AstraZeneca Plc has put a hold on the late-stage trial of its highly-anticipated COVID-19 vaccine candidate after a suspected serious adverse reaction in a study participant, health news website Stat News reported on Tuesday.
It quoted an AstraZeneca spokesperson as saying in a statement that the “standard review process triggered a pause to vaccination to allow review of safety data.”
The study is testing a COVID-19 vaccine being developed by AstraZeneca and University of Oxford researchers at sites including the United States and the United Kingdom, where the adverse event was reported.
The nature of the safety issue and when it happened were not immediately known, although the participant is expected to recover, according to Stat News.
The report said suspension of the trial was having an impact on other AstraZeneca vaccine trials - as well as on clinical trials being conducted by other vaccine makers.
Nine leading U.S. and European vaccine developers pledged on Tuesday to uphold scientific safety and efficacy standards for their experimental vaccines despite the urgency to contain the coronavirus pandemic.
The companies, including AstraZeneca, Pfizer Inc and GlaxoSmithKline, issued what they called a “historic pledge” after a rise in concern that safety standards might slip in the face of political pressure to rush out a vaccine.
The companies said they would “uphold the integrity of the scientific process as they work towards potential global regulatory filings and approvals of the first COVID-19 vaccines.”.
The other signatories were Johnson & Johnson, Merck & Co, Moderna Inc, Novavax Inc, Sanofi and BioNTech.