FDA accepts GSK’s pentavalent meningococcal vaccine for review
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Key takeaways:
- The FDA will review GSK’s five-in-one meningococcal vaccine candidate for approval.
- The agency has already approved one pentavalent meningococcal vaccine made by Pfizer.
The FDA will review GSK’s pentavalent meningococcal vaccine candidate for approval, the company announced Tuesday.
The FDA’s goal date for a decision on the application is Feb. 14, 2025.
The agency has already approved one pentavalent meningococcal vaccine made by Pfizer, which it did last October. The vaccine was recommended by the CDC days later.
Both vaccines cover the five most common serogroups causing meningococcal disease in people aged 10 to 25 years — A, B, C, W and Y. GSK’s vaccine candidate combines two of its existing meningococcal vaccines: Bexsero, a meningococcal group B vaccine; and Menveo, which covers the other four serotypes.
“Combining the protection offered by these vaccines into fewer shots aims to reduce the number of injections, simplifying immunization,” GSK said in a press release. “This can help increase series completion and vaccination coverage and help reduce the overall burden of [invasive meningococcal disease], with unvaccinated adolescents being at particular risk of infection and potential outbreaks.”
According to phase 3 trial results published last year, the vaccine candidate elicited a “clinically meaningful immune response” and met all primary endpoints when administered as two doses given 6 months apart in healthy children and young adults aged 10 to 25 years.
“These statistically significant phase 3 data are a very encouraging step toward reducing the incidence of meningococcal disease,” Tony Wood, PhD, BSc, chief science officer at GSK, said in a release that accompanied the results last year. “In the U.S., routine use of a five-in-one meningococcal vaccine with a two-dose regimen in adolescents at 16 to 18 years of age, just before this disease’s incidence peak, could drive significant public health impact.”
References:
GSK announces positive pivotal phase III data for 5-in-1 Meningococcal ABCWY vaccine candidate. https://www.gsk.com/en-gb/media/press-releases/gsk-announces-positive-pivotal-phase-iii-data-for-5-in-1-meningococcal-abcwy-vaccine-candidate/. Published Mar. 14, 2023. Accessed Apr. 16, 2024.
GSK’s 5-in-1 meningococcal ABCWY vaccine candidate accepted for regulatory review by US FDA. https://us.gsk.com/en-us/media/press-releases/gsks-5-in-1-meningococcal-abcwy-vaccine-candidate-accepted-for-regulatory-review-by-us-fda/. Published Apr. 16, 2024. Accessed Apr. 16, 2024.
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