The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency EMA has recommended the approval of the 15-valent pneumococcal conjugate vaccine (Vaxneuvance *) for active immunization for the prevention of invasive pneumococcal disease, pneumonia and acute otitis media caused by Streptococcus pneumoniae in infants, children and adolescents from 6 weeks of age to 18 years of age. The manufacturer Msd (Merck & Co. in the United States and Canada) announces it today in a note.
The 15-valent pneumococcal conjugate vaccine is currently authorized for use in the European Union for individuals aged 18 years and older. Based on the opinion of the CHMP, the European Commission will update the indications of the current marketing authorization in the countries of the European Union. A final decision is expected by the end of the year.
“We are committed to increasing protection for those who are most at risk of pneumococcal disease, including the population under the age of 2 and children of any age who have certain underlying conditions,” said Eliav Barr, senior vice president, head of Global Clinical Development Area and Chief Medical Officer of Merck Research Laboratories – We are delighted that the CHMP has expressed a positive opinion as this represents a further step towards our goal of helping protect European infants and children from Streptococcus serotypes. pneumoniae that put them at risk of disease “.
Pneumococcal disease is an infection caused by the bacterium Streptococcus pneumoniae, or pneumococcus. Although there are more than 100 different types of S. pneumoniae, called serotypes, a select number of serotypes are responsible for most pneumococcal infections. Invasive pneumococcal disease (Ipd) can cause serious and potentially life-threatening infections such as: bacteremia (infection in the bloodstream); bacterial pneumonia (pneumonia with bacteremia) and meningitis (infection in the meninges and spinal cord).
The CHMP opinion is based on data from 8 double-blind randomized clinical trials that enrolled approximately 8,400 individuals from a variety of pediatric populations and different clinical conditions; of these, approximately 5,400 received 15-valent pneumococcal conjugate vaccine.
In July 2021, the 15-valent pneumococcal conjugate vaccine received approval from the U.S. Food and Drug Administration (FDA) for active immunization for the prevention of invasive disease caused by Streptococcus pneumoniae in serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F and 33F in adults aged 18 and over and, in June 2022, the FDA approved the expansion of indications for the conjugate vaccine 15-valent pneumococcal to include individuals aged 6 weeks to 17 years.
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