Novartis, the international pharmaceutical company headquartered in Basel, Switzerland, announced today that it has submitted a Biologic License Application to the U.S. Food and Drug Administration for Bexsero, the vaccine used to treat the meningitis B outbreak at Princeton University earlier this year.
The submission is the first step in the process of obtaining a license for the vaccine for use in the United States. The FDA’s Center for Biologics Evaluation and Research is responsible for regulating vaccines in the United States. The application submission by Novartis to the center follows Bexsero’s receipt of a “breakthrough therapy” designation from the FDA in April that is intended to expedite its regulatory review process.
Bexsero is the first broad coverage meningitis B vaccine that’s been licensed to help protect against invasive meningococcal disease caused by serogroup B in adolescents and young adults ages 10 to 25. It is already been approved in 34 countries across the European Union, Canada and Australia. Since its initial launch in 2013, more than half a million doses have been shipped worldwide.
The meningitis outbreak at Princeton that began in March of 2013 led to a mass vaccination of students at the school this winter and spring. There was also a meningitis B outbreak at the University of California, Santa Barbara this year. Novartis provided students and staff at both campuses with doses of Bexsero under the “investigational new drug” designation from the FDA. To date, nearly 30,000 doses have been distributed to both campuses, a representative for Novartis said.
Meningococcal disease can be misdiagnosed and, while rare, can have serious consequences, including life-long disability and death within the first 24 hours of symptoms. It is most commonly caused by one of the five main serogroups of meningococcal bacteria. Prior to the development of Bexsero, vaccines were only available for four of the five serogroups of the meningococcus. A vaccine to protect against serogroup B was the remaining piece needed to provide populations with broad-spectrum protection against these serogroups that together cause the majority of cases in the world.
“Bexsero is the result of 20 years of groundbreaking research and a testament to our leadership in preventing rare but devastating diseases,” said Andrin Oswald, division head of Novartis Vaccines. “With today’s submission, 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.”
The US Centers for Disease Control and Prevention have recommended including the incoming freshman class at Princeton University in the at-risk group to receive Bexsero, according to Novartis representatices.
A Drexel University student who came in contact with a Princeton University football player at a mixer in Philadelphia in March died after being infected with the same strain of meningitis from the Princeton University outbreak.
A female Princeton University student who was away from campus for spring recess in March of 2013 first developed symptoms of meningococcal disease when returning to the area. Then a visitor on the campus in April of 2013 was diagnosed with bacterial meningitis after returning to another state. A male student was diagnosed with bacterial meningitis in May of 2013. A male student who lives out of state developed symptoms on his way home for summer recess in May of 2013. Another male student who developed symptoms in June of 2013 while traveling abroad. A female student developed symptoms on Oct. 1 of 2013, followed by two more students in November of 2013.
According to the CDC, there have not been any new cases of meningitis B reported at Princeton since Dec. 9 of 2013. Most adolescents who get two doses of this vaccine are protected from getting meningococcal disease, but vaccinated individuals may still be able to carry the bacteria in their throats, which could infect others through close contact.