London, United Kingdom / Tue, August 25, 2020 / 07:32 pm

Trial data for the potential coronavirus vaccine from the University of Oxford and AstraZeneca could be submitted to regulators this year but corners can not be cut to speed up approval for emergency use, a scientist leading the trials said on Tuesday. During its first clinical trials, the Oxford vaccine developed an immune response, underscoring its role as one of the leading candidates in the race to combat a virus that has caused hundreds of thousands of deaths and disrupted the global economy.

“It’s only possible that if the cases increase quickly in clinical trials, this year we could have that evidence in front of regulators,” Andrew Pollard, director of the Oxford Vaccine Group , told BBC Radio of success in broader, late stage trials.

The trials hit the headlines earlier this week when the Financial Times claimed that the Trump administration was considering fast-tracking the vaccine for use in the United States prior to the presidential election on November 3. One choice being discussed will include the US Food and Drug Administration (FDA) approving the proposed vaccine in October with “emergency use authorization,” the newspaper said. Pollard claimed that the mechanism for approving emergency use was well known. “But it also requires the careful conduct of data … and evidence that it actually works,” he said

The Financial Times claimed Washington was considering basing the vaccine’s emergency approval on just a limited UK sample of around 10,000 people. Pollard, the vaccine candidate’s chief investigator of the global clinical trials, said AstraZeneca would take the data to regulators until the scientists are pleased with it. He said Oxford had recruited around 20,000 participants in trials around Britain, Brazil and South Africa, with AstraZeneca conducting a 30,000-person trial in the US. “The size of the trials is not yet the issue here, what you need is to have enough cases accruing in the trials during the observation period,” Pollard said.

Leave a Comment

Your email address will not be published. Required fields are marked *

Scroll to Top