AstraZeneca Plc has paused a late-stage trial of one of the leading Covid-19 vaccine candidates due to a suspected serious adverse reaction in a study participant, health news website Stat reported on Tuesday.
It quoted an AstraZeneca spokesperson as saying in a statement that the "standard review process triggered a pause in 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 various sites, including the UK, where the adverse event was reported.
Recently, Beximco Pharmaceuticals Ltd announced that it would invest with Serum Institute of India (SII) for the development of the Oxford/AstraZeneca vaccine (AZD1222).
However, after the suspension of the vaccine trial, no decision has been made yet.
Dr Shamsul Hoque, a member of the government's Covid-19 vaccine committee and director at the health directorate's Maternal Nutrition and Child Healthcare Programme, told The Business Standard they came to know about the problem of the Oxford vaccine trial on Wednesday.
e said no decision had been made yet in this regard, and the health ministry would decide which vaccine trial would be held in the country.
Professor Nazrul Islam, noted virologist and a member of the national technical advisory committee on Covid-19, told The Business Standard there would be a thorough investigation into the illness of a person after receiving the Oxford vaccine. "Only then can a decision be made. We have to wait for that."
The nature of the case and when it happened were not detailed, although the participant is expected to recover, according to Stat.
It said the suspension of the trial has impacted other AstraZeneca vaccine trials as well as clinical trials being conducted by other vaccine makers, which are looking for signs of similar reactions.
The AstraZeneca spokesperson's statement said that illnesses would happen by chance in large trials but those must be independently reviewed and carefully checked.
Stat reported that serious adverse reactions vary and can include issues that require hospitalisation, life-threatening illness and death.
AstraZeneca did not immediately respond to a request for comment, it added.
Nine leading US 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.
According to the World Health Organisation, there are about 180 vaccines being developed in the world. However, so far, no vaccine has been able to complete the third-stage trial.
Meanwhile, China and Russia have begun applying locally manufactured vaccines to key workers in their countries. These vaccines are listed as being tested by the World Health Organisation.
On August 27, the Bangladesh government gave the go-ahead for human trials of the Covid-19 vaccine developed by Chinese company Sinovac Biotech.
The International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b) and Sinovac will jointly conduct the trial.