The US Food and Drug Administration has issued a speedy green light for Pfizer’s Trumenba, making it the first vaccine licensed in the country to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroup B, beating Novartis offering Bexsero to the finish line.
Until now, approved vaccines in the country only offered protection against four of the five main serogroups of N. meningitidis bacteria causing meningococcal disease: A, C, Y, and W.
Approval of Trumenba, which is to be used in 10-25 years olds, was based on data from three randomised studies showing that of those receiving three doses of Trumenba, 82% had antibodies in their blood that killed four different N. meningitidis serogroup B strains compared with less than 1% before vaccination.
Regulators used the accelerated approval pathway to quicken access to the jab, but consequently Pfizer will need to conduct further studies to verify its effectiveness against a wider range of B strains.
“Recent outbreaks of serogroup B Meningococcal disease on a few college campuses have heightened concerns for this potentially deadly disease,” said Karen Midthun, director of the FDA’s Center for Biologics Evaluation and Research. But the approval of Trumenba provides “a safe and effective way” to help protect patients from contracting it, she stressed.
Emilio Emini, head of Vaccine Research and Development at Pfizer, said the vaccine “addresses an existing and urgent need in the efforts to help prevent this uncommon but life-threatening and devastating disease” and that, as a next step, the firm will be in discussions with the Centres for Disease Control about potential meningococcal group B vaccination recommendations.
Pfizer was neck and neck with Novartis to bag the first approval in the United States of a vaccine for serogroup B meningitis. Novartis’ Bexsero has aleadry been cleared in Canada, Europe and Australia.