Sat, 16 Jan 2021

Moderna submits vaccine data for authorisation

ANI
01 Dec 2020, 10:18 GMT+10

Washington DC [US], December 1 (ANI): US biotech company Moderna said that it has submitted the results of its coronavirus vaccine trials to the country's Food and Drug Administration (FDA) in order to obtain emergency use authorisation for the vaccine.

"Moderna's data for the emergency use authorisation request for mRNA-1273 has been submitted to the US FDA," Moderna tweeted on Monday.

Moderna said that its vaccine efficacy was 94.1 percent and reached 100 percent in severe COVID-19 cases. It has also said the vaccine is generally well tolerated and devoid of serious safety concerns.

As things stand, at least three promising vaccine candidates are expected to receive emergency use authorization from US health authorities in the coming weeks.

On Monday, Moderna announced 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) after the final results from a late-stage study indicated its Covid-19 vaccine candidate is 94.1 per cent effective.

According to an official statement by the company, the primary efficacy analysis of the "Phase 3 study of mRNA-1273 conducted on 196 cases confirms the high efficacy observed at the first interim analysis. The data analysis indicates a vaccine efficacy of 94.1 per cent."Reacting to the announcement made by Moderna, the White House Press Secretary Kayleigh McEnany credited the latest development to "Trump's ingenuity at work.""President Donald Trump's Operation Warp Speed has been an astounding success, delivering multiple vaccines in RECORD time. Today's announcement that Moderna will apply for an EUA after its vaccine demonstrated 94 per cent efficacy is yet another example of Trump ingenuity at work!" said Press Secretary.

According to the latest data by Johns Hopkins University, there are 13,511,194 COVID-19 cases and 267,792 deaths in the US alone. (ANI)

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