Moderna said Monday that the Data Safety Monitoring Board (DSMB) appointed by the independent National Institutes of Health for the Phase 3 study of mRNA-1273, its candidate vaccine against Covid-19, found the vaccine to have an efficacy 94.5 percent.
“We are in dialogue not only with Moderna, but also with Pfizer, Serum Institute, Bharat Biotech and Zydus Cadila about the progress of the clinical trials of each of the candidate vaccines and where their vaccines are in terms of safety, immunogenicity and efficacy. , and regulatory approvals, “said a source.
According to the 2019 New Drug and Cosmetic Rules, any new drugs or vaccines that have been tested and obtained regulatory approval outside of India will need to undergo phase 2 and 3 bridging clinical studies for safe regulatory approval here .
“By law, CDSCO, under the 2019 New Drug and Cosmetics Rule, may omit, relax or abbreviate the requirement or regulatory conditions to submit pharmaceutical and clinical data of a vaccine candidate in the Indian population in case of any emergency or pandemic situation. “, said the source.
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 the United States. participants.
“This is a crucial moment in the development of our Covid-19 candidate vaccine. Since the beginning of January, we have been pursuing this virus with the intention of protecting as many people as possible around the world,” said Stephane Bancel, CEO. by 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 file an Emergency Use Authorization (US) with the US Food and Drug Administration (FDA) in the coming weeks and anticipates that the EUA is informed by the final safety and efficacy data (with a mean duration of at least 2 months).
Moderna also plans to submit requests for authorizations to global regulatory agencies.
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