EC approves expanded indication for Pfizer’s Nimenrix vaccine to treat IMD
The European Commission (EC) has approved an expanded indication for Pfizer’s Nimenrix (meningococcal group A, C, W-135, and Y conjugate vaccine) to treat invasive meningococcal disease (IMD).
IMD is caused by Neisseria meningitidis serogroups A, C, W-135, and Y (MenACWY) in infants as early as six weeks of age.
Nimenrix is a meningococcal ACWY (MenACWY) conjugate vaccine that uses tetanus toxoid (TT) as a carrier protein to help protect individuals against IMD.
Pfizer chief medical and scientific affairs officer Luis Jodar said: “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.
“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 lifesaving vaccines.”
The EU approval has been given based on results from a Phase III, open-label, randomised, controlled study, which involved evaluation of the immunogenicity and safety of Nimenrix in more than 1,000 healthy infants from six weeks of age.
Based on clinical evidence, the vaccine was approved for administration in infants as a two-dose primary series.
The first dose will be given from six weeks old with an interval of two months between doses, followed by a booster dose at 12 months.
The Meningococcal vaccines portfolio of Pfizer includes vaccines that will help protect against the five most common disease-causing serogroups, A, C, W-135, Y, and B.
The drug was first approved in the EU on 20 April 2012 and is licensed in more than 65 countries.
Image: The growth of Neisseria meningitidis on NYC media. Photo: courtesy of Xishan01.