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No vaccine mixing allowed in US… I hope this changes very very quickly 😱


MR_T
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3 minutes ago, Charles4515 said:

 

The PVSA does not allow technical stops so the exception to the PSVA would still have been required for Alaska cruise to happen this summer. 

Yes agree and I said this was a USA issue (even for technical stops)  so not sure why it keeps being blamed on Canada.  I think technical stops might have been negotiated between the USA and Canada but moot point anyway. 

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1 hour ago, TeeRick said:

Well at least this thread has been allowed to continue so far.  It is highly relevant to cruising.

 

cangelmd- Some thoughts along the lines of what you said here:

Maybe the authorization by EUA of a third (booster) dose might solve this problem for some?  Then they could get a dose of either vaccine that they originally had and be fully vaccinated.

 

Or just sign up for 1 dose of J&J if accessible? It is approved in both Canada and the UK but I know there are supply issues.  This is a strategy that might mean some got three different vaccines so kind of questionable regulatory-wise. 

 

Just to mention that there is a lot of data showing high effectiveness of most of these vaccines perhaps a month after only the first shot.   At least against serious COVID.  

 

All this is about officialdom (or officialdumb) and has little to do with the vaccine mixed dose effectiveness which by real world data is good.

 

I still say the FDA and Canada and UK regulatory authorities should all meet together on this issue and try to solve it.  C'mon!  It should not be too hard.  Let our cruises go!!

However, the reason why the CDC accepts the WHO and the FDA list of authorized vaccines, is because the requirements for review to get on either list is a rigorous review process that is well defined.  None of the combinations have the trials and data to meet that hurdle.

 

While the data on antibody production from the combinations would seem to indicate that they should be effective. That is really at the stage of preclinical work and together with the small studies done reach maybe to the level of phase 1 trials in the development process.  To date no one has completed the equivalent of a phase 3 that would be required to get on the FDA or WHO list. Though it appears that Pfizer might be doing one for  the combo AZ Pfizer.

 

Even a large scale retrospective study reviewing medical records to look at efficacy has not been done

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7 minutes ago, ipeeinthepool said:

 

Actually not true.  If someone has taken a non-authorized Covid vaccine, that may be offered a complete series of an approved vaccine.  Maybe Canada should do the same.  From the FDA website

 

  • COVID-19 vaccines neither authorized by FDA nor listed for emergency use by WHO
    • People who received all or some of the recommended doses of a COVID-19 vaccine that is neither authorized by FDA nor listed for emergency use by WHO may be offered a complete, FDA-authorized COVID-19 vaccine series.

All the vaccines being used in Canada are approved by the WHO.

Even the WHO mentioned that in emergency circumstances the vaccines could be mixed.

It is interesting that technically AZ is being accepted and is not approved by the FDA and the U.S was more than willing to send us millions of doses to help us get our vaccine program up and running at a heightened pace.

 

I think that you are one of those people that just like to stir the pot but you would be ranting at the top of your lungs if you were the one caught in this dilemma.

I am out of here as I have a vacation to pack for.

 

 

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16 minutes ago, ipeeinthepool said:

 

Actually not true.  If someone has taken a non-authorized Covid vaccine, that may be offered a complete series of an approved vaccine.  Maybe Canada should do the same.  From the FDA website

 

  • COVID-19 vaccines neither authorized by FDA nor listed for emergency use by WHO
    • People who received all or some of the recommended doses of a COVID-19 vaccine that is neither authorized by FDA nor listed for emergency use by WHO may be offered a complete, FDA-authorized COVID-19 vaccine series.

 

The home countries may need to do more to allow some of their citizens to travel internationally and cruise.

The difference being that we did not receive a non-authorized Covid vaccine.  AZ, Pfizer and Moderna are all authorized.  I'd be happy to take a third but if the FDA considers that "against advice" I'm no further ahead. 

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2 minutes ago, Josie201 said:

The difference being that we did not receive a non-authorized Covid vaccine.  AZ, Pfizer and Moderna are all authorized.  I'd be happy to take a third but if the FDA considers that "against advice" I'm no further ahead. 

Health Canada (not FDA) needs to solve this and make a ruling acceptable to the cruise lines.

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2 minutes ago, Josie201 said:

The difference being that we did not receive a non-authorized Covid vaccine.  AZ, Pfizer and Moderna are all authorized.  I'd be happy to take a third but if the FDA considers that "against advice" I'm no further ahead. 

 

They advise against a third because of possible side effects from too high a dose. That I understand is because they don't have enough data yet on third shots. 

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2 minutes ago, pixiedust777 said:

All the vaccines being used in Canada are approved by the WHO.

Even the WHO mentioned that in emergency circumstances the vaccines could be mixed.

It is interesting that technically AZ is being accepted and is not approved by the FDA and the U.S was more than willing to send us millions of doses to help us get our vaccine program up and running at a heightened pace.

 

I think that you are one of those people that just like to stir the pot but you would be ranting at the top of your lungs if you were the one caught in this dilemma.

I am out of here as I have a vacation to pack for.

 

 

While each vaccine  has gotten WHO authorization status when one get both shots from the same vaccine, the combinations do not have that status which requires a well defined set of testing.

 

They left it up to each national health authority to make the decision to use combinations or not.

 

The CDC only accepts FDA or WHO authorized as defining fully vaccinated.

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1 minute ago, TeeRick said:

Health Canada (not FDA) needs to solve this and make a ruling acceptable to the cruise lines.

It's easy talk to WHO and do the work needed to satisfy their approval process.

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1 hour ago, TeeRick said:

ipee- the Alaska issue was entirely USA-based and due to PVSA (archaic law).  Canada was trying to protect it's borders and people like every other country during the pandemic.  I'm sure Alaska cruising is far down on their priority list.  But the pandemic is starting to recede at least for those of us vaccinated.  And border restrictions are easing for the vaccinated.

 

Why do you think the PVSA is archaic?  Without it, a foreign company, using foreign workers not following US labour laws; could be operating the Staten Island Ferry. Almost every country in the world protects their domestic transport from foreign competition.

By the same measure British Airways can't fly passengers between London and Los Angeles.

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25 minutes ago, TeeRick said:

Not so far apart on this one.  I agree about the technical stops - but I understand about any stops at ports involving passengers. Yes I am saying that both Canada and the UK delayed second doses and then decided to use mixed vaccines (both were correct decisions for them IMO).  It is their problem to fix for their citizens - in any number of ways.  And I have no doubt it will be fixed.  But in what time frame?  It might take several months.  Not good news for people about to cruise from these countries who are in this particular Catch-22 situation.  Just like the brave folks who volunteered for Novavax and AZ (US) clinical trials who have been fully vaccinated but not officially. 

Participants in the AstraZeneca trial in the US who received the actual vaccine are considered fully vaccinated by the CDC and WHO.   Official CDC cards have been issued.

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38 minutes ago, TeeRick said:

Health Canada (not FDA) needs to solve this and make a ruling acceptable to the cruise lines.

I'm not sure what you are saying here TeeRick. Health Canada has already approved mixed doses, but nothing that it says to the cruise lines will override the FDA's lack of approval. Or are you suggesting that the cruise lines are free to decide what vaccines to accept, no matter what the FDA says?

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16 minutes ago, Fouremco said:

I'm not sure what you are saying here TeeRick. Health Canada has already approved mixed doses, but nothing that it says to the cruise lines will override the FDA's lack of approval. Or are you suggesting that the cruise lines are free to decide what vaccines to accept, no matter what the FDA says?

Actually it is CDC that is defining fully vaccinated and they accept both FDA and WHO emergency authorization lists. Which is why anyone that has received both doses of AZ is considered to be fully vaccinated by CDC even though it is not on the FDA list.

 

Health Canada  needs to work with WHO and determine what information they  need to assemble and supply to them for authorization. Or sit back and do nothing, and hope the companies themselves do the work as Pfizer is doing. Though that does nothing for those that combined AZ and Moderna.

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1 minute ago, nocl said:

Actually it is CDC that is defining fully vaccinated and they accept both FDA and WHO emergency authorization lists. Which is why anyone that has received both doses of AZ is considered to be fully vaccinated by CDC even though it is not on the FDA list.

Exactly my point, it doesn't matter what Health Canada says to the cruise lines, as the FDA and WHO approvals drive the CDC definition of fully vaccinated. 

 

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If I may ask, has anyone from Canada, the UK or any other applicable country who is scheduled to sail from Ft Lauderdale on or before Aug 7th been notified via email or phone call by Celebrity yet about this new "mixed vaccine" restriction? We just got our "Important Updates to Testing and Health Screening Requiements" email this morning regarding our Aug 7th Edge cruise and nowhere did it mention this new restriction.

 

Just curious if any applicable Canadian or UK passengers have received something different yet that referenced the new restriction? Afterall, not everyone follows CC as passionately as some of us do and this would really be bad if they learned of this new restriction when they tried to check-in at the terminal. 😎

 

Vaccination Policy

 

Following CDC guidelines we will sail with all crew vaccinated and at least 95% of guests will be fully vaccinated.

 

All guests 16 years and older must be fully vaccinated with all COVID-19 vaccine doses administered at least 14 days prior to sailing. As of August 1, 2021, all guests age 12 and older must be fully vaccinated.

 

Acceptable proof of vaccination must be in the form of the original vaccination record document issued by the country’s health authority or healthcare provider that administered the vaccination. All unvaccinated children will require a complimentary Covid-19 test at the terminal. Registration is required prior to arrival at terminal. A link will be provided via email to the unvaccinated guest.

 

Guests that do not meet the testing and health screening policy requirements will be denied boarding.

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It's interesting that Carnival brands permit mixing of mRNA vaccines.

From Princess FAQs

Guests who have received two single doses of mixed vaccines that are the same type (e.g., mRNA) will be considered fully vaccinated and will be permitted to sail, so long as the final dose is received at least 14 days prior to the beginning of the cruise.

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I think my fellow Canadians who have had mixed vaccinations should sit back and open up a nice cold bottle Molson Canadian or take a shot of Canadian Club. Chill, this will get sorted out soon enough. 🍺🥃

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2 minutes ago, DirtyDawg said:

I think my fellow Canadians who have had mixed vaccinations should sit back and open up a nice cold bottle Molson Canadian or take a shot of Canadian Club. Chill, this will get sorted out soon enough. 🍺🥃

 

I think so as well. I can't imagine this will not be resolved before the reopening of the US-Canada border in August. 

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1 hour ago, Fouremco said:

I'm not sure what you are saying here TeeRick. Health Canada has already approved mixed doses, but nothing that it says to the cruise lines will override the FDA's lack of approval. Or are you suggesting that the cruise lines are free to decide what vaccines to accept, no matter what the FDA says?

I have been saying and continue to say that this can be resolved by high level conversations between Health Canada (since they approved mixed doses) and the other parties - WHO, FDA/CDC - to approve some type of way forward pretty quickly.  A way that will not be new clinical studies.  Too slow.  And then the cruise lines will fall into place.  That is why I say it should be a Health Canada driven initiative to get the conversations or documentations going.    The same can be said for other countries like the UK with approved mixed doses.  They also need to lead their own initiative to an acceptable resolution.  The CDC or FDA will participate hopefully in a solution - but cannot lead it for other countries' citizens.  

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2 hours ago, scottbee said:

 

Why do you think the PVSA is archaic?  Without it, a foreign company, using foreign workers not following US labour laws; could be operating the Staten Island Ferry. Almost every country in the world protects their domestic transport from foreign competition.

By the same measure British Airways can't fly passengers between London and Los Angeles.

Sorry no need to divert this thread into a never-ending PVSA discussion.  

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53 minutes ago, CruiserRob said:

It's interesting that Carnival brands permit mixing of mRNA vaccines.

From Princess FAQs

Guests who have received two single doses of mixed vaccines that are the same type (e.g., mRNA) will be considered fully vaccinated and will be permitted to sail, so long as the final dose is received at least 14 days prior to the beginning of the cruise.

This is very reassuring to me as I had Pfizer initially and then Moderna second…both mRNA vaccines. Hopefully Celebrity will change their stance and accept this type of mixing as well. We don’t have a cruise booked at this time, thankfully, but had been planning a Spring ‘22 one but will wait to see if this gets sorted first. 

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5 minutes ago, TeeRick said:

I have been saying and continue to say that this can be resolved by high level conversations between Health Canada (since they approved mixed doses) and the other parties - WHO, FDA/CDC - to approve some type of way forward pretty quickly.  A way that will not be new clinical studies.  Too slow.  And then the cruise lines will fall into place.  That is why I say it should be a Health Canada driven initiative to get the conversations or documentations going.    The same can be said for other countries like the UK with approved mixed doses.  They also need to lead their own initiative to an acceptable resolution.  The CDC or FDA will participate hopefully in a solution - but cannot lead it for other countries' citizens.  

This issue is likely part of the overall discussions happening right now on reopening the border between Canadian and the U.S. governments for non essential travel. Likely way down near the bottom of the list of items discussed but it's likely on the list. 

 

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1 hour ago, DirtyDawg said:

I think my fellow Canadians who have had mixed vaccinations should sit back and open up a nice cold bottle Molson Canadian or take a shot of Canadian Club. Chill, this will get sorted out soon enough. 🍺🥃

I really hope you are right DirtyDawg! 🤞🏻

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Royal Caribbean has taken down their wording around mixed doses.  (There are references to that in the RCI area of cruisecritic).

 

That is a good sign.   Someone called in and was told by Royal Caribbean they are now reviewing the policy.

 

Hopefully, Celebrity will do the same...

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1 hour ago, TeeRick said:

I have been saying and continue to say that this can be resolved by high level conversations between Health Canada (since they approved mixed doses) and the other parties - WHO, FDA/CDC - to approve some type of way forward pretty quickly.  A way that will not be new clinical studies.  Too slow.  And then the cruise lines will fall into place.  That is why I say it should be a Health Canada driven initiative to get the conversations or documentations going.    The same can be said for other countries like the UK with approved mixed doses.  They also need to lead their own initiative to an acceptable resolution.  The CDC or FDA will participate hopefully in a solution - but cannot lead it for other countries' citizens.  

So you are saying that WHO or FDA should modify their standards and make an exception for the combinations because it would be politically expedient or because recreational tourism is more important than maintaining high review standards?

 

CDC uses FDA and WHO exactly because of those standard.  The onus is on Health Canada to provide the medical/scientific data to justify their choice, not expect the other agencies to lower their standards.  While the choice was made to save lives, it was still made with limited data and they did not do anything to start the process to get them on the list.  Because to them it was not important the decision had been made so why collect the data to really study that decision.

 

The EU (EMEA) does not even accept WHO, thus the lack of complete acceptance across the EU countries when it comes to the AZ vaccine manufactured in Australia and in India.  Again they did not submit the data for those plants to the EU because they were not planning to ship product there.  As a result you now have issues with some countries accepting that vaccine and others not.  Should the EU change their standards or should the plants do what is normal and submit their quality data (which they should have for a filing) and get certified.

 

Saving lives might be worthwhile to deviate from standards, recreational travel not so much.

 

We already have issues with lack of trust in the approving agencies do we really want to give people a real case.

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For those of you in Ontario, have you read your Ministry of Health issued COVID-19 vacination receipt (don't know about other Provinces or Territories)?

 

Mine reads -

  • Agent - COVID -19 mRNA
  • Product name - Pfizer Biontech COVID-19 Vaccine mRNA
  • Further down - You have received two valid doses (after my first dose the receipt read - you have received one valid dose)

Does your second dose receipt read any differently? Ddoes it mention the first dose you had or just as I described above?

 

If as described above, will this vacination receipt satisfy the US authorities to let you enter their country and the cruise line authorities to board their ship?  Or are we going to require an international vaccine passport?

 

If I am out to lunch on this feel free just to ignore me!!!

 

NAGooner

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