The first vaccines to protect against the respiratory disease RSV could soon be available to older adults aged 60 and over after an advisory panel to the Centers for Disease Control and Prevention voted in favor of them on Wednesday.
Their vote came during the first three-day meeting of the CDC’s Advisory Committee on Immunization Practices following the FDA’s approval of vaccines for GSK’s Arexvy and Pfizer’s Abrysvo earlier this year.
Physicians and vaccine manufacturers are not required to follow the recommendations of the influential CDC panel, although the panel’s votes ultimately govern state immunization coverage requirements.
The new guidelines fall short of a broad recommendation for all eligible older adults to get vaccinated. Instead, the panel called for “joint clinical decision-making” between doctors and patients to decide whether the individual benefits outweigh the risks.
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Among the elderly, people in their early 60s are less likely to develop serious illness from RSV — which stands for respiratory syncytial virus — than their oldest peers. Some very rare cases of severe ‘inflammatory neurological events’ have also been reported in vaccine trials, affecting the risk-benefit balance.
The potential side effects are so rare that an assessment of whether they are simply “accidental” will not be possible until post-vaccination studies are conducted, examining large databases of health records of people who have received the vaccine .
CDC officials assured the panel that they were closely monitoring data from their vaccine safety systems for 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 are able to gather information quickly, assess it quickly and act on it. We’ve seen that system have viability during the COVID pandemic, and it’s in place,” said Dr. CDC’s José Romero, director of the National Center for Immunization and Respiratory Diseases, the panel.
Vaccine manufacturers are still investigating when seniors may need to come back for a booster dose of the RSV vaccine in the years to come. You also have to decide on a final price, which makes more comprehensive recommendations even more difficult.
GSK said the price of the vaccine could range from $200 to $295 per dose, higher than it originally told the committee, as new data suggests the vaccine could provide protection for at least two RSV seasons . Pfizer said their shots could cost anywhere from $180 to $270.
At higher rates, federal modeling led some panel members to worry that vaccinations might not be cost-effective as a “reasonable and efficient allocation of resources,” particularly for the youngest of those permitted vaccinations.
During the meeting, a postponement of voting was announced until final pricing was determined by each drugmaker.
However, some said time will be of the essence to get the shots to those who are most at risk. RSV vaccines are most effective at saving lives when given before infections rise, which happened unusually early last year.
“Life, hospitalizations, we could have a significant impact this year. That’s why we don’t want to delay any longer,” said Dr. Camille Kotton, Chair of the Committee’s working group on the subject, during the meeting.
Kotton pointed to more studies expected to provide results on RSV in the coming years, as well as other new vaccines in the pipeline.
The FDA is also expected to make a decision later this year on reapproving the initial options for protecting infants from RSV. ACIP is also preparing to eventually vote on this as well.
“This area will undoubtedly change over the next five to ten years. We’ll learn a lot more. So we’re trying to make the best decision we can with the data we have now,” Kotton said.
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Alexander Zinn