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Mon Jul 12, 2021, 02:21 PM

FDA to announce new warning on Johnson & Johnson vaccine related to rare autoimmune disorder

Source: Washington Post

The Food and Drug Administration is preparing to announce a new warning for the Johnson & Johnson coronavirus vaccine saying the shot has been linked to a serious but rare side effect — Guillain-Barré syndrome, in which the immune system attacks the nerves, according to four individuals familiar with the situation.

About 100 preliminary reports of Guillain-Barré have been detected after 12.8 million doses of Johnson & Johnson vaccine were administered, the Centers for Disease Control and Prevention said in a statement. These cases have largely been reported about two weeks after vaccination and mostly in men, many aged 50 and older. Available data do not show a pattern suggesting a similar increased risk with the Pfizer-BioNTech and Moderna vaccines, after more than 321 million doses of those vaccines have been administered in the United States. The Guillain-Barré cases will be discussed as part of an upcoming meeting of CDC advisers, the agency said.

Guillain-Barré syndrome usually occurs at a rate of about 60 to 120 cases each week, according to CDC data. While the cause of the syndrome is not fully understood, it often follows infection with a virus, including influenza, or bacteria. Each year in the United States, an estimated 3,000 to 6,000 people develop the illness.

Read more: https://www.washingtonpost.com/health/2021/07/12/johnson-and-johnson-warning/?wpmk=1&wpisrc=al_news__alert-hse--alert-national&utm_source=alert&utm_medium=email&utm_campaign=wp_news_alert_revere&location=alert&pwapi_token=eyJ0eXAiOiJKV1QiLCJhbGciOiJIUzI1NiJ9.eyJjb29raWVuYW1lIjoid3BfY3J0aWQiLCJpc3MiOiJDYXJ0YSIsImNvb2tpZXZhbHVlIjoiNTk2ZDViYWFhZGU0ZTIwN2QyOTZhYmVlIiwidGFnIjoid3BfbmV3c19hbGVydF9yZXZlcmUiLCJ1cmwiOiJodHRwczovL3d3dy53YXNoaW5ndG9ucG9zdC5jb20vaGVhbHRoLzIwMjEvMDcvMTIvam9obnNvbi1hbmQtam9obnNvbi13YXJuaW5nLz93cG1rPTEmd3Bpc3JjPWFsX25ld3NfX2FsZXJ0LWhzZS0tYWxlcnQtbmF0aW9uYWwmdXRtX3NvdXJjZT1hbGVydCZ1dG1fbWVkaXVtPWVtYWlsJnV0bV9jYW1wYWlnbj13cF9uZXdzX2FsZXJ0X3JldmVyZSZsb2NhdGlvbj1hbGVydCJ9.qTGCvc2H8GNOx--pYNX5S-ocTJmiGofQL2p7ZoWYqSs

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Reply FDA to announce new warning on Johnson & Johnson vaccine related to rare autoimmune disorder (Original post)
former9thward Jul 12 OP
JohnSJ Jul 12 #1
womanofthehills Jul 12 #2
JohnSJ Jul 12 #3
PoindexterOglethorpe Jul 12 #4
NH Ethylene Jul 12 #6
PoindexterOglethorpe Jul 13 #11
NH Ethylene Jul 13 #14
summer_in_TX Jul 12 #5
NH Ethylene Jul 12 #7
summer_in_TX Jul 12 #10
PoindexterOglethorpe Jul 13 #12
samplegirl Jul 12 #8
summer_in_TX Jul 12 #9
samplegirl Jul 13 #13

Response to former9thward (Original post)

Mon Jul 12, 2021, 03:09 PM

1. Guillain-Barr Syndrome is a rare potential issue with all traditional vaccines. Read the consent

form

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Response to JohnSJ (Reply #1)

Mon Jul 12, 2021, 03:27 PM

2. Guillain-Barr is usually one in a million in childhood vaccines

So if it was similar to earlier vaccines we would only have 12 cases not 100 cases.

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Response to womanofthehills (Reply #2)

Mon Jul 12, 2021, 03:32 PM

3. Exactly. Reporting this without context is fodder for the anti-vaxers to jump on social media

platforms and distort


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Response to former9thward (Original post)

Mon Jul 12, 2021, 04:31 PM

4. So it looks as if the risk for getting Guillain-Barr

after a vaccine is even smaller than the risk of getting it anyway. The numbers cited in the article are hard to figure out. If 60 to 120 cases occur every single week anyway, than 100 after 12.8 million doses of the J&J vaccine is hardly any.

I feel as if reporting these kinds of things isn't at all helpful and only tends to encourage people not to get the vaccine.

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Response to PoindexterOglethorpe (Reply #4)

Mon Jul 12, 2021, 07:59 PM

6. They must mean above and beyond the regular background rate.

We have the right to know about side effects and the more information that is available, the safer we should feel that nothing is being hidden. The fact that anti-vaccers will use this to bolster their arguments should not deter us from doing what is right.

In fact I think we should have inoculated the public by talking about how all vaccines have potential side effects before the vaccines were released.

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Response to NH Ethylene (Reply #6)

Tue Jul 13, 2021, 01:58 AM

11. But the information posted does not make that even remotely obvious.

Earlier today I was listening to an ad for Shingrix, the vaccine that protects against shingles. It mentioned an increased risk for Guillain-Barre. Hmmm. So other vaccines are also a risk factor. Well, well, well.

In reality, the risk is miniscule, compared to the risks of not getting the vaccine.

I got Shingrix recently, in no small part because my older brother has gotten shingles, as well as my younger son when he was only 20, far too young to get a vaccine.

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Response to PoindexterOglethorpe (Reply #11)

Tue Jul 13, 2021, 10:10 AM

14. You're right. The article doesn't clarify that.

And it seems like that can't have been how they discerned this, given its rarity, which is demonstrated by this quote from the article: ". . . people who received the 1976 swine flu vaccine had an increased risk of Guillain-Barré, with about one additional case for every 100,000 people who received the swine flu vaccine."

I did find this quote, which shows what may have tipped them off: "The cases, which were from England and India, involved an unusual variant of the disease that caused severe facial weakness." Also, they noted the pattern of it occurring about 2 weeks after the vaccine.

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Response to former9thward (Original post)

Mon Jul 12, 2021, 06:26 PM

5. My brother-in-law had a bad case of Guillen-Barr Syndrome ten years ago.

Paralysis begins at the feet, then creeps up the body. His came on days after he did a 30 mile bike ride. He was a fit man of about 56 then but with underlying health problems.

At its worse his eyelids were paralyzed – open. Drops had to be used to moisten his eyeballs constantly to keep from permanent damage there. It gradually reversed itself so he was no longer paralyzed. He was left with neuropathy since the autoimmune disease attacks the myelin sheath. He was in the hospital and rehab for about six months. Then a wheelchair and rehab through home health.

He never regained easy mobility although he can walk now with difficulty, using a cane. He has become a very bitter man. My husband took Family Medical Leave to take care of him. A series of bad decisions left him without a home to live in on his own and a squandered small nest egg. He blames his brother and they are now estranged.

Sad stuff.

There is no preventive vaccine for Guillen-Barré Syndrome.

For my family that would be a deal-breaker. We've seen the damage the syndrome can do. We know a healthy young adult who got it and recovered within weeks without a huge lasting after-effect so it has a range of effects. I realize it's rare. But that is one nasty disease.

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Response to summer_in_TX (Reply #5)

Mon Jul 12, 2021, 08:01 PM

7. That sounds devastating.

It's one thing to know the odds are minuscule; it's quite another to be that one in a million person who gets a bad case.

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Response to NH Ethylene (Reply #7)

Mon Jul 12, 2021, 09:58 PM

10. Yes.

As for rare, I know two people personally (one is a mere acquaintance, but still). Not as rare as I would like.

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Response to summer_in_TX (Reply #5)

Tue Jul 13, 2021, 02:01 AM

12. A cousin got Guillain-Barre back in the mid-1950s.

He was originally diagnosed with polio, even though he, and everyone around him had gotten the Salk vaccine by then. So I know how devastating Guillain-Barre can be. Cousin Ricky lived with many constrictions on his life and mobility for the rest of his life.

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Response to former9thward (Original post)

Mon Jul 12, 2021, 09:25 PM

8. I'm a Guillain Barre survivor from back

In 1978 and I was on a vent 3 months in intensive care. Then to a rehab for another 11 weeks to learn how to use everything all over again.

I got the Maderna shot.

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Response to samplegirl (Reply #8)

Mon Jul 12, 2021, 09:57 PM

9. So glad you recovered.

My BIL dealt with pain and addiction, depression, etc. Thank goodness it was the Moderna one.

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Response to summer_in_TX (Reply #9)

Tue Jul 13, 2021, 06:44 AM

13. It was a long road back

I still suffer with my hands and feet from it.
Some people never recover. I was lucky I was 29 years old.

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