The Food and Drug Administration recently approved Novartis’ meningitis B vaccine, Bexsero, which had been used to vaccinate University students.
The vaccine is now approved for use in 10- to 25-year-olds in an effort to prevent the disease from spreading.
Seven students and one visitor were diagnosed with and survivedmeningitis B in 2013. ADrexel student died from meningitis B after coming into contact with University students on Drexel’s campus in March 2014. In response to the outbreak, the University increased awareness of the disease’s modes of transmission on campus, offered Bexsero vaccinations to students and removed the overnight component of Princeton Preview.
Bexsero was not FDA-approved at the time of the outbreak, but the University began a vaccination program on campus with special approval from the FDAin order to prevent further cases. The Centers for Disease Control and Prevention and the FDA imported thousands of doses of the vaccine to the University, and immunizations started on Dec. 9, 2013.
Novartis and the FDA did not respond to requests for comment.
Bexsero uses a two-dose regime with a flexible dosing schedule that allows a month to pass between the administration of the doses, according to a Novartis press release.
Although Bexsero has been approved in Europe, Australia and Canada for more than a year, the United States approved it on Jan. 23.
After initial approval in Europe, over one million doses have been distributed outside the United States, according to the Novartis press release. In 2013, Canada launched a large-scale vaccination campaign with Bexsero. This was the first trial of its kind globally, and it reached 81 percent of the targeted population within the first three months. This study showed that Bexsero is generally well tolerated, according to the Novartis press release.
Lynn Bozof, executive director of the National Meningitis Association,said that the University’s experience with Bexsero likely reinforced perceptions of the safety of the vaccine for the FDA and helped the FDA in its review process to allow the vaccine to be administered nationwide.
She added that the price of a dose Bexsero for Novartis divided by the cost of the vaccine over three to five years amounts to only pennies a day.
“Who wouldn’t pay pennies a day to save their child?” she said.
Although she said there are potential side effects of any vaccine, most commonly a sore arm, she added that she has full confidence in the safety of the drug due to the FDA’s approval.
“I would have it myself, if I were in the right age group," Bozof said. “Even though this is a rare disease, I would take advantage of every opportunity to protect myself.”
Meningitis B is rare in the United States, compared to other countries. Meningitis B causes up to 90 percent of meningococcal disease cases in some European countries and is responsible for more than 80 percent of cases in Canadian infants, according to the Novartis website.
Bozof said that meningitis B is still of significant importance and that people should still take measures to protect themselves against it.
University spokesperson Martin Mbugua declined to comment on behalf of the University.
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