The World Health Organization (WHO) reacted to AstraZeneca’s decision to postpone the phase three trial of its coronavirus vaccine candidate.
The agency said that its decision, which is based on safety reasons, only suggests that vaccine development is “not always a fast and a straight road.”
AstraZeneca’s announcement to delay the phase three trial of its experimental Covid-19 vaccine came after a participant manifested signs of a serious adverse reaction, which was first revealed by STAT News. AstraZeneca clarified that the delay was a “routine action” whenever there is an uncertain condition under investigation.
According to WHO Chief Scientist Dr. Soumya Swaminathan, there is no need to be “overly discouraged” by the news since “these things happen.”
“There’s a protocol for what you do when something happens,” Swaminathan told the press. “If it’s a mild side effect, there are things to be done. If it’s major as it was in this case — it was a severe side event — and therefore the trial was halted. And again this is normal procedure. This is good clinical practice because safety is of the upmost, highest priority in any clinical trial.”
The WHO said that it will wait for more data given by a data and safety monitoring board, which will assess how the trials will proceed, Swaminathan said.
“I think this is a good … perhaps a wake-up call or a lesson for everyone to recognize the fact that there are ups and downs in research, there are ups and downs in clinical development and we have to be prepared for those,” she said.
“We hope that things will be able to move on but again it depends. It depends on a lot, and we have to wait to see the details of what actually happened,” she noted.
“It could be that we see some results end of the year, it could be early next year, but that’s the time frame in which we start seeing the results. There’s no way of predicting currently which ones are going to be effective,” Swaminathan said.
Dr. Mike Ryan, executive director of the WHO’s health emergency program, noted that the development and approval of a coronavirus vaccine is “not a race between companies (and) it’s not a race between countries.”
“This is a race against time, it’s a race against the virus, it’s a race to save lives,” he said. “But let’s not bet on any horses until we get to the end of this race.”
Suspending trials is “common”
AstraZeneca CEO Pascal Soriot said that the results of the clinical trials for their experimental coronavirus vaccine may come out before the year ends.
The AstraZeneca CEO said that suspending a trial is common, and the only difference is that the world was watching.
In a statement, the drugmaker said: “As part of the ongoing randomized, controlled global trials of the Oxford coronavirus vaccine, our standard review process triggered a pause to vaccination to allow the review of safety data.”
AstraZeneca’s vaccine, dubbed the Oxford vaccine because it was developed in partnership with the University of Oxford, is being tested in various parts of the world, including the US, the UK, Latin America, Asia, Europe and Africa.