A panel of independent advisers to the Food and Drug Administration is recommending that the agency issue an emergency use authorization for the Pfizer-BioNTech vaccine in children ages 5 to 11 years old. The vote was 17 in favor and one abstention.
The FDA panel accepted Pfizer's data indicating the vaccine is safe and 90.7% effective in preventing COVID-19 infections in this age group.
The agency typically goes along with the advice of its expert panels, though it isn't bound to do so. It will issue a decision within the next several days. If the FDA authorizes the vaccine for these younger children, as seems likely, another panel of experts advising the Centers for Disease Control and Prevention would make its own recommendations and offer guidelines next week on its use among this age group.
The vaccine provides a broad defense against COVID-19 and "effectively neutralized the delta variant" in young kids, said Dr. William Gruber, senior vice president of vaccine clinical research and development at Pfizer, speaking during the committee hearing.
A dose of Pfizer for young children contains one-third the amount of active ingredient compared to the adult dose. Children would receive a second dose 21 days or more after their first shot.
Gruber said the dose size was chosen to "strike the right balance" between providing strong immunity and limiting side effects. He said that the observed adverse effects seen in the company's studies "did not suggest any safety concerns." An FDA review supported that conclusion.
Children 5-11 years of age have accounted for approximately 9% of reported COVID-19 cases in the U.S. overall, and currently account for approximately 40% of all pediatric COVID-19 cases, says Dr. Doran Fink, clinical deputy director of the division of vaccines and related products for the FDA. Currently, the case rate among children ages 5 to 11 is "near the highest" of any age group, he says.
Fink and others testifying at the meeting acknowledged that serious effects of infection, including long COVID-19, hospitalizations and deaths are less frequent among children than among adults. But they also argued that the significant numbers of serious illness in young children warrant concern.
Unvaccinated children with COVID-19 can develop a serious complication called multisystem inflammatory syndrome or MIS-C, as well as an inflammation of the heart muscle called myocarditis.
Myocarditis occurs naturally after infections with other viruses and it has also been seen as a rare side effect after vaccination with the two mRNA vaccines, Pfizer and Moderna, especially in young men.
"The annual risk of hospitalization due to Covid-19 for a healthy school age boy even with no prior immunity could conceivably drift down to a level approaching the risk of hospitalization from a second Pfizer vaccination. I have been informed in past months that this is a “fringe” belief, but as of this week Pfizer rather surprisingly admits this possibility in their documents for FDA review! In times of low community prevalence, they state: “the model predicts more excess hospitalizations due to vaccine-related myocarditis/pericarditis compared to prevented hospitalizations due to COVID-19 in males and in both sexes combined.”
Thanks kris,
Good source and points except it's a big cherry pick........and I'll explain exactly why.
"In times of low community prevalence, they state: “the model predicts more excess hospitalizations due to vaccine-related myocarditis/pericarditis compared to prevented hospitalizations due to COVID-19 in males and in both sexes combined.”
metmike:
1. In others words, the quote above says that when there isn't much COVID, the risk from vaccinations outweigh the benefits.....for this age group. Dugh! When there isn't much COVID..............there aren't many benefits........period. However, there is a very high rate of COVID right now........that's the ENTIRE REASON they authorized the vaccinations for this age group. We are in the middle of battling a worldwide pandemic that is much worse in the US because people refuse to get vaccinated here because of the anti science politics. If there wasn't much COVID...........most of us wouldn't need a vaccine!
2. Comment from somebody reading the article that I agree with. "This article completely ignores the risk of infected children bring the virus home and infecting older adults in the household. Could be deadly to some. How can you discuss the vaccination mandate for children without considering the secondary infections they may cause? Not very professional."
metmike: This is what they actually stated below. You should read it, in case you haven't already. The paragraph below summarizes exactly what their decision was based on everything........ no cherry picks.
https://www.fda.gov/media/153447/download
"DA conducted a quantitative benefit-risk analysis to evaluate predicted numbers of
symptomatic COVID-19 cases, hospitalizations, ICU admissions, and deaths that would be prevented per million fully vaccinated children 5-11 years of age over a 6-month period, as compared with predicted numbers of vaccine-associated excess myocarditis cases, hospitalizations, ICU admissions and deaths per million fully vaccinated children 5-11 years of age. The model conservatively assumed that the risk of myocarditis/pericarditis associated with
the 10 μg dose in children 5-11 years of age would the same as the estimated risk associated with the 30 μg dose in adolescents 12-15 years of age from Optum healthcare claims data.
While benefits of vaccination were highly dependent on COVID-19 incidence, the overall
analysis predicted that the numbers of clinically significant COVID-19-related outcomes
prevented would clearly outweigh the numbers of vaccine-associated excess myocarditis cases over a range of assumptions for COVID-19 incidence. At the lowest evaluated COVID-19 incidence (corresponding to the June 2021 nadir), the predicted number of vaccine-associated myocarditis cases was greater than the predicted number of COVID-19 hospitalizations
prevented for males and for both sexes combined. However, in consideration of the different clinical implications of hospitalization for COVID-19 versus hospitalization for vaccine-associated myocarditis, and benefits related to prevention of non-hospitalized cases of COVID-19 with significant morbidity, the overall benefits of the vaccine may still outweigh the risks under this low incidence scenario. If the myocarditis/pericarditis risk in this age group is lower than the conservative assumption used in the model, the benefit-risk balance would be even more favorable."
kris,
I'm very grateful to you for bringing this stuff up here in the age of vaccine disinformation because many others probably read distorted interpretations like this and won't take the time to go fact finding or use objectively to apply critical thinking and discernment.
Most people will just simply............believe it.
"Good source and points except it's a big cherry pick"
Not a big cherry pick Mike, it just states what many in the medical community, including the author believe:
"The data creates real uncertainty over personal and societal benefit for universal vaccination. It is Pfizer’s corporate duty to seek the broadest possible implementation of its vaccine, but even its most prominent board member is warning us: it’s too soon to mandate these vaccines to children. Our public health experts need to listen."
The author cherry picked kris. I showed you that. Siting a cherry picker doesn't make it not a cherry pick.
I showed you what the actual report said. Did you not read it?
I'm not even giving you my opinion. I'm just giving you the actual report and statements by those that issued the report.
Picking out an individual with an opinion that disagees with the majority and the formal statements/ruling by that body/entity is called using an outlier or cherry picking in science.
"Picking out an individual with an opinion that disagees with the majority and the formal statements/ruling by that body/entity is called using an outlier or cherry picking in science."
The individual: Buzz Hollander, MD, doesn't disagree with the majority, he is all for vaccinations.
He just demonstrates through statistical evidence that it may not be wise and/or beneficial to issue another mandate requiring young kids to get vaccinated.
You mention "cherry picking in science", so again: how about this scientist then:
"Pfizer’s most prominent board member is warning us: it’s too soon to mandate these vaccines to children. Our public health experts need to listen."
No problem in you quoting an individual that disagrees with the majority but says something that you like.
It's the quintessential example of a cherry pick, since you use that individuals quote only because it supports what you believe while ignoring all the more compelling data that contradicts that.
https://www.developgoodhabits.com/cherry-picking/
"Cherry picking is a logical fallacy that happens when someone focuses solely on evidence that supports their position on a claim and ignores any information that goes against their defense.
For example, someone engaging in cherry picking might reference only a few studies published on a certain topic in an effort to make it appear that science supports their stance. In this case, cherry picking is done intentionally, taking advantage of its persuasive rhetorical value to convince someone of something."
metmike: I posted a link to the actual comprehensive report about this and its summary and didn't go to a link that had an author that gave an interpretation that I liked or quoted a particular source that I liked(like you did)
That's NOT cherry picking
"says something that you like"
"supports what you believe"
"an author that gave an interpretation that I liked or quoted a particular source that I liked(like you did)"
Several assumptions on your part, again...?
You are totally side stepping the conclusion of one of the science communities' members:
"Pfizer’s most prominent board member is warning us: it’s too soon to mandate these vaccines to children. Our public health experts need to listen."
Must be dang good assumptions because you just repeated it and said that we needed to listen....which was your opinion interjecting.
Repeating it again, doesn't make it any more powerful or any less of a cherry pick but it does solidly confirm that it's what you too believe.
kris,
I thought you were against silly, beating a dead horse arguments that keep repeating the same things over and over?
This was you right?
Re: Re: Re: Re: Re: More censorship
By kris - Oct. 14, 2021, 5:07 p.m.
Could we just stop beating the dead horse already, darn this is getting old.
https://www.marketforum.com/forum/topic/76325/#76334
By kris - Oct. 17, 2021, 11:12 p.m.
Another dead horse? Really ... ?
"said that we needed to listen"
Never did I say anything of the sort.
"it does solidly confirm that it's what you too believe"
Another assumption on your part.
It is truly baffling to me that you make all these assumptions just because I posted some excerpts from an article I thought to be insightful. You don't know what I believe or like so just stop.
"I thought you were against silly, beating a dead horse arguments that keep repeating the same things over and over?"
You are correct on that point except for the "argument" and the "silly" part, I never argued anything. You however consider the opinion of an M.D. and a Pfizer executive "silly", okay then.
Shall we stop beating that "dead horse"? Here is where it ends:
1) You believe and maintain that the government and the medical industrial complex have the right to mandate a vaccine for every man, woman and child.
2) You believe that no individual can make a medical decision based on a personal assessment and circumstances.
You might want to go back and review this thread kris because it completely contradicts your version.
Here, let me help UN-baffle you.
1. I started the thread with an article
"FDA advisory panel recommends Pfizer vaccine for kids ages 5 to 11"
And a quote of the objective report of the news without a comment from me.
2. You don't like the decision so you cherry picked by providing a dissenting view/quote and disagreeing source/author that you repeated, while telling me that I was making bad assumptions by assuming that you are repeating other people opinions because..............they might represent yours. YOUR cherry picked sources disagreed with the FDA's advisory panel. All I did was show what the FDA panel stated and their report.
3. I told you that your source was a good source and also that it is ok to post individual sources but then proved how it was a cherry pick because it only shows what you want to show. I also told you that I'm not even giving my opinion here and just showing you the FDA report but at one of your links, there was a comment that I said that I agreed with.
4. Do you realize that we've spent much of the time discussing what kris thinks based on his (cherry picked) sources.........that he repeats to impress the significant of that opinion with his sources, then you turn around and insist that I have no idea what you believe .........and for paying attention to what you are saying, your response is to accuse me of not being able to know what you really believe.
5. Then, you attack opinions of mine...........and I intentionally have not uttered a word of my own opinion in this thread other than to agree with 1 comment from one of your links.
You only need to compare that description above to the documented posts above.
I hope that you're less baffled now.
I will adjust the exact phrasing because maybe my use of the word "silly" gave you the wrong impression.
COVID vaccinations are not a silly discussion, nor were your sources, as I repeated again they were good and it was good for you to show them....... and neither was this discussion silly in the beginning.
To word it better so that you can understand the point, please change it to "dead horse arguments, where the same thing gets repeated over and over, that turn silly as this one did several posts ago"
Are you good with that one kris?
With that being the case, its past time to go on to something more productive.
" You don't like the decision"
Again: never did I say any of the sort
"Do you realize that we've spent much of the time discussing what kris thinks based on his (cherry picked) sources".
"We" didn't, you did ...
"then you turn around and insist that I have no idea what you believe"
You are correct: you don't
"your response is to accuse me of not being able to know what you really believe"
I didn't accuse you of anything, I simply stated that you don't know
"you attack opinions of mine"
The only opinion of yours I "attacked" was that you pretend to know what I believe ...
On to something else please.
So many, many, many awesome things to be grateful for than to waste productive time in this manner.
This is an old thread. Apparently many parents worried about giving their 5-year olds the mRNA jab. Hopefully, the FDA report below will alleviate their fears.
It’s no secret…. Many vaxx recipients have suffered from myocarditis after vaccination. Pfizer addresses this issue, as far as 5-11 year-olds are concerned, as shown in the link below
They are quoting Israeli data that show that 16-19 year-olds are more likely to suffer from vaxx-related myocarditis, than 12-16 year-olds.
This, combined with the Pfizer dose for 5-11 year-olds being much weaker, should make vaccination outweigh the risk of being infected by Covid, they said.
Pfizer admits that they don’t have any data on 5-11 year-olds, as far as myocarditis is concerned, but they will engage in safety studies, as soon as FDA approval is obtained (which has happened)
They will even do a 5-year follow-up study on post-vaccination myocarditis
There you go, kris
Pfizer is on the ball
Gunter,
Here's the actual (more recent) thread where we discussed the CDC's decision to approve the vaccine for this age group.
CDC panel approves Pfizer vaccine for kids ages 5 to 11
10 responses |
Started by metmike - Nov. 2, 2021, 6:02 p.m.