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Government official defends indemnity for swine flue vaccine makers

A report published yesterday has confirmed the link between an increased risk of narcolepsy and the H1N1 vaccine Pandemrix.

File photo from October 2009
File photo from October 2009
Image: Leon Farrell/Photocall Ireland

THE CHIEF MEDICAL Officer at the Department of Health has defended the indemnity provided by the Government to pharmaceutical companies who manufactured and delivered the Pandemrix vaccination which has been linked to over 30 cases of narcolepsy in children.

Speaking on Primetime last night, Dr Tony Holohan said he was not concerned about the safety of the vaccination back two years ago, adding that it was the “right decision at the time”.

“It was critical that we got access to ‘good vaccines’ as quickly as possible,” Holohan said, recalling the swine flu pandemic of 2009. He noted that all other European states who bought the drug were required to sign the same deal.

“This was an unusual situation…in order to have access to this vaccine, we had to pay at the price demanded by the companies and to also accept the liability,” he explained.

There is no doubt that the vaccinating companies were in a strong negotiating position.

The question of compensation has arisen after a report published yesterday concluded that the increased risk for young people of developing narcolepsy was associated with Pandremix.

Similar results have been found in both Sweden and Norway.

Because of the indemnity provided to Glaxosmithkline, the makers of Pandemrix, any legal liabilities have been taken over by the Irish State. That means that any compensation bill will be footed by the taxpayer, and not the drug’s manufacturer.

Compensations

The Department of Health and the HSE, along with the Department of Education are currently working on a package of measures for the families affected by the condition.

This will include health and educational supports but it is still unclear what (if any) monetary compensation will be offered.

SOUND, a campaign group set up by those families, has said that the children should be compensated for the loss of the life they would have had if they had not been vaccinated.

“Our children…now have a life-altering, life-long condition,” said Mairead Lawless, parent of one of the sufferers. “We are not aware of what the overall package is as yet but Dr Holohan said he will revert to us in a short timeframe.”

Educational and health supports will be put in place but parents are frustrated by the slow progress being made.

Describing yesterday as a “bittersweet” day, Hilary Dowdall said that the report confirmed what the families had known for two years. She also expressed their regret that educational supports have taken this long to implement given some sufferers are sitting Leaving Cert and Junior Cert exams this year.

We are not happy with the speed at which they have taken. And we really want to talk about compensation.

Yesterday’s report said there was a 13-fold higher risk of narcolepsy in vaccinated people compared to unvaccinated individuals.

A total of 32 cases were reported, with 28 of these occurring in children and adolescents aged five to 19.

However, it added that it is “very unlikely that the vaccine alone would be sufficient to explain what has been observed”. International experts agree that a number of factors are likely to have contributed to an increased risk.

Symptoms in the 32 cases began to appear between two and 20 months after the vaccination was given.

Holohan has moved to assure the public that vaccinations are the most safe and most effective form of protection for one’s health.

Vaccination is very safe and it is important that the current vaccination programmes continue to protect children and adults against the serious consequences caused by these preventable diseases. People can continue to have a high level of confidence in our vaccination programmes.

Narcolepsy is a chronic sleep disorder which can cause sleep attacks at inappropriate times but sufferers can also be impacted by muscular weakness and dream-like hallucinations.

The use of Pandemrix has ceased in Ireland and all stocks are being returned by administering GPs.

Download the full report from the Department of Health website>

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