FDA recommends pause in Johnson & Johnson’s single shot COVID vaccine after several severe adverse reactions


Justin P. Hicks

mlive.com

Federal regulators are recommending a pause on the use of Johnson & Johnson’s COVID-19 vaccine while they review a handful of severe reactions to the shot.

On Tuesday, April 13, the Centers for Disease Control and Prevention and the U.S. Food and Drug Administration issued a statement recommending a pause in use of the one-shot vaccine “out of an abundance of caution.”

The pause comes as the CDC and FDA are reviewing data involving six reported U.S. cases of a rare and severe type of blood clot in individuals after receiving the vaccine. These adverse events “appear to be extremely rare,” the FDA said, as more than 6.8 million doses have been administered in the U.S. to date.

The CDC will convene a meeting of the Advisory Committee on Immunization Practices on Wednesday, April 14 to further review the cases and assess their potential significance. The FDA will then review their analysis.

“Until that process is complete, we are recommending this pause,” the FDA tweeted Tuesday morning. “This is important to ensure that the health care provider community is aware of the potential for these adverse events and can plan due to the unique treatment required with this type of blood clot.”

As of Monday, Michigan had administered 199,075 doses of the Johnson & Johnson vaccine. MLive attempted to reach the state’s health department for comment on the recommendation but was not immediately successful. It is unknown if any Michigan residents had a severe reaction to the vaccine.

The FDA is slated to host a virtual press conference on the subject at 10 a.m. Tuesday, which will be aired via its Youtube account.

In late February, Johnson & Johnson’s vaccine was found to be safe and effective against COVID-19 following clinical trials of about 45,000 participants. It became the third shot to receive emergency use authorization in the U.S., making it available to be used during the coronavirus pandemic.

Last week, at least four states — Georgia, North Carolina, Iowa and Colorado — reported adverse reactions of people who received the Johnson & Johnson vaccine at some locations, according to a report by the Associated Press. Some of the adverse reactions involved fainting in Georgia and North Carolina.

The CDC was investigating the incidents in those four states as of Friday, April 9.

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