Hyderabad-based Bharat Biotech on Sunday sought DCGI nod to extend the shelf life of its Covaxin. A few months ago, Covishield manufacturer Serum Institute of India (SII) too had moved the top drug regulator for a similar request and had got approval too.
However, while the DCGI gave nod to SII to extend Covishield shelf life from six to nine months, the World Health Organisation (WHO) has rejected SII’s proposal, citing insufficient data. Shelf life is the length of time for which an item remains fit for use.
Sources said Bharat Biotech has written to the DCGI to increase the shelf life of its Covaxin from six months to 24 months. Originally the shelf life of the vaccine was determined to be six months when stored at 2-8 degrees Celsius.
“Now, we are herewith applying for the extension of shelf life from six months to 24 months when stored at 2-8 degrees Celsius,” according to reports in agencies.
It said that the biotech manufacturer has submitted updated accelerated and real-time stability data of Coaxin along with the justification for the extension of shelf life.
The development comes a day after Bharat Biotech announced that it will supply Covaxin to State Governments at `600 for a dose and to private hospitals at `1,200 per dose. The company also said that it will export the vaccine at $15-20 (`1,124-1,499) per dose.
Covaxin has been developed jointly by Bharat Biotech, Indian Council of Medical Research and the National Institute of Virology (NIV).
The inoculation is based on the coronavirus sample isolated by the NIV. It also is the first indigenous vaccine against coronavirus.
Recently published Phase III trial data shows that Covaxin has an overall
interim clinical efficacy of 78 per cent and 100 per cent efficacy against severe Covid-19 disease.
Covaxin has also shown resistance against multiple variants of coronavirus, including the double mutant variant. “ICMR study shows Covaxin neutralises multiple variants of SARS-CoV-2 and effectively neutralises the double mutant strain as well,” ICMR recently announced.