Pfizer, which dominated the global pneumococcal vaccine market with 13-valent Prevnar 13, said it won approval for a 20-valent vaccine in Europe.

On Tuesday, the European Medicines Agency authorized the use of Apexxnar (brand name in the U.S.: Prevnar 20) for immunization and prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae in people aged 18 and older.

The permit allows the 20-valent vaccine in 27 EU members, Iceland, Lichtenstein, and Norway.

Apexxnar includes not only 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) in Prevnar 13 but seven additional serotypes (8, 10A, 11A, 12F, 15B, 22F and 33F) that cause invasive pneumococcal disease (IPD), associated with high case-fatality rates. Apexxnar contains the broadest serotype coverage of any available conjugate vaccine, Pfizer said.

The European nod for Apexxnar was based on results from clinical trial programs in adults, including phase 1, phase 2, and phase 3 studies -- NCT03760146, NCT03828617, and NCT03835975.

The three studies tested the vaccine in over 6,000 adults aged 18 and older, including those 65 years of age and older who had stable chronic medical conditions or were pneumococcal vaccine-naïve and adults with a history of prior pneumococcal vaccination.

Apexxnar obtained authorization as Prevnar 20 in the U.S. in June last year. The U.S. is reviewing the combination of Apexxnar and Covid-19 vaccine Comirnaty.

According to study results released by Pfizer in January, the co-administration of Apexxnar and Comirnaty in adults aged 65 or older demonstrated that the response to all 20 serotypes was similar to the vaccine given with a placebo. In addition, the effect was consistent when given with a booster shot of Comirnaty.

Pfizer is testing Apexxnar in young children in a phase 3 study and expects the results in the second half. If the company gets positive data, Pfizer will seek additional indication in the U.S. and Europe late this year, the company said.