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Johnson & Johnson Reportedly Faces FDA Warning on COVID Vaccine

The FDA will issue a warning that J&J's COVID shot 'has been linked to a serious but rare side effect — Guillain-Barré syndrome,' a media report says.

Johnson & Johnson  (JNJ) - Get Johnson & Johnson (JNJ) Report will soon face a new warning for its COVID vaccine from the Food and Drug Administration, according to a media report.

The warning says “the shot has been linked to a serious but rare side effect — Guillain-Barré syndrome, in which the immune system attacks the nerves, according to four individuals familiar with the situation,” the Washington Post reports.

Shares of the New Brunswick, N.J., health-care giant closed down 0.16% Monday at $169.48; and in after-hours trade, fell another 0.15%. The stock has climbed 6% in the past six months, trailing the S&P 500’s 15% gain.

About 100 preliminary instances of Guillain-Barré have emerged from 12.8 million doses of Johnson & Johnson vaccine that were administered, the Centers for Disease Control and Prevention said in a statement to The Post.

“These cases have largely been reported about two weeks after vaccination and mostly in men, many aged 50 years and older,” The Post said.

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“Available data do not show a pattern suggesting a similar increased risk with the Pfizer  (PFE) - Get Pfizer Inc. Report/BioNTech  (BNTX) - Get BioNTech SE Sponsored ADR Report and Moderna  (MRNA) - Get Moderna, Inc. Report vaccines.”

The FDA and the company declined comment to the Post.

The European Union’s drug regulator said in April that while cases of rare blood clots and J&J’s COVID-19 vaccine might be linked, the vaccine's benefits "outweigh the risks of side effects."

Morningstar analyst Damien Conover puts fair value for J&J at $158.

“Johnson & Johnson stands alone as a leader across the major health-care industries,” he wrote last month.

“The company maintains a diverse revenue base, a developing research pipeline, and exceptional cash flow generation that together create a wide economic moat.”