Pfizer announced Tuesday that the FDA approved Prevnar 20 to prevent invasive disease and pneumonia caused by 20 Streptococcus pneumoniae serotypes in adults. The company said its conjugate vaccine covers the 13 serotypes already included in its existing product Prevnar 13, plus the additional serotypes 8, 10A, 11A, 12F, 15B, 22F and 33F that cause invasive pneumococcal disease and have been associated with high case-fatality rates, antibiotic resistance and meningitis.
The filing for Prevnar 20, which was granted a priority review last December, was supported by data from a progamme involving three Phase III trials of more than 6000 participants 18 years and older, including those aged 65-plus, vaccine-naïve adults and adults with prior pneumococcal vaccination.
According to Pfizer, more than half of all US cases of invasive pneumococcal disease in adults ages 65 or older are due to the 20 serotypes in Prevnar 20. "Overall, the seven additional serotypes in Prevnar 20 account for approximately 40% of all pneumococcal disease cases and deaths in the US," it added. The company noted that the US Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices is expected to meet in October to update recommendations on the use of pneumococcal vaccines in adults.
A marketing application for the 20-valent vaccine is currently under review by the European Medicines Agency. The company reported recently that global sales of its 13-valent vaccine Prevnar 13/Prevenar 13 were down 11% in the first quarter to $1.3 billion, including a 57% drop in the US for the adult indication due to COVID-19-related disruptions.
Last month, Pfizer said it began testing co-administration of Prevnar 20, previously known as 20vPnC and as PF-06482077, following a booster dose of its mRNA-based coronavirus vaccine BNT162b2 co-developed with BioNTech. That trial will include 600 adults aged 65 and older who will have received their second dose of BNT162b2 at least six months before the study start.
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