Posted on 07/12/2021 6:22:14 PM PDT by definitelynotaliberal
The Food and Drug Administration (FDA) is adding a label on Johnson & Johnson's COVID-19 vaccine, warning that it has been linked to rare cases of Guillain-Barré syndrome (GBS), a neurological disorder in which the body's immune system mistakenly attacks part of its nervous system.
There have been 100 preliminary reports following vaccination after approximately 12.5 million doses administered, FDA said in a statement. Of these reports, 95 of them were serious and required hospitalization. There was one reported death.
The cases have largely occurred about two weeks after vaccination and mostly in men, many aged 50 and older, the CDC said in a statement. The cases are rare, "but do likely indicate a small possible risk of this side effect following this vaccine," the CDC said.
The CDC added that available data do not show a similar pattern with mRNA vaccines, after over 321 million doses administered in the United States. This agency said its vaccine advisory committee will discuss the issue at an upcoming meeting.
The FDA noted that while the available evidence suggests an association between the Johnson & Johnson vaccine and increased risk of Guillain-Barré, “it is insufficient to establish a causal relationship."
GBS itself is rare, affecting only about 3,000 to 6,000 people every year. The exact cause is not known, but most cases usually start a few days or weeks following a respiratory or gastrointestinal viral infection.
Some vaccines have also been shown to cause GBS in rare instances, such as the seasonal influenza shot and a vaccine to prevent shingles.
While GBS comes on rapidly over days to weeks and the person usually recovers, other disorders develop slowly and can linger or recur.Symptoms include major muscle weakness on both sides of the body, coordination problems and unsteadiness, as well as pricking sensations on the hands and feet. In the most serious cases, paralysis can occur.
The FDA noted that the vaccine is still safe and effective, and the known and potential benefits clearly outweigh the known and potential risks.
Nearly all COVID-19 hospitalizations and deaths are now occurring in unvaccinated people, and the CDC emphasized the risk of severe adverse events after COVID-19 vaccination remains rare.
The warning is the latest blow to the Johnson & Johnson vaccine, which was supposed to be an important part of the U.S. vaccination effort. But usage has lagged and the vaccine has been plagued by problems.
The CDC and FDA paused use of the vaccine for more than a week in April after it was linked to rare and potentially life-threatening blood clots.
The company has also suffered from production problems at its only U.S. manufacturing plant.
The warning could complicate the Biden administration's efforts to combat vaccine hesitation and skepticism amid the rapidly spreading delta variant, but at least one expert said he was not concerned.
"I don’t think this will have much of an impact on the uptake of this vaccine," said Paul Offit, a vaccine expert from Children’s Hospital of Philadelphia. "It’s still a very very rare event."
And nary a word on the massive reported problems with Moderna and Pfizer vaccines. Strange that…..
The problem with all these “rare” “side-effects” is that they keep finding more and more of them...
Was Big Pharma hiding them?
How many more “side effects” is Big Pharma hiding?
Once you have caught a liar lying, that is all you need to know about them...
will this be included in Biden’s door to door script
It can be difficult to distinguish something that only happens in 1 out of 100,000 cases from the normal background rate until you get enough cases. That’s the purpose of VAERS: to help identify when some rare, unexpected side effect breaks out of background rates. In this case, FDA found ~100 cases out of 12,500,000 vaccinations. In other words, 1 per 125,000.
Anaphylaxis is seen in about 1 in every 400,000 Moderna vaccinations. Blood clots are seen in about 1 in every 470,000 J&J vaccinations. So yes, these are rare. There are a few different side effects. Myocarditis is found in young males too, but what isn’t often noted is that COVID-19 causes it more than a thousand times more frequently in young males. A Big 10 study showed that 2.3% of their college athletes recovering from COVID-19 had myocarditis. That’s 23,000 per million versus somewhere around 11 per million for the mRNA vaccines.
Much ado about very rare and nearly never serious side effects. COVID-19 on the other hand, can have very serious effects. Aside from death, some research has shown that as many as 78% of people infected with COVID-19 have heard damage. That’s not great. So even those who survive can have major issues.
For being so rare, we sure see a lot of it happening.
Every single case gets its own news story. That’s how rare it is. The media loves nothing more than to talk about death and destruction (”If it bleeds, it leads”), so if it’s happening a lot, you’ll get constant stories with counts (e.g. “1,000 today” “1,800 today” “OVER 3,000 TODAY!”, etc.) and if it’s rare you’ll get constant stories with individual accounts (e.g. “a woman in Idaho today”).
Either way, the media will play it up as much as possible because fear sells. Nobody stays tuned in to “Things are looking pretty good!”
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