Pfizer receives approval in the European Union for Nimenrix (meningococcal group A, C, W-135, and Y conjugate vaccine) in infants six weeks of age and older.
Pfizer Inc. announced the European Commission (EC) has approved an expanded indication for Nimenrix (meningococcal group A, C, W-135, and Y conjugate vaccine) for active immunization against invasive meningococcal disease (IMD) caused by Neisseria meningitidis serogroups A, C, W-135, and Y (MenACWY) in infants as early as six weeks of age. Nimenrix is now the first and only MenACWY conjugate vaccine in the European Union (EU) that can be administered from six weeks of age with no upper age limit.
“With this approval, Nimenrix now has the broadest age indication of any conjugate vaccine in Europe against invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, W-135, and Y, to help protect people as young as six weeks of age,” said Luis Jodar, chief medical and scientific affairs officer for Pfizer Inc. “At Pfizer, our expertise in bringing new indications and therapies to people in need helps enable us to continually improve and expand our portfolio of potentially life-saving vaccines.”
The EU approval is based upon results from a Phase 3, open-label, randomized, controlled study (study MenACWY-TT-083) in which the immunogenicity and safety of Nimenrix was evaluated in over 1,000 healthy infants from six weeks of age. Based on clinical evidence, Nimenrix was approved for administration in infants as a two dose primary series, with the first dose given from six weeks of age and with an interval of two months between doses, followed by a booster dose at 12 months. The six confirmatory co-primary objectives of the study were met.
Pfizer’s meningococcal vaccines portfolio includes vaccines that help protect against the five most common disease-causing serogroups — A, C, W-135, Y, and B (approvals varying by country) — which can threaten the health of people at various points in their lives. The risk of contracting meningococcal disease varies year to year, by age group and by the country one travels to or lives in.
Nimenrix is indicated for active immunization of individuals from the age of six weeks and above against invasive meningococcal disease caused by Neisseria meningitidis group A, C, W-135, and Y.
(Source: Business Wire)