditions that prevent normal daily activities.
For less severe RSV disease, efficacy decreased to 67.2% during two seasons from 82% after one season.
doctor. Michael Melgar, the CDC medical officer who evaluated the data on both shots, noted during a public meeting that both Pfizer and GSK still lacked efficacy data for subgroups of the elderly population at high risk for RSV infection.
Melgar said adults age 75 and older with an underlying medical condition are underrepresented in Phase 3 clinical trials from both companies. He said that elderly people with weakened immune systems were excluded from the trials altogether.
Both companies said studies on this population are ongoing.
It’s still not clear how much the footage will cost. GSK said it would price its vaccine between $200 and $295. Pfizer said it will price it between $180 and $270.
The companies refused to guarantee pricing.
The picks will help the US battle the RSV season coming into the fall after an unusually intense RSV season last year.
Hospitals across the country have been overwhelmed by cases of the virus in children and the elderly, in large part because the public has stopped practicing Covid-sanitary measures that have helped keep the spread of RSV down.