The U.S. Food and Drug Administration is reportedly planning to announce a new warning on Johnson & Johnson’s (JNJ) coronavirus vaccine linking it to a rare neurological condition.
According to the Washington Post, federal health officials are investigating the possibility that Johnson & Johnson’s coronavirus vaccine might slightly raise the risk of Guillain-Barré syndrome. Nearly 100 reports of Guillain-Barré syndrome have been detected in the US after vaccination with the J&J vaccine. Most of them are 50 or older. Around 12.8 million people have received the one-dose jab in the country.
Guillain-Barre syndrome is a rare disorder in which the body’s immune system attacks nerves. Weakness and tingling in extremities are usually the first symptoms. These sensations can quickly spread, eventually paralyzing the whole body. The condition may be triggered by an acute bacterial or viral infection.
Meanwhile, even if the vaccine does raise the risk of the syndrome, it’s still better to get vaccinated against the coronavirus, a CDC spokesperson said, according to CNN.
“Reports of GBS after receipt of the J&J/Janssen COVID-19 Vaccine in the Vaccine Adverse Event Reporting System (VAERS) are rare but do likely indicate a small possible risk of this side effect following this vaccine. Around 100 preliminary reports of GBS have been detected in VAERS after 12.8 million doses of J&J/Janssen COVID-19 Vaccine administered. These cases have largely been reported about two weeks after vaccination and mostly in males, many aged 50 years and older,” the CDC spokesperson said.
These kinds of cases have not been reported with Pfizer and Moderna’s COVID-19 vaccines. However, last week, European regulators had recommended a similar warning for AstraZeneca’s COVID-19 vaccine.
The latest development is another setback for Johnson & Johnson after its vaccine was temporarily halted in mid-April after six recipients developed a rare blood clotting disorder. The FDA later lifted the ban after reaching a conclusion that the vaccine’s benefits outweigh the risk from the blood clotting issue.
Further, last month, the company had to throw away about 60 million vaccines produced at the problem-plagued Emergent BioSolutions plant due to possible contamination.
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