Coronavirus COVID-19 vaccine tracker: While monitoring DRL's requests, the Subject Expert Committee (SEC) had noted that overseas trials of Sputnik V had 'small' safety and immunogenicity data.
Coronavirus COVID-19 vaccine tracker: Regarding Bharat Biotech's Coronavirus vaccine candidate 'Covaxin', the SEC said that the design of phase 3 human trials was satisfactory "in principle". (Reuters image)
Coronavirus COVID-19 vaccine tracker: Pharmaceutical firms Dr Reddy’s Laboratories (DRL), Bharat Biotech, and Biological E (Bio E) have been directed by an expert committee set up under India’s top drug regulatory to revise proposals pertaining to conduct human trials of their Covid-19 candidates. The DRL sought approval to hold late-stage clinical trials of the Russian candidate Sputnik V. Bharat Biotech was seeking a nod for late-stage human trials for its inactivated Coronavirus vaccine candidate Covaxin. Bio E tendered an application for early-stage trials for its vaccine candidate being developed with Houston’s Baylor College of Medicine.
While monitoring DRL’s requests, the Subject Expert Committee (SEC) had noted that overseas trials of Sputnik V had ‘small’ safety and immunogenicity data. The panel also cited that no data is available on Indian subjects. The DRL will have to submit a revised protocol including the details of the number of participants in the human trial and the number of testing sites would also have to change, as per IE report.
Bharat Biotech’s Covaxin human trial in India
Regarding Bharat Biotech’s Coronavirus vaccine candidate ‘Covaxin’, the SEC said that the design of phase 3 human trials was satisfactory “in principle”. However, clarification is needed on topics such as ‘asymptomatic’ participants. The SEC stated that the study should be commenced with the dose identified from phase 2 safety and immunogenicity data. The panel has also asked the Bharat Biotech to submit data from the phase 2 human trial for ‘consideration’.
Biological E has been directed by the SEC to start animal challenge studies simultaneously with Phase 1 or Phase 2 human trials. The SEC also directed Bio E to provide “complete” non-clinical toxicity data from testing the vaccine on rabbits. “Firm should carry out ascending dose safety study starting with 15 mcg dose, 25 mcg dose, and 50 mcg dose before proceeding to Phase II study,” the SEC says.