The US Food and Drug Administration on Monday added a warning to Johnson & Johnson’s COVID-19 vaccine newsletter, saying the data suggests there is an increased risk of a rare neurological disorder within six weeks of inoculation.
In a letter to the company, the FDA rated the chances of contracting Guillain-Barré syndrome (GBS) after vaccination as “very low.” Still, he said recipients of the J&J vaccine should seek medical attention if they experience symptoms such as weakness or tingling, difficulty walking, or facial movements.
About 12.8 million people have got J&J’s single-dose vaccine in the United States. The FDA said that 100 preliminary reports of GBS in vaccine recipients include 95 serious cases that required hospitalization and one reported death.
J&J said in a statement that it is discussing GBS cases with regulators. He said the reported case rate of GBS in J&J vaccine recipients surpasses the background rate only by a small degree.
GBS is a very rare neurological situation in which the body’s immune system attacks the protective lining of nerve fibers. Most cases happen after a bacterial or viral infection. Most people fully recover from GBS.
The situation has previously been related to vaccines, most notably a vaccination effort during a 1976 swine flu outbreak in the United States, and decades later to the vaccine used during the 2009 H1N1 flu pandemic.
A box of Johnson & Johnson coronavirus disease vaccines (COVID-19) was seen at Forem’s vaccination center in Pamplona, Spain, on April 22, 2021.
According to a statement by the US Centers for Disease Control and Prevention (CDC), the majority of cases were in men, many of whom were aged 50 and over. He found no cases of higher-than-expected GBS in mRNA-based vaccine recipients from Pfizer / BioNTech SE and Moderna.
Last week, European regulators told a similar warning for AstraZeneca’s COVID-19 injection, which is based on technology similar to Johnson & Johnson’s vaccine.
The warning is another setback for the J&J injection, which should be an important tool for vaccination in hard-to-reach areas and among those who hesitate to be vaccinated because it only requires one injection and has less stringent storage requirements than Pfizer or Vaccines Moderna.
But the use of the vaccine has been linked to a very rare, potentially fatal blood clotting condition, delayed by production problems at the main plant where it is being made.
US regulators ruled in April that the vaccine’s benefits outweighed the risk of the blood clotting problem.