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

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by Tyler Durden
Monday, Jul 12, 2021 - 09:40 PM

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."

The CDC also acknowledged the rare side effects, and said it's monitoring reports of Guillain-Barre syndrome after the J&J jabs.

The new safety concern comes at a precipitous moment in the nation’s fight against Covid-19. The pace of vaccinations has slowed considerably just as a new, more contagious variant called Delta is spreading fast in under-vaccinated areas. Federal health officials are worried that the news could make some people even more hesitant to accept the vaccines developed by Pfizer-BioNTech or Moderna, even though well over 100 million people have received those vaccines, according to the Centers for Disease Control and Prevention.

Nearly one-third of American adults remain unvaccinated. In an attempt to try and convince them to accept the jabs, the Biden Administration has shifted its strategy to focus on enlisting "community workers" to go door to door to try and convince Americans to try and accept the vaccine, instead of relying on mass vaccination centers.

The J&J jab was supposed to play an important role in the American vaccine rollout. However, thanks to complications at the Baltimore factory where US production was based, more than 75MM doses of the jab have been destroyed due to possible contamination.

This isn't the first side effect tied to the J&J jab. American and European regulators have warned about the risks of rare blood clots stemming from all vaccines using the adenovirus vector, including J&J and Astrazeneca.