The U.S. Food and Drug Administration is adding a new warning to Johnson & Johnson’s COVID-19 vaccine because of a link to a rare neurological condition.
The federal oversight agency issued a statement Monday saying it had received preliminary reports of 100 people who developed Guillain-Barré syndrome after receiving the single-shot vaccine. According to the FDA, Guillain-Barré syndrome occurs when the immune system damages nerve cells, causing muscle weakness and occasional paralysis. Between 3,000 and 6,000 people are diagnosed each year with the condition in the United States.
The FDA said of the 100 vaccine recipients who developed Guillain-Barré syndrome, one person died and 95 were hospitalized. Most of the cases were reported in men 50 years old and older, and usually two weeks after being inoculated.
The numbers are a small fraction of the 12.8 million people who have received the Johnson and Johnson vaccine, which makes up a small proportion of the U.S. vaccine supply. The FDA said after evaluating the information it has determined that “the known and potential benefits” of the vaccine “clearly outweigh the known and potential risks.”
But the new warning casts another cloud over the Johnson & Johnson vaccine, which has been plagued with problems since it was approved by the FDA. Both the FDA and the Centers for Disease Control and Prevention briefly halted use of the vaccine back in April after several women under 50 years old developed a rare but serious blood-clotting disorder following vaccination, and at least one person died.
Another problem occurred earlier this year when millions of doses were ruined when a Baltimore-based manufacturing plant mixed the Johnson & Johnson vaccine with ingredients from the COVID-19 vaccine developed by AstraZeneca.
The company said in a statement it has been discussing the reports with the FDA and other health regulators around the world.
The latest tally from the Johns Hopkins Coronavirus Resource Center shows 187.3 million total COVID-19 infections around the world, including over 4 million deaths. The U.S. leads in both categories with 33.8 million total cases, including 607,442 deaths.
India and Brazil are second and third in total infections with 30.8 million and 19.1 million, respectively, while the positions are reversed in fatalities -- Brazil is second with 534,233, followed by India with 408,764. [[ COVID-19 Map - Johns Hopkins Coronavirus Resource Center.