[News] COVID-19: European Medicines Agency supports the use of Moderna's vaccine in the European Union

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The European Medicines Agency (EMA) on Wednesday gave its go-ahead "by consensus" to the use of the COVID-19 vaccine developed by the American Moderna in people over 18 years of age and considered it safe and effective enough for the European Commission grants you a conditional use license.

The Committee for Human Medicines (CHMP) today positively concluded its assessment of the entire data package shared by Moderna, which included information on the production process, quality, composition and data from the clinical trial carried out by the pharmaceutical.

"This will guarantee EU citizens that the vaccine complies with European Union (EU) standards and establishes the safeguards, controls and obligations that underpin vaccination campaigns throughout the EU," says the EMA about the “in-depth” evaluation of the entire data package shared by the manufacturer.

The EMA's endorsement is the first step before the Commission approves the Conditional Marketing Authorization (CMA) for Moderna, making its vaccine the second to be used in European countries after Pfizer's drug / BioNtech, authorized on December 21.

The president of the Commission, Úrsula von der Leyen, assured, minutes after the EMA's support was announced, that now that European scientists have considered that Moderna's vaccine is "safe and effective", Brussels is already "working hard speed to approve it and make it available to the European Union ”.

In a statement, the executive director of the EMA, Emer Cooke, stressed that "this vaccine gives us another tool to overcome the current emergency" and its approval in just under a year since the World Health Organization (WHO) declared the pandemic is "testimony to the efforts and commitment of all those involved."

The agency recalls that the clinical trial carried out in about 30,000 people - half received the vaccine and the rest a placebo - showed that this drug developed by Moderna was "effective in preventing COVID-19 in adults from 18 years of age" .

This vaccine is given in two injections in the arm, 28 days apart between the first and second, and the most common side effects detected were generally mild or moderate, and improved a few days after vaccination, he says.

The most common reactions to this Moderna vaccine, which the company will need to continue to monitor as it is used throughout the EU, include pain and swelling at the injection site, tiredness, chills, fever, swollen or tender lymph nodes, pain headache, muscle and joint pain, nausea and vomiting.