AMSTERDAM (AP) – The European Union Medicines Agency on Wednesday gave the green light for Moderna Inc.’s COVID-19 vaccine, a decision that gives the 27-country bloc a second vaccine to use in the desperate fight to fight the virus to tame. the continent.
The approval recommendation of the Committee for Medicinal Products for Human Use of the European Medicines Agency – to be stamped by the EU’s executive committee – comes amid high rates of infections in many EU countries and strong criticism of the slow rate of vaccination in the region of about 450 million people.
“This vaccine provides us with another tool to overcome the current emergency,” said Emer Cooke, EMA Executive Director. “It is a testament to the efforts and commitment of everyone involved that we have this second positive vaccine recommendation, just less than a year since the WHO declared the pandemic.”
Ursula von der Leyen, President of the European Commission, welcomed the move and added in a tweet: “Now we are working at full speed to approve it and make it available in the EU.”
The EMA has already approved a coronavirus vaccine made by the American drug manufacturer Pfizer and Germany’s BioNTech. Both vaccines require people to receive two injections.
The EU has ordered 80 million doses of the Moderna vaccine with an option for an additional 80 million. The block has also pledged to buy 300 million doses of the Pfizer-BioNTech vaccine.
Ahead of the meeting on the Moderna vaccine, the agency said in a tweet that its experts “were working hard to resolve any outstanding issues with the company.” It did not go into what those issues were. Moderna also declined to comment.
German Health Minister Jens Spahn – who has been critical in the past from the slow pace of the EMA – said shortly before the announcement of the EMA approval, he expected the Moderna vaccine to be rolled out to EU countries next week. Germany would receive 2 million doses in the first quarter and 50 million by 2021, Spahn told reporters in Berlin.
“The problem is the shortage of production capacity with global demand,” he said.
Spahn said if more vaccines outside of the BioNTech-Pfizer and Moderna injections are approved in the EU, “we can offer everyone in Germany a vaccine by the summer.”
He insisted that the bulk purchasing strategy had been the right one for the entire block, as it had given manufacturers the assurance to continue production and ensure fair distribution across all 27 countries.
Early results from large pending studies show that both the Moderna and Pfizer BioNTech vaccines appear to be safe and highly protective, although Moderna is easier to handle because it does not need to be stored at ultra-frozen temperatures.
The EU agency has given the green light to use the Moderna vaccine in people 18 years and older. It said side effects were “usually mild or moderate and got better within a few 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 the EU authorities “will closely monitor the data on the safety and effectiveness of the vaccine to ensure the continued protection of the EU public. Our work will always be guided by the scientific evidence and our commitment to protect the health of EU citizens. “
The United States, Canada and Israel have already approved the use of the Moderna vaccine. The US gave the green light on December 18 for emergency use in people over 18 years old, followed by Canada five days later with an interim authorization also for people over 18 years old. Israel gave permission for the vaccine on Monday.
Moderna said Monday it is raising its estimate for global vaccine production from 500 to 600 million doses by 2021. The company said it is “continuing to invest and add staff to build up to potentially 1 billion doses by 2021.”
The shots from both Moderna and Pfizer-BioNTech are mRNA vaccines made with breakthrough new technology. They do not contain coronavirus, which means they cannot cause infection. Instead, they use a piece of genetic code that trains the immune system to recognize the spike protein on the virus’s surface, ready to attack when the real thing comes along.
The EU officially began handing out Pfizer-BioNTech vaccination shots on Dec. 27, but the speed of each country’s vaccination program varied widely. France vaccinated about 500 people in the first week, while Germany vaccinated 200,000. The Dutch only started handing out vaccination shots on Wednesday, the last EU country 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 reported from The Hague, The Netherlands. Associated Press writer Frank Jordans in Berlin contributed to this report.
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