AMSTERDAM (AP) – The European Union’s drug agency gave the green light on Wednesday to COVID-19 vaccine from Moderna Inc., a decision that gives the 27-nation bloc a second vaccine to be used in the desperate battle to tame the virus that spreads across the continent.
The recommendation for approval by the European Medicines Agency’s human medicines committee – which should be stamped by the EU executive committee – comes amid high rates of infections in many EU countries and strong criticisms of the slow pace of vaccinations in the surrounding region. 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 under a year since the pandemic was declared by the WHO.”
European Commission President Ursula von der Leyen welcomed the initiative and added in a tweet: “Now we are working full steam ahead to approve and make it available in the EU”.
EMA has already approved a coronavirus vaccine made by the American pharmaceutical company Pfizer and the German company BioNTech. Both vaccines require giving people two injections.
The EU ordered 80 million doses of the Modern vaccine, with an option for an additional 80 million. The bloc also pledged to buy 300 million doses of the Pfizer-BioNTech vaccine.
Before the Modern vaccine meeting, the agency said in a tweet that its experts were “working hard to clear up any outstanding issues with the company.” He did not elaborate on what those issues were. Moderna also declined to comment.
German Health Minister Jens Spahn – who in the past has been critical the slow pace of EMA – said shortly before the announcement of EMA approval that he expected the Modern vaccine to start rolling out to EU nations next week. Germany would receive 2 million doses in the first quarter and 50 million in the entire year 2021, Spahn told reporters in Berlin.
“The problem is the lack of production capacity with global demand,” he said.
Spahn said that if vaccines other than BioNTech-Pfizer and Moderna injections are approved in the EU, “we can offer a vaccine to everyone in Germany by the summer.”
He insisted that the bulk purchase strategy for the entire block was correct, as it gave manufacturers the certainty to continue with production and guaranteed a fair distribution among the 27 countries.
The first results of large studies not yet concluded show that Moderna and Pfizer-BioNTech vaccines appear safe and strongly protective, although Moderna is easier to handle, since it does not need to be stored in deep-frozen temperatures.
The EU agency has given the green light for the use of the Moderna vaccine in people aged 18 and over. He said that the side effects “were generally mild or moderate and improved a few days after vaccination”.
The most common side effects are “pain and swelling at the injection site, tiredness, chills, fever, swollen or tender lymph nodes under the arm, headache, muscle and joint pain, nausea and vomiting,” said the EMA.
Cook emphasized that EU officials “will closely monitor data on the safety and efficacy of the vaccine to ensure continued protection for 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 the green light for emergency use to people over 18 on December 18, followed by Canada five days later, with a provisional authorization also for people over 18. Israel authorized the vaccine on Monday.
Moderna said Monday that it is increasing its estimate for global vaccine production in 2021 from 500 to 600 million doses. The company said it is “continuing to invest and add staff to potentially build 1 billion doses for 2021”.
The vaccines of Moderna and Pfizer-BioNTech are mRNA vaccines, made with a new innovative technology. They do not contain any coronaviruses – which means that 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 if the real thing comes along.
The EU officially began distributing Pfizer-BioNTech vaccines on December 27, but the speed of each nation’s vaccination program has varied widely. France vaccinated around 500 people in the first week, while Germany vaccinated 200,000. The Dutch were just starting to give vaccines on Wednesday, the last EU nation to start doing so.
Austrian Chancellor Sebastian Kurz tweeted that the approval of the Modern vaccine “is another important step in the fight against the pandemic. This means that 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, Holland. Associated Press writer Frank Jordans in Berlin contributed to this report.
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