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Oxford Coronavirus Vaccine Data May Go To Regulators This Year


LONDON (Reuters)-Oxford and AstraZeneca’s potential coronavirus vaccine trial data may be provided to regulators this year, but cutting corners to speed approval for emergency use You can not.

File Photo: A woman has a small bottle with a “Vaccine COVID-19” sticker and a medical syringe label in this illustration taken on April 10, 2020. Reuters/Daddle Bitch/Illustration/File photo

The Oxford vaccine generated one’s immune response in the first human test, killing hundreds of thousands of people and underscoring its position as one of the leading candidates in the race to fight the virus that crippled the world economy.

“If clinical trials generate cases rapidly, that data may be available in front of this year’s regulators,” said Andrew Pollard, director of the Oxford Vaccine Group, on a large late-stage trial on BBC Radio. I reported the progress. ..

“And there will be a process they go through to fully evaluate the data.”

The trial hit the headline earlier this week when the Financial Times reported that the Trump administration was considering an immediate pursuit of the vaccine for use in the United States prior to the November 3 presidential election.

One option being considered would include the US Food and Drug Administration’s “FDA” granting an “emergency license” to potential vaccines in October, the newspaper said.

Mr Pollard said the emergency licensing process is well established. “But that still includes having carefully done data… and is proof that it really works,” he said.

The Financial Times reported that Washington is considering urgent approval for a vaccine based on a small study of about 10,000 UK people.

Pollard, a lead investigator in global clinical trials for vaccine candidates, said AstraZeneca will provide data to regulators if scientists are satisfied.

He said Oxford University has enrolled approximately 20,000 people in the UK, Brazil and South Africa trials, and AstraZeneca is leading the study of 30,000 people in the US.

“The size of the case is not yet an issue. What we need is enough cases to occur during the trial’s observation period,” Pollard said.

Additional report by Mark Jones. Edited by Kate Holton and Mark Potter


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