Tag: Bharat Biotech

Will soon make final analysis of Covaxin efficacy trials public, says Bharat Biotech – ET HealthWorld

HYDERABAD: As the clamour grows for Bharat Biotech to publish the phase-III data for indigenously developed Covaxin, the company said it is committed to data transparency and will soon be making the final analysis data of the efficacy trials public. “Demonstrating its scientific commitment to data generation and data transparency, Bharat Biotech shares full data […]

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Nine research studies published on Covaxin’s safety in a year: Bharat Biotech – ET HealthWorld

(PTI Photo/Swapan Mahapatra) Hyderabad: Aimed at demonstrating data generation and data transparency, Covaxin maker Bharat Biotech on Saturday said that the company has published nine research studies on the safety and efficacy of its vaccine in a year. “The company has published as many as nine research studies on the safety and efficacy of Covaxin […]

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Experts question Covaxin’s high private market price as R&D was govt subsidised – ET HealthWorld

MUMBAI: The pricing of indigenously-manufactured Covid-19 vaccine, Covaxin, developed by Bharat Biotech, which at Rs 1,410 per dose is almost double that of Serum Institute’s Covishield has raised heckles in the vaccine ecosystem. Covaxin is the most expensive jab in the private market and even higher than Sputnik Vat Rs 1145, which is at present […]

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FDA rejects Ocugen’s emergency use authorization for Bharat Biotech’s Covaxin in the US, seeks nod from Health Canada

Biopharmaceutical company, Ocugen, has announced that recommendation from the U.S. Food and Drug Administration (FDA), the company will pursue submission of a biologics license application (BLA) for its COVID-19 vaccine candidate, COVAXIN. The Company will no longer pursue an Emergency Use Authorization (EUA) for COVAXIN. COVAXIN, India’s COVID-19 vaccine by Bharat Biotech, is developed in […]

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FDA earlier told that no new EUA will be approved for covid vaccines: Bharat Biotech – ET HealthWorld

Hyderabad-based Bharat Biotech today said that the USFDA had earlier communicated that no new Emergency Use Authorisation (EUA) will be approved for covid vaccines, a day after its US partner Ocugen hit a major bump after FDA rejected EUA for Covaxin. The Pennsylvania-based eye disease company had to change its application from an Emergency Use […]

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FDA rejects EUA for Covaxin, ‘suggests’ Biologics Licence Application route for approval in US

In a setback to Bharat Biotech’s COVID-19 vaccine Covaxin, the US Food and Drug Administration has “recommended” Ocugen Inc, the US partner of the Indian vaccine maker, to go for Biologics Licence Application (BLA) route with additional data, nixinghopes of Emergency Use Authorisation. Ocugen in a statement on Thursday announced that as recommended by theFDA,it […]

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Ocugen to file for full US approval of Covid-19 shot Covaxin instead of EUA – ET HealthWorld

Ocugen Inc said on Thursday it would no longer pursue an emergency use authorization for its Covid-19 vaccine candidate, Covaxin, and would instead aim to file for a full U.S. approval of the shot. Ocugen said the decision was based on a recommendation from the U.S. Food and Drug Administration (FDA), which also requested more […]

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Moderna offers to sell booster shots from January; indemnity-waiver talks on – ET HealthWorld

New Delhi: US vaccine maker Moderna has offered to sell booster doses of its Covid vaccine to India, from January 2022 even as the government continues to hold negotiations with Moderna and J&J on the indemnity waiver. At present, the talks involve the sale of almost 200 million doses. They include 50 million from Pfizer, […]

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Telangana: ‘Covaxin Phase-4 trials to check real-world effectiveness’ – ET HealthWorld

HYDERABAD: Bharat Biotech will be conducting Phase-4 clinical trials of indigenous vaccine Covaxin to check its real-world effectiveness and will also apply for full licensure after data from final analysis of Phase-3 studies is available in July, it said on Wednesday. The company said the phase-4 trials are also being done to “ensure its vaccine […]

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Govt places orders for 44 crore doses of Covishield & Covaxin – ET HealthWorld

REUTERS/Adnan Abidi NEW DELHI: The Centre on Tuesday said it has placed orders for 44 crore doses of Covishield and Covaxin, a day after Prime Minister Narendra Modi announced that the Centre would take over the state procurement quota and provide free jabs to state governments for inoculation of all above the age of 18. […]

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