A couple of weeks ago, the FDA handed Pfizer's meningitis B candidate its breakthrough therapy designation, setting it up for a race to market with Novartis' Bexsero. Now, the Swiss company's jab has one to match, meaning it may not be long before it can start contributing some much-needed sales to Novartis' vaccines unit.
The use of Bexsero to quell meningitis B outbreaks at two U.S. universities has given Novartis safety data from 14,000 people, but also convinced the Swiss drugmaker it cannot keep shipping the vaccine under investigational use. Novartis has now outlined its plan to make Bexsero more widely available, starting with a submission to FDA in the second quarter.
While the meningitis B outbreak has died down, the debate it stirred up continues. This week researchers at the Manhattan Institute weighed in with their opinion: If a vaccine is good enough for Europe, it is good enough for the U.S..
Last week Novartis' vaccine unit posted yet another operating loss, extending its streak in the red to four years. Yet despite its well-known, long-term problems, suitors are reportedly circling the unit, with the potential of Bexsero and Menveo likely to be a factor attracting potential buyers.
Novartis is trying to make its meningitis B vaccine Bexsero widely available in the U.S., instead of just supplying it on an ad hoc basis to tackle outbreaks.
The meningitis B outbreak at the University of California, Santa Barbara, has slowed for now, with no new cases on the campus since November. However, authorities still view the bacteria as a threat and are trying to get clearance to use Novartis' Bexsero. When that will happen is unclear, though.
Californian health officials have asked for permission to use Novartis' unapproved meningitis B vaccine Bexsero to control an outbreak at a college.
Bexsero has always carried high expectations at Novartis. As the vaccine unit posted loss after loss in recent years, Novartis pitched the meningitis B vaccine to investors as the product that would usher in an era of consistent profitability. This is yet to happen, but the slow rollout of the vaccine continues.
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.
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.