Virginia has paused use of the Johnson & Johnson COVID-19 vaccine while federal agencies investigate to determine whether it caused rare blood clots in six women, one of whom died.
The Centers for Disease Control and Prevention and the Food and Drug Administration Tuesday morning recommended vaccinators stop using the one-dose vaccine until they can investigate. About 7 million Americans have received the vaccine.
Dr. Danny Avula, coordinator of the state’s COVID-19 vaccine campaign, said the woman who died might have lived in Virginia. A Virginia Department of Health staff member on Tuesday found a Virginia case in the CDC’s adverse event system that fits the profile of the reported J&J cases. Avula said he is asking the CDC if this woman is part of the investigation, and if not, whether she should be included.
The CDC report says a 45-year-old woman who was vaccinated March 6 began to have gradually worsening headaches that started March 12. She went to a hospital March 17 with sudden worsening headache and left-side weakness, and died a day later.
The report does not say where in Virginia she had lived, only that she was vaccinated at a school on the first weekend after J&J won FDA emergency-use approval.
Avula said Virginia had planned to give out about 70,000 shots of the J&J vaccine this week but is swapping in Pfizer and Moderna vaccines for clinics early in the week. About 184,000 doses of the J&J vaccine have already been administered in Virginia, including 16,000 in the Roanoke City and Alleghany Health Districts. Nationwide, nearly 7 million doses have been given.
“I can’t state enough: Six cases out of 6.8 million is an exceedingly rare number for a serious side effect,” Avula said during a media briefing. “I think the reason they did it with such low incidences is because everybody recognizes how important public trust is in the process, in the government, so I think they were very conservative about pausing because they know we need to maintain trust.”
Dr. Cynthia Morrow, director of the Roanoke City and Alleghany Health Districts, said during her regular media briefing Tuesday that her districts had not received any J&J doses this week or last. A small number of doses set aside for a small clinic will not be used, and either the Pfizer or Moderna vaccine will be substituted, she said.
Johnson & Johnson has missed its supply schedule because of a manufacturing mix-up at one of its subcontractors. Virginia this week was set to received 14,800 doses instead of the 125,000 that were expected.
The pause by the government is to investigate whether rare blood clots that developed in six women following their vaccinations were caused by the vaccine.
“The most important thing is, one, if it does turn out to be associated with the vaccine, it is extremely rare. And, two, for me as a public health official what this says is that our system works. I think that is really critical for everyone to understand,” Morrow said.
She said she hopes that people will still want to be vaccinated and that so far no serious side effects have occurred in hundreds of millions of people vaccinated with the Pfizer and Moderna vaccines.
“I do have confidence in our process that has allowed us to identify that six people out of 7 million people may have a complication. That is extraordinary from a systems perspective,” Morrow said. “If the investigation unfolds and shows this is not causation but correlation, then that gives me confidence because I know that everything was done that needed to be done to prove this is a safe and effective vaccine. So the right thing to do is to pause vaccine administration until we can answer this question.”
She said that no one who has received the J&J vaccine in her districts has had serious side effects. She said if someone has a severe headache, shortness of breath or pain in legs or abdomen, they should seek medical treatment.
Morrow said that supplies of the Pfizer and Moderna vaccines coming into the district are exceeding demand and that appointments are available at the large clinics. She said they will begin to shift the campaign to smaller, targeted clinics.
Avula said that health districts across the state are experiencing similar shifts in demand as more open up vaccinations to the general public. He said he said it is possible that federal agencies will have enough information on Wednesday to determine whether to restart J&J vaccinations, but it could take several days or a week.
He said people might become more hesitant about vaccines because of the potential issue with the J&J vaccine, and similarly with AstraZeneca’s vaccine, which is not yet approved for use in the U.S. Blood clots and strokes also caused a pause in its use.
Avula said that both of those vaccines use a shell of a common cold virus, and that there might be more to learn about that platform.
“But hopefully that will be reassuring to people who receive Pfizer and Moderna vaccine, that is a different vaccine on a different platform and we have not seen those patterns yet,” he said.
Even if the J&J vaccine is linked to clots, Avula said it could come down to weighing the risks — comparing six cases, with one fatality, out of 6.8 million shots against the 10% of Americans, about 31 million, who have gotten COVID-19, with 1 out of 585 dying.