The Food and Drug Administration and the Centers for Disease Control and Prevention have recommended a pause in the distribution of the Johnson & Johnson COVID-19 vaccine after six cases of an unusual blood clot were reported.
The two agencies released the joint recommendation early Tuesday, prompting the Stanislaus County Health Services Agency to switch out the vaccine at a mobile clinic in Turlock. The agency was set to administer the vaccine at a mobile clinic set up at the Salvation Army in Turlock on Tuesday, but because of the recommendation, those coming to the clinic were given the Moderna vaccine instead. Unlike the Johnson & Johnson, which is a one dose vaccine, the Moderna vaccine requires two shots.
"Stanislaus County Public Health is closely monitoring the latest news regarding the Johnson and Johnson vaccine," the Stanislaus County Office of Emergency Services posted on their Facebook page. "In alignment with recommendations from Food and Drug Administration and the Centers for Disease Control and Prevention, administration of this vaccine is paused.
"At this time, all Johnson and Johnson vaccine clinics in Stanislaus County will continue as planned with Moderna vaccines. Stanislaus County is also in continuous communication with the California Department of Public Health and will continue to provide updates on our vaccine efforts locally. We will inform you regarding any changes to the future vaccine clinics as we learn more."
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 Johnson & Johnson.
"In these cases, a type of blood clot called cerebral venous sinus thrombosis (CVST) was seen in combination with low levels of blood platelets (thrombocytopenia)," the agencies said in a joint news release. "All six cases occurred among women between the ages of 18 and 48, and symptoms occurred six to 13 days after vaccination."
"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. Until that process is complete, we are recommending a pause in the use of this vaccine out of an abundance of caution."
These types of blood clots are considered unusual in that the typical treatment of heparin could actually cause more harm. The agencies said they were recommending the pause in part, "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," the FDA and CDC said in a news release.
As of April 12, more than 6.8 million doses of the Johnson & Johnson vaccine have been administered in the U.S.
"Right now, these adverse events appear to be extremely rare. 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 agencies 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 https://vaers.hhs.gov/reportevent.html.”
Following the lead of the FDA and the CDC, the California Department of Public Health has issued all health care providers to stop administering the Johnson & Johnson vaccine until further study is completed.
“California is following the FDA and CDC’s recommendation and has directed health care providers to pause the use of the Johnson & Johnson vaccine until we receive further direction from health and safety experts," said Dr. Erica Pan, state epidemiologist. "Additionally, the state will convene the Western States Scientific Safety Review Workgroup to review the information provided by the federal government on this issue. As the federal government has said, we do not expect a significant impact to our vaccination allocations. In California, less than 4% of our vaccine allocation this week is the Johnson & Johnson vaccine.”