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The biotech company Moderna said Monday that it will ask regulators in the US and Europe to issue an emergency authorization for its coronavirus vaccine, which it said is 100% effective against severe cases of COVID-19.
Moderna said the main efficacy analysis from the phase 3 study of its mRNA-1273 vaccine candidate conducted in 196 cases indicates a vaccine efficacy of 94.1 percent.
While the efficacy of the COVID-19 vaccine was 94.1 percent, the efficacy of the severe COVID-19 vaccine was 100 percent, the company said.
Moderna plans to apply for an emergency use authorization (EUA) from the US Food and Drug Administration (FDA) and conditional approval from the European Medicines Agency (EMA) for the vaccine.
“This positive primary analysis confirms the ability of our vaccine to prevent COVID-19 disease with an efficacy of 94.1% and, more importantly, the ability to prevent severe COVID-19 disease.
We believe that our vaccine will provide a powerful new tool that can change the course of this pandemic and help prevent serious illness, hospitalizations and deaths, “said Moderna CEO Stéphane Bancel.
Bancel said the company “will apply for an Emergency Use Authorization from the FDA today and will continue the ongoing reviews that have already started with various regulatory agencies around the world.” Moderna anticipates that shipment of the vaccine to designated distribution points throughout the US will occur shortly after an Emergency Use Authorization is granted.
Moderna will also file a conditional marketing authorization (CMA) application with the European Medicines Agency (EMA).
The company has already started the ongoing review process with other global regulatory bodies such as Health Canada, SwissMedic, the UK Medicines and Health Products Regulatory Agency (MHRA), the Ministry of Health in Israel and the Health Sciences Authority. in Singapore and intend to seek Prequalification (PQ) and / or Emergency Use Listing (EUL) with the World Health Organization (WHO).
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 Advanced Biomedical Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response, US Department of Health and Human Services.
The company said effectiveness was consistent across all ages, races and ethnicities, and across gender demographics.
The 196 COVID-19 cases included 33 older adults (65 years and older) and 42 participants who identified as belonging to diverse communities (including 29 Hispanics / Latinos, 6 Blacks / African Americans, 4 Asian Americans, and 3 multiracial participants).
Based on a previous analysis, the most common side effects included injection site pain, fatigue, headache, and injection site redness.
The company will submit the data from the phase 3 COVE study to a peer-reviewed publication.
Moderna is working with the US CDC and other global authorities and stakeholders to be prepared for distribution of the vaccine should it receive an EUA and similar global clearances and approvals.
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.
