Infectious Disease

Merck’s 15-valent pneumococcal vaccine receives FDA precedence evaluate

January 12, 2021

1 min read

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The FDA has approved Merck’s 15-valent pneumococcal conjugate vaccine for priority review, the company said.

V114 vaccine has previously been shown not to be inferior to the 13-valent pneumococcal conjugate vaccine currently publicly available for adults.

The FDA is expected to make a decision on V114 by July 18, Merck said.

“Invasive adult pneumococcal disease is on the rise in many countries due to highly invasive serotypes such as serotype 3, which is included in the currently approved pneumococcal conjugate vaccine, as well as non-included serotypes such as serotypes 22F and 33F.” Roy Baynes, MD, PhD, In a press release he said, director of global clinical development and chief medical officer of Merck.

According to Baynes, V114 is “another potentially important option in protecting more adults from invasive pneumococcal disease, especially those at increased risk.”

The priority review of Merck’s biologics license application will be supported by results from Phase 2 and 3 clinical trials in healthy adults, high-risk adults, adults with HIV, adults with chronic disease and adults 65 years and older, Merck said. Other studies support co-administration of the V114 vaccine with the tetravalent influenza vaccine.

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