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


MR_T
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This is perhaps a good news for some (like myself) who have received two doses of AstraZeneca, but under different brand names.  From the WHO's most recent report on AZ...
The most commonly used trade names are Astra Zeneca COVID-19 vaccine Vaxzevria and COVISHIELD. Consequently, these vaccines are considered fully equivalent, even if produced at different manufacturing sites or assigned different product names, and the interim recommendations here apply universally to all ChAdOx1-S vaccines.
https://apps.who.int/iris/rest/bitstreams/1359655/retrieve

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On 7/16/2021 at 6:08 PM, MR_T said:

just seen this on the FB cruise critic page… 😱 no mixed vaccines allowed for US departures or arrivals… via cruise ships. 
 

https://www.cruisecritic.com/news/6302/ 

 

so far celebrity hasn’t announced anything but a few other lines have confirmed this. 

Just when it looked like I could actually sail....

I live in Uruguay and got two doses of Sinovac. Now the government is offering a dose of Pfizer as a booster shot and I've signed up for that. My husband (being over 70) has had two doses of Pfizer. Our digital certificates are great but some countries require them to be translated at least into English.

Since AstraZeneca is a two dose vaccine, I can sort of understand the issue - you basically haven't completed the two doses if you get something else. But I've done my two doses. More questions without answers beyond "you should be fine".

 

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On 7/28/2021 at 10:39 PM, mom says said:

Well here's a new wrinkle.  😞 According to a poster on the Princess board, Royal Caribbean has modified it's policy on vaccination. Now, if you have received either of the mRNA vaccines, if the second dose wasn't received within 6 weeks of the first, they will consider you unvaccinated. How many Canadians managed to get their second shot that soon? Not many I'll bet. I'm going to be watching closely to see if Celebrity adopts the same policy.

Thanks for posting this wrinkle. Sigh.

RCCL should read this as the six weeks is only a CDC guideline. The landscape keeps changing.

CDC saying the following (emphasis mine):
 

Interval between mRNA doses

The second dose of Pfizer-BioNTech and Moderna vaccines should be administered as close to the recommended interval as possible, but not earlier than recommended (i.e., 3 weeks [Pfizer-BioNTech] or 1 month [Moderna]). However, individuals who receive the second dose up to 4 days before or at any time after the recommended date can be considered fully vaccinated.
 

https://www.cdc.gov/vaccines/covid-19/clinical-considerations/covid-19-vaccines-us.html#Interchangeability

This is from Australia:
https://theconversation.com/what-if-i-cant-get-in-for-my-second-pfizer-dose-and-the-gap-is-longer-than-3-weeks-162857

My husband got two Pfizer shots seven weeks apart. One more thing for me to follow. All I need is a cruise that actually sails. 

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On 7/16/2021 at 8:06 PM, Fouremco said:

At one point I read a statement that Celebrity would accept any vaccination approved by a passenger's country of residence. I wish I had bookmarked it, although Celebrity may well have changed its policy.

First question I asked when cruise lines started planning to require vaccines. My Sinovac shot wasn't FDA authorized. I was told that it would be okay. Now that WHO has authorized it I'm breathing a bit easier.

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  • 3 weeks later...

Success!

I got confirmation from Celebrity (via email) that they consider AZD1222 AstraZeneca the same as AZD1222 Covishield, and NOT a mixed dose.  Small win, but for my case the difference between going and not going.

 

---

Hello Everyone,

 

Please Note that AstraZeneca and Covishield are one in the same – both are AstraZeneca. This combination is NOT considered a mixed dose and is accepted for sailing so long as the guest is fully vaccinated and received their second dose at least 14 days prior to sailing.

 

 

XXXX XXXXX

Celebrity Cruises Reservation Representative

Celebrity Cruises  |  Trade Sales & Support

email: XXXX@celebrity.com

Consumer Website: http://www.celebritycruises.com
Travel Partner Website: http://www.cruisingpower.com
Servicing Phone Number: 800-437-3111

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On 8/4/2021 at 10:05 PM, RomanyUY said:

First question I asked when cruise lines started planning to require vaccines. My Sinovac shot wasn't FDA authorized. I was told that it would be okay. Now that WHO has authorized it I'm breathing a bit easier.

It depends on the country you are cruising from and where you are going.  If cruising out of the USA, Celebrity will not recognize Sinovac as an approved vaccine regardless of the WHO status.  In the EU it is the EMA who generally decides but some countries accept Sinovac and others do not.  See this link:

https://www.schengenvisainfo.com/news/eu-travel-covishield-sinopharm-sinovac-vaccines-are-most-widely-accepted-by-eu-countries-after-those-authorised-by-ema/

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47 minutes ago, TeeRick said:

It depends on the country you are cruising from and where you are going.  If cruising out of the USA, Celebrity will not recognize Sinovac as an approved vaccine regardless of the WHO status.  In the EU it is the EMA who generally decides but some countries accept Sinovac and others do not.  See this link:

https://www.schengenvisainfo.com/news/eu-travel-covishield-sinopharm-sinovac-vaccines-are-most-widely-accepted-by-eu-countries-after-those-authorised-by-ema/


I don't believe your statement is correct.  Where are you getting this information?  The Celebrity FAQs say that for cruises from the United States, CDC and WHO approved vaccinations are acceptable, and Sinovac is WHO approvied. (Sputnik and Cansino are not)
https://www.celebritycruises.com/healthy-at-sea/faqs
 

 

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1 hour ago, scottbee said:


I don't believe your statement is correct.  Where are you getting this information?  The Celebrity FAQs say that for cruises from the United States, CDC and WHO approved vaccinations are acceptable, and Sinovac is WHO approvied. (Sputnik and Cansino are not)
https://www.celebritycruises.com/healthy-at-sea/faqs
 

 

 

Think you missed some of the additional restrictions contained in the FAQs in your link:

 

What vaccines are accepted?

Vaccines that are fully approved or authorized for emergency use by the Food and Drug Administration (FDA) or the World Health Organization (WHO) are accepted. Sputnik V and CanSino are not accepted Covid-19 vaccines.  Please be aware that certain countries we sail from or visit during a voyage may require a specific vaccine, and only those travelers vaccinated with the requisite vaccine will be considered fully vaccinated. Be sure to review your departure country's requirements or consult our guest materials prior to sailing for these requirements.  

 

 

USA only recognizes CDC/FDA and not WHO

 

 

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2 hours ago, NantahalaCruiser said:

 

Think you missed some of the additional restrictions contained in the FAQs in your link:

 

What vaccines are accepted?

Vaccines that are fully approved or authorized for emergency use by the Food and Drug Administration (FDA) or the World Health Organization (WHO) are accepted. Sputnik V and CanSino are not accepted Covid-19 vaccines.  Please be aware that certain countries we sail from or visit during a voyage may require a specific vaccine, and only those travelers vaccinated with the requisite vaccine will be considered fully vaccinated. Be sure to review your departure country's requirements or consult our guest materials prior to sailing for these requirements.  

 

 

USA only recognizes CDC/FDA and not WHO

 

 


Yes, but the United States doesn't have any vaccination requirements to enter (just negative tests), which is the point you're missing....

For a Celebrity Cruise ship departing US ports, CDC or WHO approved vaccination protocols are accepted to be considered fully vaccinated on board. There may be specific ports of call that do not allow specific vaccination protocols, and passengers who don't have the appropriate papers wont be able to leave the ship at that specific port of call.

 

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13 hours ago, scottbee said:


Yes, but the United States doesn't have any vaccination requirements to enter (just negative tests), which is the point you're missing....

For a Celebrity Cruise ship departing US ports, CDC or WHO approved vaccination protocols are accepted to be considered fully vaccinated on board. There may be specific ports of call that do not allow specific vaccination protocols, and passengers who don't have the appropriate papers wont be able to leave the ship at that specific port of call.

 

Again read the fine print.  You might be able to enter the USA from certain countries with just a negative test.  But then you would need to show proof of vaccination for Celebrity  or cruise as part of the 5% unvaccinated.  Maybe it is confusing but to date Sinovac is not approved or accepted in the USA.

 

What vaccines are accepted?

Vaccines that are fully approved or authorized for emergency use by the Food and Drug Administration (FDA) or the World Health Organization (WHO) are accepted. Sputnik V and CanSino are not accepted Covid-19 vaccines.  Please be aware that certain countries we sail from or visit during a voyage may require a specific vaccine, and only those travelers vaccinated with the requisite vaccine will be considered fully vaccinated. Be sure to review your departure country's requirements or consult our guest materials prior to sailing for these requirements.  

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On 8/4/2021 at 6:36 PM, RomanyUY said:

Thanks for posting this wrinkle. Sigh.

RCCL should read this as the six weeks is only a CDC guideline. The landscape keeps changing.

CDC saying the following (emphasis mine):
 

Interval between mRNA doses

The second dose of Pfizer-BioNTech and Moderna vaccines should be administered as close to the recommended interval as possible, but not earlier than recommended (i.e., 3 weeks [Pfizer-BioNTech] or 1 month [Moderna]). However, individuals who receive the second dose up to 4 days before or at any time after the recommended date can be considered fully vaccinated.
 

https://www.cdc.gov/vaccines/covid-19/clinical-considerations/covid-19-vaccines-us.html#Interchangeability

This is from Australia:
https://theconversation.com/what-if-i-cant-get-in-for-my-second-pfizer-dose-and-the-gap-is-longer-than-3-weeks-162857

My husband got two Pfizer shots seven weeks apart. One more thing for me to follow. All I need is a cruise that actually sails. 

It is not just a CDC guideline.  It is the how the vaccine was tested in the Clinical trials and upon which the data for approval was based.  The data that was used for both WHO and FDA approvals.

 

Does it work with other timeframes.  Small trials indicate that it does.  However, there is no registration quality studies that have completed, and no data confirming efficacy in other periods submitted to either WHO or the FDA to support a label change for longer periods.  Until the appropriate trials are completed (Health Canada is running one such trial) and the data is submitted neither WHO or the FDA is unlikely to change the time frame. Until such a change occurs it is unlikely CDC with change its view.

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18 hours ago, NantahalaCruiser said:

 

Think you missed some of the additional restrictions contained in the FAQs in your link:

 

What vaccines are accepted?

Vaccines that are fully approved or authorized for emergency use by the Food and Drug Administration (FDA) or the World Health Organization (WHO) are accepted. Sputnik V and CanSino are not accepted Covid-19 vaccines.  Please be aware that certain countries we sail from or visit during a voyage may require a specific vaccine, and only those travelers vaccinated with the requisite vaccine will be considered fully vaccinated. Be sure to review your departure country's requirements or consult our guest materials prior to sailing for these requirements.  

 

 

USA only recognizes CDC/FDA and not WHO

 

 

Actually the CDC does accept vaccines authorized by either FDA or WHO as being fully vaccinated when the course of treatment was completed in accordance with label.

 

Only those vaccines approved by FDA can be administered in the US.

 

Of course any countries that the cruise ships stop at can have different requirements.

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2 minutes ago, nocl said:

Actually the CDC does accept vaccines authorized by either FDA or WHO as being fully vaccinated when the course of treatment was completed in accordance with label.

 

Only those vaccines approved by FDA can be administered in the US.

 

Of course any countries that the cruise ships stop at can have different requirements.

nocl.  Trying to understand what you meant. 

 

CDC will accept vaccines that are fully approved in accordance with the label, but what if approved (ex-US) by an emergency use declaration only,  like Sinovac/WHO?

And specifically for Sinovac, which was not approved by the FDA by an EUA in the USA, what is your take?  I was under the assumption that Celebrity would not accept Sinovac as an approved vaccine for any passengers sailing out of a US port like FLL or Seattle.  It is very confusing.

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15 minutes ago, TeeRick said:

I was under the assumption that Celebrity would not accept Sinovac as an approved vaccine for any passengers sailing out of a US port like FLL or Seattle.  It is very confusing.

Perhaps I'm not reading it right, but my understanding was the Celebrity are happy with anything approved by FDA or WHO.

 

Getting into each country is subject to the rules of that country.

 

So if you can get to the check-in location you are subject to the Celebrity rules at that point, so FDA/WHO both apply wherever you are.

 

Getting to the ship just requires meeting whatever rules apply to get you into the country...

 

Similarly getting off the ship at any port is subject to their local rules.

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Here is the response I received from the CDC this week when I asked about vaccines

Here is how I interpret this after getting AZ/M is that my first dose AZ is not FDA approved but my 2nd M is FDA approved which means I restarted the series.  The  shot of M now becomes my first dose which basically whips out the AZ shot.   So all i now need is another M shot. 

 

i have also just finished an online chat with Celebrity rep who advised if this is done i would be considered fully vaccinated with them to cruise from Fort lauderdale

 

I also read Biden administration recommending boosters at 8 months

Thoughts:

 

Thank you for contacting CDC-INFO.

Here is the information you requested on Covid-19 vaccine.

 

If you received all recommended doses of a COVID-19 vaccine that has been authorized for emergency use by the U.S. Food and Drug Administration (FDA) or is listed for emergency use by the World Health Organization (WHO), then you do not need any additional doses of COVID-19 vaccine. This currently includes the following vaccines:

  • Pfizer-BioNTech COVID-19 Vaccine
  • Moderna COVID-19 Vaccine
  • Johnson and Johnson's Janssen COVID-19 Vaccine
  • AstraZeneca COVID-19 Vaccine
  • Sinopharm COVID-19 Vaccine
  • Sinovac-CoronaVac COVID-19 Vaccine

If you received a COVID-19 vaccine that is not authorized by FDA or listed for emergency use by WHO, you may start over with an FDA-authorized COVID-19 vaccine. If you did not receive all recommended doses of a COVID-19 vaccine that is listed for emergency use by WHO but is not FDA-authorized, you may start over with an FDA-authorized COVID-19 vaccine.

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1 hour ago, schiff1997 said:

Here is the response I received from the CDC this week when I asked about vaccines

Here is how I interpret this after getting AZ/M is that my first dose AZ is not FDA approved but my 2nd M is FDA approved which means I restarted the series.  The  shot of M now becomes my first dose which basically whips out the AZ shot.   So all i now need is another M shot. 

 

i have also just finished an online chat with Celebrity rep who advised if this is done i would be considered fully vaccinated with them to cruise from Fort lauderdale

 

I also read Biden administration recommending boosters at 8 months

Thoughts:

 

Thank you for contacting CDC-INFO.

Here is the information you requested on Covid-19 vaccine.

 

If you received all recommended doses of a COVID-19 vaccine that has been authorized for emergency use by the U.S. Food and Drug Administration (FDA) or is listed for emergency use by the World Health Organization (WHO), then you do not need any additional doses of COVID-19 vaccine. This currently includes the following vaccines:

  • Pfizer-BioNTech COVID-19 Vaccine
  • Moderna COVID-19 Vaccine
  • Johnson and Johnson's Janssen COVID-19 Vaccine
  • AstraZeneca COVID-19 Vaccine
  • Sinopharm COVID-19 Vaccine
  • Sinovac-CoronaVac COVID-19 Vaccine

If you received a COVID-19 vaccine that is not authorized by FDA or listed for emergency use by WHO, you may start over with an FDA-authorized COVID-19 vaccine. If you did not receive all recommended doses of a COVID-19 vaccine that is listed for emergency use by WHO but is not FDA-authorized, you may start over with an FDA-authorized COVID-19 vaccine.

Thanks for the info, we had AZ first then PHZ and was lucky to get a 2nd PHZ so seems we will be ok 🤞🏻

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1 minute ago, MR_T said:

Thanks for the info, we had AZ first then PHZ and was lucky to get a 2nd PHZ so seems we will be ok 🤞🏻

Yes seems you will that’s great!  I posted my online chat with the Celebrity rep on the Canadian Board.   

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2 hours ago, TeeRick said:

nocl.  Trying to understand what you meant. 

 

CDC will accept vaccines that are fully approved in accordance with the label, but what if approved (ex-US) by an emergency use declaration only,  like Sinovac/WHO?

And specifically for Sinovac, which was not approved by the FDA by an EUA in the USA, what is your take?  I was under the assumption that Celebrity would not accept Sinovac as an approved vaccine for any passengers sailing out of a US port like FLL or Seattle.  It is very confusing.

The CDC will accept vaccines authorized (given EUA) by WHO as well as FDA.  Sinovac has been given EUA status by WHO so it should be acceptable.  After all if Celebrity is not recognizing WHO EUA vaccines then it should not recognize AZ either.  If I had Sinovac and had any concerns, I would contact the Celebrity medical department and include the appropriate page from the CDC web site and the appropriate material from WHO 

 

This is from the CDC web site it is a footnote to fully vaccinated

 

 This guidance applies to COVID-19 vaccines currently authorized for emergency use by the U.S. Food and Drug Administration: Pfizer-BioNTech, Moderna, and Johnson & Johnson (J&J)/Janssen COVID-19 vaccines.  This guidance can also be applied to COVID-19 vaccines that have been listed for emergency use by the World Health Organization (e.g. AstraZeneca/Oxford).

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2 hours ago, Airbalancer said:

Is mixing of vaccine a bad thing 

doesnt look like it 

27D42499-6491-419F-B1B8-5C1BA9106050.jpeg

Unfortunately it is not a registration quality study and not sufficient for label expansion or EUA

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23 minutes ago, nocl said:

The CDC will accept vaccines authorized (given EUA) by WHO as well as FDA.  Sinovac has been given EUA status by WHO so it should be acceptable.  After all if Celebrity is not recognizing WHO EUA vaccines then it should not recognize AZ either.  If I had Sinovac and had any concerns, I would contact the Celebrity medical department and include the appropriate page from the CDC web site and the appropriate material from WHO 

 

This is from the CDC web site it is a footnote to fully vaccinated

 

 This guidance applies to COVID-19 vaccines currently authorized for emergency use by the U.S. Food and Drug Administration: Pfizer-BioNTech, Moderna, and Johnson & Johnson (J&J)/Janssen COVID-19 vaccines.  This guidance can also be applied to COVID-19 vaccines that have been listed for emergency use by the World Health Organization (e.g. AstraZeneca/Oxford).

Yes this footnote is what I saw and it confused me I guess.  It lists every vaccine-  but not Sinovac specifically.  Even though WHO EUA (approved).  The EMA only accepts Sinovac in limited countries if you go back to the link in my post #307.  It is much more clear on the Q&A by NCL which specifically lists all vaccines it will accept (including Sinovac).

 

The question is has anybody (passengers or crew) sailed from a US port on a Celebrity ship and had their Sinovac series either accepted or denied by Celebrity yet?  This of course would mean a non-US citizen (most likely crew).   Only way to get to the bottom of it I guess.

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Just now, TeeRick said:

Yes this footnote is what I saw and it confused me I guess.  It lists every vaccine-  but not Sinovac specifically.  Even though WHO EUA (approved).  The EMA only accepts Sinovac in limited countries if you go back to the link in my post #307.  It is much more clear on the Q&A by NCL which specifically lists all vaccines it will accept (including Sinovac).

 

The question is has anybody (passengers or crew) sailed from a US port on a Celebrity ship and had their Sinovac series either accepted or denied by Celebrity yet?  This of course would mean a non-US citizen (most likely crew).   Only way to get to the bottom of it I guess.

of course the footnote states  AZ for example when referencing the WHO EUA vaccines so it does not list all of the WHO EUAs only the for example AZ.

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Does anyone know if there is a certain # of days that you must have between Dose 2 and Dose 3 for it to qualify as fully vaccinated.

 

I had the following shots:

AZ - April 17

PZ - June 28

Plan to get 3rd dose of PZ end of Sept (Sept 26-30) when I'm visiting Florida next month.

 

How easy will it be to go to a US pharmacy as a Canadian and get my 3rd dose?  If anyone has done this yet, please share your experience?  Did you have to pay?

 

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10 hours ago, Tomchick1970 said:

Does anyone know if there is a certain # of days that you must have between Dose 2 and Dose 3 for it to qualify as fully vaccinated.

 

I had the following shots:

AZ - April 17

PZ - June 28

Plan to get 3rd dose of PZ end of Sept (Sept 26-30) when I'm visiting Florida next month.

 

How easy will it be to go to a US pharmacy as a Canadian and get my 3rd dose?  If anyone has done this yet, please share your experience?  Did you have to pay?

 

I can’t help but just wanted to say good luck, it’s crazy I can get it in Quebec but in Ontario you have to travel to America to get the 3rd shot 🤷🏼‍♂️

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