FDA, CDC Recommend Pausing Johnson & Johnson COVID-19 Vaccinations After Rare, Serious Blood Clot Events

Healthcare providers urged to be on lookout for adverse events with symptoms of blood clots

After recommending a pause in the use of Johnson & Johnson’s Janssen COVID-19 vaccine due to six cases of severe blood clots, senior officials with the Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) said Tuesday that healthcare providers should plan for proper recognition and management of these adverse events due to the unique treatment required with this type of blood clot.

The CDC’s Advisory Committee on Immunization Practices (ACIP) will meet Wednesday to review the data surrounding the reported cases of cerebral venous sinus thrombosis (CVST) in combination with low levels of thrombocytopenia in six women between the ages of 18 and 48. All women had received the J&J vaccine and developed symptoms 6 to 13 days after vaccination; there was one death.

Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said what’s notable about these rare adverse events is the occurrence of CVST together with thrombocytopenia, a pattern that is very similar to reports from Europe about the AstraZeneca COVID-19. It’s important to take the time to understand this complication and for clinicians to understand how to properly manage it.

“The issue here with these types of blood clots is that if one administers the standard treatment that we … have learned to give for blood clots, one can actually cause tremendous harm, or the outcome can be fatal,” Marks said during a news conference Tuesday morning. “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 in the diagnosis and management of those individuals.”

Healthcare providers should report adverse events to the Vaccine Adverse Event Reporting System.

Janet Woodcock, acting FDA commissioner, told reporters that there are too few cases to identify subpopulations that may be predisposed to this type of adverse event. Approximately 6.85 million doses of the J&J vaccine have been administered.

The decision to pause was taken rapidly to honor a commitment to the American public to ensure that any safety signal that came up during the vaccine rollout was fully addressed in a transparent manner, Marks added.

The “pause” on J&J vaccines is not a mandate, but a recommendation. Marks said this provides healthcare providers with leeway to move forward with using the J&J vaccine after individual discussions with patients in which a determination is made that the benefit risk would be beneficial overall to the individual.

Officials reiterated their commitment to vaccination, an important tool to get the COVID-19 pandemic under control. Woodcock said the message to patients remains to get the vaccine that is available to them, because the risks from the pandemic are significant.

“I know that the information we’re providing today is going to be very concerning to Americans who have already received the Johnson & Johnson Janssen vaccine,” said Anne Schuchat, principal deputy director of the CDC. “For people who got the vaccine more than a month ago, the risk of an event is very low at this time. For people who got the vaccine within the last couple of weeks, they should be aware to look for any symptoms.”

Medical treatment should be sought for symptoms such as severe headache, abdominal pain, leg pain, or shortness of breath, Schuchat said. These symptoms differ from the typical mild flu-like symptoms that can occur after receiving any of the COVID-19 vaccines.

Officials said they have not seen similar blood clotting events with the Pfizer-BioNTech or Moderna vaccines.

The J&J vaccine, authorized for emergency use on Feb. 27, represents a minority of COVID-19 vaccine doses available in the U.S. Marks said vaccine supply has become more abundant over time and he hopes this temporary pause will not have a major impact on the president’s goal of administering 200 million doses by April 30.

Tuesday’s news meant vaccination sites across the country had to revise appointments for many patients scheduled to receive the J&J vaccine.

“In accordance with FDA and CDC guidance, Ochsner has immediately halted use of the J&J vaccine at all mass vaccination events, community sites and clinics,” said Deborah Simonson, vice president of pharmacy services at Ochsner Health. “Due to our robust teams and our adequate supply of Pfizer and Moderna vaccines, we were able to quickly shift today’s J&J vaccination sites and administer the Pfizer vaccine in its place. Throughout the pandemic and vaccine administration, I’m proud of our team’s ability to be nimble and flexible as we continue to navigate unanticipated challenges that may occur.”

Tim Lynch, chief pharmacy officer at Multicare in Washington state, said Multicare temporarily paused the use of the J&J vaccine in response to the new guidance.

“The use of the J&J vaccine has been very limited within MultiCare and this temporary pause will not impact our overall vaccination efforts,” Lynch said.

Dave Lacknauth, director of pharmacy services at Broward Health in south Florida, said the hospital system is currently primarily using the Pfizer-BioNTech vaccine.

“Broward Health is looking at the evidence and closely monitoring our patients to maximize positive outcomes,” Lacknauth said. “Pharmacy and therapeutics teams will look at data for safe application of the J&J product in the ambulatory setting. We will continue to monitor data and pivot based on strength of evidence.”

Similarly, the University of California, San Francisco Medical Center (UCSF) paused all J&J vaccine administration pending further guidance from FDA and ACIP.

“While we hope this does not lead to a negative impact on overall vaccine rollout, UCSF is focused on putting patients first and ensuring our patients and providers have the most up-to-date resources they need to recognize, manage, and report any potential adverse effects,” said Kelsey Waier, director of pharmacy operations.

In a written statement, J&J said the company has been working closely with medical experts and health authorities. J&J will “proactively delay the rollout” of the vaccine in Europe.

Wednesday’s ACIP meeting will be live-streamed for the public at 1:30 p.m. ET.