On January 3, the Union Ministry of Health and Family Welfare slammed media reports that suggested India was using expired coronavirus vaccines.
“There have been some media reports alleging that expired vaccines are being administered in India under its national COVID-19 vaccination programme. This is false and misleading and based on incomplete information,” the Health Ministry said in a statement.?
The national authority had approved the shelf life extensions of Covishield and Covaxin in February and October of 2021, respectively, according to the Centre.
In response to Bharat Biotech International Limited's letter, the Central Drugs Standard Control Organisation (CDSCO) approved the shelf life extensions of Bharat Biotech's Covaxin (Whole Virion, Inactivated Coronavirus Vaccine) and Serum Institute's Covishield COVID-19 vaccines to 12 months and nine months, respectively, on October 25, 2021.
The manufacturer often labels a medical product with an expiry date. When a product is correctly stored according to its marked storage conditions, it is intended to remain stable, or preserve its identity, strength, quality, and purity for a period of time.
The CDSCO extended the shelf life of Bharat Biotech's Covaxin late last year based on the availability of additional stability data that was submitted to CDSCO.
The Hyderabad-based firm was given licence to sell and distribute Covaxin, which has a six-month shelf life when stored at two to eight degrees Celsius. "Now, we are herewith applying for a shelf-life extension from six to 24 months when stored at two to eight degrees Celsius," the company wrote in its application to the Drugs Controller General of India (DCGI).?
Apart from Covaxin and Covishield, the Food and Drug Administration (FDA) of the United States had also increased the shelf life of the Johnson & Johnson single-dose COVID-19 vaccine from four and a half months to six months in July 2021.
Vaccines are complex and expensive mixes of proteins, carbohydrates, lipids, inactivated viruses, or adjuvants, which are compounds that are meant to boost the immune response and the vaccine's subsequent clinical efficacy.
Overall vaccine efficacy and safety are aided by these factors. Vaccines are less stable and more susceptible to temperature fluctuations than chemicals. Similar to other medicines, vaccines also have an expiration date that specifies how long it can be stored and administered to patients.
The drug agency in India conducts multiple stability evaluations to establish how long a drug product can be safe and effective, a process known as shelf life. Because of slow chemical reactions and effectiveness loss, vaccine ingredients can go bad over time.
The ability of a vaccine to preserve its chemical, physical, microbiological, and biological qualities within prescribed limitations throughout its shelf life, according to the World Health Organisation (WHO).
A series of tests is used to determine a vaccine's stability so that its shelf life and use time may be determined under certain packaging and storage conditions. The WHO recommendations specify that stability parameters are chosen on a case-by-case basis, depending on the nature of the antigen and other components, as well as the production process.
Stability studies have three distinct goals that change over the course of a vaccine's lifespan. It is first carried out to determine the shelf life and storage conditions. Second, stability studies track vaccine stability in the post-licensure phase, or after the vaccine is commercially available. Third, stability studies are undertaken in accordance with WHO criteria to support manufacturing modifications by showing the comparability of products created using different techniques.
When vaccines are manufactured, producers conduct stability assessment studies to guarantee that the vaccines are safe and effective for usage for as long as possible.
Scientists are given a longer period to study vaccinations in real-time with each passing month, allowing them to see if the shelf life of a vaccine can be increased.
The associate director in the department of pharmacy at The Ohio State University Wexner Medical Centre, Crystal Tubbs, PharmD, explained to VeryWellHealth.com, "Since we have the opportunity to study the vaccines over longer periods of time, it is not a surprise that expiration dates have been extended.”
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