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20th Aug 2022

EU agency authorises Moderna vaccine amid blame-game

  • If approved by the European Commission, Moderna's jab will become the second vaccine authorised in the EU (Photo: Marco Verch)

The European Medicines Agency (EMA) authorised on Wednesday (6 January) the use of the Covid-19 vaccine developed by US company Moderna - while the EU is involved in a blame-game over a sluggish vaccine rollout across member states.

The European Commission now has to give the final green light to the vaccine approval, after consulting with the 27 member states.

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Commission president Ursula von der Leyen said on Wednesday that the EU executive is working "at full speed to approve it and make it available in the EU".

This final step, which is a formality that can usually take up to 67 days, would last at most three days - although the commission authorised in December the vaccine jointly developed by Pfizer and BioNTech just in a few hours after EMA's opinion was made public.

If approved by the commission, Moderna will become the second vaccine authorised in the EU.

The EMA confirmed that the Moderna jab demonstrated a 94.1 percent efficacy in a clinical trial involving around 30,000 people.

The vaccine will be given as two injections into the arm, at least 28 days apart.

The commission initially secured 80 million Moderna doses, with an option for EU countries to buy an additional 80 million.

"This vaccine provides us with another tool to overcome the current emergency," said the head of the EU medicines agency, Emer Cooke, in a statement.

The European drug regulator has come under pressure to speed up the approval of Covid-19 vaccines in the bloc, after the procedures of similar non-EU agencies have been proven to be faster.

The Moderna jab had been already authorised in the United States, Canada and Israel, before it received the green light by EMA.

Following the approval of the Pfizer/BioNTech vaccine, the first batches of vaccines arrived in member states in late December to start vaccinating the most vulnerable groups.

The commission previously reached a deal with Pfizer and BioNTech to supply the bloc with 200 million doses, and up to 100 million additional doses.

However, a shortage of production capacity has caused delays in some member states, sparking criticism about the EU strategy on vaccines.

Some EU countries, such as France and Belgium, have come under fire for their slow vaccine rollout programmes.

Meanwhile, Germany has triggered a blame-game after its health minister Jens Spahn said that his country would negotiate directly with German vaccine developers to obtain more doses than under the EU plan.

The commission, on behalf of member states, has sealed deals with Moderna, AstraZeneca, Sanofi-GSK, Janssen Pharmaceutica NV, BioNTech/Pfizer and CureVac for up to two billion vaccine doses.

Under the conditional marketing authorisation, foreseen for emergency provisions, companies are responsible for monitoring the safety of the vaccine, reporting results from the main trail, which lasts two years.

EU leaders to discuss vaccine roll-out this month

EU leaders regularly held video-conferences to coordinate the pandemic reaction last year, but countries and EU institutions recently began a blame-game over the sluggish roll-out of vaccines.

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The EU is still several months away from having enough vaccines to inoculate its 450 million people, with Pfizer and BioNTech, its principle suppliers, aiming for September for delivery targets.

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