Authorities insist on safety of vaccine

The Department of Health's chief medical officer Dr Tony Holohan insisted today he is satisfied about the safety of the new swine…

The Department of Health's chief medical officer Dr Tony Holohan insisted today he is satisfied about the safety of the new swine flu vaccines.

His comments came in response to a report in today's Irish Timesof concerns in Germany about the safety of the vaccines.

There one vaccine - Pandemrix from GlaxoSmithKline - which is also to be used in Ireland is being given to the general public while another from Baxter which does not contain an adjuvant to boost the immune systems response is being given to the German government and armed forces.

Dr Holohan said Pandemrix had been licenced by the European Medicines Evaluation Agency.


"Our Irish Medicines Board and the National Immunisation Advisory committee who provide us with the national level advice are also satisfied about the safety profiles of these vaccines," he said.

He added that the elements of the vaccine over which concerns were raised in Germany - namely adjuvants - were elements which are used in many other vaccines and there are a number of safety trials on them.

There were in excess of 70 clinical trials that had established the safety of the adjuvant, he said.

"We are quite happy that this vaccine, as with all other influenza vaccines, have actually got a very good safety profile," he told RTE's Morning Ireland.

He added that it was very important young people in at risk groups get vaccinated as quickly as possible. Vaccinations for this group are now being delivered to GPs.

"Its very important that as quickly as we can get it to people that people get immunised," Dr Holohan said.

"We have no hesitation in recommending it," he added.

The HSE has also stressed that the vaccine is safe. It told The Irish Timesthat vaccination was "the most important tool we have to protect the Irish population".

It too stressed that both the GlaxoSmithKline and Baxter H1N1 vaccines to be used here had been licensed by the European Medicine Agency and would be used in many other European countries also over the coming weeks and months.

"The GSK vaccine does contain an adjuvant which helps to boost the immune response. This adjuvant contains squalene which is a natural intermediate product of endogenous human cholesterol metabolism and a component of human cell membranes.

The safety data base for the GSK adjuvant includes more than 10,000 individuals. This adjuvant allows a lower dose of influenza antigen in the vaccine and it is likely that only one dose will be required in adults receiving this vaccine," it said.

"As with any vaccines risks have to be balanced with the benefits and the authorities in Ireland are satisfied that the benefits from both vaccines outweigh any possible risks of side effects. Ireland continues to see an increase week on week in the number of cases presenting to hospitals and intensive care units. We continue to see fatalities associated with this virus. Vaccination is the most important tool we have to protect the Irish population," it added.

A fifth person died from swine flu in the Republic on Sunday.