Novavax vaccine trial part 4 - STILL waiting for approval

[Frazzled2207]

Here we are again

Cheadle trial are offering 2 Pfizer vaccines for participants, I had an email today.

I'm no longer in the trial as I withdrew and had AZ vaccines in July and September.

I had the Novavax vaccine in October and November 2020.

I'm currently undergoing chemo and am classed as immunosuppressed. I've been offered a third Covid vaccine (not a booster) and they're saying 8 weeks after the second vaccine. But I've actually had 4 vaccines in the past 12 months so goodness knows where that leaves me. I'm considering contacting the trial doctor to find out what I should do.

I hope you all get sorted with your vaccines- what a f**k up it turned out to be.

Evening all. I’ve been for my final appointment today (Bradford). Had blood taken, had counselling and got a letter signed by Prof to take to specific hospital walk in vaccination centre to get two doses of Pfizer. Prof said that all the governments and regulators are supportive of Novavax and it will be approved eventually.
What’s happened is that the Government decided to change the protocols for the blood tests analysis which has meant that all the samples from the 15000 participants in UK (and it’s four samples per person) are having to be re-analysed and the results recorded then written up. This takes ages.
Novavax have applied to WHO for emergency use license and expect to get it.
Our government is committed to Novavax having bought 60m doses and Australia is desperate for it as its the one that most of the anti vaxxers will accept.
They’ve got their fingers in lots of other pies too - not just Covid. They’re doing a combination flu/ Covid at the same time plus the booster trial and other vaccines in the pipeline. They’re going to take their time and think global because of the massive potential in the developing world.
That’s my report!
PS gift was a bottle of sanitiser.
PPS got expenses for pre travel PCR test reimbursed but only the first £100. They’ve promised to try to get the rest.

I had a consultation with a doctor on Friday, had blood taken, unblinded (it was last October/November) and signed a few papers. Then the doctor issued a letter confirming that I had a consulation with a doctor and prescribing 2 doses of Pfizer vaccine 8 weeks apart. Then I was directed to a walk-in vaccine centre in the hospital, where I had my first dose of Pfizer vaccine.

I didn't have adverse effects with Novavax vaccines, but the Pfizer one really knocked me out. Had a really high temperature, pain in the lymph nodes and headaches for a day or two. Totally fine now and glad it's done.

I am really frustrated with Novavax's late (or non) application and the inaction of the relevant authorities, but the trial site (London) has always been organised and the doctors and staff have been very pleasant. They mentioned that the government announcement happened without prior notice, so they had to get papers and procedures sorted in a short time, and they were still in the process of it. Seeing varied responses from different trial sites, even across England, it appears that each trial site was left to own devices.

The doctor advised me not to take the second dose of Pfizer vaccine IF Novavax vaccine is approved and the travel issue is solved while waiting for the 2nd dose as it will be a lot on your immune system. Could the WHO approval change the travel policies of many destination countries? Then I may not have to have the second dose.

It will be good for the UK have another vaccine and i believe this one is being made here.

I have had my final blood draw today and my first Pfizer is on the 6th November. I can't wait to get this over and done with now. Just had enough of the whole thing! I don't know when my 2nd Pfizer will be as 8 weeks is new years day! 7 weeks is Xmas day so God knows when the trial hub will get us in for 2nd jab.

I'm still feeling fairly rubbish after first Pfizer jab on Friday, really hoping I don't need to bother getting 2nd jab! Come on Novavax, get the bloody approval sorted!

I still need to go for final appointment at trial centre, but I was unblinded and had Novavax last Oct/Nov so I was pretty happy to get Pfizer 'booster'.

@Vargas

I'm still feeling fairly rubbish after first Pfizer jab on Friday, really hoping I don't need to bother getting 2nd jab! Come on Novavax, get the bloody approval sorted!

I still need to go for final appointment at trial centre, but I was unblinded and had Novavax last Oct/Nov so I was pretty happy to get Pfizer 'booster'.

I dont expect approval to come in till at least early next year sadly. They just can't seem to get their act together sadly. It's such a shame as I think it is an amazing product they have. It will do a lot of good in other countries as it is a hell of a lot cheaper than other vaccines but for us here I don't think it will be a big thing.

I am not looking forward to the Pfizer as I have seen a lot of people have had side effects and I was really ill after 2nd real novavax, I don't want that to happen again.

I hope you feel better soon xxxx

Has anyone heard from their centre? I understand that we are not meant to contact them and they will give us an appointment? My final appointment that is booked is not until December and if my first two jabs in December 2020 were the real thing then I would feel more comfortable getting a first jab of Pfizer before then.

@Evenstar I contacted them, so did many others in our trial site. If you want 2 pfizer doses for travel, you probably should contact them. One communication told us to wait until contacted, but another advised that we need to contact them if we want to travel abroad etc. It could take about 10 weeks to get the proof of the double jabs on the app. Some have specific travel dates in mind, so need jabs asap.

Thank you @StoneMap, not really planning to go abroad in the near future, I am a bit concerned as I am still blinded that I might now be coming up for a year since the jab and ideally want a booster.

I think I will phone them tomorrow.

@Evenstar I would definitely contact them if you want a booster. There's a 50% chance that it has been a year since you were vaccinated...and it's not like there aren't any Covid cases around at the moment. You could get unblinded and if you had the vaccine in the Spring you could wait a bit longer.

I just got an email from the Norwich site and now I have the email addresses for the other 315 participants!

@gazzaconns ha me too! What are you going to do about the booster, one or two?

Dear Novavax Participant

Further to the letter you received on the 11th October 2021 Ref: Receiving additional approved vaccine(s) after trial of not-yet approved vaccines

Please can you confirm which of the following you require

A single dose of the Pfizer vaccine (Booster)

Two separate doses of the Pfizer vaccine (which will allow travel prior to Novavax approval)

Or

Please confirm if you have already received an NHS Booster vaccination elsewhere and do not require further assistance.

Once you have responded that you require a further vaccination you will be contacted by the vaccination hub who will call you to book your appointment, once booked you will be contacted by a study doctor to discuss your decision. We will then send you the following that you will need to print off, sign and take with you to the vaccination hub:

The participant letter – signed by both the doctor and yourself
2 copies of the signed PSD, this is the prescription and you won’t be able to have the vaccination without it

You will also need to take with you a form of ID.

Please read the guidance via this link before you attend your vaccination appointment:
Information for UK recipients on Pfizer/BioNTech COVID-19 vaccine (Regulation 174) - GOV.UK (www.gov.uk)

We would be grateful if you could respond to this email as soon as possible to enable us to facilitate your choice, your end of study visits will go ahead as planned.

Please do not call in with your response, respond directly to this email so your choice can be recorded.

Please ignore this email if it is no longer relevant to you. As always thank you for your commitment to the study and for your continued patience.

I managed to blag my way to 2 Moderna jabs a while back, my only issue is with the App now.

@gazzaconns What is your app showing? 1 Novavax and 1 Moderna?

Yes dose 1/2 Novavax Dose 2 Moderna. So frustrating and the date for Novavax was the crossover placebo. So frustrating.

SAIS were in school today jabbing kids. There were left over doses and I had my letter with me.
Doctor cast a cursory glance over it, asked if I was pregnant and jabbed me. He's said they'll call in a month so I can get dose 2 in time to travel.
I cried.
Sod Novavax. I didn't want to do it but I really felt left with no choice.

@Mrs Hamlet Well done! 👏

My bloody arm hurts though!!

So a full 15 days since ScotGov gave said 0 regarding Pfizer.

Forgive me for being pissed at UK promises for all UK participants. If they meant f.a ,we should have had separate consent forms from day 1. At least those in Scotlsnd would know promises were genuine.
But hey the UK govt sorted it for England , what do 1000 Scottish people matter.

And mums net won't let me access my normal account.

If it's any consolation my trial team in England have been worse than useless.

You have my sympathy @MrsHamlet. My trial site are excellent, I in no way blame them.
I spoke to a Conservative MSP here who is also a Dr.
I told him the situation ppl are in. He said Sturgeon told him everyone in Novavax/Valneva were being looked after....

Then I got a very rude email from the deputy snp leader which included a line asking me if I was aware as to the fact novavax did not have an EUA yet.
They're the most obnoxious ppl in Scotland.

I think the worst thing about all of this is that we put ourselves forward when other people wouldn't, and yet no one has acknowledged that.
I didn't do it for glory but to advance science. I still think it was right to do it. I still think the vaccine is highly effective. But there is such incoherence now.
After several missed calls and messages on Friday afternoon from my clinic, I've heard nothing. They don't know I've had Pfizer and the message said they'd sort that urgently. It's ridiculous.

I was told by my centre to wait for my letter to be invited forward. They said they were clarifying the wording……I’m still waiting 🤦🏼‍♀️

I've just read a news story saying that the final data on the novavax has (finally!) been submitted to the UK regulator for approval, and that they "expect to complete additional regulatory filings in key markets, including Europe, Canada, Australia, New Zealand, the World Health Organization and other markets around the world shortly following the U.K. submission".