FDA Advisory Panel

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.
 
freedomcm said:
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?
 
'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.
 
Liar Loan said:
freedomcm said:
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.
 
Liar Loan said:
freedomcm said:
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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