AstraZeneca building in Luton, Great Britain.
Tim Ireland | Xinhua News Agency | fake images
Phase three trials for AstraZeneca’s coronavirus vaccine have resumed in the UK after they were halted earlier this week over safety concerns, the company announced on Saturday.
AstraZeneca said it received confirmation from the UK Medicines Health Regulatory Authority that it was safe to resume clinical trials. The company declined to release medical information about the trial lull, but indicated earlier this week that a potentially unexplained illness was being investigated.
The company said that “the standard review process resulted in a voluntary pause” in all global trials on Sept. 6 so that independent committees and internal regulators could review safety data. While trials can now resume in the UK, the status of trials elsewhere remains unclear.
“The Company will continue to work with health authorities around the world and guide itself on when other clinical trials can be resumed to provide the vaccine on a comprehensive, equitable and non-profit basis during this pandemic,” AstraZeneca said in a statement.
Oxford University, which developed the vaccine in partnership with AstraZeneca, said on Saturday that some 18,000 people have received the vaccine in trials so far.
“In large trials like this one, some participants are expected to feel unwell and each case must be carefully evaluated to ensure a careful assessment of safety,” Oxford said in a statement.
STAT News reported earlier this week that AstraZeneca CEO Pascal Soriot said during a private conference call that the “potentially unexplained illness” occurred in a woman in the UK who displayed neurological symptoms consistent with a spinal inflammatory disorder called myelitis. transverse. The call was established by investment bank JP Morgan, STAT reported.
In the same call, Soriot also confirmed that AstraZeneca’s clinical trials had been stopped once before in July after a participant experienced neurological symptoms, but the disease was found to be unrelated to the experimental vaccine.
AstraZeneca’s potential coronavirus vaccine, called AZD1222, is among the pioneers in the race toward a safe and effective vaccine that could make a dent in the global pandemic. The company launched its last-stage tests in late August. It is one of at least three candidate vaccines, along with those from Pfizer and Moderna, in late-stage trials.
Officials from the World Health Organization have previously hailed AstraZeneca’s vaccine candidate as one of the most promising in development today. On Thursday, WHO chief scientist Dr. Soumya Swaminathan said there is no need to be “too disheartened” by the news of the trial pause, adding that “these things happen.”
“I think this is good … maybe a wake-up call or lesson for everyone to recognize the fact that there are ups and downs in research, ups and downs in clinical development and we have to be prepared for those,” she said.
The United States has invested more than $ 10 billion in six efforts to bring a coronavirus vaccine to market. On May 21, the United States announced that it would invest $ 1.2 billion in the AstraZeneca effort in exchange for at least 300 million doses if the candidate proved safe and effective enough.
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