Explained: The shelf life of Covid-19 vaccines

How long does a vaccine stay potent? This depends on stability tests, and can be extended based on data, as has happened with Covishield and Covaxin. What data are analysed, and how is shelf life determined?

Teenagers queue up for their doses in New Delhi on Monday, as India began vaccination for the 15-18 age group. (Photo: Amit Mehra)

More than 40 lakh teenagers in the 15-18 age group received their first dose of Covid-19 vaccines on Monday as India began its drive to vaccinate the younger population groups. Some concerns were raised about ‘expired’ Covaxin being administered to this younger group, leading to the Health Ministry issuing a clarification.

The Ministry described these claims as “false and misleading” and said these were based on “incomplete information”. It pointed out that the shelf life of Covaxin, the only vaccine being given to the people below 18 years of age, had been extended in November after proper regulatory scrutiny, and as such these vaccine doses were as good as any.

What led to the concerns?

The anxiety arose after several people pointed out that vaccine batches that were supposed to expire in November were being administered to the younger people on Monday. The government later clarified that the shelf life of these vaccines had been extended from nine months to 12 months in November itself, and therefore there was nothing wrong with these batches.

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The Health Ministry said the shelf life of vaccines is extended by the national regulator, Central Drugs Standard Control Organisation, or CDSCO, based on a comprehensive analysis and examination of stability study data furnished by the vaccine manufacturers. It also pointed out that CDSCO has earlier approved the extension of shelf life of Covishield as well, and nothing special had been done to Covaxin.

Why was the date of expiry of Covaxin extended?

In response to an application from Bharat Biotech, the manufacturer of Covaxin, the CDSCO on October 25, 2021 approved the extension of the shelf life of this indigenously developed vaccine from 9 to 12 months from the date of manufacture. This approval was based on the availability of additional “stability data” which was submitted by the firm to CDSCO.

With the shelf-life extension, hospitals could utilise the stock that was nearing expiry and avoid vaccine wastage. An estimated 20 crore vaccine doses are required to fully vaccinate the nearly 10 crore people in the 15-18 age group.

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In a recent statement, Bharat Biotech had said that they had documented excellent safety and immunogenicity data readouts in children. More than 15 crore Covaxin doses have been administered in the country to adults since vaccination commenced last year.

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What are ‘stability’ and ‘shelf life’ of a vaccine?

Vaccines are complex mixtures of proteins, carbohydrates, lipids, inactivated virus, or adjuvants —which are substances that are intended to enhance immune response and subsequent clinical efficacy of the vaccine. These together contribute to overall vaccine efficacy and safety.

Like other medicinal products, vaccines come with a date of expiry and shelf life determined by the manufacturer and approved by regulatory authorities. The constituents of a vaccine can go bad over time because of slow chemical reactions and lose efficacy.

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According to the World Health Organization (WHO), stability is the ability of a vaccine to retain its chemical, physical, microbiological and biological properties within specified limits throughout its shelf life.

A series of tests are designed to obtain information on the stability of a vaccine in order to define its shelf life and utilisation period under specified packaging and storage conditions. And depending on the nature of the antigen and other components, and the manufacturing process, stability parameters are selected on a case-by-case basis, the WHO guidelines state.

There are three specific objectives of stability studies, which differ throughout a vaccine’s lifetime. First, it is conducted to determine shelf life and storage conditions. Second, the stability studies, monitor vaccine stability in the post-licensure period, that is, when the vaccine is marketed commercially. Third, according to the WHO guidelines, stability studies are conducted to support manufacturing changes by demonstrating comparability of product manufactured by different processes.

How is shelf life calculated?

Shelf life is calculated by storing the product at different temperatures for various lengths of time and then testing its effectiveness, leading virologist Dr Shahid Jameel said. By storing the particular product at various temperatures, and then periodically checking if there is any degradation of the product, an expiry date is arrived at.

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The duration over which the product is stable and effective in the specified conditions is considered its shelf life. There are various biochemical ways in which the degradation can be estimated, said Dr Vineeta Bal, leading immunologist.

According to the WHO guidelines, the shelf life of a vaccine is the period of time during which the vaccine, if stored correctly, is expected to comply with the specification, as determined by stability studies on a number of batches of the product. The shelf life is used to establish the expiry date of each batch.

For vaccines, it is done by injecting into small animals (typically mice) to assess if the ability to make antibodies goes down with storage time and temperature, Dr Jameel said. An expiry date means that roughly beyond that, the vaccine won’t raise immunity as well as earlier. It may still work but sub-optimally, he said.

“The shelf life of a vaccine is a reflection of how long the vaccine retains its potency and stability at a given storage temperature and therefore its effectiveness. The shelf life is used to establish the expiry date of each batch of the vaccine product. Expiry dates do not affect the safety of the vaccine, rather are related to the potency or amount of protection the vaccine gives,” the WHO regional office for Africa had said in a statement in May last year.

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The WHO had said that any extension in the shelf life will only apply to vaccines not yet labelled and distributed. Hence the expired or near-to-expire doses in distribution for use will not be affected by any future decision of shelf life extension.

Is this extension of date a special favour given to Covaxin?

No. As mentioned, the CDSCO had in February last year extended the shelf life of Covishield from nine months to 12 months, after a similar process. The manufacture of the vaccine has to submit data to show that its vaccine retains its stability for longer periods. If the regulator is satisfied with the data, it can extend the expiry period.

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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

Kaunain Sheriff M

As City Editor ( Delhi) at the Indian Express, Kaunain Sheriff leads city reporting with a sharp focus on accountability journalism, data-driven stories, and ground-level impact. As the National Health Editor he leads the newsroom’s in-depth coverage of pressing health issues. He is the author of Johnson & Johnson Files: The Indian Secrets of a Global Giant, a definitive investigation into the accountability of one of the world’s most powerful pharmaceutical corporations. Areas of Expertise Investigative Reporting: Has deep expertise in investigative reporting spanning public health, regulatory affairs, drug safety, and the criminal justice system. His work sits at the intersection of governance, law, and accountability, with a particular focus on how regulatory failures, institutional lapses, and policy decisions affect citizens’ rights and safety. Data Journalism: Has extensively on big data–driven investigations, including analyses of flagship government schemes and large datasets on criminal trials, uncovering systemic gaps. Global Collaborations Kaunain is a key contributor to major international journalistic projects: The Implant Files: Collaborated with the International Consortium of Investigative Journalists (ICIJ) to expose global malpractices in the medical device industry. Chinese Big-Data Investigation: Uncovered how a foreign data firm monitored thousands of prominent Indian institutions and individuals in real-time. Awards & Recognition His commitment to "Journalism of Courage" has been recognized with the industry's highest honors: Ramnath Goenka Award for Excellence in Journalism SOPA Award (Society of Publishers in Asia) Red Ink Award (Mumbai Press Club) Indian Express Excellence Awards (Triple recipient for investigations into the NSA abuse in UP, Vyapam scam, and the anti-Sikh riots). Education: Studied Mechanical Engineering at Visvesvaraya Technological University (VTU), Bangalore, before moving to Delhi to pursue his passion for journalism. His engineering training informs his analytical approach, enabling him to decode technical, legal, and data-heavy systems with precision. Social media LinkedIn: linkedin.com/in/kaunain-sheriff-3a00ab99 X ( fromerly Twitter): @kaunain_s ... Read More