The US Federal Agency known as the Food and Drug Administration or FDA warned on Monday of the possibility that Johnson & Johnson’s vaccine provokes a rare neurological autoimmune disease.
Despite the danger, the agency emphasized the benefits of the vaccine and said that those far outweigh the possible adverse effects and that the risk is very scarce, but it no longer insists that it is 100% safe, the story that they sold the public when this and other vaccines were approved for emergency use , that is, without formal risk studies.
Now we begin to see numerous cases of Guillain-Barer’s syndrome that have been linked to the administration of the vaccine.
Johnson & Johnson has confirmed through a statement that is collaborating with the FDA to find out if there is a causal relationship between the vaccine and the development of the syndrome.
Health authorities have confirmed the relationship of the drug with Guillain-Barré’s syndrome, in which the immune system attacks the nerves, causing muscle weakness and, in some cases, paralysis.
It can be originated by an acute bacterial or viral infection, but on this occasion there have been 100 cases after administration of 12.8 million doses of Johnson & Johnson vaccine throughout the US, until now.
According to the report made public by the Centers for Disease Control and Prevention another US Federal Public Health Agency.
The cases have been notified more than two weeks after inoculation, within a maximum period of 42 days, and in patients over 50 years of age.
A total of 95% of episodes of autoimmune reactions were serious and those affected had to be hospitalized. Records available up to now do not show cases of Guillain-Barré linked to the 321 million doses of the Pfizer-Biontech and Moderna vaccines administered in the US.
According to the US sanitary authority, the usual incidence of Guillain-Barré syndrome is between 60 and 120 cases per week, as a result of a virus, including influenza, or a bacterium. Each year, between 3,000 and 6,000 Americans develop the disease.
About two-thirds of those affected experience symptoms such as diarrhea or pulmonary conditions or nasal blockage several days or weeks after being sick.
Among the recipients of the Janssen vaccine, the risk of developing Guillain-Barré seems to be three to five times higher than among the general population, according to sources.
The FDA’s warning is one of many against the Johnson & Johnson vaccine, which was highly recommended due to the fact it was given in a single dose.
Last April, the US, cautiously suspended its use after a series of thrombosis cases – one of them mortal – in fertile women. Vaccination with the drug resumed after an exhaustive investigation by the FDA and the CDC.
That same month, the Baltimore plant of Emergent Biosolutions, the only producer of the vaccine in the US, was forced to close after discovering that millions of doses had been contaminated with the Astrazeneca vaccine, which was also manufactured in that center.
Some 75 million doses of Johnson & Johnson were discarded while 40 million were considered fit for vaccination.
The US government diverted the production of the Astrazeneca drug to other facilities and gave unique control of the Baltimore facility to Johnson & Johnson, although the pharmaceutical has not yet received authorization to resume production.