December 6, 2023

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FDA delays MSD’s pediatric pneumonia vaccine PDUFA date

FDA delays MSD’s pediatric pneumonia vaccine PDUFA date


FDA delays MSD’s pediatric pneumonia vaccine PDUFA date.

A few days ago, the U.S. Food and Drug Administration announced that it will extend the Prescription Drug User Fee Act (PDUFA) date for Merck’s Vaxneuvance Supplemental Biologics License Application (sBLA), with a final decision expected on July 1 this year.

Vaxneuvance is a 15-valent pneumococcal conjugate vaccine for prophylactic use in infants and children.


FDA delays MSD's pediatric pneumonia vaccine PDUFA date.


In December 2021, Merck announced that the U.S. FDA has accepted Vaxneuvance’s sBLA application for priority review, and the company submitted data from Phase II and Phase III clinical studies of Vaxneuvance in patients aged 6 weeks to 17 years old.

Data support the use of Vaxneuvance in a variety of 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 US FDA recently decided to extend the review cycle of Vaxneuvance. Regulators have made it clear that more time is needed to analyze the data submitted by Merck, though the FDA has not asked Merck to conduct additional trials.


In July 2021, Vaxneuvance was first approved by the U.S. FDA for injection in adults over the age of 18. The vaccine covers 15 strains that cause pneumococcal disease.

Five months later, the European Commission also approved Vaxneuvance in December for the prevention of disease caused by Streptococcus pneumoniae in people 18 and older.


Vaxneuvance consists of 15 serotypes of pneumococcal polysaccharides combined with the CRM197 carrier protein. The FDA approval of Vaxneuvance at that time was mainly based on data from seven clinical studies evaluating the safety, tolerability and immunogenicity of adult patients after injection.

The clinical data showed that the immune response induced by Vaxneuvance was not inferior to Pfizer’s 13-valent pneumonia currently available on the market Coccus conjugate vaccine (PCV13).


In addition to adults, pneumococcal disease also poses a major life-threatening threat to children under the age of two.

Pneumococcal infections in children can cause a range of systemic diseases, including pneumonia, meningitis, middle ear infections, and bloodstream infections, and even lead to lifelong disabilities, including deafness, brain damage, or loss of limbs. Merck is competing fiercely with several other biopharmaceutical companies in the field of pneumococcal vaccines for children.


In June 2021, the U.S. Food and Drug Administration approved a new version of Pfizer’s Prevnar 20 pneumococcal conjugate vaccine, which provides protection against 20 bacteria in adults.

The delay of Merck’s PDUFA date may be beneficial to Pfizer, which is conducting a trial of the Prevnar 20 pediatric vaccine for children aged 15 months to 17 years, which is expected to end on December 31 this year.

In addition, Inventprise is also developing the pneumococcal conjugate vaccine IVT-25, which is currently preparing for Phase I and Phase II clinical trials.




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

FDA delays MSD’s pediatric pneumonia vaccine PDUFA date

(source:internet, reference only)

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Important Note: The information provided is for informational purposes only and should not be considered as medical advice.