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Is Royal Caribbean trying to get all Canadians to cancel their planned cruises?


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6 minutes ago, mabt said:

 

Yes and no.  Definitely they need to get their story straight on whether or not the 42 day policy applies to a same-dose series as well.

 

But the mixed dose policy is a problem for many of us too, and drawing a line between mixed doses and same-manufacturer doses, at least where mRNA intervals are concerned, is completely arbitrary.  Nobody else draws this distinction, including the CDC.  Royal appears to have made it up themselves.  And this is, most likely, exactly why there is confusion over the same-manufacturer situation, because there's no rational reason to apply to one and not the other.  It's inconsistent.

 

I will be happy for others if the same-dose interval issue is resolved, and it would clear my husband to cruise.  But I had Pfizer / Moderna at 44 days, so if the mixed dose policy stands, we still don't sail.

 

And even if my problem is solved, that still leaves anyone who got AstraZeneca in the lurch.

 

So suggesting that there is no problem except that RCCL can't make up their minds about the same-dose mRNA interval is maybe a little short-sighted.  😉

BUT the CDC requires a WHO or FDA EUA approved vaccine.  Mixed doses are not EUA approved by either health agency, therefore accepting them opens one up to a litany of liability, the way the CSO is currently worded.

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Posted (edited)

Well, here is your daily update.  The person I know sailing this Saturday from Florida just received a call after he was told this morning they were meeting to discuss the matter.  They just told him (again) now that for this weekend's cruise HE IS considered UNVACCINATED because his Pfizer shots were more than 42 days apart.  They say talks with the CDC are still ongoing.

 

Just when I thought we were getting somewhere after Michael Bayley himself said that we are considered fully vaccinated, this happens...

Edited by Russ Lomas
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1 hour ago, not-enough-cruising said:

BUT the CDC requires a WHO or FDA EUA approved vaccine.  Mixed doses are not EUA approved by either health agency, therefore accepting them opens one up to a litany of liability, the way the CSO is currently worded.

 

So admittedly I'm not an expert in the US drug administration system, or any other country's, for that matter.  But I think people are mixing up the concept of "FDA approval" of a substance with the subsequent use of that substance.

 

ALL of the vaccines in question here are approved for use by the WHO and EUA.  The mRNA vaccines are also approved for use by the FDA.  Again, not an expert, but my understanding is that a drug is either approved for use, or it's not.  The approval will come with manufacturer's guidelines on how it should be used,  but drugs are used off-label all the time.  The FDA doesn't dictate that the drug must be used according to the manufacture's label.  It is approved, with guidelines, and then it's up to medical professionals to follow those guidelines, or not.  If this wasn't true, drugs would never be used in combination - because they're not approved that way.

 

The very existence of the CDC's clinical considerations document suggests, to me, that at least in the case of vaccines, it's up to the CDC to advise on appropriate use and how to proceed with off-label use, deliberate or otherwise.  That has already been done, and they are very clear that both mixed mRNA doses and mRNA doses administered outside of the manufacturers' recommended intervals are considered fully vaccinated.

 

Not to mention the inherent inconsistency of the idea that the CDC would define mixed doses and non-standard intervals as fully vaccinated in general, but then disregard their own guidelines in the case of cruise ships.  That's just non-sensical.

 

4 hours ago, DeanD said:

One is that of the most stringent interpretation, that of the FDA approval.  IMO the emotions don't play into it from a decision making standpoint.  It will change over time but the CDC is not known for making changes quickly.

 

But this is where your argument is going wrong.  You talk about RCCL following FDA guidelines, but then expect the CDC to resolve the situation.  Except that the CDC has already issued guidelines, at least on the topic of mRNA doses, and they are unambiguous.

 

And again, this is not an emotional argument.  Your logic doesn't add up.

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1 hour ago, Russ Lomas said:

Well, here is your daily update.  The person I know sailing this Saturday from Florida just received a call after he was told this morning they were meeting to discuss the matter.  They just told him (again) now that for this weekend's cruise HE IS considered UNVACCINATED because his Pfizer shots were more than 42 days apart.  They say talks with the CDC are still ongoing.

 

Just when I thought we were getting somewhere after Michael Bayley himself said that we are considered fully vaccinated, this happens...

This is insane😡😡😡😡😡😡

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1 hour ago, Russ Lomas said:

Well, here is your daily update.  The person I know sailing this Saturday from Florida just received a call after he was told this morning they were meeting to discuss the matter.  They just told him (again) now that for this weekend's cruise HE IS considered UNVACCINATED because his Pfizer shots were more than 42 days apart.  They say talks with the CDC are still ongoing.

 

Just when I thought we were getting somewhere after Michael Bayley himself said that we are considered fully vaccinated, this happens...

 

😡

 

Someone upthread (or in a different thread on the same topic) said that the cruise lines were "stepping in their own do-do and tracking it around the room".

 

That's the best description I've seen so far.  At least where RCCL is concerned.

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15 minutes ago, mabt said:

 

So admittedly I'm not an expert in the US drug administration system, or any other country's, for that matter.  But I think people are mixing up the concept of "FDA approval" of a substance with the subsequent use of that substance.

 

ALL of the vaccines in question here are approved for use by the WHO and EUA.  The mRNA vaccines are also approved for use by the FDA.  Again, not an expert, but my understanding is that a drug is either approved for use, or it's not.  The approval will come with manufacturer's guidelines on how it should be used,  but drugs are used off-label all the time.  The FDA doesn't dictate that the drug must be used according to the manufacture's label.  It is approved, with guidelines, and then it's up to medical professionals to follow those guidelines, or not.  If this wasn't true, drugs would never be used in combination - because they're not approved that way.

 

The very existence of the CDC's clinical considerations document suggests, to me, that at least in the case of vaccines, it's up to the CDC to advise on appropriate use and how to proceed with off-label use, deliberate or otherwise.  That has already been done, and they are very clear that both mixed mRNA doses and mRNA doses administered outside of the manufacturers' recommended intervals are considered fully vaccinated.

 

Not to mention the inherent inconsistency of the idea that the CDC would define mixed doses and non-standard intervals as fully vaccinated in general, but then disregard their own guidelines in the case of cruise ships.  That's just non-sensical.

 

 

But this is where your argument is going wrong.  You talk about RCCL following FDA guidelines, but then expect the CDC to resolve the situation.  Except that the CDC has already issued guidelines, at least on the topic of mRNA doses, and they are unambiguous.

 

And again, this is not an emotional argument.  Your logic doesn't add up.

Perhaps (obviously) I did not make my point clear (a recurring problem for me and the written word). Let me try again.

 

A large portion of the FDA EUA approval for these vaccines was a very specific, tested, dosing regimen; to include acceptable timing of the 2 doses.  Doses given outside of these studied parameters (not to mention mixing manufacturers) were never granted approval, therefore are not considered (by the appropriate governing body) to be a successful vaccination dose.

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Posted (edited)
2 hours ago, Russ Lomas said:

Well, here is your daily update.  The person I know sailing this Saturday from Florida just received a call after he was told this morning they were meeting to discuss the matter.  They just told him (again) now that for this weekend's cruise HE IS considered UNVACCINATED because his Pfizer shots were more than 42 days apart.  They say talks with the CDC are still ongoing.

 

Just when I thought we were getting somewhere after Michael Bayley himself said that we are considered fully vaccinated, this happens...

Were they offering a refund or at least covering the testing. The experience they sold him has definitely changed.

Edited by rvlandandsea
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Just now, not-enough-cruising said:

Perhaps (obviously) I did not make my point clear (a recurring problem for me and the written word). Let me try again.

 

A large portion of the FDA EUA approval for these vaccines was a very specific, tested, dosing regimen; to include acceptable timing of the 2 doses.  Doses given outside of these studied parameters (not to mention mixing manufacturers) were never granted approval, therefore are not considered (by the appropriate governing body) to be a successful vaccination dose.

 

I don't think you were unclear; we just disagree.  🙂

 

The CDC is the "appropriate governing body" in this case, and they are very clear that these scenarios, while not recommended, still result in a person being "fully vaccinated", and that no additional dose should be administrated.

 

Have you read the CDC document?  It's here: https://www.cdc.gov/vaccines/covid-19/clinical-considerations/covid-19-vaccines-us.html

 

See the sections on "Vaccine Administration" (specifically "Interval between mRNA doses"), "Interchangeability of COVID-19 vaccine products", and the table in "Appendix A. Vaccine administration errors and deviations", specifically under "mRNA vaccines only".

 

Again, the FDA doesn't dictate how an approved substance must be used.  (Or that's my understanding, anyway.)  They approve a substance based on manufacturer's recommended use, supported by the manufacturer's studies.  It is then up to the medical experts to follow the guidelines, or not.  And deviating from manufacturer's guidelines is (again, to my understanding) very, very common.

 

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Posted (edited)
5 minutes ago, mabt said:

 

I don't think you were unclear; we just disagree.  🙂

 

The CDC is the "appropriate governing body" in this case, and they are very clear that these scenarios, while not recommended, still result in a person being "fully vaccinated", and that no additional dose should be administrated.

 

Have you read the CDC document?  It's here: https://www.cdc.gov/vaccines/covid-19/clinical-considerations/covid-19-vaccines-us.html

 

See the sections on "Vaccine Administration" (specifically "Interval between mRNA doses"), "Interchangeability of COVID-19 vaccine products", and the table in "Appendix A. Vaccine administration errors and deviations", specifically under "mRNA vaccines only".

 

Again, the FDA doesn't dictate how an approved substance must be used.  (Or that's my understanding, anyway.)  They approve a substance based on manufacturer's recommended use, supported by the manufacturer's studies.  It is then up to the medical experts to follow the guidelines, or not.  And deviating from manufacturer's guidelines is (again, to my understanding) very, very common.

 

Sorry but you are incorrect, and as you stated earlier you were unclear on the inner workings of government health agencies. Under the EUA window, which we are still in, the FDA dictates FULLY how these substances must be used; their authority during the EUA "window" is absolute.  The CDC must abide by this authority, and declare any situation outside of the parameters as "void"

Edited by not-enough-cruising
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2 hours ago, Russ Lomas said:

Well, here is your daily update.  The person I know sailing this Saturday from Florida just received a call after he was told this morning they were meeting to discuss the matter.  They just told him (again) now that for this weekend's cruise HE IS considered UNVACCINATED because his Pfizer shots were more than 42 days apart.  They say talks with the CDC are still ongoing.

 

Just when I thought we were getting somewhere after Michael Bayley himself said that we are considered fully vaccinated, this happens...


I would like to know the ship he is sailing on this Saturday out of Florida   Is it a test sailing perhaps.   I am holding on tight to the ‘they say talks with the CDC are still ongoing’   My B2B is Sept 12 out of Bayonne 

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40 minutes ago, mabt said:

 

So admittedly I'm not an expert in the US drug administration system, or any other country's, for that matter.  But I think people are mixing up the concept of "FDA approval" of a substance with the subsequent use of that substance.

 

ALL of the vaccines in question here are approved for use by the WHO and EUA.  The mRNA vaccines are also approved for use by the FDA.  Again, not an expert, but my understanding is that a drug is either approved for use, or it's not.  The approval will come with manufacturer's guidelines on how it should be used,  but drugs are used off-label all the time.  The FDA doesn't dictate that the drug must be used according to the manufacture's label.  It is approved, with guidelines, and then it's up to medical professionals to follow those guidelines, or not.  If this wasn't true, drugs would never be used in combination - because they're not approved that way.

 

The very existence of the CDC's clinical considerations document suggests, to me, that at least in the case of vaccines, it's up to the CDC to advise on appropriate use and how to proceed with off-label use, deliberate or otherwise.  That has already been done, and they are very clear that both mixed mRNA doses and mRNA doses administered outside of the manufacturers' recommended intervals are considered fully vaccinated.

 

Not to mention the inherent inconsistency of the idea that the CDC would define mixed doses and non-standard intervals as fully vaccinated in general, but then disregard their own guidelines in the case of cruise ships.  That's just non-sensical.

 

 

But this is where your argument is going wrong.  You talk about RCCL following FDA guidelines, but then expect the CDC to resolve the situation.  Except that the CDC has already issued guidelines, at least on the topic of mRNA doses, and they are unambiguous.

 

And again, this is not an emotional argument.  Your logic doesn't add up.

I tend to look at these things big picture.  While the CDC has said to consider those with mixed doses as fully vaccinated, they also say "Any currently FDA-authorized COVID-19 vaccine can be used when indicated; ACIP does not state a product preference. However, COVID-19 vaccines are not interchangeable" as well as "The safety and efficacy of a mixed-product series have not been evaluated. Both doses of the series should be completed with the same product.".  One has to realize that anything outside the FDA approval, which means within the stated time frame with the same mRNA vaccine, is simply a compromise.  It would appear that RCL has decided to avoid the compromise situations at least for now.

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3 minutes ago, not-enough-cruising said:

Sorry but you are incorrect, and as you stated earlier you were unclear on the inner workings of government health agencies. Under the EUA window, which we are still in, the FDA dictates FULLY how these substances must be used; their authority during the EUA "window" is absolute.  The CDC must abide by this authority, and declare any situation outside of the parameters as "void"

Okay, well if you're right about that, then the CDC is clearly in violation of the FDA's "absolute authority" in their administrative guidance.

 

I don't know how you square that circle, but I won't argue it further.  My assessment was based on first principles and logic.  What you're saying might be right, but it's not logically consistent.

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1 minute ago, mabt said:

Okay, well if you're right about that, then the CDC is clearly in violation of the FDA's "absolute authority" in their administrative guidance.

 

I don't know how you square that circle, but I won't argue it further.  My assessment was based on first principles and logic.  What you're saying might be right, but it's not logically consistent.

Welcome to American federal bureaucracy, it's maddening.

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2 hours ago, Russ Lomas said:

Well, here is your daily update.  The person I know sailing this Saturday from Florida just received a call after he was told this morning they were meeting to discuss the matter.  They just told him (again) now that for this weekend's cruise HE IS considered UNVACCINATED because his Pfizer shots were more than 42 days apart.  They say talks with the CDC are still ongoing.

 

Just when I thought we were getting somewhere after Michael Bayley himself said that we are considered fully vaccinated, this happens...

Wow, well that’s really discouraging. Hopefully the talks will bring some logical decisions about vaccination requirements. Right now these criteria would mean that most of the Canadian population is unvaccinated - which totally doesn’t support the current low number of daily new COVID cases/hospitalizations here, the vaccines are having a tremendous impact. My family received 2 Pfizer doses, 47 days apart…so a whole 5 days too late to be considered fully vaccinated according to RC. We have 5 cruises booked between Aug and March, hopefully we’ll be able to go on some of them - as long as we are considered fully vaccinated. For our Aug 20 Ovation Alaska cruise, all guests 12+ must be vaccinated, so this is the cruise that’s still up in the air for us.

 

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8 minutes ago, DeanD said:

I tend to look at these things big picture.  While the CDC has said to consider those with mixed doses as fully vaccinated, they also say "Any currently FDA-authorized COVID-19 vaccine can be used when indicated; ACIP does not state a product preference. However, COVID-19 vaccines are not interchangeable" as well as "The safety and efficacy of a mixed-product series have not been evaluated. Both doses of the series should be completed with the same product.".  One has to realize that anything outside the FDA approval, which means within the stated time frame with the same mRNA vaccine, is simply a compromise.  It would appear that RCL has decided to avoid the compromise situations at least for now.

 

IMO that's not "big picture", it's cherry picking.  Yes, the CDC gives lots of reasons to support their recommendation of single-manufacturer doses, and then goes on to conclude that under certain circumstances deviation from the recommendation is justified, and that deviation still results in "full vaccination".

 

Incidentally, the situation in Canada was exactly the exception case that the CDC outlines: namely, the temporary unavailability of a second dose from the same manufacturer, resulting in a dosage interval of greater than 42 days.

 

But we're going around in circles now.  You are welcome to maintain your opinion that RCCL's position on this is rational and justified, and I will stick to my assessment that it is non-sensical, unsupported by either the available evidence (limited as it may be) or the documented position of the governing bodies involved, and inconsistent with the decision of every other cruise line operating in the same jurisdiction.  Agree to disagree.

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1 hour ago, karebare22 said:

Wow, well that’s really discouraging. Hopefully the talks will bring some logical decisions about vaccination requirements. Right now these criteria would mean that most of the Canadian population is unvaccinated - which totally doesn’t support the current low number of daily new COVID cases/hospitalizations here, the vaccines are having a tremendous impact. My family received 2 Pfizer doses, 47 days apart…so a whole 5 days too late to be considered fully vaccinated according to RC. We have 5 cruises booked between Aug and March, hopefully we’ll be able to go on some of them - as long as we are considered fully vaccinated. For our Aug 20 Ovation Alaska cruise, all guests 12+ must be vaccinated, so this is the cruise that’s still up in the air for us.

At this point, unless they change their minds, you will be considered unvaccinated for all 5 of your cruises, be treated as unvaccinated, segregated an be corralled with all the unvaccinated people, and have to pay for all of the required testing and take out additional insurance policies...all for being double doses with Pfizer like Royal told us we had to.

 

1 hour ago, emmy said:

I would like to know the ship he is sailing on this Saturday out of Florida   Is it a test sailing perhaps.   I am holding on tight to the ‘they say talks with the CDC are still ongoing’   My B2B is Sept 12 out of Bayonne 

July 31st on the Odyssey.  Inaugural cruise with paying passengers.

 

1 hour ago, rvlandandsea said:

Were they offering a refund or at least covering the testing. The experience they sold him has definitely changed.

They said if you are considered unvaccinated, you have to pay for all the testing and find supplementary insurance as well.  Nothing was mentioned that I am aware of about a refund, but my understanding is you can still request a refund since they changed the terms of the initial agreement.  That said, you are still out for flights and other non-refundable expenses if you take this option.

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14 minutes ago, Russ Lomas said:

At this point, unless they change their minds, you will be considered unvaccinated for all 5 of your cruises, be treated as unvaccinated, segregated an be corralled with all the unvaccinated people, and have to pay for all of the required testing and take out additional insurance policies..

 

Just to clarify Royal is only letting unvaccinated over 12 years of age on Florida cruises. If royal deems you unvaccinated for cruises outside of Florida...you're not getting on the ship at all. Unless I missed them backing off that stance in the other states. 

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9 minutes ago, Russ Lomas said:

At this point, unless they change their minds, you will be considered unvaccinated for all 5 of your cruises, be treated as unvaccinated, segregated an be corralled with all the unvaccinated people, and have to pay for all of the required testing and take out additional insurance policies...all for being double doses with Pfizer like Royal told us we had to.

 

Nope, that won’t be happening. I know I’m fully vaccinated and will wait to cruise when this is accepted. Not about to waste money on all those extra protocols which I agree are important for unvaccinated cruisers.

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10 hours ago, karebare22 said:

Nope, that won’t be happening. I know I’m fully vaccinated and will wait to cruise when this is accepted. Not about to waste money on all those extra protocols which I agree are important for unvaccinated cruisers.

I know how you feel.  We are FULLY vaccinated with a single accepted vaccine as well and are upset we are being told that they consider us unvaccinated.  We cannot afford to pay for all those extra tests for a family of six, still to be treated on the ship as unvaccinated.

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10 hours ago, smplybcause said:

 

Just to clarify Royal is only letting unvaccinated over 12 years of age on Florida cruises. If royal deems you unvaccinated for cruises outside of Florida...you're not getting on the ship at all. Unless I missed them backing off that stance in the other states. 

not exactly.  Those under 12 who are not currently eligible to be vaccinated are permitted to sail but they have to do all of the required Covid tests multiple times.  RCCL will not charge if the individual is under 12 years of age (until those of that age can be vaccinated that is).

 

If you are deemed unvaccinated (as it appears we are even though we all got 2 Pfizer shots months ago, they just happen to be a few days more than the 42 days RCCL is saying is permitted - otherwise THEY are considering you UNVACCINATED).  You can still get on the ship BUT you have to pay for a PCR test before coming to the port and it has to be negative.  You have to pay RCCL for them to conduct 3 tests on you for a cost of about $175.  You must also pay for extra travel insurance and provide proof to them.  You cannot get off the ship in most ports unless you pay RCCL and are restricted to their shore excursions only.  And on top of all that, you are restricted on where you can go on the ship and what activities you can participate in.

 

Basically it means even if you followed your country's vaccine protocols, RCCL is making you pay an extra $500 or so and limiting what you can do, even if the CDC says you are considered fully vaccinated.

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Seems to me RCL could avoid a lot of ill will and resolve a LOT of the issues talked about here if they would just say
"The policy is X. It is under review, however will not be changed till at least X date. We understand you may be affected by it and we will refund your cruise fare if you do not wish to sail under the policy."

At this point anyone who completes a new booking should be aware of what they're getting into.
It's the existing bookings that are causing much of the grief I would wager.

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30 minutes ago, Russ Lomas said:

not exactly.  Those under 12 who are not currently eligible to be vaccinated are permitted to sail but they have to do all of the required Covid tests multiple times.  RCCL will not charge if the individual is under 12 years of age (until those of that age can be vaccinated that is).

 

If you are deemed unvaccinated (as it appears we are even though we all got 2 Pfizer shots months ago, they just happen to be a few days more than the 42 days RCCL is saying is permitted - otherwise THEY are considering you UNVACCINATED).  You can still get on the ship BUT you have to pay for a PCR test before coming to the port and it has to be negative.  You have to pay RCCL for them to conduct 3 tests on you for a cost of about $175.  You must also pay for extra travel insurance and provide proof to them.  You cannot get off the ship in most ports unless you pay RCCL and are restricted to their shore excursions only.  And on top of all that, you are restricted on where you can go on the ship and what activities you can participate in.

 

Basically it means even if you followed your country's vaccine protocols, RCCL is making you pay an extra $500 or so and limiting what you can do, even if the CDC says you are considered fully vaccinated.

 

Of course it doesn't apply to those too young to get the vaccine, but if you're old enough to get it any cruise besides those out of Florida require it - there is no alternative to test and get on if you're eligible to be vaccinated age wise. I see no exceptions for Canadian residents on non-Florida cruises.

 

Notice the "must provide proof" for all non-Florida ports.

 

https://www.royalcaribbean.com/faq/questions/do-i-need-a-covid-vaccine-to-cruise-what-counts-as-proof

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