Oireachtas Joint and Select Committees

Wednesday, 2 December 2020

Select Committee on Health

Estimates for Public Services 2020
Vote 38 - Department of Health (Supplementary)

Photo of Stephen DonnellyStephen Donnelly (Wicklow, Fianna Fail) | Oireachtas source

I was at an EU health minister's meeting earlier at which the new executive director of the European Medicines Agency, EMA, Ms Emer Cooke, who is Irish, gave an update. The EMA will authorise the vaccines. The exact timeline is as follows: on 1 October the EMA started rolling reviews of three of the vaccines, from AstraZenica, Pfizer and Moderna; yesterday, Pfizer and Moderna submitted their marketing authorisation applications to the EMA; and yesterday, the agency announced it was starting a rolling review of the Janssen vaccine. The EMA has been working hard in the background, has set up special task forces to examine this and the first two companies made their submissions yesterday. Yesterday, Emer Cooke told us that if the applications are sufficiently robust and complete, and hopefully they are, an EMA opinion for their marketing authorisation within the EU and, therefore, Ireland could be issued within weeks.

Specifically on the Pfizer vaccine, she said the committee for medicinal products for human use planned to conclude its assessment during an extraordinary meeting scheduled for 29 December, at latest. The same committee plans to conclude its assessment of the Moderna vaccine during an extraordinary general meeting scheduled tentatively for 12 January. Once we get EMA approval, if we get such approval, as with the UK, we can distribute it in a matter of days.

Special refrigeration is required for the Pfizer vaccine. That arrived in Ireland last week. The supply chains and logistics are being put in place now. This morning, I spoke with Professor Brian MacCraith who is leading the task force. He is confident that the distribution networks will be in place if and when the EMA authorises the various vaccines.

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