Virginia woman’s death following Johnson & Johnson vaccination part of U.S. investigation into possible rare blood clot side effect

A 45-year-old Virginia woman died in mid-March of a stroke-like syndrome shortly after her Johnson & Johnson vaccination.

State public health officials said the U.S. Centers for Disease Control and Prevention confirmed for them late Tuesday the case was one of six the federal agency is investigating for a rare blood clot side effect thought to be linked to the drugmaker’s single-dose vaccine.

Virginia has stopped using Johnson & Johnson’s vaccine while federal health officials conduct the probe. That decision was made Tuesday morning following a recommendation from the CDC and Food and Drug Administration to “pause” administration while they look into an unusual but serious disorder involving blood clots.

Six women between the ages of 18 and 48 in the United States have suffered clots known as cerebral venous sinus thrombosis six to 13 days after vaccination. The Virginia woman was the one death, and another person is in critical condition.

The clots were observed in the sinuses of the brain in combination with low levels of platelets — making the usual treatment, the blood thinner heparin, potentially “dangerous.” Federal health officials declined to speculate Tuesday how many other suspected cases would be under review.

A report in the Vaccine Adverse Event Reporting System, the national surveillance system, indicates the Virginia woman died after having received her J&J vaccine just two weeks earlier. The woman went to a hospital March 17 after experiencing a worsening headache, and imaging revealed bleeding within her brain. She was intubated, then died the next day, according to that report.

Moderna and Pfizer, the other two authorized vaccines, make up the vast share of COVID-19 shots administered in the United States and are not affected by the suspension. CDC officials say there’s no evidence of this rare syndrome occurring in the other shots.

The decision will indefinitely impact thousands of would-be J&J vaccinations. For this week, Virginia received 15,000 of the drugmaker’s doses — a significantly smaller batch than the 125,000 originally expected — because of a mixing problem that resulted in 15 million doses being ruined.

But the state had about 58,000 doses left over from supplies received last week. Combined, about 72,000 vaccinations planned statewide this week have been postponed due to the change. That has impacted 30 events, Avula said, and about 15% of the vaccinations the state expected to do over the week.

Doctors who see patients with either a low blood platelet count or blood clots should establish whether they have recently gotten the shot, federal health officials said.

Vaccinated people should also seek medical attention for symptoms such as severe headache, abdominal pain, leg pain and shortness of breath that occur within a couple of weeks of receiving their shots. These symptoms are “different from the mild flu-like symptoms, fever and so forth, that many people experience in the couple of days after the vaccine,” said Dr. Anne Schuchat, the CDC’s principal deputy director, during a briefing Tuesday.

For those who received a J&J shot a month or more ago, the risk of the stroke-like syndrome is considered extremely low. About 184,400 Virginians — or 10% of the state’s vaccinated population — have been inoculated with J&J.

Virginia public health officials say if you have an upcoming appointment for the J&J vaccine, you will be contacted to reschedule. U.S. distribution channels, including mass vaccination sites, are also delaying the use of the J&J shot.

“Our partners will be working to reschedule people who have the J&J vaccine appointments in the days ahead,” Schuchat said. “This may be a bit bumpy.”

CDC’s Advisory Committee on Immunization Practices will meet Wednesday to discuss the cases and the FDA has also launched an investigation into the cause of the clots and low platelet counts.

Federal officials expect the suspension to be a “matter of days” while they review the cases and deliberate. The hold on using the vaccine is a recommendation only — not a mandate, they said.

The ripple effects were already happening in Hampton Roads early Tuesday. Christopher Newport University had plans to vaccinate faculty and students with J&J vaccines through a partnership with Riverside Health.

Adelia Thompson, the university’s chief of staff, said the hospital system would replace the brand with Moderna vaccines, which rely on a two-dose series given four weeks apart. But the switch may cause a problem for some students who will leave campus before the second shot comes due.

Thompson said the university would work with those students to help them access second doses in their hometowns.

“Everyone scheduled to receive the vaccine today will be able to keep those appointments,” she said in a statement. “Everyone receiving the vaccine will also be given clear instructions about where to go to receive the second dose.”

Virginia public health officials say the pause should be reassuring to people because it demonstrates the systems in place to monitor vaccine safety are working.

The J&J vaccine, sometimes referred to as the one-and-done shot, has been considered a critical tool in upending the pandemic around the world because it only requires one injection, rather than two. The drug can be shipped and stored at standard fridge temperatures, and the company has pledged to sell the vaccine without a profit during the public health crisis.

The decision to suspend J&J vaccinations was a quick turnabout from state officials’ position Friday.

During a call with reporters, The Virginian-Pilot asked Dr. Danny Avula, state vaccination coordinator, about several reports of dizziness and fainting — unrelated to the blood-clotting concerns — resulting in a large J&J clinic being shut down early in North Carolina while federal officials reviewed the matter.

When asked whether Virginia would consider halting J&J vaccinations, he said at the time there were no concerns.

“We will certainly continue to listen for any new developments, but I think at the end of the day, 12 or so folks who have dizziness and nausea doesn’t seem so out of the ordinary, but I can understand from the perspective of a clinical officer on the ground, who’s monitoring that and seeing something out of the ordinary here, totally understand the reason for the pause,” Avula said then. “I think they did all the right things to follow up with the CDC and to look into it further, and so far they haven’t found any reasons to not continue using that lot.”

North Carolina health officials said Thursday they stopped administering J&J doses at a mass vaccination site in Raleigh and at clinics in Hillsborough and Chapel Hill after at least 26 people experienced adverse reactions, including fainting. Four people were taken to hospitals.

The CDC noted reactions like fainting are not uncommon after someone is vaccinated, though it was reviewing similar reports in four states.

More than 6.8 million doses of the J&J vaccine have been administered in the United States, the vast majority with no or mild side effects.

The Associated Press contributed to this report.

Elisha Sauers, 757-839-4754, elisha.sauers@pilotonline.com