US regulators they delayed their decision to apply the modern anti-COVID-19 vaccine in adolescents (12 to 17 years old) while they study an unusual risk of cardiac inflammation that it can cause, according to the pharmacist reported on Sunday.
The US Food and Drug Administration (FDA) asked the company on Friday for a review, which could take until January, Moderna said.
The company also said that delay the submission of a request for authorization for emergency use of a lower dose of the vaccine for children 6 to 11 years of age.
Inflammation of the heart is an extremely rare risk in both Moderna’s and Pfizer’s vaccines, and it is most frequently recorded in young men and boys. It is difficult to detect the problem in clinical trials. And public health authorities have repeatedly stressed that COVID-19 itself can cause inflammation at a higher incidence than rare cases caused by the vaccine.
In the United States, Moderna’s vaccine It is authorized for use by people over 18 years of age.
Moderna pointed out that more than 1.5 million adolescents worldwide have received the vaccine and that the number of reports of heart inflammation “does not suggest an increased risk” for those under 18 years of age.
In the United States, children ages 12 to 17 can receive the vaccine produced by Pfizer and its partner BioNTech.
The FDA took steps last week to allow the use of Pfizer’s vaccine in children ages five to 11. The Centers for Disease Control and Prevention (CDC) will debate the issue this week.
Modern It has also been testing two injections, one month apart, for children ages six to 11, with half the dose for adults.