US' Moderna seeks emergency FDA approval for its COVID-19 vaccine

US’ Moderna seeks emergency FDA approval for its COVID-19 vaccine

November 30

15:19 2020

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Moderna, a US company, on Monday, says it will apply to the United States Food and Drug Administration (FDA) to authorise its COVID-19 vaccine for emergency use.

Moderna developed the COVID-19 vaccine which it says is about 95 percent effective against the infection.

Its trial of the vaccine reportedly involved 30,000 subjects in the US — with half being given two doses of the vaccine four weeks apart — and the rest given placebos.

In a statement on Monday, the company said the vaccine efficacy against the disease was 94.1 percent while vaccine efficacy against severe COVID-19 was 100 percent.

This development comes 10 days after Pfizer announced that it had submitted an application to the FDA to authorise its COVID-19 vaccine for emergency use.

Pfizer said if the FDA authorises its vaccine, it could produce up to 50 million doses and make it available by the end of 2020 and up to 1.3 billion by the end of 2021.

According to The New York Times, Stéphane Bancel, Moderna’s chief executive, said the first injections may be given as early as December 21 if the process goes smoothly and approval is granted.

Bancel reportedly said the company was “on track” to produce 20 million doses by the end of December, and 500 million to a billion in 2021. Each person requires two doses, administered a month apart, so 20 million doses will be enough for 10 million people.

According to Bancel, the FDA will examine the information while the application is likely to undergo a final review on December 17 by a panel of expert advisers to the agency.

He reportedly said he expects the advisers to make a decision within 24 to 72 hours.

Moderna also said it is seeking authorisation to market its vaccine in Europe, Canada, Britain, Israel and Singapore.

About 63,186,091 COVID-19 infections have been recorded globally since the beginning of the pandemic while 1,467,272 have died from complications arising from the disease.

The US accounts for the largest number of infections with 13,751,337 confirmed cases and 273,101 deaths.