Society's Child
GRBS is a rare neurological disorder caused by the body's immune system damaging nerve cells, causing paralysis in the most severely affected cases. Most people afflicted by the illness fully recover from it.
The EMA said on Thursday that its safety committee, the Pharmacovigilance Risk Assessment Committee (PRAC), established from the evidence provided and cases reported to date that there is a causal relationship between the Janssen Covid vaccine and GBS, although it is a very rare side effect.
Even though the EMA believes that GBS should be listed as a very rare side effect to the drug, the agency was clear that it still believes the benefits of the Covid jab outweigh the risks.
The EMA assessed the potential risk of the disorder after 108 cases and one death was reported among the 21 million people who have received the Janssen vaccine so far. Despite the low risk level, the EMA has stated that health officials should be aware of the potential threat, ensuring they are alert to its symptoms so that anyone affected can be diagnosed early on.
The US Food and Drug Administration (FDA) recently issued a similar warning that there is a slight risk of GBS, having assessed reports of around 100 preliminary cases of the disorder in the 12.8 million Americans who've had the Janssen Covid jab. Regardless, the US Centers for Disease Control and Prevention (CDC) notes in its guidance on the jab that the vaccine has "high efficacy at preventing hospitalization and death in people who did get sick," adding that during its clinical trials "no one who got COVID-19 at least four weeks after receiving the J&J/Janssen vaccine had to be hospitalized."
Comment: A note from the Food and Drug Administration:
On February 27, 2021, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the third vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). On April 23, 2021, the FDA amended the EUA to include information about a very rare and serious type of blood clot in people who receive the vaccine. The EUA allows the Janssen COVID-19 Vaccine to be distributed in the U.S. for use in individuals 18 years of age and older.See what the Healthcare Providers administering the vaccine are aware of before administering the jab:
The Department of Health and Human Services correspondence in updates to the EUA Fact Sheet for Healthcare Providers Administering VaccineSee also:
J&J's single-shot Covid-19 vaccine reviewed by EU's medicines agency over rare nerve disorder after US reports one death
Reader Comments
The European Medicines Agency (EMA) has listed Guillain-Barré syndrome (GBI think I know what the warning sign will look like. They've had it for years already!*S) as a very rare side effect of the Janssen Covid vaccine after examining 108 cases and one death worldwide from among recipients of the jab.
[Link]
*And people are trying to say this wasn't preplanned!
Be a good drinking game, guess the right country! Wrong answer requires a shot!
The article says the EU has labelled a warning for Guillain-Barré (GB) so I recycled the EUs GB sticker to use on the kill shot.
R.C.