Saturday, May 28th, 2022

Bharat Biotech Covaxin: Covaxin got a shock in America, emergency use was not allowed, India gave this response

Bharat Biotech’s corona vaccine ‘Covaccine’ has suffered a setback in the US. US drug regulator USFDA has rejected Ocugen’s application for emergency use. Ocugen is an American partner firm of Bharat Biotech. The Government of India has given a slow response to the non-approval of Covaxin. He has said that India respects the regulatory system of every country. This move will not affect its vaccine program.

The USFDA has advised OcuGen Inc. to request the Biological License Application (BLA) route with additional data to obtain approval for use of the Indian vaccine. In a statement on Thursday, OcuGen said it would file a BLA for Covaccine in accordance with the FDA’s advice.

Covaxin vs Covishield: Amidst the controversy and questions raised on the effect of Covaxin, Bharat Biotech announced – will conduct the fourth phase trial to check the real effect
What is BLA?
BLA is the FDA’s ‘Full Approval’ arrangement. Under this, drugs and vaccines are approved. In such a situation, it may take some more time for Covaccine to get US approval.

“The company will no longer seek emergency access permission (EUA) for Covaccine,” OcuGen said. The FDA has given a response to the master file to Okuzane. It has been advised that OcuGen should file a BLA request instead of an EUA application for its vaccine. Along with this a request has also been made for some additional information and data.

Covaxin Trial For Children: Screening started in AIIMS for Covaxin Trial on children, know what happens in it
The company is discussing
OcuGen said this could delay the launch of Covaccine in the US. OcuGen is in discussion with the FDA to understand the additional information required for the BLA request. The company anticipates that an additional clinical trial data will be needed for the application to be approved.

“While we were very close to finalizing our EUA application, the FDA has advised us to make the request via BLA,” said Shankar Musunuri, CEO and Co-Founder of Ocugen. It will take longer, but we are determined to bring the vaccine to the US.



Source link

Leave a Reply

Your email address will not be published.

Champawat By-Election: Yogi Adityanath arrives to give edge to election campaign, roadshow in Tanakpur in support of CM Dhami

{“_id”:”62919620c338c4331a23c20e”,”slug”:”champawat-by-election-campaign-up-cm-yogi-adityanath-reached-in-support-of-cm-pushkar-singh-dhami”,”type” :”story”,”status”:”publish”,”title_hn”:”Champawat By-Election: Yogi Adityanath, who reached Tanakpur in support of CM Dhami’s roadshow”,”category”:{“title “:”City & states”,”title_hn”:”City & States”,”slug”:”city-and-states”}} News Desk, Amar Ujala, Dehradun Published by: Renu Saklani Updated Sat, 28 May 2022 12:39...

America: 300 kilowatt powerful laser weapon remains, Chinese missiles will be ashes in a moment

Agency, Washington. Published by: Yogesh Sahu Updated Tue, 02 Nov 2021 07:06 AM IST Summary This new laser weapon is part of the US military’s project through which to make a defensive laser weapon...

Sultanpur News: Former Union Minister Maneka Gandhi claims – had been told 3 years ago, black-white fungus will come in India

sultanpurFormer Union Minister and BJP MP Maneka Gandhi She has reached her parliamentary constituency Sultanpur on a 4-day tour from Thursday. On the second day of the tour, she came to inspect the district...