Hyderabad-based Bharat Biotech will make a presentation before the Subject Expert Committee of the Central Drug Standard Control Organisation (CDSCO) on Wednesday evening for approval of its vaccine – Covaxin, government sources told IANS.
Earlier on Wednesday, the Serum Institute of India (SII)’s application for emergency use authorization of its Covid-19 vaccine was also considered by the Subject Expert Committee.
The development came hours after the United Kingdom accepted the recommendation of the Medicines and Healthcare Regulatory Agency (MHRA) to authorize the Oxford University-AstraZeneca’s Covid-19 vaccine, Covishield, for emergency approval use.
The authorization was significant for India as the Pune-based Serum Institute of India had tied up with Oxford University-AstraZeneca to manufacture the vaccine in India.
America’s Pfizer was the first to apply on December 4, followed by the Serum Institute of India and Bharat Biotech, who applied on December 6 and 7, respectively. Pfizer has, however, requested more time to make its presentation before the committee.
On December 9, the Subject Expert Committee had, however, asked the Serum Institute of India and Bharat Biotech to submit more data and information to get emergency use approval (EUA) for their vaccine candidates.
The expert panel had then asked SII to submit the outcome of the assessment of UK-MHRA for grant of emergency use approval, the updated safety data of the Phase-II/III clinical trials, and immunogenicity data from the clinical trial in the UK and India.
Bharat Biotech was recommended to present the safety and efficacy data from the ongoing Phase-III clinical trial in the country for further consideration. Both the firms had again submitted their applications last week seeking approval of the vaccine.
The Central government plans to vaccinate nearly 30 crore people in the first phase of the vaccine drive. It would be offered to one crore healthcare workers, along with two crore frontline and essential workers and 27 crore elderly people, mostly above 50 years with comorbidities.