Virginia puts J&J vaccine on hold, CDC investigates reports of rare blood clots

Virginia’s public health officials announced Tuesday morning that the state will temporarily stop administering doses of the Johnson & Johnson vaccine, following reports of very rare but severe blood clots.

The U.S. Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) released a joint statement early Tuesday recommending the pause. “This is important, in part, to ensure that the health care provider community is aware of the potential for these adverse events and can plan for proper recognition and management due to the unique treatment required with this type of blood clot,” the agencies said.

An advisory committee convened on Wednesday to begin investigating six cases of blood clots. According to a statement released by the Food and Drug administration, “All six cases occurred among women between the ages of 18 and 48, and symptoms occurred 6 to 13 days after vaccination.”

The CDC confirmed on Tuesday afternoon that the death of a 45-yearold Virginia woman is among the six cases under investigation. The woman received her vaccine on March 6. The Virginia woman is the only one of the six cases to have died. Officials have not released the woman’s name or where she lived.

Latest numbers from the CDC show that more than 6.8 million Americans have gotten the Johnson & Johnson shot. The Richmond Times-Dispatch on Tuesday morning cited a UC San Diego Health Study that found COVID-19 disease is far more likely — about 20 percent more likely — to cause a dangerous blood clotting disorder than any COVID-19 vaccine currently authorized in the U.S.

Based on current reports, the chance of developing a blood clot is 0.00000088 percent. Dr. Avula, Virginia’s vaccine coordinator, explained that because this adverse response is so rare, it “didn’t show up on the scale of tens of thousands” in the clinical trial. “Part of what happens at this stage of investigation is trying to determine, is this happening at a rate higher than you would normally expect in the population? … And what may come of this is clarity on subsets of the population who may not be recommended to get the Johnson & Johnson vaccine.”

In an abundance of caution, Avula said Virginia would follow the CDC’s recommendation to temporarily pause on administering Johnson & Johnson doses. The pause may take only a few days, Avula said. The state is awaiting the results of the investigation.

“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. “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,” Avula continued. “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.”

Avula said that Virginians who have received a Johnson & Johnson vaccine a month ago or more are likely at very minimal risk. “If you have had your vaccine more recently, then there are several symptoms that we should all be looking out for,” he said. Those symptoms are: severe, acute-onset headaches; abdominal pain; leg pain; or acute-onset shortness of breath. Avula said anyone experiencing one or more of those symptoms should talk to their healthcare provider and seek medical attention immediately.

Former FDA Commissioner Scott Gottlieb told NBC 4 that “there are three concerns I would have right now from a policy standpoint. First, this vaccine was being biased to use in more austere settings, places where you couldn’t deliver two doses … so now you’re going to figure out how you’re going to get the mRNA vaccines into those environments.

“Two, this will fuel the hesitancy. … Even if there’s not a causal relationship, even if this is exceedingly rare,” Gottlieb said. And third, Gottlieb added, the Johnson & Johnson vaccine was supposed to be a vital part of the global vaccination effort.

But back at home in Virginia, what does the pause mean for the state’s COVID-19 vaccination program? “This will not impact our ability to move into Phase 2,” Avula said. “What it will do is just slow down the progress through Phase 2. We will not be able to have quite as many appointments available for first doses next week and beyond until we have more news about whether we can start using Johnson & Johnson again.”

About 72,000 doses of Johnson & Johnson were scheduled to be administered between Tuesday and next week’s delivery of vaccines and Avula said those had been postponed. Those accounted for roughly 15 percent of the doses the state was planning to administer in the coming days.

As of Wednesday, 37 percent of Virginians have received at least one dose of COVID-19 vaccine and nearly 22 percent are fully vaccinated. In Rappahannock County, 2,996 residents have received one dose and 1,964 are fully vaccinated.