Johnson & Johnson’s coronavirus vaccine is reportedly about to suffer another setback – a potential warning from the Food and Drug Administration (FDA) that it could lead to increased risk of an autoimmune disorder.
The one-dose vaccine has been linked to a side effect that is rare yet serious, the Guillain-Barré syndrome, which involves the immune system attacking the nerves, four sources told the Washington Post on Monday.
There have been about 100 preliminary reports of Guillain-Barré with 12.8million doses of the Johnson & Johnson jab administered in the US, the Centers for Disease Control and Prevention (CDC) stated on Monday.
The majority of the cases have been detected in men 50 years and older and about two weeks after inoculation.
Federal officials are expected to say that the Johnson & Johnson vaccine is safe and its benefits outweigh the possible risks, the sources told the Post.
The chances of developing Guillain-Barré appeared to be three to five times higher among people who received the Johnson & Johnson shot versus the general population of Americans, people with knowledge on the matter told The New York Times.
According to the CDC, there are typically 60 to 120 cases of Guillain-Barré per week, and it often comes after an influenza or bacterial infection.
About 3,000 to 6,000 Americans contract it annually. While most people are able to recover fully, some are left with permanent damage to the nerves.
It is the latest blow to the Johnson & Johnson jab, which was the third Covid-19 vaccine to receive emergency use authorization from the FDA.
In April, federal officials halted use of the Johnson & Johnson jab as it was linked to severe blood clots in rare cases.
That pause was lifted days later following a thorough safety review by the FDA and CDC, and a warning was added to the label.
Additionally the Johnson & Johnson vaccine, which was viewed as an efficient option for protection from coronavirus early on, faced production problems.
Its subcontractor and manufacturer Emergent BioSolutions had its plant shut down in April due to cross-contamination with the AstraZeneca vaccine.
The CDC’s Advisory Committee on Immunization Practices is planning to discuss the Guillain-Barré cases at an upcoming meeting.
Data has not shown that the Pfizer or Moderna vaccines, which entail two doses, carry an increased risk of Guillain-Barré, with more than 321million doses administered in the US.