J&J seeks FDA OK for vaccine booster doses
By The Associated Press
WASHINGTON – Johnson & Johnson has asked U.S. regulators to allow booster shots of its COVID-19 vaccine as the U.S. government moves toward shoring up protection in more vaccinated Americans.
J&J says it filed data with the Food and Drug Administration on giving a booster dose between two to six months after vaccination. The U.S. government last month authorized booster doses of Pfizer’s vaccine in vulnerable groups.
A panel of FDA advisers meets next week to consider boosters for both J&J and Moderna vaccines. It’s part of a sweeping effort by the Biden administration to boost protection amid the delta variant and potential waning of vaccine strength.
The FDA is convening its outside panel of advisers next week to review booster data from both J&J and Moderna. It’s the first step in a review process that also includes sign-off from the leadership of both the FDA and the Centers for Disease Control and Prevention. If both agencies give the go-ahead, Americans could begin getting J&J and Moderna boosters later this month.
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LONDON – Officials with drugmaker AstraZeneca have asked the U.S. Food and Drug Administration to authorize the emergency use of an antibody treatment to prevent COVID-19.
The company says the treatment, known as AZD7442, will be the first long-acting antibody combination to receive an emergency use authorization for COVID-19 prevention. AstraZeneca says the drug may help protect people whose immune systems don’t fully respond to vaccination.
U.S. demand for antibody treatments soared over the summer, particularly in Florida, Louisiana and Texas, where hospitalizations among unvaccinated patients threatened to overwhelm the health care system.
The drugs are lab versions of virus-blocking antibodies that help fight off infections. The treatments help the patient by supplying concentrated doses. The main antibody treatment used in the U.S. is Regeneron’s dual-antibody cocktail.
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10/5/2021 7:24:40 AM (GMT -5:00)