The US FDA has awarded breakthrough status to Pfizer’s bivalent rLP2086, its meningitis vaccine candidate in phase III testing.
Pfizer is developing the vaccine for the prevention of invasive meningococcal disease due to Neisseria meningitidis serogroup B in people aged between 10 and 25, and expects to file it for approval in the US in the next few months.
The news comes as an outbreak of serogroup B meningitis affects Princeton and Drexel universities in the US and has already led to one fatality, according to the Centers for Disease Control and Prevention (CDC).
At the moment the primary strategy used to prevent infection is prophylactic antibiotics administered to those in contact with cases, although some of the Princeton students have also been taking part in the studies of Novartis’ rival meningococcal B vaccine Bexsero, which is already approved in Europe and is due to be filed in the US later this year.
Aside from the risk of death, meningococcal B disease can also lead to long-term disabilities such as brain damage and hearing loss. It affects between 20,000 and 80,000 people around the world every year, according to Pfizer.
“Pfizer is developing this meningococcal B vaccine candidate to help protect adolescents and young adults against a difficult to diagnose and often deadly disease,” said the firm’s head of vaccine research Dr Emilio Emini.
“The breakthrough therapy designation highlights the urgent need for prevention of meningococcal B disease,” he added.
Pfizer and Novartis will now be in a toe-to-toe battle to bring their meningococcal B disease vaccines to the US market, with Pfizer able to draw on rLP2086’s breakthrough designation to have the ear of the FDA during the review process. Meanwhile, Novartis will be able to point to the extensive clinical experience with Bexsero, which has also been given the green light in Canada and Australia.
Analysts have predicted that the market for an effective meningococcal B vaccine could be $1bn or more, with the company that wins the marketing battle likely to claim $700m-plus in annual sales.
There was also good news for Novartis today after the UK Department of Health said it plans to introduce Bexsero into the childhood vaccination programme, following advice from the Joint Committee on Vaccination and Immunisation.