FDA Requires New Warnings on J&J Vaccines

by mcardinal

Justin Bullock, FISM News


Following an Israeli study showing that the Pfizer COVID-19 vaccine is less effective against the COVID-19 Delta variant, the FDA has issued a new warning regarding side effects for the Johnson & Johnson COVID-19 vaccine. The warning is in response to the emergence of 100 cases of Guillain-Barré syndrome in vaccine recipients. J&J released a statement about the matter which can be found here

The CDC and FDA said that the observed cases of Guillain-Barré syndrome connected to the J&J vaccine most frequently impact men over the age of 50. No causal link has yet been established and the number of cases so far constitute less than .001% of Americans who have received the J&J vaccine. Guillain-Barré syndrome has been associated with a variety of other vaccines in the past, including the common flu vaccine, so many physicians have said this connection is not alarming. Yet this development will provide further material for those who are hesitant to trust a vaccine that is still under emergency use and has not had the same amount of time to be tested as other approved vaccines.

Guillain-Barré syndrome is a neurological disorder that results in the immune system attacking nerve cells. In the most extreme but rare cases the disease can cause paralysis and even death. It is a particularly rare disease in the US and is not fatal in most cases. However, the disease can often have long term effects on the body with respect to nerve and muscle strength. The CDC has asked that anyone who has received the J&J vaccine and experiences continued weakness and tingling or difficulty performing basic motor functions like walking, chewing, swallowing, talking, and general facial control contact their physician. The CDC and FDA have indicated that more study is necessary to understand the connection and have maintained that Americans should still continue to get a COVID-19 vaccine.

The J&J vaccine is the least popular COVID-19 vaccine in the US as both Pfizer’s and Moderna’s vaccines hold the number one and number two spot respectively across the country. This is widely considered to be due to the fact that this is not the first instance of concern for the J&J vaccine. When the vaccines first became available to the public, the J&J vaccine was put on a temporary hold due to concerns that it caused abnormal blood clotting. It is suspected that another halt may be introduced for the vaccine following a further in-depth study by the CDC regarding its relationship to Guillain-Barré syndrome.