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Pfizer Receives FDA Approval for Penbraya Vaccine

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Andrew R. Michaud

• October 20, 2023

Pfizer has announced that the Food and Drug Administration (FDA) has granted approval for Penbraya, a highly effective vaccine designed to prevent the five most common serogroups responsible for meningococcal disease. The vaccine is indicated for adolescents and young adults aged 10 through 25 years.

Meningococcal disease is caused by the Neisseria meningitidis bacteria and can result in severe illness and even death, according to the U.S. Centers for Disease Control (CDC). The CDC emphasizes the importance of staying up to date with recommended vaccines as the best means of protection against this serious disease.

In an official statement released by Pfizer, it was revealed that the CDC Advisory Committee on Immunization Practices is scheduled to convene on October 25 to discuss the appropriate use of Penbraya in adolescents and young adults.

Pfizer's FDA approval was based on highly positive results obtained from both Phase 2 and Phase 3 trials. The Phase 3 trial involved the evaluation of more than 2,400 patients from the United States and Europe, highlighting the vaccine's efficacy.