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UK approves Pfizer coronavirus vaccine for emergency use

02-12-2020

LONDON: British officials authorized a COVID-19 vaccine for emergency use on Wednesday, green-lighting the world’s first shot against the virus that’s backed by rigorous science and taking a major step toward eventually ending the pandemic.

The go-ahead for the vaccine developed by American drugmaker Pfizer and Germany’s BioNTech comes as the virus surges again in the United States and Europe, putting pressure on hospitals and morgues in some places and forcing new rounds of restrictions that have devastated economies.

The Medicines and Healthcare Products Regulatory Agency, which licenses drugs in the U.K., recommended the vaccine could be used after it reviewed the results of clinical trials that showed the vaccine was 95 per cent effective overall — and that it also offered significant protection for older people, among those most at risk of dying from the disease. But the vaccine remains experimental while final testing is done.

“It’s fantastic,” British Prime Minister Boris Johnson said. “The vaccine will begin to be made available across the U.K. from next week. It’s the protection of vaccines that will ultimately allow us to reclaim our lives and get the economy moving again.”

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

“We now have a vaccine. We’re the first country in the world to have one formally clinically authorized but, between now and then, we’ve got to hold on, we’ve got to hold our resolve.”

Other countries aren’t far behind: Regulators in the United States and the European Union also are vetting the Pfizer shot along with a similar vaccine made by competitor Moderna Inc. British regulators also are considering another shot made by AstraZeneca and Oxford University.

Hancock said Britain expects to begin receiving the first shipment of 800,000 doses “within days,” and people will begin receiving shots as soon as the National Health Service gets the vaccine.

Doses everywhere are scarce, and initial supplies will be rationed until more is manufactured in the first several months of next year.

A government committee will release details of vaccination priorities later Wednesday, but Hancock said nursing home residents, people over 80, and health-care workers and other care workers will be the first to receive the shot.

Pfizer said it would immediately begin shipping limited supplies to the UK and has been gearing up for even wider distribution if given a similar nod by the U.S. regulators.

Pfizer’s vaccine is among seven that Canada has pre-ordered. The U.S. Food and Drug Administration is set to meet on Dec. 10 to review the Pfizer product. Health Canada’s chief medical adviser, Supriya Sharma, has said regulators here are expected to make decisions on timelines similar to those followed by the U.S.

Pfizer CEO Albert Bourla called the U.K. decision “a historic moment.”

“We are focusing on moving with the same level of urgency to safely supply a high-quality vaccine around the world,” Bourla said in a statement.

While the U.K. has ordered 40 million doses of the Pfizer vaccine, enough for 20 million people, it’s not clear how many will arrive by year’s end. Hancock said the U.K. expects to receive “millions of doses” by the end of this year, noting that the actual number will depend on how fast Pfizer can produce the vaccine.

One concern about the Pfizer-BioNTech vaccine is that it must be stored and shipped at ultra-cold temperatures of around -70 C, adding to the challenge of distributing the vaccine around the world.

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 company says.

“Pfizer has vast experience and expertise in cold-chain shipping and has an established infrastructure to supply the vaccine worldwide, including distribution hubs that can store vaccine doses for up to six months,” the company said in a statement.

The company also says it has agreed to work with other vaccine makers to ensure there is sufficient supply and a range of vaccines, “including those suitable for global access.” (Int’l Monitoring Desk)

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