FDA advisors recommend two RSV vaccines for older adults
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An FDA advisory committee recommend the approval of two respiratory syncytial virus vaccines for older people, who are among the most susceptible to severe disease, hospitalization and death from the infection.
The two vaccines — Pfizer’s RSVpreF, which the company plans to brand as Abrysvo; and GSK’s RSVpreF3 OA, which will be branded as Arexvy — are the first against RSV to be recommended for approval by the FDA, which is expected to make its decisions on the vaccines by May.
The Vaccines and Related Biological Products Advisory Committee (VRBPAC) supported the Pfizer vaccine with votes of 7-4 for safety and 7-4 for efficacy. It recommended the GSK vaccine based on a 12-0 vote for efficacy and 10-2 vote for safety.
“[This] vote brings us an important step closer to delivering one of the world’s first vaccines for RSV, a respiratory virus that causes potentially debilitating disease and imposes a major burden on health care systems,” Phil Dormitzer, MD, PhD, global head of vaccines research and development at GSK, said in a press release.
In the United States, there are approximately 60,000 to 160,000 hospitalizations and 6,000 to 10,000 deaths among adults aged 65 years or older, according to the CDC.
There are currently no approved vaccines for RSV, and supportive care is generally all that clinicians can offer. Bavarian Nordic and Moderna also have vaccines in development for the respiratory virus.
Pfizer’s vaccine is also being reviewed for use in pregnant people, with an FDA decision expected in August.
The Pfizer and GSK vaccines are built around a recombinant subunit prefusion RSV F glycoprotein antigen, the understanding of which is based on NIH research detailing the crystal form of the protein.
Additionally, GSK’s vaccine also contains a proprietary adjuvant system called QS-21 Stimulon, the same one used in the company’s zoster vaccine, Shingrix, but about half the dose.
In the case of both vaccines, VRBPAC members questioned the number of older adults included in the trials, as well as the lack of serious cases included in the data, which raised some concern about safety and effectiveness.
Several panel members noted that they expect a second year of data on the vaccines to be available in the coming weeks, which they said they would have preferred to see before voting.
“These data are robust and demonstrate potentially high effectiveness against RSV. I also wish that we had another season of data,” Amanda Cohn, MD, director of the CDC’s Division of Birth Defects and Infant Disorders, said during the panel’s vote on the GSK vaccine.
“There really was not a substantial amount of severe disease among those that were studied [giving] me pause about applying this to the general population ... but overall I think that the data are very supportive of effectiveness,” Cohn said.
The FDA is expected to announce a decision on the GSK vaccine on May 3. Pfizer said a decision on its vaccine is also expected in May.
References:
- CDC. RSV surveillance and research. https://www.cdc.gov/rsv/research/index.html. Updated Oct. 28, 2022. Accessed March 2, 2023.
- GSK’s respiratory syncytial virus older adult vaccine candidate granted priority review by US FDA. https://www.gsk.com/en-gb/media/press-releases/gsk-s-rsv-oa-vaccine-candidate-granted-priority-review-by-us-fda/. Published Nov. 2, 2022. Accessed March 2, 2022.
- Pfizer receives positive FDA advisory committee votes supporting potential approval for vaccine candidate to help combat RSV in older adults. https://www.pfizer.com/news/press-release/press-release-detail/pfizer-receives-positive-fda-advisory-committee-votes. Published Feb. 28, 2023. Accessed March 2, 2023.
- US FDA advisory committee votes to support effectiveness and safety of GSK’s respiratory syncytial virus in older adult vaccine candidate. https://www.gsk.com/en-gb/media/press-releases/us-fda-advisory-committee-votes-to-support-effectiveness-and-safety-of-gsk-s-rsv-older-adult-vaccine-candidate/. Published March 1, 2023. Accessed March 2, 2023.
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FDA. Vaccines and Related Biological Products Advisory Committee February 28-March 1, 2023 meeting announcement. https://www.fda.gov/advisory-committees/advisory-committee-calendar/vaccines-and-related-biological-products-advisory-committee-february-28-march-1-2023-meeting. Updated Feb. 28, 2023. Accessed March 2, 2023.
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