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In December 2020, the US Food and Drug Administration issued an emergency use authorisation for the Moderna vaccine, while the European Medicines Agency granted it a marketing authorisation valid throughout the European Union in January this year.
The World Health Organization (WHO) on Friday listed the Moderna Covid-19 vaccine for emergency use, making it the fifth vaccine to receive emergency validation from the WHO.
In December 2020, the US Food and Drug Administration issued an emergency use authorisation for the Moderna vaccine, while the European Medicines Agency granted it a marketing authorisation valid throughout the European Union in January this year.
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Before being validated for the WHO Emergency Use Listing (EUL), the Moderna vaccine was already reviewed in January by WHO’s Strategic Advisory Group of Experts on Immunisation (SAGE), which makes recommendations for vaccines’ use in populations.
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The Moderna Covid-19 vaccine is an mNRA-based vaccine, which was found by the SAGE to have an efficacy of 94.1 per cent. The SAGE has recommended the vaccine for all age groups 18 and above, the Xinhua news agency reported.
WHO’s EUL procedure assesses the late phase II and phase III clinical trial data as well as substantial additional data on safety, efficacy, quality and a risk management plan of Covid-19 vaccines.
In addition to the Moderna vaccine, the WHO has previously listed the Pfizer/BioNTech, Astrazeneca-SK Bio, Serum Institute of India and Janssen vaccines for emergency use.
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