Moderna applies for emergency FDA approval for its coronavirus vaccine

World
By Editor_1
The building housing the headquarters of Moderna Therapeutics in Cambridge, Mass., on May 19, 2020. The drug maker Moderna announced on Monday (16), that its coronavirus vaccine was 94.5% effective, based on an early look at the results from its large, continuing study -Tony Luong/THE NEW YORK TIMES
0
By Denise Grady

WASHINGTON – The drugmaker Moderna said it would apply Monday (30) to the Food and Drug Administration (FDA) to authorize its coronavirus vaccine for emergency use.

The first injections may be given as early as Dec. 21 if the process goes smoothly and approval is granted, said Stéphane Bancel, the company’s chief executive.

Moderna’s application is based on data that it also announced Monday showing that its vaccine is 94.1% effective, and that its study of 30,000 people has met the scientific criteria needed to determine whether the vaccine works. The finding from the complete set of data is in line with an analysis of earlier data released Nov. 16 that found the vaccine to be 94.5% effective.

The new data also showed that the vaccine was 100% effective at preventing severe disease from the coronavirus. The product was developed in collaboration with government researchers from the Vaccine Research Centre at the National Institute of Allergy and Infectious Diseases.

Bancel 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.

Moderna is the second vaccine-maker to apply for emergency use authorization. Pfizer submitted its application Nov. 20. Pfizer has said it can produce up to 50 million doses this year, with about half going to the United States. Its vaccine also requires two doses per person.

The first shots of the two vaccines are likely to go to certain groups, including health care workers, essential workers like police officers, people in other critical industries and employees and residents in nursing homes. On Tuesday (Dec 1), a panel of advisers to the Centres for Disease Control and Prevention will meet to determine how to allocate initial supplies of vaccine.

More than 70 coronavirus vaccines are being developed around the world.

One of those is made by AstraZeneca, which announced positive but puzzling preliminary results Nov. 23: Its vaccine was 90% effective in people who received a half dose and then a full one, but 62% effective in those who received two full doses. Researchers are waiting for more data.

The government has arranged to buy vaccines from both Moderna and Pfizer and to provide it to the public free of charge.

-New York Times

Editor_1
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