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The FDA recently approved Vaxneuvance, Merck’s 15-valent pneumococcal conjugate vaccine, for adults 18 years of age and older.
The vaccine, formerly known as V114, is used to prevent invasive diseases caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F caused.
Source: Adobe Stock.
The CDC’s Advisory Committee on Immunization Practices (ACIP) is expected to meet in October to make recommendations for the use of Vaxneuvance in adults, Merck said. The vaccine is contraindicated in patients with severe allergic reactions to any component of the vaccine or to a history of diphtheria toxoid, the company said.
The FDA approval was based on data from seven randomized, double-blind clinical trials that showed the vaccine was not inferior to the 13-valent pneumococcal conjugate vaccine (PCV13) for 13 common serotypes. The immune responses were superior to PCV13 for serotype 3 and for two Vaxneuvance-specific serotypes, 22F and 33F, Merck said.
“Some adults, including older adults or those with certain chronic illnesses or immunocompromising conditions, are at increased risk of pneumococcal disease and its serious, sometimes life-threatening complications.” Jose F. Cardona, MD, Principal investigator for the Indago Research & Health Center and coordinating investigator for the clinical trial, said in a press release. “The FDA approval of Vaxneuvance is based on robust Phase 2 and 3 studies examining immune responses in a wide range of adult populations and offers an important new option in protecting against invasive pneumococcal disease.”
Randomized controlled studies to evaluate the clinical efficacy of Vaxneuvance compared to PCV13 have not been conducted.
The vaccine is also being tested in children in phase 3 studies.
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Eugene Shapiro, MD
Eugene Shapiro
It’s another vaccine that has been added to the arsenal and is only approved for use in adults. There are two additional serotypes that are not in PCV13, so it was not surprising that the two types elicited better antibody responses to the two types that are not in the 13-valent vaccine. In addition, it elicited higher mean antibody responses to serotype 3, which was a problematic serotype and one of the types responsible for much of the remaining invasive pneumococcal disease due to the types in the 13-valent vaccine that is currently at Applied to children and adults.
It’s quite complicated because the current recommendation for adults over 65 years of age is that they and their doctor decide whether they should receive the 13-valent vaccine. Children are the main reservoir and vector for pneumococcal infections, and by giving the pneumococcal conjugate vaccine to children – and there is a very high uptake of the 13-valent vaccine in children – most of these types have been greatly reduced or caused by the vaccine an invasive disease or other disease, probably in adults – even adults who don’t get it.
The ACIP will review recommendations for the use of the 15-valent vaccine. I don’t know what they will come up with, but I suspect they will say that it is up to the doctor and the patient whether they will receive this vaccine or the currently approved and recommended 13-valent vaccine. It is unclear whether the higher serotype 3 titers make a difference in terms of clinical disease, as this has not been investigated. While 22F and 33F can cause disease, they are relatively minor actors, especially when compared to serotype 3.
There is also a 20-valent vaccine that is also likely to be approved shortly. It will be interesting to see what recommendations are made.
Eugene Shapiro, MD
Member of the editorial board of infectious diseases in children
Professor of Pediatrics and Epidemiology,
Yale School of Medicine
Disclosure: Shapiro does not report any relevant financial information.
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