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

In from my appointment. Have to say it was totally different volunteers. Normally in the observation bit at the end there's only been 2 women including me.
Today I saw lots of men in 30s-50s. In observation room I was the only female with 4 men

Have to say the jab hurt less. No problems one hour in.

Here they're going to start another new drug trial for ppl aged 18-30. Partly to make up with one of the main vaccines not being recommended for under 30s.

Hope you're all fine.

It was a letter for my gp with confirmation of both date I had the vaccine and also a nice Novavax vaccination card.

Does anyone know when the end of the study is. I asked today when we would find out when we got the vaccine , and the couldn't tell me.

So I was very fortunate to help out at a vaccination centre today, was great to see another side of it. We were doing 2nd doses of pfizer. The chat among the HCPs however was that they are really keen for Moderna, J&J and Novavax. They were very relieved to not be doing AZ today (which they have been doing a lot of) as been getting lots of angst and no-shows for obvious reasons (arrrgh! We all agreed that if we hadn't had something else already we'd happily have it) and they seem concerned about Pfizer supply going forward - not necessarily of any official communication but it seemed to them that future deliveries were going to be heavily skewed towards AZ. Anyway I'm in awe of the people on the research side but also now very much of those actually delivering the stuff. Mostly HCPs on their days off. A very slick operation and nothing was wasted. No passings out either.

@Torvean
I think the autumn but nobody has been that specific. Talk of asking people to extend to do the boosters too.

@Torvean

Does anyone know when the end of the study is. I asked today when we would find out when we got the vaccine , and the couldn't tell me.

Its about November/December time. Its a 12 month trial. You will find out then when you had the vaccine and should be able to find out antibody progress etc..... at that time.

I asked about booster trials and they think everyone (including those who have had Pfizer, AZ etc will..) will get the same booster shot and there is talk of a trial but nothing has been confirmed.

@Torvean I was told we would get a certificate after our second/fourth injections telling us the dates and batch numbers of all four injections and we would find out what we had in October as some of us may need boosters.

It's lovely to hear everyone is getting their 2 jabs as part of the crossover trial.

I'm a bit envious though because I'm the one from upthread who was unblinded in a silly admin error. I didn't ask to be unblinded and had no plans to be! The unblinding revealed I had the placebo in December. So I can't take part in the Crossover Trial. They were apologetic, but I'm still gutted.

Has anyone heard any talk of 'spare' Novavax jabs?? Or can anyone think of another way I could persaude the site (Hexham) to give me the Novavax vaccine?

I am kind of resigned to waiting until May to have one of the approved ones (I'm 43), but I feel really invested in Novavax and was so disappointed when they said I couldn't take part in the Crossover Trial. Such bad luck!!

Any ideas for a cunning plan?

@AVictoryProduct
It is so shit.
I think it’s worth emailing your contact after it gets mhra approval which should be very soon. It might be legally a bit easier to give you some IF they have spare doses lying around. I imagine it’s extremely controlled right now as to who could have it.

Thanks @Frazzled2207, yes, extremely shit, thanks for hearing me!

I've sent a letter to my contact putting it on record. Once it is approved, I'll give them a ring. Hopefully it will be soon. I'm even too sad to read this thread regularly now and I used to love it!

Really nice to see that familiar names on here are getting their second two jabs though.

Hello Novavax trial people, hope you don't mind a brief intrusion but I've been on the Valneva trial. Only 150-odd of us so far, which means not many other volunteers to chat to! We're just hitting our "day 106" visits from the first jabs given in late December 2020. Positive results from phase 1/2 were announced this week and they're moving onto phase three in May.

I'm wondering how they will manage a phase three trial under the current circumstances, when even if you try to aim for a student age group of late teenagers, the participants would be entitled to a "proper" licenced vaccine by July. I know you all now have this crossover option so everyone is still blinded but will have an active dose, but you surely need a bit of time with proper unvax'd placebo participants to get the data in. I'm sure the experts will figure something out but been wondering about it!

We're being told it's not advised to mix vaccines, or no science on it yet anyway, so it's not recommended to get a jab from the main rollout when you become eligible. I'm mid thirties so wouldn't get the chance for probably two months yet anyway. So I guess currently like all of you in the crossover stage, I'm vaccinated but unofficially with a dodgy experimental drug!

So no side effects today. Not even a sore arm. I'm thinking I got my vaccinations in October.

@givemushypeasachance
other vaccine trial people welcome!
I suspect another issue is it might not be feasible to run a phase 3 trial in the UK because, touch wood, there isn't that much covid here at the moment. The way I understand it to run a trial it runs as long as it takes for either the placebo or real thing groups (hopefully the placebo group if it works!) to get to so many cases of confirmed covid. That would have been easy here in the UK with 15,000 over winter. Might be hard in the UK this summer where it (hopefully) remains mostly suppressed.

@Torvean
I can believe that about Brazil. Their president is a nutcase. But even not counting people who disappear in the night they have thousands confirmed dying every day atm so they're not completely hiding it.

Yes @Frazzled2207 even with the main stream media . Plus social media its hard to understand how their gove get away with it. Countries get invaded in case of imaginary bombs. But ppl are dying like this and nothing is done. Even if we clubbed together and sent vaccines enough for each Brazilian citizen. I would not trust their government to disperse them.

Hi @givemushypeasachance. I'm not sure how it will all work. There's a drug for 18-30 years old that they are advertising for here. When I asked about it,vthey said that it hadn't been authorised, paperwork wasn't finalised and staff had not been arranged.
Personally I thought they would have chosen a larger place than here for stage 3.

I hope things improve in your trial.

Thanks for the welcome! Yes I think it's a bit of a shame it couldn't have been started a few months earlier, when the phase three would have taken place over the last wave. But you can only work as fast as the science and practicalities of sorting it all allow can't you. I know some of the modelling suggests we're still likely to have a bit of a wave of cases when restrictions lift further, even if the direct link to hospitalisations and deaths has been weakened, so I don't know if in practice that will give it enough infection data. It just seems a bit unlikely that you'd get a lot of people keen to take part in a phase three trial from the pool of people who are eligible to be vaccinated and haven't chosen to yet! And if you're say my age or a bit younger, and would be offered a vaccine in a couple of months and are keen to have it, why risk getting given a placebo. And just ethically can you do that? I suppose young folk are considered very low risk so it's not so much you're risking people dying by giving them a placebo, mostly just the lower level infections. But then could you limit yourself to the data from only young participants...

Maybe they will run some of it in another country as well, it's a European firm. But this is one of the vaccines the UK gov bought 100 million doses of early on and there's production up in Scotland, so quite a UK-focus there. I'll be looking out for more press releases and hope their protocol will get published to find out all the nitty gritty details!

Agree they’re going to struggle to recruit enough in the UK for a phase 3 trial. Def won’t get any under 40s. Loads of the older people have dropped out of ours for obvious reasons.

I signed up in October partly because at the time it would give me a 50% chance of having a vaccine which otherwise I might have to wait up to a year for (timescales were not at all clear at the time). As it stands everyone will have at least one dose of something by July. I can’t see how many people would agree to it unless they were definitely going to get the real thing. And you’d be unlikely to find anyone in the older age groups.
Perhaps there is more to it that we’re aware of, at this rate by the time the valneva is ready everyone will be vaccinated so maybe they’re relying on it for booster shots. Which will be a wholly different thing.

Sorry I mean everyone will have been offered it which is different of course to everyone having it!!!

Crossover appointment 1 done. Super efficient, I was in and out in exactly an hour. I booked appointment 2 while I was there. Doc confirmed no other appointments after that until end of the trial. I'm fairly convinced I had vaccine first time round so will be interesting to see if I have any side effects... I forgot I had to do a Covid test and the doctor actually counted slowly to 10 while I had it up my nose, my eyes were fairly watering by the end!

Similar to Torvean - I saw more men today, I had only ever seen 1 before but there were 3 there today. This is after I told my ds that women are nicer and more likely to do a vaccine trial .

Great work Vargas, crossing fingers for no side effects

That's interesting @Vargas - i'm surprised because they won't be able to track antibodies in the new cohort as accurately if there's no blood draw after the second jab. Maybe they have enough data though.

@andadietcoke

That's interesting *@Vargas* - i'm surprised because they won't be able to track antibodies in the new cohort as accurately if there's no blood draw after the second jab. Maybe they have enough data though.

Bournemouth said the same to me. The next visit after crossover 2 vaccine is the 12 month one.

I was in nearly 2 hours this time. I would say everyone was 40s with maybe 1 in early 50s. I still have 2 more dates booked to go, the next for bloods and injection, Dr check etc. Then my next date i was told was for the last blood test.

So do ppl think they've guessed correctly when they got the vaccine?