Just after the region began dispensing Johnson & Johnson’s Janssen COVID-19 (J&J) vaccine at clinics, the CDC and the FDA recommended a pause in the use of the vaccine due to a small number of reports of blood clots.
On April 13, the departments called for a pause on the vaccine’s use after a small number of “rare and severe” blood clots were reported in people, all women between the ages of 18 and 48, after receiving the J&J vaccine. These symptoms occurred six to 13 days after vaccination. As of April 13, nearly seven million doses had been administered nation-wide.
As of April 13, the CDC reported that of the 189 million doses administered of the Pfizer and Moderna vaccines, “no reports matching those associated with the [J&J] vaccine have been received.”
Also on April 13, the CDC confirmed to the Virginia Department of Health that it is examining the March death of a Virginia woman as a part of its investigation into possible adverse side effects from the J&J vaccine.
Pittsylvania Danville Health District Director Dr. Scott Spillmann said that while correlation has not been determined to mean causation in this case, the pause of the use of the J&J vaccine is for citizen safety. What medical experts are looking into now is if there is causation.
“Association is not causation,” Spillmann said. “...Did the vaccine cause this or would this have happened without the vaccine?”
One aspect to be considered is if this is a random cluster, which Spillmann described as an event happening due solely to a large enough group being vaccinated, or a non random cluster, which would suggest causation.
Medical experts must determine how, if at all, the vaccination is related to the event.
For Spillmann, the whole pandemic, including the vaccine distribution process, has been a “worrisome issue,” in which treatment of most anything related to it has been scrutinized closely. If the same problem arose, referring to the small number of reported blood clots following the vaccination, from other medications, Spillmann said it might not have been paid attention to as much, other than the medication being pulled or adjusted.
“Almost every medication has some issues, but we have a process for this reason,” Spillmann said.
This process, Spillmann said, is important for eventually being able to resume J&J distribution. While some may want to resume quickly, it is vital to follow the process for medical experts to do their work. With millions of people now having received the vaccination, as opposed to 40,000 in the trials, there is a lot of new data and information to consider.
“If this problem was had with 40,000 people, the process [to get the vaccine out] would’ve taken longer, but this has now happened with 6 in 6.8 million people,” Spillmann said.
Locally, the J&J vaccine is not being used currently with most local clinics reverting back to the two-dose Pfizer or Moderna, including the Gretna Community Vaccine Clinic that most recently held two J&J clinics.
“Our health department and local vaccine coalition had done some J&J clinics and had good success, but we have ceased that completely,” Spillmann said.
The CDC states that those who have already received the J&J vaccine more than three weeks ago are not likely to develop a blood clot.
While the risk of developing a blood clot is still low for those who have received the vaccine within the last three weeks, they should still contact their healthcare providers and seek medical treatment urgently if they develop any of the following symptoms: severe headache, backache, new neurologic symptoms, severe abdominal pain, shortness of breath, leg swelling, tiny red spots on the skin (petachiae), or new or easy bruising.
Spillmann maintains that those who are giving the vaccinations at clinics feel the responsibility to do right by the people they are vaccinating and take it very seriously.
“They do not want to administer something that is not safe or will hurt people,” Spillmann said. “If this may hurt someone, we will look at this with caution.”