FDA Expands Approval to Merck’s Vaxneuvance Vaccine in Children From Six Weeks to 17 Years Old

The FDA has expanded the approval of Merck’s 15-valent Streptococcus pneumoniae vaccine Vaxneuvance to include children between the ages of six weeks and 17 years.

The expanded approval, which followed a Priority Review designation by the agency, was supported by positive data from seven clinical trials.

Vaxneuvance was first approved by the FDA in July 2021 for adults age 18 years and older. At the time, the FDA noted that it did not refer Merck’s application to its Vaccines and Related Biological Products Advisory Committee because its review of the company’s Biologics License Application “did not raise concerns or controversial issues that would have benefited from an advisory committee discussion.”