30 November,2020 10:33 PM IST | Washington | ANI
Image: Twitter@moderna_tx
US biotech company Moderna on Monday announced that it plans to request an Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) and conditional approval from the European Medicines Agency (EMA) after the final results from a late-stage study indicated its Covid-19 vaccine candidate is 94.1 per cent effective.
Moderna also said that its vaccine candidate had 100 per cent efficacy against severe disease. There were zero such COVID-19 cases among those vaccinated, but 30 in the placebo group.
According to an official statement by the company, the primary efficacy analysis of the "Phase 3 study of mRNA-1273 conducted on 196 cases confirms the high efficacy observed at the first interim analysis. The data analysis indicates a vaccine efficacy of 94.1 per cent. Safety data continue to accrue and the study continues to be monitored by an independent, NIH-appointed Data Safety Monitoring Board (DSMB)."
Moderna plans to request an Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) and conditional approval from the European Medicines Agency (EMA).
The Phase 3 study, known as the COVE study, enrolled more than 30,000 participants in the US and is being conducted in collaboration with the National Institute of Allergy and
Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), and the
Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the US Department of Health and Human Services.
"This positive primary analysis confirms the ability of our vaccineto prevent Covid-19 disease with 94.1 per cent efficacy and importantly, the ability to prevent severe Covid-19 disease. We believe that our vaccinewill provide a new and powerful tool that may change the course of this pandemic and help prevent severe disease, hospitalizations and death," said Stephane Bancel, Chief Executive Officer of Moderna.
The company also said that it has already initiated the rolling review process with the
EMA, Health Canada, SwissMedic, the United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA), Ministry of Health in Israel, and Health Sciences
Authority in Singapore and intends to seek Prequalification (PQ) and/or Emergency Use Listing (EUL) with the World Health Organization (WHO).
"Moderna announced that the FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting to review the safety and efficacy data package for mRNA1273 will likely be scheduled for Thursday, December 17," read the statement.
According to the latest data by Johns Hopkins University, as many as 13,389,786 people have been tested COVID-19 positive and 266,932 deaths been reported in the US till now.
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