The Centers for Disease Control and Prevention (CDC) has officially endorsed the use of the first vaccines to protect against respiratory illness RSV for adults aged 60 and older. This decision, announced on Thursday, follows a vote by the CDC’s Advisory Committee on Immunization Practices earlier this month, and will lead to federal requirements for insurance coverage of the vaccinations. The FDA approved the vaccines, GSK’s Arexvy and Pfizer’s Abrysvo, earlier this year.
While the new guidance does not recommend that all eligible older adults receive the vaccines, it calls for “shared clinical decision-making” between doctors and patients to determine if the benefits outweigh the risks for each individual. The CDC stated, “This means these individuals may receive a single dose of the vaccine based on discussions with their healthcare provider about whether RSV vaccination is right for them.”
Seniors in their early 60s are less likely to experience severe disease from RSV compared to older individuals. However, a few rare cases of severe “inflammatory neurologic events” were reported in vaccine trials, which complicates the assessment of benefits versus risks.
The potential side effects of the vaccines are so rare that determining if they are due to chance will require further studies analyzing extensive health records of vaccinated individuals. The CDC has assured the panel that they will closely monitor data from their vaccine safety systems regarding the launch of the two new RSV vaccines.
Vaccine manufacturers are still studying the need for booster doses of the RSV vaccine among seniors in the coming years. They are also yet to finalize the price, which creates challenges for broader recommendations.
GSK has stated that their vaccine could be priced between $200 and $295 per dose, while Pfizer’s shots could be between $180 and $270. The higher prices raised concerns about cost-effectiveness, especially for younger individuals. The panel considered delaying the vote until the final prices are determined by the drug manufacturers.
However, time is crucial in administering the shots to those most at risk. RSV vaccines are most effective at saving lives when given before infections surge, as seen last year. Dr. Camille Kotton, chair of the committee’s work group, emphasized the potential impact on lives and hospitalizations this year and advocated against further delays.
It is important to note that doctors and vaccine manufacturers are not obligated to follow the CDC’s recommendations. However, using the RSV shots off-label, such as vaccinating individuals under 60, may not be covered by insurance.
The FDA is expected to decide on the approval of vaccines to protect infants from RSV later this year. The ACIP is also preparing to vote on these options in the future.
As the field continues to evolve in the next five to ten years, more information will become available. The decision-making process is based on the current data at this time.
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