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Biotech company Moderna Inc will request an Emergency Use Authorization (EUA) from the US Food and Drug Administration on Monday, besides seeking conditional approval from the European Medicines Agency (EMA), on its m-RNA vaccine candidate against Covid-19.
Reiterating findings on its vaccine efficacy, Moderna Chief Executive Stéphane Bancel said, “This positive primary analysis confirms the ability of our vaccine to prevent Covid-19 disease with 94.1 per cent 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, hospitalisations and death.”
She added, “We will file today for an Emergency Use Authorization from the FDA and continue forging ahead with the rolling reviews that have already been initiated with several regulatory agencies around the globe.”
Moderna was the first to begin clinical trials on its Covid-19 vaccine candidate and is one of a handful of vaccines that have recently announced over 90 per cent efficacy, including US-based Pfizer.
Review process with EMA
The company 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 with the World Health Organization, it said.
By the end of 2020, Moderna expects to have approximately 20 million doses of mRNA-1273 available in the US and remains on track to manufacture 500 million to 1 billion doses globally in 2021.
Phase-III trials
The late-stage or Phase-III study on the Moderna candidate 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.
Efficacy was consistent across age, race and ethnicity, and gender demographics, the company said, of the new-tech vaccine whose storage and distribution requirements were a lot less challenging than Pfizer (that required -70° C).
The most common adverse reactions included injection site pain, fatigue, myalgia, arthralgia, headache, and erythema/redness at the injection site. These increased in frequency and severity in the mRNA-1273 group after the second dose, the company said, adding that its data would be peer-reviewed and published.
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