The expert panel of the Central Drugs Standard Control Organisation (CDSCO) has asked Bharat Biotech to submit the efficacy data from Phase-3 trials, before it approves the application to conduct Phase-1 trial for its nasal vaccine, said sources.
Bharat Biotech had recently sought the Drugs Controller General of India’s approval to conduct Phase 1 clinical trials of its nasal vaccine. For any clinical trial and vaccine approval, the CDSCO refers to the subject expert committee (SEC) for recommendations.
The SEC met on Tuesday to discuss the proposal from the vaccine maker. A source added that the panel has sought more data from the firm before it gives approval to conduct clinical trials of its nasal vaccine. The SEC has already recommended restricted emergency-use approval for the intra-muscular vaccine developed by Bharat Biotech — Covaxin. “The SEC has sought more data from the firm, especially showing efficacy,” said a source. The country also plans to export Bharat Biotech’s vaccine at a later stage.
Meanwhile, in the health ministry press briefing, V K Paul, member-health, NITI Aayog, said a nasal vaccine candidate has been identified and will be considered by the regulator for Phase 1 and 2 trials. He said this route could be used to deliver safe antigen that will generate an immunological response.
Balram Bhargava, director, Indian Council of Medical Research (ICMR), said, “In the past, such vaccines have been used for measles. This is a route being explored now and we are looking forward to it.”
Bharat Biotech is bullish on its upcoming nasal vaccine, which is under trials in the US. Experts say the nasal vaccine, if successful, could play a major role in halting the transmission of the novel coronavirus and lead to global eradication of the disease.
Jacob John, former head (Centre for Advanced Research in Virology), ICMR, had told Business Standard recently that while intra-muscular vaccines could potentially prevent the transmission of a disease that spreads through the respiratory tract (such as the smallpox vaccine), chances were higher in case of a nasal vaccine.
Meanwhile, India — one of the world’s biggest drugmakers — will start exports of Covid-19 vaccines as early as Wednesday, government sources said, paving the way for many mid- and lower-income countries to secure supplies of the easy-to-store Oxford-AstraZeneca vaccine.
The first batch of exports will be shipped to Bhutan, said officials.
Sri Lanka, Nepal, Myanmar, and the Maldives have all made requests for early delivery of vaccines.
Additional inputs from PTI
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