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YES to the Moderna vaccine from the Commission and the European Medicines Agency

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YES to the Moderna vaccine from the Commission and the European Medicines Agency

The European Commission has approved the second safe and effective vaccine against COVID-19. According to the Commission communication, the European Commission has conditionally granted a marketing authorization for the COVID-19 vaccine developed by Moderna, the second COVID-19 vaccine approved in the EU. This approval follows a positive scientific recommendation based on a thorough evaluation safety, efficacy and quality of the vaccine by the European Medicines Agency (EMA) and approved by the Member States.

European Commission President Ursula von der Leyen stressed that the EU provides “more COVID-19 vaccines for Europeans. With the Moderna vaccine, the second to be approved in the EU, we will have an additional 160 million doses. And more vaccines will come. Europe has secured up to two billion doses of potential COVID-19 vaccines. “We will have more than enough safe and effective vaccines to protect all Europeans.”

Stella Kyriakidou, Commissioner for Health and Food Safety, stressed that “We are all in this together and united. That is why we have negotiated the largest vaccine portfolio in the world for all our Member States. Today we are approving a second safe and effective vaccine from Moderna, which together with BioNTech-Pfizer will ensure that 460 million doses of increasing speed are available in the EU and more will come. Member States must ensure that vaccination rates are followed. “Our efforts will not stop until vaccines are available to everyone in the EU.”

Approved by the European Medicines Agency

The European Medicines Agency today gave the green light to the vaccine against Covid-19 disease of the American laboratories Moderna, the second vaccine it approves, as the authorities accelerate the vaccination efforts, aimed at stopping the pandemic, among the concerns for more contagious .

Vaccinating the 450 million people in the European Union is likely to be crucial to ending the pandemic that has killed nearly 1.9 million people worldwide. Approval is taking place as countries battle over time to control two mutations found in South Africa and Britain that are more contagious and have led to an outbreak.

The EMA said it was approving the use of the Moderna vaccine in people over the age of 18, after evaluating the data on quality, safety and efficacy.

“This vaccine provides us with another tool to overcome the current emergency situation,” said EMA General Manager Emer Cook in a press release.

The decision, taken just one year after the first outbreak of the virus in China, marks the second authorization by a regulator for the Moderna vaccine after the US and an additional confirmation of new mRNA technology.

The vaccine was approximately 95% effective in preventing the disease in clinical trials in which no serious safety issues were identified.

Among other things, the European Medicines Agency states in a statement that the Moderna vaccine is given in two doses by hand, 28 days apart.

According to the Dutch drug regulator CBG, the Moderna vaccine is expected to be effective against mutant strains of coronavirus found in Britain, but has warned that further research is needed.

The “green light” of the EMA follows the conditional approval, two weeks ago, on December 21, of the vaccine of Pfizer Inc and BioNTech SE.

“The fact that we are making this second positive recommendation for a vaccine, less than a year after the World Health Organization declared the pandemic, testifies to the efforts and commitment of all those involved,” Cook said.

For her part, European Commission President Ursula von der Leyen said it was “good news for our efforts to offer Europeans more vaccines against Covid-19”.

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Source: politis.com.cy

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