AstraZeneca CEO Pascal Soriot said that if the trial is allowed to resume shortly, the company should still be ready to submit its vaccine to regulators for approval before the end of the year, and widespread distribution will begin early 2021.
AstraZeneca, which is developing a vaccine with researchers at Oxford University, is seen as pioneering the race to deliver a Covid-19 inoculation that could help end the global coronavirus pandemic.
Pfizer CEO Albert Bourla told Fortune on Wednesday that he remains optimistic that there will be enough clinical trial data to know if the vaccine his company is developing is effective by the end of October.
Another vaccine, from the American biotech company Moderna, is also undergoing large-scale clinical trials in the US and may be ready for possible regulatory approval this year.
Several different vaccines are likely needed to immunize billions of people around the world.
Soriot, speaking at an event organized by British publication Tortoise Media, said he had little idea whether the trial would be allowed to resume or how long the hiatus would last. Those decisions are left to an independent review board, made up of experts from different disciplines, who investigates whether a serious medical condition experienced by one of the trial participants in the UK is likely to be related to vaccination.
Not the first time
Soriot said this diagnosis has not been confirmed. The company said Wednesday that vaccine trials had also stopped once before, in early summer, after one of the trial volunteers developed neurological symptoms. These were determined to be related to an undiagnosed case of multiple sclerosis unrelated to vaccination, and the trials were allowed to resume, the company said.
The CEO said such testing breaks were the norm, not the exception, in clinical trials. He said this was especially true for vaccines, which are tested in healthy people and therefore have a higher safety threshold for adverse side effects than drugs designed to treat people who are already sick.
Lives over profits
Several governments and international funding agencies have provided AstraZeneca with billions of dollars to fund this effort. The company has pledged not to benefit from the vaccine until the end of the coronavirus pandemic is declared.
The hiatus was only made public because health news site Stat News published the story on Tuesday. It’s a scientific process. Nothing is hidden, but you work with professionals, people with experience.” He said that as soon as the clinical trial was stopped, Oxford and AstraZeneca informed the appropriate government regulatory agencies in each country where the trials were taking place.
In Europe, several governments have compensated companies for legal costs.
Soriot said that in a pandemic, when billions of people must receive a vaccine, such rules were necessary to protect companies from being overwhelmed by potentially frivolous lawsuits. “Otherwise no one would develop a vaccine,” he said.
