Novavax vaccine trial part 4 - STILL waiting for approval

[Frazzled2207]

Here we are again

ir.novavax.com/2021-10-27-Novavax-Files-for-Authorization-of-its-COVID-19-Vaccine-in-the-United-Kingdom?sf153467665=1

Call me cynical but they have an earnings call in a weeks time, need some good news for their bosses. 💰

@gazzaconns

Call me cynical but they have an earnings call in a weeks time, need some good news for their bosses. 💰

I'm not going to suddenly praise Novavax. Who knows how long MHRA approval will take. Who knows when they will apply for EU approval. I've not checked but I think a lot of Anericans will be pissed at this announcement. They seem to think that as they've paid taxes America should get approval first. In fact one went so far as to say all vaccine doses should be given to America before any other country ...

So apparently it’s just a sitting and waiting game??

bepartofresearch.nihr.ac.uk/Vaccine-studies/Latest-Vaccine-News/?_cldee=anVsaWVydXR0ZXJ1a0B5YWhvby5jb20%3d&recipientid=lead-9c6188faec30ec11b6e6000d3a8747f9-280ce681f27a47f7ad7d58a2a5539723&esid=7b5d4e61-c737-ec11-8c64-000d3a871678

Phoned my centre up and was told I would be sent a letter of invitation. Received a letter today and opened it, expecting to be invited for my two further vaccination doses……it was dated 07th October and was a letter to inform me that I can claim the costs of PCRs when undertaking international travel 🤦🏼‍♀️.

And as each day passes, time goes on and I can’t prove a double approved vaccination…….

I got confirmation from the trial lead that no arrangements are being made for those in Scotland to get Pfizer. We have to attend drop in clinics, with 0 medical advice.

Reports that Novavax have been granted EUA in Indonesia. Hopefully more will follow.

At last! The next few weeks will be interesting.

Who wants to come on holiday with me to Indonesia?!

You can already go to Greece.
Americans have gone into melt-down over UK approval coming first.
Apparently they pay taxes they should be 1st.

It’s a tricky one now isn’t it? Do we cross our fingers and wait for EU approval? Do we get first Pfizer dose and hope EU approval comes during 8 week wait? Do we press on and have both Pfizer jabs regardless?
I’m thinking to have first Pfizer next week, regard that as booster and see what happens by Xmas. I want to go skiing so will need some certainty, but always book last minute anyway.

I had my final appt at Leeds today. I had bloods taken, I was unblinded (vaccinated in crossover) and I spoke to a doctor about Pfizer.

She invited me into a sub study of people who had two Novavax and a Pfizer booster. I'll have it at Elland Road on Nov 17th. Bloods on Days 0, 14, 28 and six months.

If Novavax isn't approved I can then have a second Pfizer for travel, however they fully expect it will be approved. Apparently they've applied for marketing approval not just emergency use approval so it will take longer. Closer to three months than three weeks.

I think that's it. They started off with 800 participants and have ended up with just under 300. I'm glad I made it. It's been really interesting and I've done my bit. Thankfully I didn't need to travel so I've not been disadvantaged personally. I feel very sorry for those who have. Anyway, this wasn't to open up that can of worms - I just wanted to let you know what happened today.

I had an email from my site today saying they’d completed all of the data submission for MHRA, EMA and WHO amongst others. Also emergency approval granted in Indonesia.

Got back in my normal name. I've been told by 2 separate ppl that Novavax approval should be max 4 weeks
So should be 3 now maybe ....?

Some kind of feedback has to happen from this trial from Novavax itself to the various govt.

It shouldn't be allowed to happen again.

Can’t book my booster this morning…..says I’m not eligible by the NHS system, even though I’m in the Government eligible category!! 😡

Had my 1st (and maybe last) Pfizer on Saturday and I feel like absolute crap. Been vomiting, fever of 40, sweating, shivers, huge swollen armpit, red lump at injection site, feel like my body will break if I move. This is my 2nd time of feeling like this (the 1st was after my 2nd real novavax) and I just don't know if I can do it again.

Has anyone else felt so rough?

@ItsSnowJokes

Had my 1st (and maybe last) Pfizer on Saturday and I feel like absolute crap. Been vomiting, fever of 40, sweating, shivers, huge swollen armpit, red lump at injection site, feel like my body will break if I move. This is my 2nd time of feeling like this (the 1st was after my 2nd real novavax) and I just don't know if I can do it again.

Has anyone else felt so rough?

I had chills and a fever, excessive sweating and extreme tiredness, chattering teeth in my sleep after my second Novavax. Also felt like crap after my flu vaccine three weeks ago….intense nausea and tiredness. I’ve got to go to a walk in centre for my booster this afternoon…..not looking forward to it now, after your symptoms 🥺

@Monkeygirl68 I hope you don't have it badly. Husband has got the same as me as well, he didn't react as badly to his 2nd novavax but he has been knocked out by his 1st Pfizer. We have both had to call in sick to work today as we both feel so bad. Just can't get out of bed.

I should add in hindsight we shouldn't have gone at the same time. IF we go for a 2nd Pfizer we have said we won't go together and have a few days in-between so we can look after our children as I had to get help yesterday and today was a massive struggle to get the youngest to school.

@ItsSnowJokes

I should add in hindsight we shouldn't have gone at the same time. IF we go for a 2nd Pfizer we have said we won't go together and have a few days in-between so we can look after our children as I had to get help yesterday and today was a massive struggle to get the youngest to school.

I hope you feel better soon and the effects are not long lasting 🤞🏻…. I will brave it this afternoon and see how I get on. I won’t be impressed if I have to have 2 Pfizer doses though, so really hoping for Novavax approval

Still feeling absolutely awful. I am hoping it passes overnight. Still feeling very nauseous, aching, sweats and shivers. Have a huge swelling in my arm pit which is very painful. Also my pee is really really dark brown. I have done an econsult at the gp, but I expect the brush off as side effects due to vaccine.

@Monkeygirl68 how are you feeling? Any reaction at all? Hope you are doing ok.

[quote ItsSnowJokes]@Monkeygirl68 how are you feeling? Any reaction at all? Hope you are doing ok.[/quote]
Big reaction…..deteriorated throughout the day despite taking paracetamol and ibuprofen at regular intervals. Chills, fever, vomiting and soooo cold. Collapsed on the floor tonight and running a temperature. Feel so poorly. Left hand side of my face has swelled up, and that’s what I get in reaction to naproxen or ibuprofen. Sincerely hope I don’t need another dose. Couldn’t lift my arm either…..

@Monkeygirl68 oh no, I am so sorry. It absolutely sucks doesn't it?

Me and husband still don't feel right today. I have massive swelling in my left armpit and neck since yesterday. Still feeling achy, tired and nauseous. We are about 50% better but we both called in sick to work again today and probably will tomorrow. I cannot imagine having another vaccine after this reaction at all.

[quote ItsSnowJokes]@Monkeygirl68 oh no, I am so sorry. It absolutely sucks doesn't it?

Me and husband still don't feel right today. I have massive swelling in my left armpit and neck since yesterday. Still feeling achy, tired and nauseous. We are about 50% better but we both called in sick to work again today and probably will tomorrow. I cannot imagine having another vaccine after this reaction at all.[/quote]
After a night of throwing up, I really don’t want another vaccine.

Sorry you are feeling so poorly too. I’m going to log my symptoms using the yellow card process and I’ve been advised to phone 111 🥺

@Monkeygirl68 I hear you! I did the yellow card process. We are both on day 4 and light is at the end of the tunnel. We have woken up feeling a lot better but still exhausted and our body aches and pains are still there. My third boob of swelling under my armpit has started to finally go down so i do hope this is the end of the road and we will get better every day from here on in. A family member keeps saying we should contact the trial, but I don't think they will care as we have had our final appointment with them. I am just praying and praying that Novavax gets approved in the meantime and they change the Pfizer dose to a booster so it means we won't need any other vaccines for travel (we have a cruise booked next year).