New Meningococcal Vaccine Wins FDA Approval
24 Oct 2023 • The US Food and Drug Administration has approved a meningococcal vaccine against the five most common serogroups causing disease in children and young adults. The new formulation called Penbraya is manufactured by Pfizer and combines the components from two existing meningococcal vaccines, Trumenba the group B vaccine and Nimenrix groups A, C, W-135, and Y conjugate vaccine.
Penbraya is the first vaccine available that can provide such broad protection, which may make it more convenient than current options. This is the first pentavalent vaccine for meningococcal disease and is approved for use in people aged 10-25.
The FDA's decision is based on the positive results from phase 2 and phase 3 trials, including a randomized, active-controlled and observer-blinded phase 3 trial assessing the safety, tolerability, and immunogenicity of the pentavalent vaccine candidate compared with currently licensed meningococcal vaccines. The phase 3 trial evaluated more than 2400 patients from the US and Europe.
Source: Medscape | Read full story