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rurallib

(62,406 posts)
3. any idea when it might be authorized?
Mon Aug 16, 2021, 04:18 PM
Aug 2021

At one point I thought I heard early September. We should be hearing something soon.

SYFROYH

(34,169 posts)
10. I don't think its fair to call schools death camps. Few children are dying.
Mon Aug 16, 2021, 04:48 PM
Aug 2021

Yes, more are getting sick and some will have long term issues, but not death camp rates.

[url=https://ibb.co/YjG5vvM][img][/img][/url]

Lars39

(26,109 posts)
5. Sorry, no.
Mon Aug 16, 2021, 04:22 PM
Aug 2021

Can’t even remember if it was something I heard in interview or read in an article. Investors been holding onto to that statement ‘cause I have a grand child close to 5.

rurallib

(62,406 posts)
6. Just found this - says mid-winter - Jesus mid-winter!
Mon Aug 16, 2021, 04:25 PM
Aug 2021
https://www.nbcnews.com/health/health-news/vaccines-kids-under-age-12-expected-mid-winter-fda-official-n1274057

Covid-19 vaccines have only been authorized for people ages 12 and up in the U.S., and none has received full approval yet.

Both Moderna and Pfizer-BioNTech launched trials of their Covid-19 vaccines for kids under 12 in March. Results are expected in the fall, and it will take FDA officials time to review the drug companies' applications.

The regulatory agency is asking for four to six months of safety follow-up data for kids under age 12, the FDA official said. Just two months of follow-up data was required for the clinical trials in adults.

That additional data could make the process of granting full approval easier. Six months of follow-up data is needed for what is known as a biologics license application, or BLA.

Pfizer and Moderna have applied for full licensure of their vaccine for adults 18 and up. The FDA official said granting full approval for adults is the agency's highest priority.

LisaL

(44,973 posts)
15. It's because of myocarditis observed in some of teen boys and young males.
Mon Aug 16, 2021, 07:32 PM
Aug 2021

SO FDA decided to require more safety data for kids under 12 after the heart inflammation cases in mostly young males.

FrankChurchDem

(12,690 posts)
13. FDA asked Moderna to increase the size of the ongoing study
Mon Aug 16, 2021, 07:22 PM
Aug 2021

That was a week or two which indicates that they're not comfortable with something they're seeing..

LisaL

(44,973 posts)
14. As far as I can tell, it's not because of something they are seeing at the trial itself.
Mon Aug 16, 2021, 07:26 PM
Aug 2021

This is due to the side effect seen in some cases of teen boys getting heart inflammation after being vaccinated. Not clear if the same thing would happen to children under 12.
FDA wants to make sure that vaccine is safe for young children.

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