The drug regulator is currently analysing the data submitted by Serum Institute of India, which is manufacturing Oxford-AstraZeneca vaccine and Bharat Biotech, which is making indigenous vaccine in collaboration with ICMR. The expert panel will convene a meeting on January 1 on this.
“The industry and research organisation have stood the test of time. It has been a very wonderful experience. Probably, we will have a happy new year with something in hand. That is what I can hint at,” Drug Controller General of India (DCGI) V.G. Somani said.
On Wednesday, the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO) had met to consider the Emergency Use Authorisation (EUA) request of Pfizer, Serum Institute of India and Bharat Biotech Private Limited.
Further time was, however, requested on behalf of Pfizer. Additional data and information presented by SII and Bharat Biotech was then perused and analysed by the expert panel. The analysis of the additional data and information is going on and it will convene again on January 1, the Centre had said in a statement.
America’s Pfizer was the first one to apply for the accelerated approval on December 4, followed by Serum and Bharat Biotech who applied on December 6 and 7, respectively. Pfizer had, however, requested more time to make a presentation before the committee.
On December 9, the Subject Expert Committee asked Serum Institute of India and Bharat Biotech to submit more data and information to get approval.
The expert panel had then recommended Serum to submit the outcome of the assessment of the UK-MHRA for grant of emergency use approval, the updated safety data of the Phase II/III clinical trial 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.
Their applications were reviewed again on Wednesday hours after the UK accepted the recommendation of the Medicines and Healthcare Regulatory Agency (MHRA) to authorise Oxford University-AstraZeneca’s C-19 vaccine, named Covishield, for emergency use.
The authorisation was significant for India as the Pune-based Serum Institute of India had tied up with the company to conduct clinical trials and manufacture vaccine.
The Central government plans to vaccinate nearly 30 crore people in the first phase of drive. It will be offered to one crore healthcare workers, along with two crore frontline and essential workers and 27 crore elderly, mostly above the age of 50 years with comorbidities.
As many as eight C-19 vaccine candidates are under different stages of clinical trials which could be ready for authorisation in near future, including three indigenous vaccines.
It includes AstraZeneca and Oxford university developed and Serum Institute of India manufactured Covishield, Covaxin by Bharat Biotech Limited, ZyCoV-D by Zydus Cadila and Russian vaccine candidate Sputnik-V.
The list also contains NVX-CoV2373 by SII, HGCO19 by Geneva, and two unlabelled vaccines-Recombinant Protein Antigen based vaccine by Biological E Limited-and Inactivated rabies vector platform by Bharat Biotech.
