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

I'm 61 so have been eligible to book online for a while. Got my actual invitation last week, so I may try and ring surgery to explain. I'm happy to wait because I don't need to go to work or on buses, DP and DD are both vaccinated, I'm fit and healthy so should get through the next month!

Ah good for you! I know others on this thread who are out and about more have chosen to be unblinded - a tricky but understandable decision

Of course you could have had it already. Like me, though I’m fairly sure I didn’t.

I've just had a call from Bradford - booked for 16th April for crossover vaccine. So exciting!!!!

@Yorkie127 that's brilliant!

I have had nhs invite and have left a message for someone to call me from the trial. I would happily wait if they can give me a date in early - mid April.

I got the NHS letter and the phone call from Bradford both on Tuesday last week! I’m staying with the trial and have my appointment booked for 14 April.
I discussed my concerns regarding lasting immunity and date of vax with the lad who called but he couldn’t have been less helpful.

Cross trial should be starting from April at my Centre, so I haven’t unblinded although I have been offered my first NHS jab. If I have to wait 12 weeks for the second jab then I would still be protected sooner by being on the trial. The doctor confirmed I will get a vaccine certificate/passport.

Great. I did the same. I had an NHS appt on Feb 27th but I declined and I'm staying in the trial.

@Evenstar

Cross trial should be starting from April at my Centre, so I haven’t unblinded although I have been offered my first NHS jab. If I have to wait 12 weeks for the second jab then I would still be protected sooner by being on the trial. The doctor confirmed I will get a vaccine certificate/passport.

I had the same assurance about the passport, however, in the event that these are introduced and required for travel, access to amenities etc, then you can easily imagine that one of the elements of it will be the date of vaccination. It doesn’t make sense that the passport won’t include that.

My point, having discussed this at some length with now two people at the trial, is that we will not be told the date we received the vaccination until the end of the trial.
If this scenario turns out to be the case, then we are potentially disadvantaged by being in the trial.
They can’t actually say at this point that we will get a passport because nobody knows what information will be in it, and if it does specify a date, then we can’t.

@JosephineDeBeauharnais
I worry about this. But was thinking the worst case scenario is to ask to be unblinded? Which won’t be a massive problem if everybody had it- we can all stay in the trial. We only have to leave the trial if we are unblinded and didn’t have it. Which would not apply in a few weeks time.
Question that needs answering though.

@Frazzled2207
I suspect that it’s a fast moving situation in that the NHS programme has caught up with the trial, so people now have a choice about whether to stay with Novavax and the uncertainty around some aspects of that versus going for their NHS jab and knowing what they had and when.
They did say to me that things might have changed again by the time my appointment comes around in a month’s time.
What we need is clarity from govt about the passport.

Yes also nobody really knows yet what the vaccine passport will look like IF it happens.
Maybe I’m naive but the vaccine minister Nadhim Zawahi (sp?) is on the trial which you’d hope would help the situation get sorted out

@Frazzled2207 I'm sure I read that only people who haven't been unblinded can stay in the trial. By unblinding you're withdrawing from the trial. Unless you just mean the follow up antibody bloods?

@andadietcoke

I was under the impression from someone on here that if you're unblinded and it turns out that you had it, you can carry on in terms of the blood tests etc. right to the end. If you're unblinded and it turns out that you didn't have it, you had to stop now (but after the crossover that wouldn't be anyone unless some actively decided to not be unblinded or join the crossover which is unlikely).

Hopefully it won't come to it but I need to have a date of vaccine for a vaccine passport, then presumably I could get it by asking to be unblinded when i needed to. But a lot of people (all of us) would be in a similar situation so hopefully it wouldn't come to that.

My friend is in the trial and works in the care sector so had to be unblinded so she could have her NHS jab. Turned out she was in the placebo arm but she’s carrying on with the antibody tests. Presumably that adds to the data about how long immunity lasts, regardless of which jab you have.

@JosephineDeBeauharnais
oh that's good to hear.

I received a very assuring email about the crossover trial from the trial doctor and it's a matter of waiting for the dates. (London) Here are some points I found interesting, though I have to say almost everything has to be confirmed!

@Frazzled2207
Novavax are issuing a blinded crossover document with the original vaccine dates in Oct/Nov 2020 and the crossover dates and confirming they have a had a full 2-dose vaccine regimen on 2 of these 4 dates. At the end of the trial the document with exact dates will be issued. There is no national scheme for this yet, but as soon as it become clear what the national vaccine passport will look like, there will be a common approach for all NIHR COVID-19 vaccine studies. (They suspect that the national vaccine registry cannot record Novavax vaccine until it is licensed by MHRA.)

They are considering to offer participants a booster of some kind, either a booster of the current vaccine or one adapted to new variant(s). They, however, seem to think there is no reason that other booster vaccine if offered by NHS later in the year, shouldn't work with Novavax vaccine (or natural infection), and vice versa. The vaccine mixing trial is going on in the UK, so we will have some preliminary data on safety. As the vaccine minister, and people like Kate Bingham are on the vaccine trials, I am sure that they will make noise so that volunteers won't be short-changed!

Novavax are issuing a blinded crossover document with the original vaccine dates in Oct/Nov 2020 and the crossover dates and confirming they have a had a full 2-dose vaccine regimen on 2 of these 4 dates. At the end of the trial the document with exact dates will be issued. There is no national scheme for this yet, but as soon as it become clear what the national vaccine passport will look like, there will be a common approach for all NIHR COVID-19 vaccine studies. (They suspect that the national vaccine registry cannot record Novavax vaccine until it is licensed by MHRA.)

And this is what’s problematic. I know I’m second-guessing the requirements of the passport, but I just can’t see that those blinded documents with the dates will suffice for any purpose - passport or booster. Yes they will have to have a common approach for all trial volunteers but I’m disappointed in their current intransigence in seemingly not recognising that volunteers have got a myriad of issues to consider when deciding whether to stay in the trial or not.

Do we know when MHRA approval is likely to come?

Thank you Woventabby.
Yes if it doesn’t get approved by the Mhra that would be very bad news- I would hope this would happen quite soon but not heard anything recently. However i’m sure matt Hancock wouldn’t have made a song and dance in the media about a vaccine that was unlikely to be approved

I’m on the mixing vaccines Com Cov trial and am also a bit concerned about vaccine passports. I have the little card that everyone gets which says the date but not what the vaccine was as we are blinded (either Oxford or Pfizer).

I went for my unblinding appointment today. Turns out I had the vaccine. I was quite surprised as I had no side effects whatsoever. I havered over whether or not to be unblinded or to wait for the crossover trial, but I'm glad that I went the way I did - I feel very relieved.
The doctor said they would send me a certificate with vaccination dates etc and I could show it to my GP. Also said she expected the vaccine to be approved in April.
I'll continue to attend the follow up appointments for blood tests etc.

Brilliant news @QueenAnnesHat both for you and for all of us that it is expected to be approved.

Does anyone know that if the vaccine is approved before you get invited to the crossover trial, whether the crossover trial will still go ahead?

@Monkeygirl68
I wouldn't have thought it would make any difference. They still need longer term data that they won't have yet.

@Monkeygirl68

Does anyone know that if the vaccine is approved before you get invited to the crossover trial, whether the crossover trial will still go ahead?

This is another concern of mine. Assuming the vaccine is approved in April, then it will be added to the wider offering pretty quickly and people will start to be given it. We volunteers could conceivably find ourselves in a situation where people in the general population know the date of their Novavax jab before we do, because our trial doesn’t end until early 2022. This is not fair. One of the key messages we were given at the last appointment is that we are at an advantage in that we will get both jabs in the prescribed timeframe, but it seems to me that that advantage may not be much of an advantage against knowing the dates, as it is clear that the powers that be aren’t concerned about sticking to the schedule.

@JosephineDeBeauharnais I was also told that it was a ‘no brainier’ to stay in the trial, as the crossover was ‘imminent’ and the advantage is that we would be given two doses 3 weeks apart, as opposed to 12 weeks....plus first in line to be provided with the booster. But I am now being called by the NHS to have my vaccine and my centre (in Cardiff) are apparently still waiting for the nod to go ahead with the crossover trial. I have the dilemma of wanting to stay on the trial to enable the data to better inform scientists for future vaccinations and be helpful, but at the same time don’t want to be left behind unprotected.