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Moderna Asks FDA For Emergency Approval Of Its Covid-19 Vaccine In Teens Ages 12 To 17

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This article is more than 2 years old.
Updated Jun 10, 2021, 12:31pm EDT

Topline

Moderna announced that it has filed a request with the FDA for Emergency Use Authorization of its Covid-19 vaccine in teens ages 12 to 17; the agency’s decision could come within weeks.

Key Facts

The company said in a clinical trial of more than 3,700 patients the vaccine was 93% effective at preventing Covid-19 in teenagers who had received one dose, and 100% effective in teens who had received two doses.

There were no serious safety concerns reported in the teen trial, with the most common side effects being injection-site pain, headache, fatigue and chills.

Earlier this week, Moderna also announced that it was asking regulators in the EU and Canada to authorize the use of its vaccine in teens.

The company has already started testing its vaccine in children younger than 12, but has not said when those results will be available.

Key Background

Research shows that kids and teenagers generally have less severe symptoms from the Covid-19 virus than adults do—but that doesn’t mean that they shouldn’t get vaccinated. As more adults across the country get vaccinated and become immune to Covid-19, the virus has moved into the pediatric population, where there are still plenty of susceptible hosts. In the last week of May, children represented almost a quarter of new U.S. weekly Covid-19 cases. Last week, CDC Director Dr. Rochelle Walensky urged teens to get vaccinated due to an increase in cases, several of which saw children in the intensive care unit and on mechanical ventilation. 

In addition, many kids and teens have struggled with school and mental health during the pandemic. Online learning and social isolation have led to a mental health crisis among kids, according to doctors. Vaccines could allow children to resume in-person schooling as early as this fall.  

What To Watch For

There have been several reports of a rare side effect in teens after receiving the Pfizer shot, which is similar to the shot manufactured by Moderna. Seven teenage boys have reported inflammation of the heart muscle, also known as myocarditis, after getting the Pfizer shot. None of the boys were critically ill, and no firm link between the vaccines and this rare side effect has been established yet. Additionally, myocarditis has emerged as a likely complication of Covid-19 disease itself. 

Further Reading

Why Experts Say It’s Vital That Parents Get Their Kids Vaccinated For Covid (Forbes)

Here’s What We Know About Young People Developing Myocarditis After Covid-19 Vaccine (Forbes)

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