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Merck’s Vaccine For Streptococcus Pneumoniae Lined Up for Another European Commission Approval
On September 16, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended Merck’s VAXNEUVANCE™(Pneumococcal 15-valent Conjugate Vaccine) for approval. Currently, the Streptococcus pneumoniae vaccine is approved for adults eighteen or older. However, this approval will extend that range to children aged six weeks and up. The results of eight clinical trials form the basis of the recommendation.
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VAXNEUVANCE and its Prior Approvals
VAXNEUVANCE is a vaccine protecting against infection caused by certain types of pneumococcal bacteria (Streptococcus pneumoniae). When this bacteria infects different body parts, they cause varying pneumococcal diseases. These include pneumonia in the lungs, otitis in the ears, sinusitis in the sinuses, meningitis in the brain’s lining, and bacteremia in the blood.
In July 2021, the vaccine received its first approval from the United States Food and Drug Administration (FDA) for the protection against S. pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F and 33F in adults 18 years of age and older. At the time, the approval, based on seven clinical trials, proved the vaccine’s safety, tolerability, and immunogenicity. The FDA would extend the approval range to children aged six weeks and up in June of this year. The approval followed the FDA’s review of supplemental data provided by Merck. The data showed VAXNEUVANCE’s superiority to PCV13 for shared serotype 3 following a four-dose pediatric series.
A few months after the FDA’s initial approval, the EMA recommended approval to the European Commission (EC) as well. They based their decision on the same seven clinical trials that the FDA did. This approval was also for the same age range, for adults eighteen and older.
Just as with the initial approval, the EMA’s CHMP is now recommending VAXNEUVANCE’s approval for children aged six weeks and up to the EC.
The European Commission’s Likely Amendment
Eight clinical trials tested VAXNEUVANCE on various pediatric populations, with approximately 5,400 receiving the vaccine. Based on this information, as well as prior approvals, the CHMP recommended VAXNEUVANCE for approval to the EC.
On the decision, Dr. Eliav Barr, senior vice president, head of global clinical development, and chief medical officer at Merck Research Laboratories, said, “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.”
Based on both approvals from the FDA, as well as the EC’s own initial approval, it is very likely that this amendment will gain approval as well. The EC is currently evaluating the data, with a final decision expected by the end of the year.©www.geneonline.com All rights reserved. Collaborate with us: email@example.com