The U.S. Food and Drug Administration and the Centers for Disease Control is recommending a pause in distribution of the one-dose Johnson and Johnson (also known as Janssen) COVID-19 vaccine in the United States.
The recommendation comes as the agencies are reviewing six cases of a “rare and severe type of blood clot in individuals after receiving the vaccine.”
“CDC will convene a meeting of the Advisory Committee on Immunization Practices (ACIP) on Wednesday to further review these cases and assess their potential significance. FDA will review that analysis as it also investigates these cases,” The FDA said in a series of tweets. “Until that process is complete, we are recommending this pause. 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.”
The FDA held press conference at 9 a.m. central on Wednesday on the FDA’s YouTube channel which featured comments from Acting FDA Commissioner Dr. Janet Woodcock, Dr. Peter Marks, Director for the FDA Center for Biologics Evaluation and Research and CDC Principal Deputy Director Dr. Anne Schuchat.
According to an FDA news release, the 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," the news release reads. "Treatment of this specific type of blood clot is different from the treatment that might typically be administered. Usually, an anticoagulant drug called heparin is used to treat blood clots. In this setting, administration of heparin may be dangerous, and alternative treatments need to be given."
The FDA clarified in their press conference that the "extremely rare" incidents has resulted in the death of one patient while another patient is in critical condition.
The FDA said that pause is expected to last at least "for a matter of days" while the FDA reviews evidence and plans for adapting to any additional challenges in the vaccine rollout, as well as connecting with state and local healthcare providers.
"For people who got the vaccine more than a month ago, the risk to them is very low at this time," Schuchat said. "For people who recently got the vaccine within the last couple of weeks, they should be aware to look for any symptoms. If you've received the vaccine and developed severe headaches, abdominal pain, leg pain, or shortness of breath, you should contact your healthcare provider and seek medical treatment."
Schuchat also clarified that those symptoms that could be related to the clotting issue are different from the temporary flu-like symptoms that have been associated with receiving any of the three COVID-19 vaccines.
The FDA also said that they have not seen any evidence of any similar health issues with either the Moderna or Pfizer COVID-19 vaccines.
The FDA clarified that this is a recommendation and not a mandate for providers to stop administering the Johnson and Johnson vaccine, adding that an individual and their healthcare provider may determine that the Johnson and Johnson vaccine is a good choice for a patient based on their specific health and the rarity of the clotting issue.
The FDA reports that more than 6.8 million doses of the Johnson and Johnson vaccine have been distributed throughout the nation, with 318,600 does having been distributed in Tennessee.
According to Williamson County Emergency Management Agency External Affairs Officer Hannah Bleam, the Williamson County Health Department has not distributed any Johnson and Johnson vaccines since the county began the vaccine rollout in December 2020, so this change in federal recommendation is not expected to have a significant impact in Williamson County.
The Tennessee Department of Health also announced that the state will be pausing the administration of the Johnson and Johnson COVID-19 vaccine.
"Our vaccine supply continues to surpass demand and we do not anticipate this shift will impact our efforts to vaccinate as many Tennesseans as possible. We continue to monitor the situation closely," the state said in a TDH news release.
While the state and county are pausing the administration of the specific vaccine, it is not clear how many private pharmacies or doctors may follow the new reccommendations.
As of April 9, the state of Tennessee has seen a total of 822,085 cases of COVID-19 which includes 12,001 deaths and 20,344 hospitalizations. In Williamson County this number is 27,036 positive cases and 418 deaths since last March.
On Monday MSNBC reported that the CDC's data shows that 4.6 million vaccine does were administered in the U.S. on Saturday, setting a new single-day record, followed by an additional 3.6 million doses on Sunday.
This brings the daily average of reported doses over the past week to 3.1 million. In Total more than 190 million doses of one of the three approved vaccines have been administered across the U.S.
The FDA's Wednesday press conference on the recommendation can be viewed in full below.