Bharat Biotech is all set to commence clinical trials of the third dose of its Covid-19 vaccine, Covaxin, as a booster dose six months after administering the second dose.
The latest development comes after Drugs Controller General of India’s (DCGI) subject expert committee (SEC) granted permission to the company to carry out the booster dose trials, PTI reported.
Bharat Biotech submitted amendments to the SEC in the approved Phase II trial protocol for booster dose administration.
The news agency reported the DCGI SEC as saying: “After detailed deliberation, the committee recommended that the firm should conduct the booster dose study only in 6mcg cohort and also should follow up the subjects at least for six months after the third dose.”
In addition, the panel asked Bharat Biotech to submit the details of the primary and secondary objectives and several assessments to be conducted in the participants.
During a meeting on 23 March, the SEC said: “Accordingly, firm should submit the revised clinical trial protocol for evaluation.”
Bharat Biotech, in the meeting, submitted amendments in the approved Phase III clinical trial protocol for unblinding of participants aged over 45 years in the placebo group as well as adding another cohort in Brazil as advised by the SEC.
Furthermore, the panel advised that the company should present a detailed revised clinical trial protocol for including cohorts from Brazil together with the revised statistical calculation for evaluating the vaccine’s efficacy.
In a separate development, Russia’s Gamaleya institute is all set to launch pre-clinical trials of an intranasal vaccine against Covid-19.
In February this year, Russian researchers developed the nose spray form of the Sputnik V vaccine, UNI reported.
The news agency quoted Gamaleya institute director Alexander Gintsburg as saying in an interview with Sputnik that a patent has been obtained for the intranasal vaccine and it is set to launch pre-clinical trials.
The Link LonkApril 05, 2021 at 05:34PM
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Bharat Biotech to initiate trials of booster dose of Covid-19 vaccine - Clinical Trials Arena
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