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Moderna says FDA needs more time to complete review of its COVID-19 shot for adolescents

Stock Markets Oct 31, 2021 05:42PM ET
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© Reuters. FILE PHOTO: An employee shows the Moderna COVID-19 vaccine at Northwell Health's Long Island Jewish Valley Stream hospital in New York, U.S., December 21, 2020. REUTERS/Eduardo Munoz/File Photo

(Reuters) - Moderna (NASDAQ:MRNA) Inc said on Sunday it has been told that the U.S. Food and Drug Administration will require additional time to complete its assessment of the company's COVID-19 vaccine for use in adolescents aged 12 to 17 years.

The FDA informed Moderna that the review may not be completed before January 2022, the company said in a statement, dealing a potential setback to the timing of an emergency use authorization (EUA) for that age group.

Moderna Chief Executive Stephane Bancel told Reuters last week https://www.reuters.com/business/healthcare-pharmaceuticals/exclusive-moderna-covid-19-shot-could-start-being-used-children-teens-within-2021-10-27 that based on conversations with the agency, he believed the vaccine would be authorized for those 12 to 17 in the next few weeks.

The U.S. biotech company said it was told late on Friday that the FDA needed the additional time to evaluate recent international analyses of the risk of a type of heart inflammation called myocarditis after vaccination, a rare side effect that has primarily affected young males.

Moderna said it is conducting its own review of new external analyses on the increased myocarditis risk in those less than 18 years of age as they become available.

Moderna applied for U.S. authorization of its shot for those aged 12 to 17 in June.

Americans of those ages are eligible for the similar COVID-19 vaccine from Pfizer Inc (NYSE:PFE) and partner BioNTech SE (NASDAQ:BNTX) after it was cleared by the FDA and Centers for Disease Control and Prevention in May.

Moderna also said it will delay filing its request for an EUA for a half strength 50-microgram dose of the vaccine for children ages 6 to 11 while the FDA completes its review of the 12-17 filing.

Moderna says FDA needs more time to complete review of its COVID-19 shot for adolescents
 

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Comments (12)
Rodney Dangerfield
Rodney Dangerfield Oct 31, 2021 10:22PM ET
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I'm still curious why anyone isn't upset they were victims of biological warfare everybody seems to be cool with that I'm still scratching my head from that
Marc Stellrecht
Marc Stellrecht Oct 31, 2021 8:58PM ET
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covaxin approval coming buy Ocugen!
Sol Wein
Sol Wein Oct 31, 2021 8:25PM ET
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This company has never EVER produced an FDA approved anything. Yet here they are with this garbage months after a global pandemic hit. Out of nowhere. Poof, here is a vaccine. Oh and by the way, one of their excutives left the company (while holding millions of stock), to work for the gov Agency that approved the garbage shot for EUA! Go figure
Adamu Abubakar ZAKI
Adamu Abubakar ZAKI Oct 31, 2021 6:58PM ET
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Adamu Abubakar ZAKI
Adamu Abubakar ZAKI Oct 31, 2021 6:58PM ET
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slm
Nguyen Anh
Nguyen Anh Oct 31, 2021 6:35PM ET
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signal of selling ?
Lesko Brandon
Lesko Brandon Oct 31, 2021 6:33PM ET
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And btw fully vaccinated Psaki just tested positive for COVID. This is why vaccine mandates are pointless and exposes low risk people to unnecessary heart risks. Psaki was fully vaccinated and still got infected and poses a risk to those around her.
Al CS
BHome Oct 31, 2021 6:16PM ET
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I won`t touch any of that experimental **** There are known safe treatments that they are ignoring. All of thus had a bad smell to it.
Lesko Brandon
Lesko Brandon Oct 31, 2021 6:13PM ET
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The FDA/CDC has approved/promoted vaccines even against advisory panel guidance and even when other countries have banned their use in younger individuals due to heart risks...you know the data must be horrendous for them to be making this headline/decision. These vaccines do not prevent the spread of the virus, only last a few months, the risk of heart adverse events goes up with every additional shot, and the risk to children with COVID is less than the common flu...but they are still pushing this fearmongering. Completely unrelated to pharma companies sponsoring these news corporations and donating to politicians, I'm sure...
Empire Destroyer
Empire Destroyer Oct 31, 2021 6:13PM ET
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Making money before people's lives... no way... god forbid... which country will USA blame next for their problems?
Stephen Towne
Stephen Towne Oct 31, 2021 6:09PM ET
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Genocide
 
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