In Response to Rare Guillain-Barré Cases, FDA Plans New Warning for J&J COVID-19 Vaccine

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The U.S. Food and Drug Administration (FDA) is planning a new warning for Johnson & Johnson’s COVID-19 vaccine. This time it is over a rare but serious side effect, Guillain-Barré syndrome (GBS). Guillain-Barré syndrome, which has been linked to other vaccines in the past, is a rare neurological disorder where the immune system attacks part of the peripheral nervous system. Symptoms include muscle weakness, difficulty with eye muscles and vision, difficulty swallowing, speaking, or chewing, needle-like sensations in the hands and feet, severe pain, particularly at night, abnormal heart rate or blood pressure, and problems with digestion and/or bladder control.

Approximately 100 preliminary reports of GBS have been identified out of 12.8 million doses of the J&J vaccine in the U.S., according to the Centers for Disease Control and Prevention (CDC). They appear about two weeks after vaccination and primarily in men, most 50 years of age and older.

The J&J vaccine, which is a single shot, has had a number of problems associated with side effects. Primarily it has been blood clots, which also were tied to the AstraZeneca-Oxford vaccine, which is not authorized in the U.S. The FDA and CDC had placed a pause on the J&J vaccine on April 13 over six reported cases of a “rare and severe” blood clot known as cerebral venous sinus thrombosis (CVST) in combination with low levels of blood platelets (thrombocytopenia). On April 23, they lifted the restrictions, saying that the benefits outweighed the risks.

According to the CDC, GBS cases show up about 60 to 120 cases each week, unrelated to COVID-19 or other vaccines. The cause of GBS is not well understood, although it often appears after a viral or bacterial infection. In the U.S., about 3,000 to 6,000 cases of GBS are reported each year. The majority of people recover completely, but some have permanent nerve damage. Also, about two-thirds of GBS patient experience symptoms days or weeks after they got sick with diarrhea or a lung or sinus illness.

The FDA and CDC are expected to emphasize that the J&J vaccine is safe and its benefits outweigh the potential risks.

The CDC statement indicated that GBS cases are rare, “but do likely indicate a small possible risk of this side effect following” the J&J vaccine.

Another problem that hit J&J’s vaccine for COVID-19 were production problems at Emergent BioSolutions’ manufacturing plant in Baltimore, Maryland. The facility was shut down in April after inspectors found millions of doses had been contaminated with the AstraZeneca vaccine, which was also being produced at the facility. J&J had to discard approximately 75 million doses of the vaccine. Since then, approximately 40 million have been released for use.

The Pfizer-BioNTech and Moderna COVID-19 vaccines have been associated with very rare cases of myocarditis, heart inflammation, in some young adults and teenagers, although the association has been called “likely.” Nonetheless, the CDC and the Department of Health and Human Services issued a joint statement in June that they “strongly encourage everyone 12 and older” to get the Pfizer-BioNTech and Moderna shots because their benefits significantly outweigh the potential risks.

The American Neurological Association reported two studies in the journal Annals of Neurology in June had identified 11 cases of GBS two to three weeks after the AstraZeneca-Oxford vaccine. Those cases were in England and India. The GBS was a rare variation of the disease that caused severe facial weakness. A similar case was reported in a Boston man who received the J&J vaccine.

Vaccine regulators in Europe have also recommended a GBS warning be added to AstraZeneca-Oxford’s label. Their safety committee, however, said that cases have been reported after vaccinations, but “at this stage the available data neither confirms nor rules out a possible association with the vaccine.”

In 1976, the swine flu vaccine was associated with an increased risk, about one additional case of GBS, for every 100,000 people who received that vaccine. The precise cause of the link is still unknown.

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