Moscow, Sept 9: Safety is a top priority in vaccine clinical trials and temporary suspensions are not unusual, the World Health Organization (WHO) told Sputnik after the AstraZeneca pharmaceutical, one of frontrunners in the COVID-19 vaccine race, paused its clinical trials over an unexplained illness.
Earlier on Wednesday, AstraZeneca announced it voluntarily paused its vaccine clinical trials globally to investigate an unexplained illness in a UK participant, noting that it was a routine action.
“Safety is the primary focus for vaccine clinical trials. When a potentially unexplained illness occurs in a trial participant, which may or may not be related to the vaccine being evaluated, it is rigorous, routine practice to investigate. Temporary suspensions of vaccine clinical trials are not unusual while an evaluation takes place,” the UN health agency said in an email.
WHO noted that it welcomed the fact that the vaccine developers were following standard guidelines to ensure the scientific integrity of the vaccine clinical trials.
“WHO continues to recommend strict adherence to established testing protocols in all vaccine trials to ensure the safety of volunteers, and the eventual safety and efficacy of vaccines,” it added.
The AstraZeneca vaccine is being developed in partnership with the Oxford University’s Jenner Institute and the Oxford Vaccine Group and is in its phase 3 trials, which is the final stage before safety and efficacy data can be submitted to health regulators for approval.
The pharmaceutical company AstraZeneca halted large, late-stage global trials of its coronavirus vaccine on Tuesday because of a serious suspected adverse reaction in a participant, the company said. It is not yet known whether the reaction was directly caused by the company’s vaccine or was coincidental.
The pause, which was first reported by STAT, will allow AstraZeneca, a British-Swedish company, to conduct a safety review and investigate whether the vaccine caused the illness. How long the hold will last is unclear. Drug companies are racing to complete a coronavirus vaccine that could bring an end to a pandemic that has already claimed more than 8,90,000 lives globally. AstraZeneca is a front-runner, with late-stage clinical trials underway around the world, and has said it hoped to have a vaccine ready before the end of the year. If the cause of the reaction turns out to be related to the vaccine, those efforts could be derailed.Late-stage vaccine testing remains crucial, as large trials can turn up rare but serious side effects that would surface only if many thousands of people received a vaccine.
Meanwhile, AstraZeneca may resume clinical trials of its COVID-19 vaccine early next week, after suspending it as a precaution, the Financial Times reported Wednesday, citing “people familiar with the matter.”
The UK-Swedish company reportedly froze the trials after discovering that one participant was sick with transverse myelitis. This condition results in inflammation of parts of the spinal cord and may be caused by infections, among other things.