India’s top drug regulator has approved the application of Serum Institute of India (SII) to conduct late-stage human trials in the country for the Oxford-AstraZeneca Covid-19 vaccine candidate.
Researchers in Oxford announced last month that their candidate had triggered an immune response in humans against the novel coronavirus in early trials. The Oxford candidate is considered to be one of the global frontrunners for the Covid-19 vaccine, along with candidates being developed by Moderna with the US National Institute of Allergy and Infectious Diseases, and Pfizer with BioNTech.
SII, the world’s largest maker of vaccines, has a tie-up with AstraZeneca, the Swedish-British pharma giant, to manufacture the Covid-19 vaccine for low- and middle-income countries. The vaccine is already being tested in the UK, South Africa and Brazil, where participants are being administered two doses nearly a month apart.
The clearance from the Drugs Controller General of India (DCGI) who heads the Central Drugs Standard Control Organisation (CDSCO) came after an expert committee on Friday accepted a revised proposal submitted by SII.
The Institute can now start larger phase II/III trials of the candidate in India, ahead of Bharat Biotech’s Covaxin and Zydus Cadila’s ZyCov-D, other candidates that are still in phase I/II trials. The trials for Covishield – the name given to the candidate technically referred to as AZD1222 or ChAdOx 1 nCoV-19 – will have around 1,600 participants at 18-odd sites across the country, a senior government official had told The Indian Express earlier.
The Oxford vaccine offers one of the most promising weapons against the virus. Despite the promise, it is important to remember though, that the road ahead remains uncertain, and that the vaccine is still only a candidate.
“This (the DCGI clearance) will hasten the development of the Covid-19 vaccine,” the Union Ministry of Health and Family Welfare said on Monday.
The trial sites will likely include those identified by the National Biopharma Mission and Grand Challenges India Programme, a partnership between the government and the Bill and Melinda Gates Foundation. These include the INCLEN Trust International in Palwal, Haryana, KEM Hospital in Pune, Society for Health Allied Research and Education in Hyderabad, National Institute of Epidemiology in Chennai, and Christian Medical College in Vellore.
Department of Biotechnology (DBT) secretary Dr Renu Swarup had earlier told The Indian Express that these sites had been readied as part of India’s preparations for final stage trials for the Oxford vaccine candidate.
Other trial sites may include the All India Institutes of Medical Sciences (AIIMS) in Delhi and Jodhpur; BJ Medical College and Sassoon General Hospital, Jehangir Hospital, and Bharati Hospital in Pune; Rajendra Memorial Research Institute of Medical Sciences (RMRIMS) in Patna; Mysore’s JSS Academy of Higher Education and Research; Nehru Hospital in Gorakhpur; Andhra Medical College in Visakhapatnam; and the Post Graduate Institute of Medical Education and Research (PGIMER) in Chandigarh.
It was not immediately clear when SII planned to begin the trials. Queries sent to the firm remained unanswered until press time on Monday. SII CEO Adar Poonawalla had told The Indian Express earlier that trials would begin this month after regulatory approvals were received and, if all went well, the vaccine could be out by the end of the year.
Dr Sanjay Lalwani, medical director at Pune’s Bharati Hospital, said it would take at least a week to get the ethics committee’s approval before the trials could start. Pathik Divate, director of Jehangir Clinical Development Centre, said their ethics committee would meet soon to check and approve the revised protocol.
Dr Ashish Bawdekar, principal investigator at Pune’s KEM Hospital, said each clinical trial site could get around 200 participants, but at least 160 would be enrolled. It could be two weeks before the trial starts, he said.
On Friday, the CDSCO’s Subject Expert Committee (SEC) for Covid-19 related therapies recommended that authorisation to market Covishield should be granted after considering clinical data generated from both the India and international trials. Trial participants in India should be given paracetamol afterward if required.
The Indian Express had reported on Friday that the SEC had recommended that CDSCO grant permission to SII to conduct phase II/III trials here after the firm had submitted a revised protocol. DCGI Dr V G Somani is learnt to have approved the proposal late on Sunday.
One of the reasons why SII had to revise its protocol was that the SEC felt the firm needed to take a “pan India” approach while considering trial sites. While it is unclear how many trial sites were proposed by SII in its earlier protocol, Poonawalla had earlier told The Indian Express that it intended to conduct the trials in Pune and Mumbai only.
Following suggestions to make eight changes, SII had speedily amended its proposal and resubmitted it for consideration within the course of a day, it is learnt.
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