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SHEPHERDSVILLE, KENTUCKY - MARCH 01: An employee with the McKesson Corporation scans a box of the Johnson and Johnson COVID vaccine as she fills an order at their shipping facility on March 1, 2021 in Shepherdsville, Kentucky. The FDA has approved a third vaccine and 3.9 million doses of J&J will begin distribution.
The benefits of the Johnson & Johnson COVID-19 vaccine "far outweigh" the risks of potential side effects, an advisory panel to the Centers for Disease Control and Prevention (CDC) said after a small fraction of recipients developed a rare nerve disorder.
During a meeting on Thursday, Dr. Hannah Rosenblum of the CDC said the assessment of the vaccine has found that its benefits in fighting against the COVID-19 were significantly greater than the risks of the side effects. Kaiser Permanente Vaccine Study Center's Dr. Nicola Klein also noted eight confirmed cases of the Guillain-Barre syndrome (GBS) among recipients of the J&J vaccine.
Rare Nerve Disorder
The numbers came from a backdrop of 345,000 doses administered across the region, based on Vaccine Safety Datalink data. Officials said that nearly all of the cases showed signs of the syndrome within 21 days of being inoculated. The victims included adults aged between 18 and 64 years. A reporting rate of 8.1 GBS cases per million J&J doses administered, researchers noted.
The statistics were compared with the 1.1 following mRNA vaccination and roughly 1.6 expected GBS cases per million doses administered, based on data from VAERS, a national surveillance system, Fox News reported.
On Monday, the U.S. Food and Drug Administration (FDA) updated the label on the J&J vaccine vial to warn of the possible side effects of GBS. The agency said that while it has not determined that the treatment caused the syndrome, it noted there have been increasing reports of the condition developing in recipients of the vaccine brand.
In a statement, the FDA announced the revision to the vaccination provider fact sheets on the J&J shots to include the possible side effect of developing the paralyzing condition. The updated label wrote that the use of the J&J vaccine had a reported increased risk of GBS within 42 days from the day of inoculation.
The agency added that there was not enough evidence to establish a causal relationship despite the reports on rare nerve condition being associated to J&J vaccine. Experts have not identified similar reports among recipients of vaccines from Pfizer and Moderna, CNN reported.
Vaccine Side Effects
Out of 12.8 million J&J vaccine doses that were administered, 100 preliminary reports of the GBS have been filed with the U.S. government's Vaccine Adverse Event Reporting System, the FDA said. The agency noted that the condition caused muscle weakness and, sometimes, paralysis.
The syndrome occurs when the body's immune system attacks a person's nerve cells by mistake. The CDC said that, in the United States, an estimated 3,000 to 6,000 people develop the syndrome every year.
In a statement, J&J said it was working with authorities and health regulators to discuss the reports and identify the cause of the condition. The CDC announced that it would seek the help of its panel of outside vaccine experts to analyze the data during a future meeting.
The U.S. government said that the other two major vaccine brands, Pfizer and Moderna, despite being administered for more than 320 million doses nationwide, have reported no risk of developing the condition, Aljazeera reported.
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