Vaccine not tested on teens before ‘de facto’ clinical trail, court told

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Aoife Bennett (26), of Naas, Co Kildare, claims she developed narcolepsy and cataplexy disorder as a result of being given the Pandemrix vaccine in school on December 10th, 2009 as part of a nationwide vaccination programme. She was aged 16 at the time.

Age is a critical factor in the development of auto-immune conditions such as the one developed by Ms Bennett, her counsel, Dermot Gleeson SC, said. There was a component in the vaccine that had never been given to children before.

Ms Bennett is suing the Minister for Health, the HSE, Glaxosmithkline Biologicals SA, which produced the vaccine, and the Health Products Regulatory Authority, which has responsibility for the approval of medicines. The defendants deny the claims.

“This is not an anti-vaccination case,” Mr Gleeson told Mr Justice Michael McGrath in his opening address. “There is no message going out from this courtroom that people shouldn’t vaccinate their children.”

The court would be told, Mr Gleeson said, that after clean water, vaccination was the single most positive development in public health programmes. However, he said the administration of the vaccine that Ms Bennett had taken was badly managed.

The Glaxosmithkline-produced vaccine caused approximately 1,000 children across Europe to develop narcolepsy, with approximately “75 to 100 of these children” being in Ireland.

Life-changing

Ms Bennett developed the life-changing illness as a result of the vaccination she received almost precisely 10 years ago, he said. She developed a rare auto-immune condition that affects those who are genetically pre-disposed to it. The condition included sleeplessness at night, and an uncontrollable “collapse of the body” during the day, and is also associated with changed eating patterns and weight gains.

Ms Bennett, who was nine stone at the time she received the vaccine, gained four stone in the wake of becoming unwell. It took two years before she was diagnosed.

Laughter, surprise and other emotions could spark the condition, with reactions such as the drooping of the head or the jaw, the court heard. Ms Bennett has to take naps during the day, and had to abandon her former athletic pursuits. She has since completed her studies at St Patrick’s Teacher Training college and is now pursuing a masters degree. She has not been able to get a full time job.

It was now known, Mr Gleeson said, that for those with a specific gene variant, the vaccine increased their chance of developing the auto-immune condition by up to 14 times. He said that Germany, Switzerland and Poland decided not to licence the vaccine, but it was administered in Finland, France, Sweden, Holland and the UK.

He said that in all of those countries some recipients of the vaccine had reacted in the same way as Ms Bennett. The court heard that Ms Bennett’s mother works with the Legal Aid Board and that her father is a manager with the HSE who supports vaccination programmes and had himself received the seasonal flu vaccine two weeks ago.

Badly managed

Mr Gleeson said the vaccine given to Ms Bennett was badly managed by the HSE and Glaxosmithkline, which made a profit of $2 billion from the product. Mr Gleeson said that while there was “an alleged pandemic” at the time of the vaccination programme, “what was unforgiveable was not telling anyone” about risks that were known to be associated with the product.

There was a “de facto” clinical trial on whole populations, he said, which might have been justified by the feared flu pandemic. However the recipients were entitled to know this. Glaxosmithkline had insisted the governments that were going to administer the vaccine should sign an indemnity agreement, with the first clause in the agreement referring to the fact that during pandemics, health authorities were likely to understate the warnings that would otherwise be associated with a product.

Mr Gleeson’s opening address is expected to take a number of days, with the defendants’ legal representatives then expected to take a day between them, to give their opening remarks. The trial is expected to take up to 10 weeks, and possibly longer.

Colm Keena

The Irish Times Oct 2019