News

Updated: Having obtained safety data, Novartis seeks licensure for Bexsero vaccine in the U.S.

Novartis has obtained more data from Princeton and UCSB than it did in order to get approval in the EU, but this data may not prove useful in the company's efforts toward licensure

Novartis — the manufacturer of Bexsero, the meningitis B vaccine used to vaccinate University students this spring — announced that it is currently filing an application for FDA review of its vaccine, in the hopes of obtaining licensure.

The use of Bexsero at the University and at the University of California at Santa Barbara has given Novartis safety data from 14,000 people, almost twice the number — 8,000 — that helped Novartis gain approval for Bexsero in Australia, Canada and the European Union, FierceVaccines reported. But whether the data obtained by Novartis will prove useful in its efforts to secure an approval that is also crucial for the future of the company’s vaccine division remains unclear.

The University is currently encouraging students to take a survey in order to “add to the scientific knowledge about this vaccine.”

“This vaccine campaign was unprecented and Princeton students can uniquely contribute to the success of public health vaccine campaign in the future,” an email sent by University Health Services this week to vaccine recipients read.

But Yevgeniy Feyman, research fellow at the Manhattan Institute, a healthcare policy research institute, said that the data from both campuses are quite different from what the FDA wants. Feyman explained that the data were not randomized enough to be taken as an objective statistic.

“In terms of whether the vaccine is safe for college students in Princeton and UCSB, it’s definitely a valid data; it’s just the question of will it do the same thing in other populations or not,” Feyman said. “Novartis will have a very hard time convincing the FDA to let them use that data.”

Novartis vaccine chief Dr. Andrin Oswald told FierceVaccines that the company will “work with the FDA to have [Bexsero] licensed in the U.S. as quickly as possible.”

In a press release, he said that he hoped governments around the world would act with “a sense of urgency” to combat meningitis type B.

There is currently no approved vaccine for meningitis type B in the U.S. Bexsero, however, has secured licenses in the European Union and Australia. Pfizer, another pharmaceutical giant, is currently developing a similar vaccine, but it has not yet been approved anywhere in the world.

Novartis representatives did not respond to multiple requests for comment.

However, Centers for Disease Control spokesperson Jason McDonald said that the data gathered from campus is unlikely to affect the FDA’s decision.

“FDA will base its decision whether to approve the vaccine on clinical trials, not on any safety information CDC has gathered,” McDonald said.

Bexsero is currently the only licensed vaccine for meningitis B in the European Union, Canada and Australia. In the United States, Phase I and II trials for the vaccine were completed in 2007, and the vaccine is waiting to be approved for Phase III trials.

The vaccine was used in the University and UCSB during the meningitis breakouts on both campuses through the FDA’s expanded access program for investigational products. The program allows the use of a vaccine unapproved in the United States to treat serious medical conditions when there is no alternative option.

Jill Burkoff, consumer safety officer at the Center for Biologics Evaluation and Research at the FDA, declined to comment, saying that the FDA cannot disclose any information regarding the status of investigational products.

But for Feyman, the vaccine is safe enough and should be approved by the FDA soon.

“In all likelihood, further down the line — maybe in a year or so — the drug will be approved,” Feyman said.

comments powered by Disqus