FDA investigating whether Moderna vaccine could cause rare side effects in teens
Click to enlarge the image toggle caption Angela Weiss/AFP via Getty Images Angela Weiss/AFP
According to the company, Moderna's COVID-19 vaccine will require more time for approval by the U.S Food and Drug Administration.
This extended timeline was necessary for the FDA to investigate reports of myocarditis (a rare side effect) in patients who have received the shot. Moderna stated that the FDA informed her company on Friday of the delay.
Moderna believes that vaccine recipients' safety is paramount. Moderna stated that the Company is committed to working closely alongside the FDA to support their review.
According to the company, Moderna's request for an emergency authorization of its coronavirus vaccine for adolescents could not have been completed by January. Moderna applied to the FDA for authorization of its coronavirus vaccine in adolescents in June.
Moderna reports that the FDA is currently reviewing "recent international studies" regarding possible side effects.
The Swedish Public Health Agency published a study that showed an increased risk of inflammation in the heart muscle. It was the reason why four countries have stopped giving the vaccine to their young men and women. The European Medicines Agency had approved the vaccine for children aged 12-17 years.
Moderna stated that it does not have access to international data. Moderna estimated that 1.5 million adolescents had been vaccinated and stated that there was no increased risk of myocarditis among those under 18.
Myocarditis has been reported as a side effect of both the Modern and Pfizer BioNTech COVID-19 vaccinations. Myocarditis can also be caused by viral infections, such as COVID-19. Myocarditis is a condition that affects most children and teens.
Recently, the FDA approved Pfizer BioNTech's COVID-19 vaccination for children aged 5-11 years old on an emergency basis. The advisory panel of experts concluded that the risks of COVID-19 for children outweigh any potential side effects.
Moderna was already granted an emergency authorization to use its COVID-19 vaccine for adults.
Sunday's announcement by the company stated that it would not apply for emergency authorization for the vaccine to be administered to children aged 6-11 until the FDA has completed its review.