U.K. Is First Country to Approve Pfizer's COVID Vaccine, Will Begin Distributing Next Week
The United Kingdom has become the first country in the world to approve a COVID-19 vaccine, with doses of the Pfizer vaccine planned to be distributed as soon as next week.
On Wednesday, the U.K.'s Medicines and Healthcare Products Regulatory Agency (MHRA) granted a temporary authorization for emergency use to the coronavirus vaccine developed by Pfizer and BioNTech. The same vaccine has been submitted for emergency approval by the FDA in the United States and is still under review.
Matt Hancock, U.K. health secretary, said the initial 800,000 doses will be made available next week, with nursing home residents and staff given priority for receiving the vaccine, BBC News reports.
“Today’s emergency use authorization in the U.K. marks a historic moment in the fight against COVID-19. This authorization is a goal we have been working toward since we first declared that science will win, and we applaud the MHRA for their ability to conduct a careful assessment and take timely action to help protect the people of the U.K.,” Albert Bourla, chairman and CEO of Pfizer, said in a press release.
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“As we anticipate further authorizations and approvals, we are focused on moving with the same level of urgency to safely supply a high-quality vaccine around the world,” added Bourla. “With thousands of people becoming infected, every day matters in the collective race to end this devastating pandemic.”
U.K. Prime Minister Boris Johnson called the authorization "fantastic" on Twitter, adding that "it’s the protection of vaccines that will ultimately allow us to reclaim our lives and get the economy moving again."
Speaking on the streamlined, swift process of developing, testing and approving the Pfizer vaccine, the head of MHRA, June Raine, assured that "no corners have been cut."
"It’s very clear that separate teams have been working in parallel to deliver the most rigorous review of this vaccine. No corners have been cut,” said Raine, according to Reuters.
"Our expert scientists and clinicians have worked round the clock, carefully, methodically, poring over tables and analyses and graphs on every single piece of data, hundreds, over a thousand pages of data and, absolutely critically, analyzing the pre-clinical evidence, the clinical trials, the manufacturing and quality controls, and then down to the final sampling," Raine added.
Pfizer announced last month that its phase three study results proved the vaccine is 95 percent effective with "no serious safety concerns observed" in the trial participants. Now, the company hopes to get their vaccine — which requires two shots, given three weeks apart — approved in the U.S. and have initial doses available for distribution before the end of the year.
Pfizer, along with their German partner BioNTech, said they could have 50 million doses available this year, and 1.3 billion in 2021.
The trials observed more than 43,000 participants, and the "only Grade 3 adverse event greater than 2 percent in frequency was fatigue at 3.8 percent and headache at 2.0 percent." Pfizer added the vaccine was "well tolerated across all populations."
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