Pfizer: RSV vaccine generates strong response in immunocompromised adults
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Key takeaways:
- A dose of Pfizer’s RSV vaccine was safe and generated a strong response in immunocompromised adults aged younger than 59 years.
- RSV vaccines have not been recommended for anybody aged younger than 60 years.
A dose of Pfizer’s respiratory syncytial virus vaccine was well tolerated and generated a strong immune response among adults aged 59 years or younger, the company announced in a press release.
“Immunocompromised adults, such as patients with cancer or autoimmune disorders, have a substantially increased risk of experiencing severe complications from RSV, yet there are currently no vaccines approved for those aged 18 to 59 in the United States,” Annaliesa Anderson, PhD, senior vice president and chief scientific officer for vaccine research and development at Pfizer, said in the press release.
In June, the CDC’s Advisory Committee on Immunization Practices voted unanimously to recommend RSV vaccination for all adults aged 75 years or older and any adults aged 60 to 74 years who with risk factors for severe RSV, strengthening its previous recommendation, which was based on shared clinical decision-making.
However, the ACIP declined to recommend RSV vaccination for adults aged younger than 60 years despite the FDA approving GSK’s RSV vaccine earlier this year for high-risk patients in their 50s.
Uptake of the two vaccines last year was lower than hoped but not necessarily lower than expected.
Pfizer’s newly reported top-line data are from a substudy of a phase 3 trial called MONET that tested the vaccine among 203 adults, roughly half of whom were aged 18 to 59 years and the other half aged 60 years or older.
Researchers randomly assigned study participants to receive two doses, administered 1 month apart, after being grouped based on four immunocompromising conditions — non-small cell lung cancer, hemodialysis due to end-stage renal disease, autoimmune inflammatory disorder receiving active immunomodulator therapy and solid organ transplant recipients.
According to Pfizer, the vaccine was well tolerated and, although the study evaluated a two-dose vaccine regimen, data showed that a single dose generated a strong neutralizing response against both RSV-A and RSV-B.
The press release did not include any specific data, but Pfizer said it would report findings from the substudy at an upcoming medical conference and publish them in a peer-reviewed journal.
“We are encouraged by the positive top-line data from this study, which provide important evidence that Abrysvo has the potential to address a significant unmet need in this vulnerable population,” Anderson said.
References:
- CDC. ACIP presentation slides: June 26-28, 2024, meeting: Abrysvo (Pfizer) safety and immunogenicity in non-pregnant adults aged 18-59 years. https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2024-06-26-28/02-RSV-Adult-Munjal-508.pdf. Last reviewed June 28, 2024. Accessed Aug. 13, 2024.
- Pfizer announces top-line results of Abrysvo for RSV in immunocompromised adults. https://www.pfizer.com/news/press-release/press-release-detail/pfizer-announces-top-line-results-abrysvor-rsv. Published Aug. 12, 2024. Accessed Aug. 13, 2024.
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