FDA Delays PDUFA Decision on Merck's Pediatric Pneumococcal Vaccine Vaxneuvance

Compiled by Fan Dongdong

Recently, the U.S. FDA announced that it will extend the Prescription Drug User Fee Act (PDUFA) date for MSD's Vaxneuvance supplemental Biologics License Application (sBLA). A final decision is expected to be made on July 1 this year. Reportedly, Vaxneuvance is a 15-valent pneumococcal conjugate vaccine used for the prevention in infants and children.

In December 2021, MSD announced that the U.S. FDA had accepted the sBLA for Vaxneuvance and granted it priority review. The company submitted Phase II and III clinical study data on Vaxneuvance in patients aged 6 weeks to 17 years at the time. The data supports the use of Vaxneuvance across various clinical settings, including immunization of infants and young children at increased risk of infection, such as those with sickle cell disease or HIV.

However, the U.S. FDA has recently decided to extend the review period for Vaxneuvance. The regulatory agency clearly stated that more time is needed to analyze the data submitted by MSD, but the FDA did not request MSD to conduct additional trial projects.

In July 2021, Vaxneuvance was first approved by the U.S. FDA for use in adults aged 18 and above, with the vaccine's preventive coverage encompassing 15 strains that cause pneumococcal disease. Five months later, in December, the European Commission also approved Vaxneuvance for the prevention of pneumococcal disease in individuals aged 18 and above.

Vaxneuvance is composed of pneumococcal polysaccharides from 15 serotypes conjugated to the CRM197 carrier protein. The U.S. FDA approved Vaxneuvance primarily based on data from seven clinical studies evaluating the safety, tolerability, and immunogenicity in adult patients after injection. Clinical data showed that the immune response triggered by Vaxneuvance was not inferior to Pfizer's currently available 13-valent pneumococcal conjugate vaccine (PCV13).

In addition to adults, pneumococcal disease also poses a significant life-threatening risk to children under the age of two. Pneumococcal infections in children can lead to a range of systemic diseases, including pneumonia, meningitis, middle ear infections, and blood infections, which may even result in lifelong disabilities such as deafness, brain damage, or loss of limbs. In the field of pediatric pneumococcal vaccines, MSD is fiercely competing with several other biopharmaceutical companies.

In June 2021, the U.S. FDA approved Pfizer's new version of the pneumococcal conjugate vaccine, Prevnar 20, which provides protection against 20 types of bacteria in adults. The delay of Merck & Co., Inc.'s PDUFA date could benefit Pfizer, as Pfizer is currently conducting pediatric vaccine trials of Prevnar 20 for children aged 15 months to 17 years, with the trial expected to conclude on December 31 this year. Additionally, Inventprise is also developing a pneumococcal conjugate vaccine, IVT-25, which is currently preparing for Phase I and II clinical trials.

Reference Source:

1、FDA Delays Decision on Merck's Pediatric Pneumococcal Vaccine

2、Merck's pneumococcal vaccine suffers PDUFA delay in pediatric population, with Pfizer hot on its tail