India in dialogue with Moderna, other biotech firms over progress in COVID vaccine development: Sources
PTI, Nov 17, 2020, 11:57 AM IST
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.
“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 Stéphane 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.
Udayavani is now on Telegram. Click here to join our channel and stay updated with the latest news.
Top News
Related Articles More
CM Vijayan opens Huddle Global; Says Kerala will be key player in India’s deep tech ambitions
Over 1,80,000 cases disposed off by exclusive POCSO courts: WCD
Blast near PVR in Delhi’s Prashant Vihar, 1 injured
ECI must clarify how voter turnout rose by over 7 per cent after polling ended: Patole
Indian culture resonates globally: PM Modi
MUST WATCH
Latest Additions
CM Vijayan opens Huddle Global; Says Kerala will be key player in India’s deep tech ambitions
Bengaluru to host Aero India 2025 from Feb 10-14
Karnataka cabinet decides to reopen graft case against Ex-CM Yediyurappa and family
Man attacks nurse inside hospital, caught on camera
Special tribute concert for legendary singer SPB to be held in Bengaluru on Dec 8
Thanks for visiting Udayavani
You seem to have an Ad Blocker on.
To continue reading, please turn it off or whitelist Udayavani.