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

@Frazzled2207
like you I’m pretty confident this will be solved in the end. Think the main problem has been the not knowing and differing information/knowledge across the trial sites. At my second crossover appointment I was shown the A4 certificate to be posted at a later date. Subsequently I was informed two weeks ago they were waiting for paperwork from Novavax, expected by end of that week, for registering vaccine details with my GP. My own paperwork would be posted then. Haven’t heard anything since.
Fingers crossed. My ultimate action, if this is not solved, would be to raise with my MP. Question of equality.

Another trial friend (feel like I'm cheating on you lot!) contacted her GP today and got a call back saying it was already being looked into and someone had called her GP yesterday to ask them to sort it. She said it might take a little while but it is being sorted. So that feels like good news, although the friend was unblinded a while ago as she's an HCP.

Just booked (younger) DH's vaccination for him. Bleurgh.

@andadietcoke

Just booked (younger) DH's vaccination for him. Bleurgh.

My dh had his last week. Seems a bit more straighforward to them now doesn't it (although they have to wait a while for the next one) Hope he dodges side effects. I totally expected mine to be floored - he had AZ and other than a bit of tiredness was totally fine.

Stu will be on Pfizer because under 40. I was so tempted to book one for me too but it still wouldn't be in time for the cruise - his second dose is 1/8 and the cruise is 18/7.

Stan talking again today to Bloomberg

www.bloomberg.com/news/videos/2021-05-11/sinovac-ceo-yin-discusses-coronavac-s-efficacy-video

@andadietcoke

Stu will be on Pfizer because under 40. I was so tempted to book one for me too but it still wouldn't be in time for the cruise - his second dose is 1/8 and the cruise is 18/7.

Is he not going on the cruise then☹️

@Frazzled2207 no - oh the irony - he wouldn't have been vaccinated in time so couldn't.

I have been unblinded and since late March I have asked my GP by email, phone and letter to update my records, sending them copies of the vaccination certificate the trial team emailed to me. The team have told me that they have also sent this information to the GP. My NHS app now has only one entry stating that I had my second dose of the COVID-19 vaccine (no other details) in April - my second Novavax jab was in November. I am utterly frustrated that they cannot seem to get this right.

Can we do an easy at first glance poll?

For those who have now had all four jabs, what were your side effects?

1 zero
2 zero
3 zero
4 sore arm

1 zero
2 weird hard injection site plus bruise down upper arm
3 zero
4 zero

1. Sore arm for a few days
2. Sore arm, fatigue, muscle aches, headache (for about 24 hrs, but sore arm for a few days)
3. Nothing
4. Nothing

Zero
Zero
Zero
Painful actual injection, then nothing

1. Sore neck and shoulders, headache, metallic taste in mouth
2. Sore neck shoulders. Injection site pain in first injection site. Temperature. Acute shoulder pain, metallic taste
3. Nothing
4. Nothing

Friend on other trial has been told by her lead doctor that we will still get our vaccination in the app regardless of regulatory approval. It's GP-dependent, they can't influence it, but the batch number and expiry date fields (which the GP won't have) aren't mandatory, and the brand name doesn't show in the app even if it's added in the back end. So sounds promising but I won't believe it until I see it in the app!

1. Nothing
2. Nothing other than slightly elevated heart rate but I was stressed that day so possibly unrelated
3. Nothing
4. Nothing

1- bad muscle ache like I'd ran marathon the day before lasted about 3 days. It reduced every day.

2- same muscle ache but not as painful as the first , again lasted about 72 hours

3- absolutely nothing

4 - had a reaction to vaccine. High temp and fast heart rate literally just after they did the injection I was soaked in sweat, totally gross. They kept me an hour. Was totally exhausted. Totally fine after 24 hours.

1. Painful injection, felt a cold rush go down my arm. Developed headaches and muscle aches which radiated up into my neck and down to my lower back on injection side. Lasted 48 hours.
2. Zero, slight bruise at injection site.
3. Painful injection, bruise at injection site.
4. Very unwell. Developed headaches same day, which progressed to flu like symptoms. Cold, chattering teeth, shivering one minute/hot the next. Couldn’t lift arm, tired beyond belief and stayed in bed. Clothes wet through from sweats. Lasted 4 days.

Nurse said that painful injections are when the needle hits a nerve. She told me this on my last injection, so I was very apprehensive. I feel like I was butchered having two injections out of the four that nearly made me hit the ceiling!

1 sore arm
2 sore arm
3 nothing
4 nothing

1. Nothing
2. Nothing
3. Very slight sore arm
4. Felt so unwell. Fever, chills, shakes, muscle and joint aches, pounding headache, extreme fatigue, very sore arm that I couldn't lift. It all lasted about 60 hours. I still have a sore achy arm though.

I emailed my team yesterday
I’m just wondering whether you can shed any light on the situation with vaccine passports.
Will the fact that I’m still blind and don’t know my vaccination dates be a problem?
Will the fact that the Novavax vaccine has not yet been approved be a problem?

And here's the reply
Thank you very much for your email. Once you have recieved two doses within the crossover study, our team will be giving a vaccination card with dates of doses. This will be followed up with a GP letter so the vaccination can be added to your records. In terms of vaccination approval, our team are currently undergoing MHRA inspection which will hopefully lead to vaccination approval very soon, therefore when you are ready to book a holiday, the vaccination will be accepted. Please let our team know if your GP require further information about the crossover appointments and the trial please contact us and with your permission we can speak on your behalf. Please let our team know if you would like any further information.

They don't specifically address the date issue or approval issue (which might not come until September (Stan saying Q3)), but they're saying there won't be a problem. I hope it's that simple.

And this is what I got from mine...feels a bit vague.

I have been in touch with Novavax and the best thing you can do at the moment is check what the stipulation is for vaccination, does it have to be a licenced vaccine or is evidence of vaccination enough?
I know all the vaccine makers are working with the government to standardise evidence so the impact on travel is minimised, but I don’t know when this will be.
Another thing you can do is ask you GP if they use the emis system, if they do there is a way they can add a SARs-cov-2 vaccine if they are happy to do so for an unlicensed one.

Bloody hell! Your response just fires the question back at you! WE DON'T KNOW! This every centre telling a different story thing is really beginning to piss me off now.

absolutely the lack of consistency information across the board is baffling. Our dr lead tells us that he has regular conference calls with all the uk study sites so there definitely are lines of communication(even if they are apparently not used).

I've had a standard email today saying they are coming up with an FAQ that they will send us all tomorrow.

1. Sore arm. (A mild headache and sore throat next morning.)
2. Sore arm. (A mild headache and sore throat next morning.)
3. Nothing
4. Nothing

I have just received an update from the Clinical Team. After an explanation regarding the delay, it went on to say,
"GPs are still able to input dates of Novavax vaccination into their Electronic Health Record systems so that receipt of vaccination can appear on your NHS app. The record asks for expiry date and batch number – neither of which the GP has, however those fields are not mandatory and can be left blank. The records only show that you have been vaccinated and do not specify vaccine brand name (even though this information is added ). Hopefully this will alleviate a lot of the anxiety around travel and proof of vaccination. Unfortunately this is a GP only system so we cannot do this for you and your GP will need to update records. Please get your GP to contact us if they are uncertain about this process."

Fortunately for us, our GP seems to know what they are doing. As soon as I sent them a copy of the A4 certificate, they asked that I should inform them of the dates and etc when I am unblinded at the end of the trial.

@Woventabby

if you don't mind I might copy and paste that text and send to my GP! will wait to see if mine comes back with anything first.