The U.K.'s Joint Committee on Vaccination and Immunization (JCVI) is revising its stance on Novartis' meningitis B vaccine Bexsero. The jab, originally left off Britain's routine vaccination schedule, has gained the JCVI's nod, supplying a needed boost for the Swiss company's flailing vaccine unit.
Pfizer picked up the FDA's breakthrough therapy designation for an in-development vaccine against meningococcal disease, a common cause of meningitis, lighting the path for an accelerated approval as the drugmaker looks to expand its vaccine portfolio beyond the blockbuster Prevnar 13.
Princeton University will not begin to offer Novartis' meningitis B vaccine to Bexsero to students until next week, but health officials are already considering expanding the campaign to another university. An outbreak at the University of California, Santa Barbara, is the cause of the latest concerns.
Novartis has been wanting to get its meningitis vaccine Bexsero into the U.S. market. Thanks to an outbreak at Princeton University, that's going to happen sooner than the Swiss drugmaker thought. Ahead of FDA approval, in fact.
As a meningitis outbreak has slowly spread across Princeton University over the past 8 months, the case for vaccinating students has grown stronger. The only hitch is that the vaccine, Novartis' Bexsero, has yet to win approval in the U.S. Now, though, health authorities are willing to work around this obstacle.
The ACIP decision comes two months after the FDA expanded its label for the meningococcal vaccine. Menveo is now cleared for use in babies aged two months and older, and ACIP has recommended use in infants up to the age of 23 months, but only in certain instances.
The introduction of MenAfriVac in 2010 was viewed as a big event at the time. Its story of a nonprofit stepping into the domain of Big Pharma and developing a meningitis vaccine gained international news coverage. Until this week though, nobody knew the full significance of that 2010 launch.
The FDA is not alone in cracking down on drug compounders. State authorities in Massachusetts have been taking action after being caught off-guard last year when a nationwide, fatal meningitis outbreak was tied to a compounder there. It recently ordered operations halted at two compounders.
The recent outbreak of bacterial meningitis among gay and bisexual men in New York City raised fears of an AIDS-like epidemic. Things are different this time though. Health authorities have a vaccine to hold back the spread of the disease.
Novartis' Bexsero may be the only vaccine approved for life-threatening meningitis B, but that wasn't enough to convince the U.K.'s Joint Committee on Vaccination and Immunisation to add it to Britain's routine vaccination schedule.