Commission clears Moderna Covid vaccine for use in EU

Updated / Wednesday, 6 Jan 2021 15:50
Moderna vaccine is the second vaccine for the novel coroanvirus to receive approval from Europe's medicines regulator

Moderna vaccine is the second vaccine for the novel coroanvirus to receive approval from Europe's medicines regulator

The European Commission has given approval for the use of the Moderna Covid-19 vaccine in the European Union, the final step required to allow its use across the continent.

It comes after the European Medicines Agency approved the Moderna vaccine for use earlier today.

It is the second vaccine for the novel coronavirus to receive approval from Europe's medicines regulator, following the Pfizer/BioNtech vaccine, which was approved last month.

The news has been welcomed by Tánaiste Leo Varadkar who said the vaccine would allow 10,000 more people in Ireland to be vaccinated a week.

However, the Taoiseach has said that the Government does not yet have a clear timeline on the roll-out of the vaccine.

Speaking at Government Buildings this afternoon as further restrictions were announced, Micheál Martin said it is good news nonetheless. 

He said "the AstraZeneca process is very, very importnat as well in terms of this race and this battle against this virus, as it gives us greater room for manouevre in terms of decision making, in terms of sectors of society:. 

Earlier the Amsterdam-based medicines regulator issued a statement saying: "EMA has recommended granting a conditional marketing authorisation for Covid-19 Vaccine Moderna to prevent coronavirus disease 2019 in people from 18 years of age".

The body's Executive Director, Emer Cooke, said "this vaccine provides us with another tool to overcome the current emergency.

"It is a testament to the efforts and commitment of all involved that we have this second positive vaccine recommendation just short of a year since the pandemic was declared by WHO," she added.

Health Minister Stephen Donnelly, posting a video on Twitter, said Ireland had pre-ordered 875,000 of Moderna vaccine and 3.3 million doses of the Pfizer vaccine.

"Hopefully we will get more good news about the Astraveneca vaccine soon and there are others in the pipeline.

"Between now and the end of February, we are due to receive around 40,000 Pfizer vaccines per week.

"Delivery and logistics for Moderna are now being finalised. When we have a clear delivery schedule, that will allow us to scale up and increase the number of vaccines we are administering every week."

Mr Donnelly added: "This week we are moving into 25 residential care facilities and across all hospital groups. By the end of the week the HSE intends to have administered 49,950 vaccines to nursing home residents and healthcare professionals."

European Council chief Charles Michel said that delivering vaccines to the EU's almost 450 million people was a "gigantic challenge".

However, he insisted that "alongside member states, the European Commission is working night and day to make sure we can increase the number of vaccines available", while "respecting the independence of the medicines agency".

US-based Moderna's jab was found to be 94.1% effective in preventing Covid-19 compared to a placebo, in a clinical trial of 30,400 people.

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The Dutch national drugs authority CBG has said the Moderna vaccine is expected to also be effective against the new variant of coronavirus detected in Britain.

With the UK and the US each having pushed through emergency authorisation of two vaccines, the EMA had been under pressure to speed up its regulatory process, notably from Germany.

EU countries started inoculations on 27 December with the BioNTech/Pfizer vaccine, but progress has been much slower than in the US, Britain or Israel.

While the US, Britain and Israel have each already given vaccines to more than a million of their citizens, EU countries have been lagging far behind.

Last week, the EMA said the coronavirus vaccine developed by AstraZeneca and Oxford University is unlikely to get a green light in the EU in the next month.

The European Commission's spokesperson on Public Health and Food Safety has said he does not believe that the European roll out of Covid-19 vaccines has been slow due to assessment by the EMA.

Speaking on RTÉ's News at One, Stefan de Keersmaecker said European citizens need to know that the vaccine they are getting is safe.

The EMA is an independent agency, which is doing "an extremely thorough and deep review of all these vaccine candidates", he said.

"We want to be absolutely certain about the effectiveness and the safety of these vaccines. We felt it very important not just for the safety itself, but also to convince European citizens that affected their getting are actually safe."

He said the EMA has sped up the procedure, by starting the assessment of these vaccine candidates before the company has introduced requests to have their vaccines put on the market a rolling review.

Mr de Keersmaecker said the European Commission has offered financial supports to vaccine makers to ensure that delivery, once they have been given the green light, "can be made within very quick, short deadlines".