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India in dialogue with Moderna, other biotech firms over progress in COVID vaccine development: Report

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 vac.

November 16, 2020 / 11:52 PM IST
Representative image

Representative image

India is in dialogue with the US-basedbiotech giant Modernaover the progress in the clinical trials of its coronavirus vaccine candidate, which the firm said hasshown 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.

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.

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"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. 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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COVID-19 Vaccine

Frequently Asked Questions

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How does a vaccine work?

A vaccine works by mimicking a natural infection. A vaccine not only induces immune response to protect people from any future COVID-19 infection, but also helps quickly build herd immunity to put an end to the pandemic. Herd immunity occurs when a sufficient percentage of a population becomes immune to a disease, making the spread of disease from person to person unlikely. The good news is that SARS-CoV-2 virus has been fairly stable, which increases the viability of a vaccine.

How many types of vaccines are there?

There are broadly four types of vaccine — one, a vaccine based on the whole virus (this could be either inactivated, or an attenuated [weakened] virus vaccine); two, a non-replicating viral vector vaccine that uses a benign virus as vector that carries the antigen of SARS-CoV; three, nucleic-acid vaccines that have genetic material like DNA and RNA of antigens like spike protein given to a person, helping human cells decode genetic material and produce the vaccine; and four, protein subunit vaccine wherein the recombinant proteins of SARS-COV-2 along with an adjuvant (booster) is given as a vaccine.

What does it take to develop a vaccine of this kind?

Vaccine development is a long, complex process. Unlike drugs that are given to people with a diseased, vaccines are given to healthy people and also vulnerable sections such as children, pregnant women and the elderly. So rigorous tests are compulsory. History says that the fastest time it took to develop a vaccine is five years, but it usually takes double or sometimes triple that time.

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"As per law, the CDSCO, under the 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 BioNTtech said their COVID-19 vaccine candidate was found to be more than 90 percent effective in preventing COVID-19 in participants. 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 Stphane 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. "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. Moderna also plans to submit applications for authorisations to global regulatory agencies.
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