India in dialogue with Moderna, other biotech firms over progress in COVID vaccine development: Sources
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New Delhi: India is in dialogue with the US-based biotech giant Moderna over the progress in the clinical trials of its coronavirus vaccine candidate, which the firm said has shown 94.5 percent efficacy, official sources said on Monday.
Moderna on Monday said the independent National Institutes of Health-appointed Data Safety Monitoring Board (DSMB) for the Phase 3 study of mRNA-1273, its vaccine candidate against COVID-19, found the vaccine to have an efficacy of 94.5 percent.
"We are in dialogue not only with Moderna, but also with Pfizer, Serum Institute, Bharat Biotech and Zydus Cadila over the progress of the clinical trials of each of the vaccine candidates and where their vaccines stand in terms safety, immunogenicity and efficacy, and regulatory approvals," a source said.
According to the New Drugs and Cosmetics Rules 2019, any new drug or vaccine which has been tested and got regulatory approval outside India, will have to undergo bridging phase 2 and 3 clinical studies for its secure regulatory approval here.
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