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Ahmedabad-based Zydus Cadila, Bharat Biotech’s intra-nasal candidate are among the candidates who got approval from the expert panel to conduct clinical trials, Sohini Das reports.
A bunch of COVID-19 vaccine candidates got approval from the expert panel to conduct clinical trials in India, including one from Novavax, Bharat Biotech’s intra-nasal candidate, and a measles vector-based candidate from Zydus Cadila.
In its February 3 meeting, the subject expert panel advising the Central Drugs Standard Control Organisation recommended that approval be granted for conducting phase II/III clinical trials to Serum Institute of India for the Novavax candidate.
This vaccine is based on protein nanoparticle and uses the proprietary Matrix-M adjuvant from Novavax.
Adjuvants are pharmacological or immunological agents that improve the immune response of a vaccine.
The SEC has noted that participants randomised in the placebo arm may be un-blinded 60 days after the second dose, upon request from the clinical trial participant only.
Blinded vaccine trials are those where the participant, investigator and sponsor do not know whether a person was given a vaccine or a placebo.
As for Bharat Biotech’s chimpanzee flu virus (adenovirus) based intra-nasal vaccine candidate, the SEC recommended grant of permission for phase I trials.
Ahmedabad-based Zydus Cadila got approval for conducting phase I/II trials for the 2019-nCoV vaccine 3mg (two dose schedule).
The SEC has noted that safety should be the primary objective of the study.
This is Zydus Cadila’s second vaccine candidate, developed by its European research arm Etna Biotech. It is a live weakened recombinant measles virus vector-based vaccine against COVID-19.
The genetically engineered measles virus vector would express proteins of the novel coronavirus and, thus, induce long-term specific neutralising antibodies.
Meanwhile, Aurobindo Pharmaceuticals has been asked to submit a revised clinical trial protocol for its vaccine candidate UB-612.
The firm presented animal study and phase I data before the committee.
The SEC recommended that Aurobindo submit the phase II/III clinical trial protocols approved by the regulatory authority of Brazil and some other conditions.
