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U.S. FDA advisers overwhelmingly back Moderna COVID vaccine for ages 6-17

Stock Markets Jun 15, 2022 04:26AM ET
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© Reuters. FILE PHOTO: A pharmacist holds a vial of the Moderna coronavirus disease (COVID-19) vaccine in West Haven, Connecticut, U.S., February 17, 2021. REUTERS/Mike Segar

By Manas Mishra and Michael Erman

(Reuters) -Advisers to the U.S. Food and Drug Administration on Tuesday unanimously recommended that the agency authorize Moderna (NASDAQ:MRNA) Inc's COVID-19 vaccine for children and teens aged 6 to 17 years of age.

Around 77 million people in the United States have received at least a two-dose course of Moderna's vaccine, which has long been available for people aged 18 and older.

The committee of outside experts is scheduled on Wednesday to consider the Moderna shot for children under 6, and Pfizer (NYSE:PFE) and BioNTech's COVID vaccine for children under 5 - and in both cases as young as 6 months.

There is unlikely to be significant immediate demand the Moderna shots for 6- to 17-year olds. The Pfizer/BioNTech vaccine was authorized for children aged 5 to 11 in October, and approval for teenagers preceded that by months.

Yet only around 30% of those ages 5 to 11 and 60% of 12- to 17-year olds are fully vaccinated in the United States, according to data from the U.S. Centers for Disease Control and Prevention (CDC).

"I'd like to give parents as many choices as possible, and let them make the decisions about this for their children," committee member and UC Berkeley professor Dr. Arthur Reingold said at the meeting.

The FDA - which generally follows the recommendations of its advisers but is not obligated to do so - is likely to authorize the Moderna vaccine for ages 6-17 soon. The CDC also needs to recommend the vaccine's use. A committee of its advisers is scheduled to meet Friday and Saturday.

There have long been concerns that the Moderna vaccine, which is given at a higher dose than the Pfizer/BioNTech shot, may cause types of heart inflammation known as myocarditis and pericarditis at higher rates, primarily in younger males.

Some countries in Europe have limited use of Moderna's vaccine for younger age groups after surveillance suggested it was tied to a higher risk of heart inflammation, and the FDA delayed its review of the shot to assess the myocarditis risk.

U.S. regulators presented data at the meeting on Tuesday suggesting that Moderna's vaccine may have a higher risk of heart inflammation in young men, but said the findings were not consistent across various safety databases and were not statistically significant, meaning they might be due to chance.

U.S. FDA advisers overwhelmingly back Moderna COVID vaccine for ages 6-17
 

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Comments (5)
deez nutzz
deez nutzz Jun 15, 2022 5:15AM ET
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FDA is bought and paid for by the pharmaceutical companies. kick backs and "gifts" for authorization. guarantee you the FDA isn't vaccinating their own children. rather take my chances with my own immune system that had protected humans for 100s of thousands of years then a man made chemical compound that has no long term health data and track data. no thank you. disgusting
Berthe Ablo
Berthe Ablo Jun 15, 2022 4:29AM ET
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naza0153907499
Berthe Ablo
Berthe Ablo Jun 15, 2022 4:26AM ET
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Berthe Ablo
Berthe Ablo Jun 15, 2022 4:25AM ET
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fyobkhi
Chinsect Stomper
Chinsect Stomper Jun 14, 2022 8:52AM ET
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Working as intended, now get your kids vaccinated so they can have heart problems too!
Tiffany Tran
Tiffany Tran Jun 14, 2022 8:52AM ET
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Are you suggesting that parents should not get their kids vaccinated ? I really don't think you're capable of making such recommendations. Vaccine does work in preventing severe symptoms of Covid-19 and deaths. Of course, any newly developed vaccines will have certain side effects, it can't be 100% effective without any drawbacks. Nothing is an absolute here. So please don't use this investment platform as a way to spread misinformation, causing unnecessary loss of lives!
Tiffany Tran
Tiffany Tran Jun 14, 2022 8:52AM ET
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Are you suggesting that parents should not get their kids vaccinated ? I really don't think you're capable of making such recommendations. Vaccine does work in preventing severe symptoms of Covid-19 and deaths. Of course, any newly developed vaccines will have certain side effects, it can't be 100% effective without any drawbacks. Nothing is an absolute here. So please don't use this investment platform as a way to spread misinformation, causing unnecessary loss of lives!
Jeremy Johnson
Jeremy Johnson Jun 14, 2022 8:52AM ET
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Tiffany Tran the drawbacks are many, one of which is death. Covid is not life threatening for the very age group these vaccine companies are targeting. The safety data is minimal and what we do know is not good, and there’s no longterm safety data. Vaccinating childrem agsinst Covid is reckless.
Jeremy Johnson
Jeremy Johnson Jun 14, 2022 8:52AM ET
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Jeremy Johnson Vaccinating children against Covid is reckless.
Mo Ali
Av8er31 Jun 14, 2022 8:52AM ET
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Tiffany Tran  Just look at Bieber and his girlfriend, both suffering enormous health issues, look at all the healthy people getting sick, heart palps, and side affects from vaccinations. If they are so "safe and effective" and you want kids to get vaccinated, well then, remove liability protections from pharmaceutical companies. Problem solved.
 
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