U.S. to warn of link between Janssen’s vaccine and Guillain-Barré syndrome

RIO DE JANEIRO, BRAZIL – The United States is preparing to warn of a link between the Covid-19 vaccine made by Janssen, a subsidiary of Johnson & Johnson, and Guillain-Barré syndrome, in which the immune system attacks nerves, U.S. media reported Monday (12).

The notice, which has not yet been made official, will be issued by the Food and Drug Administration (FDA), the government agency in charge of approving the use of new drugs, vaccines, and other products related to public health.

According to The New York Times, which cites sources familiar with the matter, the FDA has concluded that the likelihood of developing Guillain-Barré syndrome is three to five times higher in people who have received Janssen’s vaccine.

According to The Washington Post, of the 12.8 million people who have received the Janssen vaccine in the US, about 100 may have developed symptoms.

Most of those affected started showing symptoms two weeks after immunization, and in most cases, the profile was a man over 50 years of age.

No data shows a similar pattern among those who received the Covid-19 vaccine from Moderna or Pfizer, which in the US alone have already administered more than 321 million doses.

Guillain-Barré syndrome is a rare immune system disorder that causes inflammation of the nerves and can lead to pain, numbness, muscle weakness and difficulty walking.

Janssen’s single-dose vaccine already suffered a setback in April when US authorities halted distribution after six cases of cerebral thrombosis were detected in women under 48 who had received the vaccine, one of whom died.

The official FDA announcement could come as soon as Tuesday, according to The New York Times.