The European Medicines Agency (EMA) recommended Moderna’s COVID-19 vaccine for conditional market authorization on Wednesday, the agency announced following a meeting.
Hours later, it was approved by the European Commission, a step that was considered a formality. The rubber stamp, announced by Commission President Ursula von der Leyen, means it is now the second vaccine available in the EU to fight the coronavirus.
“With the Moderna vaccine, the second one now authorised in the EU, we will have a further 160 million doses. And more vaccines will come,” von der Leyen said in a statement.
Leaders of EU nations have come under fire for their slow vaccine rollout programs, compared with those in Israel and other countries.
The BioNTech-Pfizer vaccine is currently the only authorized coronavirus vaccination in the EU.
It received fast-track authorization by the EMA on December 21, but supply chain issues and low production capacity have marred the rollout of the mass vaccination programs across the bloc.
“This vaccine provides us with another tool to overcome the current emergency,” Emer Cooke, Executive Director of EMA, said.
Wednesday’s EMA meeting to discuss the Moderna vaccine was the second this week after an initial meeting on Monday proved inconclusive.
The United States, Canada and Israel have already authorized the Moderna shot.
The commission could finally approve the vaccine later on Wednesday, news agency Reuters reported, citing the Dutch medicines authority.
EU leaders welcome authorization
German Health Minister Jens Spahn said Germany was to receive around 50 million doses of the Moderna vaccine in 2021, including 2 million in the first quarter.
He told reporters in Berlin that he expected the vaccine to begin rolling out to EU nations next week, and that if further vaccines beyond the BioNTech-Pfizer and Moderna shots are approved “we’ll be able to offer everyone in Germany a vaccine by the summer.”
Austrian Chancellor Sebastian Kurz called the authorization “a further important step in the fight against the pandemic.”
“With it, we have more vaccines available in the EU to combat the pandemic.”
What is the Moderna vaccine?
The mRNA-1273 vaccine from US company Moderna is a gene-based vaccine that is very similar in principle to the one from BioNTech-Pfizer.
It was about 95% effective at preventing the illness in clinical trials.
No serious safety issues were found during the clinical trials. Participants tolerated the vaccine well, according to the manufacturer and testing authorities. There were some common vaccination reactions, but these were mild or moderate and didn’t last long.
Almost 10% of those vaccinated with mRNA-1273 experienced fatigue, according to an interim report by an independent surveillance panel.
The EU medicines agency did not specify at the time why it did not approve the vaccine following the initial EMA meeting on Monday. But it did say experts were “working hard to clarify outstanding issues with the company.”