LAST UPDATE | 6 Jan 2021
THE EU’S MEDICINES regulator has granted authorisation for the use of the Moderna Covid-19 vaccine.
The approval is the second coronavirus vaccine given the green light by the European Medicines Agency (EMA) following the approval of the Pfizer/BioNTech vaccine in December.
The Amsterdam-based EMA had brought forward an initial meeting on Moderna’s vaccine to yesterday but it proved inconclusive, with the EMA calling for more information.
Another meeting took place this morning and the agency has now confirmed the authorisation in a statement.
“EMA’s human medicines committee has thoroughly assessed the data on the quality, safety and efficacy of the vaccine and recommended by consensus a formal conditional marketing authorisation be granted by the European Commission,” the EMA said.
This will assure EU citizens that the vaccine meets EU standards and puts in place the safeguards, controls and obligations to underpin EU-wide vaccination campaigns.
Emer Cooke, executive director of the EMA, added:
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. As for all medicines, we will closely monitor data on the safety and effectiveness of the vaccine to ensure ongoing protection of the EU public. Our work will always be guided by the scientific evidence and our commitment to safeguard the health of EU citizens.
The authorisation is for use in people from 18 years of age and follows trials that included some 18,000 people. The EMA says trials demonstrated a 94.1% efficacy rate.
Minster for Health Stephen Donnelly said this afternoon that Ireland has ordered 875,000 doses of the Moderna vaccine and that “the logistics are being finalised”.
“Details of the delivery for individual vaccines are fluid until they’re authorised, for example between now and the end of February we’re due to receive about 40,000 Pfizer vaccines a week,” he said.
Delivery and logistics for Moderna are now being finalised. When we have a clear delivery schedule, that will allow us to scale up and we will increase the number of vaccines we’re administering every week. This week, we’re moving into 25 residential care facilities and across all hospital groups. By the end of the week the HSE intends to have administered nearly early 41,000 vaccines to nursing home residents and healthcare professionals.
“In the initial weeks we’ll be holding on to some stock. This is to ensure we can administer a second dose to those who’ve received their first dose even if we were to experience a temporary supply chain issue, as other countries already have.”
Speaking as the government announced further Covid-19 restrictions, Taoiseach Micheál Martin also said there was no timeline yet for the arrival of the Moderna vaccine but that this neews would help in the coming weeks.
“The numbers from Moderna will be an additional help on top of Pfize/BioNTech. They’re not huge numbers yet and we don’t have a clear timeline in terms of their release to us, but it’s good news nonetheless,” he said.
EU member states had been pressuring the EMA to issue a green light for the vaccine from Moderna as other nations such as the UK, the US and Israel press ahead.
The Pfizer/BioNTech vaccine was the only jab currently authorised for use in the European Union since its fast-track authorisation by the EMA on 21 December.
The United States uses it alongside the Moderna vaccine, while the UK as of Monday also started using one by UK pharmaceuticals giant, AstraZeneca.
The EU began vaccinations on 27 December, with the Netherlands today becoming the final country in the bloc to start an inoculation programme.
Around 4,000 people in Ireland received their first dose of the vaccine in the first few days of the rollout last week and the Health Minister has said the aim is to bring this number to 35,000 by the end of this week.
- With reporting by © – AFP 2021
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