bharat biotech - The Purbottar

26 Apr

Bharat Biotech’s Covaxin gets drug regulator approval for 6-12 year olds

editor0 CommentsCovid-19bharat biotech, covaxin

The Drugs Controller General of India (DCGI) has given Bharat Biotech's Covid vaccine Covaxin restricted emergency use authorisation for children between the age of 6-12 years. Cadila Health's ZyCoV-D has received restricted emergency use authorisation for children above the age of 12 years of age. ET had reported that the subject expert committee ( SEC) of the Drugs Controller General of India recommended the use of Bharat Biotech's Covaxin among children aged 6-12 years amid an uptick in cases in schools. Covaxin, one of the main vaccines administered to adults, is currently being administered to children in the age group…

25 May

COVID-19 vaccine: Bharat Biotech’s US partner Ocugen submits ‘Master File’ on Covaxin to FDA

editor0 CommentsNorth Eastbharat biotech, covaccine, Covid-19, Ocugen

Indian vaccine manufacturer Bharat Biotech's American partner Ocugen submitted a 'Master File' to the US Food and Drug Administration on Tuesday in regards to its Coronavirus vaccine candidate-- Covaxin. Ocugen which is evaluating the clinical and regulatory path for Covaxin in the United States is working on obtaining the EUA for its commercialization in the US. Ocugen has submitted scores of data including preclinical studies, chemistry, manufacturing, and controls (CMC), and clinical studies to the FDA for review and input in its 'Master File'. In a recent regulatory filing, Ocugen has said. "The company is currently evaluating the clinical and regulatory path for COVAXIN in the United…

12 May

Bharat Biotech has refused to supply doses to Delhi “under government instructions”

editor0 CommentsNorth Eastbharat biotech, covaxin

Covaxin maker Bharat Biotech has refused to supply doses to Delhi "under instructions" from the central government, Deputy Chief Minister Manish Sisodia alleged today, accusing the Centre of controlling the supply of Covid shots and of "vaccine mismanagement". The company said it was "disheartening" that some states were complaining about its intentions. Bharat Biotech has said it will not be able to supply vaccines to the capital citing directives of the government and limited availability, Mr Sisodia said at a digital press meet. "The Covaxin manufacturer has, in a letter, said it cannot provide Delhi government vaccines due to unavailability,…

11 May

Bharat Biotech has been supplying Covaxin directly to 14 states

editor0 CommentsAssam, Business, Healthbharat biotech, covaxin, Covid-19, Vaccine

Bharat Biotech, Hyderabad based vaccine manufacturer has been supplying its COVID-19 vaccine ‘Covaxin’ directly to 14 states beginning May 1. In a tweet joint managing director of Bharat Biotech Suchitra Ella said, “Glad to announce that Bharat Biotech confirms direct supply of COVAXIN to some state government since 1st May 2021, based on the allocation received by the GoI”. Here the 14 state includes Andhra Pradesh, Assam, Chhattisgarh, Gujarat, Jammu & Kashmir, Jharkhand, Madhva Pradesh, Odhisha, Tamil Nadu, Telangana, Uttar Pradesh and West Bengal. Previously the vaccine was distributed only for those above 45 years and all the frontline warriors…

20 Apr

Bharat Biotech has announced a scaling up of its manufacturing capacity to produce 700 million doses of Covaxin annually.

editor0 CommentsHealthbharat biotech, covid vaccine, Covid-19, Health, INDIA

Inactivated vaccines, while highly safe, are extremely complex and expensive to manufacture, resulting in lower yields when compared to live virus vaccines. The vaccine has received Emergency Use Authorisations (EUA) in several countries across the globe with another 60 in process including the US. Pricing for international markets and supplies to governments under EUAs have been established between $15 and $20 per dose. To further increase capacities, Bharat Biotech has partnered with Indian Immunologicals (IIL) to manufacture the drug substance for Covaxin. The technology transfer process is underway and IIL has the capabilities and expertise to manufacture inactivated viral vaccines…