‘Children dying’ over vaccine delay

Children are dying unnecessarily because of official delays in evaluating the suitability of a new vaccine for meningitis B, drug giant Novartis has claimed.

The company, which received EU approval for its Bexsero vaccine last December, has criticised the time taken by Irish authorities to evaluate its suitability for inclusion in the national immunisation programme.

It says it submitted information about Bexsero to the National Immunisation Advisory Committee last year, prior to its approval by EU authorities. Senior medical development adviser Judith Abernethy said it hadn’t heard anything since and couldn’t talk to the Department of Health about cost issues until the committee makes a decision.

“We’re prepared to make this work and we’re open to discussions with Government over cost but we need to be able to speak to them first,” she said.

A spokeswoman for the committee said the matter was “under consideration” and would be dealt with at a forthcoming meeting. The next meeting is scheduled for late November.

Vaccines are introduced into the childhood immunisation schedule based on the recommendation of the committee and subject to approval by the department after consideration of the cost implications.

Highest rates
Ireland has one of the highest rates of meningitis infection in Europe, with more than three times the average rate of the disease. Dubbed "the silent killer", meningitis is feared by parents because it mostly affects young children, develops rapidly and the symptoms are easily confused with less serious infections such as flu.

One in 10 of those who contract meningitis dies and up to one in five survivors suffer life-long complications such as limb loss, deafness and brain damage. Meningitis B, for which no vaccine was available until Bexsero was developed, accounts for more than 80 per cent of cases of meningococcal disease in Ireland.

Cost-effectiveness
In the UK, the Joint Committee for Vaccinations and Immunisations recommended against its inclusion in the immunisation schedule on cost-effectiveness grounds. Concerns were also raised about the vaccine's coverage and its impact on the carriage and transmission of men B bacteria, the Irish Medical Journal noted.

However, last Friday, the committee announced it was reviewing the earlier decision after receiving new evidence about the vaccine.

Novartis said it remained convinced that strong evidence supported the use of Bexsero. “We hope public health officials come to a swift resolution, because for every month the vaccine is not available, children keep on dying unnecessarily,” said Andrin Oswald, division head, Novartis Vaccines.

There were 84 cases of meningitis B infection in Ireland in 2011 and two deaths, according to the Health Protection Surveillance Centre.