GSK (NYSE:GSK) announced today that the European Medicine Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion on the company's single-vial, fully liquid Menveo vaccine.
The new presentation does not require reconstitution and is expected to simplify the immunization process against invasive meningococcal disease (IMD) for healthcare providers.
"As a global leader in meningococcal vaccines, we are committed to finding innovative solutions that simplify immunisation against bacterial meningitis, support vaccine uptake and help protect as many people as possible from this devastating disease," said Philip Dormitzer, GSK's Head of Global Vaccines Research & Development.
GSK's submission to the EMA is based on two positive Phase IIb trials.
The primary and secondary outcomes of these trials, supported by post-hoc pooled analyses, show that the fully liquid formulation of this vaccine has comparable immunogenicity, tolerability and a comparable safety profile to the existing lyophilized/liquid formulation.
The final decision from the European Commission regarding marketing authorization is anticipated by November 2024.