The High Court has heard claims the Chief Medical Officer in 2009 did not tell an Oireachtas Committee about concerns raised by the Irish Medicines Board about the absence of safety data on the Pandemrix vaccine.
The claim was made by lawyers for a 26-year-old woman who says she developed an incurable sleep disorder from the swine flu vaccine.
On the third day of an opening statement, lawyers for Aoife Bennett from Naas in Co Kildare, said the Irish Medicines Board had written to the Chief Medical Officer in 2009 expressing concern about the absence of data.
Senior Counsel Dermot Gleeson told the court a day after receiving the letter, the Chief Medical Officer Dr Tony Holohan told an Oireachtas Committee that he wanted to reassure people they were "dealing with a vaccine that will prove to be safe."
Mr Gleeson said the IMB had expressed concern about the absence of information on its use in children.
Mr Gleeson asked how the chief medical officer "could possibly say that in the light of the reservations carefully expressed in a letter he got in the previous 24 hours?"
He said the IMB's concerns could be summarised that it was worried about the lack of data, and did not think there was enough information at that time to recommend it. He said anyone listening to the Oireachtas Committee the following day would not have got any sense of that "grave warning" given to the Chief Medical Officer the day before.
The Court also heard that concerns were raised about a lack of information about a swine flu vaccine for parents whose children took part in a public immunisation programme ten years ago.
A school principal, a nurse, and a doctor had written letters raising concerns that information and consent forms given to parents did not contain the usual information associated with vaccines.
In one letter, a school principal said the information amounted to little more than a consent form. In another, a nurse and doctor said the fact sheet and lack of a patient information leaflet did not comply with the usual protocols.
Senior Counsel Dermot Gleeson said the concerns were met with a "patronising and patriarchal" response, and claimed to have taken advice from the medical council on the information given to parents. Mr Gleeson said a record of any such advice could not be found. He said the fact sheet given to parents was "completely silent" about the risks of the Pandemrix vaccine.
It did not contain information that the vaccine had not been tested on children aged between 10 and 17, which he says should have been disclosed.
A specialist in public health had given "unequivocal advice" that the Irish Medicines Board could not endorse or approve the fact sheets, and said they should be compliment rather than replace a patient information leaflet.
Mr Gleeson said information was available and had been repeatedly reported about much higher rates of adverse reactions to the Pandemrix vaccine compared to other vaccines. Manufacturers GlaxoSmithKline had not sought to explain this, he said.
Mr Gleeson also said that by the time Aoife Bennett was vaccinated, the threat of a swine flu pandemic was gone, and vaccination at that stage was pointless. However, he said there seemed to be an attitude of "we have bought it, so we'll use it." While other jurisdictions had halted their programmes and were prepared to dump vaccines, Ireland continued to use the vaccine on school children.
Mr Gleeson also pointed to correspondence between the Department of Health and the HSE which made reference to concerns about vaccines "building up" or being "wasted" if they were not administered.
One letter from the Department of Health to the HSE stated "it would be unacceptable to the department and the minister that the vaccine starts building up because of our inability to administer it ...I simply cannot accept a wastage rate of 20% ... more to the point, it would mean we are wasting €17m or €18m ... I don't need to spell out the implications of that."
Mr Gleeson added: "So he was saying we must use it."
In light of other countries slowing down or stalling their vaccination programmes, it was agree to consult with experts in the UK and make a decision on 13 December. However, he said the "can was kicked down the road again" and nothing was done. It would have been January 2010 before Aoife Bennett's vaccine took effect and she became immune, which was way past the 30 to 60 days from the outbreak the previous year. He said the vaccines were given too late to make a difference.
The case will hear allegations that the Minister and the HSE encouraged vaccination when it was aware the Pandemrix vaccine was not as safe as other vaccines. It is also claimed the HSE entered into an indemnity agreement with GSK in 2009 as a condition of the company supplying the vaccine.
It is also claimed that the Irish Medicines Board - now the HPRA - wrote to the Department of Health in September 2009, noting there was no safety data available with the swine flu vaccines, and no data was yet available from clinical trials which were then underway.
It is claimed that GSK had a liability to Ms Bennett under the Defective Products Act of 1991. All claims are denied, and the defendants will contend the Pandemrix vaccine was properly authorised by the European Commission for use in all EU member states and was required to address the swine flu pandemic.