The Food and Drug Administration has approved Merck’s new pneumococcal vaccine in adults aged 18 years and older.
The drug, brand name Vaxneuvance, protects against 15 strains of bacteria that can cause pneumonia and other acute respiratory disease, and has shown evidence of efficacy in older adults.
The FDA’s approval Friday comes one month after the agency greenlit Pfizer’s pneumonia shot Prevnar 20. Vaxneuvance was not compared to the Prevnar 20 shot, which adds protection against seven more microorganisms than Pfizer’s widely used Prevnar 13. However, the new vaccine did prompt a response equal to that of Prevnar 13, Merck reported. What’s more, Vaxneuvance evoked greater immune responses to three bacterial strains when compared with Prevnar 13, one of which is the leading cause of invasive pneumococcal disease in the United States, Merck reported.
Merck is encouraging the use of Vaxneuvance in older adults diagnosed with certain chronic medical conditions or who are immunocompromised and, therefore, at increased risk for pneumococcal disease and its complications, said clinical trial lead Jose Cardona, M.D., of the Indago Research and Health Center. The drug also can be safely co-administered with seasonal inactivated influenza vaccine in adults aged 50 years and older, the company said.
“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,” Cardona said in a statement.
The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices, or ACIP, is scheduled to convene in October to update its recommendations on appropriate use of the Merck and Pfizer vaccines, among other orders of business. These latest approvals could have a major impact on ACIP’s recommendations, according to BioPharmaDive.
Approximately 80% of all adult invasive pneumococcal disease is among adults 50 years of age and older, Merck reported.