Covaxin's shelf life extended to 12 months, announces Bharat Biotech
The Central Drugs Standard Control Organisation has extended the shelf life of Covaxin to up to 12 months, starting from the date of manufacture, Hydebarab's Bharat Biotech announced on Wednesday. "This approval of shelf-life extension is based on the availability of additional stability data, which was submitted to CDSCO. The shelf life extension has been communicated to our stakeholders," the company said. The present shelf life of this Covid-19 vaccine is six months which means that the vaccines can be used till six months from the date of manufacture if stored at two to eight degree celsius. Now, the vaccine doses can be stored for up to a year, provided the temperature condition is fulfilled.
Early this year, Bharat Biotech sought an extension of the shelf life of the vaccine and submitted real-time stability data for consideration.
The extension of shelf life will reduce wastage of the vaccine as shelf life of six months means if the vaccine remains unused within the six months from the date of manufacture, they are considered to be expired. Now, Covaxin doses are good for use up to one year from the date of manufacture.
Covaxin is yet to get the emergency use approval from the World Health Organization, the delay of which has spread apprehension among travellers as Covaxin is not accepted in many countries as it is still waiting for WHO's nod. WHO sought some additional clarifications from Bharat Biotech for Covaxin to conduct a final "risk-benefit assessment" for Emergency Use Listing.
Countries are independently recognising Covaxin and Australia and Guyana are the latest two countries to have approved Covaxin. The other countries where Covaxin is accepted are Iran, Mauritius, Mexico, Nepal, Paraguay, the Phillippines, Zimbabwe, Oman, Sri Lanka, Estonia and Greece.