FDA & CDC explain decision to pause J&J vaccinations in US, not stop them

Tracking Coronavirus

WASHINGTON — The U.S. is recommending a “pause” in using the single-dose Johnson & Johnson COVID-19 vaccine to investigate reports of potentially dangerous blood clots.

In a joint statement Tuesday, the Centers for Disease Control and Prevention and the Food and Drug Administration said they were investigating unusual clots in six women that occurred 6 to 13 days after vaccination. The clots occurred in veins that drain blood from the brain and occurred together with low platelets. All six cases were in women between the ages of 18 and 48.

They are especially concerned with anyone who experiences severe headaches that are significant enough to seek treatment at an emergency room.

The reports appear similar to a rare, unusual type of clotting disorder that European authorities say is possibly linked to another COVID-19 vaccine not yet cleared in the U.S., from AstraZeneca.

In a joint media call with the FDA and CDC, the vaccine maker said there is concern not only with the risk of blood clots, but also treatment. The FDA said it needed to get the word out to doctors because if a blood clot caused by the vaccine is treated in a standard way, it could actually cause tremendous harm or could be deadly.

However, the agencies are only recommending a pause, not mandating providers stop giving the vaccine.

“It’s out of an abundance of caution, we’re recommending that the vaccine be paused in terms of its administration,” Dr. Peter Marks, Director of the FDA, said on a joint media call with J&J Tuesday morning. “However, if an individual healthcare provider has a conversation with an individual patient, and they determined that the benefit risk for that individual patient is appropriate, we’re not going to stop that provider from administering the vaccine because it could be, right, in many cases.”

More than 6.8 million doses of the J&J vaccine have been administered in the U.S., the vast majority with no or mild side effects. That includes more than 10,000 people here in the Kansas City metro.

Tuesday morning the states of Kansas and Missouri both confirmed they would pause vaccination clinics using the J&J vaccine. Pfizer and Moderna vaccines would continue to be available.

“The message to patients, I think, would be to those who haven’t been vaccinated continue to be to get vaccines that are available to them. Because the risks from the pandemic are significant, and the government is really looking into very carefully any safety problems so that they can be managed properly with this particular vaccine and all vaccines.” Janet Woodcock said on the joint call with the FDA and CDC.

“121 million people have been vaccinated with at least one dose of one of the three vaccines, and the vast majority of the doses were the other two products the Pfizer and Moderna products with our intensive safety monitoring. We have not detected this type of syndrome, with the low platelets among the other vaccines, and we have real world evidence now of the vaccine effectiveness in the US.” Dr. Schuchat, Principal Deputy Director of the CDC, said.

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