Bharat Biotech seeks extension of Covaxin’s shelf life. All you need to know


Bharat Biotech International Limited has sought the Drugs Controller General of India’s (DGCI’s) permission to extend the shelf life of its Covaxin, India’s indigenous Covid-19 vaccine, to 24 months. The vaccine, which the company has said will be sold for 600 to state governments and for 1200 to private hospitals, currently has a shelf life of six months.

What is a vaccine shelf life?

Shelf life is the expiration date of a vaccine, the time frame within which it retains the same characteristics it possessed at the time of its manufacturing. In other words, shelf life denotes the length of time for which any item remains fit for use.

Why does shelf life matter?

Longer shelf life is necessary for vaccine manufacturers since they stockpile vaccines to be used over a period of time. It ensures that the vaccine is safe and of sound quality. The World Health Organization (WHO) acknowledges that the stability of vaccines has a major impact on the success of immunisation programmes worldwide.

Who can extend shelf life of vaccines?

WHO has given the power of assuring vaccine quality to national regulatory agencies like DGCI. “As part of its efforts to assure vaccine quality, WHO has acknowledged the importance of clearly defining the stability characteristics of a vaccine and emphasizes the role of national regulatory authorities in overall vaccine evaluation,” says the WHO guidelines on stability evaluation of vaccines.

Has DGCI extended the shelf life before?

DGCI, earlier in February, granted approval to Serum Institute of India (SII), the manufacturer of Covishield, for an extension of the vaccine’s shelf life from six months to nine months. WHO, however, rejected SII’s application for the extension of Covishield’s shelf life, citing the lack of sufficient data, Reuters reported.

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