mnm99

Hello,
I have been in the trial since the beginning of January and live in the US. I had both my shots and had the first follow up after the second. I was told they were not going to make an appointment for my 90 day follow up right now. I really had no reaction to both shots, but that really doesn't tell me anything. After my first shot I mentioned the Crossover to them. They were stunned I knew from there look. I asked when I would get it and she said when the FDA says it's safe. Well to me that's FDA approval and could be June or July.. I qualify for the other shots, but really like the way this one was made and want to stay in it. I don't know if I can wait till June though. Are you in the UK or somewhere else besides the US? Anyone else have info when the Crossover really might happen in the US?
Thanks

lobo411

Novavax presented at an investor fireside chat this morning. They've already finished challenge trials using a new formulation of the vaccine targeting the variants in non-human primates. Also, the updated clinical trial protocols discuss testing a "new lot" of vaccine produced using a "new manufacturing method" in the crossover. Quote:

"We expect to be in the clinic (clinical trials) with the new construct (new version of the vaccine targeting variants) early in the second quarter."

I'm thinking they're going to test the new, variant-targeting version in the crossover trial that begins in about three to four weeks.

See minute 14
https://ir.novavax.com/events/event-...-fireside-chat

lobo411

Crossover starts very soon for the UK, and most likely April for the US. Anything later and they'll have no participants left to crossover with!

Telecasterman

im in the UK. I received my NHS vaccine letter asking me to go for my approved vaccine on the same day (1/3/21) as I received the email from the novavax team outlining the new trial crossover details. When I rang the team as per the policy they said If I chose to remain blinded I would have been given either the placebo or active vaccine before the end of April (both doses).

I chose to unblind. If I had had the placebo I could take up the approved deployed vaccine first dose and leave the trial. As I had been given the active vaccine I have stayed with the program unblinded.

hope that helps T

TTT

My wife's employer (medical clinic) is opening a wait list for employee household members (e.g. spouses, parents, etc) to get extra vaccine should there be no-shows at their vaccine clinics. I'm in the AZ trial and fairly sure I received the AZ vaccine based on post-vaccine symptoms and positive spike AB test.

That said:
Should I unblind in the AZ trial to be sure I received the study vaccine?
And, either way, should I be added to the vaccine wait list to get either the Moderna or BT vaccine? Are there any potential or known issues with receiving an mRNA vaccine after a viral vector?

As I mentioned up-thread, I'm not convinced the AZ vaccine will receive FDA approval in its current state so given the option of an approved vaccine might be worthwhile.

FDA could reject AstraZeneca's COVID-19 vaccine on efficacy and manufacturing shortfalls: analyst
Though they may be seeking approval in the next few weeks anyway.
AstraZeneca to Seek FDA Approval of COVID-19 Vaccine Within Weeks

lobo411

I wouldn't unblind if I was S protein positive. We're literally going to be flooded with vaccine doses by June, and the US should become a vaccine exporter by the fall.

And this vaccine will be approved. They do what's called a futility analysis throughout the trial, and probably it would have failed already if it wasn't effective.

I'm S-protein negative myself, so I was placebo'ed. And I've had plenty of chances to get an approved vaccine (been eligible since mid-January, and just for lulz I've gone to the appointment websites. More than a few times, I could have booked with just the click of a button). If Novavax hasn't started the crossover trial and gotten EUA by May 1, then I'm out. But that's more a function of it taking 30 days to get fully vaccinated and my wanting to travel in July than it is a question of health and safety.

jbandy10

I got Johnson and Johnson yesterday.

It really knocked me out. Still feeling dead today. What a ride. These side effects are no joke.

But thank goodness I have it.

pinklighter

LOL'd at 88 teaspoons of blood...who even measures it that way

TTT

FWIW, I called the study doctor and asked about getting one of the approved vaccines. He suggested I remain blinded and then get whatever vaccine I was offered. That allows them to keep my data for the AZ trial. Not sure how but that was his suggestion.

lobo411

It's a technicality. If they officially unblind, then your data cannot be used in the efficacy analysis at the moment of unblinding. If you aren't officially unblinded, then you're still in the trial and your data can be used.

It's the same in the Novavax trial, btw. People who are asking to unblind are being advised to just take the EUA vaccine if they're worried.

lobo411

There's a lot of chatter that Novavax's crossover, where placebos get vaccine and the vaccine arm gets placebos, will begin in a few weeks. We'll see, but I believe it. Everyone I know is vaccinated by virtue of being in targeted employment groups, and all Americans are eligible starting May 1st. The handwriting is on the wall. Placebo controlled coronavirus trials will never again be held in the United States.

TTT

Ended up getting called late yesterday afternoon for a Pfizer shot from a few no-shows at a vaccine clinic. My arm is killing me and I’ve got a little insomnia but otherwise feel fine so far.

It’s nice to know I’ve been vaccinated for sure.

I’ll call the study site on Monday to let them know. As the U.S. gets more vaccine I really wonder how AZ is going to keep their trial running. Maybe it’s moot anyway since they’re submitting an application soon.

lobo411

They know that we're going to be vaccinated soon no matter what. Besides, at this point, placebo trials are unethical per the 1968 Helsinki Declaration.
​​​​

downinit

I got J&J on Friday, and it is quite the relief to have it behind me. Aside from the obvious pain related to having a needle thrust into my deltoid and receiving an intramuscular injection, nothing noteworthy to report. I had a 'fever' of 99.1 at one point the following day, which is about 1 degree higher than normal for me but definitely not reason enough to make an appointment at the mortuary.

I have a completely unvalidated and unscientific 'hypothesis' that the degree of a reaction to the vaccine is likely proportionate to the degree of a reaction to the illness. My SO almost certainly contracted Covid in Feb 2020, with lingering long-term COVID symptoms for the next six months. There were no tests available at the time unless there was confirmed exposure,which there was not. The only thing the doctor did was perform a chest X-ray, which showed nothing abnormal. He was the first person at the hospital to show up with COVID symptoms and they did not have much in the way of a procedure established, beyond requesting a chest X-ray. He was sent on his way, despite an unexplainable chronic dry cough and fatigue. He did have a stronger reaction to the Pfizer vaccine, mostly in the way of fatigue. I never had any symptoms at at any point when he was ill, despite spending a lot of time together in close proximity, so I presumably had a higher degree of natural immunity. But that is the problem with C-19, it is a lot like Russian Roulette. Most people will be just fine, but a few will be SOL. There is no way to know what group you are in until after you pull the trigger.

i0wnj00

That's what Pfizer did to my arm and couldn't sleep on that side for two nights.
I used my left arm for this shot because I used my right arm one time for a flu shot and that was a bad idea. Couldn't write that well, didn't really have good grasp of the steering wheel, picking up certain items became difficult, etc..
I'm a wee bit worried about the second one, I heard that the second one from Pfizer has a punch to it.

I only choose Pfizer because my mother got it, I figured that if she turned out ok, I will be, because of whatever genetics I inherited from her. She told me that her second one turned out better than the first, so that's encouraging.

I applied for the Novavax trial in February but I wasn't selected to participate. I answered No on a question if was going to take a covid-19 vaccine in the next 3 months. About one month later my turn came up and signed up for an appointment. In hindsight it was a blessing because I didn't know what to do if I was chosen to participate and my turn came up. I thought I would have needed to wait till July-August and had nothing to lose by participating.