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FDA Approves Antibody Therapy as US Passes 12 Million Cases

A pedestrian walks past a sign advising mask-wearing during the coronavirus outbreak in San Francisco, Nov. 21, 2020.
A pedestrian walks past a sign advising mask-wearing during the coronavirus outbreak in San Francisco, Nov. 21, 2020.

The U.S. Food and Drug Administration on Saturday authorized the emergency use of a COVID-19 antibody therapy that President Donald Trump said helped cure him of the disease caused by the coronavirus.

On the same day, the Johns Hopkins Coronavirus Resource Center reported that the U.S. had passed 12 million COVID-19 cases.

“It’s really a moment that we want to call on every American to increase their vigilance,” Dr. Deborah Birx, the White House coronavirus response coordinator, said this week.

The Regeneron Pharmaceuticals Inc. therapy approved by the FDA is made up of the monoclonal antibodies, casirivimab and imdevimab. They are to be administered together to treat mild to moderate COVID-19 in adults, including those 65 and older with some chronic medical conditions, and children who are at high risk of a more severe case.

The company expects to have enough of the treatment ready for about 200,000 patients by the first week of January.

Canada's chief public health officer, Dr. Theresa Tam, said Friday she expects the number of new daily cases to reach 20,000 per day, up from just under 5,000 per day currently, if Canadians maintain their current number of personal contacts.

However, she warned that number could spike to 60,000 a day by the end of December if Canadians increase their level of contact with other people, a possible scenario with the Christmas holiday season looming.

Canadian Prime Minister Justin Trudeau has called on Canadians to stay home and follow public health rules to help slow the spread of COVID-19.

Friday, U.S. pharmaceutical company Pfizer and its German partner, BioNTech, said they have filed for emergency authorization from the U.S. Food and Drug Administration to use their COVID-19 vaccine, saying they are poised to begin distribution within hours of receiving approval.

The application comes after the companies said testing shows the vaccine has an effectiveness rate of 95%, with no serious safety concerns observed to date.

U.S. Health and Human Services Secretary Alex Azar said Friday that the FDA could decide about emergency use for the vaccine candidate within weeks.

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