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This is the second warning of the Johnson & Johnson vaccine. The first one caused a 10-day “pause” on the rollout. Will this one do the same?
The FDA approved the Johnson & Johnson (Janssen) coronavirus vaccine for “emergency use authorization” on February 27, 2021.
It’s the one-shot adenovirus vaccine that had an efficacy rate of 66.3% in clinical trials.
The Mayo Clinic explains the way the J&J vaccine works this way:
What’s done to the virus is that actually a little genetic snippet is exchanged and placed into the adenovirus that is actually from the COVID virus. It’s the section of genetic code that codes for the spike protein. The adenovirus is like a Trojan horse, except that what it’s delivering is a good thing, instead of delivering something that you don’t want in your body. You get the vaccine, the adenovirus goes into your cell, it’s got this Trojan horse code on it that makes the spike protein. That spike protein then goes to the surface of your cell and then your immune system recognizes it and starts to make antibodies to it.
Source: Mayo Clinic
It’s not quite like the mRNA vaccines produced by Pfizer and Moderna, but the effect is the same, “your body makes the spike protein and you develop the immune response to that spike protein.”
On April 13, the FDA and the CDC recommended a “pause” on the J&J vaccine due to “a rare adverse event called thrombosis with thrombocytopenia syndrome (TTS).” The serious condition “involves blood clots with low platelets” mainly occurring in adult women younger than 50 years old. The pause was lifted 10 days later.
It is now being reported that there is an increased risk for a rare neurological condition called Guillain-Barré Syndrome that can cause muscle weakness and sometimes temporary paralysis.
The Food and Drug Administration is planning to warn that Johnson & Johnson’s coronavirus vaccine can lead to an increased risk of a rare neurological condition known as Guillain-Barré syndrome, another setback for a vaccine that has largely been sidelined in the United States.
Although regulators have found that the chances of developing the condition are low, they appear to be three to five times higher among recipients of the Johnson & Johnson vaccine than among the general population in the United States, according to people familiar with the decision.
Federal officials have identified roughly 100 suspected cases of Guillain-Barré disease among recipients of the Johnson & Johnson shot through a federal monitoring system that relies on patients and health care providers to report adverse effects of vaccines. The reports are considered preliminary. Most people who develop the condition recover…
…“It’s not surprising to find these types of adverse events associated with vaccination,” said Dr. Luciana Borio, a former acting chief scientist at the FDA under President Barack Obama. The data collected so far by the FDA, she added, suggested that the vaccine’s benefits “continue to vastly outweigh the risks.”
Source: Baltimore Sun (Emphasis Added)
Guillain-Barré syndrome is a “rare neurologic disorder where the body’s own immune system attacks the nerves” explains Web MD.
More than 100 cases of Guillain-Barre reported to the Vaccine Adverse Event Reporting System, a federal program for reporting vaccine issues, spurred the FDA to act.
Men and people older than 50 appear to be at highest risk, according to reports of a July 12 Centers for Disease Control and Prevention (CDC) statement . The CDC also revealed that most cases occur about 2 weeks following immunization.
Guillain-Barre syndrome often causes muscle weakness and sometimes, temporary paralysis. Most people who develop the syndrome recover.
Source: Web MD
The new warning is not being added to the Pfizer or Moderna mRNA vaccines.
This is yet another setback for the Johnson & Johnson vaccine. Earlier this year, 15 million doses had to be tossed after a manufacturing error. After an inspection, federal investigators found multiple problems at the Baltimore manufacturing plant where the Janssen vaccines are produced. The issues ranged from unsanitary conditions to failing to properly train workers.
The manufacturing company, Emergent BioSolutions, temporarily halted production at the request of the FDA in April to make improvements and “restore confidence” in the product.
In June, the FDA and the CDC ordered another 60 million doses from the Emergent BioSolutions plant needed to be scrapped.
Now that the media has been fearmongering about the more easily spread — but less deadly — “Delta variant” that was first detected in India, there has been a lot of discussion by medical experts on whether a booster will be needed for those who got the J&J shot, or if that should be a dose of one of the mRNA vaccines.
The World Health Organization’s top scientist warned on Monday about mixing and matching vaccines. Dr. Soumya Swaminathan called the practice that is being mulled over by some countries — and approved by America’s “woke” neighbors to the North — a “bit of a dangerous trend” and said, “We’re in a data-free, evidence-free zone as far as mix and match.”
At what point, exactly, do the “medical experts” admit that this is just one giant medical experiment on a global scale?
