Even as Covid-19 cases are rapidly increasing across the US, the Food and Drug Administration has issued a new warning regarding the Johnson & Johnson coronavirus vaccine. The FDA said that the shot has been linked to a serious but rare side effect called Guillain-Barré syndrome.
Revisions to Vaccine Recipient and Vaccination Provider Fact Sheets for J&J Vaccine
The FDA has updated a label on the single-dose vaccine which says: "Reports of adverse events following use of the Janssen COVID-19 Vaccine under emergency use authorization suggest an increased risk of Guillain-Barré syndrome during the 42 days following vaccination".
The US drug regulator has stated that out of the 12.8 million Janssen vaccines administered, as many as 100 preliminary reports of GBS had been registered with the US Vaccine Adverse Reporting System.
"In most of these people, symptoms began within 42 days following receipt of the Janssen COVID-19 Vaccine. The chance of having this occur is very low," the FDA said, reports CNN.
'No Such Issues observed in Moderna and Pfizer-BioNTech Vaccines'
The FDA has stated that although the available evidence suggests an association between the Janssen vaccine and increased risk of GBS, it is insufficient to establish a causal relationship. It also revealed that no similar signal has been identified with the Moderna and Pfizer-BioNTech COVID-19 vaccines.
What is Guillain-Barré syndrome?
According to the website of the National Institute of Neurological Disorders and Stroke Weakness (NINDS), Guillain-Barré syndrome (GBS) is a rare neurological disorder in which the body's immune system mistakenly attacks part of its peripheral nervous system—the network of nerves located outside of the brain and spinal cord. It can strike at any age (although it is more frequent in adults and older people) and both sexes are equally prone to the disorder. GBS is estimated to affect about one person in 100,000 each year. Some reports also say that the GBS may cause muscle weakness and sometimes paralysis.
Latest Blow to the Shot
The vaccine faced a major setback in April when the CDC and the FDA had halted its use after a small number of patients in the US developed a rare blood clot disorder after receiving it. The agencies later ended the restrictions and said that vaccine's benefits outweigh its risks.
FDA Warning Amid the New COVID Infections
The warning by FDA has come at a crucial point as the US is witnessing a rise in Covid-19 cases. According to a report published in USA Today, more than 99% of deaths are now among people who have not been vaccinated.
The delta variant is also spreading across several US states. Some reports suggest that the news of another side effect could worry few citizens and can impact the vaccination drive. On the other hand, some health officials are optimistic and stated that the risk is low and it should not deter people from getting inoculated.