Pfizer and Novartis have been racing to get their meningitis B vaccines to market for years. But as of Tuesday, the contest has never been closer, with both companies submitting approval applications to the FDA. Now, it's up to the agency to decide which shot gets the green light first--and first crack at the wide-open patient pool that comes with it.
Novartis' Bexsero, approved in 34 countries, was the world's first marketed vaccine to protect against the deadly meningitis B. And now, it's one step closer to becoming the first in the U.S.--that is, if a Pfizer candidate doesn't beat it to the finish line.
Australian survivors of the deadly meningococcal B strain are mounting pressure on the country's Pharmaceutical Benefits Advisory Committee to include Novartis' Bexsero, the only approved vaccine for the disease, on its national immunization plan when it meets next month.
In an announcement full of surprises from Novartis and GlaxoSmithKline, the sale of the Swiss company's vaccines division to Glaxo may have been the least surprising part.
When a U.K. advisory committee reversed its earlier guidance and recommended the country's National Health Service add Novartis' meningitis B vaccine Bexsero to its national immunization program, it did so on condition that the NHS secure a "cost-effective price" for the jab. And now, it seems the country and the Swiss company may have different ideas of what that price should be.
Dr. John Porter, formerly the U.K. medical team lead for Pfizer, will become Novartis' medical affairs director for Northern Europe.
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.
Going into 2014 Novartis said this was the year Bexsero, the great hope of its struggling vaccine unit, would begin to generate significant sales. Exactly how significant depends on whether governments agree to pay for the vaccine, and in this regard Novartis received a big boost this week. Britain could begin vaccinating all babies with Bexsero as early as this summer.
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.
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.