The Food and Drug Administration will announce a new warning on the Johnson & Johnson coronavirus vaccine about cases of a rare but very severe autoimmune disorder, the latest in a series of blows to the shot’s reputation.
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Guillain-Barré syndrome is a rare disorder in which a person’s own immune system damages the nerves, causing muscle weakness and, in some cases, paralysis. Once lauded as a solution to getting vaccines to hard-to-reach parts of the country, the single-dose vaccine was linked to about 100 reports of Guillain-Barré syndrome in the United States, mostly in men, among roughly 12.8 million doses administered, the Washington Post reported.
The rare neurological disorder has been associated with viral infections such as Zika and the influenza virus.
Physicians documenting cases of the disorder in the Centers for Disease Control and Prevention vaccine side effect tracker VAERS reported patients experienced symptoms, such as muscle tingling and numbness, within a few weeks of getting the shots.
For instance, a 52-year-old female patient in Michigan diagnosed with Guillain-Barré received the vaccine on March 20 but did not start to complain about “numbness and tingling in lower extremities” or “numbness of tongue and upper extremities along with back pain” until April 2. The online report said she spent seven days recovering in the hospital.
The warning will strike a blow to the vaccine’s reputation after the FDA recommended a pause on administering the shots believed to be linked to a severe blood clotting disorder in April. The recommended pause lifted about 10 days later, but confidence in the shot suffered.
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Johnson & Johnson’s vaccine was hobbled further when a manufacturing mishap at a Baltimore lab, Emergent BioSolutions, forced the company to throw out 75 million doses of the vaccine contaminated with key ingredients of the AstraZeneca shot, which was also made in the facility at the time.
The Biden administration is expected to announce the warning label as early as Tuesday. Health officials are expected to add that the benefits of the shot have been shown to far outweigh the risks.
