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Moderna to seek emergency clearance for COVID-19 vaccine from USFDA, European regulators


Washington, Nov 30: US-based biotechnology giant Moderna on Monday said that it will request an emergency use authorization from the from the United States Food and Drug Administration (USFDA) and European regulators after its coronavirus vaccine showed 94.1 per cent effective rate in the trials.

 Moderna to seek emergency clearance for COVID-19 vaccine from USFDA, European regulators

It also reported a 100 percent success rate in preventing severe cases, news agency Reuters reported.

Moderna said that its COVID-19 vaccine showed to be 94.5 per cent effective in preventing the deadly disease, bringing a glimmer of hope to a world ravaged by the pandemic.

Cambridge, Massachusetts-based Moderna's announcement had come just a week after Pfizer and Biontech said their COVID-19 vaccine candidate was found to be more than 90 per cent 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. All along, we have known that each day matters," said Stephane 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 severe disease," Bancel said as the pandemic has killed more than 1.3 million people worldwide, more than 245,000 of them in the US.

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"The independent, NIH-appointed Data Safety Monitoring Board (DSMB) for the Phase 3 study of mRNA-1273, its vaccine candidate against COVID-19, has informed Moderna that the trial has met the statistical criteria pre-specified in the study protocol for efficacy, with a vaccine efficacy of 94. 5 per cent," Moderna said in a statement.

This study, known as the COVE study, enrolled more than 30,000 participants in the US, it added.

Earlier on November 16, reports had suggested that Moderna Inc's experimental COVID-19 vaccine is more stable than expected at temperatures than ordinary refrigerators can provide and can be distributed using existing cold-chain shipping and storage infrastructure.

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