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Source: NCDHHS, 4/13/21
Good
afternoon: DHHS
shared the following information about the J&J vaccine today. Vaccine
events for farmworkers that were going to use J&J are either switching to
another vaccine (Moderna or Pfizer) or being paused. We will share more
information as we have it.
Robin Tutor Marcom, EdD, MPH Director, NC Agromedicine Institute 252.744.1008 Joint CDC and FDA Statement on
Johnson & Johnson COVID-19 VaccineThe following statement is attributed toDr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research andDr. Anne Schuchat, Principal Deputy Director of the CDCApril 13, 2021As
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.html. CDC and FDA will provide additional information and answer questions later today at a media briefing. A recording of that media call will be available on the FDA’s YouTube channel here.
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