The EU agency approves the Moderna COVID-19 vaccine

AMSTERDAM (AP) – The European Union Medicines Agency on Wednesday gave the green light to Moderna Inc.’s COVID-19 vaccine, a decision to give the 27-nation bloc a second vaccination in a desperate battle to rage the virus. the continent.

The recommendation of the European Medicines Agency’s Committee for Medicinal Products for Human Use, which should be rubber-stamped by the EU Executive Committee, is amid high infection rates in many EU countries and slow criticism of vaccinations at around 450 million. people.

“This vaccine provides us with another tool to deal with the current emergency,” said Emer Cooke, executive director of EMA. “Evidence of the efforts and commitment of all concerned is that this is the second positive vaccination recommendation in the year since the WHO announced the outbreak.”

European Commission President Ursula von der Leyen welcomed the move and added in a tweet: “We are now working at full speed to approve and make it available in the EU.”

The EMA has already approved a coronavirus vaccine from U.S. pharmaceutical company Pfizer and German BioNTech. Both shots require two shots.

The EU has ordered 80 million doses of Moderna vaccine, with an additional 80 million options. The block has also committed to purchasing 300 million doses of Pfizer-BioNTech vaccine.

Prior to discussing the Moderna vaccine, the agency said in a tweet that its experts are “working hard to clarify all outstanding issues with the company”. He did not detail what these issues were. Moderna also refused to comment.

Jens Spahn, German health minister – who has been critical in the past from the slow pace of the EMA – shortly before the announcement of the EMA approval, he said he expected the Moderna vaccine to start launching in EU countries next week. Germany would receive 2 million servings in the first quarter and 50 million in 2021 as a whole, Spahn told Berlin reporters.

“The problem is the lack of production capacity in addition to global demand,” – he said.

Spahn said that if BioNTech-Pfizer and Moderna approve additional vaccinations in the EU in addition to the recordings, “we will be able to offer vaccination to everyone in Germany until the summer.”

He insisted that the strategy of mass purchasing was the right one for the whole bloc, as it ensured that producers could continue production and ensured a fair distribution among all 27 countries.

Early results from large, unfinished studies show that Moderna and Pfizer-BioNTech vaccines appear to be safe and highly protective, although Moderna is easier to handle as it does not need to be stored frozen.

The EU agency has given the green light to the use of the Moderna vaccine in people aged 18 and over. He said the side effects were “usually mild or moderate and improved within 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,” the EMA said.

Cook stressed that EU authorities “are closely monitoring data on the safety and effectiveness of the vaccine to ensure continued protection for EU citizens. Our work will always be guided by our scientific evidence and our commitment to protecting the health of EU citizens. “

The United States, Canada, and Israel have already approved the use of the Moderna vaccine. On December 18, the United States gave a green light to people over the age of 18 for emergency use, followed five days later by Canada, with a temporary permit for people over the age of 18 as well. Israel allowed the vaccination on Monday.

Moderna said on Monday it will increase its estimate of global vaccine production from 500 to 600 million doses in 2021. The company said it will “continue to invest and increase staff to potentially raise 1 billion servings by 2021”.

Recordings from Moderna and Pfizer-BioNTech are mRNA inoculations, pioneering new technology. They do not contain coronavirus – that is, they cannot cause infection. Instead, they use a piece of genetic code that allows the immune system to recognize the spike protein on the surface of the virus, ready to attack if the real thing happens.

The EU officially began releasing Pfizer-BioNTech vaccination recordings on December 27, but the pace of each country’s vaccination program has changed greatly. France vaccinated about 500 people in the first week, while Germany vaccinated 200,000. The Dutch only started giving the vaccine on Wednesday, it was 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 more vaccines are available in the EU and we can fight the epidemic faster. “


Mike Corder made a report from The Hague, the Netherlands. Frank Jordans, writer for the Associated Press, contributed to the report in Berlin.


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