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Friday, June 18, 2021

Covaxin’s US approval delayed as FDA asks for more data | THP India News

NEW DELHI: Bharat Biotech’s American partner Ocugen Inc on Thursday said it would no longer pursue an emergency use authorization (EUA) for its Covid-19 vaccine, Covaxin. The company has announced that it would now instead aim to file for a full US approval of the vaccine shot.
Ocugen is co-developing Covaxin with Hyderabad-based Bharat Biotech for the US market.
Ocugen said the decision was based on a recommendation from the US Food and Drug Administration (FDA), which also requested more information and data for full approval.
The company said it expects data from an additional clinical trial will be required to support the marketing application submission for Covaxin.

“While this will extend our timelines, we are committed to bringing Covaxin to the US,” Ocugen chief executive officer (CEO) Dr Shankar Musunuri said.
Ocugen recently secured exclusive rights to market the vaccine in Canada and has started discussions with Health Canada for regulatory approval, it said.
The company’s shares were down about 40 per cent at $5.56 before the bell.
Bharat Biotech to conduct Covaxin phase-4 trials
Bharat Biotech will be conducting phase-4 clinical trials of indigenously developed Covaxin to check its real-world effectiveness.
The company is also expected to submit the final analysis data of phase-3 studies ahead of applying for full licensure for Covaxin.

According to the company, the phase-4 trials will not just help check the real-world effectiveness but also ensure that “its vaccine met every rigorous scientific standard for safety, effectiveness, and manufacturing quality needed to support EUA”.
The Hyderabad-based vaccine maker also said that the full data of Covaxin’s phase-3 trials will first be submitted to the Central Drugs Standard Control Organisation (CDSCO), followed by peer-reviewed journals and will be made public during July.
As per interim data announced by Bharat Biotech and the Indian Council of Medical Research (ICMR), Covaxin, which was given EUA in early January while phase-3 trials were underway, reported an overall efficacy of 78 per cent and a 100 per cent efficacy against hospitalisations.
(With inputs from agencies)

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Nilesh Desaihttp://www.TheNileshDesai.com
Nilesh Desai is a Commerce, Computer and Law Graduate. Having wide experience in many fields. Doing IT Business since 1993.

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