Pfizer announces EMA Acceptance for Review of MAA for Trumenba

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, 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.

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.