The FDA slaps a new warning label on Johnson & Johnson’s COVID vaccine

A serious but rare side effect of the Johnson & Johnson coronavirus vaccine has caused the U.S. Food and Drug Administration (FDA) to take action.

Fox News reports that the FDA has added a new warning to the Johnson & Johnson coronavirus vaccine. 

Why?

According to the FDA, the new warning comes in response to 100 preliminary reports of Guillain-Barré syndrome (GBS) following the administration of the Johnson & Johnson vaccine.

According to the Centers for Disease Control and Prevention (CDC), GBS “is a rare disorder where the body’s immune system damages nerve cells, causing muscle weakness and sometimes paralysis.” The good news according to the CDC is that “most people fully recover from GBS.” But, the agency notes that some are left with “permanent nerve damage.”

The FDA’s new warning for the Johnson & Johnson vaccine advises people with the following symptoms to seek immediate medical help: “weakness or tingling sensations (especially in the legs or arms) worsening or spreading to other parts of the body, difficulty walking, difficulty with facial movements including speaking, chewing or swallowing, double vision or inability to move eyes, or difficulty with bladder control or bowel function.”

Those most at risk for experiencing this side effect, according to the CDC, are men who are 50 years old or older.

Benefits “clearly” outweigh the risks

If one goes by the numbers, then the chances of experiencing GBS as a side effect of the Johnson & Johnson vaccine are very low.

So far, there have been about 12.8 million doses of this vaccine administered in the United States. That’s compared to 100 preliminary cases of GBS. Accordingly, the FDA continues to encourage people to get vaccinated against the coronavirus, even with Johnson & Johnson’s vaccine.

“Importantly, the FDA has evaluated the available information for the Janssen COVID-19 Vaccine and continues to find the known and potential benefits clearly outweigh the known and potential risks,” the agency states.

Going forward, the CDC says that it will ask outside vaccine experts to investigate these cases of GBS.

Other issues

The FDA noted that the other coronavirus vaccines, namely Pfizer’s and Moderna’s, have not been shown to have this GBS risk. There have been reports, however, that these mRNA vaccines could have other issues, such as heart inflammation in young males.

This link is also being investigated by the CDC. Here too though, the CDC is encouraging people not to let this discourage them from getting their kids vaccinated.

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  13. I’m more than a little skeptical on this latest “warning” being placed on the J&J vaccine, based solely on conjecture.

    No causal relationship has been established;
    No higher risk than the non vaccinated populace has been established; and
    The infinitesimal number of SUSPECTED cases 100/12,800,000 =00000781 are not even confirmed, just potentially might be and then might be linked to J&J vaccine.
    Meanwhile Phizer and Moderna are USG endorsed and tied to heart inflammation and lung scarring but, no warning issued

  14. I’m more than a little skeptical on this latest “warning” being placed on the J&J vaccine, based solely on conjecture.

    No causal relationship has been established;
    No higher risk than the non vaccinated populace has been established; and
    The infinitesimal number of SUSPECTED cases 100/12,800,000 =00000781 are not even confirmed, just potentially might be and then might be linked to J&J vaccine.
    Meanwhile, as pointed out in the article, Phizer and Moderna are USG endorsed and tied to heart inflammation and lung scarring but, no warning issued

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