FDA Approves Conjugate Pneumococcal Vaccine for Adults Ages 18 and Older
The vaccine includes all 13 serotypes in the Prevnar 13 vaccine, as well as conjugates for 7 additional serotypes associated with high case-fatality rates, antibiotic resistance, and meningitis.
Officials with the FDA have approved Pfizer’s pneumococcal 20-valent conjugate vaccine (Prevnar 20) for the prevention of invasive disease and pneumonia caused by the 20 Streptococcus pneumoniae serotypes in adults 18 years of age and older.
The vaccine includes capsular polysaccharide conjugates for the 13 serotypes already included in the Prevnar 13 vaccine, in addition to conjugates for 7 additional serotypes: 8, 10A, 11A, 12F, 15B, 22F, and 33F. These 7 serotypes cause invasive pneumococcal disease and have been linked to high case-fatality rates, antibiotic resistance, and meningitis, according to a press release.
More than half of all cases of invasive pneumococcal disease in the United States among adults 65 years of age or older are caused by the 20 serotypes in the vaccine. Furthermore, in adults 18 years of age and older, these 20 serotypes are estimated to cause up to 250,000 cases of invasive pneumococcal disease and community-acquired pneumonia, as well as more than 10,000 deaths. The 7 additional serotypes in the new vaccine account for approximately 40% of all pneumococcal disease cases and deaths in the United States.
“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 of the International Federation on Ageing, in the press release. “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.”
The FDA approval is based on evidence from Pfizer’s clinical program in adults, which included phase 1 and 2 trials as well as a trio of phase 3 trials. The phase 3 trials included more than 6000 adult participants, including individuals 65 years of age and older, vaccine-naïve adults, and adults with prior pneumococcal vaccination.
Prevnar 20 had been given Fast Track designation in September 2017, as well as Breakthrough Therapy Designation in September 2018. According to the press release, the CDC Advisory Committee on Immunization Practices is expected to meet in October 2021 to discuss recommendations on the use of pneumococcal vaccines in adults.
“Today’s approval of Prevnar 20 marks a significant step forward in our ongoing fight to help address the burden of pneumococcal disease, including pneumonia in adults, and broadens global protection against more disease-causing serotypes than any other pneumococcal conjugate vaccines,” said Kathrin U. Jansen, PhD, senior vice president and head of Vaccine Research & Development at Pfizer, in the press release. “With a single injection, Prevnar 20 provides adults with strong and meaningful protection against serotypes responsible for the majority of circulating pneumococcal disease around the world.”
US 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