Udayavni Special

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

Navy finds some debris of crashed MiG-29K in Arabian sea

Serum Institute rejects charges levelled by vaccine trial participant, threatens to seek damages

K’taka COVID-19 update: 1291 new cases, 1530 recoveries, 15 deaths on Nov 28

India ‘pharmacy of world,’ focusing on deeper ties in S&T: Swedish amb

PM hailing farm laws shows govt ‘drunk with power’, ‘rigid’ in face of protests: Cong

UP registers first case under anti-conversion law in Bareilly

Modi’s Hyd visit: A testimony of Telangana achievement, KCR should have been invited, says KTR



Related Articles More

K’taka COVID-19 update: 1291 new cases, 1530 recoveries, 15 deaths on Nov 28

Pandemic calls off Christmas markets in Europe

DCGI and institutional ethics committee investigating claim of adverse event in COVID vaccine trial: Officials

COVID-19 caseload in India climbs to 93,92,919

COVID-19: 1,522 new cases in Karnataka, 12 deaths

MUST WATCH

Meet the man with the largest collections of Newspapers | Umesh Rao Ekkar Mangalore

Mangalore: Woman rescues a cat from 30 feet deep well | Ranjini Shetty | Udayavani

CM and central leadership will take final call on Cabinet expansion: Ashwath Narayan

Assorted flowers, fruits, and vegetables are grown in the terrace garden

Celebrating 25 Years of Laveena Masala | Since 1996 | Udayavani

Latest Additions

Navy finds some debris of crashed MiG-29K in Arabian sea

Serum Institute rejects charges levelled by vaccine trial participant, threatens to seek damages

Will Hold Punjab CM Responsible if Farmers’ Gatherings Aggravate Covid in Haryana, Says Khattar

High Octane Campaign for Hyderabad Polls Ends; 67 Lakh Voters to Decide Fate of 1,222 Candidates on Dec 1

K’taka COVID-19 update: 1291 new cases, 1530 recoveries, 15 deaths on Nov 28

Thanks for visiting Udayavani

You seem to have an Ad Blocker on.
To continue reading, please turn it off or whitelist Udayavani.