The vaccine for COVID-19 being developed by Oxford University could be submitted to regulators as early as this year, a professor said.
“But it is also just possible that if the cases accrue rapidly in the clinical trials that we could have that data to put before regulators this year, and then there would be a process that they go through in order to make a full assessment of the data,” Professor Andrew Pollard told the BBC.
But the priority is to “demonstrate a vaccine works and is safe, and then to go through the processes of regulators looking at that very carefully to make sure everything’s been done correctly.”
Confusion on the US front
On Monday, the Financial Times reported Donald Trump is looking to fast-track the UK vaccine before the November elections.
The deep state, or whoever, over at the FDA is making it very difficult for drug companies to get people in order to test the vaccines and therapeutics. Obviously, they are hoping to delay the answer until after November 3rd. Must focus on speed, and saving lives! @SteveFDA
— Donald J. Trump (@realDonaldTrump) August 22, 2020
The White House would be mulling over an emergency use authorisation to be awarded in October based on a study conducted on 1,000 people in the UK.
Such a decision could be met with hostility by top health officials: earlier this week, Peter Marks, the director of the agency’s Center for Biologics Evaluation and Research, warned he would quit if the government pushes for approval before tests are completed.
However, the FTSE 100 firm told The Guardian it has not discussed this option with the US authorities and “it would be premature to speculate on that possibility”.
The UK government is claiming first access to the formulation if it is approved, having signed a deal for 100mln doses.
Published at Tue, 25 Aug 2020 11:14:00 +0000-Oxford coronavirus vaccine potentially submitted to regulator this year, says scientist