FDA-approved: Pneumococcal 20-Valent Conjugate Vaccine for Adults

The FDA On June 9, 2021, approved the pneumococcal 20-valent conjugate vaccine (Prevnar 20; Pfizer) for use in adults aged ≥18 years.

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 a Pfizer statement.

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).

More than half of all cases of invasive pneumococcal disease (IPD) in the US in adults aged ≥65 years are caused by the 20 serotypes in the newly approved vaccine. Those serotypes are responsible for up to 250 000 cases of IPD and community acquired pneumonia and <10 000 deaths in adults aged ≥18 years, according to the statement.

FDA approval is based on findings results from the company's clinical trial program, including 3 phase 3 studies, that evaluated the safety and immunogenicity of the vaccine in <6000 adults. Participants included those aged ≥65 years, vaccine-naïve adults, and adults previously vaccinated against pneumococcal disease.

“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,” said Jane Barratt, PhD, secretary general, International Federation on Ageing, in the Pfizer 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.

Prevnar20 Full Prescribing Information