The FINANCIAL — Pfizer Inc. on May 20 announced the European Medicines Agency (EMA) has accepted the Marketing Authorization Application (MAA) for TRUMENBA (Meningococcal Group B Vaccine) for review.
TRUMENBA has been developed for the prevention of invasive meningococcal disease (IMD) caused by Neisseria meningitidis serogroup B (MnB) in individuals aged 10 years and older. The acceptance marks the beginning of the regulatory review process for this vaccine in the EU.
The EMA’s acceptance of TRUMENBA’s Marketing Authorization Application brings us one step closer to fighting this uncommon yet life-threatening disease worldwide, by helping to protect adolescents and adults who are at risk to contract meningococcal disease caused by serogroup B,” said Kathrin Jansen, Ph.D., senior vice president and head of Vaccine Research and Development for Pfizer Inc. “At Pfizer we are committed to providing innovative vaccines that help people live the longest, healthiest lives possible.”
The MAA for TRUMENBA is based upon a clinical trial dataset of approximately 20,800 adolescents and adults aged 10 years and older, studied globally. This dataset demonstrates the consistency of vaccine-induced immune responses to diverse disease-causing MnB strains and the well-studied safety and tolerability profile, according to Pfizer.
Vaccines are one of the greatest public health advances, demonstrating control, elimination or near-elimination of numerous infectious and vaccine-preventable diseases. Pfizer’s portfolio is built with vaccines that help protect against five of the most common serogroups causing invasive meningococcal disease (A, B, C, W and Y) – approvals varying by country – which can threaten the health of people at various points in their lives.
TRUMENBA is currently approved in the U.S.
Indication for TRUMENBA in the U.S.
TRUMENBA (Meningococcal Group B Vaccine) is indicated for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroup B in individuals aged 10 through 25 years of age.
Approval of TRUMENBA is based on the demonstration of immune response, as measured by serum bactericidal activity against four serogroup B strains representative of prevalent strains in the United States. The effectiveness of TRUMENBA against diverse serogroup B strains has not been confirmed.
Important Safety Information
TRUMENBA should not be given to anyone with a history of a severe allergic reaction after a previous dose of TRUMENBA.
Individuals with weakened immune systems may have a reduced immune response.
The most common adverse reactions were pain at the injection site, fatigue, headache, muscle pain, and chills.
Data are not available on the safety and effectiveness of using TRUMENBA and other meningococcal group B vaccines interchangeably to complete the vaccination series.
Tell your healthcare provider if you are pregnant, or plan to become pregnant.
Ask your healthcare provider about the risks and benefits of TRUMENBA. Only a healthcare provider can decide if TRUMENBA is right for you or your child.
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