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.

While I agree that we should consider ourselves fully vaccinated, what are the chances that the Test and Trace system will agree with us? Is it possible to argue this with someone who calls you up and reads at you from a script? Would we have access to the daily tests needed to avoid self isolation? I feel another massive cock up coming on…

I've emailed my GP again today to ask them to get my vaccination record on the app. I'm not hopeful though.

@QueenOfThorns

While I agree that we should consider ourselves fully vaccinated, what are the chances that the Test and Trace system will agree with us? Is it possible to argue this with someone who calls you up and reads at you from a script? Would we have access to the daily tests needed to avoid self isolation? I feel another massive cock up coming on…

If our covid status on the app shows up as fully vaccinated with a green tick - which it should soon - then you would hope (?) that was enough.

Stockport participants getting a personalised letter this week, but it's very clear it's for domestic use only (DCMS events) and can't be used for international travel. Well clearly, because they have no jurisdiction.

indeed it doesn't look very exciting/helpful does it. Unless you have tickets to wimbledon!
apart from the whole foreign travel thing which they can influence but is out of their control the two things they really need to be clarifying are that
a.the supposed freedom from self isolation if a close contact will apply to us and
b. assuming we can go abroad at some point, there is talk of double vaccinated people from amber countries being allowed to skip quarantine when they return to the UK.

I suspect there will be no answer for a while as neither of these are actually confirmed to happen, but these are two points where it's all under the UK government's control and you'd bloody hope they can sort it.

www.theguardian.com/society/2021/jun/18/ex-novavax-covid-vaccine-guinea-pig-relieved-first-authorised-jab

Interesting article on another volunteer

I am hopping mad. We need unblinding, now, so we are in a better place to argue for booster jabs, if/when available. I cannot understand how a manufacturing issue stops the jab being approved by MHRA. Approve the jab, let us be “counted” on the nhs app as having had a full dose, and let us get on with our lives. I will never offer myself up to science again.

@Dreamer1989 it's because for MHRA approval they have to have produced enough vaccine to be able to prove that the quality is the same as used in the study, in the labs it'll be produced in going forward. So that's fine in the UK, and we should be fine for MHRA approval, but not in the US and for some reason they've decided to wait until they can apply for both together (potentially a higher jump for investors?!).

I'm exhausted by it all now and very close to going to one of the pop up clinics and getting Pfizer (I'm under 40). In DH's paperwork though he had to tick saying that he hadn't been on a covid trial.

@andadietcoke ahh thank you that is really interesting.
I have written an angry (but not aimed at my local trial team) email, sent to the local team asking them to send on my feelings to the Novavax team, saying I am sick of the anxiety, esp around any booster jabs. If I was vaccinated last year, then surely I should be pretty much first in line for a booster - but am I even applicable for a booster if my initial doses arent approved by MHRA/NHS.
God I need a lie down!

I'm losing the will to live with it now.

@Dreamer1989

I am hopping mad. We need unblinding, now, so we are in a better place to argue for booster jabs, if/when available. I cannot understand how a manufacturing issue stops the jab being approved by MHRA. Approve the jab, let us be “counted” on the nhs app as having had a full dose, and let us get on with our lives. I will never offer myself up to science again.

I don't get it it either but there must be more issues than they are letting on I reckon. As far as I'm aware the stuff is actually already in production in Billingham. Goodness knows what's happening to it - just sitting there when so many countries are desperate to get their hands on vaccine? as @andadietcoke suggested it could well be some kind of investor motivated delay. Bloody ludicrous if so (and I've invested myself!)

on the travel abroad issue there really does need to be some internationally coordinated system. Eg as it stands the US doesn't even recognise astra zeneca as they've not approved it yet. We can't blame novavax or the NIHR for the lack of international cooperation but we can blame them for a heck of lot of other things, mostly lack of bloody information and transparency.

I think there’s something going on that we haven’t been told about. A month ago, when I went for my second crossover jab, Dr Baxter told us that the primary manuscript for this study was due to appear on the New England Journal of Medicine website that week. I’ve just looked, and it still isn’t there. The South Africa manuscript did appear that week, but he isn’t an author on that one, so it’s unlikely he got them mixed up. So where is it? Have the results been queried in some way?

Anyway, how do I go about getting myself unblinded? I think that’s the next step - if I had the real thing in November, I’m not too worried about getting an NHS jab now. If it was last month, I’ll have to think about it a bit harder. If I do go for a jab, I think I’ll have to lie, as I don’t want to risk them saying no.

I've spoken to a GP friend today who has been running a vaccination clinic in London. She basically said that if I told the truth they would bounce me back to the trial. She also suggested I talked to my gp.

So it sounds like lying about enrolment is the way to go...

@QueenOfThorns medical academic publishing has got a lot more complex over the last year. They've been inundated by articles and there have been lots of issues with peer reviews. I was second author in a paper that was submitted to the lancet this time last year. It was actually published in February in a different journal. The volume of submissions have been insane. So despite being a co-author he would have no control over if / when it was published even if they'd been told it would be available pre-print online (the same happened to us).

@andadietcoke
that's interesting. What's your field?

@QueenOfThorns
I think call your study centre and say you want to be unblinded. They will probably try and put you off. I'm not far behind you in my thinking - I keep thinking 'if they haven't sorted it by the end of this week...' but that's been the case for about 7 weeks now!

I work for a healthcare research company. Interestingly we own one of the companies running some of the US trial sites, not that I would ever admit to it on the fb group!

The paper we had published was on global HCP attitudes to COVID assays - antigen and antibody.

@andadietcoke I am also interested in what you do! I work on these things without being an actual author - some of the crappier papers would easily take that long at the best of times, unfortunately

(I’m very impressed that you submitted to The Lancet, by the way!)

I’m sure they are getting lots of submissions, but he said it was accepted and would be appearing imminently. I doubt the phase 3 trial would have been bumped elsewhere if they’ve published the phase 2! And they don’t need to wait until they’ve got a free slot in a print issue to publish online.

Oh no @QueenOfThorns did I just mansplain you? SORRY!!!!

i'm impressed too!!

@andadietcoke

Oh no *@QueenOfThorns* did I just mansplain you? SORRY!!!!

Ha ha, no don’t worry!

Am definitely waiting for some Novavax news here - I managed to get Wimbledon tickets and ideally need to show my full vaccination status for the day (or a negative lateral flow test I suppose).

I've been pretty chilled about this and thought it will be fine and they will sort it out, but now I am very concerned as my elderly DM lives in Canada, I haven't seen her for 2 years and Canada have now said that anyone coming in doubly vaccinated will not have to quarantine.

Which is great news as I thought I could finally visit her, but of course Novavax is NOT on their list so I would have to quarantine whereas my sibling won't. Now I'm angry....

@Vargas

I've been pretty chilled about this and thought it will be fine and they will sort it out, but now I am very concerned as my elderly DM lives in Canada, I haven't seen her for 2 years and Canada have now said that anyone coming in doubly vaccinated will not have to quarantine.

Which is great news as I thought I could finally visit her, but of course Novavax is NOT on their list so I would have to quarantine whereas my sibling won't. Now I'm angry....

urgh. Hold out as Trudeau said last week that he was working internationally to come up with a plan for trial participants. Not novavax but am fairly sure some trials for something took place in Canada.

@Bearsbearsbears40

Am definitely waiting for some Novavax news here - I managed to get Wimbledon tickets and ideally need to show my full vaccination status for the day (or a negative lateral flow test I suppose).

the letters we are getting should def cover this. This is what we've been told anyway. Should come in the next week or so but worth chasing up your trial site if not heard.

Well the news is full of double vaccination quarantine exemption. Any thoughts on whether this would constitute 'domestic use'?!

In unrelated news I still haven't heard back from Disney since submitting my vaccination status evidence.

Also, my NHS app still not showing my vaccine status, but my app has changed and now has a section with NHS Covid Pass divided into Event Trials and Travel. This is new to me.

I've got Wimbledon tickets too but didn't see anything about showing my vaccine status, but will just now take a photo of the letter just in case!!