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15th Dec 2020

Pfizer/BioNTech Covid-19 vaccine could be rolled out in Ireland this year, says Donnelly

Alan Loughnane

If the vaccine receives approval from the European Medicines Agency, it could be rolled out at a very low level before the end of December.

Minister for Health Stephen Donnelly has said that the Pfizer/BioNTech vaccine could be rolled out a very low level in Ireland before the end of the year, depending on approval from the European Medicines Agency.

Donnelly was speaking on Tuesday as the government outlined details of its vaccination plan.

The government said vaccines would be rolled out in three phases; initial roll-out, mass ramp-up and open access.

The highest priority recipients, including healthcare workers and those over the age of 65 living in long-term care home settings would be targeted with the initial roll-out.

But it looks likely to be well into next year before a large proportion of the population is inoculated.

The vaccination allocation sequencing approved by Government is set out below:

“The National Covid-19 Vaccination Strategy announced today means that we will be ready if a vaccine passes the rigorous quality and safety tests by the European Medicines Agency,” Donnelly said.

“The scale of the Covid-19 vaccination programme will be bigger and more complex than previous vaccination programmes. It will play a central role in our exit from the pandemic. Over time it will allow us to return to re-open our society and to reconnect in the ways we once took for granted.”

All of this is pending approval from the European Medicines Agency and while it’s not received approval at this time, the EMA has moved forward a meeting to approve the Pfizer/BioNTech Covid-19 vaccine.

The EMA approves drugs for use in the EU and had been due to conclude its evaluation of the vaccine at a meeting on 29 December this year, however this meeting has now been moved forward to 21 December.

“EMA’s human medicines committee (CHMP) and its experts have been working intensively over the past weeks to evaluate data submitted by BioNTech and Pfizer in the context of the conditional marketing authorisation (CMA) application for BNT162b2, a COVID‑19 mRNA vaccine,” the EMA said in a statement.

“The rate of progress is reliant on a robust and complete assessment of the quality, safety and efficacy and is determined by availability of additional information from the company to respond to questions raised during the evaluation.

“Following receipt yesterday evening of additional data requested by the CHMP from the company and pending the outcome of its evaluation, an exceptional meeting of the CHMP has now been scheduled for 21 December to conclude if possible. The meeting planned for 29 December will be maintained if needed.”

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