NCL Counters CDC new phase with it's own plan. Really bold move.

[RocketMan275]

8 hours ago, giustot said:

This 115 year-old ruling gives Cities and States the right to require vaccinations. But both the Trump and Biden Administrations have said no US citizen will be required to be vaccinated. So what do we do? This is why issue of proof of vaccinations is so complicated and unsettled.

 

Rather than requiring vaccinations, some states are going in the opposite direction by specifically banning proof of vaccinations.

 

And, in my view as a non-lawyer, the Supreme Court case applies to States rights, not the rights of cruise lines and other businesses.

 

If States want to allow cruise lines that sail in their waters to require proof of vaccinations, that's fine with me. But, in my opinion, we are not there yet.

Whether the federal government chooses to enforce mandatory vaccinations doesn't affect the fact that the USSC ruling remains the law of the land and that law states that governments do have the right to require vaccinations.  An effort by the federal government to enforce mandatory vaccinations would be limited to areas within the purview of the federal government, ie, federal employees, federal property, and other areas as provided by law. That would certainly include cruise lines entering/departing federal waters.  Think the federal masking mandate currently in effect.

 

I'm not arguing for or against mandatory vaccination. I am pointing out the USSC ruling exists.  

 

[Jobeth66]

17 hours ago, DCGuy64 said:

Yes, there is a difference. However, FDA approval in the USA for the current vaccines was granted only under Emergency Use Authorization (EUA). There's a strong legal argument that you cannot require people to get a vaccine that is only authorized for emergency use, still less to make this a condition for employment, for example. Once all of the studies have been done and the vaccines are no longer just in EUA use, that could change. I am vaccinated but I sympathize with those who are hesitant, and given the murky legal territory, I can understand why some cruise lines aren't requiring passengers to be vaccinated.

 

It's expected that both Pfizer and Moderna will shortly be applying for full regulatory approval, possibly as soon as this month.

[DCGuy64]

3 minutes ago, Jobeth66 said:

 

It's expected that both Pfizer and Moderna will shortly be applying for full regulatory approval, possibly as soon as this month.

Yes, and that approval process typically takes years due to FDA requirements regarding long term health effects and study groups. I am definitely hopeful about the vaccines, which is why I've been vaccinated. But the approval process takes a long time, and in the meantime, it's unclear what the legal ramifications of a vaccine requirement will be. Too early to tell.

[Jobeth66]

34 minutes ago, DCGuy64 said:

Yes, and that approval process typically takes years due to FDA requirements regarding long term health effects and study groups. I am definitely hopeful about the vaccines, which is why I've been vaccinated. But the approval process takes a long time, and in the meantime, it's unclear what the legal ramifications of a vaccine requirement will be. Too early to tell.

Once they have all their data submitted?  Typically takes 6 months or so.  Not years.  I see no reason why this would take years.

[DCGuy64]

5 minutes ago, Jobeth66 said:

Once they have all their data submitted?  Typically takes 6 months or so.  Not years.  I see no reason why this would take years.

There are several phases in the process of getting approval from the FDA. I hope it won't take years, but that's always a possibility.

https://www.uchicagomedicine.org/forefront/coronavirus-disease-covid-19/how-does-the-fda-approve-vaccines

Quoted from the article I posted:

How does the FDA approve a new vaccine?

The process of getting a vaccine approved for use in the general public is no picnic and can take several years.

 

[RocketMan275]

25 minutes ago, DCGuy64 said:

The process of getting a vaccine approved for use in the general public is no picnic and can take several years.

Certainly, if they were starting from scratch but there have already completed the three trial stages and there is lots of data available on effectiveness and safety.  It really depends upon how quickly they want to move.  What is more relevant is the approval may be rather unimportant when one considers how many have already been vaccinated.

[BermudaBound2014]

25 minutes ago, Jobeth66 said:

Once they have all their data submitted?  Typically takes 6 months or so.  Not years.  I see no reason why this would take years.

 

Yikes! I hope this vaccine isn't "warp speeded" into FDA full approval in just 6 more months. If it is, that's a huge red flag for me. The Pandemic Accelerated model was a year, but a typical vaccine takes nearly a decade to reach full approval and requires an extensive study on effectiveness. Best I can tell, those who have already received the vaccine are part of phase 3.

 https://www.vumc.org/viiii/immuknow/covid-vaccine-pandemic-speed

 

 

[BermudaBound2014]

On 4/20/2021 at 10:10 PM, Silver Sweethearts said:

 

Speaking of numbers, you do the math on the following (courtesy Maui Now this afternoon):

 

"Lt. Gov. Josh Green said herd immunity is not an exact science, but anticipates the state will approach that point around the July 4th weekend. “We won’t see a magic light go off,” he said, but said Hawaiʻi would have to get around 75 to 85 percent of the population vaccinated–translating to 1.8 to 2 million people."

 

The population of the whole state of Hawai'i is 1.4 million. No matter what percentages they think they need, how can you get 1.8 to 2 million vaccinated when there are only 1.4 million people here?  We are obviously missing something here.  

 

 

Like you, I follow the Maui numbers weekly. I agree, something is amiss. The way that data has been disseminated throughout the entire pandemic is irresponsible (IMO).  Statistician are willing and able to  "crunch the numbers until they confess' based on who is signing their paycheck. Anyone who does not acknowledge this needs a quick refresher course in Stats101. 

[Jobeth66]

13 minutes ago, BermudaBound2014 said:

 

Yikes! I hope this vaccine isn't "warp speeded" into FDA full approval in just 6 more months. If it is, that's a huge red flag for me. The Pandemic Accelerated model was a year, but a typical vaccine takes nearly a decade to reach full approval and requires an extensive study on effectiveness. Best I can tell, those who have already received the vaccine are part of phase 3.

 https://www.vumc.org/viiii/immuknow/covid-vaccine-pandemic-speed

 

 

 

Pfizer & Moderna have over 6 months of vaccine efficacy data, which is all that's needed to submit for approval per FDA guidelines.  The long-term work is already done.  The full approval from here would be standard procedure, not 'warp speeded'

[BermudaBound2014]

4 minutes ago, Jobeth66 said:

 

Pfizer & Moderna have over 6 months of vaccine efficacy data, which is all that's needed to submit for approval per FDA guidelines.  The long-term work is already done.  The full approval from here would be standard procedure, not 'warp speeded'

 

I'm not following your logic. Even Pfizer and Moderna aren't claiming long term effectiveness. 

 

Even if you are correct  and the vaccines can obtain full FDA approval (and nothing surprises me anymore); I am still suspect. How can we possibly know the long-term effects of a vaccine that was designed to protect us from a virus that is just over a year old?  

 

I'm cautiously optimistic.

[Jobeth66]

Just now, BermudaBound2014 said:

 

I'm not following your logic. Even Pfizer and Moderna aren't claiming long term effectiveness. 

 

Even if you are correct  and the vaccines can obtain full FDA approval (and nothing surprises me anymore); I am still suspect. How can we possibly know the long-term effects of a vaccine that was designed to protect us from a virus that is just over a year old?  

 

I'm cautiously optimistic.

 

The FDA only requires 6 months of vaccine testing and efficacy data in order to apply for full approval.  Pfizer & Moderna have that.  They don't need years.  Phase IV (which continues to monitor effectiveness and side effects) continues even after full approval.  This is normal and part of the customary process for vaccines.

[BermudaBound2014]

Just now, Jobeth66 said:

 

The FDA only requires 6 months of vaccine testing and efficacy data in order to apply for full approval.  Pfizer & Moderna have that.  They don't need years.  Phase IV (which continues to monitor effectiveness and side effects) continues even after full approval.  This is normal and part of the customary process for vaccines.

 

Thank you. You are correct in the timeline.

 

 However; I am still very suspect of a vaccine that can reach full Federal approval so quickly. We can't possibly know the long term effects until actual time has elapsed.  It appears that once the FDA gives full approval, other companies in trial can not apply for  emergency approval and will be locked out. Another reason to rush full federal approval is that once Covid is no longer considered a pandemic,  Emergency Use Vaccines can't be administered. There is a lot of $$ at stake for the vaccine industry to get this pushed through to approval. I'm cautious.

 

https://www.10news.com/news/coronavirus/in-depth-how-full-fda-approval-would-impact-vaccine-mandates-competition

[eileeshb]

2 hours ago, BermudaBound2014 said:

 

Thank you. You are correct in the timeline.

 

 However; I am still very suspect of a vaccine that can reach full Federal approval so quickly. We can't possibly know the long term effects until actual time has elapsed.  It appears that once the FDA gives full approval, other companies in trial can not apply for  emergency approval and will be locked out. Another reason to rush full federal approval is that once Covid is no longer considered a pandemic,  Emergency Use Vaccines can't be administered. There is a lot of $$ at stake for the vaccine industry to get this pushed through to approval. I'm cautious.

 

https://www.10news.com/news/coronavirus/in-depth-how-full-fda-approval-would-impact-vaccine-mandates-competition

A lot of people seem to have forgotten the covid-19 vaccine leveraged a decade or more of work on vaccines for MERS and SARS it’s a large part of the reason they were so quick to have a vaccine ready for approved use.
 

Think of all the various flu strains, we got the swine flu vaccine variant in less than a year because it was part of the same family of viruses. Covid-19 is the same family as SARS and MERS, there’s a good chance we could be getting an annual covid vaccine/booster with different strains the same way the flu vaccine happens every year with a set of specific strains included. 

[BermudaBound2014]

34 minutes ago, eileeshb said:

A lot of people seem to have forgotten the covid-19 vaccine leveraged a decade or more of work on vaccines for MERS and SARS it’s a large part of the reason they were so quick to have a vaccine ready for approved use.
 

Think of all the various flu strains, we got the swine flu vaccine variant in less than a year because it was part of the same family of viruses. Covid-19 is the same family as SARS and MERS, there’s a good chance we could be getting an annual covid vaccine/booster with different strains the same way the flu vaccine happens every year with a set of specific strains included. 

 

I do understand they were working on the technology for a long time, but I don't believe testing ever got to level 3 with the new technology. Even so, lots of products make it through FDA approval only to be recalled at a later date. I am old enough to remember the DDT debacle that happened in Michigan.  A co-worker's wife died from Fen-phen. Ironically, this commercial just came on .......

 

"If you, or any of your loved ones, were prescribed Zantac you maybe eligible for financial compensation......" 

 

I am not eligible for the vaccine because I am legally a Michigan resident who is living in Hawaii, but I must admit I'm thankful I don't need to make the decision immediately.

Edited April 22, 2021 by BermudaBound2014

[eileeshb]

On 4/22/2021 at 10:19 PM, BermudaBound2014 said:

 

I do understand they were working on the technology for a long time, but I don't believe testing ever got to level 3 with the new technology. Even so, lots of products make it through FDA approval only to be recalled at a later date. I am old enough to remember the DDT debacle that happened in Michigan.  A co-worker's wife died from Fen-phen. Ironically, this commercial just came on .......

 

"If you, or any of your loved ones, were prescribed Zantac you maybe eligible for financial compensation......" 

 

I am not eligible for the vaccine because I am legally a Michigan resident who is living in Hawaii, but I must admit I'm thankful I don't need to make the decision immediately.

They may not have reached level 3 in the USA but I know the Oxford team had already started trials on the mRNA vaccine vector with a generic coronavirus that didn’t cause serious illness. There are some varieties of ye olde fashioned head-cold that are coronaviruses and would have been among the test cases in vaccine development. 
 

I heard one of the Oxford researchers on Irish radio talking about that testing in the early days of covid-19. I think the fact that one of the lead scientists in the development of the Oxford/Astra-Zeneca vaccine was why the Irish government ordered such high quantities of it. They also ordered a lot of the Pfizer vaccine because they have a factory here.  There’s a lot of the main bio-medical manufacturers with production facilities here, heck pre-COVID-19 it was an Irish factory that supplied something like 60% of  ventilators world wide. 

[RocketMan275]

On 4/22/2021 at 12:28 PM, BermudaBound2014 said:

 

Yikes! I hope this vaccine isn't "warp speeded" into FDA full approval in just 6 more months. If it is, that's a huge red flag for me.

The really "huge red flag" for anyone should be having to wait for several more years to get a vaccination.  The long term effects of the virus include death

[RocketMan275]

On 4/22/2021 at 4:19 PM, BermudaBound2014 said:

"If you, or any of your loved ones, were prescribed Zantac you maybe eligible for financial compensation......" 

Personally, I loved the commercial that said: "If you or a loved one died after taking..."

 

I'm wondering how a loved one who died might call?  Perhaps someone placed a cell phone in their casket?

[BermudaBound2014]

3 hours ago, RocketMan275 said:

The really "huge red flag" for anyone should be having to wait for several more years to get a vaccination.  The long term effects of the virus include death 

 

 

Absolutely disagree. This suggestion makes zero sense in my case.  I’m less than 55 years old and do not have any conditions which put me into a high risk category. I don’t smoke, rarely drink, not a diabetics, not obese, no blood pressure issues, no breathing issues, exercise 5 times a week, etc.... Sure something could happen with covid, but my plane could crash next week too. In fact, I best i can tell it appears that, Statistically, I have a significantly greater chance of dieing in a car accident than suffering anytype of covid complications (let alone death from the virus as you implied). 

 

The data indicates I have less than a .02% chance of long term covid complications. At this time, we do not know the risk associated with the vaccine. It may turn out to be less than .02% but we simply don’t know just yet. Everyone accepting the vaccine acknowledged this when you signed off.
 

Pfizer and Moderno state that their vaccines will still be under study until April, 2023 (Pfizer) and October, 2022 (moderno).  In the meantime, neither has published the results of clinical trials because there has not been enough time elapsed. 

 

https://clinicaltrials.gov/ct2/show/results/NCT04368728?view=results

 

 https://clinicaltrials.gov/ct2/show/results/NCT04470427

 

Of course, this doesn’t mean the vaccines aren’t safe, but anyone taking the vaccine signed off stating that they understand the vaccines are still under trial and have been granted emergency use only.

I believe I have a .02% chance of long term  covid complications (and even less of a chance of death). Im comfortable with those odds. I don’t know the odds of being injured from the vaccine. Anyone with even the most basic critical thinking skills acknowledges there is risk with every single decision we make in life, including getting a vaccine (or not). 

 

Fear mongering doesn’t work on me. If I do decide to get a vaccine (I’m still not eligible), it won’t be because I’m afraid of catching covid. It will be because I am convinced that the risk of a vaccine injury is less than the benefit of helping society reach heard immunity. In my case, helping my community is the only rational reason I can see to take the jab.

[Silver Sweethearts]

3 hours ago, BermudaBound2014 said:

 

Fear mongering doesn’t work on me. If I do decide to get a vaccine (I’m still not eligible), it won’t be because I’m afraid of catching covid. 

 

From what we can tell, you are eligible now.  Effective April 5th, everyone 16 and older in Michigan can get the vaccinations.

[BermudaBound2014]

37 minutes ago, Silver Sweethearts said:

 

From what we can tell, you are eligible now.  Effective April 5th, everyone 16 and older in Michigan can get the vaccinations.

That would work if I was living in Michigan, but I’m still on Maui with you 😉

Edited April 25, 2021 by BermudaBound2014

[mianmike]

11 hours ago, BermudaBound2014 said:

Absolutely disagree. This suggestion makes zero sense in my case.  I’m less than 55 years old and do not have any conditions which put me into a high risk category. I don’t smoke, rarely drink, not a diabetics, not obese, no blood pressure issues, no breathing issues, exercise 5 times a week, etc.... Sure something could happen with covid, but my plane could crash next week too. In fact, I best i can tell it appears that, Statistically, I have a significantly greater chance of dieing in a car accident than suffering anytype of covid complications (let alone death from the virus as you implied). 

 

The data indicates I have less than a .02% chance of long term covid complications. At this time, we do not know the risk associated with the vaccine. It may turn out to be less than .02% but we simply don’t know just yet. Everyone accepting the vaccine acknowledged this when you signed off.
 

Pfizer and Moderno state that their vaccines will still be under study until April, 2023 (Pfizer) and October, 2022 (moderno).  In the meantime, neither has published the results of clinical trials because there has not been enough time elapsed. 

 

https://clinicaltrials.gov/ct2/show/results/NCT04368728?view=results

 

 https://clinicaltrials.gov/ct2/show/results/NCT04470427

 

Of course, this doesn’t mean the vaccines aren’t safe, but anyone taking the vaccine signed off stating that they understand the vaccines are still under trial and have been granted emergency use only.

I believe I have a .02% chance of long term  covid complications (and even less of a chance of death). Im comfortable with those odds. I don’t know the odds of being injured from the vaccine. Anyone with even the most basic critical thinking skills acknowledges there is risk with every single decision we make in life, including getting a vaccine (or not). 

 

Fear mongering doesn’t work on me. If I do decide to get a vaccine (I’m still not eligible), it won’t be because I’m afraid of catching covid. It will be because I am convinced that the risk of a vaccine injury is less than the benefit of helping society reach heard immunity. In my case, helping my community is the only rational reason I can see to take the jab.

 

How could we possibly know conclusively the long-term effects of covid?  The bottom line: we don't know the long-term effects from either the vaccine or the disease.  It will take years of data to know what covid exposure does to the human body.   

[oteixeira]

2 hours ago, mianmike said:

 

How could we possibly know conclusively the long-term effects of covid?  The bottom line: we don't know the long-term effects from either the vaccine or the disease.  It will take years of data to know what covid exposure does to the human body.   

I would have to whole heatedly agree with this.  You can't argue we haven't had enough time to study the vaccines or it's effects and in the same breath argue we are experts on what covid-19 will do to us long term.  They are both unknowns, it is just a matter of which unknown you choose to gamble with.  Since one has the benefit of returning us back to living a more "normal" life, I know which one I would pick (and already have picked).

[philv]

Knowing the unknowable, absolute certainty are unobtainable aspirations. I agree with oteixeira that we have a path back to normal life that is safe and effective and is the most certain way to get us back to where we want to be. We should take it.💉😀

[HowardK]

Its a risk either way but I preferred choosing the vaccine. However, I would like to know what the duration is before a booster is needed. More interim results based on 6th months and 9th months after.

it is as if I would need a booster before going to a concert or cruise or show.

 

I've done a complete 180 perhaps after watching the NCL videos and am looking at 2023 cruises (2022 didn't have the ones I wanted for now but I had other plans that year)

[BermudaBound2014]

Absolutely Agree- We do not know the long term effects of the virus OR the vaccine.
 

I disagree with pushing the vaccine because “the long term effects of covid include death” - that is fear mongering. It may prove to be true, but I currently like my odds against the virus.

 

Since I'm personally not afraid of the virus, at this point the biggest reason (for me) to get the vaccine appears to be to protect the vulnerable and help us reach herd immunity. Both valid reasons.

Edited April 25, 2021 by BermudaBound2014