Vaccine trial participants classed as unvaccinated

[Tony UK]

This is a heads up to anyone booked on a cruise who stepped forward to take part in a covid vaccine trial.

I did for Novavax in October / November last year.  Initially information from Celebrity was that the vaccine was acceptable, that was changed recently to needing a pcr test and now changed again to not accepted.

The only vaccines acceptable to Celebrity are vaccines approved by WHO or FDA. The trial precludes me from having an approved vaccine in addition so we are stuck in limbo.

People in the UK were ready to go on Silhouette this month and have had to now cancel. Only my facebook post stopped them going and being turned back on the pier. Travel agents are giving reassurance without realising that Celebrity has changed their stance.

I am due to go on Apex in September but can only go if the vaccine is approved, unlikely, or the trial allows me to have an approved vaccine also unlikely and not without personal risk

It is vital you check your status with Celebrity to ensure they will allow you to board. The country allows me entry, it is the cruiseline who deny me embarkation. This also applies to UK citizens sailing from the UK.

 

I feel so disillusioned that we who took the risk to test vaccines are disadvantaged.....I wish I'd never done it. We were assured that we would not be disadvantaged in any way by taking part. I guess companies can have their own terms and conditions so we are helpless to do anything but wait and hope.

 

[Fouremco]

The issue is that Novavax hasn't been approved. When and if it is, then you and other volunteers will be considered vaccinated. AFAIK, Celebrity has never accepted any vaccine that hasn't received emergency use authorization at minimum.

[CHEZMARYLOU]

It really s&#&s that you put your self on the line to test a vaccine and then get caught in a Catch 22. We have 2 friends in their 70's who volunteered for vaccine trials.  He was in the Moderna trial which is approved for EUA.  She was in Astra Zeneca's trial which is not so they would be in the same position.

[kearney]

I read that Novavax plans on applying for Emergency Use Authorization sometime this fall.. so you may have a timing problem... https://www.clickondetroit.com/health/2021/07/14/why-do-medical-facilities-still-require-masks-when-will-novavax-be-available/

[kiwimum]

41 minutes ago, CHEZMARYLOU said:

It really s&#&s that you put your self on the line to test a vaccine and then get caught in a Catch 22. We have 2 friends in their 70's who volunteered for vaccine trials.  He was in the Moderna trial which is approved for EUA.  She was in Astra Zeneca's trial which is not so they would be in the same position.

Is your friend who participated in the AstraZeneca trial in the US.   The reason I ask is we participated in the trial on San Diego and now have the official CDC cards, originally we did not, just the AZ card showing we were fully vaccinated in a trial.   
AstraZeneca has applied for full approval with the FDA rather than the EUA route.   

[s0479]

6 minutes ago, kiwimum said:

Is your friend who participated in the AstraZeneca trial in the US.   The reason I ask is we participated in the trial on San Diego and now have the official CDC cards, originally we did not, just the AZ card showing we were fully vaccinated in a trial.   
AstraZeneca has applied for full approval with the FDA rather than the EUA route.   

Novavax has CDC cards too - but not officially approved - I have a friend in the trial.

Edited July 16, 2021 by s0479

[CHEZMARYLOU]

1 hour ago, kiwimum said:

Is your friend who participated in the AstraZeneca trial in the US.   The reason I ask is we participated in the trial on San Diego and now have the official CDC cards, originally we did not, just the AZ card showing we were fully vaccinated in a trial.   
AstraZeneca has applied for full approval with the FDA rather than the EUA route.   

Yes, she is in the US. They travel internationally but don't cruise much. Right now they are traveling in the US. Since the FDA hasn't approved it yet Celebrity probably does not recognize it.

 

[vermonter16]

18 hours ago, CHEZMARYLOU said:

It really s&#&s that you put your self on the line to test a vaccine and then get caught in a Catch 22. We have 2 friends in their 70's who volunteered for vaccine trials.  He was in the Moderna trial which is approved for EUA.  She was in Astra Zeneca's trial which is not so they would be in the same position.

I am in that position.  I am currently in the AstraZeneca trials and received that vaccine last December.  I have a non-CDC approved piece of paper with my vaccine info on it.  The WHO did approve that vaccine though, but I am a U.S. resident - so not sure, how I will be affected.  I guess I can go and get the Moderna vaccine and drop out of the AZ trials if it comes down to it....but I don't want to unless I absolutely have to....

[kiwimum]

20 minutes ago, vermonter16 said:

I am in that position.  I am currently in the AstraZeneca trials and received that vaccine last December.  I have a non-CDC approved piece of paper with my vaccine info on it.  The WHO did approve that vaccine though, but I am a U.S. resident - so not sure, how I will be affected.  I guess I can go and get the Moderna vaccine and drop out of the AZ trials if it comes down to it....but I don't want to unless I absolutely have to....

You need to contact your trial leaders.  We received an email along with our AstraZeneca newsletter that indicated the CDC would be issuing authorized cards.   
This is from the newsletter:

CDC Card Status
The AstraZeneca vaccine is not authorized by the FDA but is listed for emergency use by the World Health Organization. According to CDC’s clinical considerations, people who have received all recommended doses of a COVID-19 vaccine that has been listed for emergency use by WHO do not need any additional doses with an FDA-authorized COVID-19 vaccine. Therefore, once it has been confirmed that a trial participant received ‘active’ vaccine and not placebo, the participants can be considered ‘fully vaccinated’ in terms of CDC guidance. In addition, they can receive a “CDC card” and can have their vaccine recorded in IIS systems. Upon request, your site can now provide a CDC card to you.
               
We have had our card for several weeks.

[vermonter16]

I will definitely contact them and see what they say.  I have not even received any newsletter, etc during the vaccine trials.  They sent me a full size piece of paper for my vaccine 'card' but if they have an actual approved 'CDC' card that would be exceptional!  Thanks so much for the information.

 

 

[Kristal Blade]

I did the Johnson & Johnson trial in the U.K.

the only evidence Ihave that I have been vaccinated is a letter from the trial team. It was sent to my gp too, but I have had to ring them to update my records as they were texting me to go for my jab.

 

fortunately I don’t sail till next September.

 

I can’t believe an act of altruism is being punished!

[Tony UK]

My understanding is that a vaccine approved by WHO is acceptable so that might be good news but I'd check with Celebrity to make sure and get something in writing for the pier just in case.

Glad to know we aren't alone. We dont want a round of applause or anything just not disadvantaged as we were promised.

[citruscruiser]

I was in the Novavax trial (who advised we should have EUA by end of April). Didn’t happen. I have since received J&J. Celebrity will not accept non EUA vaccine  

[Shadow9612]

I know this comment doesn't help those of you who were in trials, wanting to cruise, but....

 

I just want to say thank you to anybody who volunteered for a vaccine trial.

 

You play a large part in vaccination success, which allows others to get vaccinated, and travel.

 

Too bad there isn't a sailing only for people who were in trials!

[Covepointcruiser]

We volunteered for every vaccine trial but were never accepted.   Finally received Moderna in March after spending hours on the internet each day trying for a vaccine slot.   Very glad we received the one that appears to be working against the variants.

[ipeeinthepool]

At least in the US, the CDC will allow you to get vaccinated with an approved Covid vaccine if you were previously vaccinated with an unapproved vaccine.  This would allow you to cruise and to make sure you are protected in your everyday life.  Just because you were in the trial doesn't mean that you have adequate protection.  Perhaps you received a reduced dose and could be better protected with an approved vaccine.

 

Good Luck and enjoy your cruise.

[vermonter16]

3 hours ago, ipeeinthepool said:

At least in the US, the CDC will allow you to get vaccinated with an approved Covid vaccine if you were previously vaccinated with an unapproved vaccine.  This would allow you to cruise and to make sure you are protected in your everyday life.  Just because you were in the trial doesn't mean that you have adequate protection.  Perhaps you received a reduced dose and could be better protected with an approved vaccine.

 

Good Luck and enjoy your cruise.

I received the proper dosing as this was the 2nd, 3rd phase trials for AZ with the correct dosing as the first trials were botched.  I am more than happy to get another vaccine - but then it doesn't help the trials as these last 2 years so I would have to bow out of the trial. 

 

[dogs4fun]

10 hours ago, Shadow9612 said:

I just want to say thank you to anybody who volunteered for a vaccine trial.

You play a large part in vaccination success, which allows others to get vaccinated, and travel.

I also extend my heartfelt thanks!

On 7/16/2021 at 12:49 PM, Tony UK said:

I did for Novavax in October / November last year.  Initially information from Celebrity was that the vaccine was acceptable, that was changed recently to needing a pcr test and now changed again to not accepted.

The only vaccines acceptable to Celebrity are vaccines approved by WHO or FDA. The trial precludes me from having an approved vaccine in addition so we are stuck in limbo.

I am so sorry that you are stuck in limbo - especially after taking a risk for the good of us all. 

[sippican]

My son participated in the US AZ trial. 

Since it has not been approved by the FDA, he just went ahead and got vaccinated with an approved vaccine.

[sanger727]

5 hours ago, ipeeinthepool said:

At least in the US, the CDC will allow you to get vaccinated with an approved Covid vaccine if you were previously vaccinated with an unapproved vaccine.  This would allow you to cruise and to make sure you are protected in your everyday life.  Just because you were in the trial doesn't mean that you have adequate protection.  Perhaps you received a reduced dose and could be better protected with an approved vaccine.

 

Good Luck and enjoy your cruise.

 

Most of the trials were scheduled to run 2 years. If you were to get a second vaccine you would no longer be part of the trial. This may or may not be related to why the OP isn't getting an authorized vaccine. 

[vermonter16]

1 hour ago, sippican said:

My son participated in the US AZ trial. 

Since it has not been approved by the FDA, he just went ahead and got vaccinated with an approved vaccine.

I am in the AZ trials and that is the issue  If I get an approved vaccine after already getting the AZ vaccine (which I know that I got because I was unblinded) I cannot then get another vaccine and continue in the trials as that would skew the numbers and I would have to leave the trial.

 

[ipeeinthepool]

4 hours ago, sanger727 said:

 

Most of the trials were scheduled to run 2 years. If you were to get a second vaccine you would no longer be part of the trial. This may or may not be related to why the OP isn't getting an authorized vaccine. 

 

You could be correct, but at this point I think there is little to be gained from the AZ trials in the US.  I would abandon the trial and get another vaccine.    I doubt the AZ vaccine will be approved for use in the US and AZ largely has themselves to blame because of the errors in the early trials.  Most trials can end early when the participants can benefit from a different treatment.  I think it's time for the participants to make the decision for themselves.

[Jim_Iain]

Really curious about trials.   

 

Aren't most trial's double blind with half of the recipients receiving a placebo?   If so did they unblind the results and  advise the placebo participants and offer  a "real vaccine.

[kiwimum]

37 minutes ago, Jim_Iain said:

Really curious about trials.   

 

Aren't most trial's double blind with half of the recipients receiving a placebo?   If so did they unblind the results and  advise the placebo participants and offer  a "real vaccine.

Yes, it was double blind.  We received an email from our team indicating we could be unblinded.  Fortunately we both received the vaccine and now have the CDC card.   We have two additional blood draws to complete the trial over the next six months.   
According to our team (US Navy) AstraZeneca applied to the FDA for full approval in June.  

Edited July 19, 2021 by kiwimum

[UnorigionalName]

57 minutes ago, Jim_Iain said:

Really curious about trials.   

 

Aren't most trial's double blind with half of the recipients receiving a placebo?   If so did they unblind the results and  advise the placebo participants and offer  a "real vaccine.

 

I believe it's a research ethics issue.

 

Once there is a publically available intervention (eg Pfizer under EUA) that has been shown to work better than the control arm, then it is not ethical to leave trial subjects blinded, as it takes away their agency to decide if they want to stay in the trial to benefit research, or to exit the trial and get vaccinated.