The FDA granted breakthrough therapy designation to Novartis' meningococcal serogroup B vaccine Bexsero, the company reported Monday. The drugmaker indicated that it plans to file for US approval of the vaccine as early as the second quarter of this year.
According to Novartis, it has provided nearly 30 000 doses of Bexsero over the last four months to students and staff at Princeton University and the University of California Santa Barbara following meningitis B outbreaks on their campuses under an investigational new drug designation from the FDA. The company noted that Bexsero, which is already cleared in Europe, Canada and Australia to help protect against invasive meningococcal disease caused by serogroup B, is the only broad coverage meningitis B vaccine that can be used from two months of age.
Last month, the UK's Department of Health said it will work to introduce Bexsero into the childhood vaccination programme for infants from two months of age following a recommendation from the Joint Committee on Vaccination and Immunisation, overturning a negative interim decision on the vaccine last July.
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