Merck & Co – known as MSD outside the US and Canada – has announced that the US Food and Drug Administration (FDA) has extended the date of the company’s application for its pneumococcal vaccine Vaxneuvance to 1 July 2022.
The FDA has requested further data analyses of the existing paediatric studies, which Merck has submitted, along with a further three months to evaluate the data. No new studies have been requested.
After an initial approval in July 2021 for the use of Vaxneuvance in adult patients, Merck’s application for the vaccine to be used to prevent pneumococcal disease in children aged 6 weeks to 17 years of age was accepted by the FDA in December 2021 and was granted Priority Review.
Last year it was predicted that the vaccine, at that point approved for use in adults, could make over $1bn in peak sales.
Merck Research Laboratories chief medical officer, Eliav Barr, said: “We are confident in the strength of the data from our paediatric studies with Vaxneuvance and will continue to work expeditiously with the FDA to bring this important vaccine forward to infants and children in the United States as soon as possible.”
After Merck’s 15-strain pneumococcal vaccine was approved by the FDA on 16 July 2021, the company hoped it could compete with Pfizer’s FDA-approved 20-strain pneumococcal vaccine, Prevnar 20.
Pfizer is currently conducting an FDA-required paediatric study for Prevnar 20 in children aged 15 months to 17 years of age, with an end date of 31 December this year.