US health officials said Monday that Johnson & Johnson’s COVID-19 vaccine may pose a “low potential risk” of a rare but potentially serious neurological reaction.
The Centers for Disease Control and Prevention said in a statement that it had received reports of 100 people with J&J’s Janssen who developed Guillain-Barré syndrome, an immune system disorder that can cause muscle weakness and sometimes paralysis.
This number represents a small portion of the approximately 13 million Americans who received the single-dose vaccine. Most cases of side effects have been reported in men – many people age 50 and over – and usually about two weeks after the vaccination.
The Centers for Disease Control and Prevention said it will ask an external committee of vaccine experts to review the problem at an upcoming meeting.
J&J did not immediately respond to an Associated Press request for comment.
Earlier on Monday, J&J issued a statement Saying he has been in discussions with the FDA about rare cases of Guillain-Barré.
“The chance of this happening is extremely low,” the statement said. The company also said that the number of reported cases of Guillain-Barré after using the vaccine exceeded the number of cases normally expected in the population “by a small degree.”
The US government said the most widely used vaccines in the US, made by Pfizer and Moderna, show no risk of disruption after more than 320 million doses have been given.
Guillain-Barré syndrome occurs when the body’s immune system mistakenly attacks certain nerve cells, causing muscle weakness and sometimes paralysis that is usually temporary. An estimated 3,000 to 6,000 people develop the syndrome each year in the United States, according to the CDC.
Most people with Guillain-Barré recover fully, according to CDC . website, but there have been cases of permanent nerve damage.
The syndrome can be caused by influenza and other infections
Vaccines historically provide broad spectrum protection with little risk but come with occasional side effects as do medications and other medical treatments. The three COVID-19 vaccines used in the United States have been tested on tens of thousands of people, but even such massive studies cannot rule out extremely rare side effects.
The CDC and the Food and Drug Administration have been monitoring reports of side effects submitted by doctors, drug makers, and patients to a federal vaccine safety database.
A number of infections can cause Guillain-Barré, including influenza, cytomegalovirus, and Zika virus. But there have also been rare cases of people developing the disorder days or weeks after receiving certain vaccines.
J&J’s vaccine was highly anticipated due to its individual composition and ease of refrigeration. But early on, it was linked to another rare risk, blood clots, and the company was unable to produce what was expected due to problems at the Baltimore plant helping to make the injections.
Not used in Canada
Health Canada J&J’s Janssen vaccine has been approved But it has never been used in Canada. There does not appear to be any definite plan to do so.
Public Services and Procurement Minister Anita Anand recently said that the Johnson & Johnson contract is still valid and Canada can count on supplies from this company at a later date.
But with millions more shots of mRNA arriving from Pfizer and Moderna in the coming weeks, she said shipments from J&J may not be necessary.