Covid-19: ‘possible’ Oxford vaccine data will be put before regulators this year

Trials of the Oxford coronavirus vaccine may have gathered enough data to show whether it works and is safe by the end of the year – but it will then need to go through the regulatory process, scientists say.

Prof Andrew Pollard, the director of the Oxford Vaccine Group, said it is “just possible” that there may be enough clinical trial data on Oxford University’s Covid-19 vaccine to put before the regulators this year.

Prof Chris Whitty, England’s chief medical officer, has said a vaccine may not be ready until next winter. Pollard suggested they were hoping to go faster.

“I think that Chris Whitty is quite rightly being cautious, that it could take as long as that to first of all 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,” Pollard told BBC Radio 4’s Today programme.

He said they would want to have evidence that the vaccine actually works before going to any regulator, including in the US where Donald Trump has said he could seek emergency approval for a vaccine such as the Oxford one in October.

“Emergency use authorisations are well established by regulators both in the United States and in Europe; in fact, you may be aware just this week, the FDA [the US Food and Drug Administration] has granted emergency use authorisation for plasma therapy,” he said.

“So the process of going through emergency use authorisation in an emergency is well established but it still involves having carefully conducted data, just as we are collecting information about the vaccines in clinical trials that are conducted rigorously and evidence that it actually works.

“And so, for our suite of trials that we’re running from Oxford, we would expect to first of all have safety data and then evidence that the vaccine actually works.

“And before anything were to progress from there and of course it’d be AstraZeneca who would then take that forward to regulators.”

AstraZeneca, the pharmaceutical company that is Oxford’s partner in the vaccine development, is separately trialling a new drug that it hopes will prevent and treat Covid-19, with the first volunteers already receiving doses.

The company said the drug, known as AZD7442, is a combination of two monoclonal antibodies.

AstraZeneca said the trial, which will include up to 48 healthy volunteers in the UK aged 18 to 55, will be focused on safety, and the body’s reaction to the drug and how it processes it.

Sir Mene Pangalos, the executive vice-president of biopharmaceuticals research and development at AstraZeneca, said: “This trial is an important milestone in the development of our monoclonal antibody combination to prevent or treat Covid-19.