FDA approves Merck’s pneumococcal vaccine for adults
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Key takeaways:
- Capvaxive is made to protect against strains of pneumococcus bacteria that cause disease in adults.
- A CDC advisory committee will meet June 27 to vote on recommendations for the vaccine.
The FDA has approved Merck’s 21-valent pneumococcal vaccine, which is specifically made for adults, the company announced.
The vaccine, called Capvaxive, covers serotypes of pneumococcus bacteria that are responsible for around 84% of invasive pneumococcal disease occurring in adults aged 50 years or older and 85% of invasive pneumococcal disease in adults aged 65 years or older, compared with 52% and 51% covered by the 20-valent pneumococcal conjugate vaccine (PCV20), respectively, according to Merck.
It is the first pneumococcal conjugate vaccine designed specifically for adults and includes eight serotypes not covered by other currently available pneumococcal vaccines, Merck said.
“Many cases of adult disease are caused by serotypes not included in other approved pneumococcal conjugate vaccines,” Walter A. Orenstein, MD, professor emeritus of medicine, epidemiology, global health and pediatrics at Emory University and member of Merck’s scientific advisory committee, said in a press release. “Capvaxive is designed to include the serotypes that cause the majority of invasive pneumococcal disease in adults, helping to protect adults against invasive pneumococcal disease and pneumococcal pneumonia.”
Supporting evidence
The approval came after several phase 3 studies demonstrated that the vaccine induces a robust immune response in both vaccine-naive and vaccine-experienced adults, including the STRIDE-3 trial, which evaluated Capvaxive compared with PCV20 among adults aged 18 years or older who had not previously received a pneumococcal vaccine.
STRIDE-3 enrolled participants aged 50 years or older in one cohort (n = 2,362) and those aged 18 to 49 years in another (n = 300). Data showed that among adults 50 years of age and older, Capvaxive was noninferior to PCV20 for the 10 serotype polysaccharides shared with both vaccines — 3, 6A, 7F, 8, 10A, 11A, 12F, 19A, 22F and 33F — at 1 month post-vaccination, and was superior to PCV20 for 10 serotype polysaccharides included in Capvaxive but not in PCV20 — 9N, 15A, 16F, 17F, 20A, 23A, 23B, 24F, 31 and 35B — after 1 month.
Among the younger cohort, Capvaxive elicited noninferior immune responses compared with individuals aged 50 to 64 years of age after 1 month post-vaccination, according to Merck.
STRIDE-5, which assessed Capvaxive administered with a quadrivalent influenza vaccine (QIV), and STRIDE-6, which assessed Capvaxive in vaccine-experienced adults, also produced positive data, the company noted. The trials showed that the most commonly reported adverse reactions in patients aged 18 to 49 years included injection-site pain (73.1%), fatigue (36%), headache (27.5%), myalgia (16.4%), injection-site erythema (13.8%) and injection-site swelling (13.3%). Among older patients, aged 50 years and older, common adverse events included injection-site pain (41.2%), fatigue (19.7%) and headache (11%).
Current PCV recommendations
The CDC’s Advisory Committee on Immunization Practices is scheduled to meet June 27 to vote on recommendations for Capvaxive.
The CDC has standing recommendations on several other previously approved pneumococcal vaccines:
- For children, the CDC recommends PCV15 or the more recently approved PCV20 for patients aged younger than 5 years. Those aged 2 to 18 years with certain risk conditions may need more vaccines depending on which shots they have already received and when. The CDC recommends speaking with a vaccine provider to clear up any questions about pneumococcal vaccines.
- For adults, the CDC recommends PCV15 or PCV20 for patients aged 65 years or older — or 19 to 64 years with certain risk conditions — if they have never received a pneumococcal vaccine. If PCV15 is administered, it should be followed by a dose of PPSV23 — the pneumococcal polysaccharide vaccine. If patients received earlier PCVs — PCV7 or PCV13 — the CDC recommends they speak with their provider regarding how to best complete their pneumococcal vaccine series. Patients aged 65 years or older do have the option to receive PCV20 if they already received PCV13 at any age and PPSV23 at or after the age of 65 years.
References:
- CDC. Pneumococcal vaccinations. https://www.cdc.gov/vaccines/vpd/pneumo/index.html. Accessed June 18, 2024.
- US FDA approves Capvaxive (pneumococcal 21-valent conjugate vaccine) for prevention of invasive pneumococcal disease and pneumococcal pneumonia in adults. https://www.merck.com/news/u-s-fda-approves-capvaxive-pneumococcal-21-valent-conjugate-vaccine-for-prevention-of-invasive-pneumococcal-disease-and-pneumococcal-pneumonia-in-adults/. Posted June 17, 2024. Accessed June 18, 2024.
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