The European Union’s Medicines Agency gave the green light on Wednesday to Moderna Inc .:’s COVID-19 vaccine, a decision that gives the 27-nation bloc a second vaccine to use in the desperate battle to tame the virus that is raging across the continent.
The approval recommendation from the European Medicines Agency’s Committee for Medicinal Products for Human Use – which must be stamped by the EU Commission – comes amid high levels of infection in many EU countries and strong criticism of the slow pace of vaccinations in the region of around 450 million people. .
“This vaccine gives us another tool to overcome the current emergency,” said Emer Cooke, CEO of EMA. “It is a testament to the efforts and commitment of all involved that we have the second positive vaccine recommendation just one year since the pandemic was declared by the WHO.”
European Commission President Ursula von der Leyen welcomed the approval, adding in a tweet: “We are now working at full speed to approve it and make it available in the EU.”
EMA has already approved a coronavirus vaccine manufactured by the American pharmaceutical manufacturer Pfizer and Germany’s BioNTech. Both vaccines require humans to receive two shots.
Ahead of the meeting on the Moderna vaccine, the agency said in a tweet that its experts “worked hard to clarify all outstanding issues with the company.” It did not elaborate on what these issues were. Modern also declined to comment.
German Health Minister Jens Spahn – who has previously been critical of the EMA’s slow pace – said he expected the Moderna vaccine to start rolling out to EU countries next week. Germany would receive 2 million doses in the first quarter and 50 million in 2021, Spahn told reporters in Berlin.
“The problem is the lack of production capacity with global demand,” he said.
Early results from large, still unfinished studies show that both Moderna and Pfizer-BioNTech vaccines appear safe and highly protective, although Moderna is easier to handle because it does not need to be stored at ultra-frozen temperatures.
The United States, Canada and Israel have already approved the use of the Moderna vaccine. The United States gave the green light for emergency use in people over the age of 18 on December 18, followed by Canada five days later with a temporary permit also for people over the age of 18. Israel approved the vaccine on Monday.
Moderna said on Monday that it is raising its estimate for global vaccine production in 2021 from 500 to 600 million doses. The company said it “continues to invest and add staff to build up to a potential 1 billion doses by 2021.”
Both Moderna and Pfizer-BioNTech’s shoots are mRNA vaccines, made with a groundbreaking new technology. They do not contain coronavirus – which means they can not cause infection. Instead, they use a piece of genetic code that trains the immune system to recognize the nail protein on the surface of the virus, ready to attack if the real thing comes along.
The EU officially launched Pfizer-BioNTech vaccination shots on December 27, but the speed of each country’s inoculation program has varied widely. France vaccinated about 500 people in the first week, while Germany vaccinated 200,000. The Dutch first started issuing vaccine shots on Wednesday, the last EU nation to start doing so.