Va. woman’s death connected to Johnson & Johnson vaccine pause

March death is part of CDC investigation into vaccine's adverse side effects

Published April 13, 2021 by Kate Andrews

A 45-year-old Virginia woman’s death due to a rare blood clot days after receiving the Johnson & Johnson COVID-19 vaccine is connected to the Centers for Disease Control & Prevention’s call for a pause on administering the one-dose vaccine, state health officials confirmed Tuesday.

“The U.S. Centers for Disease Control & Prevention (CDC) confirmed to the Virginia Department of Health (VDH) that it is examining the March death of a Virginia woman as part of its investigation into possible adverse side effects from the Johnson & Johnson COVID-19 vaccine,” state vaccination coordinator Dr. Danny Avula said in a statement released Tuesday night.

The Virginia woman died on March 18 from stroke-like symptoms in a Virginia hospital, according to a CDC report in the public Vaccine Adverse Event Reporting System.

She went to the hospital March 17 complaining of a suddenly worsening headache, dry heaves and left-sided weakness. A CT scan revealed a brain hemorrhage. After being admitted, she was intubated “for worsening mental status.” After further decline, she was diagnosed as “brain dead” on March 18, the day she died. The CDC report does not confirm whether the death was caused by the vaccine, which she received March 6, and then began to feel ill six days later.

More than 6.8 million people have received Johnson & Johnson shots. The Virginia woman was one of six U.S. women between the ages of 18 and 48 who developed a rare blood clot disorder in combination with low levels of blood platelets within six to 13 days after receiving the Johnson & Johnson vaccine. She was the only one among the six who died from the clot, which is called cerebral venous sinus thrombosis.

“We are closely monitoring the actions by the federal government to pause all Johnson & Johnson vaccinations while it investigates an extremely rare possible side effect,” Avula said. “In Virginia, we will cease all Johnson & Johnson vaccines until this investigation is complete. If you have an upcoming appointment for the Johnson & Johnson vaccine, you will be contacted to reschedule that appointment.

“This pause is reassuring in that it demonstrates that the systems that are in place to monitor vaccine safety are working. We look forward to a thorough review by federal health officials. Meantime, we will continue Virginia’s vaccine rollout at this time with the other two authorized vaccines, developed by Pfizer and Moderna.”

VDH recommends that anyone who has received the Johnson & Johnson vaccine and develops severe headache, abdominal pain, leg pain or shortness of breath within three weeks after vaccination should contact their health care provider, or call 911 if it is a medical emergency.

The Food and Drug Administration and the CDC said in a joint statement Tuesday morning that the agencies are recommending a pause in the vaccine’s use, and they will not be offering Johnson & Johnson shots at federal clinics. Other states, including Ohio and Virginia, have followed suit in the hours after the announcement, advising health practitioners in their states to stop using the vaccine for now.

“We are recommending a pause in the use of this vaccine out of an abundance of caution. Right now, these adverse events appear to be extremely rare,” read the statement from Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, and CDC Principal Deputy Director Dr. Anne Schuchat.

The CDC will convene a meeting of the Advisory Committee on Immunization Practices (ACIP) Wednesday to further review the six blood-clot cases and assess their potential significance, according to VDH, and the FDA will review that analysis as it also investigates these cases.

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