Valneva trial

[valnevavaxx]

NC’d for this.

Has anyone else signed up to participate in the Valneva trial? I’ve got my assessment booked in this week, if I’m deemed suitable I’ll get my first jab then with the second within a month- I’ll admit the lure of being double jabbed by June was the main draw! Will be nice to feel like I’m contributing to the vaccine effort as well.

It’s a comparison trial, so if you’re in your thirties you will either get the unapproved Valneva or the AZ jab (more likely to be Valneva) and you won’t ever find out which it is. After both jabs I have to go back to the clinic for some more visits, 7 total over a year.

Has anyone else signed up, or had their jab already? How are you feeling?

@valnevavaxx that's interesting and to read that if offered the approved vaccines, they can unbind you so yu can take it. That put my mind at rest slightly.

I'll ask about that today. I've no intention of going abroad anytime soon, definitely not this year but I worry that if vaccine passports for pubs etc so become a thing ill be left behind. I doubt they will though and to be honest I'm not a big pub goer but I was so excited about getting my approved vaccine when offered, I just wonder now if I'm risking that.

Hello again from the novavax trial. Yeah do ask about the passport and I suspect there will be no clear answers yet but the same civil servant bod somewhere will (hopefully) sort all of us out when it comes to sorting your status with the app etc.

It’s a bit more pertinent to you guys as there are now several approved vaccines- when we started (in the autumn) they were a long way off at least for the younger people involved.

I suspect in terms of being able to prove you’ve been vaccinated for anything in the UK it will be fine but as it stands the EU has said it will let people in with a EU approved vaccine which novavax is currently definitely not nor is valneva.

On the plus side there won’t ever be an issue being unblinded if you want to be. But ideally you will want to be blinded- yet have no disadvantages- for the duration.

I understand the concerns about it not being approved, but the nice doctor I saw was very patient with all my questions!

As this vaccine is an inactivated vaccine then it's likely to be highly effective- this basically means that unlike the approved vaccines currently available, which are based on a 'fake' strand of covid created in a lab, the valneva uses an actual strand of covid taken from a patient, which they have inactivated so it can't turn into a virus in your body. That is a very dumbed down and unscientific explanation so I do apologise!

Basically it's a more old-fashioned way of creating vaccines, and what we've done for years and years before someone figured how to create them in a lab. It's how the polio vaccine and original flu vaccine were made, along with many others. Therefore it's very very unlikely to not be effective.

@valnevavaxx

I understand the concerns about it not being approved, but the nice doctor I saw was very patient with all my questions!

As this vaccine is an inactivated vaccine then it's likely to be highly effective- this basically means that unlike the approved vaccines currently available, which are based on a 'fake' strand of covid created in a lab, the valneva uses an actual strand of covid taken from a patient, which they have inactivated so it can't turn into a virus in your body. That is a very dumbed down and unscientific explanation so I do apologise!

Basically it's a more old-fashioned way of creating vaccines, and what we've done for years and years before someone figured how to create them in a lab. It's how the polio vaccine and original flu vaccine were made, along with many others. Therefore it's very very unlikely to not be effective.

That's helpful Valnevavaxx, thank you. 😊

I've made a list of questions I have for later and will of course ask then. Appointments at 3 so will feedback how I feel if I have my jab.

Hello new phase three trial participants, hope you get on well with it! I took part in the phase one trial for Valneva, back in Dec/Jan. So I was one of the first 15 guinea pigs where they were doing the safety testing on the doses, we got low, medium and high doses. Then for phase two they had 150-odd people who got low, medium or high doses to see which produced a better antibody response. They went for high in the end which is what they've taken forward into your phase three trial. I only had a low dose of it, so there was mention that they may want to "top up" us low and medium trial participants at some stage!

As people have said, this is old school technology of an inactivated virus, it's very safe and established way to make a vaccine. And from our initial trial data they were very pleased with the antibodies and t-cell responses.

I've heard the reasoning that because it's a whole dead virus, rather than just getting your body to make some spike protein, there's more 'data' for your immune system to work with and it could produce a broader response for e.g. the variants to be picked up. Great if that's the case!

I was very interested to see how they're running the phase three, and if I hadn't been involved earlier I'd be a keen volunteer for this part of the trial. Good luck to you all and roll on another vaccine signed off for use in the future!

Inactivated vaccines are actually proving to be less effective than others but better against other variants, the Chinese vaccine is a perfect example. They still exceed the 50% threshold though.

Hopefully valneva performs higher than this.

When I say less effective I mean slightly lower efficacy.

Hope it goes well for everyone

Thanks Little Wren, this is all really helpful.

Mine has been rescheduled by them so I have another week to deliberate!!!! Annoying!!!

So rumours are my age group opens up next week for national vaccination... another curve ball for me!

I'm taking part in the trial too, and had my first vaccine this morning. I think I may be getting a headache but that's probably psychological. I found everything really efficient, if long.

I'm in the Valneva trial and had my assessment and vaccine on May 1st. No side effects for me, and also found out I have Covid antibodies, so a useful experience on two counts.

We've been assured our participation will count towards the vaccine passport. Our participation is only 13months, and I'm motivated because it has the potential to be mass produced and transported really easily.

I can't get the medidata app to work at all, but my site has asked me to manually record for 7 days instead.

@espresso14 useful to know thank you. I was told if we had anti bodies we couldn’t participate? Did they take a huge amount of blood from you also?

The UK vaccine passport isn’t my concern it’s the EU for travelling as this won’t be on their approved list.

Good to know about the passport @espresso14. Also glad you've not had side effects- I haven't had anything yet either, if my arm wasn't sore when I poked it I wouldn't even know I'd had anything. I don't think I'll feel completely relaxed until at least 24 hours after the jab, but so far so good!

Hi all, back after my screening and first jab.

It was a very slick system and worked well. I was there about an hour and a half and had all types of tests. Feel a bit prodded and poked. Have 10 vials of blood, surprised there was any left!

All the staff very friendly and knowledgeable, mentioned that they had done this last week too but they'd had lots of problems with the timings and it hadn't been as slick.

I asked the questions I needed, mainly focusing on whether I would be protected enough and am I missing out of the chance of a proper jab. The Doctor was very reassuring and said they had expectations that it would work as well as, if not better than other vaccines, and that the Valneva jab would like protect against more variants because of its make up.

He also explained if I rang when I got invited for my 'normal' jab, I could have a discussion with the team about what they think is best, and that I can have it if I want, though they do discourage it as it may affect the trial.

I've got an app to fill in for the next 7 days, and I have to go back next week and 2nd jab early June.

My arm axhes, but that's from the bloods, my actual jab arm is fine!

@LittleRen our study lead said he will personally write a letter to help get the paperwork for travel permissions

I didn't look at the blood taken, it will be the same amount as everyone else, but ordinarily I'm a blood donor so my perspective is probably different.

There's nothing in our site about no participation if you have antibodies. I'm in the over 40 group.

Hello I started a thread as I didnt know this one was here but I've hot footed it across to read all your experiences. I have my first appointment on Tuesday.

I have decided not to do it. With the recent announcement about under 40s having a choice and the fact I will probably be called for national vaccine in two next two weeks I can’t justify passing up the Pfizer or moderna.

I will keep checking on here though for updates as it’s such a great thing.

How's everyone feeling? I'm just 24 hours since having my jab. My arm ached a bit this morning but minor, though I have now got a headache. Checked temperature as asked and normal, and logged results on the app.

Not sure if the headache is related or not. I'm terrible for not drinking enough anyway and often get headaches late afternoon. This also may be linked to the two kids who insist on squabbling with each other after school. More likely that I imagine 😁

I have been conscious of my body and any odd twinges all day though. I coughed earlier after getting a fish finger crumb stuck in my throat, it did cross my mind it might be vaccine related 😁

Haha I know what you mean @GrumpySausage, because I know some people have had side effects I was subconsciously waiting for them I think? I haven’t had any though, the site of the jab hurts if I poke it but that’s to be expected I don’t think I’d even class that as a side effect.

My appointment today has been cancelled due to them having to obtain permission to continue after the new government advice that all under 40s should be offered an AZ alternative. Study is on hold now apparently

@Bettyswollockhead

My appointment today has been cancelled due to them having to obtain permission to continue after the new government advice that all under 40s should be offered an AZ alternative. Study is on hold now apparently

Ah this did cross my mind yesterday when they announced the astra Zeneca news.

I'm wondering whether to contact my study or wait until my next appointment this week?

I would definitely call beforehand- the call to cancel came whilst I was parking! Might save you a wasted journey. They did say they would call hopefully next week to rearrange, but if I get offered a vaccine appointment down the “normal” route first then I will bow out of the study. I’d rather get Pfizer or Moderna than a 1 in 3 chance of AZ

@Bettyswollockhead

I would definitely call beforehand- the call to cancel came whilst I was parking! Might save you a wasted journey. They did say they would call hopefully next week to rearrange, but if I get offered a vaccine appointment down the “normal” route first then I will bow out of the study. I’d rather get Pfizer or Moderna than a 1 in 3 chance of AZ

Thanks @bettyswollockhead. I'll give them a ring on Monday. I've got a number to call for emergencies over the weekend but not sure if this is classed as one. It may be they have contacted my by then.

God, I wonder what will happen then. I've had my first vaccine through the trial - surely I'll get my second?