EMA Recommends VAXNEUVANCE Pneumococcal Vaccine for Approval

The European Medicines Agency’s (EMA’s) human medicines committee has recommended approval for a pneumococcal vaccine in adults.

The agency’s Committee for Medicinal Products for Human Use (CHMP) granted a positive opinion for VAXNEUVANCE on October 14 for active immunization for the prevention of invasive disease and pneumonia caused by 15 strains of Streptococcus pneumoniae in people aged 18 years or older. VAXNEUVANCE, which is manufactured by Merck, received approval from the US Food and Drug Administration on July 16 of this year.

S pneumoniae is the most common cause of pneumonia-associated death globally, according to the Centers for Disease Control and Prevention. Any healthy adult can get pneumococcal disease; adults older than 65 years, people with HIV, and those with certain chronic health conditions are particularly vulnerable to infection.

This CHMP recommendation was based on data from clinical studies evaluating VAXNEUVANCE in over 7400 individuals, according to an EMA press release. The recommendation will now be reviewed by the European Commission. Official approval is expected before the end of the year.

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