Bharat Biotech seeks DCGI nod to extend Covaxin shelf life to 24 months

Bharat Biotech has reportedly written to the Drugs Controller General of India (DCGI) to extend the shelf life of its COVID-19 vaccine Covaxin. 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," news agency PTI cited the firm's application to the drugs regulator.

The Hyderabad-based vaccine manufacturer has submitted updated accelerated and real-time stability data of Coaxin along with the justification for the extension of shelf life.

ALSO READ: Bharat Biotech's Covaxin to cost Rs 600 for state govts, Rs 1,200 for pvt hospitals

The development comes a day after Bharat Biotech announced that it will supply Covaxin to state governments at Rs 600 for a dose and to private hospitals at Rs 1,200 per dose. The company also said that it will export the vaccine at $15-20 (Rs 1,124-1,499) per dose.

Covaxin is one of the two vaccines, along with Serum Institute of India's Covishield, being used in India's vaccination programme against the coronavirus. DCGI had extended the sheld life of Covishield from six to nine months in February. Sputnik V, the Russia-made vaccine developed by Gamaleya Research Institute of Epidemiology and Microbiology, has also been given approval for emergency use in India.

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.

ALSO READ: E-pharmacies plan COVID-19 vaccination; PharmEasy to vaccinate 3 crore people in coming months

Covaxin has also shown resistance against multiple variants of coronavirus, including the double mutant variant. "ICMR study shows Covaxin neutralises against multiple variants of SARS-CoV-2 and effectively neutralises the double mutant strain as well," ICMR recently announced.

In order to arrive at this conclusion, the ICMR-National Institute of Virology isolated and cultured multiple variants of the virus - B.1.1.7 (UK variant), B.1.1.28 (Brazil variant) and B.1.1.351 (South Africa variant). India's premier health research body said that COVAXIN has shown its potential in neutralising the UK and Brazil variants.

Recently, ICMR-NIV was successful in isolating and culturing the double mutant strain B.1.617 SARS-CoV-2 which has been identified in Maharashtra, and several other countries outside India. This led to countries like Hong Kong, New Zealand, Pakistan, Singapore, the US and the UK impose travel restrictions on India. According to ICMR, "Covaxin has been found to effectively neutralise the double mutant strain as well."

ALSO READ: India to expand COVID-19 vaccination but supplies run short, imports delayed