Novavax vaccine trial part 2

[Frazzled2207]

A continuation of the thread for those of us taking part in the Vaccine trial.
Never had a thread continue to part 2 before so quite excited.

Old thread
www.mumsnet.com/Talk/coronavirus/4048789-novavax-vaccine-trial-anyone-else

@Frazzled2207 Not yet. I am expecting a call at some point tomorrow. (The NHS vaccine offer is for Friday, and the trial wants people to be blinded as long as possible, so I was told that they will unblind only a day before the vaccine appointment. It's all bureaucracy they have to follow, I guess.)

I really want to stay blinded in the trial, but I will be torn if I get offered a vaccine as we have heard nothing about the crossover trial here. I am at an appt on the 8th so will ask then. If I had a choice I would choose the Novavax vaccine so really hope we get the vaccine crossover here.

It's such a tricky decision to make because you've got to think about your own health.

They're going to end up with hardly anyone in the trial at this rate. I bet they dread every phone call.

I could hear the disappointment in the Drs voice.

Exactly @BG2015 I am pretty sure I didn't have it as I had totally different side effects to my husband who I am pretty sure did have it. All I had was about 1.5 hours of chills about 2 hours after my first vaccine, nothing at all after my 2nd vaccine. He was fine after his first one but really poorly after his second one, which seems how most people have reacted who have had the vaccine. I think I just got a chill when I had my first vaccine as I was really cold.

Another thing I was told yesterday was that 42% of participants had been unblinded so far.

Oh gosh that’s high. I hope they manage to get a move on.

@Daftapath

Those with emails about start dates for the crossover study, what centres are you at?

Leeds.

I've been called for the vaccine so I emailed them and said I was intending to decline and stay in the trial but they could help make me feel better about it by confirming the crossover. They emailed back saying they had approval and will start March 22nd.

I've heard March 22 a few times. I suppose a silver lining of so many people dropping out is that they'll get through the ones left a lot quicker.

Kings in London said end of March to me yesterday. I know some 50+ people who have been invited for their vaccines locally so I think there’s a chance I may get invited before then. I’d like to stick in the trial if I can, so fingers crossed they hurry.

Novavax must be cursing the UK for rolling out the vaccines so quickly. They probably didn't expect it given the normal level of incompetence in our government!

I haven't heard a date yet...(London)

No email here (Bradford trial).

Nothing here either (Stockport) though they did tell us what was happening at our last appointments in early feb. So I would expect an email or phone call (soon please) to fix the appointment

Frazzled2207 I am also in Stockport and have my 4th appointment tomorrow, so I will let you know what is said about this. I hope we’re participating in the crossover.

@QueenOfThorns
Ok great. We were told we are definitely participating but they might have more news for you tomorrow (I last went at the beginning of feb)

Ooh yes please @QueenOfThorns do report back (Stockport too!)

Yesterday I asked Novavax to unblind me as I received an NHS vaccine invitation. They phone to unblind me today. After a lot of thinking back and forth, I decided to stick with Novavax, and asked them not to unblind me. I believe I had the real vaccine last year, so I probably wouldn't be qualified to an NHS one anyway. We as a family have a low risk and low exposure lifestyle. DC goes back to school next month, but he tested positive for Covid less than 3 months ago, so I expect him to have some level of immunity for another couple of months, and our local infection rate has come down really nicely. In the end, I went back to where I started. Why did I volunteer? I wanted to contribute and they have already lost lots of volunteers, and I am in a fortunate position to continue. To be honest, if I were a key worker, or had a vulnerable family member, a decision would have been different.

One point I am glad to report is that they said that they have already been talking with the Provider so that a vaccine passport will be issued to the volunteers if that becomes the thing. This is important, as I really want to travel abroad later in the year!

Great decision and good news about the possible vaccine passport.

I think I may have done the same if lockdown had continued until after Easter

@Woventabby
Great decision and good about the passport too. I’m not sure I will go abroad this year but am pleased that when the travel passport does happen which it inevitably does we are not forgotten about.

I joined the Wrexham hub for the trial and had an email re the crossover trial yesterday. It says more information to follow. I have a follow up appointment shortly so hopefully there will be more information then.

I bit the bullet and emailed my trial centre and they came back this morning to say they hope to get approval to do the crossover- they're just waiting on paperwork and dates (no idea of dates given.) I really hope they manage to fast track this for all the reasons other have stated! Given my local demographic and the ages of local people now getting their letters for nhs vaccines I expect to get my letter very soon....

Thank you all of you who participated in this trial for advancing science and helping the world to beat this pandemic

I rang the Bradford trial centre this morning and they said they have sent out letters, but mine hasn't arrived yet, so he emailed it to me. I'll paste the relevant bits below. Although I'm only 61 I've found I could get an NHS vaccine locally now. As I'm not mixing socially much(!) and am fit and healthy, I've decided to wait for Novavax - hopefully before end of April (his word on the phone, no dates in letter). With 2nd dose 3 weeks later.
Of course that means I won't know the date of my vaccination if they bring in passports - I wonder if they can unblind by then?
Anyway, here's the email:
We are aware that many of you are being offered appointments for the nationally deployed licensed COVID-19 vaccines and we will continue to unblind you in this situation if you wish to receive a licensed vaccine.

However, we would like to inform you that there are now plans to modify this current trial to offer participants the opportunity to take part in ‘cross-over’ vaccinations.

In the proposed cross-over visits you will be offered either two doses of the Novavax COVID-19 vaccine (if you haven’t received them already) or the placebo (if you have received the Novavax COVID-19 vaccine already). You would remain ‘blinded’ - meaning that you will not know whether you received the Novavax COVID-19 vaccine in the first ‘part’ of the study or in the ‘second’ part of the study, but this ensures that you will receive 2 doses of the Novavax COVID-19 vaccine which we now know to be effective.

Your continued participation in this study in this way will not only ensure you receive a Novavax vaccine but will also assist in maintaining the integrity of this important study. Details of this process will be sent to you in the coming weeks. Please note this would require that you voluntarily decline the licensed vaccine if it is offered to you.

I’m back and I’m not sure I know much more than I did before! For Stockport, there will be emails sent out in the next couple of weeks about the crossover. I registered my interest as I left, but they’re not making appointments yet, as they don’t know when the vaccine supply will be secured. March 22nd was mentioned, but also the possibility that it could be slightly sooner. The plan is for everyone to have 2 doses by April 20th, so if you participate you’ll definitely have completed both jabs sooner than if you unblind and go with the NHS. There will be another efficacy analysis released in the next couple of weeks too, so that should help people make this decision

I did have a very odd conversation with Dr Baxter and the lead nurse about certification. I assume that any national scheme will use data from our medical records via GPs. They said that they have already informed GPs that we are participating, and if we go into the crossover they will write again to let them know that we’re definitely vaccinated. I pointed out that this isn’t going to wash - just telling them that we’ve definitely had our 2 doses by April 20th won’t work, as they’ll probably need the exact dates. Everyone will need to be unblinded so the dates can be communicated. They agreed with me, but said that this hadn’t been considered so they’ll raise it at their call on Monday. So hopefully they’ll find a way to get the info into our medical records in time for any ‘vaccination passports’ to be required.

Still no news here in Bournemouth. I may email them today as I really want to stay in the trial. I don't know when I will be offered a vaccine (I'm an unpaid carer) but I do want to have one to protect my mum.

@QueenOfThorns
Sorry to hear you don’t have more info!
re vaccination dates that is right although I suppose it’s conceivable that a. Dates may not be critical (it might be a case of a green tick if you’ve had both doses?), b. Gps could be informed but not us therefore leaving us blinded (odd but possible I guess) c. An exemption of some kind on actual dates is allowed for those taking part in a trial.
I’m sure it will be somehow sorted as @Woventabby suggested but any such thing is in the very early stages of development anyway. Clarity sooner rather than later would be good though.