20-Valent Pneumococcal Conjugate Vaccine Candidate for Infants and Children Received Positive Opinion

Pfizer Inc. recently announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion, recommending the granting of a marketing authorization for its 20-valent pneumococcal conjugate vaccine candidate (20vPnC, PREVNAR 20®, APEXXNAR®) for active immunization for the prevention of invasive disease, pneumonia and acute otitis media caused by Streptococcus pneumoniae in infants, children and adolescents from 6 weeks to less than 18 years of age.

The CHMP’s positive opinion will now be reviewed by the European Commission (EC) to decide whether to approve the vaccine.

This EC decision is expected in the coming weeks and will apply to all 27 EU member states plus Iceland, Liechtenstein, and Norway.

“Pfizer has a longstanding history of developing groundbreaking pneumococcal conjugate vaccines to help protect infants and their families from life-threatening infections,” said Annaliesa Anderson, Ph.D., Senior Vice President and Chief Scientific Officer, Vaccine Research and Development, Pfizer, in a press release on January 26, 2024.

“Today’s CHMP positive opinion represents a significant step forward in our continued efforts and, if approved, 20vPnC has the potential to cover more disease burden than any other available pediatric pneumococcal conjugate vaccine in the EU.”

In April 2023, the U.S. Food and Drug Administration approved PREVNAR 20® for most infants and children.

In February 2022, the EC Decision was adopted for APEXXNAR® (20vPnC) to prevent invasive disease and pneumonia caused by the 20 S. pneumoniae serotypes in the vaccine in adults.

The unedited Pfizer press release is available at this link.