Pharmaceutical giant Pfizer announced Thursday that it has formally submitted data to federal health regulators that its COVID-19 vaccine is safe and effective for children ages 5-11.
The trial for the two-dose vaccine co-developed by Pfizer and the biotechnology company BioNTech included 2,268 participants between ages 5 and 11 and “demonstrated a favorable safety profile and elicited robust neutralizing antibody responses,” according to a statement Pfizer released last month on the trial’s initial study data.
The U.S. Food and Drug Administration is expected later this month or early in November to approve the vaccine for emergency use authorization, a designation under which federal regulators have approved vaccination of older cohorts prior to the vaccine’s formal approval, but which still requires detailed clinical trial data showing the immunization’s safety and efficacy.
Once approved by federal regulators, children age 5-11 will receive a slightly smaller dose of the vaccine than subjects in the vaccine’s first study, which included people age 16 and older.
The Pfizer vaccine is the only vaccine available in the U.S. that has received full authorization from the FDA in any age cohort — in this case, people ages 16 and older.
Children ages 12-15 are also currently eligible for the Pfizer vaccine under emergency use authorization. Additional clinical trials for the vaccine’s safety and efficacy among children age 4 and younger are still ongoing.
An FDA advisory panel is expected to consider the Pfizer’s trial data for children 5-11 on Oct. 26. If the panel deems the data sufficient, it will then recommend emergency use authorization by the FDA itself.
At what point do people realize these companies don’t care about doing what makes sense or what’s best for kids, they only care about taking as much taxpayer money as they can from scared people willing to let companies experiment on their kids…..
Fear sells.
Ahhhhh, yes….the “emergency use” drug. 👍 By all means, give to the children. 👍
Why perpetuate the lies Claycord? There are actually two Pfizer vaccines, 1) the FDA approved but unavailable Comirnaty and 2) the currently available but EUA vaccine also by Pfizer. (see page 2, footnote 8) https://www.fda.gov/media/150386/download
If you want to say that they are formulaically identical, but “legally distinct”, that’s fine. But why not use the extra sentence to accurately explain the situation. Why continue to mislead people?
Also Pfizer is seeking FDA approval for kids, because it will grant then greater legal immunity. Once granted this greater legal immunity, we will then likely see Comirnaty become widely available.
I suspect the Comirnaty branding was to make a distinction between the EUA version and the commercial version Comirnaty so no one could sell any leftover EUA versions which of course might happen and instead have a resale version available (Comirnaty).
Wow amazing. How long have you been watching Judge Judy to become such a legal genius yoyohop?
@ Captain Bebops, You raise a plausible explanation – except the effectiveness of such a strategy would rely on widespread public knowledge that there is a distinction between the EUA and FDA version of the drug. The majority of people have no idea what Comirnaty even it.
The other aspect to these Big Pharma shenanigans is that a drug is not supposed to be EUA if there is an available FDA approved alternative. Thus if Comirnaty became widely available, all of the other EUA vaccines would either have to discontinued or become FDA approved as well.
🤣🤣🤣 Look at little jwb trying to edge in on some grown folks conversation. Judge judy?? Really guy? You sound so desperate. Go ahead and tell us what the difference is and why COMIRNATY (the only approved shot) is not available anywhere but Israel. Go on, we’re waiting. Then go on and tell us why your boy ain’t shooting straight with his “mandates” that osha knows nothing about.
biden dictating from the podium is not law. It’s a old schmuck babbling. Game recognize game.
Let’s go Brandon!!!
What’s best for Gavin:
Sept 27, 2021
LA Times
“Gavin Newsom fights COVID vaccine mandate for prison guards”
And you think he cares about the kids?
Child abuse, plain and simple.
Will!! Finally, someone with a brain. 100% agree
Wow who sent their child to get experimented on
Is this where we are
Or rather dem voters
Sending their children to gov science experiment
Lest we forget the scientist said children are not effected
And pose no risk
Now they are mandated to succumb to gov wishes and demands
America sunk by a dem voter self absorbed hatred torpedo
On their children’s future and health
Stupid is as stupid does…
I think most parents won’t be stupid to give the to their kids with it shoved thru stages not completely done mm
EUA is mentioned several times along with clinical trails; thus should be a wake up call. Pfizer won’t be FULLY approved until 2024/25. Per Phizer, because I called Phizer directly, there is nothing new about the “new” vaccine. Comirnaty is just renaming the original name for marketing purposes. When you do your own research and make your own phone calls and ask your own questions, you get the truth.
Time to call a General Strike, bring it to a grinding halt.
I hope all of America realizes that all of this nonsense has nothing to do with a virus this is an absolute takeover of our country by globalists and socialists Biden was installed for a reason and you are seeing it play out we already have tens of thousands of deaths due to this shot that they want to push on our children now not to mention the hundreds of thousands of injuries and now they want to do the same thing to our children how many of them have to die or become permanently injured they will never put it into this as long as people comply over 60 studies prove that mask do nothing to prevent the spread of a virus but yet here we are wearing masks again it amazes me that the things that do not work we keep trying the social distancing the masks I cannot leave any reasonable person would be willing to subject their child to an experimental gene therapy injection this nation is in a world of hurt if we do not stand up for our rights we will have no rights left. Just so we’re clear I did not vote for Biden anybody that knows his history knows what a liar he is and now with his cognitive decline things are much worse it makes me wonder who was actually running this country is it China
Yea, let’s load up our kids with a shot even though you still have to wear masks everywhere you go. Sounds legit.