FDA approves Merck’s 15-valent pneumococcal vaccine
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The FDA recently approved Vaxneuvance, Merck’s 15-valent pneumococcal conjugate vaccine, for adults aged 18 years or older.
The vaccine, formerly known as V114, is for the prevention of invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F and 33F.
The CDC’s Advisory Committee on Immunization Practices is expected to meet in October to make recommendations for the use of Vaxneuvance in adults, Merck said. The vaccine is contraindicated for patients with a history of severe allergic reactions to any component of the vaccine or to diphtheria toxoid, the company noted.
The FDA approval was based on data from seven randomized, double-blind clinical studies, which showed that the vaccine was noninferior to the 13-valent pneumococcal conjugate vaccine (PCV13) for 13 shared serotypes. Immune responses were superior to PCV13 for serotype 3 and for two serotypes unique to Vaxneuvance, 22F and 33F, Merck said.
“Some adults, including older adults or those with certain chronic medical conditions or immunocompromising conditions, are at increased risk for 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 news release. “The FDA’s approval of Vaxneuvance is based on robust phase 2 and 3 studies assessing immune responses in a broad range of adult populations and provides an important new option in protection from invasive pneumococcal disease.”
Randomized controlled studies assessing the clinical efficacy of Vaxneuvance compared with PCV13 have not been conducted.
The vaccine is also being tested in children in phase 3 trials.
Perspective
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It's another vaccine added to the armamentarium, which is approved for use in only adults. There are two additional serotypes not included in PCV13, and so, not surprisingly, 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 has been a problematic serotype and one of the types that is accounting for a lot of the residual invasive pneumococcal disease due to types in the 13-valent vaccine, which is the one currently being used in children and adults.
It's fairly complicated because the current recommendation for adults older than age 65 years is that they use shared clinical decision-making with their physician to decide whether they should get the 13-valent vaccine. Children are the major reservoir and the major vector for pneumococcal infections, and by giving the pneumococcal conjugate vaccine to children — and there's a very high uptake of the 13-valent vaccine in children — most of those types in the vaccine have been greatly reduced or eliminated as causes of invasive disease or any disease, presumably, in adults — even adults who don't get it.
The ACIP is going to consider recommendations for use of the 15-valent vaccine. I don't know what they're going to come up with, but my guess is that they will say that it's up to the clinician and the patient whether to get this vaccine or the currently approved and recommended 13-valent vaccine. Whether the higher titers of serotype 3 makes a difference is unclear in terms of clinical disease, because that was not studied. Although 22F and 33F can cause disease, they are relatively minor players, especially compared with serotype 3.
In addition, there's a 20-valent vaccine that is probably close to being approved as well. It will be interesting to see what recommendations are made.
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