Search and Hit Enter

FDA delaying decision on Moderna vaccine for adolescents

The Food and Drug Administration (FDA) is delaying its decision on authorizing Moderna’s COVID-19 vaccine for adolescents to check if the shot could increase the risk of heart inflammation, the Wall Street Journal reported on Friday.

The FDA has been looking into the risk of myocarditis among younger men vaccinated with the Moderna vaccine, after certain Nordic countries limited use of the vaccine, said the report.

Earlier this month, Finland, Sweden and Denmark paused the use of Moderna’s COVID-19 shot for younger males due to reports of myocarditis in men.

Denmark later clarified that the Moderna vaccine is indeed available to adolescents.

The UK’s health regulator approved Moderna’s COVID-19 vaccine for use in children aged 12 to 17 years in August.

While the FDA is delaying the decision on Moderna’s vaccine for adolescents, the agency’s expert advisers on Thursday unanimously voted to recommend booster shots of Moderna’s COVID-19 vaccine for Americans aged 65 and older and those at high risk of severe illness or occupational exposure to the virus.

If the FDA signs off on Moderna’s booster, the US Centers for Disease Control and Prevention (CDC) will make specific recommendations on who should get the shots. CDC advisers are scheduled to meet next week.

Thursday’s vote came two days after FDA staff said in documents that data for Moderna’s vaccine showed that the booster does increase protective antibodies.

But they also said the difference in antibody levels before and after the shot was not wide enough by one measure of success specified by the FDA, particularly in those whose antibody levels had remained high.

Source: Arutz Sheva