proof of vaccination or COVID-19 test to attend game

[Dhersh]

what about?

Many things... but please, let's not be dense regarding the situation.

Governors infringing on the rights of institutions to implement their own policies, and then blackmailing them for a power grab is not right. If it comes to it, FSU deserves to be treated better by Florida's leaders.

 

[GbrNole]

Of course and we should be outraged. I've been outspoken (usually elsewhere) about political decisions I view as un-American on both sides of the aisle, and imo anyone with an ounce of patriotism in their blood should be too. The fact that someone is elected doesn't mean they shouldn't be held accountable. That more Floridians aren't outraged is extremely concerning, especially as it relates to many of us with our political party, and even more so as it could have a direct negative impact on education, including within this institution that everyone here claims to love.

i think the dilemma lies in that the Governor openly encourages the various methods of protection and treatment related to COVID-19 (vaccination, masks, social distancing, hygiene, antibody treatments etc.) but rejects mandates of those instead leaving that up to personal decision of self.

no one is prohibiting people in florida from taking personal measures they feel necessary for the safety of themselves and their family members. in fact those decisions couldn't be more accessible.

 

[Vasili Zaitsev]

People who are overly dense.

you're greatly outnumbered in this country, now that everyone has the internet, everyone is an expert.

 

[Dhersh]

you're greatly outnumbered in this country, now that everyone has the internet, everyone is an expert.

First I shouldn't have said that and I apologize. I already edited my comment.

Second, could you explain what you mean by outnumbered?

 

[SteveT1]

I recognize that, but that shouldn't makes us any less outraged. I've been outspoken (usually elsewhere, but now implications are with FSU) about political decisions I view as un-American on both sides of the aisle, and imo anyone with an ounce of patriotism in their blood should be too. The fact that someone is elected doesn't mean they shouldn't be held accountable. That more Floridians aren't outraged is extremely concerning, especially as it relates to many of us with our political party, and even more so as it could have a direct negative impact on education, including within this institution that everyone here claims to love.

I don't agree with DeSantis's threat in this instance, but he has far less control over universities. Unfortunately, Floridians transferred valuable authority from the universities to the board of governors years ago. But DeSantis's view re mask mandates isn't off-base, as we've discussed in this thread. He's certainly not prohibiting masks being worn, just a requirement that they be worn. I don't see the problem with the policy, but I understand your point regarding forcing local officials to vote one way or lose their salary (I don't think that part passes constitutional muster, particularly for elected school board officials). I think it's a rather informed policy judgment--though perhaps less correct with the delta variant than it would've been last year. I doubt FSU wants to be in the business of policing masks/vaccine cards. I've always thought you throw a disclaimer on the ticket, make N95 masks available for purchase in the stadium, and let people make their own decision. Hopefully anyone sick stays home. For players, I don't like asking healthy players to inject something into their body that may or may not cause harm.

One question - I've read that the Pfizer-BioNTech vaccine that's widely available isn't the one that received full FDA approval. Is that true? If not, wouldn't it necessarily end the EUA's for the other vaccines?

 

[ryeknow]

You know the tide has turned when LSU mandates a vaccine. Good for them!

I know right?! I still think Alabama being Alabama will insist that you attest to NOT being vaccinated before being admitted into the stadium.

 

[Vasili Zaitsev]

First I shouldn't have said that and I apologize. I already edited my comment.

Second, could you explain what you mean by outnumbered?

its ok, its an electronic message board, it doesn't hurt me or offend me. always found it pathetically weak that people get mortally offended by a message board.
you said 'overly dense' people.. I meant the 'dense people' outnumber you. there are more dense people than 'free thinkers' out there.

 

[GbrNole]

a huge ass vat and squirt of purell, and a temperature scope for each person at the entrance gate wouldn't hurt either.

 

[NoleFan2U]

Heard LSU tickets had been selling for almost nothing after the announcement. Did not verify myself though.

Being sold on Stub Hub or by LSU? I paid for my tickets in February so FSU has my money. Wouldn't the same be true for LSU? I am just trying to understand how LSU loses from this.

 

[Dhersh]

One question - I've read that the Pfizer-BioNTech vaccine that's widely available isn't the one that received full FDA approval. Is that true? If not, wouldn't it necessarily end the EUA's for the other vaccines?

Hmmmm I have not heard that rumor, but I do not believe it is true. The Pfizer-BioNTech vaccine BNT162b2 that has been widely studied is now officially marketed under brand name Comirnaty after FDA approval. They are one in the same. Perhaps there is confusion regarding the name switch? BNT162b2 is the research name, but it was not assigned the name Comirnaty until after approval.

 

[GbrNole]

One question - I've read that the Pfizer-BioNTech vaccine that's widely available isn't the one that received full FDA approval. Is that true? If not, wouldn't it necessarily end the EUA's for the other vaccines?

i'd heard it was basically the same sans the marketing name. from a legal standpoint i'd probably prefer the vial being used for the vaccination to have Comirnaty on its label.

 

[Dhersh]

Hmmmm I have not heard that rumor, but I do not believe it is true. The Pfizer-BioNTech vaccine BNT162b2 that has been widely studied is now officially marketed under brand name Comirnaty after FDA approval. They are one in the same. Perhaps there is confusion regarding the name switch? BNT162b2 is the research name, but it was not assigned the name Comirnaty until after approval.

Also, @SteveT1 each vaccine requires its own individual EUA, and each is completely independent of the others. Therefore, what happens with one would have no impact on the others.

 

[Donnie_Please]

Many things... but please, let's not be dense regarding the situation.

Governors infringing on the rights of institutions to implement their own policies, and then blackmailing them for a power grab is not right. If it comes to it, FSU deserves to be treated better by Florida's leaders.

Absolutely.

 

[Donnie_Please]

If that number is correct/accurate, I wish we could have had this vaccine in trial for 5 years. Will I wait 5 years? I don't know. Likely not, as I'd imagine there will be some side effects, if they exist, coming to light well before the 5 year mark. The problem will be correlation/causation, of course. So, someone gets XYZ condition, was it the vaccine, was it something else? Who knows, and folks on all sides will continue to both manipulate the numbers and ignore the numbers.

I understand the concern about time of trial, but you must take into account the technology we have now vs what we were working with 50 years ago, for example. In the medical field, it is widely agreed upon that these vaccines have actually undergone the most safety monitoring, while in production, of any vaccines in history.

 

[SteveT1]

Also, @SteveT1 each vaccine requires its own individual EUA, and each is completely independent of the others. Therefore, what happens with one would have no impact on the others.

So I guess my question relates to the statutory requirement for EUA's, and specifically the bolded text below. But I think they get around it by saying in a footnote of the authorization that there's not enough to fully meet the demand/need--which I italicized below.
d. No Alternatives
For FDA to issue an EUA, there must be no adequate, approved, and available alternative to the candidate product for diagnosing, preventing, or treating the disease or condition. A potential alternative product may be considered “unavailable” if there are insufficient supplies of the approved alternative to fully meet the emergency need.

 

[GbrNole]

So I guess my question relates to the statutory requirement for EUA's, and specifically the bolded text below. But I think they get around it by saying in a footnote of the authorization that there's not enough to fully meet the demand/need--which I italicized below.
d. No Alternatives
For FDA to issue an EUA, there must be no adequate, approved, and available alternative to the candidate product for diagnosing, preventing, or treating the disease or condition. A potential alternative product may be considered “unavailable” if there are insufficient supplies of the approved alternative to fully meet the emergency need.

yep. here's the actual letter that pfizer received from the FDA.

http://labeling.pfizer.com/ShowLabeling.aspx?id=14471&format=pdf&

the footnote at the bottom of page 1 provides both comfort and concern. (emphasis added).

The licensed vaccine has the same formulation as the EUA-authorized vaccine and the products can be used interchangeably to provide the vaccination series without presenting any safety or effectiveness concerns. The products are legally distinct with certain differences that do not impact safety or effectiveness.

 

[SteveT1]

yep. here's the actual letter that pfizer received from the FDA.

http://labeling.pfizer.com/ShowLabeling.aspx?id=14471&format=pdf&

the footnote at the bottom of page 1 provides both comfort and concern. (emphasis added).

The licensed vaccine has the same formulation as the EUA-authorized vaccine and the products can be used interchangeably to provide the vaccination series without presenting any safety or effectiveness concerns. The products are legally distinct with certain differences that do not impact safety or effectiveness.

Which allows the widely available vaccine to be delivered under the EUA.

 

[SteveT1]

yep. here's the actual letter that pfizer received from the FDA.

http://labeling.pfizer.com/ShowLabeling.aspx?id=14471&format=pdf&

the footnote at the bottom of page 1 provides both comfort and concern. (emphasis added).

The licensed vaccine has the same formulation as the EUA-authorized vaccine and the products can be used interchangeably to provide the vaccination series without presenting any safety or effectiveness concerns. The products are legally distinct with certain differences that do not impact safety or effectiveness.

There's some issue squaring fully approved status with this (p. 13 under Authority for Issuance of the EUA header):

This EUA for the Pfizer-BioNTech COVID-19 Vaccine and COMIRNATY will end when the Secretary of HHS determines that the circumstances justifying the EUA no longer exist or when there is a change in the approval status of the product such that an EUA is no longer needed.

 

[AllNoles]

@Dhersh

Want your thoughts on the current situation. Seems clear vaccines are fine for those over 18. Phizer approved so if folks want approval they pick that one (good for your 401K!). If that was ALL that we had to deal with, it’s easier to even avoid the mask issue because it doesn’t matter if it works if people have the choice to even more substantially protect themselves with the vaccine. I know that’s over simplified but its basically true. If vaccines bring danger down to flu or cold level, then it’s up to people to take own risks.

But we’re not ok vaxxing kids yet. That leaves a very large and very mobile population that doesn’t have vax protection. But aren’t their numbers great with or without it? Are their numbers alone worth trying secondary measures?

It seems more abs more I hear form says kids aren’t wearing masks to protect them, but to protect the adults with whole they come in contact. If that’s true then we should leave to adults to get vaxxed or take the risk.

It seems we are coming to a point of predicable protection that can truly be limited to personal choice.

 

[GbrNole]

@Dhersh

Want your thoughts on the current situation. Seems clear vaccines are fine for those over 18. Phizer approved so if folks want approval they pick that one (good for your 401K!). If that was ALL that we had to deal with, it’s easier to even avoid the mask issue because it doesn’t matter if it works if people have the choice to even more substantially protect themselves with the vaccine. I know that’s over simplified but its basically true. If vaccines bring danger down to flu or cold level, then it’s up to people to take own risks.

But we’re not ok vaxxing kids yet. That leaves a very large and very mobile population that doesn’t have vax protection. But aren’t their numbers great with or without it? Are their numbers alone worth trying secondary measures?

It seems more abs more I hear form says kids aren’t wearing masks to protect them, but to protect the adults with whole they come in contact. If that’s true then we should leave to adults to get vaxxed or take the risk.

It seems we are coming to a point of predicable protection that can truly be limited to personal choice.

the pfizer vaccine comirnaty was approved for ages 16+. the survival rate for kids 16 and under in Florida is 99.997%

 

[AllNoles]

I know. That’s part of my consideration. I like hearing from him because we approach things a little differently but still analytically. Sometimes I need to test what I’m thinking.

 

[Dhersh]

So I guess my question relates to the statutory requirement for EUA's, and specifically the bolded text below. But I think they get around it by saying in a footnote of the authorization that there's not enough to fully meet the demand/need--which I italicized below.
d. No Alternatives
For FDA to issue an EUA, there must be no adequate, approved, and available alternative to the candidate product for diagnosing, preventing, or treating the disease or condition. A potential alternative product may be considered “unavailable” if there are insufficient supplies of the approved alternative to fully meet the emergency need.

This always takes me down a rabbit hole to get hopefully correct info lol.

I'm no law man, but on the surface it would appear that section relates to the issuance (specifically) of an MCM under EUA, as it can be found in section III.B.1.d of the FDA's guidance document under Criteria for Issuance. So, "for FDA to issue an EUA" for a given MCM, that criteria must be met (along with additional criteria is sections a-c).

However, there are additional sections that cover how and when an EUA will end. Section III.G of the guidance document, titled Duration and Revision of an EUA states:

In general, an EUA will remain in effect for the duration of the EUA declaration under which it was issued...​

​

Hopefully that is good info. I wouldn't want to mislead!

 

[Dhersh]

yep. here's the actual letter that pfizer received from the FDA.

http://labeling.pfizer.com/ShowLabeling.aspx?id=14471&format=pdf&

the footnote at the bottom of page 1 provides both comfort and concern. (emphasis added).

The licensed vaccine has the same formulation as the EUA-authorized vaccine and the products can be used interchangeably to provide the vaccination series without presenting any safety or effectiveness concerns. The products are legally distinct with certain differences that do not impact safety or effectiveness.

Legally distinct. Imo that does not cause concern, because if I am interpreting it correctly, these legal distinctions would have no impact on the physical vaccine - BNT162b2 or Comirnaty - which the FDA states "have the same formulation."

 

[GbrNole]

Legally distinct. Imo that does not cause concern, because if I am interpreting it correctly, these legal distinctions would have no impact on the physical vaccine - BNT162b2 or Comirnaty - which the FDA states "have the same formulation."

it would if someone had to sue pfizer though.

 

[SteveT1]

This always takes me down a rabbit hole to get hopefully correct info lol.

I'm no law man, but on the surface it would appear that section relates to the issuance (specifically) of an MCM under EUA, as it can be found in section III.B.1.d of the FDA's guidance document under Criteria for Issuance. So, "for FDA to issue an EUA" for a given MCM, that criteria must be met (along with additional criteria is sections a-c).

However, there are additional sections that cover how and when an EUA will end. Section III.G of the guidance document, titled Duration and Revision of an EUA states:

In general, an EUA will remain in effect for the duration of the EUA declaration under which it was issued...​

​

Hopefully that is good info. I wouldn't want to mislead!

Law man or not, I think that’s right—and while fda has authority to terminate euas now that 1 vaccine is approved, fda regs provide enough discretion to keep euas in place. I think they’ve done that here.

my only issue with the Pfizer approval is the apparent dangerous heart condition it may cause men under the age of 40. That’s problematic for our students and student athletes.

 

[Dhersh]

@Dhersh

Want your thoughts on the current situation. Seems clear vaccines are fine for those over 18. Phizer approved so if folks want approval they pick that one (good for your 401K!). If that was ALL that we had to deal with, it’s easier to even avoid the mask issue because it doesn’t matter if it works if people have the choice to even more substantially protect themselves with the vaccine. I know that’s over simplified but its basically true. If vaccines bring danger down to flu or cold level, then it’s up to people to take own risks.

But we’re not ok vaxxing kids yet. That leaves a very large and very mobile population that doesn’t have vax protection. But aren’t their numbers great with or without it? Are their numbers alone worth trying secondary measures?

It seems more abs more I hear form says kids aren’t wearing masks to protect them, but to protect the adults with whole they come in contact. If that’s true then we should leave to adults to get vaxxed or take the risk.

It seems we are coming to a point of predicable protection that can truly be limited to personal choice.

Children's numbers are good, relatively speaking. I saw a statistic last week that of the more than 644,000 Americans who have died of COVID (hate saying that every time), less than 400 were under the age of 18.

Vaccine approval for children, even under EUA, is still months off. I recently heard that we can expect to wait until the winter holiday season or later before any type of decision is made. People are asking why it is taking so long. It didn't take this long to study other age groups, right? They may have been close to emergency approval for children, but more recently, the government decided they wanted to see a larger sample size for the trials. Their reasoning was heart issues. The majority of cases of myocarditis (inflammation of muscle tissue of the heart) that were determined to be caused by COVID vaccines occurred in individuals in their 20s or younger. They are taking additional time to make sure they collect enough data. They want to make sure there isn't a correlation between age and specific heart issues, and they would have to weigh those risks if there is.

Like you said, the numbers are better, but you also have to think about why that is. Due to the medicinal magic of youth, the percentage of children who have been infected thus far is low when compared with adults. It seems like their bodies were initially able to fight off infection better, but similar to increasing "breakthrough infections" with the vaccine, we are now seeing increasing "breakthrough infections" in children whose bodies are no longer able to fight off the virus. On one hand, mortality rates remain very low. That is most important in the short term, but we are beginning to see an increased number of infections and hospitalizations in children, probably because of the delta variant.

The sky isn't falling, but it isn't trending in the right direction. And I've rambled on about kids and COVID long enough. To answer one of your questions, yes it is worth trying to stop the spread of infections in kids through secondary measures. Did you have anything specific in mind? I've seen some nifty strategies that school districts throughout the country are taking in their classrooms. A personal opinion of mine is that testing should be done at a minimum of 3 times per week at schools. For positive cases, monoclonal antibody therapy should be prescribed immediately. However, I'm not sure what else we can do that hasn't already been recommended.

 

[Dhersh]

Law man or not, I think that’s right—and while fda has authority to terminate euas now that 1 vaccine is approved, fda regs provide enough discretion to keep euas in place. I think they’ve done that here.

my only issue with the Pfizer approval is the apparent dangerous heart condition it may cause men under the age of 40. That’s problematic for our students and student athletes.

Can I ask which heart condition you are referring to? The only ones I know of that are confirmed to be related to vaccines (specifically mRNA vaccines) are myocarditis and pericarditis. I haven't reviewed the data, but the CDC considers it "rare" and both conditions are treatable.

It is noteworthy that COVID-induced myocarditis is also a thing. Limited data, but it is interesting to see. I found this article that examines both COVID-induced myocarditis and vaccine-induced myocarditis. I found it very interesting and maybe you could give it a read. It may give you a jumping off point to get you on your way to making an informed decision about it.

 

[Dhersh]

it would if someone had to sue pfizer though.

Haha that's a legal battle I wouldn't want to be involved in. Especially considering the FDA determined Comirnaty and BNT162b2 to be "interchangeable." I think its just important that they make that distinction because the same vaccine is available for kids 12-16 but only under EUA, while 16 and up has full FDA approval.

 

[AllNoles]

So the lady who attacked me on FB saying the majority of ICU cases in Florida are 18 and under is wrong?

I know she is. I get my info directly from DOH. But it’s funny how all it takes is a post and people believe it.

 

[Dhersh]

So the lady who attacked me on FB saying the majority of ICU cases in Florida are 18 and under is wrong?

I know she is. I get my info directly from DOH. But it’s funny how all it takes is a post and people believe it.

I think the first mistake that was made was logging onto FB 🙃

 

[AllNoles]

Very much. But she’s actually a pretty rational person and posted that today. I know there are some numbers that don’t match well, but that would be shocking to me.

 

[ChiefWB]

But it’s funny how all it takes is a post and people believe it.

Kind of like people posting “masks don’t work”.

 

[GbrNole]

the percentage of children who have been infected thus far is low when compared with adults

in florida nearly 17% of all cases were kids. the only age groups in the state with a higher percentage share are 20-29 and 30-39 that each account for about 18% respectively. the 65+ only account for 13% of the cases but 80% of the deaths.

CDC COVID-19 burden estimates fall inline with what florida is seeing.

Cases, Data, and Surveillance

Cases, data, and surveillance to track and analyze COVID-19.

www.cdc.gov

 

[Dhersh]

in florida nearly 17% of all cases were kids. the only age groups in the state with a higher percentage share are 20-29 and 30-39 that each account for about 18% respectively. the 65+ only account for 13% of the cases but 80% of the deaths.

CDC COVID-19 burden estimates fall inline with what florida is seeing.

Cases, Data, and Surveillance

Cases, data, and surveillance to track and analyze COVID-19.

www.cdc.gov

Thanks for the data. I probably should have used the past tense. Initially, children were less likely to be infected. But like I said, it's happening more often now, especially since they are the age group who can't be vaccinated and with the Delta variant.

 

[ChiefWB]

Thanks for the data. I probably should have used the past tense. Initially, children were less likely to be infected. But like I said, it's happening more often now, especially since they are the age group who can't be vaccinated and with the Delta variant.

And that they are in some cases maskless and on top of each other in schools.

 

[GbrNole]

So the lady who attacked me on FB saying the majority of ICU cases in Florida are 18 and under is wrong?

I know she is. I get my info directly from DOH. But it’s funny how all it takes is a post and people believe it.

it's difficult to get accurate data on that but it is a complete fallacy. for example, in our local hospital system kids (people under 18) make up about 7% of all COVID ICU patients in the two county hospital system.

one of the biggest problems we have had in our local hospitals is parents taking their kids to the ER with suspected COVID rather than to their GP's or an urgent care. Our local hospitals reported 123 pediatric admissions last friday for COVID, all but 5 of those kids were sent home after being seen. 2 were placed in ICU.

 

[flmom777]

Hmmmm I have not heard that rumor, but I do not believe it is true. The Pfizer-BioNTech vaccine BNT162b2 that has been widely studied is now officially marketed under brand name Comirnaty after FDA approval. They are one in the same. Perhaps there is confusion regarding the name switch? BNT162b2 is the research name, but it was not assigned the name Comirnaty until after approval.

Now that it has approval is it still protected against lawsuits?

 

[SteveT1]

Major win for property rights, federalism and property owners, IMO. Major loss for cdc, and those tenants who actually needed the moratorium due to hardship (e.g., waiters). Opinion was well-reasoned. Some on right think it should’ve called out admin on bad faith move to delay lifting moratorium, but I don’t think it can be considered bad faith. Like ACB rejecting IU vax mandate case, there was no prior scotus ruling on the merits. Bad faith accusation wouldve been unwarranted..

 

[F4Gary]

Major win for property rights, federalism and property owners, IMO. Major loss for cdc, and those tenants who actually needed the moratorium due to hardship (e.g., waiters). Opinion was well-reasoned. Some on right think it should’ve called out admin on bad faith move to delay lifting moratorium, but I don’t think it can be considered bad faith. Like ACB rejecting IU vax mandate case, there was no prior scotus ruling on the merits. Bad faith accusation wouldve been unwarranted..

Should have been done a 9 months ago.

 

[AllNoles]

Kind of like people posting “masks don’t work”.

They don’t. And at best it’s debatable. Numbers in hospitals are objective.