Clearing the air around UK pharma major AstraZeneca putting a pause on the COVID-19 trials after a UK patient reported illness, Serum Institute CEO Adar Poonawalla has said the Indian trials, which are being conducted on the same Oxford vaccine, have not been stopped. "Trials have not been stopped yet...and there's nothing to worry about. It's related to some unrelated issue (neurological issue) with a patient in the UK and we have to wait for AstraZeneca to explain what happened but this is not vaccine-related. So, nothing to really worry about, and the India trials are also going on, and it has not been stopped," Poonawalla told BusinessToday.In.

British-Swedish biopharmaceutical firm AstraZeneca PLC, which is working with a team of the University of Oxford, temporarily paused the clinical trial of its coronavirus vaccine in the UK after one of the volunteers developed an "unexplained" illness. AstraZeneca and the Oxford University team is a frontrunner in the global race for coronavirus vaccine.

A spokesperson of AstraZeneca described the pause as a "routine action", which has to happen whenever there is a potentially unexplained illness in one of the trials.

The development comes a day after after AstraZeneca and eight other drugmakers vowed to uphold the highest ethical and scientific standards in developing their vaccines. A New York Times report had earlier cited a person familiar with trials that one UK participant had 'transverse myelitis', an inflammatory syndrome in the spinal cord which is normally caused by viral infections. It's still not clear yet if this was in direct response to the vaccine or due to some other health related issue.

Without divulging other details regarding the illness in the participant, the company said it is expediting the "standard review process" in hope that it will not cause any extreme delays. AstraZeneca also did not comment on when the last stage trials are expected to resume.

Notably, clinical development trials of AZD1222 (better known as the Oxford COVID-19 vaccine) are being conducted globally, with late-stage clinical trials ongoing in the UK, Brazil and South Africa and more trials planned to start in Japan and Russia. More than 50,000 participants have been enrolled to undergo final phase trials with the COVID-19 vaccine, including about 30,000 in the US, and more in India, Brazil and the UK.

In India, Serum Institute of India is the partner of the University of Oxford's Jenner Institute's to conduct the trials. SII is currently progressing about 17 trial sites, each with over 1,000 patients.

AstraZeneca is one of nine companies currently in late-stage Phase 3 trials for their vaccine candidates. The vaccine uses an adenovirus that carries a gene for one of the proteins in SARS-CoV-2, the virus that causes COVID-19. The adenovirus is designed to induce the immune system to generate a protective response against SARS-2.

Findings related to AstraZeneca trials

The interim results of the Phase 1 and 2 trials had shown that the Oxford vaccine generated "robust immune responses" against the COVID-19 virus in all evaluated participants.

According to The Lancet report, the Phase 1/2 of AstraZeneca had reported that about 60 per cent of 1,000 participants given the vaccine experienced side effects. All of the side effects, which included fever, headaches, muscle pain, and injection site reactions, were deemed mild or moderate. However, all of the side effects reported also subsided during the course of the study.