Updated: 3 p.m.
The U.S. is recommending a “pause” in administration of the single-dose Johnson & Johnson COVID-19 vaccine to investigate reports of potentially dangerous blood clots.
In a joint statement Tuesday, the Centers for Disease Control and Prevention and the Food and Drug Administration said they were investigating unusual clots in six women that occurred six to 13 days after vaccination. The clots occurred in veins that drain blood from the brain and occurred together with low platelets. All six cases were in women between the ages of 18 and 48.
The reports appear similar to a rare, unusual type of clotting disorder that European authorities say is possibly linked to another COVID-19 vaccine not yet cleared in the U.S., from AstraZeneca.
At a Tuesday morning briefing, acting FDA Commissioner Janet Woodcock said, “The time frame will depend obviously on what we learn in the next few days. However, we expect it to be a matter of days for this pause.” Officials will use the time to figure out what guidance to give to vaccine providers.
In a press briefing at the White House, Dr. Anthony Fauci said Americans who have recently received a Johnson & Johnson vaccine shouldn’t be anxious about the “pause” in shots, taken to investigate six reports of potentially dangerous blood clots, among more than 6.8 million doses administered.
The nation’s top infectious disease expert said, “It’s less than one in a million.” Fauci added that people should “pay attention” to symptoms associated with the blood clots, particularly between one and three weeks after the shot
People who have received the J&J vaccine and have developed a severe headache, abdominal pain, leg pain, or shortness of breath within three weeks after the vaccination should contact their health care providers.
Here’s what we know about how vaccine providers are responding in Pennsylvania, New Jersey, and Delaware:
The Johnson & Johnson pause will not significantly affect the city’s vaccine timeline, with the end of June still the target for widespread vaccine availability, Philadelphia Health Commissioner Dr. Thomas Farley said in a Tuesday afternoon press conference.
“This is a setback, but I would say it’s a small setback,” Farley said. “I don’t think it changes it that much. I know Johnson & Johnson was a pretty small fraction of the total doses we were delivering. We were already dealing with a shortage of Johnson & Johnson vaccine.”
He said those who have received the Johnson & Johnson vaccine should not be worried.
“The risk is extremely low here,” said Farley. “We’re talking one in a million, that’s about the risk of dying from being struck by lightning. So most people should just relax that they’ve still made the right decision to get vaccinated.”
The Convention Center and Esperanza sites will switch to Pfizer starting tomorrow and reschedule appointments as needed.
Some pop-up and neighborhood clinics, operated by the Fire Department and the Office of Emergency Management, that relied on the Johnson & Johnson vaccine will be closed until officials get further guidance from federal officials. An answer is expected within days.
Center City Vaccination Center (FEMA-supported clinic at the Pennsylvania Convention Center)
- Will be open today, April 13, at noon and administer the Pfizer vaccine. The clinic will continue with the Pfizer vaccine for the foreseeable future and will maintain the current 6,000 appointments and walk-ups per day.
Esperanza Community Vaccination Center (FEMA-supported clinic at Esperanza)
- Will be closed today, April 13. Beginning tomorrow, April 14, the clinic will switch to Pfizer vaccine and will maintain the current 1,000 appointments and walk-ups per day.
Health Department Community Clinics and Health Centers
- Will be open with normal hours and operations, but will not use Johnson & Johnson vaccine.
Philadelphia Fire Department Community Clinics
- Will be closed until at least Monday, April 19.
Health Department and Partner Mobile Teams
- Will continue operating, but will not use Johnson & Johnson vaccine.
Partner Vaccine Clinics (including Black Doctors COVID-19 Consortium, federally qualified health centers, independent and chain pharmacies, hospitals, etc.)
- These clinics will move to Pfizer or Moderna vaccine if they are using Johnson & Johnson vaccine. If they are unable to use Pfizer or Moderna vaccine, they may close. Please call ahead if you have an appointment scheduled with them.
At FEMA’s Esperanza vaccine site in Hunting Park Tuesday, Port Richmond resident Anthony Merlo arrived early, about 10:20 a.m., for his 11 a.m. appointment — beating by about 10 minutes the voicemail message from the city Department of Public Health saying that his scheduled appointment for a J&J shot had been canceled. (He also got texts and emails about the cancellation.)
But it all worked out, Merlo said: He was greeted warmly at the Esperanza gate by a FEMA rep, who told him he could schedule a Pfizer vaccine there this week.
“I waited only about five minutes in a short line of about four or five people. … It was a quick and friendly experience,” Merlo said. He’s set for a shot Wednesday afternoon.
A Bucks County spokesman said in a statement Tuesday morning that only one of the county’s five vaccination sites was using the Johnson & Johnson vaccine — the newest site at Warwick Square.
“That is not opening today, per the state’s directive,” the spokesman said. “Our other four sites, at Neshaminy Mall and the three community college campuses, use only Pfizer, and will proceed as scheduled.”
The Montgomery County Office of Public Health announced it would pause use of the J&J at its vaccination clinics scheduled for Tuesday and Wednesday. Clinics distributing the Pfizer vaccine will run on a normal schedule. Anyone with a scheduled appointment to receive the J&J vaccine for April 13 or 14 will be contacted via email to reschedule their appointment for a later date. The Montgomery County COVID-19 vaccine site will be updated with any further operational updates.
Chester County’s clinic at the Brandywine YMCA in Coatesville and the evening clinic at the Government Services Center in West Chester — the only clinics that were slated to administer the Johnson & Johnson vaccine on Tuesday — have transitioned to Moderna vaccine for Tuesday. The county Health Department is working to contact residents with vaccine appointments at those locations.
Delaware County said it had no timeline yet on when it would resume administering the J&J vaccine, pending further guidance from the federal authorities. The county had been using the J&J vaccine for its homebound program and its homeless outreach program and will now be using the Moderna vaccine for these two programs.
The J&J vaccine had been used at the county’s large-scale vaccination site at Delaware County Community College. Delco will be temporarily relocating this site and will administer either the Moderna or Pfizer vaccine. People who have appointments at Delaware County Community College will be contacted with updated appointment information.
“While this announcement is challenging, it highlights the vaccine evaluation process,” said Acting Pennsylvania Health Secretary Alison Beam. “The CDC and the FDA are closely monitoring vaccines for safety and effectiveness, and if there is a cause for concern, they will take action because safety is paramount. This protocol should give all Pennsylvanians confidence in the safety and effectiveness of the Pfizer and Moderna vaccine, and individuals should proceed with getting vaccinated as soon as possible to fight the virus, particularly as our case counts rise.”
In Pennsylvania, 262,739 doses of the Johnson & Johnson vaccine have been administered. The state was scheduled to receive 20,000 doses of the vaccine this week, along with 250,000 doses of the Moderna and Pfizer vaccines combined, Beam said at a Tuesday afternoon press conference.
Initially, the J&J vaccines were allocated primarily to teachers and educators in Pennsylvania, as well as several groups of essential workers, leading some to wonder whether they should be worried about a shot they already received.
“From the information that’s been coming out today, it seems like these six cases occurred within two weeks of the J&J vaccine,” said acting physician general Dr. Denise Johnson, adding that the teachers who received the Johnson & Johnson single-dose vaccines got them over two weeks ago. Those who were vaccinated less than two weeks ago and have concerns should monitor for symptoms and seek guidance from their health provider.
“There’s been a high level of scrutiny of this vaccine, and even though there are only six cases that have come to our attention, we have this pause so that we can evaluate closely to see whether action needs to be taken,” Johnson added. “People should feel more confident that we are scrutinizing this process so closely, much [more] closely than we’ve ever done with any other process like this.”
The pause on Johnson & Johnson vaccine distribution will continue until at least April 20, Beam said.
The Johnson & Johnson vaccine was used to vaccinate about 112,000 educators through a state-run program. That program ended two weeks ago.
The state’s largest teachers union, the Pennsylvania State Education Association (PSEA), said in a statement that it didn’t know of any members reporting severe blood clots. The association commended the FDA and the Wolf administration for its caution.
“We still stay vigilant about this,” said a PSEA spokesperson. “The CDC and FDA have said that the effects they are concerned about have occurred within six and 13 days after people received the vaccine. The last school staff members in Pennsylvania who received their Johnson & Johnson vaccine were vaccinated two weeks ago.”
The Pennsylvania Department of Corrections will stop administering the Johnson & Johnson vaccine to staff and incarcerated people until at least April 20.
DOC spokesperson Maria Bivens said the state Department of Health relayed the news Tuesday morning in an email sent to COVID-19 vaccine providers. It states the “pause” in administering the one-shot vaccine will continue “as we await further guidance from the CDC and the FDA.”
The announcement comes roughly a week after the Department of Corrections began administering doses of the Johnson & Johnson vaccine to all correctional facilities not included in the first phase of the state’s vaccine distribution plan, which covered residents of long-term care facilities, as well as people 65 and older and those with certain high-risk medical conditions.
Under the expanded rollout, vulnerable prisoners are being prioritized.
The DOC began vaccinating staff and prisoners at three of its 23 correctional facilities in mid-February — SCI Laurel Highlands, SCI Waymart, and SCI Muncy. Those prisons are federally designated long-term care facilities, with more than half of their populations being 65 and older.
Incarcerated people and staff at those facilities received the two-shot Moderna vaccine.
Approximately 2,689 prisoners and 617 staffers have received the Moderna vaccine with 18 cases of adverse reactions, said Bivens.
To date, approximately 17,427 prisoners and 1,891 staff members have received the Johnson & Johnson vaccine.
Eighty-nine of those individuals experienced adverse reactions, including an incarcerated person with “a significant number of comorbidities” who died 48 hours after receiving the shot.
“Presently, there is no clear causal relationship between that death and the Johnson & Johson vaccine,” said Bivens. “Our data does not suggest that the DOC is experiencing an unexpected rate of adverse reactions or adverse reactions more severe than anticipated.”
As of March 31, the latest date for which data is available, the DOC housed 37,187 prisoners at its 23 correctional facilities. There were additional 263 individuals at the Quehanna Boot Camp.
As of Friday, there were 112 active positive cases of COVID-19 among prisoners, according to the department. Roughly half of those cases are inside SCI-Smithfield in central Pennsylvania.
A total of 119 people incarcerated in state prisons have died from COVID-19 since the start of the pandemic. The virus has killed four DOC employees.
The Philadelphia Department of Prisons, which operates four county jails, also halted its use of the Johnson & Johnson vaccine as of Tuesday morning, according to spokesperson Shawn Hawes. The one-shot vaccine was being distributed to both staff and incarcerated people.
“We are continuing to offer the Moderna vaccine to staff and inmates,” said Hawes.
At a vaccine site in Trenton, vaccine doses were already being switched out Tuesday morning.
I’m here to get my #CovidVaccine at the Cure Arena in Trenton. We were just told that they are not going to give out the Janssen (J&J) vaccine out of an abundance of caution due to the news this morning. @WHYYNews #NewJersey (1/3) pic.twitter.com/RpnuFGi8jU
— P. Kenneth Burns (@PKBNews) April 13, 2021
All New Jersey vaccination sites were told to cancel or put on hold appointments for the J&J vaccine until further notice, according to New Jersey Health Commissioner Judith Persichilli.
The New Jersey Department of Health will work with vaccination sites to make arrangements for the administration of alternative two-dose vaccines.
Delaware Division of Public Health spokesperson Jen Brestel said Tuesday, “We are unaware of any issues of blot clots in Delaware that may be related to this vaccine. Out of an abundance of caution, we are recommending that our Delaware vaccine partners hold off on using the J&J vaccine until the situation has been further assessed. The state will not use J&J at its vaccination sites until we receive further federal guidance.”
Acting FEMA Administrator Bob Fenton said, “FEMA is committed to helping the President’s goal to ensure everyone who wants to be vaccinated can be. In alignment with the Centers for Disease Control and Prevention and Food and Drug Administration’s recommendation to pause the use of the Johnson & Johnson vaccine, effective immediately FEMA will stop administering this vaccine at our pilot Community Vaccination Clinics, as well as via our Mobile Vaccine Units. We are working with our state partners to determine the path forward and find alternative vaccine options for these sites.”
It was unclear exactly how some pharmacy chains and supermarket pharmacies would shift course.
A message on the CVS website said: “Per CDC/FDA guidance, we are pausing the use of Johnson & Johnson (Janssen) vaccine until further notice. We will provide information as we learn more. CVS Health will continue to offer the Moderna and Pfizer-BioNTech vaccines.”
Following the recommendations of the CDC & FDA, Wegmans has canceled all Johnson & Johnson vaccine appointments, including those scheduled for today’s clinic at the Wegmans Conference Center. We will pause use of the J&J vaccine while the CDC & FDA further investigate the issue.
— Wegmans Food Markets (@Wegmans) April 13, 2021
Acme Markets’ parent company, Albertsons, said it will be canceling all J&J appointments until further notice. Those who have booked an appointment for J&J under their program will receive cancellation notices. If your appointment was canceled, you must manually reschedule online for either the Moderna or Pfizer vaccine.
What the CDC and FDA are saying
More than 6.8 million doses of the J&J vaccine have been administered in the U.S., the vast majority with no or mild side effects.
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. The other two authorized vaccines, from Moderna and Pfizer, make up the vast share of COVID-19 shots administered in the U.S. and are not affected by the pause.
CDC’s Advisory Committee on Immunization Practices will meet Wednesday to discuss the cases, and the FDA has also launched an investigation into the cause of the clots and low platelet counts.
“Until that process is complete, we are recommending a pause in the use of this vaccine out of an abundance of caution,” Dr. Anne Schuchat, principal deputy director of the CDC, and Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in a joint statement.
The pause is a recommendation not a mandate, the federal officials said in the morning briefing. If your doctor says your risk is low, you can get the J&J vaccine if your provider has it.
They noted that it was not clear whether the clots experienced were connected to use of contraceptive pills.
Marks said that routine treatment of these blood clots could possibly be dangerous if a patient has been vaccinated with the Johnson & Johnson vaccine. “If someone appears with very severe headache or any types of shortness of breath, pain in their legs, pain in their abdomen that is severe, they would want to seek medical attention. If there are low platelets at that time, one needs to consider this entity [the J&J vaccine].”
“Treatment of this specific type of blood clot is different from typical treatments for other types of blood clots, which usually involve an anticoagulant called heparin. With cerebral venous sinus thrombosis, heparin may be dangerous and alternative treatments need to be given, preferably under the guidance of physicians experienced in the treatment of blood clots,” Marks said. “The issue here with these types of blood clots is that if one administers the standard treatments that we as doctors have learned to give for blood clots, um, one can actually cause tremendous harm, um, uh, or the outcome can be fatal. Um, so one needs to make sure that providers are aware that if they see people who have low blood platelets, or if they see people who have blood clots, they need to inquire about a history of recent vaccination and then act accordingly.”
The clotting seems to be similar in mechanism to what has been reported in connection with the AstraZeneca vaccine. U.S. health authorities cautioned doctors against using a typical clot treatment, the blood thinner heparin.
“In this setting, administration of heparin may be dangerous and alternative treatments need to be given,” the FDA and CDC said.
European authorities investigating the AstraZeneca cases have concluded clots appear to be similar to a very rare abnormal immune response that sometimes strikes people treated with heparin, leading to a temporary clotting disorder.
Officials say they also want to educate vaccine providers and health professionals about the “unique treatment” required for this type of clot.
Johnson & Johnson said it was aware of the reports of “thromboembolic events,” or blood clots, but that no link to its vaccine had been established.
“We are aware that thromboembolic events including those with thrombocytopenia have been reported with Covid-19 vaccines,” said Johnson & Johnson in a statement. “At present, no clear causal relationship has been established between these rare events and the Janssen Covid-19 vaccine.”
The J&J vaccine received emergency use authorization from the FDA in late February with great fanfare, with hopes that its single-dose and relatively simple storage requirements would speed vaccinations across the country. Yet the shot only makes up a small fraction of the doses administered in the U.S. as J&J has been plagued by production delays and manufacturing errors at the Baltimore plant of a contractor.
Last week the drugmaker took over the facility to scale up production in hopes of meeting its commitment to the U.S. government of providing about 100 million doses by the end of May.
Only about 9 million of the company’s doses have been delivered to states and are awaiting administration, according to CDC data.
Until now concern about the unusual blood clots has centered on the vaccine from AstraZeneca, which has not yet received authorization in the U.S. Last week, European regulators said they found a possible link between the shots and a very rare type of blood clot that occurs together with low blood platelets, one that seems to occur more in younger people.
The European Medicines Agency stressed that the benefits of receiving the vaccine outweigh the risks for most people. But several countries have imposed limits on who can receive the vaccine; Britain recommended that people under 30 be offered alternatives.
But the J&J and AstraZeneca vaccines are made with the same technology. Leading COVID-19 vaccines train the body to recognize the spike protein that coats the outer surface of the coronavirus. But the J&J and AstraZeneca vaccines use a cold virus, called an adenovirus, to carry the spike gene into the body. J&J uses a human adenovirus to create its vaccine while AstraZeneca uses a chimpanzee version.
The Associated Press and WHYY’s Hannah Chinn and Avi Wolfman-Arent contributed to this report.