WHO gives Moderna Covid vaccine emergency approval

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The World Health Organization (WHO) said Friday that it listed the Moderna vaccine for emergency use for the coronavirus disease 2019 (Covid-19) – the fifth injection to receive emergency validation from the United Nations agency.

“One of the things done under the process is to review how the manufacturing is done,” WHO spokeswoman Margaret Harris told journalists at a UN news conference.

The WHO said the Emergency Use Listing assesses the quality, safety and efficacy of Covid-19 vaccines – a prerequisite for COVAX Facility vaccine supply.

COVAX is a global initiative aimed at equitable access to Covid-19 vaccines led by Gavi, the vaccine alliance, the Coalition for Epidemic Preparedness Innovations and the WHO.

It also allows countries to accelerate their regulatory approval to import and administer Covid-19 vaccines.

The US pharmaceutical company’s vaccine has already been reviewed by the WHO’s Strategic Advisory Group of Experts on Immunization (SAGE), making recommendations for vaccines’ use in populations.

The US Food and Drug Administration issued an emergency use authorization for the Moderna vaccine on Dec. 18, 2020.

And a marketing authorization valid throughout the European Union was granted by the European Medicines Agency on Jan. 6, 2021.

The Moderna vaccine is an mNRA-based vaccine, a new type of shot to protect against infectious diseases.

SAGE found it to have an efficacy of 94.1 percent.

Although the vaccine is provided as a frozen suspension at -25 C to -15 C (-13 F to 5 F) in a multidose vial, vials can be stored refrigerated at 2 – 8 C (36 – 46 F) for up to 30 days before the withdrawal of the first dose.
WHO has also listed the Pfizer/BioNTech, Astrazeneca-SK Bio, Serum Institute of India and Janssen vaccines for emergency use.

 


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