Merck’s 15-valent pneumococcal vaccine gets FDA priority review
The FDA has accepted Merck’s 15-valent pneumococcal conjugate vaccine for priority review, the company announced.
The vaccine, V114, has previously been shown to be noninferior to the 13-valent pneumococcal conjugate vaccine that is currently publicly available for adults.
The FDA is expected to make a decision on V114 by July 18, Merck said.
“Invasive pneumococcal disease in adults is on the rise in many countries, driven by highly invasive serotypes including serotype 3, which is included in the currently licensed pneumococcal conjugate vaccine, as well as serotypes not included, such as serotypes 22F and 33F,” Roy Baynes, MD, PhD, head of global clinical development and chief medical officer for Merck, said in a press release.
Baynes said V114 is “another potentially important option to help protect more adults from invasive pneumococcal disease, especially those who are at increased risk.”
The priority review of Merck’s biologics license application is supported by results from phase 2 and 3 clinical studies of healthy adults, adults with increased risk, adults with HIV, adults with chronic medical conditions and adults aged 65 years or older, Merck said. Other studies support coadministration of the V114 vaccine with the quadrivalent influenza vaccine, the company noted.