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Federal health officials are expected to add a warning label to the Johnson and Johnson single-dose vaccine that brings awareness to what the authorities said was a small number cases of a rare neurological disorder, according to multiple U.S. reports, including from the Wall Street Journal, the Washington Post and CNN.
The Food and Drug Administration decided on the label after a small number of individuals who took the J&J vaccine developed Guillain-Barré syndrome, according to the reports. Guillain-Barré syndrome is a rare neurological disorder in which the immune system attacks nerves, causing temporary but potentially severe paralysis. WSJ said the risk is a known one with vaccines, including some influenza vaccines and a leading shot to prevent shingles.
Johnson and Johnson responded to the reports on Monday, stating that it has been in discussions with the FDA and other regulators regarding Guillain-Barré syndrome after persons had taken its Covid-19 vaccine. “Evidence has demonstrated that Johnson & Johnson’s single-shot COVID-19 vaccine offers protection against Covid-19 disease and prevents hospitalization and death, including in countries where viral variants are highly prevalent,” J&J said.
The Guillain-Barré syndrome cases were reported in three to five out of every one million J&J vaccine recipients, said WSJ, citing a person with knowledge of the matter. The general risk for such cases is 1 in one million. Roughly 12.7 million people have taken the Johnson and Johnson vaccine.
The latest development could lead to more vaccine hesitation. On April 13, U.S. health authorities recommended that use of the Johnson & Johnson vaccine be paused, allowing the authorities to investigate some rare but severe cases of blood clot. The temporary pause was lifted on April 23, but U.S. health authorities added a label warning of the risk of rare but severe blood clots.
