Moderna Applies for Emergency F.D.A. Approval for Its Coronavirus Vaccine

Moderna Applies for Emergency F.D.A. Approval for Its Coronavirus Vaccine

The drugmaker Moderna announced highly encouraging results on Monday, saying that complete data from a large study show its coronavirus vaccine to be 94.1 percent effective, a finding that confirms earlier estimates.

The company said that it would apply on Monday to the Food and Drug Administration to authorize the vaccine for emergency use, and that if approved, injections for Americans could begin as early as Dec. 21.

The hopeful news arrives at a particularly grim moment in the U.S. health crisis. Coronavirus cases have surged and overwhelmed hospitals in some regions, and health officials have warned that the numbers may grow even worse in the coming weeks because of travel and gatherings for Thanksgiving.

The new data from Moderna show that its study of 30,000 people has met the scientific criteria needed to determine whether the vaccine works. The findings from the full set of data match an analysis of interim data released on Nov. 16 that found the vaccine to be 94.5 percent effective.

 

Moderna headquarters in Cambridge, Mass.

The study also showed that the vaccine was 100 percent effective at preventing severe disease from the coronavirus. The product was developed in collaboration with government researchers from the Vaccine Research Center at the National Institute of Allergy and Infectious Diseases. Stéphane Bancel, the chief executive of Moderna, said in an interview that the company was “on track” to produce 20 million doses by the end of December, and from 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 on 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. More than 100,000 Covid deaths have occurred in U.S. nursing homes and other long-term care centers.

On Tuesday, a panel of advisers to the Centers for Disease Control and Prevention will meet to determine how to allocate initial supplies of vaccine.

 

Emilia
Emilia

0

Dodaj komentarz