Frontrunner Oxford vaccine for Covid-19 cleared for advanced trial in India

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.

Written by: Prabha Raghavan, Anuradha Mascarenhas

5 min readNew Delhi, PuneUpdated: Aug 4, 2020 01:50 PM IST

coronavirus, coronavirus vaccine, coronavirus vaccine update, covid 19, covid 19 vaccine, covid 19 vaccine update, coronavirus vaccine covaxin, covid 19 vaccine covaxin, covaxin vaccine, oxford vaccine, oxford covid 19 vaccine, oxford coronavirus vaccine, moderna, moderna coronavirus vaccine, moderna vaccine, moderna covid 19 vaccine, india moderna vaccine, india covid 19 vaccine, corona vaccine

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. (Representational image)

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.

Explained

Hope and caution

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.

Story continues below this ad

Explained: The significance of having the Oxford phase-III vaccine trials in India

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.

Story continues below this ad

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.

Story continues below this ad

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.

Anuradha Mascarenhas

Anuradha Mascarenhas is a Senior Editor at The Indian Express, based in Pune. With a career spanning three decades, she is one of the most respected voices in Indian journalism regarding healthcare, science and environment and research developments. She also takes a keen interest in covering women's issues . Professional Background Education: A gold medalist in Communication and Journalism from Savitribai Phule Pune University and a Master’s degree in Literature. Author: She authored the biography At The Wheel Of Research, which chronicles the life and work of Dr. Soumya Swaminathan, the former Chief Scientist at the WHO. Key Focus: She combines scientific accuracy with storytelling, translating complex medical research into compelling public and human-interest narratives. Awards and Recognition Anuradha has won several awards including the Press Council of India's national award for excellence in journalism under the gender based reporting category in 2019 and the Laadli Media award (gender sensitivity -2024). A recipient of the Lokmat journalism award (gender category-2022), she was also shortlisted for the RedInk awards for excellence in journalism-2021. Her debut book At The Wheel Of Research, an exclusive biography of Dr Soumya Swaminathan the inaugural chief scientist of World Health Organisation was also nominated in the Popular Choice Category of JK Paper AUTHER awards. She has also secured competitive fellowships including the Laadli Media Fellowship (2022), the Survivors Against TB – New Research in TB Media Fellowship (2023) and is part of the prestigious 2025 India Cohort of the WomenLift Health Leadership Journey.” Recent Notable Articles (Late 2025) 1. Cancer & Specialized Medical Care "Tata Memorial finds way to kill drug-resistant cancer cells" (Nov 26, 2025): Reporting on a breakthrough for triple-negative breast cancer, one of the most aggressive forms of the disease. Discipline, diet and purpose; How a 97-year-old professor defies ageing'' (Nov 15, 2025) Report about Prof Gururaj Mutalik, the first Head of Department at Pune's B J Government Medical College who at 97 credits his longevity to healthy habits and a strong sense of purpose. 2. Environmental Health (The "Breathless Pune" Series) Long-term exposure even to 'moderate' air leads to chronic heart, lung, kidney issues" (Nov 26, 2025): Part of an investigative series highlighting that even "safe" pollution levels are damaging to vital organs. "For every 10 µg/m3 increase in PM2.5 level, there was 6-8% jump in medicine sales" (Nov 23, 2025): Using commercial data to prove the direct link between air quality and respiratory illnesses in Pune. 3. Lifestyle & Wellness News "They didn't let cancer, diabetes and heart disease stop them from travelling" (Dec 22, 2025): A collaborative piece featuring survivors who share practical tips for traveling with chronic conditions. At 17, his BP shot up to 200/120 mmHG; Lancet study flags why child and teen hypertension doubled between 2000 and 2020'' (Nov 12,2025)--A report that focusses on 17-year-old-boy's hypertensive crisis and reflects the rising global trend of high blood pressure among children and adolescents. 4. Scientific Recognition & Infrastructure For promoting sci-comm, gender diversity: IUCAA woman prof highlighted in Nature" (Nov 25, 2025): Covering the global recognition of Indian women scientists in gender studies and physics. Pune researchers find a spiral galaxy like the Milky Way from early universe'' (December 3, 2025)- A report on how Indian researchers discovered a massive galaxy that existed when the universe was just 1.5 billion years old , one of the earliest to have been observed so far. Signature Beat: Health, Science & Women in Leadership Anuradha is known for her COVID-19 reportage, where she was one of the first journalists to provide detailed insights into the Covishield and Covaxin trials. She has a dedicated interest in gender diversity in health and science, often profiling women researchers who are breaking the "leaky pipeline" in STEM fields. Her writing style is scrupulous, often featuring interviews with top-tier scientists and health experts from various institutions. ... Read More

Stay updated with the latest - Click here to follow us on Instagram

Loading Recommendations...

May 16: Latest News

Live Blog