Moderna Vaccine Nears European Rollout... EMA Recommends Conditional Marketing Authorization
Moderna, a U.S. pharmaceutical company, COVID-19 vaccine
[Image source=Reuters Yonhap News]
[Asia Economy Reporter Chunhee Lee] The vaccine developed by the American pharmaceutical company Moderna is expected to become the second COVID-19 vaccine approved for use in Europe, following the Pfizer-BioNTech vaccine.
The European Medicines Agency (EMA) announced on the 6th (local time) that it has decided to recommend conditional marketing authorization for Moderna's COVID-19 vaccine.
The EMA's Committee for Medicinal Products for Human Use (CHMP) thoroughly evaluated data on the vaccine's quality, safety, and efficacy, and recommended that the European Union (EU) Commission grant conditional marketing authorization.
Once the EU Commission makes the final official approval decision, each EU member state can begin vaccinations.
EMA Director Emer Cook stated, "This vaccine will be another tool for us to overcome the current emergency," adding, "It is thanks to everyone's efforts and dedication that less than a year after the World Health Organization (WHO) declared the pandemic, we have secured a positive recommendation for a second vaccine."
She further added, "We will continue to protect EU citizens through close monitoring of the vaccine's safety and efficacy."
Previously, on the 21st of last month, the EU Commission approved the COVID-19 vaccine jointly developed by the American pharmaceutical company Pfizer and the German company BioNTech. Member states then began full-scale vaccinations on the 27th of the same month.
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According to Moderna, the final analysis of the phase 3 clinical trial showed that Moderna's vaccine has a preventive efficacy of 94.1%. Like the Pfizer-BioNTech vaccine, Moderna's vaccine was developed using messenger ribonucleic acid (mRNA) containing the virus's genetic information, but unlike the Pfizer vaccine, which requires ultra-cold storage at minus 70 degrees Celsius, Moderna's vaccine can be stored at minus 20 degrees Celsius.
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