In response to the joint CDC and FDA announcement and out of an abundance of caution, today the Colorado Department of Public Health and Environment (CDPHE) and the Colorado Joint Vaccine Task Force are alerting providers to temporarily pause use of the Johnson & Johnson (Janssen) COVID-19 vaccine.
Federal health officials recommended temporarily suspending use of the vaccine after reviewing reports of six individuals in the U.S. who got rare and severe blood clots after receiving the vaccine. The federal government is allowing states to determine whether to pause use, and CDPHE is requiring providers to stop administration of the Johnson & Johnson (Janssen) vaccine until additional information becomes available. One of the reasons the FDA and CDC are recommending this pause is to ensure health care providers are aware of these potential but rare adverse events and can respond accordingly. The treatment for these types of blood clots is not the common treatment and thus time is needed to make sure healthcare providers know how to recognize and treat these rare occurrences.
COVID-19 vaccine safety and the health and safety of all Coloradans is a top priority. These adverse events appear to be extremely rare. Individuals who received the Johnson & Johnson (Janssen) vaccine more than a month ago are at very low risk of serious side effects. Anyone who received the Johnson & Johnson (Janssen) vaccine within the last three weeks and who develops severe headache, abdominal pain, leg pain, or shortness of breath should contact their health care provider. These symptoms are different from the flu-like symptoms people may experience after receiving a COVID-19 vaccine. Healthcare providers should report any adverse events to the Vaccine Adverse Event Reporting System (VAERS).
“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). 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,” the FDA and CDC stated in a joint statement.
The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices will hold an emergency meeting Wednesday, April 14, to further review the cases and assess their potential significance, and the Food and Drug Administration will continue to investigate. The state will share additional information on how this affects Coloradans as soon as it becomes available.
The Johnson & Johnson (Janssen) vaccine makes up only a small portion of Colorado’s weekly vaccine allocation. This week, for example, the state’s Johnson & Johnson (Janssen) allocation is 9,700, compared to nearly 280,000 doses of Pfizer and Moderna the state expects to receive this week. Most vaccine clinics will not be significantly affected.
Anyone scheduled to receive the Johnson & Johnson (Janssen) vaccine will either receive the Pfizer or Moderna vaccine instead, or the vaccine provider will contact them to reschedule their appointment once FDA and CDC release additional information.
The state’s mobile vaccination buses, which have been administering only the Johnson & Johnson (Janssen) vaccine, are canceled today and Wednesday. More information will be provided when it becomes available.
Providers who already have a Johnson & Johnson (Janssen) vaccine supply should keep it and continue to maintain proper storage.
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Source: Colorado office of Communications/Colorado State Emergancy Operations Center