A+ A-

Moderna to apply Monday for FDA authorization for its Covid-19 vaccine

WASHINGTON, Nov 30 (KUNA) -- Biotechnology company Moderna announced Monday that it plans to request an Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) and conditional approval from the European Medicines Agency (EMA) for its coronavirus vaccine.
The company said in a statement that the "vaccine efficacy against COVID-19 was 94.1 percent," and that "efficacy against severe COVID-19 was 100 percent." "A continuous review of safety data is ongoing and no new serious safety concerns have been identified by the Company," it affirmed.
Chief Executive Officer of Moderna Stephane Bancel said in this regard "webelieve that our vaccine will provide a new and powerful tool that may change the course of this pandemic and help prevent severe disease, hospitalizations and death." By the end of 2020, the Company expects to have approximately 20 million doses of the vaccine available in the US, saying it "remains on track to manufacture 500 million to one billion doses globally in 2021." (pickup previous) si