A health worker prepares a flu vaccine shot before administering it to a local resident in Los Angeles, the United States, on Dec. 17, 2022.
Xinhua News Agency | Getty Images
An advisory committee to the Centers for Disease Control and Prevention on Wednesday recommended that adults ages 60 and above, after consulting their doctors, receive a single dose of RSV vaccines from Pfizer other GSK.
The panel said seniors should use “shared clinical decision-making,” which involves working with their healthcare provider to decide how much they will benefit from a shot.
Outgoing CDC director Rochelle Walensky will decide whether to finalize the recommendation.
The panel’s decision moves the US one step closer to making jabs against respiratory syncytial virus available to the public this fall, when the disease typically 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 RSV.
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 the CDC.
Pfizer and GSK on Wednesday both presented new clinical trial data to the panel, which provided a first glimpse of their shots’ durability after one RSV season. The season typically 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 disease with three or more symptoms through the middle of a second RSV season, according to new clinical trial results presented Wednesday. That’s down from more than 85% at the end of the first season in older adults.
Pfizer said that efficacy fell to 48.9% at “mid-season two” for less severe forms of the disease in that age group, down from about 66%.
One dose of GSK’s shot was 78.8% effective against severe RSV disease after two seasons, compared with 94% after one season, the company said Wednesday. Severe disease refers to cases that prevent normal, daily activities.
For less severe RSV disease, efficacy declined to 67.2% over two seasons from 82% after one season.
dr Michael Melgar, a CDC medical officer who evaluated data on both shots, noted during a public meeting that both Pfizer and GSK still lack efficacy data on subgroups of the elderly population at the highest risk of severe RSV.
Melgar said adults ages 75 and older and those with an underlying medical condition are underrepresented in the phase three clinical trials from both companies. Seniors with a weak immune system were excluded from the trials altogether, he said.
Both companies said studies on those populations are ongoing.
It’s still unclear how much the shots will cost. GSK said it will price its vaccine between $200 and $295. Pfizer said it will price its shot between $180 to $270.
The companies declined to guarantee the pricing.
The shots would help the US combat the upcoming RSV season in the fall after an unusually severe RSV season last year.
Cases of the virus in children and older adults overwhelmed hospitals across the country, largely because the public stopped practicing Covid pandemic health measures that had helped keep the spread of RSV low.