Bexsero® vaccine approved by US Food and Drug Administration (FDA)
26 January 2015
MRF welcomes news that the US Food and Drug Administration
(FDA) has granted accelerated approval of Bexsero® to prevent meningitis and septicaemia caused by serogroup B meningococcal infection (also known as meningitis B) in adolescents and young adults from 10 years through 25 years of age.
Over a million doses of Bexsero have been distributed since it was first approved in Europe, and its two-dose regimen for older children and adolescents is now approved in the US. This license means that the vaccine can now be used in the US, and considered for use in the immunisation programme.
As part of the accelerated approval process, Novartis will complete its ongoing studies to confirm the effectiveness of Bexsero against diverse serogroup B strains. The tolerability profile of Bexsero was demonstrated as part of a US Centers for Disease Control and Prevention (CDC)-sponsored clinical trial conducted in more than 15,000 individuals at Princeton University and the University of California, Santa Barbara (UCSB) during MenB outbreaks on these college campuses in that began in 2013.
MRF Chief Executive, Christopher Head said: “The potential for protection against meningococcal B infection
(MenB) is continuing to advance across the world and we are delighted to see yet another country take action to protect against this life changing disease. This accelerated approval demonstrates just how seriously the US views MenB, especially after worrying outbreaks of the disease at some of its universities last year.
“But the UK has had a licensed MenB vaccine, Bexsero®, since January 2013 and a national programme to immunise infants was recommended in February 2014. The UK was leading the world in protecting against this deadly disease and it’s frustrating that nearly two years on we still don’t know when the UK Government will make the vaccine freely available on the NHS and start rolling out a MenB vaccination programme.”
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