No safety concerns related to the Covishield vaccine trial: Serum chief

Adar Poonawalla, CEO of SII said preliminary results have shown that there are no immediate concerns pertaining to the Covishield vaccine. A total of 1600 people have been administered the first dose across 17 sites, and each participant is being followed up for six months to ensure safety of the vaccine.

3 min readPuneNov 5, 2020 11:07 AM IST

Serum Institute of India, Serum Institute of India CEO, Adar Poonawalla

CEO of Serum Institute of India, Adar Poonawalla.

The phase 2/3 human clinical trial for a vaccine against coronavirus has been running smoothly in the country with no safety concerns so far, and the entire recruitment process of 1,600 volunteers for the Covishield vaccine trial has been completed across 17 trial sites by October 31, according to the Serum Institute of India (SII).

Serum Institute, the world’s largest vaccine manufacturer by the number of doses produced, is working on several candidates for a vaccine against Covid-19, including one from AstraZeneca-Oxford University as well as developing its own.

Stating that there are no safety concerns related to the Covishield vaccine trial, SII’s CEO, Adar Poonawalla, said, “It is too early to comment on the vaccine’s availability, or the (chances of) trial completion by December 2020.”

There are more than 83 lakh reported cases of Covid-19 and over 1.23 lakh deaths recorded across the country until now, and the rollout of the vaccine may take a few months.

Poonawalla said: “Preliminary results have shown that there are no immediate concerns pertaining to the Covishield vaccine. So far, thousands of people have had it in India and abroad with no safety concerns.”

Poonawalla said prioritising the vaccine’s distribution lies with government agencies and the Health Ministry, but it is “likely” that frontline workers and young and old adults will be on the priority list.

He said that based on some initial reports of the trials in the UK, the AstraZeneca-Oxford vaccine has shown immune response. “However, it is too early and is dependent on trial’s success in proving the vaccine immunogenic and efficacious,” he said in an email interview with The Indian Express.

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From the first volunteer for the Covishield trial enrolled on August 24 to a total of 1,600 recruited by October 31, each person has been administered the first dose across 17 sites, and each participant is being followed up for six months to ensure safety of the vaccine.

There are a few sites that are part of the immunogenicity cohort where participants are being randomly assigned in a 3:1 ratio to receive either Covishield or Oxford/AZ-ChAdOx1 nCov 19, respectively. The remaining 1,200 participants from the safety cohort are being randomly assigned in a 3:1 ratio to receive either Covishield or Placebo, respectively.

At some sites, several volunteers have received the second dose as part of the phase 2/3 observer blind, randomised, controlled study to determine the safety and immunogenicity of Covishield vaccine in healthy Indian adults.

The SII chief said that doses will be allocated proportionally across 92 countries in the COVAX AMC (Advance Market Commitment) and in accordance with WHO’s global allocation framework, which is currently under development. “As part of the alliance with GAVI and Gates Foundation, we will deliver 200 mn [million] doses of AstraZeneca-Oxford and Novavax vaccines in 67 and 92 countries, respectively,” Poonawalla said.

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“As per our current agreement with AstraZeneca, GAVI Alliance, and the Gates Foundation, the vaccines will be distributed through them and as part of government immunisation programmes (once proven immunogenic) to low and middle-income countries (GAVI countries) and India,” Poonawalla said.

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

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