EMA for Pfizer Vaccine Emergency License



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EuropeThe European Drug Administration (EMA) issued an emergency license for the Covid-19 vaccine from Pfizer and BioNTech on December 21.

The decision comes weeks after the UK approved the vaccine and began rolling out vaccines. The European Commission is expected to approve the decision later in the day, paving the way for efforts to distribute the Pfizer vaccine to all 27 member countries.

“This is truly a historic scientific achievement, a great step forward in our fight against the pandemic,” said Emer Cooke, director of the EMA.

On the official Twitter, the president of the European Commission, Ursula von der Leyen, said that the approval of the EMA is “a decisive milestone in the effort to provide safe vaccines to people across the continent.”

“Now we will act quickly,” he said. The European Union executive board is expected to take two to three days to approve the EMA’s decision.

Officials in Germany and some other countries said vaccination could start on December 27.

Headquarters of the European Drug Administration in Amsterdam, the Netherlands.  Photo: Reuters

Headquarters of the European Drug Administration in Amsterdam, the Netherlands. Image: Reuters

“Today is a special day for me and BioNTech,” said Ugur Sahin, CEO and co-founder of the company. “We are ready to start distributing the first dose of vaccine in Europe as soon as the green light comes on.”

Last week, European regulators came under heavy pressure from many member states. They called for the vaccine to be authorized as quickly as possible amid the second Covid-19 outbreak that is getting worse.

The EMA initially designated December 29 as the vaccine evaluation date, but the agency moved the meeting to December 21, after many countries called for a quick discussion.

“Our goal is to get vaccinated before Christmas,” German Health Minister Jens Spahn said in mid-December. “We want to start vaccination this year.”

Like Germany, France will start vaccinating the elderly in nursing homes.

The Amsterdam-based EMA, which is responsible for approving all new drugs and vaccines in the 27 member countries, has roughly the same authority as the US Food and Drug Administration (FDA). T

Since then, Pfizer vaccines have received emergency approval in the UK, Canada, Singapore and the US On December 19, Switzerland also became the first European country to authorize the vaccine under normal procedures.

In an official statement last week, the EMA emphasized that the vaccine should only be approved after undergoing an evaluation, showing that the overall benefits outweigh the risks. Scientists are waiting for more data to see how long the side effects and immunity induced by the vaccine are controlled.

Thuc Linh (According to the AP)

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