07/23/2021 5:31 AM
Clarín.com
Society
Updated 7/23/2021 5:31 AM
The European Medicines Agency (EMA) determined that Johnson & Johnson's coronavirus vaccine can cause
a rare neurodegenerative disorder
, Guillain-Barré syndrome, according to a report prepared after examining 108 reported cases worldwide.
"After evaluating the available data, the PRAC (EMA Risk Assessment Committee) concluded that
a causal relationship
between the Janssen vaccine and Guillain-Barré syndrome is possible," the agency reported.
This is a "very rare" side effect, the EMA specified, reiterating that "the benefits of the Janssen vaccine continue to
outweigh the risks
."
The United States health authorities, the Food and Drug Administration (FDA, for its acronym in English) had already issued a similar warning based on a federal monitoring system on the safety of vaccines.
The US agency identified
100 cases of the rare
neurological
disorder
after the application of 12.5 million doses of Janssen's vaccine.
Of these, 95 were serious and required hospitalization, while one death was reported.
Earlier this month, the European agency had already advised against the use of the Janssen vaccine in people who have previously had capillary leak syndrome (SCLS), after the registration of three cases in patients who developed this condition after inoculation.
The EMA safety committee (PRAC) examined three cases of capillary leak syndrome in people who had been vaccinated with Janssen and that occurred within two days after vaccination: one of those affected had a clinical history of this syndrome and two of them later passed away.
The PRAC also recommended including this syndrome in the vaccine package insert as a new side effect and urged to raise awareness about the symptoms of this disease, and to warn patients about this risk.
Capillary leak syndrome is a very rare serious condition that causes a loss of fluid from the small blood vessels (capillaries), resulting in swelling mainly in the arms and legs, in addition to low blood pressure, thickening of the blood and levels low blood albumin (an important blood protein).
Johnson & Johnson's vaccine is much less effective against the Delta variant
To the recommendations of the international control organisms, the Janssen vaccine also added another warning this week that warned that these doses are much
less effective against the Delta variant
.
The report, which has not yet been peer-reviewed or published in a scientific journal, was released recently by a team
at New York University
and is based on a series of laboratory experiments with blood samples.
Although the efficacy of the vaccine under real-world conditions could be different, the study's findings reinforce the idea that those vaccinated with this single-dose product might require
a booster
with messenger RNA vaccines such as those from Pfizer and Moderna.
The data, according to the authors, underscore the importance of monitoring infections among vaccinees that result in severe cases of Covid-19 and "suggest the benefit of a second immunization (….) To increase protection against variants."
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