After SII's Covishield, Bharat Biotech plans to put its COVID-19 vaccine for approval before expert panel
Dec 30, 2020, 17:30 IST
New Delhi, 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.
Earlier on Wednesday, the Serum Institute of India (SII)'s application for emergency use authorisation 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 authorise the Oxford University-AstraZeneca's Covid-19 vaccine, Covishield, for emergency approval use.
The authorisation 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 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 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 immunogenecity 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.
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Earlier on Wednesday, the Serum Institute of India (SII)'s application for emergency use authorisation 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 authorise the Oxford University-AstraZeneca's Covid-19 vaccine, Covishield, for emergency approval use.
The authorisation 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 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.
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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 immunogenecity 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.
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India detects 14 new cases of UK COVID-19 strain, putting the tally at 20India detects 14 new cases of UK COVID-19 strain, putting the tally at 20
2021 could finally be the year of India’s tech IPOs as startups like Zomato, Delhivery, Policybazaar head for the public markets