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FDA, CDC Urge Halting Of Johnson & Johnson Vaccine Over ‘Extremely Rare’ Blood Clotting

Johnson & Johnson vaccine

While the CDC and FDA said blood clotting appears to be “extremely rare,” federal distribution of any Johnson & Johnson vaccine doses is expected to pause.

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The Food and Drug Administration along with the Centers for Disease Control and Prevention are urging COVID-19 vaccination sites to cease administering doses of the Johnson & Johnson vaccine after a minimum of six women in the United States suffered from a type of blood clotting that, in at least one case, was fatal.

The women who suffered this specific blood clotting, all between the ages of 18 and 48, saw symptoms after six to 13 days post-inoculation. While clotting is generally treated by anticoagulant drugs such as heparin, the federal agencies warned that for this particular type of coagulation, “administration of heparin may be dangerous, and alternative treatments need to be given.”

While the CDC and FDA said these adverse events appear to be “extremely rare” given that nearly 7 million people in the U.S. have received a Johnson & Johnson shot thus far, federal distribution of any Johnson & Johnson doses is expected to halt until the agencies’ committees can review, analyze, and investigate why the clotting is occurring and if the vaccine should still be approved for emergency use.

“Until that process is complete, we are recommending a pause in the use of this vaccine out of an abundance of caution. This is important, in part, to ensure that the health care provider community is aware of the potential for these adverse events and can plan for proper recognition and management due to the unique treatment required with this type of blood clot,” the agencies warned in a joint statement.

Johnson & Johnson defended its product in a news release, saying there is currently “no clear causal relationship” between the vaccine and the clotting.

Just days before the FDA and CDC issued a warning about the vaccine, multiple states were forced to shut down some of their vaccination sites after patients had adverse reactions after receiving their single dose of the Johnson & Johnson COVID-19 vaccine. Among Georgia, Colorado, and North Carolina, nearly 40 people fell ill with symptoms such as dizziness, nausea, and fainting.

Even before the symptoms surfaced, some such as the Vatican and the U.S. Conference of Catholic Bishops warned against the use of the Johnson & Johnson vaccine because it was manufactured using a cell line derived from the tissue of aborted babies. While some dioceses such as the Diocese of Bismarck in North Dakota stated that the Johnson & Johnson vaccine is “morally compromised and therefore unacceptable,” others in Catholic leadership such as the Vatican merely stated that the one-dose vaccine should be avoided if other choices are available.