2 min read.Updated: 05 Feb 2021, 09:52 PM ISTLeroy Leo
Typically, the Drugs Controller General of India V.G. Somani, who heads CDSCO, adheres to the recommendations of the SEC when taking his decision for companies’ proposals
NEW DELHI :
A subject expert committee of the Central Drugs Standard Control Organisation (CDSCO) has given a greenlight to Serum Institute of India to conduct a phase 2 and 3 bridging study for Covovax, the Pune-based firm’s version of vaccine originally developed by Novavax Inc.
A bridging study is conducted to prove that a vaccine is similar to the original version and only involves a safety and immunogenicity study of a small group and not a large efficacy study.
“After detailed deliberation, the committee recommended for grant of permission to conduct Phase II/III clinical trial subject to the condition that the participants randomized to the placebo arm may be unblinded 60 days after the second dose upon request of the clinical trial participant only. Such participant may be offered the investigational vaccine as per the dose and schedule prescribed in the protocol," minutes of the SEC meeting on Wednesday showed.
Typically, the Drugs Controller General of India V.G. Somani, who heads CDSCO, adheres to the recommendations of the SEC when taking his decision for companies’ proposals.
In its statement last week, Novavax said that its vaccine had shown efficacy of 89.3%, in its Phase 3 clinical trial conducted in the United Kingdom (UK) at a time when the new mutant virus, which was more transmissible than the original, was the dominant strain. The vaccine showed a 60% efficacy in South Africa, where another more transmissible mutant strain was dominant.
Under a contract signed between Novavax and Serum Institute in August, the Pune-based vaccine manufacturer will produce 1 billion doses of the protein subunit vaccine at its facility for supply to India and other low- and middle-income countries.
Serum Institute is also in a pact with the Bill and Melinda Gates Foundation and Gavi, the Vaccine Alliance to supply 200 million doses of Covovax and Covishield—the version of a vaccine developed by the University of Oxford and AstraZeneca plc—to Covax in lieu of $300 million in funding. Covax is a facility supported by Gavi, the World Health Organization and the Coalition for Epidemic Preparedness Innovations (CEPI) for equitable access to covid-19 vaccines.
The regulatory panel also recommended allowing Serum Institute to unblind participants who received placebo 60 days after the second dose if the participant requested for it.
“Such participant may be offered the investigational vaccine as per the dose and schedule prescribed in the protocol," the SEC minutes noted.
The regulatory panel also gave its go-ahead to Bharat Biotech to conduct its phase 1 clinical trial of an intranasal vaccine, which is based on the chimpanzee adenovirus vector platform, similar to Serum Institute of India except that it is given through the nasal route.
Bharat Biotech’s proposal to make certain changes to its phase 3 trial and rollout also received the SEC’s go-ahead.
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