J&J Vaccine Administration On Hold

Following a joint statement from the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC), NYS Commissioner of Health Dr. Howard Zucker released a statement this morning that “out of an abundance of caution” the NYS Department of Health (DOH/The Department) will pause the administration of the Johnson & Johnson/Janssen COVID-19 vaccine. Commissioner Zucker stated that the occurrence of adverse events with the J&J vaccine appears to be extremely rare. DOH is in constant contact with the federal government and New Yorkers will be updated as more information is available.

CDC and FDA Investigating

As of April 12, nearly 7 million doses of the J&J vaccine have been administered in the US. CDC and FDA are reviewing data involving six (6) case reports of a rare and severe type of blood clot occurring in recipients of the vaccine here in the US. FDA is investigating the cases, and CDC will conduct a meeting with the Advisory Committee on Immunization Practices (ACIP) on Wednesday to discuss the reports and determine their potential significance. As that analysis unfolds, FDA and CDC are recommending a pause in the vaccine’s use out of extreme vigilance. 

 All six US blood clot cases occurred in young women, aged 18 to 48. These clots are called cerebral venous sinus thrombosis (CVST) and are associated with low levels of platelets in the blood (thrombocytosis). The clots are not typical, and must be medically treated differently from other, more common clotting occurrences. Heparin, typically used in patients with clots, may have dangerous outcomes in CVST patients, and alternative treatments are necessary. Health care providers need to be aware of CVST and familiar with clinical guidelines. Note that treatment IS available.

CDC and FDA report that the adverse events appear to be extremely rare, and reiterate that COVID-19 vaccine safety continues to be a top priority for the federal government. All reports of problems following vaccinations are taken very seriously, as evidenced by the pause on administration of this product following the rare accounts of CVST. 

What You Can Do

All those who have received the J&J vaccine need to be aware of CVST symptoms. They include: severe headache, abdominal pain, leg pain, and neurological symptoms such as fainting or blurred vision. Anyone experiencing these symptoms withing 3 weeks of receiving the J&J vaccine must promptly contact their health care provider. Health care providers are being made aware of the symptoms and treatments for CVST. 

Per Dr. Zucker’s statement, all appointments for J&J vaccines today at NYS mass vaccination sites will be honored with Pfizer vaccine.  Capital District HCP members: According to a press release from the Executive Chamber, the UAlbany COVID vaccine location will relocate to Crossgates Mall on Friday, April 16, and "those who have existing appointments at the former SUNY Albany location will receive an email or text update with information about the move."  Dates and appointments will be unaffected.

HCP hopes that the recent reports raise awareness, not panic, with regards to vaccination efforts. Continue to watch HCP News Alerts and your weekly HCP Insider, as your Public Policy team will keep you up to date as news is released from FDA, CDC, and DOH. Contact us with any questions or concerns: deyoe@nyshcp.org or kerwin@nyshcp.org