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CDC and FDA Release Joint Statement on Johnson & Johnson COVID-19 Vaccine

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On April 13th,2021, the CDC announced that they that they will convene a meeting of the Advisory Committee on Immunization Practices (ACIP) in order to review data involving six reported U.S. cases of a rare and severe type of blood clot in individuals after receiving the Johnson & Johnson vaccine. Furthermore, FDA will review this analysis as a part of their investigation into these cases. Until this process is completed and out of an abundance of caution, the CDC and FDA are recommending a pause in the use of the J&J vaccine. Black Hawk County Public Health and our health care partners providing vaccine will comply with this recommendation and pause in administering the J&J vaccine until further notice.

 

It is important 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. As of this posting,these adverse events appear to be extremely rare; with more than 6.8 million doses of Johnson & Johnson vaccine administered there have been six reported cases. All six cases occurred among women between the ages of 18 and 48, and symptoms occurred 6 to 13 days after vaccination. COVID- 19 vaccine safety is a top priority for the federal government, and all reports of health problems following COVID-19 vaccination are taken 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.html.

 

CDC and FDA will provide additional information and answer questions during a briefing later today and a recording of that media briefing will be available on the FDA’s YouTube channel.

 

For information and updates related to COVID-19, visit www.blackhawkcovid19.com and follow us on Facebook (@BlackHawkCountyHealthDepartment) and Twitter(@BHCHD). Additionally, you can subscribe to our Notify Me tool that includes weekly COVID-19 updates.