A vaccine against coronavirus
it may be approved in India soon, the country’s top drug regulator hinted on Thursday, saying the country will have a “happy new year with something in hand.”
The Comptroller General of Drugs of India (DCGI) assurance comes ahead of a crucial meeting of the expert panel on licensing vaccines for emergency use, which is scheduled for Friday. “We will probably have a Happy New Year with something in hand. That’s what I can hint at,” said Dr. VG Somani of DCGI.
The drug regulator is currently analyzing data submitted by the Serum Institute of India, which makes the Oxford-AstraZeneca vaccine, and Bharat Biotech, which is making a indigenous vaccine in collaboration with ICMR. The expert panel will convene a meeting on January 1 on this.
On Wednesday, the Subject Matter Expert Committee (SEC) of the Central Medicines Standards Control Organization (CDSCO) met to consider the application for Emergency Use Authorization (EUA) from Pfizer, Serum Institute of India and Bharat Biotech Private Limited.
The expert panel has asked both the Serum Institute and Bharat Biotech to provide additional data and information, while Pfizer has requested more time to submit details.
US-based Pfizer was the first to apply for expedited approval on December 4, followed by Serum and Bharat Biotech, who applied on December 6 and 7, respectively. However, Pfizer had requested more time to make a presentation to the committee.
The Serum Institute’s application was reviewed again on Wednesday hours after the UK accepted the recommendation of the Medicines and Health Regulatory Agency (MHRA) to authorize the University of Oxford-AstraZeneca COVID-19 vaccine, called Covishield, for emergency use. Britain was the first country to approve the vaccine.
The authorization was significant for India, as the Pune-based Serum Institute of India had partnered with the company to conduct clinical trials and manufacture vaccines.
The central government plans to vaccinate nearly 30 million people in the first phase. It will be offered to one crore of healthcare workers, along with two crore of essential and frontline workers and 27 crore of elderly, mostly over 50 with comorbidities.
Up to eight COVID-19 The vaccine candidates are in different stages of clinical trials that may be ready for authorization in the near future, including three indigenous vaccines.
It includes Covishield developed by AstraZeneca and the University of Oxford and manufactured by the Serum Institute of India, Covaxin by Bharat Biotech Limited, ZyCoV-D by Zydus Cadila and the Russian vaccine candidate Sputnik-V.
The list also contains NVX-CoV2373 from IBS, HGCO19 from Geneva, and two unlabeled vaccines: recombinant protein antigen-based vaccine from Biological E Limited and inactivated rabies vector platform from Bharat Biotech.
.
