mRNA vaccine inventor speaks out, YouTube deletes video discussing risks

[cockerpunk]

Originally Posted by onewhippedpuppy

I know you seem averse to doing any meaningful research CP, but I’m not doing it for you. Especially something simple like a vaccine on average taking about 5 years to be approved.

The vaccine doesn’t work against the new variants but get the vaccine and it all goes away. Lol. Sorry buddy but this isn’t going away anytime soon. We have had a flu vaccine for decades and many years it is about 50% effective due to the many variants of the flu. The vaccines can’t stop them all so doctors make an educated guess as to which ones will be more prevalent, sometimes they guess better than others. The flu is a form of coronavirus, the behaviors between the flu and CV19 are very similar. This will go away when people shut off the tv and media BS and go back to living life again.

the vaccine is effective against all known variants, SO FAR. eventually, if covid19 is allowed to spread unchecked in large numbers of people, its only a matter of time until (like the flu), a new variant comes out that the vaccine does not protect against. in which case we will have to do more lockdowns and masks etc.

for claiming someone else needs to do their research, that seems like an obvious one to miss.

[Mahler9th]

I don't think the term "experimental" has anything to do with the FDA category called Emergency Use Authorization.

The term can be used by anyone when it comes to FDA-regulated products, and for any reason. But the regulations and laws are pretty clear, and of course they evolve over time.

FDA-required labeling for medical equipment, medical devices, drugs, vaccines, et cetera is all in public domain, and of course there are regulations with respect to marketing and advertising materials, directions for use and packaging and all of that.

Labeling of course includes information about intended use, directions for use, and so on.

And labeling can change throughout a product's commercial life.

None of this is new, and none of it a mystery.

One might ask, for example:

"What additional or different information (if any) will/has Pfizer presented to FDA for licensure of its covid vaccine, as compared to what was provided to achieve EUA status?"

I am sure answers are in the public domain if one wants to learn more.

[flipper35]

Originally Posted by onewhippedpuppy

Big tech censorship? That would NEVER happen! Obviously this doctor needs to consult real experts like Bill Gates.

I don’t know a single person who has died of CV. I know plenty of people that have tested positive and a handful that have had flu like symptoms that resolved on a few days. I know far more people who became seriously ill after being vaccinated. One of my sister in law’s neighbors died 24 hours after receiving his from blood clots. Nope.

I know 2 people that died from COVID 19 and one is on permanent disability (they originally thought only 18 months) after 6 weeks on a ventilator and he is only 22 years old. That said, all of my family had it and only one member was hospitalized with kidney issues but he had underlying health issues.

[Mahler9th]

I just skimmed this article:

https://blog.petrieflom.law.harvard.edu/2021/06/15/whats-the-difference-between-vaccine-approval-bla-and-authorization-eua/

It has links to related FDA guidance documents for those who wish to learn more details.

[Mahler9th]

Pfizer:

https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-initiate-rolling-submission-biologics

Most folks would be absolutely astounded by the legal/regulatory details involved with all of this.

[pmax]

Originally Posted by drcoastline

'The government is not being transparent with us about what those risks are,' said Dr. Robert Malone
...

This is on topic, government transparency.

From the CDC/FDA as of today...
https://www.cdc.gov/vaccines/covid-19/info-by-product/pfizer/reactogenicity.html#18-unsolicited-adverse-events

"Bell’s palsy was reported by four vaccine recipients and none of the placebo recipients.

The observed frequency of reported Bell’s palsy in the vaccine group is consistent with the background rate in the general population, and there is no basis upon which to conclude a causal relationship."

Here's a published paper ...

https://www.thelancet.com/pdfs/journals/laninf/PIIS1473-3099(21)00076-1.pdf




IMO Bell's palsy is the next warning label to be added.

[Skillet83]

Originally Posted by sugarwood

Mercola is a known snake oil con artist who has been warned of selling scam health cures.
Of course, it's nothing more than a coverup by the evil mind control blood-drinking Baby raping lizard Cabal of Satan-worshiping pedophiles of the government !

https://quackwatch.org/11ind/mercola/

Dude, you have issues. Who knew Vitamin D, C etc... were snake oil. I see where you are trying to go, not gonna happen with me. Why are the left wing nuts so angry?

[Mahler9th]

"...government transparency."

In my experience, transparency or lack thereof might be considered differently from the likely fact that even amongst experts, there can be disagreement.

I remember attending the FDA advisory panel hearing for a new type of medical equipment for which I had US commercialization responsibility when I was 27. Quite a while ago.

We had spent $$$ on the trials, worked with top doctors and teaching hospitals, et cetera. Lots of highly-paid consultants. Our company was a big European player.

The same day the panel heard the presentation from a Costa Mesa-based US start up that I think was already publicly traded-- slightly different technology. Second tier docs, poor data, some deaths, et cetera.

The panel advised FDA to grant their PMA but not ours. I remember the speculators running to the pay phones 'cause the market was still open.

Our scientific, healthcare and regulatory system includes opportunities for disagreement, et cetera. I think that is good.

[Z-man]

Originally Posted by pmax

This is on topic, government transparency.

From the CDC/FDA as of today...
https://www.cdc.gov/vaccines/covid-19/info-by-product/pfizer/reactogenicity.html#18-unsolicited-adverse-events

"Bell’s palsy was reported by four vaccine recipients and none of the placebo recipients.

The observed frequency of reported Bell’s palsy in the vaccine group is consistent with the background rate in the general population, and there is no basis upon which to conclude a causal relationship."

Here's a published paper ...

https://www.thelancet.com/pdfs/journals/laninf/PIIS1473-3099(21)00076-1.pdf




IMO Bell's palsy is the next warning label to be added.

The wife of my colleague's wife was diagnosed with Bell's Palsy just last week - never had any symptoms prior to getting the Pfizer shot. The doctor's expect a full recovery, but they do attribute the onsite to the vaccine. She got the jab about 2 months ago.

[pmax]

Originally Posted by Z-man

The wife of my colleague's wife was diagnosed with Bell's Palsy just last week - never had any symptoms prior to getting the Pfizer shot. The doctor's expect a full recovery, but they do attribute the onsite to the vaccine. She got the jab about 2 months ago.

Wow, 2 months is a long "incubation" if that's what it is.

[pmax]

Originally Posted by Mahler9th

"...government transparency."

In my experience, transparency or lack thereof might be considered differently from the likely fact that even amongst experts, there can be disagreement.

I remember attending the FDA advisory panel hearing for a new type of medical equipment for which I had US commercialization responsibility when I was 27. Quite a while ago.

We had spent $$$ on the trials, worked with top doctors and teaching hospitals, et cetera. Lots of highly-paid consultants. Our company was a big European player.

The same day the panel heard the presentation from a Costa Mesa-based US start up that I think was already publicly traded-- slightly different technology. Second tier docs, poor data, some deaths, et cetera.

The panel advised FDA to grant their PMA but not ours. I remember the speculators running to the pay phones 'cause the market was still open.

Well, the FDA approved that Alzheimer drug so ...

Our scientific, healthcare and regulatory system includes opportunities for disagreement, et cetera. I think that is good.

The scientific disagreements, absolutely. As you hinted somewhat if I read it correctly, the behind the scenes promotion lobbying activities and the money involved can skew the outcome. Even apart from that, when it comes to overall public healthcare, it's oftentimes a subjective decision. In the Bell's palsy case however, someone in the FDA got the math wrong as far as I can tell.

[Mahler9th]

In my experience, FDA does not generally "get math wrong."

Too many people involved....

And of course, FDA and the manufacturer are separate.

Doubtful any Pfizer lawyer would sign off on anything sketchy.

This is all very fluid and humankind will continue to learn.

Perhaps without any vaccines, humankind would learn in parallel with more hospitalizations, deaths, and folks with long term health issues due to Covid.

Folks can speculate about that of course, and such speculation will go on for decades...

As far as Bell's Palsy goes... I have not done any reading, so I do not know if some envisioned physiologic response to any of the authorized Covid vaccines could create a pathway to that condition.

I would surmise that my good friend with 20+ years of running clinical affairs in the vaccine space might have some experience with a range of reactogenicity expectations even with the newer Covid vaccines.

Not gonna bother her about this...

My personal belief is that we will learn more, and that challenges with correlation versus cause and effect will exist as long as there are humans to consider the challenges.

[Mahler9th]

I vaguely remember that one of my large company employers may have faced a lawsuit from a "psychic" who claimed she lost her abilities when she got a CAT scan using one of our machines.

Ionizing radiation can be dangerous.

[Mahler9th]

https://jamanetwork.com/journals/jamaotolaryngology/fullarticle/2781367

Back and forth...

This is the nature of things I reckon...

[pmax]

Yes, not the math per se but what goes into the formula in this case where the time interval used to calculate the expected rates are different. Have a look when free, I'm interested in what you find.

Yeah, radiation therapy machines can be dangerous ... particularly when the software driving it's buggy Not totally unfounded, it is the price we pay.

[Sooner or later]

If one were to do a search for "Bell’s palsy and SARS-CoV-2 vaccines" one would find several more recent studies that show far lower risk than the one earlier study that was posted. One study speaks directly about the early study and says they overestimated the risk. Other later studies show no difference. Amazing that the study with the highest rate was the one that was posted.

Earlier study
https://www.thelancet.com/journals/laninf/article/PIIS1473-3099(21)00076-1/fulltext
Therefore, the observed incidence of Bell's palsy in the vaccine arms is between 3·5-times and 7-times higher than
would be expected in the general population

Study about the study above
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8184125/
Here, we offer a different interpretation of their findings and statistical consideration of risks associated with mRNA and non-mRNA SARS-CoV-2 vaccines.

Given this, and considering Bell's palsy as the possible outcome of individual doses, the observed incidence in the mRNA vaccine trials would be roughly 1·5 to three times higher than in the general population (table).

https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2779389
When compared with other viral vaccines, mRNA COVID-19 vaccines did not display a signal of facial paralysis

https://jamanetwork.com/journals/jamaotolaryngology/fullarticle/2781367
Association of COVID-19 Vaccination and Facial Nerve Palsy

Conclusions and Relevance In this case-control analysis, no association was found between recent vaccination with the BNT162b2 vaccine and risk of facial nerve palsy.

If we were to do a search of Bell's palsy and flu vaccine we can find similar differences in various studies. Some show no difference. A few show a higher incident rate, though more research needed.

There are also cases of Bell's palsy that have been associated with the disease itself.

I would not be surprised if the vaccines increase risk of Bell's palsy when compared to an unvaccinated group. I would also not be surprised if Bell's palsy in vaccinated groups is similar in rate to disease infected people.

[Mahler9th]

CAT scanners are not radiation therapy machines, they are medical imaging machines. Decades ago I was part of the systems engineering team on GE's second generation whole body CAT scanner as it was in its later stages just before commercialization.

I was just a summer engineering student... I was really there to learn.

Years later I had global biz responsibilities for the same machine...

When I was with the employer that, if I recall correctly had a potential legal exposure from a patient/psychic, our radiation therapy folks got into hot water with FDA. They were in Concord, CA if I recall correctly, and there was some tension. Again this was decades ago.

I remember that was a bit of a backdrop when we were trying for FDA PMA on my machine...

Radiation therapy has likely come a long way since I first became acquainted with the technology in the late 70's...

.. the world is small...

I know a Porsche fanatic/racer that has a degenerative condition that I think is a result of old and poorer RT tech. Great man, loves Porsches and racing. Uses hand controls.

[pmax]

^^^ Interesting stuff Mahler. Thanks for sharing.

Originally Posted by Sooner or later

If one were to do a search for "Bell’s palsy and SARS-CoV-2 vaccines" one would find several more recent studies that show far lower risk than the one earlier study that was posted. One study speaks directly about the early study and says they overestimated the risk. Other later studies show no difference. Amazing that the study with the highest rate was the one that was posted.

Bad form Stooner to be on the attack and barking up the wrong tree to boot ... realize that .... no .... whether the vaccine causes Bell's palsy is not the main thread of discussion though I will confess to the aside, consequently the rest of your post, haven't dug into them yet but I will later, is irrelevant in that context.

My previous post pertains to what was reported by the FDA, as is relevant to the government transparency topic, based on the results of the trials which was done at that time and the concomitantly published study by independent scientists based on the same results which points out the inaccuracy in the FDA/Pfizer's characterization of the risk.

See the difference ?

[Sooner or later]

Originally Posted by pmax

^^^ Interesting stuff Mahler. Thanks for sharing those anecdotes.



Bad form Stooner to be on the attack and barking up the wrong tree to boot ... realize that .... no .... whether the vaccine causes Bell's palsy is not the main thread of discussion though I will confess to the aside, consequently the rest of your post, interesting but haven't dug into them yet but I will later, is irrelevant in that context.

My previous post pertains to what was reported by the FDA, as is relevant to the government transparency topic, at that time based on the results of the trials which was done at that time and the concomitant published study by independent scientists which points out the inaccuracy in the FDA/Pfizer's characterization of the risk.

See the difference ?

And there is a study that questions the accuracy of the information in the study you posted.

[pmax]

And no, to be clear if it's not yet clear to you, I didn't handpick the study from a group of studies in an attempt to mislead.

The time interval switcheroo is there which impacts the expected number of cases and hence the conclusion.