FDA Approves Pneumococcal 20-Valent Conjugate Vaccine for Adults

Jennifer Barrett

Jennifer Barrett is the senior editor for Drug Topics® and Total Pharmacy®.

The vaccine is indicated to prevent invasive disease and pneumonia caused by 20 Streptococcus pneumoniae serotypes.

The FDA has approved the pneumococcal 20-valent conjugate vaccine (Prevnar 20; Pfizer) for use in adults 18 years and older.

The vaccine is indicated to prevent invasive disease and pneumonia caused by 20 Streptococcus pneumoniae serotypes, including 7 responsible for 40% of pneumococcal disease cases and deaths in the United States, according to Pfizer.

The pneumococcal 20-valent conjugate vaccine includes capsular polysaccharide conjugates for the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) already included in the pneumococcal 13-valent conjugate vaccine [Diphtheria CRM197 Protein]). Additionally, the vaccine contains capsular polysaccharide conjugates for 7 other serotypes (8, 10A, 11A, 12F, 15B, 22F, 33F).

This approval is based on results from the clinical trial program evaluating the safety and immunogenicity of the vaccine in more than 6000 adults. Participants included those aged 65 and older, vaccine-naïve adults, and adults with prior pneumococcal vaccination.

“Adult vaccinations play a pivotal role in helping protect our health and wellness, especially as we age and our immune systems begin to naturally weaken,” Jane Barratt, PhD, secretary general, International Federation on Ageing, said in a statement. “We are delighted with today’s approval as it addresses a critical need to continually expand coverage to meet the changing burden of disease. We encourage all adults to speak with their health care professionals about vaccinations.”

In October, the CDC’s Advisory Committee on Immunization Practices will meet to discuss and update recommendations on the safe and appropriate use of pneumococcal vaccines in adults.

Reference

1. U.S. FDA Approves Prevnar 20™, Pfizer’s Pneumococcal 20-Valent Conjugate Vaccine for Adults Ages 18 Years or Older. News release. Pfizer; June 8, 2021. Accessed June 9, 2021. https://www.pfizer.com/news/press-release/press-release-detail/us-fda-approves-prevnar-20tm-pfizers-pneumococcal-20-valent