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Pfizer-BioNTech vaccine cleared: UK gets first shot next week

800,000 doses of mRNA vaccine in first phase; US regulators to meet December 10; minus 70 degrees Celsius distribution a challenge.

By: Reuters | London | December 3, 2020 1:35:56 am
Pfizer, Coronavirus vaccine, Canada Pfizer, Canada Covid vaccine, Health canada, world newsThe finding is one of several significant new results featured in the briefing materials, which span 53 pages of data analyses from the agency and from Pfizer.

Written by Guy Faulconbridge & Paul Sandle

Britain approved Pfizer’s Covid-19 vaccine Wednesday, 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.”

British Prime Minister Boris Johnson touted the approval of the vaccine, which uses novel mRNA technology, as a global win and a ray of hope amid the gloom of the coronavirus that has killed nearly 1.5 million people, hammered the economy and upended life worldwide.

Britain’s Medicines and Healthcare products Regulatory Agency (MHRA) granted emergency use approval to the Pfizer-BioNTech vaccine, which they say is 95 per cent effective in preventing illness, in record time — just 23 days since Pfizer published the first data from its final stage clinical trial which involved more than 43,000 people.

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

The world’s big powers have been racing for a vaccine for months in an attempt to be first to begin the long road to recovery.

The approval of a vaccine for use almost exactly a year since the novel coronavirus emerged in Wuhan, China, is a triumph for science, Pfizer boss Albert Bourla and his German biotechnology partner BioNTech.

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

Also Read | How Pfizer Covid vaccine was developed in record time

But the European Union’s drug regulator said on Wednesday that its longer approval process for Covid-19 vaccines was safer, as it was based on more evidence and checks that the emergency procedure chosen by Britain.

British leaders said that, while they would love to get a jab themselves, priority had to be given to those most in need — the elderly, those in care homes and health workers.

“This authorization is a goal we have been working toward since we first declared that science will win,” said CEO Bourla. “As we anticipate further authorisations 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 regulator, Food and Drug Administration (FDA), 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.

“The data submitted to regulatory agencies around the world are the result of a scientifically rigorous and highly ethical research and development programme,” said Ugur Sahin, chief executive and co-founder of BioNTech.

US media reported Tuesday that the White House had summoned FDA head Stephen Hahn to discuss why the US agency hadn’t moved faster to authorise Pfizer’s vaccine.

Britain said it would start vaccinating ordinary people early next week after it gets 800,000 doses from Pfizer’s manufacturing centre 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.

Health Secretary Matt Hancock said hospitals were ready to receive the shots and vaccination centres 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, the sort of temperature typical of an Antarctic winter.

Pfizer has said the shots can be kept in thermal shipping boxes for up to 30 days, from up to 15 days previously guided. Afterwards, the vaccine can be kept at fridge temperatures for up to five days.

Other frontrunners in the vaccine race include U.S. biotech firm Moderna, which has said its shot is 94% successful in late-stage clinical trials. Moderna and Pfizer have developed their shots using new messenger RNA (mRNA) technology.

AstraZeneca said last month its shot, which is based on traditional vaccine technology, was 70 per cent effective in pivotal trials and could be up to 90 per cent effective.

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