In the war against Corona, there is no good news for Bharat Biotech, the company that makes the vaccine. Bharat Biotech’s emergency use of the vaccine has not been approved in the US. The US Food and Drug Administration (FDA) has rejected Bharat Biotech’s application for an emergency use authorization (EUA) for the Kovid vaccine, delaying the company’s vaccine launch in the US. Let us inform that in the past, the US partner for Bharat Biotech’s Covaccine, Okugen, had sent a master file to the US drug regulator FDA, seeking permission for emergency use of this vaccine.
Here, the US partner of Bharat Biotech, Okugen, said on Thursday that the company will now seek full approval of Covaxin. Indeed, the US FDA is asking the company to start an additional trial so that the company can file for a Biologics License Application (BLA), which is a full approval.
In a statement, OcuGen said that the FDA’s response was in response to the Ocugen master file submitted by the company in the past. The FDA recommended that Occugen focus on BLA submissions rather than EUA (Emergency Use Authorization) applications for its vaccine. Also, the regulator has requested additional information and data regarding the vaccine.
He further said that the company is in discussion with the FDA about additional documents needed to approve its vaccine application. OcuGen Chief Executive Shankar Musuniri said that even though this will delay the introduction of the vaccine, we are determined to bring the vaccine to the US. Let us tell you that OcuGen sent the results of preclinical studies, chemicals, manufacturing and control (CMC) and clinical studies as master files to the FDA for review.
Let us tell you that this development regarding Covaccine has come at a time when Bharat Biotech has come under criticism in India for not sharing the data of its Phase III clinical trial, almost six months after the company’s vaccine was included in India’s vaccination programme. being victimized.
Here, Bharat Biotech expects a peer review by vaccine experts in two to four months after the data of its Kovid-19 vaccine Vaccine Phase-3 is submitted to scientific journals. Reches Illa, Project Head of Kovid-19 Vaccines at Bharat Biotech gave this information on Wednesday. The company has not yet made the data of this vaccine public.
He wrote on Twitter that so far there have been nine publications of Covaccine and the 10th publication will be about the impact of the Phase-3 trial. Illa said that to be fair, Bharat Biotech/ICMR cannot collect any data. Our service provider IQVIA has started the final statistical analysis. The effectiveness and safety of two months is expected to reach the pre-print servers immediately after handing over to CDSCO (July). Peer review takes two to four months. According to his tweet, about 25,800 people took part in the third phase of the test.