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The FDA Delays Their Decision on Using Moderna COVID Shot For Children Above 12 Years Old

The pharmaceutical giant Moderna stated on Sunday that the U.S. Food and Drug Administration (FDA) delayed their decision on whether they should approve the Moderna COVID vaccine for children aged 12 and above.

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According to the official statement released by 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 stated, while adding that the “safety of vaccine recipients is of paramount importance to Moderna.

“Moderna added it would delay filing a request for an emergency use authorization for a smaller dose of its mRNA vaccine among children aged 6 to 11. Late last week, the FDA granted emergency use authorization of pharmaceutical giant Pfizer’s COVID-19 vaccine for children in that age group, although the U.S. Centers for Disease Control and Prevention (CDC) has to sign off on it before it can be distributed.”

In the United States, Moderna’s two-dose vaccine is only available to those aged 18 and older.

However, the Scandinavian countries, including Sweden and Finland have stopped the usage of the Moderna shot to younger adults and children—primarily younger males—due to the risk of myocarditis. Their decision took place last month.

The FDA issued a response in mid-October after the Nordic countries had limited Moderna’s usage, again stating that the shot’s benefits outweigh the risks.

“The FDA is aware of these data. At this time, FDA continues to find that the known and potential benefits of vaccination outweigh the known and potential risks for the Moderna COVID-19 Vaccine,” an FDA official said in a statement in response to the Nordic nations’ decision to suspend the vaccine for certain age groups.

Moderna’s Sunday statement noted that about 1.5 million children have been given its COVID-19 vaccine, adding that the risk of myocarditis appears to be small.

“An increased risk of myocarditis has been described for COVID-19 vaccines, including the Moderna COVID-19 vaccine, particularly in young men and following the second dose,” the Cambridge, Massachusetts-based company stated.

“Moderna is committed to conducting its own careful review of new external analyses as they become available,” Moderna said, but it stressed that “the company does not yet have access to data from some recent international analyses.”

What’s your personal opinion on this? Would you vaccinate your own child with the Moderna shot?

Source
investors.modernatx.comtheepochtimes.com

Ava Garcia

A small town girl, dreaming big, expecting to change the world with presenting the truthful events of the world today. Law degree with a master in criminology, and a devoted journalist for over 7 years, and counting. "The pen is mightier than the sword."

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