AstraZeneca ‘still on track’ to submit Covid vaccine data before end of year

AstraZeneca ‘still on track’ to submit Covid vaccine data before end of year

AstraZeneca is still on target to submit data on its Covid-19 vaccine candidate to regulators before the end of the year, providing it can restart trials halted temporarily after a participant fell ill, the company’s chief executive has said.

Talking at an event organised by news organisation Tortoise, Pascal Soriot said that if the safety monitoring committee examining a possible link between the illness and the vaccine gave the go-ahead to resume, “I still think we are on track for having a set of data we would submit before the end of the year and then it depends how fast regulators will review it and give approval”.

A vaccine “by the end of this year, early next year” was still possible, he added. As well as the AstraZeneca-Oxford university vaccine, two others — manufactured by Pfizer and Moderna — were “also advancing quite quickly”, he said.

But many questions remained, he indicated, including for how long a vaccination would provide protection — he suggested the range could be from three months to two years — and whether it would eliminate the virus entirely from the respiratory tract, to the point where a vaccinated person who caught Covid-19 would not be infectious.

Mr Soriot played down the significance of the trial pause, saying it was “very common” in vaccine development. Highlighting the exceptional levels of scrutiny of the development of a Covid-19 vaccine, he said: “The difference with other vaccine trials is the whole world is not watching them.”

People with knowledge of the events have said that the condition developed by the trial participant was transverse myelitis, an inflammation of the spinal cord that is known to be a very rare complication of vaccination. But Mr Soriot said that diagnosis was not yet certain.

“A full work-up on this person is being done. The physicians and experts will analyse this, submit it to the independent safety committee and the safety committee will tell us what to do,” he said.

“We hope that in the end the sequence will be, as it often is, that the safety committee tells you you can restart the study. They may also reach a different conclusion and we have to accept that.”

Mr Soriot also responded to questions about why the information on a possible adverse participant reaction was disclosed at a private event organised by JPMorgan.

He said the event was part of a long-planned series of interviews with chief executives and that an earlier episode of a trial participant being taken ill that he also mentioned on the call had already been disclosed. “The information about the first patient was public before I mentioned it,” he said.

Mr Soriot also expressed confidence that rare reactions linked to the vaccine would be picked up during the trials, which would eventually expand to include 50,000 to 60,000 participants, he said.

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