Swine flu jab fears reported two years before Irish recall


A leading medical journal has warned that serious safety "indicators" were raised over the swine flu vaccine Pandemrix in 2009 - almost two years before the vaccine was finally suspended from use in Ireland.

'The British Medical Journal' published a major investigation into the use of the drug across Europe where it is now linked to cases of narcolepsy or severe sleep disorders in children.

Last night, one solicitor acting for Irish children who developed narcolepsy said it was "a scandal" families have been fighting for justice for seven years while the State was aware of such data.

Support group Sufferers of Unique Narcolepsy Disorder (SOUND) said the report was "shocking and utterly appalling."

The British report relies on multiple European investigations and ongoing legal actions over the drug, manufactured by GlaxoSmithKline (GSK).

Last August, a major Irish Independent investigation revealed some children received a double dose of Pandemrix when stocks of the vaccine were used from January 2011 amid fears there would be a shortfall for the normal winter flu jab.

Thousands of children received a single vaccine dose in 2009/2010 at the height of swine flu scare.

But the 2011 re-issue was almost two years after research data showed indicators that Pandemrix had a far higher rate of adverse incidents than other comparable vaccines.

Pandemrix was re-issued to GPs nationwide in 2011 despite the fact major studies were already under way in Sweden and Finland into potential links with narcolepsy.

Re-issued in Ireland on January 7, 2011, the vaccine was recalled on March 28, 2011 when both studies indicated there was a likely link to narcolepsy.

The new UK study revealed that even in 2009 there were indications Pandemrix had a rate of adverse reactions far higher than other vaccines.

It calculated Pandemrix had a 500pc greater rate of "adverse events" reported than another swine flu vaccine.

In Ireland, Pandemrix was only made available before it had completed its testing protocols because the Government had offered GSK a full indemnity.

Almost 100 families are now suing the Government, Health Service Executive and GSK.

Many of the narcolepsy cases are being handled by solicitors Michael Boylan and Gillian O'Connor.

"The fact that the general public were not made aware by the Minister for Health or the HSE that Pandemrix was untested prior to or even during the vaccination programme as adverse data emerged is one of the reasons why we have now served the State defendants with claims for aggravated and exemplary damages," Ms O'Connor said.

"It is a scandal and totally unacceptable that our clients have had to fight tooth and nail for accountability and appropriate redress for the dreadful injuries caused for the past seven years given that this information has been within the defendants knowledge all this time."

GSK declined to comment given ongoing legal action.

SOUND said the group was "shocked and appalled" at the report.

"These revelations now present very serious questions for the State, the HSE and GSK as to what exactly happened with Pandemrix.

"These shocking revelations require immediate answers to who knew what and when. We need accountability now," SOUND co-founder Tom Matthews warned.

The HSE insisted its vaccine selections in 2009 were on the basis of expert medical advice supported by an external panel of experts.

Irish Independent