FDA To Add Warning Over Rare Neurological Side Effects Linked To J&J Jabs

The NYT and WaPo reported on Monday that the Johnson & Johnson vaccine has been found to be associated with even more rare side effects that could be potentially harmful to a small number of patients who accept the vaccine. According to the reports, the FDA has determined that the vaccine can lead to an increased risk of a rare neurological condition known as Guillain-Barré syndrome, anther setback for a one-shot ‘miracle’ jab that has been sidelined in the US.

Although chances of developing the disease are extremely small, the link between the jab and the symptoms has been well-established. Patients who receive the J&J jab are 3-5x more likely to exhibit the rare syndrome.

Federal officials have identified roughly 100 suspected cases of Guillain-Barré disease among recipients of the J&J shot through a federal monitoring system that records complaints about potential vaccine-linked side effects reported by the public.

Just like it did after it was made aware of the heart inflammation caused in rare instances by the Pfizer and Moderna jabs, the FDA has concluded that the benefits of the vaccine in preventing severe disease or death from the coronavirus still very much outweigh rare risks and side effects.

But the agency plans to include a warning in fact sheets about the jab distributed to providers and patients.

“It’s not surprising to find these types of adverse events associated with vaccination,” said Dr. Luciana Borio, a former acting chief scientist at the F.D.A. under President Barack Obama. The data collected so far by the F.D.A., she added, suggested that the vaccine’s benefits “continue to vastly outweigh the risks.”

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