Merck ( MRK Quick Quote MRK - Free Report) announced that the FDA has approved Vaxneuvance, its newly approved pneumococcal 15-valent conjugate vaccine, for use in children and infants. Vaxneuvance can now be given to children 6 weeks through 17 years of age to protect against invasive pneumococcal disease.
The U.S. Centers for Disease Control and Prevention’s (CDC’s) Advisory Committee on Immunization Practices (ACIP) also unanimously voted to provisionally recommend Vaxneuvance as an option for vaccination in infants and children, including routine use in children under 2 years of age.
In December, the FDA had accepted and assigned priority review to the supplemental biologics license application (sBLA) seeking approval of Vaxneuvance for the pediatric population. However, in April, the FDA announced delaying its decision on the sBLA by three months as it needed more time to analyze Merck’s data from the pediatric studies on Vaxneuvance. The FDA had not requested any new studies to be conducted. The FDA was to give its decision on Jul 1.
Merck’s stock has risen 16.3% this year so far against a decrease of 0.3% for the
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Merck’s Vaxneuvance vaccine includes pneumococcal serotypes 22F and 33F, which are not included in the currently licensed 13-valent pneumococcal conjugate vaccines (PCV13). These two serotypes, along with the leading serotype 3, contribute significantly to the burden of invasive pneumococcal disease (IPD). These are three of the top five serotypes causing childhood cases of IPD. The vaccine was approved in the United States in July and in Europe in December last year for use in adults.
The FDA’s approval for the pediatric population was based on data from seven studies evaluating Vaxneuvance in infants, children and adolescents.
Data from a pivotal study showed that immune responses elicited by Vaxneuvance were non-inferior to PCV13 for all 13 shared serotypes, following a four-dose pediatric series based on serotype-specific response rates. However, immune responses were superior for shared serotype 3 and unique serotypes 22F and 33F compared to PCV13.
Pfizer’s ( PFE Quick Quote PFE - Free Report) Prevnar-20, a 20-valent pneumococcal conjugate vaccine, was approved in the United States in June last year and in Europe in February 2022 (to be marketed as Apexxnar) for use in adults. However, Prevnar-20 is not approved for use in the pediatric population.
Prevnar 20 includes all the 13 serotypes contained in Pfizer’s popular 13-valent pneumococcal conjugate vaccine, Prevnar 13 along with seven additional serotypes. Pfizer is also conducting studies to evaluate the co-administration of its Prevnar-20 vaccine with its COVID-19 vaccine.
Merck currently carries a Zacks Rank #3 (Hold). You can see
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