Health officials: Pause J&J shots
‘Extremely rare’ cases of blood clotting cited
The Oklahoma State Department of Health has asked all vaccine sites across the state to immediately pause giving Johnson & Johnson vaccinations after two federal agencies recommended doing so, citing “extremely rare” cases of blood clotting in people who had received the one-shot COVID-19 vaccine.
In a joint statement Tuesday from leaders of the Food and Drug Administration and the Centers for Disease Control and Prevention, the agencies recommended a pause “out of an abundance of caution.”
They pointed to six U.S. cases of a severe type of blood clot in people who had received the vaccine — less than
“Today’s action demonstrates the sensitivity of our monitoring system and our commitment to take any potential adverse reaction very seriously.” Keith Reed, Deputy Commissioner of Health
one in a million of the more than 6.8 million doses of the Johnson & Johnson vaccine that had been distributed in the U.S. as of Monday.
“Right now, these adverse events appear to be extremely rare,” Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research and Dr. Anne Schuchat, Principal Deputy Director of the CDC, said in the joint statement. “COVID-19 vaccine safety is a top priority for the federal government, and we take all reports of health problems following COVID-19 vaccination very seriously.”
The six cases were among women ages 18 to 48, and their symptoms occurred between six to 13 days after they were vaccinated. USA TODAY reported that one of the women died and one was hospitalized in critical condition.
In a statement, Johnson & Johnson said it was proactively delaying the rollout of its vaccine in Europe.
The CDC’s Advisory Committee on Immunization Practices will meet Wednesday to review the six cases. The FDA will review the committee’s analysis.
Oklahoma’s response
State health officials learned about the recommendation to pause administration of the vaccine the same time the public did early Tuesday morning.
Within a few hours, the Oklahoma State Department of Health had asked vaccine providers across the state to stop giving doses of the Johnson & Johnson vaccine.
“I want to stress that this type of potential adverse reaction following administration of the Johnson & Johnson vaccine is extremely rare — it has occurred in less than one in every million patients,” Health Commissioner Dr. Lance Frye said. “However, the health and safety of Oklahomans remains our top priority, and we feel it best to pause the administration’s vaccine in alignment with the CDC and FDA recommendations until more data on this potential adverse reaction is available.”
Across the state, 62,000 doses of the Johnson & Johnson vaccine have been administered, which accounts for about 2.5% of the state’s total vaccine administration. Deputy Commissioner of Health Keith Reed said the state has no reason to believe any Oklahomans have been affected by the rare blood clotting response.
Effect on vaccine supply and scheduling
The pause in administration will have a “minimal impact” on the state’s vaccination efforts, Reed said. Oklahoma has enough doses of Pfizer and Moderna vaccines on hand to ensure that any Oklahoman who wants a shot can get one, he said.
The pause affects roughly 60,000 doses of the Johnson & Johnson vaccine in Oklahoma’s inventory. About another 60,000 doses of the vaccine in the state are part of federal vaccine inventory, Reed estimated.
It’s unclear how long the Johnson & Johnson pause might last – maybe a week or more, Reed guessed. But he said a temporary pause likely wouldn’t pose an issue for the state, since the vaccine doses can be stored for a few months.
“Today’s action demonstrates the sensitivity of our monitoring system and our commitment to take any potential adverse reaction very seriously,” Reed said. “After the administration of tens of millions of doses across the country, the Moderna and Pfizer vaccine have proven to be extremely safe. We continue to encourage all Oklahomans to get their shot to protect themselves and loved ones.”
The Oklahoma City-County Health Department said in a statement that the department immediately paused giving the Johnson & Johnson vaccine after the recommendation Tuesday.
The department also paused allocating Johnson & Johnson vaccines to its partners in Oklahoma County, including the four major hospital systems and medical clinics, until the federal review of the vaccine is complete. As of Tuesday, 9,974 doses of the Johnson & Johnson vaccine have been given in Oklahoma County, about 2.3% of the total vaccinations administered in the county.
Several providers had to shift plans to give doses of the Johnson & Johnson vaccine this week. IMMY Labs, for example, had multiple events this week to provide Johnson & Johnson vaccines. Those were canceled and replaced with first-dose Pfizer events.
The state Health Department said it was working with vaccine providers to offer Pfizer and Moderna as alternatives for those who had already scheduled an appointment to receive a Johnson & Johnson vaccine.
Providers that don’t have Pfizer or Moderna on hand will reach out to patients to reschedule, according to the state Health Department.
What do we know about the blood clotting disorder that prompted this pause?
It’s a rare, but not unheard-of, condition called cerebral venous sinus thrombosis, said Dr. Dale Bratzler, Chief COVID Officer at the University of Oklahoma.
“It is a condition that I’ve seen cases of in the past, though not recently. We occasionally see it in kids with sickle cell anemia, you can occasionally see it in patients who are pregnant,” he said. “The numbers I was reviewing this morning said it’s pretty rare: five to 10 cases per million people.”
At this point, it’s unclear whether the six women who developed the severe, rare clotting disorder had any underlying health condition in common.
“That’s ... what I think CDC and FDA are going to do, is do that very deep dive into what caused these particular women to develop these blood clots,” Bratzler said. “It could be genetic, it could be environmental. It could be some underlying medical condition — we don’t know.”
Dr. Gitanjali Pai, an infectious disease specialist, said experts believe the six cases of clotting could be a result of an immune response after receiving a vaccine.
This type of blood clots are treated differently than other blood clots, she said.
What should you do if you’ve had the Johnson & Johnson vaccine?
First, remember that this type of clotting after a Johnson & Johnson vaccine is very rare, experts said.
Dr. Aaron Wendelboe, an epidemiologist and a professor at the OU College of Public Health, put the clotting cases in context: a person in Oklahoma is 100 times more likely to die in a car crash than to get a blood clot from the Johnson & Johnson vaccine, he said at a news conference with the Healthier Oklahoma Coalition.
Health experts urged people to keep the vaccine news in perspective.
“If you calculate the percentage chance that an individual would have the side effect, it’s a really, really tiny percentage,” Bratzler said.
You can look out for symptoms that may indicate an adverse reaction, Pai said. If you received a Johnson & Johnson vaccine more than a month ago, your risk of blood clotting is very low, she said.
“If you received the vaccine one to three weeks ago and have experienced the following symptoms, you should call your personal health care provider: severe headache, abdominal pain, leg pain or shortness of breath,” Pai said.
Those symptoms would feel markedly different from the typical flu-like symptoms that are common side effects of many vaccinations, she said.
It’s not uncommon to feel tired or nauseated and experience muscle pain after a COVID-19 vaccine. Other common side effects include headaches, fever and chills, as well as soreness or redness on the arm you received your shot. Those typically go away within a few days of receiving a shot.