FDA Needs More Time To Review Moderna Covid Shot For Adolescents
Approval to administer the Moderna mRNA vaccine to those ages 12 to 17 may not come until January, as the Food and Drug Administration tells Moderna that it's pushing out the timeline in order to review more data about the rare risks of heart inflammation.
The FDA Is Probing Whether The Moderna Vaccine Can Cause A Rare Side Effect In Teens
The U.S. Food and Drug Administration will need more time to decide whether to approve Moderna's COVID-19 vaccine for use in children ages 12 to 17, the company announced Sunday. The extended timeline is so the FDA can look into reports of a rare side effect — myocarditis, or the inflammation of the heart muscle — in those who've gotten the shot. Moderna said the FDA informed the company of the delay on Friday. "The safety of vaccine recipients is of paramount importance to Moderna. The Company is fully committed to working closely with the FDA to support their review and is grateful to the FDA for their diligence," Moderna said in a statement. (Hernandez, 10/31)
Moderna: FDA Delaying Decision On Its Shot For Adolescents
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. (11/1)
Moderna Says FDA Needs More Time To Review Its Covid Vaccine For Teens
Moderna also said it will delay filing a request for emergency use authorization for a smaller dose of the vaccine for younger kids ages 6 to 11 while the FDA completes its review. Moderna said on May 25 its Covid vaccine was 100% effective in a study of 12-to-17-year-olds. The company then applied to expand the emergency use of its vaccine for adolescents in June. (Dickler, 10/31)