Bharat Biotech Seeks DCGI's Permission To Extend Covaxin’s Shelf Life

Bharat Biotech International Limited has written to India's drug regulator for their permission to extend the shelf life of the home-grown Covid-19 vaccine, Covaxin to 24 months.

Covaxin along with Serum Institute of India’s (SII) Covishield are two vaccines that are being used to inoculate the entire population of the country.

However, the Russian vaccine, Sputnik V—developed by the Gamaleya National Research Institute of Epidemiology and Microbiology—has also been approved for emergency use in India.

In terms of Covaxin, which is India’s indigenous Covid-19 vaccine, the Hyderabad-based company has said that it will be sold for Rs 600 to state governments and Rs 1,200 to private hospitals.

The vaccine currently has a shelf life of six months when stored at two to eight degrees Celsius.

But in an application to the Drugs Controller General of India (DCGI), Bharat Biotech said: "Now, we are herewith applying for the extension of shelf life from six months to 24 months when stored at 2-8 degrees Celsius."

Shelf Life of Vaccines

Vaccine shelf life means its expiration date—basically the period within which a vaccine holds on to the same characteristics which it possessed at the time of the manufacturing.

In April, while citing lack of sufficient data, the World Health Organisation (WHO) rejected SII’s proposal for extending the shelf life of the Oxford-AstraZeneca vaccine, Covishield, from six to nine months.

As reported the WHO urged for a meeting with DCGI to discuss the matter regarding SII’s vaccine after the Indian regulators extended its shelf life from six to nine months from its manufacturing date.

Vaccine manufacturers need a longer shelf life as they stockpile the vaccine doses to be used over a period of time.

Covaxin producers Bharat Biotech has already submitted updated accelerated and real-time stability data of the jab along with the justification for the extension of shelf-life.

However, the Phase III trial data has shown that Covaxin has overall efficacy of 78 per cent against the Covid-19 and 100 per cent efficacy against a severe form of the coronavirus caused disease.

The vaccine has also shown resistance against several variants of coronavirus, including the double mutant.

Indian Council of Medical Research (ICMR) has recently announced that according to a study, Covaxin neutralises against multiple variants of SARS-CoV-2 and effectively neutralises the double mutant strain as well.