Coronavirus tally: FDA to approve omicron-specific booster shots before data from study is available

The Food and Drug Administration is expected to authorize new COVID-19 booster shots this week that target the latest versions of the omicron variant but will do so without data from a study showing the shots were safe and worked in humans, the Wall Street Journal reported. Clearance of the doses, without data from human testing known as clinical trials, is similar to the approach the FDA takes with flu shots, which are updated annually to keep up with mutating flu viruses. “Real world evidence from the current mRNA COVID-19 vaccines, which have been administered to millions of individuals, show us that the vaccines are safe,” FDA Commissioner Robert Califf said in a recent tweet. The news comes as U.S. known cases of COVID are continuing to ease, although the true tally is likely higher given how many people are testing at home, where the data are not being collected. The daily average for new cases stood at 88,391 on Sunday, according to a New York Times tracker, down 14% from two weeks ago. The daily average for hospitalizations was down 10% at 38,252, while the daily average for deaths is down 2% to 478. Globally, the confirmed case tally rose above 601 million on Monday, according to data aggregated by Johns 2Hopkins, while the death toll is above 6.48 million with the U.S. leading the world with 94.1 million cases and 1,043,840 deaths.