Hours after the Pfizer vaccine was granted full FDA approval. Kill shot doesn't have full approval... not approved for those under 16 and not approved as booster.
I'm not sure where this argument came from (that the shot isn't REALLY approved because it's not approved for everyone) but I'm seeing it everywhere and I hope it vanishes soon because it makes us look uneducated.
FDA approval isn't based on a drug being approved for use on everyone. Simply that it is approved for what is listed on the label. If the label says that it's only for use on those 16 and older, then it's still FDA approved.
Because its EUA is for those 12-15 and approved for label usage, which is 16+. Yes, as crazy as it sounds, it can be both approved for 16 and older and under emergency usage for 12-15. I think you're getting hung up on the word "fully". They're not talking about ages when they say "fully".
The FDA granted the EUA for ages 12-15 after it was already on the market for 16 and older. So I would expect FDA approval for ages 12-15 to be following soon, once they reach whatever time frame they were using for the approval for 16+.
Please note: just because I understand the basics of how FDA approval and EUA work doesn't necessarily mean I agree with their usage.
I just don't want people to look uneducated when they try to tell normies this stuff.
I get it fren, I read the report today as well... I'm only saying that it really isn't 100% approved which still gives hope to us...The fda is playing g with the lives of people and any ammo that can be used against them is needed... Stay safe and be well...
That's what threw me as well. The phase 3 clinical trials aren't supposed to be completed until May 31 2023... But look at ImaSueDeNym's reply for a little more clarity...
Hours after the Pfizer vaccine was granted full FDA approval. Kill shot doesn't have full approval... not approved for those under 16 and not approved as booster.
I'm not sure where this argument came from (that the shot isn't REALLY approved because it's not approved for everyone) but I'm seeing it everywhere and I hope it vanishes soon because it makes us look uneducated.
FDA approval isn't based on a drug being approved for use on everyone. Simply that it is approved for what is listed on the label. If the label says that it's only for use on those 16 and older, then it's still FDA approved.
Question: How can something still be classified EUA and be "fully" approved??? Something smells about this whole thing and it isn't my stink foot...
Because its EUA is for those 12-15 and approved for label usage, which is 16+. Yes, as crazy as it sounds, it can be both approved for 16 and older and under emergency usage for 12-15. I think you're getting hung up on the word "fully". They're not talking about ages when they say "fully".
The FDA granted the EUA for ages 12-15 after it was already on the market for 16 and older. So I would expect FDA approval for ages 12-15 to be following soon, once they reach whatever time frame they were using for the approval for 16+.
Please note: just because I understand the basics of how FDA approval and EUA work doesn't necessarily mean I agree with their usage.
I just don't want people to look uneducated when they try to tell normies this stuff.
I get it fren, I read the report today as well... I'm only saying that it really isn't 100% approved which still gives hope to us...The fda is playing g with the lives of people and any ammo that can be used against them is needed... Stay safe and be well...
How are the trials still ongoing and it’s federally approved?
Because it wasn't given EUA for kids 12-16 at the same time it was given a EUA for 16+.
EUA for 12-15 was given months after the EUA for 16+. So they still have months to go for their protocol to end.
That's what threw me as well. The phase 3 clinical trials aren't supposed to be completed until May 31 2023... But look at ImaSueDeNym's reply for a little more clarity...