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 Stephane 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.