“Extremely disappointing” – Bexsero doesn’t find a home in the UK

In Featured on App, Prophylactic Vaccines, Regulation and Policy by tim peplowLeave a Comment

bexsero novartis uk jcvi meningitis b

A UK body has ruled that Bexsero, Novartis' pioneering vaccine for meningitis B, is not cost-effective and should not be adopted by the NHS, the BBC reports.

Back when Novartis received EU approval for Bexsero in January, Meningitis UK founder Steve Dayman MBE labelled the meningitis B vaccine as "the most important medical breakthrough in the 30 years since I lost my son to the disease" and called for the vaccine to "be made widely available through the immunisation schedule as soon as possible."

But the calls of Dayman and other campaigners for the vaccine's introduction have not been enough to convince the Joint Committee on Vaccination and Immunisation (JCVI) that it should recommend the vaccine.

The JCVI said in its interim recommendation: “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.”

One of the key issues here is a lack of 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," said Prof David Salisbury, director of immunisation at the Department of Health. "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."

Naturally, Novartis were disappointed with the decision. “The interim position by the JCVI is inconsistent with its recommendations for other meningococcal vaccines. The meningitis C vaccination campaign in the UK, following JCVI recommendation, was a tremendous public health success saving thousands from serious illness and death,” said Andrin Oswald, Division Head, Novartis Vaccines and Diagnostics. “It is disappointing to see that the decision was mostly driven by financial considerations and without any pricing discussion with Novartis. The evaluation model does not do justice to the vaccine`s ability to prevent babies and young children from dying or surviving with severe lifelong disabilities.”

The meningococcal group-B vaccine has been shown to be broadly effective against the life-threatening bacterial infection, and is the only approved vaccine that can protect against the disease which affects about 1870 people in the UK each year. Approximately 1 in 10 people with the infection dies. 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.”

The Independent reports that the JCVI is calling for more evidence on the vaccine's effectiveness and cost-effectiveness to delivered by September before it makes a final recommendation to the Government. However, if the decision remains unchanged by then, there will continue to be no available vaccine for this devastating disease.

Are you disappointed by the news? Do you think the decision by the JCVI was the right one? What should happen now? What do you think? You can leave a comment in the box below, or on LinkedIn group discussion. Sign up to our newsletter for more news from Vaccine Nation.

If you want to know more about strategy and innovation in vaccines, you might be interested in attending the World Vaccine Congress Europe 2013, 16-17 October 2013, Lille.

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