Hydebarab’s Bharat Biotech announced on Wednesday that the Central Pharmaceutical Standards Control Organization has extended the shelf life of Covaxin to up to 12 months from the date of production. “The approval of the shelf life extension is based on the availability of additional stability data, which has been submitted to CDSCO. The shelf life extension has been communicated to our stakeholders,” the company said.
The current shelf life of this Covid-19 vaccine is six months, which means that if stored at a temperature of 2 to 8 degrees Celsius, the vaccine can be used up to six months after the production date. Now, as long as the temperature conditions are met, the vaccine dose can be stored for up to one year. Earlier this year, Bharat Biotech sought to extend the shelf life of vaccines and submitted real-time stability data for consideration.
Extending the shelf life will reduce the wastage of the vaccine, because the six-month shelf life means that if the vaccine is not used within the validity period, it will be considered expired within six months from the date of production.
Now, the Covaxin dose can be used for up to one year from the date of production. Covaxin has not been approved for emergency use by the World Health Organization, and its delay has spread among travelers because Covaxin is not accepted in many countries because it is still waiting for a nod from the WHO.
WHO asked Bharat Biotech to provide some additional clarifications on Covaxin in order to conduct a final “risk-benefit assessment” on the emergency use list. Countries independently recognize Covaxin, and Australia and Guyana are the latest two countries to approve Covaxin. Other countries that accept Covaxin are Iran, Mauritius, Mexico, Nepal, Paraguay, Philippines, Zimbabwe, Oman, Sri Lanka, Estonia and Greece.
News Source : Hindustan Times