'Happy New Year With Something in Hand': Drug Regulator Hints at Covid-19 Vaccine Approval Soon

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A vaccine against coronavirus can be approved in India soon, the country’s apex drug regulator hinted on Thursday and said the country will have a “happy new year with something in hand.”

The assurance from the Drug Controller General of India (DCGI) comes ahead of a crucial meeting of the expert panel on emergency use vaccine authorization, which is set for Friday. "Probably we will have a happy New Year with something in hand. That is what I can hint at,” DCGI Dr VG Somani said.

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 an indigenous vaccine in collaboration with ICMR. The expert panel will convene a meeting on January 1 on this.

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.

The expert panel has asked both Serum Institute and Bharat Biotech to furnish additional data and information, while Pfizer has requested more time to submit details.

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.

The application of Serum Institute was 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 Covid-19 vaccine, named Covishield, for emergency use. Britain was the first country to approve the vaccine.

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. 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 Covid-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.