FDA recommends pause for Johnson & Johnson COVID vaccine after extremely rare blood clotting cases

FDA: ‘Right now, these adverse events appear to be extremely rare’

The Johnson & Johnson COVID-19 vaccine is seen at a pop up vaccination site inside the Albanian Islamic Cultural Center, Thursday, April 8, 2021, in the Staten Island borough of New York. Ahead of Ramadan, Islamic leaders are using social media, virtual town halls and face-to-face discussions to spread the word that its acceptable for Muslims to be vaccinated during daily fasting that happens during the holy month. (AP Photo/Mary Altaffer) (Mary Altaffer, Copyright 2021 The Associated Press. All rights reserved.)

United States health officials are calling for the immediate pause of the Johnson & Johnson (J&J) single-dose COVID-19 vaccine after six recipients developed a rare blood clot disorder.

UPDATE: FDA says pause of Johnson & Johnson COVID-19 vaccine to investigate clots to last ‘matter of days’

The FDA and CDC announced Tuesday morning that they are recommending a pause in the use of the J&J vaccine “out of an abundance of caution.”

More: Michigan temporarily pausing use of Johnson & Johnson COVID-19 vaccine

The FDA said as of April 12 more than 6.8 million doses of the J&J vaccine have been administered in the U.S. The FDA and CDC are reviewing data involving six reported U.S. cases of a rare and severe type of blood clot in individuals after receiving the vaccine. That means the percentage of people who have developed problems from it is only 0.00008% of recipients.

All six cases occurred among women between the ages of 18 and 48, and symptoms occurred six to 13 days after vaccination.

“Right now, these adverse events appear to be extremely rare,” reads the statement from the FDA. “Treatment of this specific type of blood clot is different from the treatment that might typically be administered.”

“CDC will convene a meeting of the Advisory Committee on Immunization Practices (ACIP) on Wednesday to further review these cases and assess their potential significance. FDA will review that analysis as it also investigates these cases,” reads the FDA statement. “Until that process is complete, we are recommending this pause. 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.”

The Food and Drug Administration (FDA) approved Johnson & Johnson’s COVID-19 vaccine for an emergency use authorization at the end of February.

The New York Times reports the federal government will pause administration of the J&J vaccine at all of its federally run vaccination sites. They are hoping this is a signal to state health officials to do the same.

As of Monday, April 12, 199,075 doses of J&J have been administered in Michigan while 2.8 million doses Pfizer and 2.3 million doses of Moderna have been administered in the state.

About 328,700 J&J vaccine doses have been distributed to Michigan as of April 12.

“More than 6.8 million doses of the Johnson & Johnson vaccine have been administered in the U.S., and these adverse events appear to be extremely rare. However, out of an abundance of caution, we are following recommendations from FDA and CDC and pausing the use of the Johnson & Johnson vaccine in Michigan,” said Dr. Joneigh Khaldun, Michigan’s chief medical executive and chief deputy for health. “As we learn more about this from our federal partners, we will update vaccine providers and Michiganders across the state. We encourage everyone to continue making appointments to be vaccinated with the safe and effective Pfizer and Moderna COVID-19 vaccines at this time. These vaccines are the way we are going to end this pandemic as quickly as possible and move toward a sense of normalcy.”

The Michigan Department of Health and Human Services said

More: Michigan Medicine blood clotting expert explains J&J vaccine pause

Halted J&J vaccines in Metro Detroit

Locally as of Tuesday morning, Oakland University and Detroit have both halted their Johnson & Johnson vaccinations.

An important note for Detroiters participating: If you have an appointment at a neighborhood clinic, keep the appointment and you will receive a Pfizer vaccine dose instead.

Oakland University is doing the same: Don’t cancel the appointment and you will receive a Pfizer dose instead.

The Associated Press reported last week that Johnson & Johnson had to discard 15 million doses of its coronavirus vaccine last month because the batch did not meet quality standards. The loss in expected vaccines was a greater problem for the military, because it had targeted the Johnson & Johnson shot for distribution overseas since it only requires one dose and doesn’t need the strict temperature controls that others do.

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