Big Pharma In Neck And Neck Race Toward Meningitis Vaccine Approval
By Lori Clapper
Each year, approximately 500,000 cases of meningococcal disease occur worldwide due to N. meningitidis. Not to mention, the majority of invasive meningococcal disease cases worldwide can be attributed to five N. meningitidis serogroups (A, B, C, W-135 and Y).
In efforts to battle meningitis outbreaks, both Pfizer and Novartis submitted Biologics License Applications (BLA) to the U.S. Food and Drug Administration (FDA) Tuesday, in hopes of getting the green light to move forward with their respective vaccine candidates.
Pfizer’s bivalent recombinant LP2086 (rLP2086) is targeted for the prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroup B in 10 to 25 year olds, the company said in a recent press release.
“The BLA submission for bivalent rLP2086 marks an important step toward our goal of helping to protect adolescents and young adults against this difficult to diagnose and often deadly disease,” said Dr. Emilio Emini, senior vice president of Vaccine Research and Development for Pfizer Inc. “There is an urgent public health need to help prevent meningococcal B disease through vaccination, and we will continue to work closely with the FDA in our efforts to advance our vaccine candidate.”
The FDA has a 60-day filing review period to determine whether the BLA is complete and acceptable for filing.
Novartis’ vaccine Bexsero, which protects against invasive meningococcal disease caused by serogroup B (meningitis B), has already been granted emergency use status at both Princeton University and the University of California, Santa Barbara — having used nearly 30 thousand doses following outbreaks on these campuses. The vaccine is also approved in 34 different countries, including Europe, Canada and Australia, according to an NBC report.
However the company still faces the FDA hurdle for the widespread use of Bexsero. This BLA is just the next step in its rolling submission process to the FDA, following the Breakthrough Therapy designation in April. And it certainly has not been an overnight process, according to Andrin Oswald, division head, Novartis Vaccines.
"Bexsero is the result of 20 years of groundbreaking research and a testament to our leadership in preventing rare but devastating diseases," Oswald explained. "We are one step closer to ensuring that no family in the U.S. has to endure the loss of a loved one from vaccine-preventable meningitis."