ON MONDAY, the US Food and Drug Administration updated its label for the Johnson & Johnson vaccine. The attempt aims to eliminate the possibility of a rare neurological condition called Guillain-Barré syndrome.
The agency is yet to find evidence to associate the J&J vaccine with the complication. Still, it has noticed an increase in such instances after receiving the Johnson & Johnson vaccine. The condition may even cause paralysis.
Johnson & Johnson Vaccine May Cause Guillain-Barré Syndrome, FDA Warns
In a statement released in this regard, the agency said that it is updating the fact sheet for recipients of the Johnson and Johnson vaccine. This is to add information on the reports of the neurological condition it has received about the vaccine. Such a report suggests an increased risk of such a condition upon receiving the vaccine.
The reports it has received present evidence of the neurological condition upon receiving the J&J jab. But they are not sufficient enough to cite a causal association, FDA said. No such symptom has been reported with the other two vaccines, Moderna and Pfizer.
The Government has received 100 reports of this rare neurological condition in its vaccine-adverse reaction reporting mechanism. These come from more than 12.8 million doses of the vaccine administered, it added.
Guillain-Barré syndrome is a condition where the immune system attacks your nerves. Its symptoms begin with a tickling sensation in the extremities. This, then, spreads to other parts of the body and may even cause weakness of muscles or paralysis. FDA has noted thin its label update for caregivers and patients.
In such an instance, the symptoms start within 42 days after receiving the jab, FDA observes.
Contact your doctor if you notice a tingling sensation or a weakness in your legs or arms. Quick urgent intervention if you see that it is spreading. Other symptoms may include:
- Difficulty to speak, walk and chew
- Problem controlling bowl or bladder
- Double vision
95 people among those who reported the condition required hospitalization. One among them died.
Every year, up to 6000 people suffer from this condition. Most of them recover upon receiving treatment. GBS is also associated with other vaccines like the one for seasonal influenza and the one to prevent shingles.
Johnson & Johnson, in the meanwhile, confirmed that it is in talks with the CDC and FDA in the matter. The company said this in a statement released recently. It also added that the number of such reports is quite small. In fact, its risk profile is quite low.
Even if the vaccine causes certain risks, it is best to stay protected from the coronavirus infection. You are sure to see some adverse reactions for every vaccine; health officials point out. It is quite natural when hundreds of millions of people get vaccinated. Even then, vaccines’ benefits outweigh their risks. This has always been the Government’s decision about the jabs available in the country at present.
The agencies are closely observing the reports of GBS. Gastrointestinal infections and even a lung infection can trigger this condition; they point out. CDC says that its committee on immunization practices will take up the matter during its next meeting.
In the US, hospitalizations and deaths happen largely among unvaccinated people. Besides, the risk of such a serious adverse reaction is quite low, health officials say. The Government recommends that everyone above 12 years of age should get vaccinated.
For Johnson & Johnson, the update is another setback for its campaign. The production of its vaccine has always been fraught with problems. The FDA and CDC had recently paused administering the J&J vaccine. The agencies lifted the restrictions after deciding that the adverse events are curable.
J&J vaccine is the third jab to get emergency authorization in the United States.
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