A health worker prepares a flu shot before administering it to a resident in Los Angeles, the United States, on December 17, 2022.
Xinhua News Agency | Getty Images
An advisory committee to the Centers for Disease Control and Prevention on Wednesday recommended that adults age 60 and older receive a single dose of RSV vaccines after consulting their doctors Pfizer And GSK.
The panel said seniors should use “shared clinical decision-making,” where they work with their healthcare provider to decide how much they would benefit from vaccination.
Outgoing CDC Director Rochelle Walensky will decide whether to finalize the recommendation.
The panel’s decision brings the U.S. one step closer to opening respiratory syncytial virus vaccines to the public in the 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 approved vaccines against RSV.
The virus is a common respiratory infection that usually causes mild, cold-like symptoms but causes more severe cases in older adults and children. According to the CDC, 6,000 to 10,000 seniors and a few hundred children under the age of 5 die from RSV each year.
Pfizer and GSK both presented new clinical trial data to the panel on Wednesday, giving a first look at the durability of their vaccines after an RSV season. In the northern hemisphere, the season usually lasts from October to March.
A single dose of the Pfizer vaccine was 78.6% effective in preventing lower respiratory disease with three or more symptoms by the middle of a second RSV season, according to new clinical trial results presented Wednesday. This is a decrease from more than 85% at the end of the first season in older adults.
Pfizer said efficacy for less severe forms of the disease in this age group dropped from about 66% to 48.9% “midway through the second season.”
One dose of GSK’s vaccine was 78.8% effective against severe RSV disease after two seasons, compared to 94% after one season, the company said on Wednesday. Serious illness is defined as cases that make normal, daily activities impossible.
For less severe RSV disease, efficacy decreased from 82% to 67.2% over two seasons after one season.
dr Michael Melgar, a CDC medical officer who reviewed data for both vaccines, noted during a public meeting that both Pfizer and GSK still lack efficacy data for subgroups of the elderly population at highest risk for severe RSV.
Melgar said that adults ages 75 and older and those with an underlying medical condition are underrepresented in both companies’ Phase III clinical trials. Seniors with a weak immune system are completely excluded from the experiments, he said.
Both companies said studies of these populations are ongoing.
It’s still unclear how much the recordings will cost. GSK said its vaccine will be priced between $200 and $295. Pfizer said the price of his shot will range from $180 to $270.
The companies declined a price guarantee.
The shots would help the US navigate the upcoming fall RSV season after last year’s RSV season was unusually tough.
Cases of the virus in children and older adults were flooding hospitals across the country, largely because the public had stopped implementing health measures amid the Covid pandemic that had helped contain the spread of RSV.