Novavax trial thread number 3

[Frazzled2207]

Yet more chat about novavax, (un)blinding, general vaccine passport stress, approval (please please please) and more.
Those involved in other vaccine trials also welcome.

@PleaseReferToMeAsBritneySpears Thank you for the information. I am still blinded, too, as I missed the boat to get approved vaccines being indecisive. It looks like a Novavax booster is not happening, so it will be a matter of if we should wait until the trial finishes in a couple of months, or unblind now to get the ball rolling for a booster. I suspect that there may be some bureaucratic 'obstacles' waiting for us when trying to get a booster...

I was hoping they'd recognise my Novavax vaccine as it appears in the NHS app and give me a Pfizer booster. It should be as simple as that but who knows. I'm CEV so in group 4 of the rollout order. If I had my vaccine in the crossover I can have the booster on Nov 10th. They probably wouldn't get to be before then anyway.

I didn't go into details with the Leeds trial. I simply asked whether Novavax are doing boosters for the trial.

Sorry - any booster I'm offered. It's the 12-15 year olds that specifically Pfizer.

Novavax have missed the boat with boosters.
The govt have released about AZ being a booster, yet AZ are querying the need.

I'm still blinded and pretty sure I got Novavax in October. I won't be entitled to a booster.

Hey @CardinalCat I got yet another useless email from my MSP claiming no registration/ NHS inform/QR Code and that crap bit of A4 paper is equal status.
The A4 paper that was supposed to list Novavax as generic, date it as April, add batch numbers and place of vaccination..... all blank.

So I replied back the same Qs they've refused to answer since June.

The only bit he was interested in was hearing if any venues rejected the letters.

I asked him if the govt will provide monetary compensation for ticket costs, and does that also factor travel/accommodation.

Sad day when you get nowhere because who have a MSP ( Who you didn't vote for) and the Govt are the same party. It shouldn't even be a political issue.

They should register us as an act of decency. NS claims she's grateful and thanks us, Yet NS/HealthSec/CMO/public health are causing this crap.

Excuse my typos i was involved in
Car vs my hand..... I lost

@Frazzled2207

sorry to hear you've been unwell.

Is anyone else here from the Valneva trial? very bad news about that yesterday with the UK government order cancelled abruptly. I suspect that means that the UK government will be in no rush at all to approve that one now.

I was concerned when I heard about the Valneva order being axed. I know Scotland ran some of the trials. If you're in Scotland the govt will make like difficult. If outside I'd say get another vaccine. The clinics have hold if the NIHR article that allows it.

I wouldn't choose AZ personally , not just because of the raised clot factor, but also because its now linked to Guillian Barre syndrome.

Taken from the facebook group in a communication to Bradford participants but affects us all. Pleased I got out when I did tbh. Though that doesn't help the many thousands of left in limbo. Well done to bradford for broadly keeping their people (and everyone else too indirectly) in the loop

Dear Participant,

On the 14th September 2021 we were made aware verbally from the sponsor that there has been a delay in the regulatory approval to the Novavax Vaccine. This was not foreseen and under the guidance from the MHRA, Novavax are now running the assays on the manufactured product and writing up the results for the final manufacturing submission. The submission will now happen at a similar time in the EU and the UK (and other countries too) but Novavax now does not expect to complete regulatory filing in the 3rd quarter of 2021. It is anticipated this will take an additional couple of months. The length of time required to adjudicate/approve the file is of course, unknown and will vary by regulatory agency.

As a result of the above a booster vaccine will not be offered as part of the UK phase 3 trial. Novavax received communications from the MHRA on September 10th stating that a booster study should not be added to this current study. Any booster study conducted should be performed under a new, separate protocol. Novavax is urgently discussing the feasibility of such a study. For all participants on the study this means the last appointment in October and November are the End of study visits and any further follow up visits at this stage are not planned.

When attending the end of study appointment if you have had to pay for a PCR test for travel could you bring your receipt of this to the visit, we will need you to re-sign a consent form to be able to complete the refund, there will be a limit on the amount of swabs and a upper limit on the cost per swab.

Authorized vaccine/booster:
Novavax is unable to provide guidance on the safety of receiving either 2 doses of an authorized vaccine or a booster of an authorized vaccine after having previously received 2 doses of the Novavax vaccine. Novavax cannot provide this guidance as there are no data on this vaccination schedule and Novavax are unable to comment on the safety of such a schedule.

If you do get a Booster offered through the NHS, please let the study team know and we will be able to guide you with further steps
As Novavax has not had regulatory approval and participants have not been able to travel to the EU without a valid vaccine passport, this has posed serious difficulties to our participants. We apologise for this. If you do intend to have 2 doses of a NHS Covid vaccine in spite of having had 2 doses of the Novavax Vaccine, please contact the study team and we will withdraw you from the study.

As always please contact us if you require any further information, the NIHR email is also available for further complaints. Again we would like to express our sincere apologies, official communications will be sent from the sponsor as soon as we receive them however with the changes in government guidelines as a site we felt our participants required information sooner rather than later.

Thank you again for your ongoing commitment. We do apologise for the difficulties and frustrations that we know you are facing.
Thanking You
Yours Sincerely

Thanks for sharing - I wonder if they will change the official rules on obtaining 2 doses of approved vaccine. They really need to and at least that gives people the choice - especially 40 somethings who aren’t currently eligible for boosters but had their jabs last year.

@Frazzled2207 Thank you for the information. This confirms that some of us are really stranded by participating in the clinical trial. Although still blinded, I am certain I got my real vaccine last October. My best shot now will be to withdraw from the trial, and try to get the approved vaccine, somehow, if possible...

@Stillmuddlingthrough

Thanks for sharing - I wonder if they will change the official rules on obtaining 2 doses of approved vaccine. They really need to and at least that gives people the choice - especially 40 somethings who aren’t currently eligible for boosters but had their jabs last year.

Sadly I don't think they officially will because of no safety data but am hearing of more and more trial docs recommending we do so - and some have def been involved in facilitating. I think it might become easier once the trial has come to an end though which is not far off now.

Agree entirely that they should though
I'm 43 and would be pretty cross as I had my novavaxes nearly a year ago. Feel very lucky to have jumped ship and got moderna before they uploaded my novavax data to the system.
Don't feel bad for lying anymore!

Not entirely clear if 50+ who were on the trial will be eligible for boosters in the normal way. I hope they will be though.

Authorized vaccine/booster:
Novavax is unable to provide guidance on the safety of receiving either 2 doses of an authorized vaccine or a booster of an authorized vaccine after having previously received 2 doses of the Novavax vaccine. Novavax cannot provide this guidance as there are no data on this vaccination schedule and Novavax are unable to comment on the safety of such a schedule.

Ohhh shit. We are up the creek without a paddle arent we. We cant access a booster if and when we become eligible…

I have emailed the trial to withdraw. I am so upset and angry with the way this has gone. I have done trials before and never seen such a poorly run trial as this one. We have been majorly fucked over and now the Novavax jabs are on our app it is a lot harder to get an official jab. Husband is over a year since his first jab now, he is very worried. I am pretty sure I had mine in crossover so not as worried but we have finally booked our rescheduled holiday for next year and as its a cruise I need an approved jab and a booster!

@Dreamer1989

Authorized vaccine/booster: Novavax is unable to provide guidance on the safety of receiving either 2 doses of an authorized vaccine or a booster of an authorized vaccine after having previously received 2 doses of the Novavax vaccine. Novavax cannot provide this guidance as there are no data on this vaccination schedule and Novavax are unable to comment on the safety of such a schedule.

Ohhh shit. We are up the creek without a paddle arent we. We cant access a booster if and when we become eligible…

Why do you think we won't be given an NHS booster when we become eligible?

I emailed my surgery today asking them to confirm I'll be able to have the NHS booster when offered. I'm CEV so will be in priority group 4.

I'm still blind and in the study.

Leeds sent me the following yesterday when I asked if they're doing boosters...

"We have been advised from NOVAVX, that the Novavax booster trial will no longer be happening. This is based on MHRA advice.

Novavax can not advise on if you should get a 3rd vaccine. However, if you do decide to get a 3rd vaccine (the booster vaccine) you can remain in the trial.

We appreciate the difficulties of this uncertainty."

@PleaseReferToMeAsBritneySpears I read what Novavax said to mean we have no data or safety on a booster - so I dont think NHS will want us to have a different vaccine as a booster because its untested. I am so tired of waiting for news, I think novavax should hold their hands up and admit it was a flawed trial. I dont want compensation, I want an apology.

[quote Dreamer1989]@PleaseReferToMeAsBritneySpears I read what Novavax said to mean we have no data or safety on a booster - so I dont think NHS will want us to have a different vaccine as a booster because its untested. I am so tired of waiting for news, I think novavax should hold their hands up and admit it was a flawed trial. I dont want compensation, I want an apology.[/quote]
Agree they've fucked up big time.
They just need to let people move on and get their own approved vaccines. Make us sign some kind of disclaimer if you must but definitely sort out the IT so they can actually get it.

What is really worrying is that older 50s that got it last autumn, if still in the trial they won't be called up when they should be (if at all) because the system I think gave April dates to everyone.

I’m in the Bradford group and got that email yesterday. I’ve emailed back a furious response saying that it’s been obvious for months to anyone who follows the share price that Novavax can’t get their act together and in all likelihood won’t get approval. I think they’ve probably got a great vaccine, possibly the best vaccine, but they just cannot get the paperwork in order for approval.
I asked weeks ago what was Plan B in the event of approval not being achieved and got an email back saying there was no need for a Plan B because approval would definitely happen. I don’t believe it will.
We’re high and dry here, nobody can tell us what’s our best course of action because the work on interaction of our vaccine with the others hasn’t been done.
We all knew going in that we were taking a risk for the common good, and accepted that, but we didn’t sign up to in effect be left behind while the world moves on around us.
I have no idea what course of action to take now. I’m assuming we’ll be unblinded next month and at that point will at least have some information to help us decide what to do next.

And another thing - in the event of approval not being granted, where does that leave the JVT letter? Surely the govt can’t hold the line that we’re to be regarded as fully vaxxed for UK purposes if the vaccine is actually turned down by the regulator as opposed to being in limbo as we are right now? What’s our status then?

In England you're registered it won't change.
I saw a post on FB from SNP writing about concerns about those on the Valneva trial. I replied saying Scotland won't register them either. And maybe the SNP member would advocate for registration....

Looked just now, post deleted. So I put it back up.

My email from Comms Scot also pissed me off when they yet again said a bit of A4 paper is equal to NHS Inform/QR codes and we don't need to act on it.
Are they deluded/stupid or both??

@CardinalCat have you made any progress.

@JosephineDeBeauharnais

And another thing - in the event of approval not being granted, where does that leave the JVT letter? Surely the govt can’t hold the line that we’re to be regarded as fully vaxxed for UK purposes if the vaccine is actually turned down by the regulator as opposed to being in limbo as we are right now? What’s our status then?

I think the gist of the letter was that we would be vaxxed for domestic purposes whatever happened.

But I think the issue is I don't think it will necessarily ever be 'rejected' for approval. It could well however leave everyone in limbo indefinitely which is worse!

I believe it will get both UK/EU approval. However if ppl can't wait they can get another vaccine.

This really made my day yesterday. This is Scotlands health secretary.
An SNP person posted on twitter to say everyone that had bookmarked it should delete ummm no. I will watch it at my pleasure.
Amusing regardless if your Scottish or not.

twitter.com/AngloScot2/status/1438509580854521864?s=19

Ps turn your sound on.

I received an email from my trial team. London. They are promised an update from Novavax next week regarding the approval process and booster studies.

They also mentioned that the JCVI is currently reviewing the issues regarding advice around boosters and accessing a licensed vaccine, and they are hoping to have an update to share soon.

I doubt there would be any meaningful update from Novavax, but I am glad to learn that the JCVI is aware of the issues. We need some authority (not sure which) to intervene and solve this mess!

The market doesn’t have much confidence in the company either. Shares are off $35 each since two weeks ago.

Novavax have announced that they're now doing a trial with adolescents in the US. The try got a lot of angry comments in reply.

JVT doing his best...
www.theguardian.com/society/2021/sep/18/ministers-told-bar-eu-uk-trial-data-vaccines-row-england-deputy-chief-medical-guinea-pigs

If you google the person in this article, you can see a petition regarding the Novavax problem.

Has anyone who has received the vaccine been invited for a booster? I’m frontline NHS and was unblinded before they announced the crossover study. Just wondering if anyone is in the same position? I’m planning to contact my trial team in the morning.