Vaccine trial participants classed as unvaccinated

[kiwimum]

32 minutes ago, UnorigionalName said:

 

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.

 

We could have been unblinded at any stage of the trial and free to obtain another vaccine if we chose.   It was our choice entirely, there was absolutely no pressure.  We were asked if we wanted to remain in the program after unblinding. There was no question in our mind we would continue.   It is all in the massive packet we signed.    
 

Edited July 19, 2021 by kiwimum

[s0479]

2 hours 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.

For the Novavax - because the vaccine is so available they gave those that got the vaccine a placebo a couple months later and those that got the placebo got the vaccine so everyone in the trial ultimately got the vaccine.  And they now have given them the CDC vaccine card.  

[Jim_Iain]

Wonderful to hear about them unblinding all of you.   Makes me happy for all of you brave souls who volunteered for the benefit of all of us.  You are our Hero's.

 

 

[kiwimum]

1 hour ago, s0479 said:

For the Novavax - because the vaccine is so available they gave those that got the vaccine a placebo a couple months later and those that got the placebo got the vaccine so everyone in the trial ultimately got the vaccine.  And they now have given them the CDC vaccine card.  

Is Novavax a one or two shot vaccine.  If they switched between actual and placebo then you have only received one.  

[s0479]

35 minutes ago, kiwimum said:

Is Novavax a one or two shot vaccine.  If they switched between actual and placebo then you have only received one.  

It’s two - they gave two shots around March and then the opposite (placebo vs real) in May so everyone got fully vaccinated.

[Shadow9612]

1 hour ago, Jim_Iain said:

Wonderful to hear about them unblinding all of you.   Makes me happy for all of you brave souls who volunteered for the benefit of all of us.  You are our Hero's.

 

 

🙏👍

[kiwimum]

1 hour ago, s0479 said:

It’s two - they gave two shots around March and then the opposite (placebo vs real) in May so everyone got fully vaccinated.

Still sounds different than usual trials as they are a year or two in duration and there is no mixing of actual and placebo.    I see Novavax may apply for approval in September/October.

Good luck

[s0479]

18 minutes ago, kiwimum said:

Still sounds different than usual trials as they are a year or two in duration and there is no mixing of actual and placebo.    I see Novavax may apply for approval in September/October.

Good luck

They did it to keep people from dropping out and getting other vaccines.  This was the third phase.

[upwarduk]

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

The country allows me entry, it is the cruiseline who deny me embarkation. This also applies to UK citizens sailing from the UK.

Surely there will be a record on the NHS app, which CelebrityCruises require to be shown at the pier.

[Tony UK]

We I have a certificate showing I had the vaccine kast Octobet and November. A  CDC CARD which shows trial vaccination has been issued in USA.  The NHS app does not show our vaccination for travel.Even when it does I suspect it will show a trial vaccine.

However  the issue with Celebrity is that they will only accept vaccinations APPROVED by FDA or WHO so none of what we have counts for anything at all!

Some lines, like P&O have now specified that those like us who have been vaccinated with a government approved vaccine are allowed to travel with them. Celebrity will not so its likely to be no go and a late cancellation if nothing changes!

 

[Kristal Blade]

1 hour ago, upwarduk said:

Surely there will be a record on the NHS app, which CelebrityCruises require to be shown at the pier.

I don’t have the app, I am using my trusty old Nokia which is a phone and texting gadget for me. 
 

I’m not sure my J&J trial jabs would show up on it. 
 

I fill out the Zoe Covid info every day and because I participated in a trial I have to click on the “I have not had a vaccine” box. 
 

Thanks for the thumbs up for participating in the trial, just hope Celebrity gets over  themselves about their vaccine rules soon. 

Edited July 20, 2021 by Kristal Blade
Extra word removed

[Tony UK]

Lets hope something opens up soon. Either allowing us to have approved vaccines or approval or something to enable us to get back to the sea again!

[drarill]

7 hours ago, kiwimum said:

Still sounds different than usual trials as they are a year or two in duration and there is no mixing of actual and placebo.    I see Novavax may apply for approval in September/October.

Good luck

Hope they do.  My 23 y/o son is on this trial and I feel awful for him right now, he can't travel or do some things all of us can.  Looking at the volunteers posts in Twitter I fear many will leave the trial if they don't apply for approval soon, some are really angry.  

[vermonter16]

17 hours ago, ipeeinthepool said:

 

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.

I guess I am looking at it from more of a global perspective.  The AZ vaccine will be more largely distributed to 3rd world countries because of the refrigerated shelf life and without having to be in a deep freeze.  I really want to see it through...the good news is that I have time.  Our cruise is not until the beginning of January so they may have things sorted out by then.

[delondin]

5 hours ago, Tony UK said:

Lets hope something opens up soon. Either allowing us to have approved vaccines or approval or something to enable us to get back to the sea again!

I believe Cunard will let you sail with a letter confirming your trial status. Might be worth considering. 

[Tony UK]

3 hours ago, delondin said:

I believe Cunard will let you sail with a letter confirming your trial status. Might be worth considering. 

Thank you for that!

[delondin]

4 minutes ago, Tony UK said:

Thank you for that!

If you haven’t been with them before they are usually a very good product. More formal in terms of dress, entertainment and dining but I like them. Not such a good drinks package! 

Edited July 20, 2021 by delondin

[sippican]

On 7/19/2021 at 12:19 PM, vermonter16 said:

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.

 

Yes, he did leave the trial, but his goal was to get vaccinated one way or another.  He also knew he received the AZ vaccine and was provided with a letter as proof. 
 

[nocl]

On 7/19/2021 at 8:20 PM, kiwimum said:

Still sounds different than usual trials as they are a year or two in duration and there is no mixing of actual and placebo.    I see Novavax may apply for approval in September/October.

Good luck

Not unusual. If they have reached the stage in the trial where they have the needed efficacy data, and the data is positive, it is normal to treat the placebo group if there is any risk posed by remaining untreated.

 

In other words if they have the data they need it would be unethical not to treat the placebo group since they face risk from Covid.

[Junit]

Thank you Tony. It was by chance we read your post. We were booked On a celebrity staycation around UK and I am a participant on the Novavax crossover clinical. Sadly we can’t go as a result. Very unhappy, neither travel agent or Celebrity cruises let us know. We only found out yesterday for a Saturday sailing. I feel saddened, at the way trial participants have been disadvantaged. If if weren’t for trial participants nobody would be able to travel.

[gubby]

We received mixed vaccines so are considered to be unvaccinated by the cruise lines. This made me quite upset and angry due to the uncertainty of our possibility of being able to take our booked cruises in 2022. Then I read your post and I was livid! If people like you hadn't  been willing to take the risk you did, would these hard hit cruise lines even been able to do any type of start up. Foolish adherence to Foolish interpretation of misunderstood rules will lead to a complete 

breakdown of the ongoing startup. 

 

Thanks for  being a risk taker.

 

Nikki 

 

 

 

 

 

 

 

 

 

 

[TeeRick]

Unfortunately the Novavax vaccine has not been approved for emergency use in the USA or anywhere else.  Not by the WHO either yet.  Despite impressive clinical results the company has lagged in the approval process for a number of reasons.  The company now says 4th quarter sometime.  Unlike the AZ vaccine which has been approved in multiple countries (except the US) and the WHO.

 

So what are cruise lines to do?  They cannot call it an approved vaccine until it is one.  It is a terrible situation for those in the Novavax trials who at least can take comfort that they are protected from COVID.  

 

One solution for Celebrity would be to let the Novavax trial participants sail in the 5% unvaccinated category- but waive all fees for the onboard testing that the other unvaccinated passengers have to pay.  

 

https://www.reuters.com/business/healthcare-pharmaceuticals/novavax-again-delays-seeking-us-approval-covid-19-vaccine-2021-08-05/

[whirlybird3]

On 7/17/2021 at 8:01 AM, Kristal Blade said:

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!

I too volunteered for the J&J trial at Stanford.  

On 7/18/2021 at 7:31 PM, Shadow9612 said:

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!

It was the least I could do to help be part of the solution,  

 

I recently read that people are flying in from around the world to SFO for a complimentary J&J vaccine.  

https://abc7news.com/10938165/?ex_cid=TA_KGO_FB&utm_campaign=trueAnthem%3A Trending Content&utm_medium=trueAnthem&utm_source=facebook&fbclid=IwAR3FcRaarP4K6uEAbkLerZARJM4sh6vAXlPmIrzMI4JCzAnCZIGpAj_Ypcs

[cruise kitty]

On 7/19/2021 at 2:28 PM, 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.

In our case (pfizer) they unblinded us starting in early January, & gave placebo folks (me & DD) an option to get vaccinated within the trial & remain in a crossover trial.... DH & SIL both received active vaccinations last October, & were pulled into the first phase of the booster trial.. so on both of their CDC cards, they have three official stamped vaccinations showing, I'm hoping that the cruiselines understand why they have 3 shots on their cards...  I should be getting my booster in the trial in about 3 weeks, & can't decide whether or not to have it put on my CDC card or not..

 

& to @Tony UK I really, really hope that they come up with a solution for you to be able to travel with an accepted card,  I totally understand the feeling of wanting to step up & help, but having to put up with some roadblocks along the way.  Happy blood draws to you, lol 😉

 

[cangelmd]

4 hours ago, Junit said:

Thank you Tony. It was by chance we read your post. We were booked On a celebrity staycation around UK and I am a participant on the Novavax crossover clinical. Sadly we can’t go as a result. Very unhappy, neither travel agent or Celebrity cruises let us know. We only found out yesterday for a Saturday sailing. I feel saddened, at the way trial participants have been disadvantaged. If if weren’t for trial participants nobody would be able to travel.

Thank you for your participation. Stay safe, a tech in my lab who is an avid investor, and did extensive research on Novavax also participated in the trial. She got a nasty case of Covid last week, and is just beginning to recover, late 30s, healthy single mom. I don’t know how far out from her crossover dose she is, but was almost hospitalized.