FDA approves 15-valent pneumococcal vaccine for youngsters

June 22, 2022

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Merck introduced Wednesday that the FDA accredited an expanded indication for Vaxneuvance, the corporate’s 15-valent pneumococcal conjugate vaccine, to incorporate its use in infants and youngsters aged 6 weeks to 17 years.

The vaccine, previously often known as V114, was approved by the FDA last July for adults. It prevents invasive illness brought on by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F and 33F.

Sourec: Adobe Stock.
The FDA has accredited an expanded indication for a 15-valent pneumococcal vaccine to be used in kids. Supply: Adobe Inventory

Steven Shapiro, DO, chairman of the division of pediatrics at Jefferson Abington Hospital in Rydal, Pennsylvania, and investigator for Merck’s PNEU-PED trial, described the vaccine’s significance in a press launch.

“Regardless of decreases in incidence of invasive pneumococcal illness in kids, sure key serotypes proceed to trigger severe sickness that may result in demise in kids beneath the age of 5, with serotypes 3, 22F and 33F liable for greater than 1 / 4 of all invasive pneumococcal illness circumstances on this inhabitants,” Shapiro stated. “With the strong scientific knowledge supporting Vaxneuvance and this FDA approval, Vaxneuvance will likely be an essential new choice to assist advance safety for youngsters.”

Merck stated the FDA’s approval was primarily based on data from seven randomized, double-blind scientific research assessing the protection, tolerability and immunogenicity of Vaxneuvance amongst infants, kids and adolescents. Scientific knowledge confirmed that immune responses elicited by Vaxneuvance following a four-dose pediatric sequence had been “noninferior to the at present out there 13-valent pneumococcal conjugate vaccine (PCV13) for the 13 shared serotypes primarily based on serotype-specific immunoglobulin G geometric imply concentrations.”

The FDA’s preliminary approval of the vaccine for adults was primarily based on knowledge from seven randomized, double-blind scientific research, which confirmed that the vaccine was noninferior to the PCV13 for 13 shared serotypes.

Eliav Barr, MD, senior vice chairman, head of world scientific improvement and chief medical officer at Merck Analysis Laboratories, stated in an announcement that the objective is to broaden vaccine protection towards disease-causing serotypes.

“With this approval, we carry ahead our first pediatric pneumococcal conjugate vaccine — and the primary pediatric pneumococcal conjugate vaccine to be accredited in virtually a decade — constructing on our dedication to stopping invasive pneumococcal illness and on our legacy in pediatric vaccine improvement,” Barr stated within the press launch. “We thank the investigators and the households of our scientific trial individuals for taking part within the analysis research and the function they performed on this milestone.”



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