UK rejects meningitis B vaccine Bexsero
pharmafile | July 25, 2013 | News story | Sales and Marketing | Bexsero, Novartis, Vaccine, meningitis b
The UK government’s department for vaccinations has stunned observers by failing to back the world’s only vaccine for meningitis B.
The Joint Committee on Vaccination and Immunisation (JCVI) said its initial decision is that the meningococcal B vaccine Bexsero, manufactured by Novartis, is too costly for the NHS.
The JCVI said: “On the basis of the available evidence, routine infant or toddler immunisation using Bexsero is highly unlikely to be cost effective at any vaccine price based on the accepted threshold for cost effectiveness used in the UK and could not be recommended.”
Bexsero was approved by the European Medicines Agency in January this year and became the first vaccine against MenB, a bacterial infection that can kill in 24 hours and poses the greatest risk to infants.
There are vaccines against other forms of meningitis, but the injection developed by Novartis is the only one to protect against meningitis B.
But rates of the disease have been declining and now only affect a handful of people each year, leading to austerity hit governments to re-think the cost of the vaccine.
Novartis’ drug has been shown to be effective against 73% of the different strains of the disease.
But despite these numbers, questions remain about its overall effectiveness, and researchers say that bigger trials are needed to see just how well it can stop the spread of the disease. The vaccine has to date not been introduced into any other market.
Blow for Novartis
Bexsero is seen as crucial to the Novartis vaccine unit, and was the only one of the Swiss company’s five divisions to report an operating loss in the second quarter, results of which were released this week.
The unit is struggling to compete against more established vaccine units seen from MSD, GlaxoSmithKline and Sanofi.
“This decision represents a material setback to Novartis’ beleaguered vaccine division. In the absence of a successful appeal, Bexsero revenue will likely be restricted to a minimal private-payer market,” said the Citi analyst Andrew Baum.
“More importantly, it could force Novartis to sell, partner or more likely integrate its vaccine business within its pharmaceutical infrastructure.”
Novartis said in a statement that the committee’s decision underestimated the ‘potentially devastating impact’ of the disease. “It’s disappointing to see that the decision was mostly driven by financial considerations and without any pricing discussion with Novartis,” Andrin Oswald, head of the Novartis Vaccines and Diagnostics division, told Reuters.
Difficult situation
Director of Immunisation Professor David Salisbury said: “This is a very difficult situation where we have a new vaccine against Meningitis B but we lack important evidence. We need to know how well it will protect, how long it will protect and if it will stop the bacteria from spreading from person to person.
“We need to work with the scientific community and the manufacturer to find ways to resolve these uncertainties so that we can come to a clear answer.”
It is mostly children under five who are at risk from the bacterial infection, which leads to inflammations of the brain and spinal cord. Of those who survive a meningitis B infection, one in four is left with life altering after-effects such as brain damage or limb loss.
Sue Davie, the chief executive of the Meningitis Trust and Meningitis UK, said: “This is extremely disappointing news after all our supporters and our hard work over decades to introduce a vaccine.
“We understand the committee’s concerns about impact and cost, but we believe this vaccine is safe and we know it will save lives. The more we delay the more lives are being lost.”
Ben Adams
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