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Old 05-10-2021, 04:19 PM
 
17,574 posts, read 13,355,792 times
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https://www.aol.com/news/u-authorize...213629358.html


Quote:
U.S. regulators on Monday authorized Pfizer and BioNTech's COVID-19 vaccine for use in children as young as 12, widening the country's inoculation program as vaccination rates have slowed significantly.
The vaccine has been available under an emergency use authorization (EUA) to people as young as 16 in the United States. The vaccine makers said they had started the process for full approval for those ages last week.



The U.S. Food and Drug Administration said it was amending the EUA to include the millions of children aged 12 to 15.
Mod, if not happy with this in H&W, please move to Current Events



Not for pro/anti vaccination discussion. Just for information!


This will move the US closer to herd immunity (probably will never reach it, but the closer we get, the lower the cases become)


ALSO, both Pfizer and Moderna should be approved for FULL, NOT EMERGENCY, use by end of month! Great news
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Old 05-11-2021, 01:28 AM
 
1,013 posts, read 725,242 times
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I think it’s good news. My grandkids are 15 and 13—the girl especially has had difficulty health and emotional, from the almost total isolation. Virtual learning hasn’t been nearly has effective for either one. I hope by fall their schools and sports will be close to normal.
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Old 05-11-2021, 02:12 PM
 
Location: Seattle area
9,182 posts, read 12,128,391 times
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Quote:
Originally Posted by mike1003 View Post
ALSO, both Pfizer and Moderna should be approved for FULL, NOT EMERGENCY, use by end of month! Great news
End of the month? That's the first time I am hearing this. I thought it would take another 6 months at least. Do you have a link?
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Old 05-11-2021, 02:52 PM
 
Location: Georgia, USA
37,102 posts, read 41,267,704 times
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Quote:
Originally Posted by Botev1912 View Post
End of the month? That's the first time I am hearing this. I thought it would take another 6 months at least. Do you have a link?
It may be optimistic but FDA already had the data it needs, I think. It's not as if they are starting from scratch with a new drug application. In addition there is the info coming out of Israel confirming safety and efficacy.
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Old 05-11-2021, 03:49 PM
 
5,713 posts, read 4,286,950 times
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Pfizer is the first COVID vaccine maker to request full approval in the U.S., and it will likely take several months for the FDA to review additional data and make an approval decision.


https://abcnews.go.com/Health/pfizer...ry?id=77549532
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Old 05-12-2021, 01:46 PM
 
4,624 posts, read 9,278,272 times
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Going to get my 13 year old vaccinated as soon as the school year ends at the end of May. Don't want him having side effects the same time as finals but this should be early enough put him in fully vaccinated status by early July and before next school year.
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Old 05-12-2021, 02:28 PM
 
Location: Early America
3,124 posts, read 2,068,179 times
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Quote:
Originally Posted by Botev1912 View Post
End of the month? That's the first time I am hearing this. I thought it would take another 6 months at least. Do you have a link?
Right, the OP made it up.

Quote:
Originally Posted by suzy_q2010 View Post
It may be optimistic but FDA already had the data it needs, I think. It's not as if they are starting from scratch with a new drug application. In addition there is the info coming out of Israel confirming safety and efficacy.
No, it does not, not by a long shot. Your thinking is wrong.
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Old 05-12-2021, 04:04 PM
 
Location: Georgia, USA
37,102 posts, read 41,267,704 times
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Quote:
Originally Posted by SimplySagacious View Post
Right, the OP made it up.



No, it does not, not by a long shot. Your thinking is wrong.
I think the idea that Pfizer had not been providing accumulated data all along is wrong. The licensure request is built on updated info from the phase 3 study. It is not starting over from scratch.

https://www.wsj.com/articles/pfizer-...ne-11620415712

Pfizer has requested priority review from the FDA, which would mean max 6 months and it could come sooner.
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Old 05-12-2021, 07:16 PM
 
175 posts, read 203,619 times
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Pediatricians are already vaccinating kids 12 and up in Georgia using Pfizer starting this week. I don't know about other states.
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Old 05-13-2021, 06:00 AM
 
21,382 posts, read 7,943,676 times
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How long was the follow up in the 12-15 year old group? I think it was only 2,000 kids?

What's the safety data as well as implications on continued developed in these kids?
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