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European Union regulators approve Pfizer-BioNTech COVID-19 vaccine

A vial of the Pfizer-BioNTech COVID-19 vaccine, containing five doses, is seen at the Shaare Zedek Medical Center in Jerusalem, Israel, on Sunday. Photo by Debbie Hill/UPI
A vial of the Pfizer-BioNTech COVID-19 vaccine, containing five doses, is seen at the Shaare Zedek Medical Center in Jerusalem, Israel, on Sunday. Photo by Debbie Hill/UPI | License Photo

Dec. 21 (UPI) -- European regulators gave conditional approval Monday for the COVID-19 vaccine developed by Pfizer and BioNTech.

The European Medicines Agency recommended approval for the vaccine, which allows for its distribution in the European Union.

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"Today's positive news is an important step forward in our fight against this pandemic, which has caused suffering and hardship for so many," EMA executive director Emer Cooke said in a statement.

"We have achieved this milestone thanks to the dedication of scientists, doctors, developers and trial volunteers as well as many experts from all EU member states."

The EU's executive branch must also approve the vaccine before it can be distributed in the 27-member bloc. That is expected sometime Monday.

The EMA said the vaccine will be given in two doses 21 days apart. The most common side effects are pain and swelling at the injection site, tiredness, headache, muscle and joint pain, chills and fever, it said.

"Our thorough evaluation means that we can confidently assure EU citizens of the safety and efficacy of this vaccine and that it meets necessary quality standards. However, our work does not stop here," Cooke added.

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"We will continue to collect and analyze data on the safety and effectiveness of this vaccine."

The vaccine from Pfizer and BioNTech has also been approved in the United States, Britain and Canada. A second vaccine developed by Moderna was approved in the United States over the weekend.

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