Vaccine Trials

[gerntz]

Maybe but oddly enough, french polio was a major side effect of the swine flu vaccination. Both a nerve or nervous system thing. I don't know what it means but I do know Bell's palsy is no joke..french polio can kill you.

I'm ready to get the vaccine because of my age.

Why you quoted a post of mine for this I have no idea.

 

[anethum]

8 out of 73,000 people in the trials got bells palsy. 23 out of 100,000 people in the general population get Bells Palsy. Obviously there is no reason to think the vaccine causes Bells Palsy when it occurs less often in those who got the vaccine than in those who did not.

23 out of 100,000 people over what period of time? Without that information, your figures are meaningless. And what is the source?

According to an NIH website, "Bell’s palsy affects about 40,000 people in the United States every year."

https://www.ninds.nih.gov/Disorders/Patient-Caregiver-Education/Fact-Sheets/Bells-palsy-Fact-Sheet

IIRC, I believe that adverse effect data from the stage 3 trials of the Pfizer & Moderna vaccines cover approx. 90 days on average from when trial participants received their first dosage of either the vaccine or placebo. (On Nov. 9, Pfizer released data based on a median period of 2 months after trial participants received their 2 dosage.)
https://www.pfizer.com/news/press-r...d-biontech-announce-vaccine-candidate-against

There were approx. 73,000 participants total in the 2 trials, half of whom received a placebo, so approx. 36,500 received a vaccine. There were 8 cases of Bell's Palsy reported, of which 7 cases were in people who received a vaccine, and just 1 in a trial participant who received a placebo.

Based on the NIH annual figure of 40,000, we can expect approx. 10,000 people in the US to get Bell's Palsy in any 90 day period. I calculate that in a random group of 36,500 people, on average 1 person would get Bell's Palsy in a 90 day period. And in fact 1 person out of approx. 36,500 who got the placebo were diagnosed with Bell's Palsy, but 7 people out of approx. 36,500 who got a vaccine were diagnosed with Bell's Palsy. I would not blithely discredit this information, and the FDA is not ignoring it.

 

[JoeWras]

For a variety of reasons, people are inherently bad at evaluating relative risks. Here are a few interesting articles about those reasons.

https://www.psychologytoday.com/us/blog/the-inertia-trap/201303/why-are-people-bad-evaluating-risks

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC385301/

https://psychcentral.com/blog/dying...were-really-bad-at-accurately-assessing-risk/

Good articles. The third one addresses control. Many people feel out of control when it comes to COVID or vaccines. Yet, they feel perfectly fine driving because they are in control

No they are not. Especially on a 2 lane road.

 

[travelover]

I thought this was a really easy to understand explanation of how the new vaccines work. Apologies if it has been posted before.


https://threadreaderapp.com/thread/1339624815137722368.html

 

[RetireBy90]

I thought this was a really easy to understand explanation of how the new vaccines work. Apologies if it has been posted before.


https://threadreaderapp.com/thread/1339624815137722368.html

Thanks. I’ve seen a couple of descriptions but this is good. Basic but covers what I/we need.
I’m still wondering how infection works to understand if you can still be infectious if you are imune. That is to say, if I’m exposed to joe who has the virus, and breath in some of those nasty things, at what point can I start breathing them out ? If you run across a rundown for that I’d love to see it.

 

[Go-NoGo]

I thought this was a really easy to understand explanation of how the new vaccines work. Apologies if it has been posted before.


https://threadreaderapp.com/thread/1339624815137722368.html

Another article with a good explanation on how your body's immune system fights off viruses"

https://www.theatlantic.com/health/...nity-is-the-pandemics-central-mystery/614956/

There’s a joke about immunology, which Jessica Metcalf of Princeton recently told me. An immunologist and a cardiologist are kidnapped. The kidnappers threaten to shoot one of them, but promise to spare whoever has made the greater contribution to humanity. The cardiologist says, “Well, I’ve identified drugs that have saved the lives of millions of people.” Impressed, the kidnappers turn to the immunologist. “What have you done?” they ask. The immunologist says, “The thing is, the immune system is very complicated …” And the cardiologist says, “Just shoot me now.”

That's the lead into the article, the rest is just as interesting.
And apologies if this has been posted before.

 

[PaunchyPirate]

My best friend got his first dose of the Pfizer vaccine yesterday. He is a Registered Nurse at a hospital and has been running their Covid testing facility since they opened it last Feb/March. I’m so proud of his long, hard work over the last few months. The only side effect he has had so far is that it feels like someone punched him in the arm. Hopefully this is the beginning of the end to this huge disruption in everyone’s lives.

 

[YVRRocketSurgery]

Moderna vaccine already designed by mid-Jan 2020?

Interesting article from NY Magazine describing the speed in which their vaccine (and others) were developed (days the genetic sequence was made public) after the but it obviously needed to go through trials. The article talks about vaccine development, timelines, vaccines' roles in the past coming at the tail end of pandemics, the concern about the covid vaccines vs the less cautious embrace of unproven treatments like hydroxychloroquine and remdesevir, and how vaccines can be developed and rolled out in future pamdemics.

I looked up another article from Business Insider that references the genetic sequence being released on Jan 11 and Moderna's vaccine being developed two days later to do a cursory check to see if I was reading correctly that it was that fast.

 

[Alan]

Threads merged

 

[sengsational]

Novavax Trial: Army Worms!

On 12/28, Novavax announced a Phase III trial where 2/3 of the participants will get the "real thing". Recruiting (or recruited...I don't know if it's still open, but I imagine so) 30,000 people from the US and Mexico. I think there's another 30,000 elsewhere in the world (not on the press release, but seem to recall reading that the total was 60,000).

All the other vaccines use the cellular machinery (ribosomes) in our own human cells to make the spike protein. This technology has spike proteins already built, outside the body.

But the technology is wild/weird/creepy to me.

They say that a genetically engineered virus was designed to infect "moth cells". That's where the spikes are assembled. My question is how do they infect the moth cells with the virus. Given they use "army worms" to make this vaccine, I wonder if they spray the virus on plant material, then let the army worm moth lay eggs on the plant material, then, after the army worms have devoured the plant material, throw all the worms in a blender, and filter out the spikes from the caterpillar guts. Pretty gross process, if that's it. But maybe they can coax just caterpillar cells to replicate in some kind of growing medium. That wouldn't be quite as gross.

But I think the participants of the trial have to agree not to get a vaccination for some number of days, and they hope to recruit some >75. I sure wouldn't do it: unproven vaccine and also barred from getting a proven vaccine. But for those of us that are <65, and really have a bad case of cabin fever, it might be worth it because after a few months, when they unblind the study, you might be protected, or at least first in line to get the "real thing".

https://ir.novavax.com/news-release...nitiation-prevent-19-pivotal-phase-3-efficacy

 

[kyzymurgist]

OP here. I'm in the Novavax phase 2 trial. We were told not to get any other Covid-19 vaccines when they became available. With one big exception.

When any vaccine becomes available to me, I can request to be unblinded and will be informed if in the control group. We can the be released from trial if desired.

DW and already functionally unblinded the test using the Assure rapid test with 99% sensitivity for IgG antibodies. Both negative.

DW and I are both in Phase 1c groups for vaccine distribution in our county. We will be eligible on Feb 1.

Our next study appointment is February 2 when we receive our 3rd and final injection (at least 1 of the injections is saline for all study groups). We will request to be unblinded.

Looking forward to the real vaccine in a couple weeks.

 

[anethum]

The Novavax coronavirus vaccine contains an adjuvant which is similar, I believe, to the adjuvant in the Shingrix vaccine. Both adjuvants are saponins. I think that neither the Pfizer nor Moderna vaccine uses an adjuvant. For myself, the Novavax vaccine is one which I would not get due the severe adverse reaction I had to my sole Shingrix shot. I would eagerly get either the Moderna or Pfizer vaccine, however. The high rate of adverse effects from the Shingrix vaccine is thought to be due to the adjuvant it contains.

Here is an interesting article about the development of the Novavax vaccine. It was published by Science on Nov. 3, 2020, before any covid-19 vaccines had been approved. Also since the article was published, the Sanofi Pasteur phase III vaccine trial, cited in the article as Novavax' chief rival, announced disappointing phase III trial results.

https://www.sciencemag.org/news/202...ompany-end-producing-best-coronavirus-vaccine

 

[kyzymurgist]

I still think the Novavax vaccine has great potential. As for Shingrix adjuvant, I also had a strong reaction. Spent most of the next day on the sofa.

But virtually no reaction to the second shot. Pharmacist said that's typical so you may want to rethink that second shot.

The Novavax coronavirus vaccine contains an adjuvant which is similar, I believe, to the adjuvant in the Shingrix vaccine. Both adjuvants are saponins. I think that neither the Pfizer nor Moderna vaccine uses an adjuvant. For myself, the Novavax vaccine is one which I would not get due the severe adverse reaction I had to my sole Shingrix shot. I would eagerly get either the Moderna or Pfizer vaccine, however. The high rate of adverse effects from the Shingrix vaccine is thought to be due to the adjuvant it contains.

Here is an interesting article about the development of the Novavax vaccine. It was published by Science on Nov. 3, 2020, before any covid-19 vaccines had been approved. Also since the article was published, the Sanofi Pasteur phase III vaccine trial, cited in the article as Novavax' chief rival, announced disappointing phase III trial results.

https://www.sciencemag.org/news/202...ompany-end-producing-best-coronavirus-vaccine

 

[anethum]

I still think the Novavax vaccine has great potential. As for Shingrix adjuvant, I also had a strong reaction. Spent most of the next day on the sofa.

But virtually no reaction to the second shot. Pharmacist said that's typical so you may want to rethink that second shot.

I had a severe adverse reaction. I lost all hearing in one ear. My hearing degradation & tinnitus began overnight following the shot. Fortunately, I was able to get very prompt treatment with an oral steroid which restored my hearing, but I am stuck with tinnitus permanently. I won't go anywhere near the 2nd Shingrix shot. My primary care doctor also told me not to get the 2nd dose. She was aware, as was I, that according to GSK, a single dose provides 85% protection vs. 95% from both doses.

Did you have any reaction to either of your first 2 Novavax shots? If no reaction, I would guess there's a fair chance you got placebos. Although I wonder if those getting the placebo still receive a shot with the adjuvant, but without the biological component?

 

[kyzymurgist]

Virtually no reaction. Plus a negative on the 99% sensitivity Assure test for IgG antibodies.

Either I'm in the control group or am immunocompromised. Most likely the former given my strong response to the Shingrix shot. Or Novavax is pulling a major scam. Unlikely.

And sorry to hear of your experience with the Shingrix vaccine. Thankfully, that's rare. I hope it eventually resolves.

 

[Boho]

To those who've had serious reactions to the Shingles vaccine or an adjuvant containing Covid vaccine, are you severely allergic to anything else?

 

[sengsational]

Virtually no reaction. Plus a negative on the 99% sensitivity Assure test for IgG antibodies.

Either I'm in the control group or am immunocompromised. Most likely the former given my strong response to the Shingrix shot. Or Novavax is pulling a major scam. Unlikely.

Novavax (the company) doesn't have a great track record, and the technology of making the antigen protein in moth cells is, well, less proven than other technologies. Did they tell you how they got the engineered virus into the moth cells?

 

[anethum]

To those who've had serious reactions to the Shingles vaccine or an adjuvant containing Covid vaccine, are you severely allergic to anything else?

No, I'm not. I want to make clear that my Shingrix adverse reaction was very different from anaphylaxis, which has been reported by a small number of covid vaccine recipients. I continue to get an annual flu vaccine which also has an adjuvant, but a very different one from Shingrix. The Shingrix adjuvant had never been used in a human vaccine before, only animal vaccines. While my hearing loss was a very rare reaction to Shingrix, it was not a unique reaction according to the CDC's VAERS database.

I've had plenty of vaccines during my life and never had an adverse reaction to any of them before or after Shingrix.

My doctor put in my electronic record that I'm "allergic" to Shingrix, but a physician friend of mine told me it's not really an allergy, but that she would have noted it the same way in my record.

 

[Boho]

I'm wondering if anyone experienced unexpected good effects from a vaccine. With an immune system boost from the adjuvant, maybe your body can better fight things in addition to what the vaccine causes. Anyone have a wart go away or something?

 

[harllee]

To those who've had serious reactions to the Shingles vaccine or an adjuvant containing Covid vaccine, are you severely allergic to anything else?

My mother and I have allergies to many things--aspirin, penicillin, many foods, I even break out from PEG which is an ingredient in many vaccines, yet neither of us has ever had any adverse reaction to any vaccines--no reaction to the first Covid vaccine, no reaction to Shingrix, no reaction to flu shots.

 

[explanade]

Novavax (the company) doesn't have a great track record, and the technology of making the antigen protein in moth cells is, well, less proven than other technologies. Did they tell you how they got the engineered virus into the moth cells?

I seem to recall reading that Novavax's candidate had some of the best titers of antibodies and T cells in the Phase 1/2 trials.

 

[kyzymurgist]

I seem to recall reading that Novavax's candidate had some of the best titers of antibodies and T cells in the Phase 1/2 trials.

Yes. Reported much higher antibody response compared to convalescent plasma in phase 1 trial.

Plus they were possibly the only vaccine candidate to report macaque monkey trial results. Complete protection.

I still think Novavax has great potential. Much easier distribution requirements.

But they currently have a real problem with 60+ age trial 2 and 3 participants requesting to be unblinded so they can get the Pfizer or Moderna vaccines now.

DW and I will be contributing to that problem. And when vaccine release phase 2 people (under 60) can get vaccinated, the ongoing trials will face a real challenge. Very unfortunate timing.

 

[kyzymurgist]

Novavax is apparently having a problem with their supply chain. DW and I were scheduled for our 3rd and final injection next week but the vaccines for this phase 2 trial never arrived.

We were originally told that we should not receive any competing vaccine unless and until informed that we are in the control group (which we strongly suspect based on antibody testing).

We qualify next week based on our age so requested to be unblinded. Not sure what changed but DW and I were told to just go ahead and get whatever vaccine is available regardless of what group we are in. Just to let them know.

That's just a bit concerning and seems somewhat unprofessional. Perhaps they learned that there is very little risk with extra dosing of a completely different vaccine. I hope.

 

[harllee]

I just read that Novavax reported their vaccine was only 50% effective in South Africa and 90% effective in the UK so I wonder if they have gone back to the drawing board?

 

[explanade]

I just read that Novavax reported their vaccine was only 50% effective in South Africa and 90% effective in the UK so I wonder if they have gone back to the drawing board?

50% effective vs. the South African strain. Other vaccines are showing less efficacy vs. this strain.

I think they just applied for EUA with the UK agency.

So I would imagine they'd do the same with the FDA soon.

We're suppose to get data from J&J next week.