Following guidance from the Centers for Disease Control and Prevention (CDC), Food and Drug Administration (FDA) and the state of New Jersey, Hudson County will pause administering the Johnson & Johnson COVID-19 vaccine out of an abundance of caution.
Currently, 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 J&J vaccine.
In these cases, a type of blood clot called cerebral venous sinus thrombosis (CVST) was seen in combination with low levels of blood platelets, also known as thrombocytopenia. All six cases occurred among women between the ages of 18 and 48, and symptoms occurred 6 to 13 days after vaccination.
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.
As of April 12, more than 6.8 million doses of the J&J vaccine have been administered in the U.S.
Advisory committee to convene
The CDC will convene a meeting of the Advisory Committee on Immunization Practices (ACIP) on April 14 to further review these cases and assess their potential significance. The FDA will review that analysis as it investigates these cases.
Until that process is complete, both entities are recommending a pause in the use of the J&J vaccine out of an abundance of caution. This is 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.
“Right now, these adverse events appear to be extremely rare,” according to the statement by the CDC and FDA. “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.”
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 providers. Health care providers are asked to report adverse events to the Vaccine Adverse Event Reporting System at vaers.hhs.gov/reportevent.html.
New Jersey halts distribution
The New Jersey Department of Health paused the administration of the J&J vaccine across all vaccination sites in the state on April 13, according to a statement by state Health Commissioner Judith Persichilli.
All state vaccination sites have been told to cancel or put on hold appointments for the J&J vaccine until further notice. For individuals scheduled to receive the J&J vaccine, the state Health Department will work with all vaccination sites to make arrangements for the administration of an alternative two-dose vaccine.
The Department will await further guidance from the federal government, Persichilli said.
Hudson County too
For the remainder of the week, the Hudson County Vaccine Distribution Center at the USS Juneau Center will continue to vaccinate residents as scheduled using its supply of the Moderna and Pfizer vaccines. The decision to suspend the use of the J&J vaccine will not impact operations at the county-run site in Kearny, officials said.
“After reviewing the new information released from the CDC and consulting with our own experts, Hudson County has decided to proceed with caution and suspend administering the Johnson & Johnson vaccine,” said Hudson County Executive Tom DeGise. “Our vaccination site at the USS Juneau Center remains open for all eligible residents who will continue to be cared for under the watchful eye of the Hudson Regional Health Commission, which has done a remarkable job vaccinating our community safely and efficiently.”
None of the rare side effects that have been reported as a result of the J&J vaccine occurred in Hudson County.
In a statement, J&J said it has been working closely with medical experts and health authorities, and “we strongly support the open communication of this information to healthcare professionals and the public.”
“The safety and well-being of the people who use our products is our number one priority,” according to J&J. “We are aware of an extremely rare disorder involving people with blood clots in combination with low platelets in a small number of individuals who have received our COVID-19 vaccine.”
J&J continued: “In addition, we have been reviewing these cases with European health authorities. We have made the decision to proactively delay the rollout of our vaccine in Europe.”
For updates on this and other stories, check www.hudsonreporter.com and follow us on Twitter @hudson_reporter. Daniel Israel can be reached at email@example.com.