No approval for Covaxin, expert panel seeks more data from Bharat Biotech


New Delhi, Jan 1 (IANS): The Subject Expert Committee of the Central Drug Standard Control Organisation on Friday has held that the data provided by Bharat Biotech for its coronavirus vaccine 'Covaxin' is not sufficient for grant of emergency use approval and has asked for more information, top sources said.

Earlier on Friday, the expert committee, which is tasked with vetting covid-19 vaccine proposals, recommended emergency licensure for the Serum Institute of India-manufactured 'Covishield'. It become the first vaccine to secure recommendation for emergency use in India.

The Pune-based Serum Institute has partnered with Oxford-AstraZeneca for conducting clinical trials and manufacturing 'Covishield' while Bharat Biotech has collaborated with the Indian Council of Medical Research (ICMR) for 'Covaxin'.

The committee had convened a meeting to take a call on the emergency use authorisation sought by the Serum Institute, Bharat Biotech and America's Pfizer for their coronavirus vaccines candidates.

Pfizer was the first one to apply for the accelerated approval on December 4, followed by the Serum Insstitute and Bharat Biotech on December 6 and 7, respectively.

The meeting comes a day before dry run of the vaccine is slated to commence in all the states and Union Territories to equip the administration in management of vaccine supply, storage and logistics including cold chain management.

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 2 crore frontline and essential workers and 27 crore elderly, mostly above the age of 50 years with co-morbidities.

 

  

Top Stories


Leave a Comment

Title: No approval for Covaxin, expert panel seeks more data from Bharat Biotech



You have 2000 characters left.

Disclaimer:

Please write your correct name and email address. Kindly do not post any personal, abusive, defamatory, infringing, obscene, indecent, discriminatory or unlawful or similar comments. Daijiworld.com will not be responsible for any defamatory message posted under this article.

Please note that sending false messages to insult, defame, intimidate, mislead or deceive people or to intentionally cause public disorder is punishable under law. It is obligatory on Daijiworld to provide the IP address and other details of senders of such comments, to the authority concerned upon request.

Hence, sending offensive comments using daijiworld will be purely at your own risk, and in no way will Daijiworld.com be held responsible.