U.S. Authorizes Pfizer/BioNTech vaccine for children 12-15 (effects, immunity, emergency)
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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
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.
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.
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.
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.
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
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.
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.
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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