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U.S. health regulators should warn that the Johnson & Johnson JNJ -0.19%
The Covid-19 vaccine is linked to a very low incidence of cases of a rare neurological disorder associated with other injections.
The United States Food and Drug Administration plans to add warning language to the J&J shot label, after finding a handful of cases of Guillain-Barré syndrome among the millions of people who received the vaccine, according to a person familiar with the matter.
Guillain-Barré syndrome is a rare neurological disorder in which the immune system attacks nerves, causing temporary but potentially severe paralysis. The risk is known with vaccines, including some influenza vaccines and a leading vaccine to prevent shingles.
J&J did not immediately provide a comment.
The warning would be the latest for a vaccine that federal health officials say increases the risk of a rare blood clotting disease.
The risk of Guillain-Barre is however very low, said the person concerned, with a rate of around three to five cases per million beneficiaries. The risk in the general population is about 1 in a million.
In the United States, some 12.7 million people have received the single-dose J&J vaccine, according to the Centers for Disease Control and Prevention.
As more and more American adults receive their Covid-19 vaccines, various side effects are appearing. WSJ’s Daniela Hernandez speaks with an infectious disease specialist about what’s common, what isn’t and when to see a doctor. Photo: Associated press
The Johnson & Johnson vaccine uses a harmless type of cold virus called adenovirus. It’s designed to carry a piece of genetic code that instructs cells in the body to make something resembling the spike protein that protrudes from the surface of the coronavirus.
The production of the spikelike protein, in turn, triggers an immune response that can protect a person vaccinated against Covid-19.
Another Covid-19 vaccine, from AstraZeneca PLC, which is not licensed in the United States but used in the United Kingdom and other countries, uses technology similar to that of J&J. AstraZeneca firing is also linked to an increased risk of Guillain-Barre, federal health officials said.
AstraZeneca did not immediately respond to a request for comment.
The United States authorized the Johnson & Johnson vaccine in late February. Its deployment ran into trouble after regulators ordered a temporary break in its administration as investigators studied the rate of rare bleeding disorders in those vaccinated.
The FDA recommends the use of the vaccine, saying the benefits outweigh the risks. The agency, however, attached a warning to the vaccine’s label about the risk of the disease and made recommendations for treatment.
The vaccine requires only a single dose and does not need to be stored at ultra-low temperatures like messenger RNA vaccines do, making it a simpler and easier vaccine to vaccinate people, in particular. especially in places where freezing conditions and monitoring patients for a second shot would be more difficult to achieve.
Write to Thomas M. Burton at [email protected] and Felicia Schwartz at [email protected]
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