Kolkata, India: Concerns about the Johnson & Johnson coronavirus vaccination have resurfaced, US media reported.
The J&J vaccination, which has been praised for its ease of use, was halted for ten days in April while federal health regulators investigated reports of six women getting rare but serious blood clots within two weeks of receiving the vaccine.
The benefits of the vaccine were later proven to outweigh the hazards.
The US Food and Drug Administration (FDA) issued a warning on Monday about a probable relationship between the vaccine and Guillain-Barré syndrome, an autoimmune condition.
The data “suggests a link” between the vaccine and an increased risk of the condition, according to the CDC, but not enough to “establish a causative relationship,” the report said.
According to the Washington Post, about 100 cases of a suspected link have been identified, largely among men and in many cases among individuals aged 50 and older.
The J&J shot has been given out in a total of 12.8 million doses.
People who have had Guillain-Barré syndrome can be vaccinated against COVID-19, according to the Centers for Disease Control and Prevention, and no incidences of the disorder have been documented in clinical trials for Pfizer and Moderna vaccines.
In the J&J trials, one case was reported, however.
According to a statement from the Centers for Disease Control and Prevention, which monitors vaccine safety systems with the FDA, about 100 preliminary reports of Guillain-Barré syndrome have been detected in vaccine recipients after the administration of 12.8 million doses of the Johnson & Johnson vaccine in the United States.
According to the FDA statement, 95 of these cases were serious enough to necessitate hospitalization.
Only one person died. Neither agency gave any information concerning the death.
Guillain-Barré syndrome is usually reversible.
According to the CDC, around 60 to 120 cases of Guillain-Barré syndrome are diagnosed each week. While the exact etiology is unknown, it frequently occurs after infection with a virus or bacteria, such as influenza. An estimated 3,000 to 6,000 persons in the United States contract the disease each year.
The Johnson & Johnson vaccine warning is the latest setback for a vaccine that had been widely anticipated due to its ease of use – it only requires one injection, making it ideal for immunizing hard-to-reach groups and places.
However, the vaccine has had numerous issues, including major setbacks at its U.S. manufacturing facility.
The recent revelation comes at a particularly perilous time, as the highly contagious delta form sweeps the world, fueling an increase in coronavirus cases in numerous regions, the Washington Post noted.
Although J&J has said its vaccine can effectively combat the delta variant.
And the new warning could make it more difficult for the Biden administration to increase vaccinations in areas where there is still a lot of skepticism about coronavirus vaccines and vaccination rates are low.