Second Serum Institute vaccine set for phase-3 clinical trial by mid-May

The Data Safety Monitoring Board has reviewed the initial safety data of 200 participants of phase-2 clinical trial of Covovax and has given its recommendation. The Drugs Controller General of India has given the go-ahead for a larger phase-3 trial.

Phase 3 clinical trials of Covavax may begin by mid-June

Covovax was approved by the DCGI for a restricted emergency use in children aged seven to 11 years in June. (File)

Covovax, the second Covid-19 vaccine candidate being developed and manufactured by the Pune-based Serum Institute of India (SII), is likely to go into phase-3 clinical trials by mid-May.

The Data Safety Monitoring Board has reviewed the initial safety data of 200 participants of phase-2 clinical trial of Covovax and has given its recommendation. The Drugs Controller General of India has given the go-ahead for a larger phase-3 trial.

The ICMR and SII are jointly performing a phase-2/3 observer-blind, randomised, controlled study to determine the safety and immunogenicity of Covovax [SARS-CoV-2 recombinant spike protein nanoparticle vaccine (SARS-CoV-2 rS) with Matrix-M1™ adjuvant] in Indian adults.

The largest vaccine manufacturer, SII has already manufactured Covishield vaccine in technical collaboration with AstraZeneca and Oxford University. The firm’s CEO, Adar Poonawalla, had earlier tweeted that they hope to launch Covovax by September this year.

Dr Abhijit Kadam, Scientist C, coordinating principal investigator from ICMR-National AIDS Research Institute of the trial, said that tentatively phase-3 should start by mid-May. There are 19 sites across the country, four of them in Pune. Researchers across these sites said the process of recruiting volunteers for the larger phase-3 trial will begin soon.

Last year, US-based biotechnology company Novovax had announced a licence agreement with SII for the development and commercialisation of NVX-COV2373, its Covid-19 vaccine candidate in low- and middle-income countries and India. Novavax subsequently published results of the study, which assessed the efficacy of NVX-COV2373 vaccine during a period with high transmission and with the UK variant circulating widely.

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 . 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.” 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. 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 X (Twitter): @runaanu ... Read More

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