Novavax trial thread number 3

[Frazzled2207]

Yet more chat about novavax, (un)blinding, general vaccine passport stress, approval (please please please) and more.
Those involved in other vaccine trials also welcome.

Eh up we have a Yorkshire variant

www.bbc.com/news/uk-england-57199475

No wonder they are struggling to get the desired amount of volunteers for the valneva trial.

Email from Midlands NHS trust

And final Q and A

[quote gazzaconns]Eh up we have a Yorkshire variant

www.bbc.com/news/uk-england-57199475[/quote]
That’s ok....it’s treatable with a flat cap and a whippet 😂😂

Scottish people- I called the NHS Protect COVID-19 Status helpline today (0808 196 8565) to ask how they were going to get the information they need regarding trial participants so that they can update our status on the website. I was told this won't and can't happen until the trial vaccine has regulatory approval. I really hope this is wrong. I'm feeling totally duped. Trying to keep the faith that the powers that be are on the case but finding it hard to get any answers, so I think I need to chase the Glasgow centre again for some more reassurances.

@CardinalCat

Scottish people- I called the NHS Protect COVID-19 Status helpline today (0808 196 8565) to ask how they were going to get the information they need regarding trial participants so that they can update our status on the website. I was told this won't and can't happen until the trial vaccine has regulatory approval. I really hope this is wrong. I'm feeling totally duped. Trying to keep the faith that the powers that be are on the case but finding it hard to get any answers, so I think I need to chase the Glasgow centre again for some more reassurances.

urgh. Have your centre said anything at all?

@Frazzled2207 I've emailed them (again) but not holding my breath for a response any time soon. I do understand that the nhs protect system has only been live for a few days (and there was no advance warning of how Scotland's covid certification was going to operate until this week) but it's alarming that there seems to be no plan in place for how they get out details onto the system (and the even more alarming suggestion that this can't happen in any event until approval, which is July earliest.)

@CardinalCat
Have your site been on radio silence or do they at least acknowledge there is an issue here?

I suspect you spoke to someone who didn’t know much about it. If they can organise a fix on the app for England I imagine they can for Scotland too.

Meanwhile the NIHR website faq seems quite clear that they are working on a fix, assuming the NIHR covers research in Scotland (?) I’d be surprised if the fix didn’t include you guys

Hi @CardinalCat. I spoke to my study centre about it. They've said it's not to do about approval. It's the database not being set up to allow entry of trial vaccines.
She said its being worked on as a priority and the clinic staff will enter the data. I've not been given a time scale but I do believe they know its a priority.

@Lwoj

No wonder they are struggling to get the desired amount of volunteers for the valneva trial.

I thought they'd stopped recruiting for Valneva as it stopped being advertised as ppl needed here.

My reason for not getting involved in the guardian thing is, I dont want to put off ppl from being involved in future research whether related to Covid or not.
That's just my thoughts though. I can understand the frustration.

Sorry I'm spamming now. I wish clarification had been made over who in the FB group is getting alternative vaccines. As the way it reads it look like is us , instead of the Americans.

I've been trying to find the new person in the fb group who claimed he was getting phone calls and emails from an unnamed Novavax VP.
I called him out as I thought he was talking total nonsense and ppl were panicking. Cant find him now.

I don't know why ppl automatically believe ppl on a fb group..

Evening everyone. Thanks for the tag @Frazzled2207. Nothing to add from me. I won’t be going for an approved vaccine #keepingthefaith . I don’t think there’s any point as I’d be undermining the trial.

Received a letter from the trial team today, with a copy of the letter they've sent my GP. But my GP surgery were already aware so I'm assuming it's belt and braces.

I felt quite reassured by the FAQs on the website, so I'm not planning to worry about the missing NHS app info for a good few weeks yet.

I really hope the Guardian article doesn't put people off future trials. From my point of view it was massively over-dramatised, but maybe I've been lucky as the communication I've had has been really good so far.

@Vargas

Received a letter from the trial team today, with a copy of the letter they've sent my GP. But my GP surgery were already aware so I'm assuming it's belt and braces.

I felt quite reassured by the FAQs on the website, so I'm not planning to worry about the missing NHS app info for a good few weeks yet.

I really hope the Guardian article doesn't put people off future trials. From my point of view it was massively over-dramatised, but maybe I've been lucky as the communication I've had has been really good so far.

agree the take from the guardian article wasn't quite what I hoped. I think, for me anyway, it's just the 'in limbo' situation I'm annoyed at....I really don't intend to quit the trial unless it's a last resort. And it would be really bad if others got put off. I think in practice there will be little disadvantage, if any...mostly we have to just wait a bit for it to work itself out.

press release from novavax
Doesn't really tell us anything we don't know but is reassuring that they are aware of the issue affecting us

ir.novavax.com/news-releases/news-release-details/novavax-statement-proof-vaccination-phase-3-clinical-trial?sf144171765=1

@andadietcoke
Wow. Assume they didn’t get official permission from the trial doc?

That's interesting to know @andadietcoke. I loosely mentioned ppl doing this last time I was there. I asked what happened if the study found out. The nurse told me she would have to inform the lead Dr and they'd be removed from the study.

Seems the Americans have got a loop hole round it though.

I think the delay is not all Novavax's fault. The databases both in Scotland and England need changes to allow trial participants data to be entered. Its not reliant on approval first.

I am no good at lying so unlikely to do this myself but I do get it. It’s a shame, with a bit more transparency and information I think in most cases this could have been avoided.

To be fair to the trial doctors, I just don’t think this scenario was envisaged.

The one tonight wasn't asked so at least she didn't have to lie. I'd be too anxious to do it I think!!

I couldn't have another vaccine, I'd be too scared of something happening.

@BG2015

I couldn't have another vaccine, I'd be too scared of something happening.

Me too!

If I found out I had it in it october I’d be more tempted I think but yes quite scary without a docs approval.
One of the Americans has just gone and got j&j less than a week after having his fourth crossover shot. If you’re going to do it at least give yourself a few weeks! Idiot