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Merck’s Streptococcus pneumoniae Expansion Finally Receives European Commission Approval
The European Commission (EC) expanded the indication of VAXNEUVANCE™ (Pneumococcal 15-valent Conjugate Vaccine). The pneumococcal disease vaccine now includes immunization for diseases caused by the Streptococcus pneumoniae bacteria in infants, children, and adolescents from 6 weeks to less than 18 years of age.
The EC based its decision on the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) opinion following a review of data from eight clinical studies.
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The Grounds for the Streptococcus Pneumoniae Vaccine Extension
VAXNEUVANCE provides immunization against Streptococcus Pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F and 33F. The vaccine received its first approval in July 2021 from the United States Food and Drug Administration (FDA). At the time, seven clinical trials proved the vaccine’s safety, tolerability, and immunogenicity.
The FDA extended their approval from adults 18 years of age and older to also include children aged six weeks and up. This extension came from supplemental data provided by Merck, demonstrating that VAXNEUVANCE was “non-inferior” to other available 13-valent pneumococcal conjugate vaccines.
A little while later, the CHMP indicated its intention to agree with the FDA. The data provided by Merck included eight clinical studies conducted on around 8,400 individuals. An estimated 5,400 of that total received VAXNEUVANCE. Pediatric patients included healthy infants, children, adolescents, pre-term infants, and children living with HIV infection or sickle cell disease.
After a few months of review, the EC finally released its opinion, granting the approval.
On the regulatory agency’s decision, Dr. Eliav Barr, senior vice president, head of global clinical development and chief medical officer at Merck Research Laboratories, said, “With this approval, we are pleased to bring an important new PCV option to a vulnerable population in Europe, including infants less than one year of age, who typically experience the highest rates of disease.”
The EC’s approval of Merck’s Streptococcus Pneumoniae includes all 27 member states of the European Union, in addition to Iceland, Norway, and Lichtenstein.©www.geneonline.com All rights reserved. Collaborate with us: email@example.com