Clearing the air around British-Swedish biopharmaceutical major AstraZeneca putting a pause on the COVID-19 trials after a UK patient reported illness, Serum Institute CEO Adar Poonawalla told BusinessToday.In the Indian trials, which are being conducted on the same Oxford vaccine, have not been stopped. "The Indian trials have not been stopped yet...and there's nothing to worry about. It's some unrelated issue that happened... neurological issue with a patient in the UK and we have to wait for AstraZeneca to explain what happened there but this is not vaccine-related. So, nothing to really worry about, and the India trials are also going on, that has not been stopped," Poonawalla said.
AstraZeneca PLC, which is working with a team of the University of Oxford, today decided to temporarily pause the clinical trials of its coronavirus vaccine after one of the volunteers in the UK developed an "unexplained" illness. The candidate vaccine developed by Oxford University and AstraZeneca is one of the frontrunners in the race to find the coronavirus vaccine. Earlier, an AstraZeneca spokesperson described the pause as a "routine action", which must be done as part of the process in case of an "unexplained illness" in any of the participants.
The company halted the stage-3 trials a day after nine drug makers, including AstraZeneca itself vowed to uphold the "highest ethical and scientific standards" in developing their vaccines against the virus.
Without divulging other details regarding the illness in the participant, the company said it is expediting the "standard review process" and hoped it will not cause any further delay in the trials. The New York Times, however, published a source saying the UK participant concerned had suffered 'transverse myelitis', which is an inflammatory syndrome in the spinal cord. The health problem is caused by viral infections. However, it's yet to be established whether this was in direct response to the vaccine or due to other health-related issue.
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 in Japan and Russia. More than 50,000 participants have been enrolled for the final phase of trials in the US, Brazil, the UK and India.
In India, Cyrus Poonawalla-led Serum Institute of India (SII) is the partner of the University of Oxford's Jenner Institute to conduct vaccine trials. The domestic vaccine major is right now conducting phase two/three trial across 17 sites in the country.
The Oxford vaccine has been described by the World Health Organisation (WHO) as the world's leading candidate and the most advanced in terms of development. However, temporary pausing of trials at such a crucial stage could delay the prospects for its approval this year.
Besides AstraZeneca, there are nine companies that are currently undertaking the late-stage Phase 3 trials for their vaccine candidates.
Findings related to AstraZeneca trials
The interim results of Phase 1 and 2 trials had shown that the Oxford vaccine generated "robust immune responses" against the COVID-19 virus in all evaluated participants.
However, the Phase 1/2 of AstraZeneca also reported that about 60 per cent of 1,000 participants given the vaccine experienced side effects, The Lancet report said. All effects, which included fever, headaches, muscle pain, and injection site reactions, were deemed mild or moderate and subsided during the course of the study only.
How does the Oxford vaccine work
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.
SII's big plan for India
If trial process goes smoothly in India, Serum Institute's COVID-19 vaccine candidate, named 'Covishield', would be commercialised in November. A Serum Institute of India (SII) top official had told BusinessToday.In on August 23 that the government had given the company a 'special manufacturing priority licence' and fast-tracked the trial protocol processes to get the trials completed in 58 days.
The company had started trials among 1,600 volunteers at 17 centres, each with about 100 volunteers, on August 22. However, SII had declined to confirm the time when the vaccine will be available in the market.
Serum Institute has promised to provide 400 million doses to low-and middle-income countries by 2020, and 1 billion doses in total. It aims to make over 6 crore doses per month of its vaccine candidate, which will be increased to 10 crore per month by April 2021. It has also partnered with many countries and organisations like The Bill & Melinda Gates Foundation to produce and fund the vaccine.