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2022-06-23| Trials & Approvals

FDA Blesses Merck’s Pneumococcal Vaccine for Pediatric Use

by Fujie Tham
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Merck, or MSD outside the United States and Canada, announced that the US Food and Drug Administration (FDA) has approved an expanded indication for its 15-valent pneumococcal conjugate vaccine – Vaxneuvance to include children from 6 weeks to 17 years old.

Vaxneuvance offers better protection against more pneumonia-causing variants than the standard of care Pfizer 13-valent pneumococcal conjugate vaccine (PCV13), this approval gave Merck an even better edge against the Pfizer competitor.

According to the CDC, about 2,000 cases of serious disease (bacteremia, pneumonia with bacteremia, and meningitis) occur each year in children under five in the United States, and around 1 out of 12 children who get pneumococcal meningitis dies.

Related article: Pfizer: Pneumonia Shot Can Be Given with COVID-19 Vaccine in Older Adults

 

First Pediatric Pneumococcal Conjugate Vaccine Approved in Almost a Decade

 

The FDA approval was based on data from seven randomized double-blind clinical studies in infants, children, and adolescents, the trials also proved that Vaxneuvance can be administered as per scheduled or in a “catch-up” setting for older children. Additionally, the trials support its use in special populations, such as preterm infants and children living with HIV or sickle cell disease.

First approved by the FDA in July 2021 for adults, Merck’s vaccine provides additional protection against Streptococcus pneumoniae serotypes F22 and F33, which are two of the top five serotypes causing childhood cases of invasive pneumococcal disease (IPD). IPD means that bacteria invade parts of the body that are normally free from germs. Examples of IPD are bacteremia (an infection in the blood) and meningitis (an infection of the coverings of the brain and spinal cord).

Vaxneuvance’s expanded pediatric indications mean that Merck can tap into the demands accounting for almost 80% of the market for pneumococcal vaccines, while Pfizer is catching up with both protections and pediatric indications.

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