LAST UPDATE | 15 Dec 2020
THE EUROPEAN MEDICINE’S Agency (EMA) has brought forward the meeting that could approve the BioNTech/Pfizer Covid-19 vaccine by a week until 21 December.
The Amsterdam-based agency approves drugs for use in the EU and had been expected to conclude its evaluation of the vaccine on 29 December.
The EMA has said this afternoon however that “following receipt yesterday evening of additional data” the meeting has now been scheduled for 21 December.
“The EMA’s human medicines committee will conclude its assessment at the earliest possible timepoint and only once the data on the quality, safety and effectiveness of the vaccine are sufficiently robust and complete to determine whether the vaccine’s benefits outweigh its risks,” the agency said in a statement.
Once the committee recommends a marketing authorisation, the European Commission will then fast track its decision-making process with a view to granting a marketing authorisation valid in all EU and EEA Member States within days.
The EMA says the marketing authorisation “ensures that Covid-19 vaccines meet the same high EU standards as for all vaccines and medicines”.
Speaking yesterday, Taoiseach Micheál Martin said that he would hope the vaccine could start being administered to priority groups in Ireland “the following week” after it is approved.
Health authorities in the UK, US and Canada are among those who have approved the use of the BioNTech/Pfizer jab and begun vaccinating citizens.
Ireland’s High-Level Task Force on Covid-19 vaccinations is due to publish its strategy for vaccine roll-out at 2pm this afternoon.
Germany
The EMA’s move comes as Germany had led calls for the EU health regulator to speed up its decision process.
“The goal is to get approval before Christmas,” German Health Minister Jens Spahn told a press conference in Berlin. “We want to start vaccinating in Germany before the end of the year.”
Spahn’s growing impatience had become clear in a series of tweets on Sunday, in which he said the European vaccine delay could undermine confidence “in the European Union’s ability to act”.
The German hospital association (DKG) has likewise expressed concern about the time taken by the EMA to validate the vaccine.
Spahn has nevertheless defended Berlin’s decision to stick with an EU-wide approval process for all 27 member states rather than going it alone and granting emergency use authorisation on a national basis.
‘Summer 2021′
Opting for a European approach “is also about strengthening trust in the vaccine”, the minister told reporters.
“We want a thorough review, we want a proper authorisation and at the same time we want a swift review,” he added.
Berlin’s irritation is more acute as BioNTech is a German firm and the country is preparing to go into partial lockdown from tomorrow with non-essential shops and schools to close.
Germany coped relatively well with the first wave of the coronavirus in the spring, but it has struggled to contain a resurgence in Covid-19 cases in recent months.
Last week saw a record high of nearly 30,000 new infections in one day, with the number of deaths also rising steadily.
With reporting by © – AFP 2020
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