The Centers For Disease Control and Prevention is currently reviewing the death of a Michigan woman who received the Johnson & Johnson vaccine, though there is currently no evidence that her death and the vaccine are linked, officials said.
J&J vaccine pause
The Food and Drug Administration recommended pausing the use of the Johnson and & Johnson vaccine for a short time earlier this month as officials investigated a rare instance of blood clots forming in a few women who received the shot.
On April 12, 6.8 million doses of the Johnson & Johnson vaccine had been administered across the country, and six cases of the blood clot had been identified.
In other words, only 0.00008% of Johnson & Johnson recipients were affected, according to experts.
Officials said a type of blood clot called cerebral venous sinus thrombosis and low levels of blood platelets were seen in these cases.
All six of the reported blood slot cases were in women between the ages of 18 and 48. Symptoms surfaced six to 13 days after receiving the vaccine, officials said.
Usually, an anticoagulant drug called heparin is used to treat blood clots, but in these instances, alternate treatments are used because administration of heparin could be dangerous, officials said.
Michigan officially paused its use of the Johnson & Johnson vaccine later that day.
“More than 6.8 million doses of the Johnson & Johnson vaccine have been administered in the U.S., and these adverse events appear to be extremely rare,” said Dr. Joneigh Khaldun, chief medical executive of the Michigan Department of Health and Human Services. “However, out of an abundance of caution, we are following recommendations from FDA and CDC and pausing the use of the Johnson & Johnson vaccine in Michigan.”
Nearly 200,000 doses of the Johnson & Johnson vaccine had been administered in Michigan, as of April 12.
Administration resumes
Eleven days after its recommendation to pause the use of the Johnson & Johnson vaccine, the CDC gave the green light to resume administration.
The outside panel of experts said the benefits of the single dose vaccine in preventing COVID-19 infections and deaths outweighed the risks. The FDA agreed to include a warning statement with the Emergency Use Authorization detailing the risk of rare blood clots.
By this time -- April 23 -- health officials had confirmed 15 cases of the rare blood clots, including three deaths. Nearly 8 million doses of the Johnson & Johnson vaccine had been administered.
All 15 cases were in women, but the CDC said it can’t rule out risk for men.
“There could be cases that simply weren’t reported and there could be cases that become apparent later on that just haven’t appeared,” said Dr. Tom Shimabukuro, of the CDC COVID-19 response team. “As of now we had zero cases in males.”
The highest risk was in women, ages 30-39. In that age group, the risk was 11.8 per million.
The manufacturer of the Johnson & Johnson vaccine stressed that there are unique benefits to having a single-dose vaccine that can be stored at refrigerator temperatures.
“An absent or a restricted Johnson & Johnson vaccine will not just delay the full vaccination of the U.S. population but potentially leave unvaccinated a portion of the population,” Dr. Mathai Mammen said.
Michigan followed suit and restarted its use of the Johnson & Johnson vaccine the next day.
Starting Tuesday (May 4) Ford Field is offering walk-in appointments for the Johnson & Johnson vaccine. That offer includes anyone 18 and older and will last until May 17.
Michigan woman’s death
The family of Annie VanGeest, 35, of Saranac in Ionia County, released a statement after her death that she died “as the result of complications after receiving the Johnson & Johnson COVID-19 vaccine.”
Health experts have not yet found any evidence that the vaccine was connected to her death.
VanGeest received the Johnson & Johnson vaccine April 8 -- five days before the CDC recommended the pause in administration.
VanGeest’s family said she developed a headache that started April 16. She died three days later, officials said.
Her death certificate says VanGeest died a natural death from an acute subarachnoid hemorrhage, or bleeding between the brain and tissue around the brain.
You can watch Jason Colthorp’s full report on her story below.
VAERS report
VanGeest’s physician filed a Vaccine Adverse Event Reporting System (VAERS) report to the CDC.
VAERS is a vaccine safety system managed by the CDC and FDA that takes reports of possible adverse events or side effects after vaccinations. Its viewed more as an early warning system than an investigative tool after possible cases.
When VAERS receives a report of serious illness or death after someone receives a vaccine, the hospital where the patient was treated is contacted for medical records to better understand what happened.
Health officials acknowledged when they resumed administration of the Johnson & Johnson vaccine that there would likely be more cases of the rare blood clots, but they believe doctors have a better understanding of how to treat them.
Doctors reiterated that there is currently no evidence that VanGeest died from a clot in the brain. The death certificate said she had bleeding in her brain, which is different than a clot.
Subarachnoid hemorrhages -- the official cause of death listed on VanGeest’s death certificate -- didn’t have anything to do with why use of the Johnson & Johnson vaccine was paused.
