COVID-19: FDA Adds New Warning For a Rare Autoimmune Disorder to J&J’s Vaccine
On July 12th, Johnson & Johnson announced that the FDA had added a new warning to its COVID-19 vaccine. This the second time the vaccine has been linked to a very rare but potentially deadly adverse event. The benefits of the vaccine outweigh the risks, but this development could contribute to vaccine hesitancy.
The J&J vaccine was approved for emergency use in February 2021. The vaccine is 85% effective against the original COVID-19 variant, and it leads to the production of neutralizing antibodies against the Beta and Delta variants.
Additionally, J&J pledged to sell it on a not-for-profit basis. All these factors made the J&J vaccine an integral component of vaccination efforts around the world. The EU alone ordered 200 million doses, and last week it ordered an additional 40 million.
The J&J vaccine suffered several setbacks, including manufacturing delays due to irregularities found at a Baltimore plant. The plant, owned by Emergent BioSolutions, was subcontracted to help with vaccine production. However, an inspection revealed a lack of sanitation and proper procedure. As a result, millions of doses were discarded.
Additionally, back in April, vaccination was paused due to a very rare but potentially life-threatening blood clotting. Although an extremely rare event, the CDC advised women younger than 50 years old to be aware. However, vaccination efforts resumed after it was determined that the benefits of the vaccine outweigh the risks.
After a review of the available data, the FDA added a warning for Guillain-Barre ́ syndrome (GBS), an autoimmune disease where the body’s immune system attacks the myelin fibers that coat neurons. This damage leads to weakness, tingling, problems walking, and difficulty with facial movement. In severe cases, it can lead to full-body paralysis.
The condition is extremely rare. Currently, more than 12 million people have received the J&J vaccine, and only 100 cases of GBS have been reported. That is 0.0008% of all people that received the vaccine. Of the cases, 95 required hospitalizations, and there was one reported death. Most of the cases were in men 50 older, and they occurred within 6 weeks post-inoculation.
A higher rate of GBS has been observed with the AstraZeneca vaccine. This led European regulators to place a similar warning for that vaccine. Interestingly, the AstraZeneca and J&J vaccines use adenovirus-based vaccines. Crucially, the mRNA-based vaccines were not associated with a higher likelihood of developing GBS.
In a statement, J&J said, “We strongly support raising awareness of the signs and symptoms of rare events to ensure they can be quickly identified and effectively treated.”
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