CDC will monitor for Bell’s palsy among Pfizer vaccine recipients, but sees no causal relationship

Becky1951

Becky1951

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CDC will monitor for Bell’s palsy among Pfizer vaccine recipients, but sees no causal relationship

The U.S. federal government will continue to monitor occurrences of Bell's palsy — a partial paralysis in the face — among people who receive Pfizer's Covid-19 vaccine after four cases were reported among trial participants, though the vaccine doesn't appear to cause the condition.

Dr. Sara Oliver, an officer at the Centers for Disease Control and Prevention, said during the agency's Advisory Committee on Immunization Practices on Friday that there is "no known or expected causal relationship between the vaccine and Bell's palsy." The ACIP develops recommendations on how to use vaccines to control diseases in the United States, according to the CDC.

"Post authorization safety and effectiveness studies will be critical as well. Specifically, surveillance for Bell's palsy could help determine any possible causal relationship," Oliver said.

U.S. officials plan to continue watching for any adverse reactions to Pfizer's vaccine in the health-care workers and nursing home residents who receive it, Dr. Nancy Messonnier, director of the CDC's National Center for Immunization and Respiratory Disease, said during a meeting of the Food and Drug Administration Thursday.

Officials will use a text-messaging system, called v-safe, which is intended to provide early indications about possible adverse reactions from the vaccines.

Bell's palsy is a sudden freezing or weakness in a person's facial muscles, and for most people it's temporary, according to the Mayo Clinic. A member of the group on the ACIP call Friday confirmed that there were four cases of "facial paralysis" among those who received the vaccine. One of the participants experienced the paralysis as soon as three days after the dose while another recipient experienced paralysis as late as 48 days after inoculation.

The four cases of Bell's palsy among vaccine recipients were considered to be "consistent with the expected background rate in the general population" and "there is no clear basis upon which to conclude a causal relationship at this time," the FDA said in its briefing documents before its Vaccines and Related Biological Products Advisory Committee meeting Thursday.

During the meeting on Thursday, FDA vaccine reviewer Dr. Susan Wollersheim noted the trial data showed a "numerical imbalance" in cases of Bell's palsy.

Wollersheim said there were four cases in the vaccine group and none in the placebo group. While the frequency of cases was not above that of the general population, the FDA recommended further surveillance if the vaccine is authorized for broader use.

The VRBPAC on Thursday voted 17 to 4 with one abstention to recommend the vaccine, which the company developed alongside BioNTech, for emergency authorization. The FDA is expected to grant Pfizer's coronavirus vaccine emergency authorization at any moment following the recommendation.

https://www.cnbc.com/2020/12/11/cdc...e-recipients-sees-no-causal-relationship.html
 

I can't say that I buy into the idea of... "The four cases of Bell's palsy among vaccine recipients were considered to be "consistent with the expected background rate in the general population" and "there is no clear basis upon which to conclude a causal relationship at this time," the FDA said in its briefing documents before its Vaccines and Related Biological Products Advisory Committee meeting Thursday".
 
This is just what has happened so far with only the with the trial participants.

Until a few months goes by we and they won't know for sure what effects it will have on those getting the vaccine..That's why I'm waiting to take it.
 
Becky1951 said:
Aunt Marg, it doesn't seem to be so nonchalantly common does it?
Research it, even though it mostly goes away after treatment, some are left with life long facial paralysis.

Bell's palsy affects about 40,000 people in the United States every year.Oct 2, 2020
https://www.ninds.nih.gov › Disorders

Bell's Palsy Fact Sheet | National Institute of Neurological Disorders and Stroke​

Click to expand...
You said it, Becky.

I had a great uncle that suffered an episode of Bells Palsy, with my aunt saying it came on "just like that, and fast", leaving my uncles face distorted with one eye that always watered. It never went away.

It broke my heart to know my uncle used to breakdown in tears because of his looks afterwards.
 
Tish said:
Oh gosh, I swear the more I hear about the side effects of these vaccines the more I am thinking of not getting one.
Between The HIV false positives in the Queensland trials and now this.
Sometimes ignorance is indeed bliss.
Click to expand...
A friend of mine had Bell's Palsy and a relative also. Nasty.
 
chic said:
They recovered. But it's tough for women because it really is disfiguring and takes a while to subside.
Click to expand...
They're so lucky.

I know a few people who got Bells Palsy, and only one recovered, the rest wear permanent facial paralysis/deformities.

I agree, I would say it's always harder for a woman, too.
 
I just googled this subject and found this, by the Poynter Institute:


Social media has seen an uptick in anti-vaccination claims as the Pfizer-BioNTech coronavirus vaccine moves closer to emergency use in the U.S.

Some Facebook users amplified a single data point in an FDA briefing document on the vaccine: Four of the vaccinated trial participants in a clinical study developed Bell’s Palsy, a form of temporary facial paralysis.

The post features a screenshot of the FDA document and a photo of three people purported to have Bell’s Palsy. This photo does not actually depict people involved in the coronavirus vaccine trial. It dates back to at least 2019.

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This post was flagged as part of Facebook’s efforts to combat false news and misinformation on its News Feed. (Read more about our partnership with Facebook.)

The post does contain some accurate information. Four people vaccinated with the coronavirus vaccine did develop Bell’s Palsy, according to the FDA, and the agency has recommended "surveillance" for cases of Bell’s Palsy as larger groups of people are vaccinated.

However, posts like these mislead by seeming to imply that the Pfizer vaccine caused Bell’s Palsy. So far, there’s no evidence of a direct link.

First, four people out of 22,000 in the vaccinated group developed Bell’s Palsy, about 0.02% of participants. According to the FDA, this is "consistent with the expected background rate in the general population" and there is "no clear basis upon which to conclude a causal relationship at this time."

Paul Offit, director of the Vaccine Education Center at the Children's Hospital of Philadelphia, told us that many vaccine studies unearth correlations that end up not being causally related to the vaccine.

"It’s the problem with taking small numbers out of a large database," said Offit, who was a member of the advisory panel of independent experts that recommended the FDA greenlight the vaccine for emergency use authorization.

As an example, Offit cited a clinical trial that tested the safety of heplisav-B, a hepatitis vaccine. According to Offit, researchers initially found that small numbers of heart attacks had occurred among vaccinated individuals while none had occurred in a placebo group. However, follow-up studies that looked at even larger numbers of people found no correlation between that vaccine and heart attacks.

What’s more, Offit said, the same study of heplisav-B found that some individuals in the placebo group were diagnosed with prostate cancer, while none were diagnosed in the vaccinated group. "You could conclude that the vaccine prevented prostate cancer because it was a statistically significant correlation, but that would be wrong," Offit said.

With the advisory committee’s recommendation in hand, the FDA is likely to authorize the vaccine for emergency-use, a special provision allowing the use of a product during a public health crisis before it is formally approved by the agency.

A vaccine granted an emergency use authorization differs from an FDA-approved vaccine in that for emergency authorization, "the totality of scientific evidence" must make it "reasonable to believe that the product may be effective." For official approval, vaccines must demonstrate "substantial evidence" of efficacy and proof of safety.

Vaccines that are granted an emergency use authorization still go through a rigorous review process, including all phases of clinical trials.
 
Sunny said:
I just googled this subject and found this, by the Poynter Institute:


Social media has seen an uptick in anti-vaccination claims as the Pfizer-BioNTech coronavirus vaccine moves closer to emergency use in the U.S.


Some Facebook users amplified a single data point in an FDA briefing document on the vaccine: Four of the vaccinated trial participants in a clinical study developed Bell’s Palsy, a form of temporary facial paralysis.


The post features a screenshot of the FDA document and a photo of three people purported to have Bell’s Palsy. This photo does not actually depict people involved in the coronavirus vaccine trial. It dates back to at least 2019.

Ad Choices
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Sponsored Content

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By GSK

This post was flagged as part of Facebook’s efforts to combat false news and misinformation on its News Feed. (Read more about our partnership with Facebook.)


The post does contain some accurate information. Four people vaccinated with the coronavirus vaccine did develop Bell’s Palsy, according to the FDA, and the agency has recommended "surveillance" for cases of Bell’s Palsy as larger groups of people are vaccinated.


However, posts like these mislead by seeming to imply that the Pfizer vaccine caused Bell’s Palsy. So far, there’s no evidence of a direct link.


First, four people out of 22,000 in the vaccinated group developed Bell’s Palsy, about 0.02% of participants. According to the FDA, this is "consistent with the expected background rate in the general population" and there is "no clear basis upon which to conclude a causal relationship at this time."


Paul Offit, director of the Vaccine Education Center at the Children's Hospital of Philadelphia, told us that many vaccine studies unearth correlations that end up not being causally related to the vaccine.


"It’s the problem with taking small numbers out of a large database," said Offit, who was a member of the advisory panel of independent experts that recommended the FDA greenlight the vaccine for emergency use authorization.


As an example, Offit cited a clinical trial that tested the safety of heplisav-B, a hepatitis vaccine. According to Offit, researchers initially found that small numbers of heart attacks had occurred among vaccinated individuals while none had occurred in a placebo group. However, follow-up studies that looked at even larger numbers of people found no correlation between that vaccine and heart attacks.


What’s more, Offit said, the same study of heplisav-B found that some individuals in the placebo group were diagnosed with prostate cancer, while none were diagnosed in the vaccinated group. "You could conclude that the vaccine prevented prostate cancer because it was a statistically significant correlation, but that would be wrong," Offit said.


With the advisory committee’s recommendation in hand, the FDA is likely to authorize the vaccine for emergency-use, a special provision allowing the use of a product during a public health crisis before it is formally approved by the agency.


A vaccine granted an emergency use authorization differs from an FDA-approved vaccine in that for emergency authorization, "the totality of scientific evidence" must make it "reasonable to believe that the product may be effective." For official approval, vaccines must demonstrate "substantial evidence" of efficacy and proof of safety.


Vaccines that are granted an emergency use authorization still go through a rigorous review process, including all phases of clinical trials.
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Even if there was a link that the Pfizer Vaccine caused Bell's Palsy, such information would not be released, it would simply be downplayed, lied about, and quietly quashed before it gained momentum and traction.
 
Great, having had Bells Palsy twice, five years apart I certainly don’t want it again

Fortunately I was diagnosed quickly, given an intense course of steroids and left with no lasting effects, unlike some poor sufferers
 
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Aunt Marg said:
Even if there was a link that the Pfizer Vaccine caused Bell's Palsy, such information would not be released, it would simply be downplayed, lied about, and quietly quashed before it gained momentum and traction.
Click to expand...
What makes you think that, Marg? If there was a link between the vaccine and any illness/syndrome, why would it be downplayed, lied about, etc.? That is not how science works. And without knowing anything about the Poynter Institute, it sounds like a fair-minded group of fact finders, who are simply telling it like it is.

Scientists are not bad guys. They are not out to get us all killed or disfigured, no matter what you have been told.

Jeez.
 
"Scientists are not bad guys. They are not out to get us all killed or disfigured, no matter what you have been told."

I've never thought scientists were out to harm humans.

However with the rush to develop a vaccine, and not enough time to have witnessed an array of symptoms possible, or effects later on, harm may very well occur.
 
Wren said:
Great, having had Bells Palsy twice, five years apart I certainly don’t want it again

Fortunately I was diagnosed quickly, given an intense course of steroids and left with no lasting effects, unlike some poor sufferers
Click to expand...
What caused yours @Wren? I'm happy you recovered quickly.
 
Sunny said:
What makes you think that, Marg? If there was a link between the vaccine and any illness/syndrome, why would it be downplayed, lied about, etc.? That is not how science works. And without knowing anything about the Poynter Institute, it sounds like a fair-minded group of fact finders, who are simply telling it like it is.

Scientists are not bad guys. They are not out to get us all killed or disfigured, no matter what you have been told.

Jeez.
Click to expand...
No, scientists are not out to get anyone killed or disfigured.
But they are out of make back the millions they invested on the vaccine race before they can profit. Naturally, they'd have to downplay any obstacles to that.
 
chic said:
What caused yours @Wren? I'm happy you recovered quickly.
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Thank you Chic, mine could have been caused by stress, but the first time I had also been out walking in cold, windy weather, it’s very frightening, I thought I’d had a stroke but when it reoccurred five years later, I recognised the symptoms

The following report from Health central is interesting, especially the last sentence !

‘The cause of the nerve irritation associated with Bell’s palsy is unknown. Anecdotally, exposure to cold is a frequently cited cause – for example, driving with a car window open in frigid weather, or sleeping with the window open on a chilly night. This association remains speculative. Some evidence suggests that the cause is inflammation of cranial nerve VII triggered by a viral infection, perhaps in the herpes family. The risk increases through the first 30 years of life, remains steady until approximately 70 years, then increases further. People with diabetes or high blood pressure, as well as pregnant women, are at slightly greater risk, but most patients are ordinary people with no known predisposing factors. Some cases have recently been reported after administration of intranasal influenza vaccine’
 
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Wren said:
Thank you Chic, mine could have been caused by stress, but the first time I had also been out walking in cold, windy weather, it’s very frightening, I thought I’d had a stroke but when it reoccurred five years later, I recognised the symptoms

The following report from Health central is interesting, especially the last sentence !

‘The cause of the nerve irritation associated with Bell’s palsy is unknown. Anecdotally, exposure to cold is a frequently cited cause – for example, driving with a car window open in frigid weather, or sleeping with the window open on a chilly night. This association remains speculative. Some evidence suggests that the cause is inflammation of cranial nerve VII triggered by a viral infection, perhaps in the herpes family. The risk increases through the first 30 years of life, remains steady until approximately 70 years, then increases further. People with diabetes or high blood pressure, as well as pregnant women, are at slightly greater risk, but most patients are ordinary people with no known predisposing factors. Some cases have recently been reported after administration of intranasal influenza vaccine’
Click to expand...
Thanks very much @Wren. I appreciate this. My cousin was in her thirties when she got it and she never got it again, but she couldn't work while she had it because she was a teacher and the kids would've given her a hard time over the way she looked 'm sure. Kids being kids. I don't know if my friend ever got it again. We were in a discussion group, but I left it years ago due to a busy schedule. It's helpful to know this info.
 
Pleased to hear your cousin didn’t get it again Chic, but God, I would rather have died than gone to work, when I had Bells Palsy I didn’t set foot outside my door (and only let a few set foot inside it) !

I had to wear an eye patch, use a straw for drinks and felt like Quasimodo when I tried to eat,
also had to use Artificial tears, and remember saying to my daughter ‘who would’ve thought I’d ever need fake tears’ ......😲
 
Becky1951 said:
"Scientists are not bad guys. They are not out to get us all killed or disfigured, no matter what you have been told."

I've never thought scientists were out to harm humans.

However with the rush to develop a vaccine, and not enough time to have witnessed an array of symptoms possible, or effects later on, harm may very well occur.
Click to expand...

Absolutely true, Becky, and that's why new vaccines have to be monitored very carefully.

But the post I was responding to accused scientists who discover a medication's bad side effects of "lying, downplaying, and quashing the information" about Bell's palsy... in other words, lying to the public for some nefarious reason. That is where I take exception. The scientists are like some mad villains in a horror movie who are either 1) out to do harm to the public, or 2) so greedy that they lie about the results of their research? (BTW, I doubt that it's the scientists who get rich off a successful vaccine or medication, but that's another issue.)

Here's another thought: four people out of 22,000 got Bell's palsy? Is this number even significant? Sounds like a pretty tiny percentage to me. I'm sure it was very unpleasant, or maybe even tragic, for those four people, but wouldn't that percentage be vulnerable to getting Bell's palsy anyway? Or any number of other diseases that no one would want to get? Where is the causal connection between the vaccine and the palsy?

Of course, it has to be looked into, along with any other suggestions that the vaccine causes this or that. But accusing the scientific community of all those evil shenanigans is just totally ridiculous. That is what I was responding to.
 
Wren said:
Thank you Chic, mine could have been caused by stress, but the first time I had also been out walking in cold, windy weather, it’s very frightening, I thought I’d had a stroke but when it reoccurred five years later, I recognised the symptoms

The following report from Health central is interesting, especially the last sentence !

‘The cause of the nerve irritation associated with Bell’s palsy is unknown. Anecdotally, exposure to cold is a frequently cited cause – for example, driving with a car window open in frigid weather, or sleeping with the window open on a chilly night. This association remains speculative. Some evidence suggests that the cause is inflammation of cranial nerve VII triggered by a viral infection, perhaps in the herpes family. The risk increases through the first 30 years of life, remains steady until approximately 70 years, then increases further. People with diabetes or high blood pressure, as well as pregnant women, are at slightly greater risk, but most patients are ordinary people with no known predisposing factors. Some cases have recently been reported after administration of intranasal influenza vaccine’
Click to expand...
My sister had Bell's Palsy during her first pregnancy but not her second.
 
chic said:
Thanks very much @Wren. I appreciate this. My cousin was in her thirties when she got it and she never got it again, but she couldn't work while she had it because she was a teacher and the kids would've given her a hard time over the way she looked 'm sure. Kids being kids. I don't know if my friend ever got it again. We were in a discussion group, but I left it years ago due to a busy schedule. It's helpful to know this info.
Click to expand...
That sounds just awful. No wonder you wish to avoid it again. My friend from the discussion group stopped wearing makeup and explained to everyone right away why she looked the way she did. It is pretty bad. You have to see someone with it to fully understand. Thanks so much for sharing your experience.
 

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