New warning added to J&J vaccine in US
pharmafile | July 13, 2021 | News story | Manufacturing and Production | COVID-19, FDA, J&J, JJ, US, Vaccine
The FDA has made the decision to add a warning to the fact sheet for Johnson & Johnson’s COVID-19 vaccine, as data suggests there is an increased risk of a rare neurological disorder, Guillain-Barré syndrome (GBS), in the six weeks after inoculation.
In a letter to J&J the FDA did acknowledge that the chances of contracting GBS were “very low” but that individuals should seek medical attention if they show any of the following symptoms: weakness or tingling sensations, difficulty walking, or difficulty with facial movements.
In a statement J&J said that it was in discussion with regulators about the cases of GBS, stating that the rate of reported cases of GBS in J&J vaccine recipients exceeds the background rate only by a small degree.
GBS is a rare neurological condition in which the body’s immune system attacks the protective coating on nerve fibers. Most cases follow a bacterial or viral infection. The condition has been linked in the past to vaccinations – most notably to a vaccination campaign during a swine flu outbreak in the US in 1976, and to the vaccine used during the 2009 H1N1 flu pandemic.
According to a statement from the US Centers for Disease Control and Prevention, the majority of cases were in men, many of whom were 50 or older. It did not find higher than expected cases of GBS in recipients of the mRNA-based vaccines from Pfizer/BioNTech and Moderna.
The EMA has made similar recommendations for the labelling of the AstraZeneca jab, which is based on the same technology as J&J’s vaccine.
The labeling of J&J’s vaccines comes as another blow to the jab, which has already been hampered with claims over blood clotting and production problems at the main plant where it is being made.
Kat Jenkins
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