SEC approved Bharat Biotech's phase 3 clinical trials of COVID booster intranasal vac
SEC approved Bharat Biotech's phase 3 clinical trials of  COVID booster intranasal vac
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New Delhi: The Drug Controller General of India's (DCGI) Subject Experts Committee (SEC) approved Bharat Biotech's phase 3 trials and heterologous trials for COVID-19 booster intranasal vaccine for those who have taken both doses of Covaxin and Covishield on Wednesday.

The SEC has requested that the Hyderabad-based vaccine maker submit a new protocol for clinical trials.

"In light of the pandemic scenario, the SEC 'in principle' consented to conduct both the phase 3 superiority study and the phase 3 booster dose study in parallel after extensive thought. As a result, Bharat Biotech has been instructed to submit the protocol(s) for approval as indicated "reads the meeting's SEC minutes.

The vaccine maker intends to perform clinical trials on 5,000 healthy people, half of whom will receive Covishield and the other half will be vaccinated with Covaxin. Bharat Biotech's analysis also suggested inoculating the COVID-19 Booster dose six months after receiving both primary doses. Around the middle of December, the company requested for approval to conduct clinical trials for its intranasal booster dosage vaccine.

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