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December 3, 2020

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UK becomes first Western country to approve vaccine

BRITAIN approved Pfizer’s COVID-19 vaccine yesterday, jumping ahead of the United States and Europe to become the West’s first country to formally endorse a jab it said should reach the most vulnerable people early next week.

Britain’s Medicines and Healthcare products Regulatory Agency granted emergency use approval to the vaccine developed by American drugmaker Pfizer and Germany’s BioNTech, which they say is 95 percent effective in preventing illness, in record time — just 23 days since Pfizer published the first data from its final stage clinical trial.

“Everybody can be confident that no corners whatsoever have been cut,” MHRA Chief Executive June Raine said.

Prime Minister Boris Johnson touted the approval as a global win and a ray of hope amid the gloom of the novel coronavirus which has killed nearly 1.5 million people globally, hammered the world economy and upended normal life.

“Help is on its way,” British Health Secretary Matt Hancock told the BBC, adding that the situation would start to improve in the spring.

Hancock said nursing home residents, people over 80, and health-care workers will be the first to receive the shot. Britain said it would start vaccinating ordinary people early next week after it gets 800,000 doses from Pfizer’s manufacturing center in Belgium. The speed of the rollout depends on how fast Pfizer can manufacture and deliver the vaccine.

Johnson said last month that Britain had ordered 40 million doses of the Pfizer vaccine — enough for just under a third of the population as two shots of the jab are needed per person to gain immunity.

Hancock said hospitals were ready to receive the shots and vaccination centers would be set up across the country but he admitted distribution would be a challenge given that the vaccine must be shipped and stored at -70 degrees Celsius.

Pfizer says it has developed shipping containers that use dry ice to keep the vaccine cool. GPS-enabled sensors will allow the company to track each shipment and ensure they stay cold.

The US drugmaker called Britain’s emergency use authorization “a historic moment” in the fight against COVID-19. Pfizer announced its vaccine breakthrough on November 9 with stage III clinical trial results.

“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,” said Pfizer CEO Albert Bourla. “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.”

Britain’s medicines regulator approved the vaccine in record time — partly by doing a “rolling” concurrent analysis of data and the manufacturing process while Pfizer raced to conclude trials.

“With 450 people dying of COVID-19 infection every day in the UK, the benefits of rapid vaccine approval outweigh the potential risks,” said Andrew Hill, senior visiting research fellow in the Department of Pharmacology at the University of Liverpool.

“However, we need new independent clinical trials to monitor long-term safety and efficacy.”

The US Food and Drug Administration is set to meet on December 10 to discuss whether to recommend emergency use authorization of the Pfizer/BioNTech vaccine and the European Medicines Agency said it could give emergency approval for the shot by December 29.

China has already given emergency approval for three experimental vaccines and has inoculated around 1 million people since July. Russia has been vaccinating front-line workers after approving its Sputnik V shot in August before it had completed late-stage testing.

Other frontrunners in the vaccine race include US biotech firm Moderna, which has said its shot is 94 percent successful in late-stage clinical trials. Moderna and Pfizer have developed their shots using new messenger RNA technology. AstraZeneca said last month its COVID-19 shot, which is based on traditional vaccine technology, was 70 percent effective in pivotal trials and could be up to 90 percent effective.


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