Merck & Co. (NYSE: MRK) has announced that the Vaxneuvance pneumococcal 15-valent conjugate vaccine has won approval for children 6 weeks through 17 years of age.
The vaccine is indicated to protect against infection from Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F and 33F.
The vaccine is contraindicated in those with a severe allergic reaction to any of the vaccine’s ingredients or to diphtheria toxoid.
In addition, CDC’s Advisory Committee on Immunization Practices (ACIP) unanimously voted to recommend Vaxneuvance to vaccinate infants and children, including routine use in children under 2.
“Despite decreases in incidence of invasive pneumococcal disease in children, certain key serotypes continue to cause serious illness that can lead to death in children under the age of 5, with serotypes 3, 22F and 33F responsible for more than a quarter of all invasive pneumococcal disease cases in this population,” said Dr. Steven Shapiro, chairman, department of pediatrics, Jefferson Abington Hospital, and investigator for the PNEU-PED trial, in a statement. “With the robust clinical data supporting Vaxneuvance and this FDA approval, Vaxneuvance will be an important new option to help advance protection for children.”
Streptococcus pneumoniae is responsible for a variety of types of invasive pneumococcal disease (IPD), including bacteremia and meningitis.
To win the expanded approval, Merck submitted data from seven randomized, double-blind clinical studies.
The vaccine is administered as a four-dose series.
After announcing the news, Merck shares ticked up 1.28% to $89.16.