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LONDON (Dec. 2): Britain approved Pfizer’s Covid-19 vaccine today, ahead of the United States and Europe to become the first country in the West to formally endorse a vaccine that it said should reach the most vulnerable people. early next week.
Prime Minister Boris Johnson touted the approval of the medical authority as a global victory and a ray of hope amid the sadness of the new coronavirus that has killed nearly 1.5 million people worldwide, has hit the world economy. and it has disrupted normal life.
Britain’s Medicines and Healthcare Products Regulatory Agency (MHRA) granted emergency use approval to the Pfizer-BioNTech vaccine, which they said is 95% effective in preventing disease, in record time – just 23 days since Pfizer published the first data of its final stage. clinical trial.
“It’s fantastic,” Johnson said. “The vaccine will become available across the UK from next week. It is the protection of vaccines that will finally allow us to get our lives back and get the economy moving again.”
The world’s great powers have been vying for a vaccine for months in a bid to be the first to begin the long road to recovery.
The approval of a vaccine for use almost exactly one year after the novel coronavirus emerged in Wuhan, China, is a triumph for science, said Pfizer chief Albert Bourla and his German biotech partner BioNTech.
China has already given emergency approval for three experimental vaccines and has inoculated about a million people since July. Russia has been vaccinating frontline workers after approving their Sputnik V injection in August, before completing late-stage safety and efficacy tests.
But the European Union’s drug regulator said today that its longer approval process for Covid-19 vaccines was safer as it relied on more tests and controls than Britain’s chosen emergency procedure.
British leaders said that while they would love to take a hit themselves, priority should be given to those most in need: the elderly, those living in nursing homes and healthcare workers.
‘Historic moment’
The American drugmaker said Britain’s emergency use authorization marks a historic moment in the fight against Covid-19. Pfizer announced the advancement of its vaccine on November 9 with results from stage three clinical trials.
“This authorization is a goal we have been working towards since we first declared that science will win, and we applaud the MHRA for its ability to conduct a careful assessment and take timely action to help protect the people of the UK. “said the CEO. Officer (CEO) Bourla.
“As we anticipate more authorizations and approvals, we are focused on moving forward with the same level of urgency to safely deliver a high-quality vaccine around the world.”
Britain’s drug regulator approved the vaccine in record time, in part by doing “ongoing” simultaneous analysis of the data and the manufacturing process as Pfizer rushed to complete trials.
“With 450 people dying every day from Covid-19 infection in the UK, the benefits of rapid vaccine approval outweigh the potential risks,” said Andrew Hill, senior visiting researcher in the University’s Department of Pharmacology. from Liverpool.
“However, we need new independent clinical trials to monitor long-term safety and efficacy.”
The US Food and Drug Administration (FDA) will meet on December 10 to discuss whether to recommend emergency use authorization for the Pfizer / BioNTech vaccine, and the European Medicines Agency said it could grant emergency approval. for injection before December 29th.
“The data submitted to regulatory agencies around the world is the result of a scientifically rigorous and highly ethical research and development program,” said Ugur Sahin, CEO and co-founder of BioNTech.
US media reported yesterday that the White House had summoned FDA Director Stephen Hahn to discuss why the US agency had not moved faster to authorize the Pfizer vaccine.
First in line?
Britain said it would start vaccinating ordinary people early next week after receiving 800,000 doses from Pfizer’s manufacturing center in Belgium. The speed of delivery depends on how quickly Pfizer can manufacture and administer 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, since it takes two injections of the jab per person to gain immunity.
Health Secretary Matt Hancock said hospitals were ready to receive the injections and vaccination centers would be established across the country, but conceded that distribution would be challenging given that the vaccine must be shipped and stored at -70 ° C, the typical temperature type. of an Antarctic winter.
Pfizer has said that injections can be stored in insulated shipping boxes for up to 30 days, from up to 15 days pre-guided. The vaccine can then be kept at refrigerator temperature for up to five days.
Other leaders in the vaccine race include American biotech firm Moderna, which has said its injection is 94% successful in late-stage clinical trials. Moderna and Pfizer have developed their shots using new messenger RNA technology.
AstraZeneca said last month that its Covid-19 injection, which is based on traditional vaccine technology, was 70% effective in pivotal trials and could be up to 90% effective.
Read also:
EU warns of vaccine race risks after UK approval of Pfizer injection
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