The Food and Drug Administration approved Trumenba, a vaccine against meningitis type B, for active immunization in 10- to 25-year-olds on Tuesday, according to a press release by Pfizer, the manufacturer of the vaccine.
This is the first vaccine against this strand of bacterial meningitis approved in the United States. An outbreak of meningitis B on campus affected seven students and one visitor last year, all of whom survived. A student at Drexel University died in March after reportedly being in contact with Princeton football players, local health authorities said at the time.
The University received a special permission late last year to distribute Bexsero, a competing vaccine against meningitis B developed by Novartis. Bexsero has yet to be approved in the United States, although it has been licensed in 34 other countries.
It remains unclear if the University will switch to distributing Trumenba in the future or if it will continue distributing a meningitis vaccine at all. The University's special license to distribute Bexsero is set to expire in the near future, and no more vaccination clinics are scheduled.
Emilio Emini, senior vice president of vaccine research and development at Pfizer,explained that, shortly after the outbreak at the University at the end of 2013, the FDA asked Pfizer if the company felt it had sufficient data to apply for accelerated approval. Since Pfizer felt that its data had met the requirements, it decided to apply.
At the time, the Centers for Disease Control and Prevention had considered both Trumenba and Bexsero as possible vaccines to be used to curb the outbreak at the University, ultimately deciding in favor of Bexsero.
“To us, the threshold that seemed reasonable for everybody’s comfort level was to have a vaccine that was licensed somewhere,” said CDC meningitis branch head Tom Clark in November of 2013. “The Pfizer vaccine isn’t licensed anywhere yet.”
Emini explained that Trumenba had been in research and development for over 10 years. He added that serogroup B was the only serogroup not covered by existing vaccines and that many cases of meningitis B had been reported over the years.
"Obviously, you had the outbreak in Princeton last year, and after that, you saw it reported more in the news, but serogroup B cases are reported all the time," Emini said.
The FDA used the accelerated approval pathway to approve the drug, according to Pfizer's press release. The accelerated approval program allows faster approval for drugs that fill an unmet medical need. The FDA granted Trumenba a Breakthrough Therapy designation, which allowed for an expedited review of the drug in March. Pfizer submitted its Biologic License Applicationto the FDA in June, and the FDA accepted the application for Trumenba under Priority Review in August.
The FDA aims to take action on a drug within six months under Priority Review, as opposed to 10 months under standard review. The drug was approved around four months ahead of what was anticipated, even under Priority Review.
Pfizer is working to make the vaccine available to healthcare providers within a few weeks, according to Sally Beatty, a media relations representative of Pfizer specializing in vaccines.
Emini explained that shortly after the outbreak at the University at the end of 2013, the FDA asked Pfizer if the company felt that it had sufficient data to apply for accelerated approval. Since Pfizer felt that its data had met the requirements, it decided to apply.
Emini explained that the vaccine specifically targets individuals between the ages of 10 and 25, since a majority of the cases involving this disease have been identified in adolescents and young adults. Emini added that the meningococcal bacterium is typically transmitted among adolescents and young adults and that this age group is also largely responsible for transmitting the disease to other people.
Older adults and young infants, who also tend to be more vulnerable to the disease, typically receive the bacterium through transmission from adolescents and young adults, Emini said. As part of the agreement with the FDA, Pfizer is continuing subsequent studies and clinical trials of the drug, and will conduct more studies on the vaccine's effectiveness in younger individuals.
Dr. Karen Midthun, director of the Center for Biologics Evaluation and Research at the FDA, explained in the FDA's press release that the recent meningitis B outbreak at the University and other college campuses heightened awareness and concern regarding the disease.
Novartis submitted its Biologic License Application to the FDA for licensure of Bexseroin the United States in June. Thevaccine received Breakthrough Therapy Designationand Priority Review from the FDA in April.
Director of Medical Services at University Health Services Dr. Peter Johnsen said that the University would most likely not conduct any more meningitis B vaccination clinics, since over 90 percent of upperclassmen have already received both doses of Bexsero. He noted that Trumenba could not be used as a booster for Bexsero, since the vaccines are different.
Johnsen said that there is a possibility in the future that UHS might offer Trumenba as a licensed vaccine for students who have not received any dose of the vaccine yet, but he added that if Bexsero were to be licensed in the future as well, UHS would need to examine a number of factors before making recommendations.
"At this point, one vaccine is licensed, and the other is not," Johnsen explained. "We're not planning to use one vaccine in preference over the other, but as of now, we're not planning to use Bexsero again once our license expires"