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.

I really dont want to have another vaccine, but with no info, what do I do!? (Rhetorical quesrtion). My site has asked that I inform them if I do have additional vaccines, I guess cos it will affect the 12 month blood test.

Just saw this. Already knew that the UK had file but its proof the USA has too. They say it takes 5 weeks after filing to get EUAs

www.genengnews.com/news/novavax-plans-fda-filing-for-covid-19-vaccine-after-positive-efficacy-data/

@Torvean
Yes but nobody is actually really sure they actually will file in q3. We will know when they have ,I think.

I have just read that some west end theatres will ask for vaccine statuses via the NHS app… musicals are my favourite thing to do, and I wont be able to until this fucking vaccine is approved.

@Dreamer1989

I have just read that some west end theatres will ask for vaccine statuses via the NHS app… musicals are my favourite thing to do, and I wont be able to until this fucking vaccine is approved.

Not true it should be on the app by the end of July. And in the meantime the letter we have all received explains it. People have got into Wimbledon/silver stone etc last few weeks with the app and/or letter without trouble.

Hey @CardinalCat and anyone Scottish watch this.

fb.watch/v/4Xp3JsTPw/

I got sent it by my MSP , but I see it as empty promises.

NHS app now shows 'Domestic' with QR code valid in England for me. Should be fine for theatre and anything, well, domestic. So no issues for events as long as they're in the UK.

Travel still not updated for me.

Still nothing for me. I've emailed my mp, for all the good it will do.

For anyone who didn’t see Boris & co 5pm BBC, asked about double jab travel for clinical trial vaccines, usual reply from Van Tam “working on it”.

@Torvean thank you for this! Like you say, sounds like more meaningless platitudes.

I got off my bum and sent a long letter to my MSP today asking him to intervene at parliament or directly with Mr Yousaf. It's clear that once again Scotland lags behind England. He's an snp msp so I was careful not to be TOO critical but I did point out that at least those in England had been given a timeline for the app to be fixed to show their status. We are just left in total limbo, again.

My trial site (glasgow) are ignoring all of my emails asking to unblind and speak to a doctor about getting a deployed vaccine- I'm pretty sure that puts them in breach of the terms of the protocol that they, and I, signed up to. I'm pretty cross.

I replied to my MSP saying it provide no reassurance at all.That Scotland refused to accept the letter all UK participants could have had. Yet we don't have one.
I also told him that we were aware that all that is need is permission from the govt to allow us on the website.

And she says we are not disadvantaged as areas inside Scotland are not asking for it. However English areas may.
So what we all just stay in Scotland til they can be bothered to fix it.

As always NS is full of hot air. She prob think she'll win us over by finally saying thank you for doing it...more fool her.

I contacted the Scottish NIHR 2 weeks ago now with no reply. The English one answers within 48 hours.

All the positive feelings I've had have been lost due to the govt and Novavax.

For the Scots amongst us. I think you’ve been treated appallingly.
It’s not great for those of us in England and Wales but at least there is a firm commitment to sort the app out by the end of July. (Whether or not that happens remains to be seen).

I just received this email;

Dear Leeds Novavax trial participants,

Many thanks for your continued participation in the trial and patience with the trial team, we wanted to further update you.

This week we are doing a second upload of data to NHS digital for the NHS app which will indicate your vaccination status. This upload should be completed by end of July. This time the data upload will only apply to participants that have had Novavax- both those who are already unblinded and those in the crossover.

We are required to indicate the dates of your Novavax vaccine. For crossover blinded participants the dates that will be inputted into the app are the last 2 vaccine dates irrespective of whether you received placebo or Novavax at the crossover. It is our understanding that it will have no impact on when you are called for booster doses which will be based on age and health condition status rather than when you had the original vaccine doses.

A batch number is required for the upload. This will be a ‘dummy’ batch number for participants that remain blinded and will be the same for all blinded participants.

If you are a novavax participant which has gone on to have a deployed vaccine despite having had novavax please be aware we think that the upload will result in the first and last vaccine date going into the covid pass- this may mean it states you have had one dose of novavax and one dose of approved covid vaccine. If this might be an issue for you please get in touch with a member of the study team.

We are expecting a letter from novavax shortly to send onto you outlining the reasons for delays in approvals we will forward this on as soon as we receive this. Novavax are still confident to have all their submission for approval within the 3rd quarter of 2021.

Kind regards

Leeds Covid-19 research team

I emailed NHIR this morning, and I've had an email from the clinical director asking to call me!

@JPLeeds
Will be interested on feedback regarding mixed vaccines in app. Just went rogue last week after lots of thought.

[quote Ragdoll4]@JPLeeds
Will be interested on feedback regarding mixed vaccines in app. Just went rogue last week after lots of thought.[/quote]
Indeed that’s potentially concerning but seems to be good news generally

I'm booked in tomorrow, it's going to be awkward if it's uploaded by then. Athough not showing on NHS app today.

@JPLeeds
Take it you still want approved vaccine?

I've just spoken to the man at the NIHR - who also happens to be involved in the trial. He shared our concerns about the pace of getting approval - in some part, it's apparently because the regulator had to look into the blood clots with AZ which slowed them down.
He claims that we should be in the app by the end of the month, and that NHS data people are working on it.
I'll believe it when I see it.

Yeah I think so quite a few people seem to have done it on this forum and on the Novavax Facebook groups and been okay (one advised by her doctor too)

@JPLeeds
while I have concerns as to how the app will cope with both my novavax and moderna jabs, vaccination centres don't have access to app info. They have a different system which uploads to the app database at regular intervals (took about 24 hours for my moderna to show up, still have zilch for novavax)

@Frazzled2207
are you suggesting in effect we’d be ok to turn up for 2nd approved jab if centre doesn’t have access to app?

Can't be certain but from what I understand yes. Vaccination database uploads to app. But it's one way traffic - it doesn't know what's on the app.
Certainly my plan at the present time. If any issues I will just explain that I've left the trial.

The trial data has to be manually uploaded by the nhs data people. And it hasn't been so no one knows we've been done except us and the trial people.

Thanks Frazzled, I’ll follow with interest.