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Pneumococcal 15-valent Conjugate Vaccine for Minors Gains Positive Opinion

September 19, 2022 • 9:51 am CDT
by Jonas Kakaroto
(Precision Vaccinations)

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recently recommended an expansion of its approval of VAXNEUVANCE™, a pneumococcal 15-valent conjugate vaccine for active immunization for the prevention of invasive disease, pneumonia, and acute otitis media caused by Streptococcus pneumoniae.

On September 16, 2022, New Jersey-based Merck announced the CHMP recommended VAXNEUVANCE be approved for infants, children, and adolescents from 6 weeks to less than 18 years of age.

The European Commission will now consider the CHMP opinion, with a final decision expected by the end of 2022.

VAXNEUVANCE is currently authorized in the European Union for individuals 18 and older.

“We are committed to advancing protection for those at increased risk for pneumococcal disease, which includes those under the age of 2 years and children of any age who have certain underlying conditions,” said Dr. Eliav Barr, SVP, head of global clinical development and chief medical officer, Merck Research Laboratories, in a related press release.

“We are pleased with the CHMP’s positive opinion as it brings us one step closer to our goal of helping to protect against pneumococcal strains that pose a substantial risk to infants and children in Europe.”

Pneumococcal disease is an infection caused by the bacterium Streptococcus pneumoniae.

While there are more than 100 types of S. pneumoniae, called serotypes, several are responsible for most pneumococcal infections.

Invasive pneumococcal disease can cause serious and potentially life-threatening infections such as bacteremia (infection in the bloodstream), bacteremic pneumonia (pneumonia with bacteremia), and meningitis (infection of the coverings of the brain and spinal cord).

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