AMSTERDAM (AP) – The European Union’s Medicines Agency on Wednesday gave the green light to Moderna Inc.’s COVID-19 vaccine, a decision giving the 27-nation bloc a second vaccine to use in the desperate struggle to tame the virus that generally prevails. the continent.
The European Medicines Advisory Committee’s approval recommendation – to be printed by the EU’s executive commission – comes amid high infection rates in many EU countries and strong criticism of the slow pace of vaccinations in the environment of about 450 million. people.
“This vaccine offers us another tool to overcome the current emergency,” said Emer Cooke, executive director of EMA. “It is a testament to the commitment and commitment of all concerned that we have this second positive recommendation of vaccine, just a year ago since the WHO declared the pandemic.”
Ursula von der Leyen, President of the European Commission, welcomed the move and said in a tweet: “Now we are working hard to approve it and make it available in the EU.”
The EMA has already approved a coronavirus vaccine by US drugmaker Pfizer and German BioNTech. Both vaccines should give people two shots.
The EU has ordered 80 million doses of the Moderna vaccine with an option for another 80 million. The block also committed to buying 300 million doses of Pfizer-BioNTech vaccine.
Ahead of the meeting on the Moderna vaccine, the agency said in a tweet that its experts were “working hard to clear up any outstanding issues with the company.” It did not elaborate on what these issues were. Moderna also declined to comment.
German Health Minister Jens Spahn – who has criticized in the past of the slow pace of the EMA – said shortly before the announcement of the EMA approval that he expects the Moderna vaccine to launch to EU countries next week. Germany received 2 million doses in the first quarter and 50 million in the entire 2021, Spahn told reporters in Berlin.
“The problem is the shortage of production capacity with global demand,” he said.
Spahn said that if further vaccines are approved outside the BioNTech-Pfizer and Moderna shots in the EU, “we could offer a vaccine in Germany by the summer.”
He insisted that the strategy to buy bulk for the whole block was the right one, because it gave the manufacturers assurance to continue production and that it had spread fairly among all 27 countries.
Early results from large, as yet unfinished studies show that both the Moderna and Pfizer BioNTech vaccines appear safe and highly protective, although Moderna’s are easier to handle as they do not need to be stored at ultra-frozen temperatures.
The EU agency has given the green light to use the Moderna vaccine on people aged 18 and older. Side effects are said to have been “usually mild or moderate and improved within days of vaccination.”
The most common side effects are ‘pain and swelling at the injection site, fatigue, chills, fever, swollen or tender lymph nodes under the arm, headache, muscle and joint pain, nausea and vomiting’, the EMA said.
Cook stressed that EU authorities “will closely monitor the safety and efficacy of the vaccine to ensure continuous protection of the EU public. Our work will always be guided by scientific evidence and our commitment to the health of the EU.” to protect citizens. ”
The United States, Canada and Israel have already approved the use of the Moderna vaccine. The U.S. gave the green light for emergency use in people over the age of 18 on December 18, followed by Canada five days later with an interim authorization also for people over the age of 18. Israel approved the vaccine on Monday.
Moderna said Monday it is increasing 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 2021 doses by 2021.”
Both the Moderna and Pfizer-BioNTech shots are mRNA vaccines, made with a groundbreaking new technology. It contains no coronavirus, which means it can not cause infection. Instead, they use a piece of genetic code that trains the immune system to recognize the vein protein on the surface of the virus, ready to attack when the real thing comes along.
The EU officially launched Pfizer-BioNTech vaccination surveys on December 27, but the speed of each country’s vaccination program varied greatly. France vaccinated about 500 people in the first week, while Germany vaccinated 200,000. The Dutch only started giving the vaccine shots on Wednesday, the last EU nation to start doing so.
Austrian Chancellor Sebastian Kurz tweeted that the approval of the Moderna vaccine ‘is another important step in the fight against the pandemic. This means that we have more vaccines available in the EU and can fight the pandemic faster. ”
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Mike Corder reports from The Hague, The Netherlands. Associated Press author Frank Jordans in Berlin contributed to this report.
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