India is in dialogue with the US-based biotech giant Moderna over the progress in the clinical trials of its Covid-19 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 of 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.
"As per law, the CDSCO, under the New Drugs and Cosmetics Rule 2019, can omit, relax or abbreviate the regulatory requirement or conditions of submitting pharmaceutical and clinical data of a vaccine candidate in Indian population in case of any emergency or pandemic like situation," the source said.
Cambridge, Massachusetts-based Moderna's announcement comes just a week after Pfizer and Biontech said their COVID-19 vaccine candidate was found to be more than 90 percent effective in preventing COVID-19 in participants.
"This is a pivotal moment in the development of our COVID-19 vaccine candidate. Since early January, we have chased this virus with the intent to protect as many people around the world as possible," said Stephane Bancel, Chief Executive Officer of Moderna.
"This positive interim analysis from our Phase 3 study has given us the first clinical validation that our vaccine can prevent COVID-19 disease, including severe disease," he said.
Based on these interim safety and efficacy data, Moderna intends to submit for an Emergency Use Authorisation (EUA) with the US Food and Drug Administration (FDA) in the coming weeks and anticipates having the EUA informed by the final safety and efficacy data (with a median duration of at least 2 months).
Moderna also plans to submit applications for authorisations to global regulatory agencies.
(Except for the headline, this story has not been edited by NDTV staff and is published from a syndicated feed.)
New Cancer Vaccine Offers Hope: Early Trials Of mRNA Vaccine Show Encouraging Results Bharat Biotech Adds Top Medical Body ICMR As Co-Owner Of Covid Vaccine Patent Covid Vaccinated Pregnant Women At Lower Risk Of Caesarean Births: Study Not All Private Property Can Be Taken Over By Government: Supreme Court Canada Cop Who Attended Khalistani Protest Outside Hindu Temple Suspended Explained: Sunita Williams Experiences 16 Sunrises And Sunsets Every Day "Complaints Of Bias And Inaccuracies": Wikipedia Gets Centre's Notice Ivanka Trump's Rise, Post-Poll Unrest: AI Nostradamus' Shock Predictions US Election: Trump Or Harris? Bigger Surprises Are In The Offing Track Latest News Live on NDTV.com and get news updates from India and around the world.