Merck gets EMA Committee positive opinion for Pneumococcal 15-valent Conjugate Vaccine in infants, children
Pneumococcal disease is an infection caused by the bacterium Streptococcus pneumoniae, or pneumococcus.;
Rahway: Merck, known as MSD outside of the United States and Canada, has announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of VAXNEUVANCE(Pneumococcal 15-valent Conjugate Vaccine) (pronounced VAKS-noo-vans) for active immunization for the prevention of invasive disease, pneumonia and acute otitis media caused by Streptococcus pneumoniae in infants, children and adolescents from 6 weeks to less than 18 years of age. VAXNEUVANCE is currently authorized for use in the European Union (EU) for individuals 18 years of age and older.
The CHMP opinion will now be considered by the European Commission (EC) for amending the marketing authorization in the EU, and a final decision is expected by the end of the year.
"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, senior vice president, head of global clinical development and chief medical officer, Merck Research Laboratories. "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 substantial risk to infants and children in Europe."
Disclaimer: This website is primarily for healthcare professionals. The content here does not replace medical advice and should not be used as medical, diagnostic, endorsement, treatment, or prescription advice. Medical science evolves rapidly, and we strive to keep our information current. If you find any discrepancies, please contact us at corrections@medicaldialogues.in. Read our Correction Policy here. Nothing here should be used as a substitute for medical advice, diagnosis, or treatment. We do not endorse any healthcare advice that contradicts a physician's guidance. Use of this site is subject to our Terms of Use, Privacy Policy, and Advertisement Policy. For more details, read our Full Disclaimer here.
NOTE: Join us in combating medical misinformation. If you encounter a questionable health, medical, or medical education claim, email us at factcheck@medicaldialogues.in for evaluation.