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CDC & FDA put out joint statement on Johnson & Johnson COVID-19 vaccine; NYS to pause J&J

Tue, Apr 13th 2021 11:20 am

On Tuesday, Centers for Disease Control Principal Deputy Director Dr. Anne Schuchat and Federal Drug Administration Center for Biologics Evaluation and Research Director Dr. Peter Marks released the following statement on the Johnson & Johnson (Janssen ) coronavirus vaccine:

“As of April 12, more than 6.8 million doses of the Johnson & Johnson (Janssen ) vaccine have been administered in the U.S. 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 (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.

“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. This is important, 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.

“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. 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.htmlexternal icon.”

New York State Health Commissioner Dr. Howard Zucker said, "Today the CDC and FDA issued a statement recommending a pause in the use of the Johnson & Johnson vaccine out of an abundance of caution. New York state will follow the CDC and FDA recommendation and pause the use of the Johnson & Johnson vaccine statewide immediately today while these health and safety agencies evaluate next steps. All appointments for Johnson & Johnson vaccines today at New York state mass-vaccination sites will be honored with the Pfizer vaccine.

"As the CDC and FDA have said, any adverse events related to the Johnson & Johnson vaccine 'appear to be extremely rare' and, '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.'

"I am in constant contact with the federal government and we will update New Yorkers as more information becomes available."

The Erie County Department of Health said it will pause distribution of the Johnson & Johnson COVID-19 vaccine following the recommendation from the CDC, FDA and the New York State Department of Health.

ECDOH does not have any point-of-distribution events scheduled with the Johnson & Johnson COVID-19 vaccine. ECDOH PODs planned for this week will administer Moderna vaccine, which is a two-dose series.

The department stated it has received a very limited quantity of the J&J vaccine, which is a one-dose course. This supply was primarily used for vaccinating homebound and home-limited Erie County residents and individuals in congregate living settings. Any additional J&J vaccine administration to any Erie County resident has been placed on pause until further guidance is available.

ECDOH said it is closely monitoring the situation and will provide more information as it becomes available.

Niagara County Public Health Director Daniel J. Stapleton said, “We had planned on also scheduling appointments for about 500 first doses of Johnson & Johnson’s (J&J) Janssen vaccine, but we are postponing that for right now until we receive further guidance from the New York State Department of Health related to CDC’s directive to pause J & J.”

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