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novavax vaccine trial - anyone else?

996 replies

Frazzled2207 · 12/10/2020 14:39

Have just had the call and am going tomorrow. Very excited. Anyone else doing this?

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andadietcoke · 05/02/2021 12:07

@PleaseReferToMeAsBritneySpears (LOVE the username by the way, especially since Handforth is so close to Cheadle where the vaccine trial is!). No, didn't mention nationwide, just said that this was what was happening and we needed to decide if we wanted to continue to participate or not. Did say there would potentially be more sub trials too, with boosters, combos with flu jabs etc, and that anyone that gets a vaccination appt soon might want to think about whether they withdraw or not as if they stay on the trial they'll have both doses by mid April vs a 3 month gap with the ones in play already.

PleaseReferToMeAsBritneySpears · 05/02/2021 12:21

That all sounds great. Thanks for reporting back.

(User name JackieWeaver was taken 😂)

andadietcoke · 05/02/2021 13:06

One interesting thing - they said that when the results were published it was based on 60 cases. Now they have a lot more so are expecting new efficacy stats to be released.

PleaseReferToMeAsBritneySpears · 05/02/2021 13:15

Yeah, I was amazed they draw conclusions on so few cases.

Frazzled2207 · 05/02/2021 14:02

I'm just back from mine, not particularly happily as the nurse struggled to get blood out of me this morning and only managed on the 4th attempt!
Anyway was told the same thing as @andadietcoke

Two interesting observations though. Dr Baxter admitted that a lot of people had been unblinded already due to being called up for a vaccine and that he expected many more to do so before starting the crossover - other than me and one other, everyone else there at my time was in their 60s and he advised them to wait and see for now but admitted that if they got a call for a vaccine next week they should ask to be unblinded. He advised me (42) to stay in, obviously I needed no persuasion.

Someone asked a very good question, basically is this trial a proper cross section of society and therefore can we think about the term % efficacy being the same across the whole cross section. Dr Baxter said that basically people in the trial are not really representative of society generally. They are less likely to be in at risk/key worker jobs for starters, mostly due to time. Many are retired (and therefore have the time). And they know that trial participants are more likely to be rule-followers than people generally! I'll take that as a compliment. So he acknowledged that that is an issue generally, but no more so in this trial than others. He admitted that nationally they had failed to get as many BAME people to sign up as they wanted to.

Finally I am quite flabbergasted by the amount of paperwork generated by this. And really surprised things can't be done electronically. This slow everything down considerably. Someone somewhere has to spend goodness knows how much time inputting all the stuff that goes down on paper. And Dr Baxter looks absolutely exhausted, he admitted he is spending most of his time these days actually vaccinating.

In a few days I'll set up this thread part 2.

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Frazzled2207 · 05/02/2021 14:16

oh I've remembered more.
He said 'in the next 7 days' they expect to get 120 people getting covid which means they can release the next batch of data.
But we shouldn't think about the actual % efficacy too much as it is somewhat arbitrary and you need to look at the bigger picture (eg hospitalisations, which doesn't officially count in the statistics)

  • To his mind vaccines come in three different types - 'good efficacy' - is 70% plus and the vaccine is definitely in this category. It may not stop people getting it entirely but in almost all cases will reduce serious illness and death. Most flu jabs are 'medium efficacy' - still definitely worth doing. The third category is 'doesn't work'.
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PleaseReferToMeAsBritneySpears · 05/02/2021 15:30

Thanks for that Frazzled.
Great to roll over into thread two! It's been really useful.

Jerble · 05/02/2021 22:47

It is really interesting to read these updates. I am BAME and registered early on but have never been contacted to take part in any trial. I guess it’s because I don’t live near any of the sites running trials. It’s a shame as a I very interested in and have signed up for anything going (and end up reading threads like this because I find it fascinating!).

Jerble · 05/02/2021 22:50

Gosh sorry for the terrible typos there. I give blood, am signed up on the bone marrow register (and organ donation and brain/body donation), and am volunteering at vaccine clinics, so I am definitely doing my bit. It’s great to read about all you lovely people and your trial!

Frazzled2207 · 06/02/2021 10:23

@Jerble

It is really interesting to read these updates. I am BAME and registered early on but have never been contacted to take part in any trial. I guess it’s because I don’t live near any of the sites running trials. It’s a shame as a I very interested in and have signed up for anything going (and end up reading threads like this because I find it fascinating!).
Oh that’s rubbish. Yeah it will be because you don’t live within the catchment of the 20 or so hospitals running it. MiL lives a short distance from me yet “over the country boundary” and didn’t get a call. They should make exceptions for the groups they really want though.
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Frazzled2207 · 07/02/2021 09:07

A very insightful interview with kate Bingham about what the UK did to secure all those vaccines. Including ours . www.repubblica.it/cronaca/2021/02/07/news/kate_bingham_interview_vaccines_covid_astrazeneca_uk_coronavirus_johnson-286384093/

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Potter53 · 07/02/2021 12:34

Has anyone been told how/when the vaccine will be registered on your NHS vaccination record ? I have checked through all of the information that I was given and there is no mention of it at all. This could give problems in the future if it is never recorded on our records. I intend to ask the question when I have my appointment on Thursday this week.

Frazzled2207 · 07/02/2021 13:14

@Potter53
No but would really like to know. We will get a certificate apparently and hoping there should be a mechanism for this.

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Potter53 · 07/02/2021 14:12

@Frazzled2207 I will post on Thursday when I get home from my appointment.

Stopyourhavering64 · 07/02/2021 16:06

@Frazzled2207

oh I've remembered more. He said 'in the next 7 days' they expect to get 120 people getting covid which means they can release the next batch of data. But we shouldn't think about the actual % efficacy too much as it is somewhat arbitrary and you need to look at the bigger picture (eg hospitalisations, which doesn't officially count in the statistics) - To his mind vaccines come in three different types - 'good efficacy' - is 70% plus and the vaccine is definitely in this category. It may not stop people getting it entirely but in almost all cases will reduce serious illness and death. Most flu jabs are 'medium efficacy' - still definitely worth doing. The third category is 'doesn't work'.
The amount of paperwork required is following good clinical practice guidelines and all source data needs to be available should the MHRA request an inspection . All data from each visit is transferred from paper notes to electronic trial data base which can be accessed remotely by trial monitors across the world ....one of the reasons they can review the data so quickly and provide results ( I was involved with the remote data entry and there are numerous pages which need to be completed for each visit)
andadietcoke · 07/02/2021 16:24

Yes I was told everyone would get a certificate after their second dose of the crossover trial. Presumably there must be some mechanism for giving people who have been unblinded and found to have had the active vaccine a certificate too.

PleaseReferToMeAsBritneySpears · 07/02/2021 21:06

Has this been posted before? Interesting piece about the reasons behind Novavax doing the crossover.

www.google.co.uk/amp/s/www.vox.com/platform/amp/22202902/covid-vaccine-pfizer-moderna-clinical-trial-placebo

AVictoryProduct · 08/02/2021 10:14

[quote PleaseReferToMeAsBritneySpears]Has this been posted before? Interesting piece about the reasons behind Novavax doing the crossover.

www.google.co.uk/amp/s/www.vox.com/platform/amp/22202902/covid-vaccine-pfizer-moderna-clinical-trial-placebo[/quote]
Thanks for posting, very interesting.

Woventabby · 08/02/2021 10:58

Thank you, everyone, who provided lots of interesting information on this thread. I am eagerly waiting for official confirmation about the crossover trial here. Hoping I get some information in my next appointment next week.

BG2015 · 08/02/2021 16:35

I'm due to go next week too for appointment number 4!

Will be interested in what they tell us. I'm based in Staffs and go to Cheadle for my appointments

Frazzled2207 · 08/02/2021 16:45

as far as I can tell this instruction has come straight from Novavax hq so I'd be really surprised if the plan was any different at any other sites. But timescales could be. At stockport we are due to be jabbed again in mid-march.

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ItsSnowJokes · 09/02/2021 09:40

I really really hope we all get the vaccine soon (if we haven't already had it). I am back on the 8th March for my next blood test, hoping they have news then.

Daftapath · 09/02/2021 12:35

Just returned from my appointment. They confirmed that the protocol is changing to a crossover study and anyone who has not been unblinded already will be asked to take part. I signed my new paperwork so ready to go when they are.

The new protocols are still going through the ethics process. They hope to know more by the end of March but obviously to call before if I get offered a different vaccine in the meantime. Next appointment is early May but she suggested I call them at the end of March if I hadn't heard anything about the vaccine appointment .

She confirmed that we would get some sort of certificate, they would contact our GPs about us getting the vaccine and that the next injections would also be three weeks apart as per the first ones.

So exciting!

PleaseReferToMeAsBritneySpears · 09/02/2021 12:54

Thanks for the feedback. Great news!

Torvean · 09/02/2021 15:39

Im just back from my blood test appointment.

They've made more changes so more paper work.

The interesting thing is Novovax are talking about giving the vaccination to those who had placebo. But they still want to keep it blind. So 2 mire injections for everyone.

When the volunteers newsletter came out it said they had to unblind a lot as there was a high level of health care professionals involved.

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