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UK first country to authorize Pfizer COVID-19 vaccine
Published in The Saudi Gazette on 02 - 12 - 2020

The UK has become the first country to approve the Pfizer and BioNTech coronavirus vaccine.
"The government has today accepted the recommendation from the independent Medicines and Healthcare products Regulatory Agency (MHRA) to approve Pfizer-BioNTech's COVID-19 vaccine for use," the government said Wednesday.
Health Minister Matt Hancock announced that the UK's medicines regulatory agency has given its authorization to the vaccine and that the NHS would be ready to start vaccinating early next week.
The news comes as three candidate vaccines have announced promising results from phase three trials in the past month.
The two companies announced this month from preliminary results that the vaccine is 95% effective and in particular, is 94% effective in people over the age of 65 who are more at risk of developing severe COVID-19.
BioNTech, the German biotech that developed the vaccine with Pfizer, said in a statement that the companies are ready to deliver the first doses to the UK immediately.
Pfizer's Chairman and CEO Albert Bourla said the authorization from the UK's Medicines & Healthcare Products Regulatory Agency (MHRA) was a "historic moment."
"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 UK," he said.
"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. With thousands of people becoming infected, every day matters in the collective race to end this devastating pandemic."
Pfizer and BioNTech announced in July an agreement with the UK to supply 30 million doses of its mRNA-based vaccine, formally known as "BNT162b2," once authorized for emergency use. That agreement was increased to 40 million doses in early October.
"The Emergency Use Authorization in the UK will mark the first time citizens outside of the trials will have the opportunity to be immunised against COVID-19," said Ugur Sahin, CEO and co-founder of German company BioNTech.
"We believe that the roll-out of the vaccination program in the UK will reduce the number of people in the high-risk population being hospitalized," Sahin added in a statement.
The EU has secured a deal with the companies for 300 million doses. Pfizer and BioNTech have said that they have the capacity to produce 50 million doses of the vaccine in 2020 and up to 1.3 billion doses of the vaccine in 2021.
The vaccine requires two doses received about three weeks apart. The mRNA vaccine is based on new technology that contains genetic instructions that help the body to recognize the coronavirus' spike protein, which is used to enter the body's cells.
The vaccine was "well-tolerated" by the more than 43,000 participants enrolled in phase three trials, the company said earlier in the month. Those trials continue even as the vaccine is approved for emergency use.
Participants will continue to be monitored to determine how it protects and its safety for an additional two years after their second dose. The vaccine could be more difficult to distribute than others, experts have said, since it needs to be stored at ultracold temperatures (-70 degrees Celsius). — Agencies


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