Experts say FDA should clear Moderna COVID: Shots recall


A nurse draws a dose of vaccine from a vial of Moderna’s COVID vaccine at the Cameron Grove Community Center in Bowie, Md., In March.

Win McNamee / Getty Images


hide caption

toggle legend

Win McNamee / Getty Images


A nurse draws a dose of vaccine from a vial of Moderna’s COVID vaccine at the Cameron Grove Community Center in Bowie, Md., In March.

Win McNamee / Getty Images

On Thursday, a group of Food and Drug Administration advisers unanimously recommended that the agency allow a booster dose of the Moderna COVID vaccine at least six months after the initial two-dose regimen ends.

The recommendation applies to people 65 and over, 18 to 64 years of age who are at high risk of severe COVID, and people in the same age group whose work or institutional exposure puts them at high risk of COVID.

The recommendation reflects the FDA clearance for Pfizer-BioNTech in September.

The 19-0 vote came after presentations by representatives from the FDA and Moderna and committee discussions. The FDA generally follows the advice of its advisory committees, although it is not obligated to do so.

Moderna’s COVID-19 vaccine booster is half the dose of the initial injections used in her two-shot vaccination – 50 micrograms of mRNA versus 100 micrograms.

To set the stage, Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, made opening remarks as the meeting began Thursday morning. “Vaccines always offer strong protection against serious consequences,” he said. “The vaccine’s effectiveness against mild and moderate illness appears to decrease over time. And mild to moderate illness can lead to blood clots and long-term COVID.”

The panel heard from researchers in Israel who provided an update on the experience with the Pfizer-BioNTech booster, which uses the same type of mRNA technology as Moderna’s vaccine.

“Administering the booster dose helped Israel alleviate infections and severe cases in Wave 4,” said Dr Sharon Alroy-Preis, director of public health services at Israel’s Ministry of Health. An analysis of side effects, including heart inflammation, was reassuring, she said, especially for the issues of greatest concern. “I am very confident about serious events.”

Several committee members said the Israeli data shed important light on the role of boosters and was compelling.

Some committee members said consistency with the previous action on the Pfizer-BioNTech booster was also important.

“I support this [emergency use authorization] because we’ve already approved it for Pfizer, and I don’t see how we can not approve it for Moderna and have most people in the United States completely confused, ”said Dr. Stanley Perlman of the ‘University of Iowa. “I think it’s a pragmatic question.”



Source Link

Please follow and like us: