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 had mine in October and November so 5/6 months ago. If it was September and we still don't have it added to our NHS apps I'd be tempted.

I'd still seek medical advice though first. Plus my last appointment is in November for bloods so it would seem detrimental to the trial.

Hopefully it won't come to that.

I think by July I'll be considering it. That'll be 9-months post-vaccination for me, and about the point that I'd have to have my first vaccination to get both doses in by mid-October for US travel on the 23rd. But hoping between now and then the US will reopen travel from the UK and there will be some clearer guidance on what vaccinations they'll be accepting / what proof is needed.

@BG2015
Yeah absolutely

I think I’m slightly more worried about the fact that the media right now is going on about efficacy of Pfizer and AZ against the Indian variant

As far as I’m aware we have no data about the efficacy of Novavax against the Indian variant do we. Living in the Nw this is personally slightly concerning. If the Indian variant does as expected become dominant here I can’t see the government wanting to use novavax eg For boosters unless we know it’s effective against the Indian variant. However hopefully the new booster trial will throw up some useful data on this.

The doctor I saw at my No4 jab on May 10th said Novavax is looking very good against ALL the variants. Don't know what data was available to him at that point. He said I should feel very confident in my protection.

@PleaseReferToMeAsBritneySpears

The doctor I saw at my No4 jab on May 10th said Novavax is looking very good against ALL the variants. Don't know what data was available to him at that point. He said I should feel very confident in my protection.

Ok good. Will cross fingers that that turns out to be the case.

I got this email from my study site today.

Good afternoon

You'll be aware from reports in the media that there could be plans for Covid-status certification (sometimes referred to as 'vaccine passports'). These would allow an individual to demonstrate that they have been vaccinated, tested or have natural immunity. This could be used to give them access to certain places or events like concerts or football matches, or with the agreement of other countries, to travel internationally. The review is ongoing and no final decision on whether domestic certification will go ahead has been confirmed at the time of writing (23 May).

NIHR (National Institute for Health Research) are in discussions with the UK Governments about the inclusion of all trial participants who have received an active vaccine to be included in this. This would mean if you were on the Novavax trial, and had received a cross-over vaccine, or been unblinded and had had an active vaccine, you would be included. There is no need for you to take any action at this stage or to request unblinding. We are working on a system so that all the information from the trial team about whether you had received a cross-over vaccine, or been unblinded and had an active vaccine, will flow through automatically. We are very keen to make sure trial participants are not disadvantaged and to reduce the need for participants to request unblinding. We will issue further information as soon as there are further developments.

Further frequently asked questions can be found at the Link here

Kind regards

Grampian Novavax Study Team

Hello all, can I join you? I'm on ComCov2 which is for people (55+ I think) who have had either AZ or Pfizer as a first jab & then the same or Moderna or Novavax as the second. We are likely to be in the same position in spite of being reassured in the consent form that we wouldn't be placed at a disadvantage. I've had a text & a letter from the NHS telling me it's time for my second vaccination, and of course only my first one appears in the NHS App.

@Cookerhood
Welcome and sorry you’re in a similar situation though presumably you could be unblinded as a last resort and there is a good chance you have two “approved” vaccines unlike us! Hopefully it won’t come to that, and I hope your site is being helpful in the interim

Thank you for the welcome.
It's early days yet, we aren't supposed to be unblinded until next February. I suppose, yes 2/3 chance I have an approved vaccine, but of course the combination isn't approved. And getting it to show up on my NHS app might be a challenge.
I haven't really spoken to the site about it yet as I haven't been on the study long & it's early days. They did say they were trying to find a way to show we've had 2 vaccines on our NHS records. I do have it in writing (in the consent form) that we won't be disadvantaged so it will be interesting to see how it plays out.

If they can fix it for us and we are led to believe they are on the case the I can imagine they can for you too.
Most of us are on a Facebook novavax group with lots of very annoyed Americans- they have nothing like the NIHR to fight our corner so they seem to be mostly going to get other vaccines anyway!!! 😳

Fingers crossed for all of us. It would be a shame to volunteer in the spirit of wanting to help & to then be penalised.

@Cookerhood welcome. If you read my last post , it's an email I got from my study site. They include the fact that they are working on getting all vaccine studies entered on the apps.

It's the app set up that delays this. Its not reliant on approval. It's the individual govts that need to permit changes to allow us entry on the database.

I think our American friends are getting worse @Frazzled2207. I mean getting 2 vaccines 1 week apart is crazy 🤪. But there's the one guy that keeps saying a vaccine stays in your body as long as ibuprofen does.

And I think some new comers have joined just to complain. It's been worse recently. And they've been in the study only since Jan/Feb. It's proof that payment does not equal committed participants.

It is true that the vaccine only stays in your body a short while, it's your body making spike protein & your immune system kicking that makes the vaccines effective. The actual vaccine bit disappears very quickly.
PS, yes it is crazy to have 2 vaccines a week apart, even though the actual vaccine ingredients don't hang around, the effects do.

I know I keep banging on about this, but why are we still blinded? What difference does it make to the trial? Especially assuming all restrictions are going to be lifted on 21 June and all UK adults offered a vaccine by end July?

@JosephineDeBeauharnais

I know I keep banging on about this, but why are we still blinded? What difference does it make to the trial? Especially assuming all restrictions are going to be lifted on 21 June and all UK adults offered a vaccine by end July?

It’s a good point given that we all know that we all had it. I am assuming not completely impossible that our subconscious behaviour could be affected given that we still don’t know when we had it. We can ask to be unblinded at any time though. I do wonder how many will make it through to the end. I hope I will, but only if they sort something out for us soonish.

@JosephineDeBeauharnais

I know I keep banging on about this, but why are we still blinded? What difference does it make to the trial? Especially assuming all restrictions are going to be lifted on 21 June and all UK adults offered a vaccine by end July?

The 21st of June is a date for England only.

I received the vaccine registry letter today. I've taken 2 screenshot that I hope are legible.
Seems ppl from the Medicago trial have had difficulties

Interesting news on study involving mixing first 2 vaccine. Not quite the advice being used by the ppl in the states.

I've done my daily NHS app check and.....vaccine status is still not there. I live in hope...

I've just had an email from the vaccine registry, which says:
If you have received a vaccine through a study and are concerned about the possibility of vaccine certification as COVID-19 and travel restrictions ease, rest assured that we’re working closely with the government to ensure study participants are not disadvantaged. Your research study team will offer more guidance when it is finalised - check out the Be Part of Research Frequently Asked Questions for the latest information.

Yeah cookerhood - that faq is actually very reassuring.

@Vargas

I've done my daily NHS app check and.....vaccine status is still not there. I live in hope...

I'm checking it daily too 🤦🏼‍♀️

And me!

www.prnewswire.com/news-releases/novavax-to-present-at-international-society-for-vaccines-virtual-congress-covid-19-vaccine-update-301298080.html
This on Twitter just now. Looks positive.

@JustMeAndWheatley is going to join us she has been in the JNJ/Janssen trial.