Florida Looking to Push Back Against CDC

[nocl]

26 minutes ago, fatcat04 said:

And if this were a fully FDA approved and cleared vaccine you would be spot on but it isn't and may not be for another year. Once again, these vaccines are an Emergency Use Authorized vaccine. The distinction may seem minor but to the law it isn't. These vaccines have not completed the full FDA approval process though they are a long way down the path.

 

https://www.fda.gov/media/144414/download

WHAT IS THE PFIZER-BIONTECH COVID-19 VACCINE? The Pfizer-BioNTech COVID-19 Vaccine is an unapproved vaccine that may prevent COVID-19. There is no FDA-approved vaccine to prevent COVID-19. The FDA has authorized the emergency use of the Pfizer-BioNTech COVID-19 Vaccine to prevent COVID-19 in individuals 16 years of age and older under an Emergency Use Authorization (EUA). For more information on EUA, see the “What is an Emergency Use Authorization (EUA)?” section at the end of this Fact Sheet.

 

WHAT IS AN EMERGENCY USE AUTHORIZATION (EUA)? The United States FDA has made the Pfizer-BioNTech COVID-19 Vaccine available under an emergency access mechanism called an EUA. The EUA is supported by a Secretary of Health and Human Services (HHS) declaration that circumstances exist to justify the emergency use of drugs and biological products during the COVID-19 pandemic. The Pfizer-BioNTech COVID-19 Vaccine has not undergone the same type of review as an FDA-approved or cleared product. FDA may issue an EUA when certain criteria are met, which includes that there are no adequate, approved, available alternatives. In addition, the FDA decision is based on the totality of scientific evidence available showing that the product may be effective to prevent COVID-19 during the COVID-19 pandemic and that the known and potential benefits of the product outweigh the known and potential risks of the product. All of these criteria must be met to allow for the product to be used in the treatment of patients during the COVID-19 pandemic. The EUA for the Pfizer-BioNTech COVID-19 Vaccine is in effect for the duration of the COVID-19 EUA declaration justifying emergency use of these products, unless terminated or revoked (after which the products may no longer be used).

 

Now I took this vaccine and have every confidence in it but I knew it was an EUA when I did so. 

 

And when these vaccines have completed the full approval process, then according to US laws and FDA regulations that are on the books now, they can be mandated. All of this was stated in the documents I previously provided. 

 

And once again as I said before, I assume this will probably not impact the bulk of the cruise lines fleets themselves as they are not US flagged ships with US crews under US laws. I heartily applaud their efforts to get their crews vaccinated however. It is a very good thing. 

 

And again, Congress and the FDA/CDC can choose to change the laws and regulations presently on the books. Of course that process would probably take longer than just getting full FDA approval. 

  The fact that is an EUA means people can not be required to take it, but it does not protect them from the other consequences of not taking it. I know very well what an EUA is I spent 10+ years with FDA and another 10+ in the pharmaceutical industry.

 

From the appropriate regulation. 21 U.S. Code § 360bbb–3 - Authorization for medical products for use in emergencies

 

(ii)Appropriate conditions designed to ensure that individuals to whom the product is administered are informed—

(I)

that the Secretary has authorized the emergency use of the product;

(II)

of the significant known and potential benefits and risks of such use, and of the extent to which such benefits and risks are unknown; and

(III)

of the option to accept or refuse administration of the product, of the consequences, if any, of refusing administration of the product, and of the alternatives to the product that are available and of their benefits and risks.

 

It is fairly widely reported for example that in the military they can refuse to be vaccinated, but one cannot be deployed if they are not vaccinated.  So the consequence is that they cannot be deployed as their position might require.  Kind of career limiting.

 

Employers can do the same thing.  An employee can refuse. But if their job is customer facing or in an environment where the vaccine is required for safety their consequence could include loss of job.

 

 

 

 

[nocl]

1 hour ago, Mary229 said:

I think the letter lays out a framework but that's me.  I still think ultimately the emergency health declaration will be lifted.  (my opinion for saying this are not based in science but in social science especially the beast called politics).  But I can see where you think it doesn't and that perhaps it is just a push back.  Push away.   

 

 

A framework is not a plan.

 

Eventually the emergency will be lifted once the pandemic is over.  Its not over yet.  By any scientific definition concerning pandemics that one might want to reference.

[fatcat04]

5 minutes ago, nocl said:

  The fact that is an EUA means people can not be required to take it, but it does not protect them from the other consequences of not taking it. I know very well what an EUA is I spent 10+ years with FDA and another 10+ in the pharmaceutical industry.

 

From the appropriate regulation. 21 U.S. Code § 360bbb–3 - Authorization for medical products for use in emergencies

 

(ii)

 

the product is administered are informed—

(I)

that the Secretary has authorized the emergency use of the product;

(II)

of the significant known and potential benefits and risks of such use, and of the extent to which such benefits and risks are unknown; and

(III)

of the option to accept or refuse administration of the product, of the consequences, if any, of refusing administration of the product, and of the alternatives to the product that are available and of their benefits and risks.

 

It is fairly widely reported for example that in the military they can refuse to be vaccinated, but one cannot be deployed if they are not vaccinated.  So the consequence is that they cannot be deployed as their position might require.  Kind of career limiting.

 

Employers can do the same thing.  An employee can refuse. But if their job is customer facing or in an environment where the vaccine is required for safety their consequence could include loss of job.

 

 

 

 

Let me quote the whole section as it seems to pertain not to consequence suffered by a remiss employee at the hand of their employer but the health consequences a patient must be made aware of by the health professional administering the vaccine should they decide to not take the vaccine. 

 

(e)Conditions of authorization

(1)Unapproved product

(A)Required conditionsWith respect to the emergency use of an unapproved product, the Secretary, to the extent practicable given the applicable circumstances described in subsection (b)(1), shall, for a person who carries out any activity for which the authorization is issued, establish such conditions on an authorization under this section as the Secretary finds necessary or appropriate to protect the public health, including the following:

(i)Appropriate conditions designed to ensure that health care professionals administering the product are informed—

(I)

that the Secretary has authorized the emergency use of the product;

(II)

of the significant known and potential benefits and risks of the emergency use of the product, and of the extent to which such benefits and risks are unknown; and

(III)

of the alternatives to the product that are available, and of their benefits and risks.

(ii)Appropriate conditions designed to ensure that individuals to whom the product is administered are informed—

(I)

that the Secretary has authorized the emergency use of the product;

(II)

of the significant known and potential benefits and risks of such use, and of the extent to which such benefits and risks are unknown; and

(III)

of the option to accept or refuse administration of the product, of the consequences, if any, of refusing administration of the product, and of the alternatives to the product that are available and of their benefits and risks.

 

 

[nocl]

A couple of articles concerning the requirement issue

 

‘Authorization’ status is a red herring when it comes to mandating Covid-19 vaccination

 

https://www.statnews.com/2021/04/05/authorization-status-covid-19-vaccine-red-herring-mandating-vaccination/

COVID-19: An Employer’s Role in Vaccination

 

https://www.natlawreview.com/article/covid-19-employer-s-role-vaccination

[nocl]

3 minutes ago, fatcat04 said:

Let me quote the whole section as it seems to pertain not to consequence suffered by a remiss employee at the hand of their employer but the health consequences a patient must be made aware of by the health professional administering the vaccine should they decide to not take the vaccine. 

 

(e)Conditions of authorization

(1)Unapproved product

(A)Required conditionsWith respect to the emergency use of an unapproved product, the Secretary, to the extent practicable given the applicable circumstances described in subsection (b)(1), shall, for a person who carries out any activity for which the authorization is issued, establish such conditions on an authorization under this section as the Secretary finds necessary or appropriate to protect the public health, including the following:

(i)Appropriate conditions designed to ensure that health care professionals administering the product are informed—

(I)

that the Secretary has authorized the emergency use of the product;

(II)

of the significant known and potential benefits and risks of the emergency use of the product, and of the extent to which such benefits and risks are unknown; and

(III)

of the alternatives to the product that are available, and of their benefits and risks.

(ii)Appropriate conditions designed to ensure that individuals to whom the product is administered are informed—

(I)

that the Secretary has authorized the emergency use of the product;

(II)

of the significant known and potential benefits and risks of such use, and of the extent to which such benefits and risks are unknown; and

(III)

of the option to accept or refuse administration of the product, of the consequences, if any, of refusing administration of the product, and of the alternatives to the product that are available and of their benefits and risks.

 

 

There is nothing in the law or definitions limiting the use of the term consequences to the health consequences.

 

Seems like quite a few articles out there saying that employers can require employees to get vaccinated in they wish to maintain their employment for example.

 

https://www.webmd.com/vaccines/covid-19-vaccine/news/20201229/your-boss-may-require-you-to-get-a-covid-19-vaccine

 

The only way to know for sure would require a court case since this situation is unique.

 

[fatcat04]

29 minutes ago, nocl said:

A couple of articles concerning the requirement issue

 

‘Authorization’ status is a red herring when it comes to mandating Covid-19 vaccination

 

https://www.statnews.com/2021/04/05/authorization-status-covid-19-vaccine-red-herring-mandating-vaccination/

COVID-19: An Employer’s Role in Vaccination

 

https://www.natlawreview.com/article/covid-19-employer-s-role-vaccination

Thank you for sharing. Good info and compelling arguments. I have read some of this and the counter argument and the dismissed Isaac Legaretta suit. That one was dismissed simply because his job was in the end not threatened. I think most employers do not wish to end up in court but yes, I get the feeling sadly at least some of this will end up in court unless the government clears up the issue. BUT hopefully approval will be forthcoming and this will all be moot. 

Edited April 7, 2021 by fatcat04

[Mary229]

1 hour ago, nocl said:

A framework is not a plan.

 

Eventually the emergency will be lifted once the pandemic is over.  Its not over yet.  By any scientific definition concerning pandemics that one might want to reference.

That has been an issue since when it was first declared a pandemic. Since I do business with many Asians I was well aware of the disease in early January 2020. I canceled a trip for January 15, 2020 so I recall very well.  There was a call even then for WHO to declare a pandemic.   It took weeks.  My point is that it is very hard to separate public health policy from politics.  I think the politics will end the public health emergency, not science.  (Personal disclosure- I am not stating a preference, merely stating what I think will happen)

[HappyInVan]

Let's be realistic. Israel has their vax passport. UK will have one in order to allow mass events to resume with minimal restrictions.

 

“People who have been vaccinated, received a recent negative test or have natural immunity after recovery from infection in the last six months, will be able to take part in test events at sports venues, conference centers and nightclubs. That includes the semi-finals this month of football's FA Cup and the final in May.”

 

https://www.politico.eu/article/united-kingdom-coronavirus-certificate-sporting-events-nightclubs/

 

For a digital document to work, it would have to be a national passport managed by a central authority.

 

Should FL insist on no mask, no passport, and no vax enforcement while allowing mass events. Then, it will be a 24/7 superspreader state; not just during spring breaks.

 

What would a responsible person do? FL will definitely not see my $$$$ for the next 10 years.

 

How's the weather in California? Positivity rate 1.5%. Re-opening in June with a mask mandate. They should be rewarded for their sacrifices.

 

[LewiLewi]

6 hours ago, HappyInVan said:

Let's be realistic. Israel has their vax passport. UK will have one in order to allow mass events to resume with minimal restrictions.

 

“People who have been vaccinated, received a recent negative test or have natural immunity after recovery from infection in the last six months, will be able to take part in test events at sports venues, conference centers and nightclubs. That includes the semi-finals this month of football's FA Cup and the final in May.”

 

https://www.politico.eu/article/united-kingdom-coronavirus-certificate-sporting-events-nightclubs/

 

For a digital document to work, it would have to be a national passport managed by a central authority.

 

Should FL insist on no mask, no passport, and no vax enforcement while allowing mass events. Then, it will be a 24/7 superspreader state; not just during spring breaks.

 

What would a responsible person do? FL will definitely not see my $$$$ for the next 10 years.

 

How's the weather in California? Positivity rate 1.5%. Re-opening in June with a mask mandate. They should be rewarded for their sacrifices.

 

I agree with you and I live in Flori duh.

[nocl]

23 hours ago, fatcat04 said:

Thank you for sharing. Good info and compelling arguments. I have read some of this and the counter argument and the dismissed Isaac Legaretta suit. That one was dismissed simply because his job was in the end not threatened. I think most employers do not wish to end up in court but yes, I get the feeling sadly at least some of this will end up in court unless the government clears up the issue. BUT hopefully approval will be forthcoming and this will all be moot. 

Always good having a good debate. 

You are probably correct about the intent of the use of consequences (I have seen both sides brought up in legal opinions). 

 

One of the big gaps in the law is that while it says one can refuse the product, no where does it include language that one (as in companies, businesses, individuals) cannot discriminate based upon that decision. 

 

The EEOC would seem to take that side that the law does not prevent employers from requiring it in order to maintain work place safety.

 

As far as I can find doing a search of LexisNexis the only case that seems to be relevant is the Army and the Anthrax vaccine.  Where the courts rules that the Army could not force soldiers to take it.

However the response with the Covid vaccine is that they do not force anyone to take it, just remove them from deployment status if not vaccinated.

[ontheweb]

10 hours ago, nocl said:

Always good having a good debate. 

You are probably correct about the intent of the use of consequences (I have seen both sides brought up in legal opinions). 

 

One of the big gaps in the law is that while it says one can refuse the product, no where does it include language that one (as in companies, businesses, individuals) cannot discriminate based upon that decision. 

 

The EEOC would seem to take that side that the law does not prevent employers from requiring it in order to maintain work place safety.

 

As far as I can find doing a search of LexisNexis the only case that seems to be relevant is the Army and the Anthrax vaccine.  Where the courts rules that the Army could not force soldiers to take it.

However the response with the Covid vaccine is that they do not force anyone to take it, just remove them from deployment status if not vaccinated.

Could there also be legal implications that the vaccines are not fully approved as they only have emergency approval?

[Hlitner]

I think the idea of government forced vaccinations is more of an invention of folks with an agenda rather then anything close to a fact.  Can anyone point to government mandated vaccinations in the USA or even a viable attempt to force vaccinations?  We think not.   What we may see with COVID vaccines is that some private businesses (such as airlines and cruise lines) will require vaccines as part of their requirements.  Private businesses have always had a lot of ability to do such a  thing and there is no US law that prohibits discrimination on the basis of vaccines of the lack thereof.  There are numerous examples of healthcare facilities (such as hospitals) mandating certain vaccines (i.e. flu shots, Tdap, etc) for their employees.

 

When it comes to cruises we do not have the "right" to cruise.  Cruise lines do have the right to refuse boarding to just about anyone as long as they are not violating the discrimination laws of the host country.  Airlines now mandate that folks wear masks, even in jurisdictions where there is no law that requires mask wearing.  And countries around the world are absolutely able to set their own entry requirements be it a vaccine, test, etc.  

 

As to what documentation will be required when vaccines are mandated, that is up to each individual business or government (when they require vaccine proof).  Some countries such as Iceland have already published their document requirements and offer alternatives for those who do not have such proof (which usually involves a lengthy quarantine at the person's own expense with COVID testing at the person's own expense).   Even the US Government now requires Americans flying to the USA to present a negative COVID Test done within 3 days of the flight.  And those tests are at the person's own expense (it cost us about $33 to get tested in Mexico).  The US Government has avoided getting into the EUA issue by saying that even those who are vaccinated still need to get an Antigen or molecular test.

 

Hank

[wdw1972]

It's official - Governor DeSantis (of FL) has issued a press release formally announcing Florida is suing the Biden administration in federal court to overturn the "unlawful" Conditional Sailing Order enacted by the CDC. 

 

The media outlets should have it and I'm sure someone will see it and post a link.  I received it via work email since I work for the state of FL.

 

Sue/WDW1972

[wdw1972]

Here - I was able to copy/paste it.   For Immediate Release: April 8, 2021 Contact: Governor’s Press Office, (850) 717-9282, Media@eog.myflorida.com   Governor Ron DeSantis & Attorney General Ashley Moody Announce Lawsuit Against Biden Administration Shutdown of Cruise Industry The CDC’s “So-called” Conditional Sailing Order greatly exceeds the narrow authority given to the CDC by federal law. Miami, Fla. - Today, under the direction of Governor DeSantis, Florida is suing the Biden Administration in federal district court to overturn the unlawful “Conditional Sailing Order” enacted by the Centers for Disease Control and Prevention (CDC). This unprecedented year-long lockdown of an entire industry by the federal government has directly harmed the State of Florida, its citizens, and their families, resulting in the loss of billions of dollars in economic activity. “We must allow our cruise liners and their employees to get back to work and safely set sail again,” said Governor DeSantis. “To be clear, no federal law authorizes the CDC to indefinitely impose a nationwide shutdown of an entire industry. This lawsuit is necessary to protect Floridians from the federal government’s overreach and resulting economic harm to our state.” “Cruises are a vital part of Florida’s tourism industry—employing thousands and boosting our state’s economy. Every day the federal government unfairly keeps this economic giant docked, our economy suffers. The ripple effect of this misguided federal lockdown has far-reaching implications for the cruise industry, international tourism, businesses that would benefit from the influx of visitors, our state’s economy and the thousands of Floridians who work in the industry,”  said Attorney General Ashley Moody. “But what is even worse than the economic damage caused by this heavy-handed federal overreach is the precedent being set by an eager-to-regulate Biden administration that is unfairly singling out and keeping docked our cruise industry on the basis of outdated data. Our litigation seeks to end this federal overreach and allow Floridians to safely get back to work and travel.” “The unwillingness of the CDC to adapt its guidelines to the ever-changing nature of the country’s pandemic response unrelentlessly destroys an industry that generates hundreds of thousands of jobs and several billions of dollars to our economy. These federal bureaucrats, who have no concept of what is actually happening out in the real world, have never had to face the reality of a prolonged furlough or have had their job jeopardized by the pandemic,” said Congressman Carlos Gimenez. “ I guarantee if it were their job on the line and they had to handle the things hardworking Americans have had to face ahead of this pandemic, they would find the solution and rectify this issue immediately. It is time to hold the CDC and this Administration accountable for the damages they are committing against these hardworking Americans and for what they are doing to our local economies. I applaud Attorney General Ashley Moody for filing this lawsuit and Governor Ron DeSantis for backing these efforts.” “Unlike Florida, some have forgotten the most important element of a successful transportation system: the people and their families,” said Florida Department of Transportation Secretary Kevin J. Thibault, P.E. “The CDC’s No Sail Order remains an arbitrary policy that clearly discriminates against one transportation method, and I applaud Governor DeSantis for continuing to advocate for the cruise industry and the thousands of Florida families who are struggling to make ends meet.” The CDC’s Conditional Sailing Order harms the State and its citizens in at least 4 ways: Preventing numerous businesses and employees from earning a living; Contributing to our State’s unemployment; Exacerbating the massive shortfalls in revenues experienced by our State’s seaports; and Reducing state and local taxes associated with the cruise industry.   In March of 2020, following the CDC’s “No Sail Order,” Florida’s cruise industry came to a screeching halt. To this day—over 1 year later—the Biden Administration continues to prohibit Florida’s cruise ships from operating under its Conditional Sailing Order. This prohibition continues notwithstanding the fact that COVID-19 vaccines are widely available, that other countries have safely and successfully resumed cruise sailings, and that other industries like airlines, bus lines, hotels, restaurants, universities, theme parks, casinos, and bars have successfully reopened. The economic devastation wrought by the CDC’s Conditional Sailing Order cannot be overstated. A September 2020 report from the Federal Maritime Commission estimated that during the first 6 months of the pandemic, losses in Florida due to the cruise industry shutdown totaled $3.2 billion in economic activity, including 49,500 jobs paying $2.3 billion in wages. To date, over 6,000 former cruise industry employees have filed for State unemployment. Since the CDC’s shutdown went into effect, Florida’s seaports have suffered a decline in operating revenue of almost $300 million, and this figure is projection to increase to nearly $400 million in July of 2021. And projections show that Florida’s cruise industry could have produced over $150 million in state and local tax revenues in the 2020-2021 fiscal cruise year.

[KirkNC]

Funny how it’s all the Biden administration fault, that’s rich.

[Mtn2Sea]

A short news report on the Governor’s action.

 

https://wsvn.com/news/local/desantis-announces-lawsuits-against-cdc-biden-administration-to-allow-cruises-to-resume-sailing-out-of-florida/

[wdw1972]

16 minutes ago, KirkNC said:

Funny how it’s all the Biden administration fault, that’s rich.

Well, gotta consider the source.  DeSantis was/is a big Trump supporter.  😉

 

Sue/WDW1972

[Heartgrove]

Interesting that there is allegedly an indefinite hold on the cruise lines operating. I thought there were three possibilities of resuming operation, including a November 1, 2021 date? Plus all the current administrations fault?

 

Found some interesting information today regarding the "data" that the CLIA and members are using to show how safe they have been - not!

 

 

Edited April 8, 2021 by Heartgrove

[Reagan0712]

When the 1st ship sails from, say covid hotbed Italy, & passengers become ill is DeSantis going to allow the ship to dock & disembark in Ft Lauderdale?  Is he going to make sure all those passengers are sent to quarantine facilities like Iceland does with arriving people? Is he going to make sure everyone is tested and then tested again before leaving the quarantine facilities?

It was my understanding from the get go that the CDC didn’t want ships coming into FL from overseas, hence, the ban.  And considering the EU is way behind the US in vaccinations there is a good chance that someone coming here will be infected/asymptomatic.  Someone I know with duel US/Italian citizenship had to go to Italy on a family matter and just returned.  They are still in an almost complete lockdown. So even if Florida opens there won’t be any ships coming from Europe for a while.

[Cruise NH]

Okay this is totally unscientific on my part but outside these cruise forums I don't hear the general public clamoring for cruises.  I'd be curious what you are all hearing from your non-cruising friends. 

 

When this subject comes up at family (zoom) discussions or with our neighbors, hair dresser, etc they give me that grimace that says 'are you kidding'?  

 

I know there is an economic impact, as there is for all tourist related industries, and I feel bad for those affected, but I wonder (again outside these forums) how many people are ready to jump on a ship.  They are going to have to do some major PR to prove to folks that they are safe.

[Reagan0712]

@CruiseNH I believe you are correct in your assessment.  I’m getting pushback for trying to schedule a trip to Iceland in July.  Iceland is in the green for cases and is letting in fully vaccinated people with proof of vaccination.  And, they do not hesitate to immediately deport people who refuse testing if not vaccinated or can prove they’ve had covid.  As far as my scheduled trans-atlantic in October not much as been said but I think they think it won’t come off.

[Mary229]

@Cruise NH  i have never gotten great responses from friends, neighbor, etc... about cruises. It just isn’t on their radar.   That said cruisers and travelers in general are an avid bunch. 
 

All cruise lines are reporting excellent bookings.  Princess and P&O are both reporting outstanding bookings for the summer UK sailings. 
 

in other travel news the airlines are reporting they domestic flight schedules are expanding with increased demand

Edited April 8, 2021 by Mary229

[Cruising-along]

1 hour ago, Cruise NH said:

I'd be curious what you are all hearing from your non-cruising friends. 

My non-cruising friends and family have been totally supportive and understanding of my desire to cruise.  They've seen how much we enjoy it, and even though they may not want to or be able to cruise themselves, they don't ever make "that" grimace or act like we're nuts to want to be on a ship.

[rkacruiser]

4 hours ago, wdw1972 said:

Governor DeSantis (of FL) has issued a press release formally announcing Florida is suing the Biden administration in federal court to overturn the "unlawful" Conditional Sailing Order enacted by the CDC. 

 

Let's keep the attorneys for the State of Florida employed.  

[Mary229]

13 minutes ago, rkacruiser said:

 

Let's keep the attorneys for the State of Florida employed.  

Right?  Like there is no better use of taxpayer dollars.  Private business should have managed this themselves 

Edited April 8, 2021 by Mary229