Moderna said the primary efficacy analysis of the Phase-3 study of its vaccine candidate indicates a vaccine efficacy of 94.1%.
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) for its coronavirus vaccine, which it said is 100% effective against severe COVID-19 cases.
Moderna said the primary efficacy analysis of the Phase-3 study of its vaccine candidate mRNA-1273 conducted on 196 cases indicates a vaccine efficacy of 94.1%.
While the vaccine efficacy against COVID-19 was 94.1%, vaccine efficacy against severe COVID-19 was 100%, the company said. 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%. Safety data continue to accrue and the study continues to be monitored by an independent, NIH-appointed Data Safety Monitoring Board (DSMB)."
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.
The company said efficacy was consistent across age, race and ethnicity, and gender demographics.
The 196 COVID-19 cases included 33 older adults (ages 65+) and 42 participants identifying as being from diverse communities (including 29 Hispanic or LatinX, 6 Black or African Americans, 4 Asian Americans and 3 multiracial participants).
Based on prior analysis, the most common side effects included injection site pain, fatigue, headache, and redness at the injection site.
"This positive primary analysis confirms the ability of our vaccine to prevent Covid-19 disease with 94.1% efficacy and importantly, the ability to prevent severe Covid-19 disease. We believe that our vaccine will 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 mRNA-1273 will likely be scheduled for Thursday, December 17," read the statement.
By the end of 2020, the Company expects to have approximately 20 million doses of the vaccine available in the US and remains on track to manufacture 500 million to 1 billion doses globally in 2021.
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.
(With agency inputs)
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