FDA approves J&J’s 1-dose shot, giving U.S. 3rd COVID-19 vaccine
The U.S. is getting a third vaccine to prevent COVID-19, as the Food and Drug Administration on Saturday cleared a Johnson & Johnson shot that works with just one dose instead of two.
“The more vaccines that have high efficacy that we can get into play, the better,” Dr. Anthony Fauci, the top U.S. infectious disease expert, said ahead of the FDA’s ruling.
Shipments of a few million doses to be divided among states could begin as early as Monday. By the end of March, J&J has said it expects to deliver 20 million doses to the U.S., and 100 million by summer.
“We’re going to use every conceivable way to expand manufacturing of the vaccine — the third vaccine — to make even more rapid prog- ress at getting shots in people’s arms,” President Joe Biden said Friday in Hous- ton, where he had traveled to showcase the government’s latest mass vaccination site.
The shots can’t come fast enough.
As Saturday dawned, the United States had recorded about 28.5 million corona- virus cases — representing more than 8% of the population — and a staggering 510,373 deaths. And it will be many weeks before vaccinations make a dent in the pandemic. Meanwhile, the virus has been mutating, creating variants that may partly sidestep the immune system.
Daily case numbers are about where they were in October, far below the sin- gle-day record of about 300,000 infections set in early January. And daily vaccination numbers have started to increase again after a decline brought on by severe weather.
Yet federal health officials warned impatient governors against relaxing pandemic control measures, saying that the recent steep drop in cases and deaths could be leveling off.
The seven-day average for new cases — 69,483 as of early Saturday — has been tick- ing up. Progress has largely stalled in New York City, where the latest coronavi- rus variant was discovered this past week. And another concerning version of the virus is spreading at a rapid pace in California.
“Things are tenuous,” Dr. Rochelle Walensky, director of the Centers for Disease Control and Prevention, said Friday. “Now is not the time to relax restrictions.”
More than 68 million shots have been given since vaccinations began in December. The country is averaging about 1.5 million reported vaccinations a day.
The Johnson & Johnson shot, which was unanimously endorsed Friday by a panel of experts advising the FDA, had an overall efficacy rate in clinical trials of 72% in the United States and 64% in South Africa, where a concerning variant emerged in the fall. It also showed 86% efficacy against severe COVID-19 in the United States, and 82% in South Africa.
On Friday, Biden described the federal government’s mass inoculation drive as “the most difficult operational challenge this nation has ever faced logistically.” He said he expected challenges in reaching people in remote areas and in persuading others who are “hesitant to take the shots.”
“We all know there’s a history in this country of subjugating certain communities to terrible medical and scientific abuse,” Biden said. “But if there’s one message that needs to cut through all this: The vaccines are safe. I promise you.”