- Cases of a neurological disorder called Guillain-Barré syndrome have been reported following vaccination with the J&J single-dose vaccine.
- There have, however, been only around 100 cases reported out of close to 13 million people receiving the jab in the US.
- In SA's Sisonke trial, there was one reported case of the disorder among nearly 500 000 healthcare workers.
The Covid-19 vaccine by Johnson & Johnson (J&J) has been linked to a small increased risk of Guillain-Barré syndrome, a rare but potentially serious neurological condition, federal officials in the US said on Monday.
As a result, the US Food and Drug Administration (FDA) plans to add a warning about the syndrome to the J&J vaccine, as reported by The Washington Post. The federal agency has also added a warning about this potential side effect to its fact sheets about the jab.
“Guillain Barré syndrome … has occurred in some people who have received the Janssen Covid-19 Vaccine. 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. You should seek medical attention right away if you develop any of the symptoms after receiving the Janssen Covid-19 Vaccine,” it said.
According to preliminary reports by the US Centers for Disease Control and Prevention (CDC), out of 12.8 million J&J doses administered in the US, there have been only about 100 cases of this syndrome.
What is Guillain Barré syndrome?
Guillain Barré syndrome is a neurological disorder in which the body’s immune system begins to attack the body itself and damages nerve cells.
As explained in this Health24 article, it is called a syndrome rather than a disease because it is not clear if a specific disease-causing agent is involved.
The precise cause is unknown although Johns Hopkins Medicine notes that it often develops after a respiratory or gastrointestinal viral infection.
What are the symptoms?
Symptoms can include varying degrees of weakness or tingling sensations in the legs, which, sometimes, spread to the arms and upper body, explains Johns Hopkins Medicine. Symptoms generally pass within weeks.
In some cases, however, they can increase in intensity until the muscles cannot be used at all and the person is almost totally paralysed. This then becomes life-threatening and is considered a medical emergency.
Partial recovery is possible from even the most severe cases of the disorder, although the person may always have some degree of weakness.
Has it previously been linked to vaccination?
It is not the first time a vaccine has been associated with a risk of Guillain Barré syndrome. The CDC points out that swine flu vaccination in the 1970s was linked to a small rise in cases of the disorder (roughly one extra case per 100 000 people vaccinated).
Additionally, the seasonal influenza (flu) shot is also associated with around one to two additional cases for every 1 million vaccine shots administered.
Dr Daniel Salmon, director of the Institute for Vaccine Safety at Johns Hopkins University told The New York Times that it is not entirely clear why some vaccines may lead to an increased risk for the disorder. “We don’t really understand the biological mechanism. It’s an incredible frustration,” he said.
Guillain Barré and J&J vaccine in SA
Results from the J&J Sisonke study, wherein the single-dose vaccine was given to close to 500 000 healthcare workers in South Africa, revealed that one participant – a 40-year-old man – was diagnosed with Guillain Barré syndrome.
Co-principal investigator of the study and president of the SA Medical Research Council, Professor Glenda Gray also commented that the warning is simply a precautionary measure and that it’s critical to document and follow these cases.
“It’s hard to attribute it all to vaccination but it’s also good to be cautious and to overstate safety concerns, rather than understate them,” she said, adding: “The important thing is that if we had one case in [almost] half a million people, and it was resolved, it puts it into context. But it’s also important for people to be aware of side effects so that they can then monitor it and get interventions early.”
Symptoms to look out for
Guidance by the FDA states that people should seek medical attention right away if they develop any of the following symptoms after receiving the J&J vaccine:
- Weakness or tingling sensations, especially in the legs or arms, that become worse and start spreading to other parts of the body
- Difficulty walking
- Difficulty with facial movements, including speaking, chewing, or swallowing
- Double vision or inability to move the eyes
- Difficulty with bladder control or bowel function
The agency also said that, based on the available scientific evidence, “the known and potential benefits of the [vaccine] outweigh the known and potential risks of [it]”.