U.S. Food and Drug Administration (FDA) expected to warn about link between Johnson & Johnson Covid-19 vaccine and cases of a rare neurological disorder associated with other shots.
The Food and Drug Administration (FDA) shares jurisdiction over vaccines with the Centers for Disease Control and Prevention (CDC), but is ultimately responsible for issuing product warnings.
The U.S. health regulator is planning to warn that the J&J vaccine increases the risk of Guillain-Barré Syndrome, according to The Wall Street Journal (WSJ).
The FDA’s move to add warning language to J&J’s vaccine label came after discovering cases of Guillain-Barré syndrome among the millions who have taken the shot.
The CDC has detected about 100 preliminary reports of the disease via the Vaccine Adverse Events Reporting System (VAERS).
Guillain-Barré syndrome, which affects thousands (3,000 to 6,000) of people per year in the U.S., causes the immune system to attack the body’s nerves, in turn causing at times severe paralysis. The risk is a known one with vaccines, WSJ notes, including some influenza and shingles vaccines.
Although regulators have found that the likelihood of developing the disorder is “low, they appear to be three to five times higher among recipients of the Johnson & Johnson vaccine than among the general population in the United States, according to people familiar with the decision,” The New York Times (NYT) reports.
Dr. Luciana Borio, a former acting chief scientist at the FDA under President Barack Obama, said, “It’s not surprising to find these types of adverse events associated with vaccination,” also according to NYT. Accordingly, in June, the American Neurological Association reported two studies published in the journal Annals of Neurology which analyzed 11 cases of Guillain-Barré syndrome from England and India. “An accompanying editorial described a similar case involving a Boston man who received the Johnson & Johnson vaccine,” according to The Washington Post.
Although “The U.S. authorized the Johnson & Johnson vaccine in late February,” writes WSJ, “Its rollout has struggled after regulators ordered a temporary pause in its administration as investigators studied the rate of the rare clotting disorder among vaccinated people.”
In a statement released Monday, the Centers for Disease Control and Prevention said the cases [of Guillain-Barré] have largely been reported about two weeks after vaccination and mostly in males, many aged 50 years and older.
The database reports indicate that symptoms of Guillain-Barré developed within about three weeks of vaccination. One recipient, a 57-year-old man from Delaware who had suffered both a heart attack and a stroke within the last four years, died in early April after he was vaccinated and developed Guillain-Barré syndrome, according to a report filed to the database.
Demand for the [J&J] shot also plummeted after the April safety pause. At that time, 15 women in United States [sic] and Europe who had received the Johnson & Johnson shot had been diagnosed with the disorder. Three had died.
In fact, Johnson & Johnson had to throw away about 75 million doses worth of the vaccine because of problems at its Baltimore plant.
The Guillain-Barré cases are expected to be discussed in an upcoming committee meeting of advisors to the CDC called the Advisory Committee on Immunization Practices (ACIP). The CDC has also linked Guillain-Barré syndrome to the 1976 swine flu vaccine as well as the GlaxoSmithKline’s shingles vaccine.
Last month, the FDA alerted the public of the increased risk of myocarditis and pericarditis among recipients of Pfizer-BioNTech or Moderna shots, particularly among adolescents and young adults.
Despite these problems associated with the COVID jab, pro-vaccine doctors like Paul A. Offit, a pediatrician and director of the Vaccine Education Center at Children’s Hospital of Pennsylvania, say the U.S. “government needs to compel vaccination” among its citizens.
Jon Fleetwood is Managing Editor for American Faith.