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Watchdog expects no delay in rollout of vaccine after EU nod


Trials of Pfizer’s Covid vaccine show it to be 95pc effective

Trials of Pfizer’s Covid vaccine show it to be 95pc effective

Trials of Pfizer’s Covid vaccine show it to be 95pc effective

Ireland's medicines watchdog has said there will be no delay in authorising a Covid-19 vaccine for use in the country once it is approved as safe and effective by the European Medicines Agency.

The Health Products Regulatory Authority (HPRA) will not have to do its own individual domestic assessment after the European agency gives approval.

It comes as the task force overseeing the roll-out of the vaccine here met yesterday to work out a plan which is due at the end of next week.

Chief medical officer Dr Tony Holohan said that the aim is to have the plan finalised by December 11.

Asked about its role in overseeing the potential vaccines, the HPRA said that all medicines must first be authorised in line with regulations before they can be made available on the market.

"For this to happen, the vaccine developers need to submit an application with comprehensive supporting clinical data to the regulatory authorities," a spokesperson said.


"For Covid-19, it is expected the applications for vaccines will be made to the European Medicines Agency and if approved, they can be used in all member states."

The European agency relies on scientific expertise from all the national regulatory agencies, including the HPRA, when conducting its assessment of products.

"The HPRA will be an active participant in the review of Covid-19 vaccine applications being made," the spokesperson said.

"Our role, working with the European Medicines Agency, is to carry out a thorough assessment of the supporting data to reach a scientific opinion on whether the vaccine is safe, effective and of suitable quality to vaccinate people.

"As with all medicines, when the vaccine is in use, the HPRA will closely monitor the safety profile by reviewing all reports of 'suspected adverse events' it receives.

"All reports submitted by healthcare professionals or the public at a national level come to the HPRA.

"This data is then assessed closely both nationally and at European level."

The HPRA is also an expert member of Nphet, advising on the regulatory aspects of medicines including vaccines.

Ireland will now have access to five potential vaccines following the signing of another deal between the European Commission and CureVac yesterday.

Pfizer's vaccine looks set to be the first to get emergency approval.

Supplies of the vaccine for Ireland will come from its plant in Belgium and be transported here via a special cold chain.

Moderna yesterday filed for authorisation with the European Medicines Agency.