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Moderna’s COVID-19 vaccine gets green light for European Union

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The European Commission on Wednesday granted final approval for Moderna’s COVID-19 vaccine, officially clearing the way for a second vaccine to rollout among European Union member states.

The formal, conditional marketing authorization was announced just hours after Europe’s regulatory agency endorsed the jab, recommending it for those 18 years old and older.

“We have just authorised the second COVID-19 vaccine! Following the recommendation of the European Medicines Agency, we have granted a conditional marketing authorisation for the Moderna vaccine for all EU countries,” the European Commission said in a tweet announcing the news on Wednesday. 

“We are providing safe & effective COVID-19 vaccines for Europeans,” Ursula von der Leyen, the president of the European Commission, said on Twitter following the news. 

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“We have authorised the @moderna_tx vaccine, the 2nd vaccine approved in the EU. Europe has secured so far 2 billion doses of potential vaccines – more than enough for protecting us all #StrongerTogether,” she added. 

The approval of the Moderna vaccine, which proved more than 90% effective in late-stage clinical trials, comes after the European Commission granted approval to the COVID-19 jab developed by Pfizer and BioNTech on Dec. 21. Vaccinations began shortly after, on Dec. 27., among member states.

However, growing criticism in member states about the slow rollout of COVID-19 shots across the region of 450 million inhabitants led the European Commission to defend its coronavirus vaccination strategy during a news conference on Monday.

Vaccination programs in the 27 nation-bloc have gotten off to a slow start and some EU members have been quick to blame the EU’s executive arm for a perceived failure of delivering the right amount of doses. 

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“It’s obvious that such a complex endeavor is always going to bring with it difficulties, there will always [be] bumps on the road, but we are confident that with all the efforts that we have put in, we will be able to ensure vaccination of Europeans as quickly as possible,” Eric Mamer, chief spokesperson of the European Commission, said at the news conference when addressing rollout concerns. 

Stefan de Keersmaecker, the commission’s health policy spokesman, said at the same news conference that the contract with Moderna provides for an initial purchase of 80 million doses on behalf of all EU nations but that the commission intends to use its option to request a further 80 million doses once the vaccine is approved.

With the Pfizer-BioNTech vaccine, the commission has an option for an extra 100 million doses that will bring the total to 300 million shots. Both vaccines require two shots to be fully effective. The Commission added without elaborating that it is in negotiation with Pfizer and BioNTech for the purchase of additional doses.

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The slow rollout of vaccines has sparked widespread disappointment across the bloc. The cautious approach has seen just a few hundred people vaccinated in France after the first week, while the Dutch government faced criticism for its late start in delivering vaccinations, lagging well behind many other EU nations. Consequently, the Dutch health ministry said it is bringing forward the start of vaccinations by two days, with the first shots being administered Wednesday.

To date, Europe has reported 27.3 million cases of COVID-19, per estimates from the World Health Organization, and some 596,707 deaths. 

The Associated Press contributed to this report. 

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