New warning to be added to J&J vaccine over rare side effect

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New warning to be added to J&J vaccine over rare side effect

The Johnson & Johnson vaccine will soon have a new warning from the Food and Drug Administration after the shot was linked to a rare but serious side effect in a handful of patients, it was revealed Monday. 

The side effect, Guillain-Barré syndrome — a condition that occurs when the immune system attacks the body’s nerves — has been detected in about 100 people after 12.8 million jabs of the single-dose shot were administered, the Centers for Disease Control and Prevention told the Washington Post

The outlet, citing four individuals familiar with the situation, reported the FDA is preparing to announce the warning after the adverse reactions came to light. 

Instances of Guillain-Barré syndrome post-vaccination were predominantly seen in men age 50 and older and reported about two weeks after inoculation, the outlet said. Current data doesn’t suggest a similar risk with the mRNA vaccines from Pfizer and Moderna.

About 60 to 120 cases of the condition are seen each week and it typically occurs following a viral infection, but the exact causes are unknown. While most people fully recover, some people have permanent nerve damage and the condition is particularly risky for those over 50, the CDC said. 

A man shows a vial of the US Johnson and Johnson vaccine against the Covid-19 coronavirus donated by the United States, at the Sukraraj tropical hospital vaccine storage cold room in Kathmandu on July 12, 2021.
The Johnson & Johnson vaccine will soon have a new warning from the Food and Drug Administration.
AFP via Getty Images

The side effect is the latest setback for the Johnson & Johnson vaccine, which has been plagued by a series of hurdles since it was approved for emergency use in late February. 

Use of the vaccine, which has been heralded for its single-shot ease and its ability to inoculate hard-to-reach populations, was paused after it was linked to severe blood clots among younger patients

Within days, the pause was lifted and the vaccine was back on the shelves with a new warning label after an extensive safety review by the FDA and CDC found the benefits of using the medicine far outweighed the risks. 

Production efforts have also been hampered by issues, including an April incident that saw the shutdown of a Baltimore manufacturing plant after the vaccine was contaminated with the Astra-Zeneca inoculation, which was being made in the same facility. 

The latest side effect will be discussed at an upcoming meeting of CDC advisers where officials are expected to emphasize again that any risks associated with the vaccine are rare and the benefits outweigh the issues, the outlet reported. 

The FDA and Johnson & Johnson declined comment. 

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