The Central Drugs Standard Control Organisation (CDSCO) has approved the extension of Covid-19 vaccine Covaxin Shelf Life to up to 12 months from the date of manufacturing, said Bharat Biotech in a statement on Wednesday.
Bharat Biotech had earlier this year written to India’s drug regulator seeking an extension of the shelf-life of its vaccine. The Hyderabad-based firm said that it submitted necessary real-time stability data of Covaxin to the drug regulator to substantiate its application.
COVAXIN shelf life extended by Indian Regulator
Currently, Covaxin has an approved shelf-life of six months, which was extended to 9 months, and now the extension is granted for 12 months subject to its storage at two to eight degrees celsius.
Vaccine maker Bharat Biotech on Wednesday said the Central Drugs Standard Control Organisation (CDSCO) has approved the extension of shelf life of its COVID-19 vaccine Covaxin up to 12 months from the date of manufacture.
“The CDSCO has approved the extension of shelf life of Covaxin up to 12 months, from the date of manufacture. This approval of shelf life extension is based on the availability of additional stability data, which was submitted to CDSCO,” Bharat Biotech said in a tweet.
Meanwhile Technical Advisory Group (TAG) of the World Health Organisation (WHO) is likely to decide on Covaxin’s Emergency Use Listing (EUL) on Wednesday.
“The TAG met on 26 October and decided to seek additional clarifications from the Covaxin manufacturers that are needed to conduct a final EUL risk-benefit assessment for global use of the vaccine,” a WHO official was quoted as saying by news agency.
Covaxin has demonstrated 77.8% effectiveness against symptomatic Covid-19 and 65.2% protection against the new Delta variant. Bharat Biotech said that it concluded the final analysis of Covaxin efficacy from Phase 3 trials.