Feds: Pause Johnson & Johnson COVID Vaccine In CT, Elsewhere

CONNECTICUT — The Food and Drug Administration and the Centers for Disease Control and Prevention recommended a pause in the use of the Johnson & Johnson COVID-19 vaccine on Tuesday because of blood-clot concerns.

"We are recommending a pause in the use of this vaccine out of an abundance of caution," the FDA announced on Twitter.

The FDA reported that, as of Monday, more than 6.8 million doses of the company's vaccine have been administered in the U.S. The CDC and FDA are reviewing data involving six reported U.S. cases of a rare and severe type of blood clot in individuals after receiving the vaccine.

"Roughly 100,000 Connecticut residents have received the J&J vaccine with no reported serious adverse events," said Connecticut Department of Public Health spokesperson Maura Fitzgerald in a statement Tuesday. "The CDC, FDA and Connecticut DPH all take vaccine safety extremely seriously. Although the reported complications are extremely rare, we will await the results of the investigation before proceeding with further use of the J&J vaccine."

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Fitzgerald said DPH has informed vaccine providers that were planning to hold clinics using J&J today and in the coming days to delay these clinics or offer an alternative vaccine if they have alternative vaccines available.

"DPH will work with providers to minimize the disruptions from this announcement in the near-term to the extent possible, but we anticipate that some cancellations will occur," Fitzgerald said.

The CDC will convene a meeting of its Advisory Committee on Immunization Practices on Wednesday to further review these cases and assess their potential significance. The FDA will review that analysis as it also investigates these cases.

"Until that process is complete, we are recommending this pause," the FDA said. "This is important to ensure that the health care provider community is aware of the potential for these adverse events and can plan due to the unique treatment required with this type of blood clot."

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The CDC and FDA also issued a joint statement from the Johnson & Johnson COVID-19 vaccine from Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, and Anne Schuchat, principal deputy director of the CDC.

The statement said a type of blood clot called cerebral venous sinus thrombosis (CVST) was seen in combination with low levels of blood platelets (thrombocytopenia).

All six cases occurred among women between the ages of 18 and 48, and symptoms occurred 6 to 13 days after vaccination, according to the statement.

The pause is important, the statement said, "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."

"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 statement said. "People who have received the J&J vaccine who develop severe headache, abdominal pain, leg pain, or shortness of breath within three weeks after vaccination should contact their health care provider."

Health care providers are asked to report adverse events to the Vaccine Adverse Event Reporting System at the CDC.

The J&J vaccine was a godsend for state officials managing the rollout logistics in Connecticut. Not only does it require just one dose for complete inoculation, it can also be stored at relatively warmer temperatures than its rivals from Pfizer and Moderna. For these reasons, nearly all the state's Johnson & Johnson supply was being allocated to mobile vaccine vans supplied by the Federal Emergency Management Agency, state Chief Operating Officer Josh Geballe said. The FEMA vans have been deployed to Connecticut neighborhoods with high Social Vulnerability Index scores, such as New Haven:

The FEMA mobile unit, which is currently in New Britain, is working to further modify its schedule, according to a statement from DPH. It will be offering an mRNA vaccine instead of J&J vaccine when it resumes. The Griffin vaccine vans, which currently administer J&J vaccine, have suspended their clinics for today.

Contingency plans were already being developed to use Pfizer or Moderna doses if need be for the mobile vaccination vans, following an earlier kink in J&J's supply chain. Last month, the J&J vaccine became available at Stop & Shop grocery stores throughout the state.

DPH has also encouraged providers to reach out to everyone who was scheduled to come to a J&J clinic and let them know that their appointment will need to be rescheduled once the FDA and CDC have recommend resuming administration of the J&J vaccine.

Hartford HealthCare announced Tuesday morning it is following the guidance of the FDA and CDC and has halted all use of the J&J vaccine.

"We have adjusted our vaccine distribution in everyone of our vaccines clinics to provide only Pfizer and Moderna products," said Dr. James Cardon, Hartford HealthCare's chief clinical integration officer.

Connecticut's vaccine supply dropped from around 288,000 first doses last week to 180,000 this week, mainly due to a reduction in doses from Johnson & Johnson.

This pause in the J&J vaccinations will not have a significant impact on the nation's overall rollout, according to a statement released by the White House on Tuesday.

"Johnson & Johnson vaccine makes up less than 5 percent of the recorded shots in arms in the United States to date," said Jeff Zients, White House COVID-19 response coordinator. "Based on actions taken by the President earlier this year, the United States has secured enough Pfizer and Moderna doses for 300 million Americans. Over the last few weeks, we have made available more than 25 million doses of Pfizer and Moderna each week, and in fact this week we will make available 28 million doses of these vaccines. This is more than enough supply to continue the current pace of vaccinations of 3 million shots per day, and meet the President’s goal of 200 million shots by his 100th day in office—and continue on to reach every adult who wants to be vaccinated."

Tom Davis and Ellyn Santiago contributed to this story.