Tag: Covaxin

Covaxin trials: ‘AIIMS-Delhi to screen kids aged 6-12 years from tomorrow’ – ET HealthWorld

(PTI Photo/Atul Yadav) NEW DELHI: The screening of children aged 6 to 12 years for the clinical trials of indigenously developed Covid-19 vaccine, Bharat Biotech’s Covaxin is scheduled to start from Tuesday. According to sources, the recruitment for clinical trials of Covaxin among those aged 12 to 18 years is over. They have been given […]

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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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COVID-19: Bharat Biotech ready for Covaxin’s clinical trial in US

New Delhi: Bharat Biotech said in a statement that it will be carrying out clinical trials in the United States to support the marketing application for Covaxin. The US Food and Drug Administration (USFDA) had decided not to give Emergency Use Authorisation (EUA) to Bharat Biotech’s Covaxin.  The regulator also recommended Ocugen, the US partner […]

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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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Over 300 COVID vaccination sites closed in Indore – ET HealthWorld

(PTI Photo) Indore: Due to a shortage of vaccines in Indore, district health authorities on Friday opened only nine vaccination centres out of 350 for administering the second dose of Covid vaccine to beneficiaries. Several vaccination centers were closed in Indore from Thursday due to the shortage of vaccines, however, the Health Department was able […]

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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 denies emergency use nod for Covaxin in US – ET HealthWorld

New Delhi: The US Food and Drug administration has denied approval for emergency use of Bharat Biotech’s Covaxin, and has asked for additional data, biopharmaceutical Ocugen, the US partner of the Indian vaccine maker has said. FDA recommended that Ocugen “pursue a Biologics Licence Application (BLA) submission instead of an EUA application” and “requested additional […]

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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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