FDA takes a longer look at Moderna shot for teens

U.S. regulators are delaying their decision on Moderna’s COVID-19 vaccine for 12- to 17-year-olds while they study the rare risk of heart inflammation.

The U.S. Food and Drug Administration told the company Friday evening that its review could last until January, Moderna said.

The company also said it will delay filing a request for emergency-use authorization of a lower dose of the vaccine for 6- to 11-year-olds.

Heart inflammation is an exceedingly rare risk of both the Pfizer and Moderna vaccines, and it more commonly seen in young men or boys. It’s difficult for clinical trials to detect such a rare problem. And public health officials have repeatedly stressed that COVID-19 itself can cause heart inflammation at higher rates than the rare cases caused by the vaccine.

In the U.S., the Moderna vaccine is authorized for people 18 and older.

Moderna said more than 1.5 million adolescents around the world have received its vaccine and that the number of heart inflammation reports “does not suggest an increased risk” for those under 18.

U.S. children from 12 to 17 can get the vaccine produced by Pfizer and its partner BioNTech.

The FDA last week moved to allow use of the Pfizer shots in children between 5 and 11. The Centers for Disease Control and Prevention is debating that this week.

Moderna also has been testing two shots, one month apart, for children 6 to 11, at half the dose given to adults.

While the Moderna vaccine undergoes more study, the White House said Monday it is shipping millions of doses of the Pfizer-BioNtech vaccine for children 5-11 ahead of a Tuesday meeting of federal health regulators.

The first shots could go into kids’ arms by midweek. Pfizer’s shot has already been authorized for teens.

“We are not waiting on the operations and logistics,” said White House  coronavirus coordinator Jeff Zients.

In other vaccine news, U.S.-based biotechnology company Novavax said Monday that Indonesia has given the world’s first emergency use authorization for its COVID-19 vaccine, which uses a different technology than current shots.

The vaccine is easier to store and transport than some other shots, which could allow it to play an important role in boosting supplies in poorer countries around the world.

The two-dose Novavax vaccine is made with lab-grown copies of the spike protein that coats the coronavirus. That’s very different from widely used mRNA vaccines such as Pfizer and Moderna that deliver genetic instructions for the body to make its own spike protein.

In June, Novavax announced the vaccine had proven about 90% effective against symptomatic COVID-19 in a study of nearly 30,000 people in the U.S. and Mexico. The shot also worked against variants circulating in those countries at the time, it said.

from Boston Herald https://ift.tt/3bwNFi3