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.

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.

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.

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.

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.

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

http://forums.pelicanparts.com/uploa...1624926811.jpg
http://forums.pelicanparts.com/uploa...1624926822.jpg

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

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?

"...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.

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.

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

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.

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.

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.

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

Back and forth...

This is the nature of things I reckon...

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.

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.

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.

^^^ Interesting stuff Mahler. Thanks for sharing.

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 ?

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

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.

I don't think I have ever witnessed sooner or later being on any "attack," but I do not spend a lot of time reading all of the threads and posts.

Many here have me beat by a large number in terms of posts.

However I would surmise that few here have as much experience with the regulatory system overseen by FDA.

And how it has evolved...

Somewhere I have an xray of the former CEO of GE Healthcare who came down and got imaged on a prototype digital xray system. I remember wearing my film badge. I did some "student design work" on that system.

I remember when regulatory requirements for SW development for medical equipment was quite simpler than it is today.

Do you folks realize that a tongue depressor is a regulated medical device?

Here is what the US CFR says about them:

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=880.6230

In any case...

"...the inaccuracy in the FDA/Pfizer's characterization of the risk."

I think it is more likely FDA came up with their conclusion based on information, and Pfizer came up with their conclusion based on information. Their conclusions may have been related, different, identical, et cetera.

If this is true, just because some different folks got something published and came to a different conclusion does not mean that either Pfizer or the FDA or both were "inaccurate."

Disagreements happen. Mistakes happen. Products are recalled. Labeling changes. New types of safety risks are identified... "strength" of efficacy changes...

All of these things are inherent in our systems.

And lawyers make money.

And folks benefit from new and improved drugs, vaccines, medical devices and medical equipment each and every hour of each and every day. Globally.

And other folks do not benefit or are actually harmed.

The world is not perfect... humans are part of that!

Fair enough. Thanks.

Speaking of imperfection, I'll chalk it up to a little spillover from another arena ...
Happens.

Now back to this study of the study that Sooner didn't post a link for in this previous reply ...

I'm listening.

ROFLMAO! Thanks for this post. I needed the laugh.

I always enjoy when you share your knowledge and experience for things where you're an SME. Thanks for your posts.

Yep!

post 136.

I linked your study. The study that questioned the methodology of that study that shows risks at half.of your study. And two other studies that showed no additional risk. Mahler also posted one of those 2 links.

Here it is from post 136.
Study about the study above
https://www.thelancet.com/journals/laninf/article/PIIS1473-3099(21)00076-1/fulltext
Here, we offer a different interpretation of their findings and statistical consideration of risks associated with mRNA and non-mRNA SARS-CoV-2 vaccines.

Sooner

That's what I posted !
PIIS1473-3099(21)00076-1

http://forums.pelicanparts.com/uploa...1625103123.jpg

My bad. I posted the wrong link.

Try this one.

I have now corrected the original post.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8184125/

NP

OK the article spells out two points of argument.

First, given the vaccine consists of 2 doses, the Bell's palsy rate per dose is half that per patient aka recipient ... to which my response is well, that's a big fat duh. Comparing the expected rate per recipient (column 1) to the rate per dose (column 3) is a sleight of hand, apples to oranges so to speak, won't you agree ?

http://forums.pelicanparts.com/uploa...1625107665.jpg

The second with regards to extending the time interval from 2 months to 12 weeks from the 1st dose, I will give them that but that doesn't change the conclusion that much namely there being an obvious causation signal here, just reduced to ~2.5 to 5x from 3.5-7x . BTW the placebo matches the expected cases the last time I looked.

http://forums.pelicanparts.com/uploa...1625107774.jpg

I am not saying that any are right or wrong. Some state higher risks while others state no higher risk.

As I said earlier, I would guess it is higher than non vaccinated folks. I would also guess it could be similar to cases in people that were infected. Also, the actual rate in a normal population is estimated in a wide range which can bring in more questions about actual increases in the closely tracked vaccines. That fact is mentioned in the Medpage article. There is far too much difference in the various studies to claim any are definitive.

To me you must look at both sides. Rate vs non vaccinated and rate vs those that have been infected. Eventually, everyone would be infected without the vaccine.

Here is the latest info on Bells palsy after infection. This is the first info I have found making a comparison.
There may be others.. I would hope we see more. Also, the study below could under report actual vaccine cases due to the time frame. Released on 6/24/2021. More info at link.
https://www.medpagetoday.com/infectiousdisease/covid19vaccine/93274

People with COVID-19 were more likely to develop Bell's palsy (peripheral facial nerve palsy) than people who were vaccinated against the virus, an analysis of medical records showed.

Matching COVID-19 patients with vaccinated individuals showed that people with COVID-19 were nearly seven times more likely to have a diagnosis of Bell's palsy than those who were vaccinated (OR 6.8, P<0.001), reported Akina Tamaki, MD, of University Hospitals Cleveland Medical Center, and co-authors in a research letter in JAMA Otolaryngology-Head & Neck Surgery.

When Pfizer-BioNTech and Moderna revealed adverse events in their trials, concerns about Bell's palsy and the vaccines grew, observed C. W. David Chang, MD, of the University of Missouri in Columbia, writing in an invited commentary accompanying the two papers.

"Epidemiologically, linking the vaccine with an adverse event requires accurate estimation of event incidence in association with the vaccine, comparison with a nonvaccinated group, and understanding of the background incidence," he explained.

Historical background rates for safety surveillance offer some context, but come with caveats, Chang added: Many publications cite an incidence of 11.0 to 51.9 per 100,000 person-years, but these rates can vary widely. "Further confounding background rates, the COVID-19 pandemic itself has been theorized to affect the incidence of Bell palsy, with mixed findings," he noted.

Tamaki and co-authors searched a large database of records from 41 healthcare organizations from Jan. 1 to Dec. 31, 2020, to determine the rates of Bell's palsy in patients with a COVID-19 diagnosis. Of 348,088 people with COVID-19, 284 had a Bell's palsy diagnosis within 8 weeks of COVID diagnosis, including 153 people with new-onset Bell's palsy.

"The authors translate this to an 8-week incidence of 82 per 100,000 patients with COVID-19," Chang said. "However, if using a crude analysis and assuming a pre-pandemic rate of 40 per 100,000 person-years and no seasonality, Bell's palsy would be expected to naturally occur in only 21 of 348,088 patients during an 8-week period."

A comparison of patients with 63,551 matched individuals who were vaccinated from Jan. 1 to March 31, 2021, showed that the incidence of Bell's palsy was lower among people who received COVID-19 vaccines.

In the second paper, Shemer and colleagues evaluated the COVID vaccination and facial nerve palsy risk in a case-control study. Israel is a leading country in vaccination rates per capita, exclusively using the Pfizer-BioNTech vaccine. All residents are part of the national digital health registry system.

From Jan. 1 to Feb. 28, 2021, a total of 37 people were admitted to the emergency department of a tertiary referral center in central Israel. Of these, 21 people (56.8%) had received the vaccine. The researchers compared these people with a group of 74 matched controls and found no difference in vaccination rates (59.5%; adjusted OR 0.84, 95% CI 0.37-1.90, P=0.67).

An analysis of the number of patients with acute-onset facial nerve palsy during January and February in the preceding 5 years showed that the volume was about the same, with an average of 26.8 cases from 2015 to 2020. This figure may have been biased by unmeasured factors such as referral patterns, Shemer and co-authors noted.

The mRNA COVID-19 vaccines also showed no higher safety signal for facial paralysis than other vaccines in VigiBase, the World Health Organization pharmacovigilance database, earlier this year.

Underreporting may be a factor in both JAMA Otolaryngology-Head & Neck Surgery studies, Chang noted, explaining that adverse effects of COVID vaccines were studied for only a short period; some patients would not have had 8 weeks of observation after vaccination.

Last Updated June 25, 2021

I'll give you an analogy.

It's generally agreed that cigarette smoking increases the risk of lung cancer. How about we compare the incidence of lung cancer per cigarette over 10 years versus the rate per person in the population over the same 10 years ? That would be asinine, wouldn't it ?

But it's the same line of "reasoning" that rebuttal paper takes.