First vaccine for prevention respiratory disease RSV It will be made available to seniors 60 and older through a vote by an advisory panel at the Centers for Disease Control and Prevention (CDC) on Wednesday.
Their vote followed the first meeting of the CDC Advisory Committee on the 3-Day Immunization Implementation. FDA vaccine approval for Arexvy from GSK and Abrysvo from Pfizer earlier this year.
Doctors and vaccine manufacturers are not required to follow the recommendations of an influential CDC panel, but the panel’s vote will ultimately govern federal requirements for insurance coverage of immunizations.
The new guidelines do not outright recommend that all eligible older adults get the shot. Instead, the panel decided to call for “shared clinical decision-making” between physicians and patients to determine whether the individual benefits outweigh the risks.
Among older people, people in their early 60s are less likely to get serious illness from RSV (which stands for Respiratory Syncytial Virus) than their oldest peers. Very rare cases of serious “inflammatory neurological events” have also been reported in vaccine trials, balancing benefits and risks.
Because potential side effects are so rare, it will be impossible to assess whether they are simply “by chance” until studies are completed after the release of studies that scrutinize large databases of the health records of people who have been vaccinated.
CDC officials assured the panel that they would closely follow the Vaccine Safety System’s data on the launch of the two new RSV vaccines.
“I want to remind everyone that we have one of the best vaccine safety systems in the world. We have the ability to gather information quickly, evaluate it quickly, and act accordingly. We have COVID-19 We’ve seen that system work during the pandemic, and it’s in place.
Vaccine manufacturers are still working on when older adults should return for a booster dose of RSV vaccine over the next few years. They also have yet to determine a final price, which further complicates their broad recommendation.
GSK said their vaccine could cost between $200 and $295 per dose, higher than it first told the committee, given new data showing the vaccine could provide protection for at least two RSV seasons. Pfizer says their injections can cost between $180 and $270.
Due to federal modeling at higher prices, some on the panel were concerned that injections might not be cost-effective with “reasonable and efficient allocation of resources”.
Voting was deferred during the meeting until a final price was established by each pharmaceutical company.
But time will be the key to getting the shot to those most at risk, some said. RSV vaccine will be most effective in saving lives if given before the unusual spike in infections early last year.
“Life, hospitalization, we could have a significant impact this year, which is why we don’t want to delay any longer,” said Dr. said Camille Kotton.
Kotton pointed to additional studies that are expected to yield future results for RSV and additional new vaccines in the pipeline.
The FDA is also expected to decide on a new approval of the first option to protect infants from RSV later this year. ACIP is also preparing to eventually vote on them as well.
“This field will undoubtedly change in the next five to 10 years,” Kotton said. ” said Kotton.
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