CDSCO extends COVAXIN's shelf life up to 12 months, WHO grants emergency use listing status
Central Drugs Standard Control Organisation (CDSCO) has approved the extension of the shelf life of Covaxin up to 12 months, from the date of manufacture.
New Delhi: Central Drugs Standard Control Organisation (CDSCO) has approved the extension of the shelf life of Covaxin up to 12 months, from the date of manufacture. This approval is based on the availability of additional stability data, which was submitted to CDSCO.
Bharat Biotech, Makers of COVAXIN, shared the announcement on the social media platform.
India's indigenous COVID-19 vaccine by Bharat Biotech is developed in collaboration with the Indian Council of Medical Research (ICMR) - National Institute of Virology (NIV). The indigenous, inactivated vaccine is developed and manufactured in Bharat Biotech's BSL-3 (Bio-Safety Level 3) high containment facility.
The vaccine received DCGI approval for Phase I & II Human Clinical Trials in July 2020.
Recently, Prime Minister Narendra Modi thanked Australia PM Scott Morrison for recognition of COVAXIN. The prime minister called this an important step forward in the post-COVID partnership between India and Australia.
Meanwhile, The World Health Organization (WHO) has granted emergency use listing (EUL) to Covaxin, adding to a growing portfolio of vaccines validated by WHO for the prevention of COVID-19.