PHILADELPHIA (KYW Newsradio) — U.S. health officials are recommending a pause in the use of the Johnson & Johnson COVID-19 vaccine as they investigate six cases of rare and severe blood clots.
Following the announcement Tuesday morning, Pennsylvania, New Jersey, Delaware and the City of Philadelphia ordered providers to pause use of the J&J vaccine.
In a joint statement released Tuesday morning, the Food and Drug Administration and the Centers for Disease Control and Prevention said the recommendation was made “out of an abundance of caution.”
In a statement released on Tuesday, the drugmaker said also that they will delay their rollout in Europe, after reviewing cases with health authorities there.
According to a CDC report, the six people who became sick are women between 18 and 48 years old. One of the them died, and another is in the hospital in critical condition.
U.S. health officials stress that “these adverse events appear to be extremely rare.” These six cases are out of 6.8 million doses that have been administered in the United States as of Monday.
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"While these events are very rare, we’re recommending a pause in the use of the J&J COVID-19 vaccine in order to prepare the health care system to recognize and treat patients appropriately," said CDC Deputy Director Dr. Anne Schuchat.
FDA researchers say one of the primary concerns is the typical treatment for blood clots could be fatal if given to someone with this disorder. So part of the pause is to put health care workers on alert.
"So one needs to make sure that providers are aware if they see people who have low blood platelets or if they see people who have bloods clots, they need to inquire about a history of recent vaccination," said Dr. Peter Marks, director of the FDA Center for Biologics Evaluation and Research.
Anyone who received a J&J shot in the last three weeks is advised to be alert for symptoms of a clot. These include severe headache, abdominal pain, leg pain or shortness of breath, which they say are different from the flu-like symptoms most people get after vaccination.
Officials say it will be at least a matter of days before they would recommend resuming use of the vaccine.
KYW Medical Editor Dr. Brian McDonough said regulators are doing the right thing and should be as transparent as possible.
“It’s essential to keep building trust with the vaccines. What you don’t want to do is give even the perception that you’re hiding something or not looking at something totally and thoroughly,” McDonough said.
Pennsylvania acting Health Secretary Alison Beam said she hopes this shows the federal government is committed to protecting everyone.
"The federal action that was taken today is really indictive of our dedication to making sure this entire process is monitored so tightly, and with such integrity, that folks really can trust in the vaccine they are getting," Beam said. "We hope that continues with the Moderna and Pfizer vaccines while we have the Johnson and Johnson vaccine on pause."
U.S. federal distribution channels, including mass vaccination sites, will pause the use of the J&J shot, and states and other providers are expected to follow.
Regional impact
Both the Pennsylvania and New Jersey health departments ordered vaccine providers on Tuesday morning to follow suit and pause the use of J&J pending a review. The Pennsylvania Department of Health says the pause will least one week.
Gov. Phil Murphy said adverse reactions were extremely rare, and he called the statewide pause a "precautionary and smart step."
The Philadelphia Department of Public Health, whose vaccine distribution operation is separate from that of the state, issued a statement saying that the city and all partner clinics have paused the use of this vaccine until they get more guidance.
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FEMA’s main clinic, at the Pennsylvania Convention Center, was preparing to switch over to the J&J vaccine on Tuesday, but the agency has pivoted back to Pfizer, using the city’s own supply temporarily so that it can continue its pace of 6,000 shots a day.
This will require that people return for a second shot, which means the clinic will be staying in Philadelphia beyond its original closing date.
The new FEMA clinic at Esperanza in North Philadelphia, however, is closed Tuesday, and any appointments there will have to be rescheduled.
The same is true of the Philadelphia Fire Department clinic in Oak Lane. The department is cancelling its clinics until next week. The health department says all the other providers should be able to switch back to Pfizer or Moderna.
Philadelphia Department of Public Health Commissioner Tom Farley said several hundred appointments had to be rescheduled, but the city still plans to open vaccines to all adults Monday and should be done giving them to every resident who wants one by the end of June.
"This is a setback, but I would consider it to be a small setback in a program that is, overall, very successful," said Farley.
The city has administered more than a million shots. Just over 26,000 were Johnson & Johnson.
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All clinics in southeastern Pennsylvania that were using the J&J vaccine over the next few days are being cancelled, but Moderna and Pfizer clinics will continue to operate.
Bucks County Commissioner Bob Harvie says they are reaching out to everyone who had an appointment for J&J to let them know their appointment is postponed for now.
"Obviously until we know more about the J&J, we can’t reschedule anybody for that specific dose," he said.
Harvie says other vaccine clinics are not affected, but their schedules are at capacity for the next couple weeks for Moderna and Pfizer, so they can’t shift people at this point.
Clinics in Delaware and Chester counties will shift to other vaccines where possible, and the clinic at Delaware County Community College will have to relocate.
Montgomery County’s Pfizer vaccine will continue as planned, but the Willow Grove, Lansdale and Pottstown clinics are suspended. Dr. Eric Sachinwalla, medical director for infection prevention and control for Einstein Medical Center, says it’s a good reminder that safety surveillance doesn’t stop after a vaccine is released into the market.
"I think it’s the right thing to do, reassess when we have a potential concern to make sure it’s not something significant, that we need to change how we handle the entire vaccine roll-out which I don’t think it is."
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In Camden County, the nearly 1,600 patients who were to get the one-dose J&J vaccine Wednesday and Saturday at Camden County College will be given either the Moderna or the Pfizer vaccine, said county spokesman Dan Keashen.
"All of those appointments will still be honored at the same times, but the vaccine will be different," Keashen said.
Burlington County has administered the J&J vaccine to about 1,000 homebound people, those in domestic violence shelters and other vulnerable populations.
The county will be reaching out to them, but says no adverse reactions have been reported.
“COVID-19 vaccines are safe and effective and the best weapon we have to bringing an end to the pandemic,” Burlington County Health Department Director Herb Conaway said in a statement.
“This pause is out of an abundance of caution and shows the process is working to review all potentially adverse effects of vaccination.”
The J&J vaccine makes up only 4% of the COVID-19 vaccines given in New Jersey, and the governor says no adverse side effects have been reported so far.
"In New Jersey we have administered roughly 235,000 doses of the J&J vaccine with no similar reported adverse effects. No one who has received this vaccine should panic or worry," Murphy said.
As to whether the pause would discourage people who were already hesitant to get the vaccine, Keashen said Camden County’s strategy is to double-down on community outreach.
“Utilizing stakeholders in the community. Utilizing individuals that people know and are comfortable with,” Keashen said.
“Going back to bringing the vaccine to places that people live in the same way that we’re doing with the popup clinics right now.”
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Delaware Governor John Carney announced that J&J shots are paused for now in his state as well.
"Hopefully, it's just for a short period of time, so we can get those one-dose-and-done vaccines flowing into people's arms," Governor Carney said.
Division of Public Health Director Dr. Karyl Rattay said some appointments will end up being canceled as a result, but overall they weren’t expecting as many J&J doses coming.
"We had already adjusted our public events based on the fact we were not going to be getting much Johnson & Johnson in the coming weeks," Rattay explained.
Delaware health officials believe this shouldn’t drastically affect future appointments.
Governor Carney also announced Delawareans 16 and older can sign up to get their shots anywhere, including hospitals.
Medical providers were only giving shots to people 16 and older if they have a high risk medical condition until now.
Dr. Paul Offit, the director of the vaccine education center at Children's Hospital of Philadelphia and a member of the FDA vaccine advisory committee, says both the J&J and AstraZeneca shots are vector virus vaccines. When AstraZeneca came under scrutiny in Europe for similarly rare blood clots, he said Tuesday, "there was always a question of whether there would be this effect here as well."
Listen to more of Offit's conversation with KYW Newsradio's Carol MacKenzie here:
Offit says, despite this setback, he believes it's still possible to get everyone vaccinated by the summer.
CDC's Advisory Committee on Immunization Practices will meet Wednesday to discuss the cases and the FDA has also launched an investigation of the cases.
"Until that process is complete, we are recommending a pause in the use of this vaccine out of an abundance of caution," Schuchat and Marks in a joint statement.