US FDA WARS OF UNUSUAL NEUROLOGICAL RESPONSE TO JANSSEN
US FDA warns of unusual neurological response to Janssen vaccine?
Press Association - Novinite contributed reporting.
According to US specialists, there have been instances of individuals who had the jab getting Guillain-Barre syndrome. Muscle weakness and, in rare cases, paralysis may result from the disease. Health authorities characterised the adverse effect as a "small potential danger" to health care workers in the Guillain-Barre syndrome, which may be caused by a variety of illnesses, including the flu, cytomegalovirus, and Zika virus. There have been isolated reports of individuals developing the condition days or weeks after taking specific vaccinations. The vaccine is currently accessible at pharmacies to those aged 18 to 35.
According to US specialists, there have been instances of individuals who had the jab getting Guillain-Barre syndrome.
The EMA's safety committee (PRAC) is reviewing data supplied by Johnson & Johnson on Guillain-Barre syndrome patients recorded after immunisation with the one-dose injection.
"PRAC has sought additional comprehensive data from the marketing authorization holder (Johnson & Johnson")," the agency stated in a statement to The Journal.
The EMA will continue to investigate the instances and will update the public when new information becomes available.
The new warning was issued by the US Food and Drug Administration (FDA) in response to reports of Guillain-Barre syndrome, an immune system disease that may cause muscular weakness and, in rare cases, paralysis. The adverse effect was identified as a "small potential danger" by health authorities.
The FDA and the Centers for Disease Control and Prevention took the move after reviewing reports of about 100 individuals getting the condition after receiving the one-dose vaccination. According to the FDA, almost all of them needed hospitalisation, and one person died.
Guillain-Barre syndrome occurs when the body's immune system erroneously assaults part of its nerve cells, resulting in acute muscular weakness and paralysis. According to the CDC, the condition affects between 3,000 and 6,000 individuals each year.
The number of documented instances associated with J & J's vaccination is a small fraction of the roughly 13 million Americans who have gotten the injection. The majority of instances were recorded in males, many of whom were 50 or older, and typically two weeks after immunisation.
J&J said that it had discussed the reports with the FDA and other health authorities worldwide.
The CDC said that during an upcoming meeting, it would ask its panel of independent vaccination experts to examine the problem.
The additional warning will be included in booklets sent to J & J vaccination recipients. They should seek medical care if they have any symptoms such as tingling, difficulty walking, or double vision, according to the FDA.
Vaccines have traditionally provided wide protection with minimal danger, although they, like other medicines and medical treatments, have occasional adverse effects.
Even while the four Covid-19 vaccinations used in Ireland, including the Janssen jab, were studied on tens of thousands of individuals, such large trials cannot rule out very uncommon adverse effects.
According to the most current HSE statistics, a total of 72,092 doses of the Janssen vaccine were given in Ireland as of yesterday. This amounts to 1.5 percent of the total quantity of vaccinations distributed so far.
The vaccine was just made accessible to 18-35-year-olds via pharmacies, depending to availability.
Guillain-Barre syndrome may be caused by a variety of illnesses, including the flu, cytomegalovirus, and Zika virus, but in rare instances, individuals acquire the condition days or weeks after taking specific vaccinations.
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