Moderna plans to submit authorization requests to global regulatory agencies.
New Delhi:
India is in dialogue with US biotech giant Moderna over the progress of clinical trials of its coronavirus vaccine candidate, which the company said showed 94.5% effectiveness, official sources said on Monday. .
Moderna said on Monday that the Data Security Oversight Board (DSMB) appointed by the independent National Institutes of Health for the Phase 3 study of mRNA-1273, its COVID-19 vaccine candidate, had found that the vaccine was 94.5% effective.
“We are in dialogue not only with Moderna, but also with Pfizer, Serum Institute, Bharat Biotech and Zydus Cadila on the progress of clinical trials of each of the candidate vaccines and the position of their vaccines in terms of safety, immunogenicity and efficiency, and regulatory approvals, ”a source said.
According to the new drugs and cosmetics rules 2019, any new drug or vaccine that has been tested and obtained regulatory approval outside of India, will have to undergo phase 2 and 3 clinical studies for its secure regulatory approval here. .
“In accordance with the law, the CDSCO, under the New Drugs and Cosmetics Rule 2019, may omit, relax or shorten the regulatory requirements or the conditions for submitting pharmaceutical and clinical data of a vaccine candidate in the Indian population in the event of emergency or pandemic 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 more than 90% effective in preventing COVID-19 in participants.
“This is a pivotal moment in the development of our COVID-19 vaccine candidate. Since the beginning of January, we have chased this virus with the intention of protecting as many people as possible in the world ”, declared Stéphane Bancel, CEO 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 serious illness,” he said.
Based on these interim safety and efficacy data, Moderna intends to submit an Emergency Use Authorization (EUA) to the United States Food and Drug Administration (FDA) within weeks to come and plan to inform the EUA of the final safety and efficacy data (with a median duration of at least 2 months).
Moderna also plans to submit authorization requests to global regulatory agencies.
(Except for the title, this story was not edited by GalacticGaming staff and is posted from a syndicated feed.)
