The Food and Drug Administration (FDA) has granted accelerated approval to Prevnar 20™ (pneumococcal 20-valent conjugate vaccine) for the prevention of pneumonia and invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F in adults 18 years of age and older. The effectiveness of the vaccine was assessed by measuring serotype-specific serum opsonophagocytic activity (OPA) of antibodies at 1 month postvaccination.
The accelerated approval was based on evidence from several clinical trials including three phase 3 studies involving more than 6000 adult participants. In an active-controlled, double-blind noninferiority trial (ClinicalTrials.gov Identifier: NCT03760146), 3880 pneumococcal vaccine-naïve adults were enrolled into 1 of 3 cohorts based on their age and were randomly assigned to receive either Prevnar 20 or control.
The trial was designed to compare immune responses in patients 60 years of age and older after Prevnar 20 administration to responses in a control group receiving 13-valent pneumococcal conjugate vaccine (Prevnar 13®) followed 1 month later with 23-valent polysaccharide vaccine (PPSV23). The immune responses to Prevnar 20 in patients aged 18 to 59 years were also assessed, along with the safety profile of Prevnar 20 in all patients.
Results showed that the primary immunogenicity objectives of noninferiority for the 20 serotypes in Prevnar 20 in patients aged 60 years and older at 1 month after vaccination were met for all serotypes in common with Prevnar 13, and 6 of the 7 additional serotypes when compared with PPSV23; 1 of the new 7 serotypes missed noninferiority by a small margin.
When measured 1 month after vaccination, Prevnar 20 also elicited serotype-specific immune responses to each of the 20 vaccine serotypes in both of the younger age groups (18-49 years and 50-59 years) that were within 2-fold of the corresponding serotype-specific responses in adults 60 to 64 years of age.
The safety of Prevnar 20 was found to be comparable to licensed pneumococcal vaccines, meeting the study objectives. In adults 60 years of age and older, the most commonly reported solicited adverse reactions were pain at the injection site, muscle pain and fatigue, headache, and arthralgia. Similar side effects were reported in adults 18 to 59 years of age.
Immune responses to Prevnar 20 in adults 65 years of age and older previously vaccinated with pneumococcal vaccine were also investigated in an open-label clinical trial (ClinicalTrials.gov Identifier: NCT03835975). Results showed that OPA geometric mean titers in participants who received PPSV23 one to 5 years prior to Prevnar 20 were diminished compared with participants who received Prevnar 13 at least 6 months previously and compared with those who received Prevnar 13 followed by PPSV23, with the last PPSV23 dose given at least 1 year before Prevnar 20.
With this new approval, an update to the recommendations for pneumococcal vaccination is expected in October following a meeting by the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices.
“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, Pfizer. “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.”
Prevnar 20 is supplied in single-dose prefilled syringes containing 0.5mL suspension for intramuscular injection.
- US FDA Approves Prevnar 20™, Pfizer’s pneumococcal 20-valent conjugate vaccine for adults ages 18 years or older. [press release]. New York, NY: Pfizer, Inc; June 8, 2021.
- Prevnar 20™ [package insert]. New York, NY: Pfizer, Inc; 2021.