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NEW BRUNSWICK, NJ—The Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) on April 13 recommended a pause in the use of the Johnson & Johnson (J&J) Janssen COVID-19 vaccine.
Dr. Janet Woodcock, Acting FDA Commissioner, told reporters that half a dozen “cases of a rare and severe type of blood clot, following vaccine administration,” had occurred nationwide in women between the ages of 18 and 48, about a week to nearly two weeks following administration.
“Of the clots seen in the United States, one case was fatal and one patient is in critical condition,” said Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research.
The woman who died was a resident of Virginia, while the woman in the hospital was a resident of Nebraska.
Woodcock stressed that the events “appear to be extremely rare,” and that the stoppage was to fully understand the events, but also get information out to health care providers and vaccine recipients.
More than 6.8 million doses of J&J’s vaccine have been administered to people, as of April 12. And while less than one in a million doses of the Janssen vaccine are correlated with the disorder, the pause reportedly represents a dramatic step.
Based in New Brunswick since the 1880’s, Johnson & Johnson was the third pharmaceutical company to secure an emergency use authorization for a COVID-19 vaccine since the COVID-19 virus was declared a pandemic on March 11, 2020. One year later, the J&J vaccine was being shipping out, and hailed as a “gamechanger.”
More than 244,000 people received J&J’s vaccine in New Jersey. But none have reported serious adverse symptoms, according to officials, who said that no one should panic if they already received the shot.
Dr. Vivek Murphy, Surgeon General of the United States, said April 14 on the Rachel Maddow Show on MSNBC that the main concern was the cases were rare, but serious blood clots that developed in the women.
“And in one case somebody died,” Murphy said. “And so the CDC made the difficult, but important decision with the FDA to take time to investigate it and to push pause by giving further vaccine until we could determine if there’s a connection between the vaccine and these dangerous blood clots.”
He explained that it’s not an uncommon move for new drugs and when new vaccines come out, it’s not unusual to pause when you see a signal to investigate it and then to unpause and resume with modifications or stop altogether.
“This is a reflection of how deeply we are prioritizing safety, recognizing that if we want people to take this vaccine they’ve got to know it’s effective and safe,” added Murphy.
But the unique combination of blood clots, together with low platelets, prompted the pause, though clots are not rare and happen with a significant frequency.
“What was unusual about this is that these blood clots were happening at the same time as another finding, which were low platelet counts,” Murphy said. “Platelets are the cells that help your body in the clotting process. The fact that you had clotting at the same time that you had low platelets was a warning sign.”
Treatment does not call for counteracting with typical blood thinners, as is usual with routine clots, added the doctor.
Murphy said the recommendation was instituted to allow the time for officials to speak to and engage the medical community in hopes that they be on the lookout for similar symptoms in other patients.
A CDC Advisory Committee on Immunization Practices (ACIP) is meeting to further review the cases and assess their potential significance. FDA will review that analysis as it also investigates the cases. 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 New Jersey Department of Health on April 13 paused the administration of J&J’s vaccine at all vaccination sites in the state.
“All New Jersey vaccination sites have been told to cancel or put on hold appointments for the J&J vaccine until further notice,” Judith Persichilli, New Jersey’s health commissioner said on April 13.
“For individuals scheduled to receive the J&J vaccine, the department will work with all vaccination sites to make arrangements for the administration of an alternative two-dose vaccine.”
J&J said on April 14 that it would proactively delay the rollout of its vaccine in Europe.
“We are aware of an extremely rare disorder involving people with blood clots in combination with low platelets in a small number of individuals who have received our COVID-19 vaccine,” said J&J in a news release. “We strongly support the open communication of this information to health care professionals and the public.”
Many people who receive the vaccines may reportedly experience flu-like symptoms for a few days. These may include fatigue, low grade fever, chills, nausea, or a mild headache.
But symptoms of deeper concern — that indicate a doctor should be called if a person received J&J’s vaccine, include: severe headaches, abdominal pain, swelling in the legs, or a shortness of breath, which may indicate a clot has traveled to the lungs.
“As a person who personally received the Johnson & Johnson vaccine within the last week, who turned 48 at the same time, I felt like on the one hand you never want to wake up and see the headline that says ‘oh this thing you got turns out that there might be an issue,’” Maddow said on her April 14 broadcast. “I feel a little bit of a sense of relief knowing that this is a decision that was made [by officials] based on the science… They want to make sure that they’re nailing down any potential danger… I can tell you that I’m having both of those feelings at once.”
Several hospitals in the Garden State, including Robert Wood Johnson University Hospital in New Brunswick, confirmed said they had paused shots of J&J’s vaccine, after the CDC and FDA advisory was released.