Prevnar 20 Approved to Prevent Pneumococcal Disease

Prevnar 20 Approved to Prevent Pneumococcal Disease

June 8, 2021 – The U.S. FDA has granted accelerated approval to Prevnar 20TM (pneumococcal 20-valent conjugate vaccine), manufactured by Pfizer, for use in adults to prevent invasive disease and pneumonia caused by the 20 Streptococcus pneumoniae (pneumococcus) serotypes in the vaccine. Continued approval may be contingent on verification and description of clinical benefit in confirmatory trials.

Prevnar 20 is designed to protect against the same serotypes as Prevnar 13® [pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein)], plus an additional seven serotypes that cause invasive pneumococcal disease (IPD) and are associated with high case-fatality rates, antibiotic resistance, and/or meningitis. A type of bacterial infection, IPD can cause life-threatening bacteremia (the presence of bacteria in the bloodstream), meningitis (swelling of the protective membranes of the brain and spinal cord), and pneumonia (inflammation of the air sacs in the lungs).

The FDA based its approval for Prevnar 20 on clinical trials that evaluated the safety and immunogenicity (ability to stimulate an immune response) of the vaccine in adults 18 years and older, including adults never vaccinated against S. pneumoniae and adults with a history of prior pneumococcal vaccination. Recommended dosing is a single, 0.5mL dose given as an intramuscular injection by a healthcare provider.

Launch and pricing plans have not yet been announced.