Johnson & Johnson Covid-19 Vaccine May Trigger Neurological Condition In Rare Cases, FDA To Add Warning

U.S. drug regulator Food and Drug Administration( FDA) will attach a label to the Johnson & Johnson(J&J) coronavirus vaccine warning of a slightly increased risk of a rare nerve disorder known as Guillain-Barre syndrome(GBS).

The agency said there have been 100 preliminary reports of GBS in people who have received the J&J vaccine. To date, about 12.8 million doses of the J&J vaccine have been used in the United States, suggesting a rate of about one case of GBS per 128,000 people vaccinated.

The FDA chose to add a warning label because the risk of developing Guillain-Barre syndrome is believed to be roughly three to five times higher in those who have taken the Johnson & Johnson vaccine.

In most cases, the people reporting the condition developed it about two weeks after receiving the one-dose vaccine. Most are older males, which fits with the known pattern of GBS,.

J&J vaccines are viral-vectored vaccines — meaning they carry harmless genetic material from the SARS-CoV-2 virus into the body to trigger an immune response. The J&J vaccine is one shot dose.

The FDA had previously halted administering Johnson & Johnson vaccine in April, to investigate a rare clotting disorder among six recipients of the vaccine out of seven million American recipients in total at the time.