Author Topic: FDA Advisory Panel on vaccine for 5-11 olds  (Read 283 times)

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Offline PSForever

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FDA Advisory Panel on vaccine for 5-11 olds
« on: October 30, 2021, 05:53:18 PM »
FDA Advisory Panel voted 17-0 in favor of approving the Pfeizer vaccine for 5-11 year olds.  (One member abstained.)  https://twitter.com/US_FDA/status/1452975809174585345

Dr. Mark Ruben, FDA voting member stated that: "We're never gonna learn about how safe the vaccine is until we start giving it. That's just the way it goes...that's how we found out about the ...complications of rotavirus vaccine..." - FDA panel on approval for children 5-11.
https://twitter.com/theofficialSBG/status/1454386072180383747

FDA Adviser Explains Why He Abstained From Vote On Pfizer’s COVID-19 Vaccine For Kids
Dr. Kurilla told The Epoch Times in an email that he opposed the specific, binary wording of the question, which opens up the possibility that any child between 5 and 11 will be able to get the Pfizer vaccine. He was also concerned about the longest follow-up for the clinical trial involving the age group being only three months. He also questioned the need for the vaccine as data showed children experience much less severe cases of COVID-19 disease than adults, and how a large chunk of children have already had the disease, giving them some level of immunity.
https://invesbrain.com/fda-adviser-explains-why-he-abstained-from-vote-on-pfizers-covid-19-vaccine-for-kids/

Additionally, one of the presenters to the panel referenced the following med journal: https://pubmed.ncbi.nlm.nih.gov/34601006/ The full paper states that within 8 weeks of public offering of the vaccine to 12-15 year old age group, they found 19 times the expected number of myocarditis cases in vaccination volunteers over background myocarditis rates for the age group.  In contrast, Dr. Matthew Oster, a pediatric cardiologist with the CDC, said his agency has not seen increased rates of the myocarditis among vaccinated children between the ages of 12 and 17.  https://www.forbes.com/sites/jemimamcevoy/2021/10/29/fda-authorizes-pfizer-covid-vaccine-for-kids-ages-5-to-11/?sh=4290466c22f7  Although Dr. Oster does reference CDC data on rates exceeding background rates for 12-24 year old males in his presentation.  See time 1:29:32 on the fda video.

« Last Edit: October 30, 2021, 07:09:15 PM by PSForever »

Offline PSForever

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Re: FDA Advisory Panel on vaccine for 5-11 olds
« Reply #1 on: October 30, 2021, 06:25:06 PM »
Another presenter, Beatrice Setnik Ph.D, references the FDA's August 23, 2021, approval letter for Comirnaty, (see P.9 for the pediatric section) to argue against approval of the vaccine for 5-11 age group.  https://www.fda.gov/media/151710/download


In it, FDA acknowledges that Pfiezer has not completed pediatric studies.  Instead, Pfeizer is required to submit post-marketing studies which include:

1. Deferred pediatric Study to evaluate the safety and effectiveness of COMIRNATY in children 12-15 years of age:

         Final Protocol Submission:   October 7, 2020

         Study Completion:   May 31, 2023

         Final Report Submission:   October 31, 2023

2.  Deferred pediatric Study to evaluate the safety and effectiveness of COMIRNATY in children 6 mos - 12 years of age: 

         Final Protocol Submission:  February 8, 2021

        Study Completion:  November 30, 2023

        Final Report Submission:  May 31, 2024 

3.  Deferred pediatric Study to evaluate the safety and effectiveness of COMIRNATY in infants <6 months of age:

        Final Protocol Submission:  January 31, 2022

        Study Completion:  July 31, 2024

        Final Report Submission:  October 31, 2024

« Last Edit: October 30, 2021, 07:26:28 PM by PSForever »

Offline PSForever

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Re: FDA Advisory Panel on vaccine for 5-11 olds
« Reply #2 on: October 30, 2021, 06:35:55 PM »
Also, in the letter (https://www.fda.gov/media/151710/download), the FDA states that the analysis of spontaneous postmarketing adverse events will not be sufficient to assess known serious risks of myocarditis and pericarditis. Therefore, the FDA requires Pfiezer to do further study on their vaccine's effect on Myocarditis for several age groups including children:

Required by FDA: 
A study with at least 5 years of follow-up for potential long-term consequences of myocarditis after vaccination in collaboration with Pediatric Heart Network:

           Final Protocol Submission:  November 30, 2021

           Study Completion:  December 31  , 2026

           Report Submission:  May 31  , 2027



Interestingly, the letter also acknowledges that Pfeizer will continue to study the effects of the vaccine on pregnancy and infant outcomes, of which study completion date is June 30, 2025.




« Last Edit: October 31, 2021, 08:56:01 PM by PSForever »

Offline freedomcm

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Re: FDA Advisory Panel on vaccine for 5-11 olds
« Reply #3 on: November 01, 2021, 06:53:51 AM »
post-approval studies are very common for many different indications where a five or ten year pre-approval study is not practical/ethical, including many cancer drugs.

it is clear that the risk of pediatric myocarditis is around ten times higher from the virus as from the vaccine.  it is hard for me to believe that any parent of an at-risk teen (as the complication is seen primarily in teen males, not 5-11 year olds) would opt for the high risk encountered during covid infection.

Offline Liar Loan

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Re: FDA Advisory Panel on vaccine for 5-11 olds
« Reply #4 on: November 02, 2021, 09:43:49 AM »
post-approval studies are very common for many different indications where a five or ten year pre-approval study is not practical/ethical, including many cancer drugs.

it is clear that the risk of pediatric myocarditis is around ten times higher from the virus as from the vaccine.  it is hard for me to believe that any parent of an at-risk teen (as the complication is seen primarily in teen males, not 5-11 year olds) would opt for the high risk encountered during covid infection.

Playing devil's advocate here, but wouldn't it depend on the risk of that teen contracting the virus? 

Suppose a teen has already had covid, does it make sense to expose them to the risk of myocarditis for the nominal level of added protection the vaccine would provide?  Even for a teen that hasn't yet had covid, what is their likelihood of catching the virus at this stage of the pandemic?  Shouldn't that math be factored in to the risk calculation?

Offline freedomcm

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Re: FDA Advisory Panel on vaccine for 5-11 olds
« Reply #5 on: November 03, 2021, 07:29:30 AM »
'natural immunity' from infection appears to be relatively short-lived in adults, and is greatly aided by a 'booster' of the vaccines.

its not clear yet that the same holds in kids (but likely) and so the risk of re-infection after six months is high again.  so in my estimation, risks of vaccination in kids are much lower than the risks that accompany re-infection.

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Re: FDA Advisory Panel on vaccine for 5-11 olds
« Reply #6 on: November 03, 2021, 05:12:56 PM »
post-approval studies are very common for many different indications where a five or ten year pre-approval study is not practical/ethical, including many cancer drugs.

it is clear that the risk of pediatric myocarditis is around ten times higher from the virus as from the vaccine.  it is hard for me to believe that any parent of an at-risk teen (as the complication is seen primarily in teen males, not 5-11 year olds) would opt for the high risk encountered during covid infection.

Playing devil's advocate here, but wouldn't it depend on the risk of that teen contracting the virus? 

Suppose a teen has already had covid, does it make sense to expose them to the risk of myocarditis for the nominal level of added protection the vaccine would provide?  Even for a teen that hasn't yet had covid, what is their likelihood of catching the virus at this stage of the pandemic?  Shouldn't that math be factored in to the risk calculation?

Isn't the risk of myocarditis much lower than the possible bad effects of getting Covid?

At least that's what I hear on TV and radio... maybe Mety can find the data for us.
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Offline nosuchreality

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Re: FDA Advisory Panel on vaccine for 5-11 olds
« Reply #7 on: November 03, 2021, 05:16:42 PM »
post-approval studies are very common for many different indications where a five or ten year pre-approval study is not practical/ethical, including many cancer drugs.

it is clear that the risk of pediatric myocarditis is around ten times higher from the virus as from the vaccine.  it is hard for me to believe that any parent of an at-risk teen (as the complication is seen primarily in teen males, not 5-11 year olds) would opt for the high risk encountered during covid infection.

Playing devil's advocate here, but wouldn't it depend on the risk of that teen contracting the virus? 

Suppose a teen has already had covid, does it make sense to expose them to the risk of myocarditis for the nominal level of added protection the vaccine would provide?  Even for a teen that hasn't yet had covid, what is their likelihood of catching the virus at this stage of the pandemic?  Shouldn't that math be factored in to the risk calculation?

Given the number of colds and flu the average school student brings home, I would guess the risk of getting is pretty high if a sizable portion foregoes vaccination.

 

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