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Moderna asking US, European regulators to greenlight Covid-19 vax

Moderna asking US, European regulators to greenlight Covid-19 vax
November 30
19:25 2020

New York, Moderna Inc, which has reported its Covid-19 vaccine is 94 per cent effective, on Monday announced it is filing with US and European regulators for emergency use authorisation.

Moderna follows barely a week after Pfizer and its German partner BioNTech filed for US regulatory approval. By the end of 2020, Moderna expects to have approximately 20 million doses of its mRNA-1273 vaccine available in the U.S and is “on track to manufacture 500 million to 1 billion doses globally in 2021.

Moderna created its shots in collaboration with the U.S. National Institutes of Health and got a final batch of results over the weekend which show the vaccine is more than 94% effective.

Moderna’s efficacy results are based on 196 Covid-19 cases in its huge U.S. study with more than 30,000 participants. Of the 196 cases, 185 were in participants who received the dummy shot and 11 who got the vaccine. Severe cases and one death were reported in participants who got the dummy shot.

Moderna expects to present its data to the US Food and Drug Administration on December 17. First up will be Pfizer and BioNTech, on December 10. Both Pfizer and Moderna are two-shot vaccines.

The US government’s vaccine management chief has said all systems are ready to deliver the vaccines to priority groups within 24 to 48 hours of FDA approval.

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