No deliveries of Covid vaccines before regulatory approval, EU says

No Deliveries Of Covid Vaccines Before Regulatory Approval, Eu Says
The AstraZeneca/Oxford vaccine. Photo: PA Wire/PA Images
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The European Commission has said that Covid-19 vaccines cannot be delivered before they get regulatory approval, denting Ireland’s hopes of securing early supplies of the AstraZeneca shot.

Minister for Health Stephen Donnelly said last weekend that discussions were under way on securing early deliveries of the vaccine to enable it to be rolled out immediately following approval.


In response to queries from The Irish Times, a European Commission spokesman said: “Vaccines cannot be delivered before EMA [European Medicines Agency] delivers its recommendation for authorisation and the commission then grants marketing authorisation. This is a requirement as per the Advance Purchase Agreement.”

Asked about the early rollout of the AstraZeneca on RTÉ on Tuesday night, Mr Donnelly said that it was an “ambitious ask” to get the supplies in early, and that it would have to be agreed with both the company and the European Commission as “it would have to be done on an EU basis”.

The Irish Examiner reports that Ministers were told during a Cabinet meeting on Tuesday that AstraZeneca has advised the HSE that deliveries of the vaccine can be expected by mid-February, but that firm delivery timetables have not yet been finalised.


Rollout timeline

This revelation casts doubt on the Government’s timeline as the Cabinet approved a €91 million scheme to allow GPs and pharmacists administer the vaccine to some 1.5 million people.

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“The company has advised the HSE that deliveries of the AstraZeneca vaccine can be expected by mid-February but the date/s for this are not yet available as a delivery schedule has not yet been finalised,” a memo shared at Cabinet states.

“A European Medicines Agency decision on the conditional marketing authorisation of the AstraZeneca vaccine may be made on January 29th. Ireland will get an allocation of 3.3m doses of AstraZeneca in line with the signed advanced purchase agreement.”

Cabinet was told preparations were being made for a significant scaling up of the vaccine programme in the weeks ahead, with doses administered growing from 165,000 in January to 770,000 in March.

The expansion will rely on the GP and pharmacist network, with vaccinators working in clinics as well as in mass vaccination centres.

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