FDA to warn on potential Johnson & Johnson COVID-19 vaccine link to rare disorder, report says

[libertybele]

No surprises here. Some in here will sit and argue that the occurrence of any side effect from the vaccines are rare ... let's see; death, endocarditis, a 12 year old winding up in a wheelchair, etc., and now Guillain-Barre occurring. IMHO these are some of the immediate rare side effects being seen ... I'm afraid that soon, the long term side effects will start to roll in. 

FDA to warn on potential Johnson & Johnson COVID-19 vaccine link to rare disorder, report says

The Food and Drug Administration (FDA) is reportedly expected to administer a new warning on the Johnson & Johnson COVID-19 vaccine and a possible link to Guillain-Barré, a rare autoimmune nerve disorder.

The Washington Post, citing four individuals familiar with the matter, said the warning is expected after about 100 cases of Guillain-Barré occurred against a backdrop of nearly 12.8 million Johnson & Johnson vaccine recipients. Johnson & Johnson has been in talks with the FDA and other regulators over the rare cases, the company said in a statement on Monday.

"The chance of having this occur is very low, and the rate of reported cases exceeds the background rate by a small degree," reads the statement from Johnson & Johnson, which also urged awareness over signs and symptoms of rare adverse events for prompt identification and treatment.................

https://www.foxnews.com/health/fda-to-warn-potential-johnson-johnson-covid-19-vaccine-link-guillain-barre-report

[PeteS in CA]

.00078%. This will be on the list of possible complications.

[mountaineer]

FDA is set to announce new warning on J&J vaccine after 100 reports of it being linked to rare autoimmune disease Guillain-Barré syndrome

    The FDA is planning to release a new warning that the Johnson & Johnson COVID-19 vaccine is linked to a rare autoimmune disease
    Officials say there have been 100 reports of patients developing Guillain-Barré syndrome, a rare disorder that temporarily paralyzes parts of the body
    Most the cases have occurred about two weeks after vaccination and mostly in men aged 50 and older
    Guillain-Barré is very rare after vaccination, occurring in just 0.000781% of patients who have received J&J's one-dose shot
    The warning presents another setback for the company, which has been plagued by challenges including a pause due to rare blood clots and ingredient mix-ups

By Mary Kekatos Acting U.S. Health Editor For Dailymail.Com
Published: 13:59 EDT, 12 July 2021 | Updated: 16:11 EDT, 12 July 2021

...   Most the cases have occurred about two weeks after vaccination and mostly in men aged 50 and older.

With just 100 cases reported out of 12.8 million doses administered, this means the condition is very rare occurring in just 0.000781 percent of cases.

The warning is yet another setback for J&J's vaccine, which has plagued by pauses, ingredient mix-ups and doses needing to be thrown out.  ...

[libertybele]

.00078%. This will be on the list of possible complications.

I'd say this is more than a "complication", this is a rare, but serious illness. What about the 12 year old that is now in a wheelchair?.  Is that just a "complication"? 

[libertybele]

Gee....this is so insignificant that I didn't find that CNN is even reporting this.

[PeteS in CA]

I'd say this is more than a "complication", this is a rare, but serious illness. What about the 12 year old that is now in a wheelchair?.  Is that just a "complication"?

I guess the points of my post were unclear, somehow. Let me try again:

Guillain-Barré was observed in .00078% of people who received the J&J vaccine. Read nothing more into that statement.

The FDA will require this information to be listed by J&J among warnings of potential complications from the J&J Covid vaccine. Read nothing more into that statement.

Don't put words into my mouth, @libertybele.

[PeteS in CA]

Gee....this is so insignificant that I didn't find that CNN is even reporting this.

https://www.cnn.com/2021/07/12/health/johnson-vaccine-guillain-barre-syndrome-fda/index.html

[jmyrlefuller]

I'd say this is more than a "complication", this is a rare, but serious illness. What about the 12 year old that is now in a wheelchair?.  Is that just a "complication"?

She did not take this vaccine. The only one approved for under 18 right now is Pfizer.

[Hoodat]

The FDA is picking sides again, favoring one vaccine manufacturer over another.

[art.prout]

The FDA is picking sides again, favoring one vaccine manufacturer over another.

The fda is thoroughly corrupt.  You may have seen this:

https://www.theamericanconservative.com/articles/the-regulatory-capture-of-the-fda/

[libertybele]

She did not take this vaccine. The only one approved for under 18 right now is Pfizer.

I wasn't really referring to this vaccine in particular, but the vaccines in general.  People have experienced negative side effects from ALL of them.  Death, disabilities, serious illnesses, attacks on the immune system, having to be in a wheelchair, etc., I don't see as complications.

Yes, the serious and sometimes debilitating side effects are rare, but the point I was trying to make is I don't see them as just a complication.  Death is not a complication nor is contracting a rare disease.  Those are life altering side effects.