AMSTERDAM (AP) – The European Union’s drug agency gave the green light to Moderna Inc.’s COVID-19 vaccine on Wednesday, a decision that gives the 27-nation bloc a second vaccine to be used in desperation battle to domesticate the virus. the continent.
The recommendation for approval of the European Medicines Agency’s human medicines committee (to be stamped by the EU executive committee) is set amid high rates of infections in many EU countries and strong criticism of the slow pace of vaccinations in the region of about 450 million people.
“This vaccine provides us with another tool to overcome the current emergency,” said Emer Cooke, executive director of EMA. “It is a testament to the effort and commitment of all involved that we have this second positive vaccine recommendation shortly after a year since the WHO declared the pandemic.”
European Commission President Ursula von der Leyen welcomed the decision and added in a tweet: “We are now working at full speed to approve it and make it available in the EU.”
The EMA has already approved a coronavirus vaccine manufactured by US drug manufacturer Pfizer and Germany’s BioNTech. Both vaccines require giving people two shots.
The EU has ordered 80 million doses of the Modern vaccine with an option for an additional 80 million. The blog has also pledged to buy 300 million doses of the Pfizer-BioNTech vaccine.
Prior to the meeting on the Modern Vaccine, the agency said in a tweet that its experts “worked hard to clarify all outstanding issues with the company.” He did not detail what those issues were. Modern also declined to comment.
German Health Minister Jens Spahn has been critical in the past of the slow pace of the EMA – he said shortly before the announcement of the EMA approval that he hoped the Modern vaccine would begin to roll out to EU nations next week. Germany would get 2 million doses in the first quarter and 50 million in the whole of 2021, Spahn told reporters in Berlin.
“The problem is the shortage of production capacity with global demand,” he said.
Spahn said that if more vaccines are approved in the EU beyond BioNTech-Pfizer and Moderna injections, “we will be able to offer Germany a vaccine in the summer.”
He insisted that the mass-buying strategy of the whole block had been the right one, as it had given manufacturers the certainty of moving forward with production and ensured a fair distribution among the 27 countries.
The first results of large yet unfinished studies show both Moderna and Pfizer-BioNTech vaccines appear safe and strongly protective, although Moderna vaccines are easier to handle as they do not need to be stored at freezing temperatures.
The EU agency gave the green light to the use of the Modern vaccine in people over 18 years of age. The side effects were said to “usually be mild or moderate and improve a few days after 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 data on vaccine safety and efficacy to ensure continued protection of the EU public. Our work will always be guided by scientific evidence and our commitment to safeguard the health of EU citizens “.
The United States, Canada and Israel have already approved the use of the Modern vaccine. The United States gave it the green light for emergency use in people over the age of 18 on December 18, followed by Canada five days later with a provisional permit also for those over the age of 18. Israel authorized the vaccine on Monday.
Modern 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 accumulate up to 1 billion doses by 2021.”
Both the Modern and Pfizer-BioNTech features are mRNA vaccines, made with innovative new technology. They do not contain any coronavirus, that is, they cannot cause infection. Instead, they use a piece of genetic code that trains the immune system to recognize the spike protein on the surface of the virus, ready to attack if the real one arrives.
The EU officially began giving vaccines against Pfizer-BioNTech on December 27, but the speed of each nation’s inoculation program has varied greatly. France vaccinated about 500 people in the first week, while Germany vaccinated 200,000. The Dutch only started making vaccines on Wednesday, the last EU nation to start making them.
Austrian Chancellor Sebastian Kurz has tweeted that the approval of the “Modern Vaccine” is another important step in the fight against the pandemic. This means we have more vaccines available in the EU and we can fight the pandemic more quickly. “.
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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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