COVID-19: Moderna Wants Emergency Approval For Vaccine Use

Moderna, a US pharmaceutical company, says it will approach the United States Food and Drug Administration (FDA) to grant approval for emergency use of its COVID-19 vaccine.

The company made this known in a statement on Monday.

Moderna two weeks ago announced the development of the COVID-19 vaccine which it says has about 95 percent efficacy in treating 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 the statement on Monday, the company averred that 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.

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.

New York Times quoted Bancel to have 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.

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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.

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