EMA recommends Moderna’s Covid-19 vaccine for market authorisation
Wednesday, 06 January 2021
The European Medicines Agency (EMA) has recommended granting conditional marketing authorisation for Moderna’s Covid-19 vaccine on Wednesday.
The vaccine is “safe and effective” in preventing Covid-19 in people from 18 years old, according to the experts who evaluated it.
If the European Commission follows the recommendation, the vaccine may soon be administered in the EU Member States, making it the second vaccine that can be used in Europe against the coronavirus after the BioNTech/Pfizer vaccine was granted on 21 December.
“Good news for our efforts to bring more Covid-19 vaccines to Europeans,” tweeted Commission President Ursula von der Leyen in a reaction to the announcement. “Now we are working at full speed to approve it and make it available in the EU.”
Good news for our efforts to bring more #COVID19 vaccines to Europeans! @EMA_News assessed that the @moderna_tx vaccine is safe & effective.
Now we are working at full speed to approve it & make it available in the EU.
This news comes after an unsuccessful first meeting concerning the virus on Monday, with several questions from member states left outstanding, but hope remained high a solution would be found this week.
Speaking on Tuesday, European Council President Charles Michel said that the Moderna vaccine could be approved “in the next few hours” and announced a new virtual summit on the health crisis to be held before the end of January. While this proved not to be the case, he wasn’t far off.
At a press conference in Lisbon, he spoke of the “enormous challenge” posed by the deployment of these vaccines for a population of some 450 million people.
“The Commission, with the support of the Member States, is working day and night to ensure that the number of vaccines available can be increased,” while “respecting the independence of the Medicines Agency,” he said.
The EU has earmarked 160 million doses of Moderna vaccine. Their distribution among the 27 member states must be proportional to the population.
The Moderna vaccine is taken in two doses, a few weeks apart, like the Pfizer/BioNTech vaccine. However, Moderna’s formula can be stored at -20°C, not -70°C like Pfizer’s one, which forced the group to develop special containers for transport.