FDA pause J&J COVID-19 vaccine; 6 blood clotting cases reported


FDA Dr. Peter Marks: 1 death, 1 patient in critical condition

ARKANSAS (KNWA/KFTA) — Nearly 7 million doses of the Johnson & Johnson (Janssen) COVID-19 vaccine have been administered in the U.S. as of April 12, according to the Centers for Disease Control (CDC).

After reviewing data, the CDC said there have been six reported cases in the U.S. that have caused a rare and severe type of blood clot. Because of this, the FDA recommended to “pause” the use of the single-dose Johnson & Johnson vaccine.

“In these cases, a type of blood clot called cerebral venous sinus thrombosis (CVST) was seen in combination with low levels of blood platelets (thrombocytopenia),” the CDC stated.

FDA Center for Biologics Evaluation and Research Director Dr. Peter Marks said they are reviewing data, “involving six reports of a rare type of blood clot … of the clots seen in the United States, one case was fatal and one patient is in critical condition.”

On Wednesday, April 13, the CDC’s Advisory Committee on Immunization Practices (ACIP) will meet to review the situation. Arkansas Secretary of Health Dr. José, Romero chairs the ACIP.

Dr. Romero acknowledged a positive of the situation and that is the country’s Vaccine Adverse Event Reporting System VAERS). “For the system to find these very rare events to be detected … the system has been in place for decades. This is a success story [referring to the VAERS system],” said Dr. Romero at the governor’s COVID-19 weekly briefing on Tuesday, April 13.

The six cases involved women between the ages of 18 and 48. Symptoms happened six to 13 days after getting vaccinated.

Treatment for CVST is different than other types of blood clots. Usually, an anticoagulant drug, heparin, is used, but in this setting that may be dangerous, and another treatment drug needs to be given, according to the CDC.

People who have received the J&J vaccine who develop a severe headache, abdominal pain, leg pain, or shortness of breath within three weeks after vaccination should contact their health care provider. 

Health care providers are asked to report adverse events to the Vaccine Adverse Event Reporting System

“Right now, these adverse events appear to be extremely rare. COVID-19 vaccine safety is a top priority for the federal government, and we take all reports of health problems following the COVID-19 vaccination very seriously,” said the CDC.

The Food and Drug Administration (FDA) is also doing its own investigation of the Janssen vaccine.

The vaccine received emergency use authorization (EUA) from the FDA in late February.

The ACIP met from February 28 to March 1, 2021, about COVID-19 vaccines. The committee, and other doctors, reviewed Janssen’s single-dose vaccine in five different reports.

Copyright 2021 Nexstar Media Inc. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.

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