Covaxin's shelf life extended by CDSCO to 12 months; Bharat Biotech issues statement

In a key development, the Central Drugs Standard Control Organisation (CDSCO) on Wednesday approved the extension of the shelf life of Bharat Biotech's Covaxin up to 12 months from the date of manufacturing. In a statement issued by Bharat Biotech, the Indian vaccine manufacturer stated that the approval has been granted on the basis of the availability of the additional stability data, which was earlier submitted with CDSCO. With the submission of the additional stability data, the company had sought approval for the extension of the shelf-life of its vaccine to 24 months. 

Prior to this, Covaxin had an approved shelf-life of six months subject to its storage at two to eight degrees celsius.

Approval from WHO expected today

The development comes on the same day the Technical Advisory Group of WHO will conduct a EUL risk-benefit assessment meeting for the global use of the Indian vaccine. It must be noted that this will be the final risk-benefit assessment meeting regarding Bharat Biotech's vaccine.

The Indian vaccine manufacturer has been submitting data on the EUL of Covaxin regularly to a technical committee. Following the continual seeking of approval, the WHO had conducted a meeting regarding the same on October 26 and asked the manufacturer for some additional data. The company has now provided the data needed and the health organization will hold its final meeting to discuss a possible global EUL approval of Covaxin.

About Covaxin

Covaxin is a Whole Virion Inactivated Coronavirus Vaccine developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV). While the phase 3 trials entailed 25,800 participants between 18-98 years of age including 10% over the age of 60, the analysis was conducted 14 days after administering the second dose of the vaccine. It has shown overall 77.8% efficacy and 93.4% efficacy against severe COVID-19 disease as per the final results. 

On the other hand, efficacy data demonstrates 63.6% protection against asymptomatic COVID-19 disease. Most importantly, it has proven to neutralize variants such as B.1.1.7 (Alpha), B.1.617 (Kappa), B.1.351 (Beta), and B.1.617.2 (Delta). The Haffkine Biopharmaceutical Corporation Ltd, Mumbai, Indian Immunologicals Limited in Hyderabad and Ankleshwar, Bharat Immunologicals Biologicals Limited in Bulandshahr, and the Biovet facility in Bengaluru have also been permitted to produce Covaxin.

So far, Covaxin has been approved only in select countries such as India, Estonia, Iran, the Philippines, Mauritius, Mexico, Nepal, Guyana, Paraguay and Zimbabwe.