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CDC and FDA Review Of Johnson & Johnson COVID-19 Vaccine

Wednesday, April 14, 2021

According to a joint statement released from the CDC and FDA, more than 6.8 million doses of the Johnson & Johnson (Janssen ) vaccine have been administered in the U.S. The 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 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.

To review these cases' potential significance, the CDC is convening an Advisory Committee on Immunization Practices (ACIP) today, Wednesday, April 14th. The FDA will also investigate the cases and provide an analysis. Out of an abundance of caution, while these processes are occurring, the FDA and CDC recommend a pause on the administration of the Johnson & Johnson vaccines.

At MHCC, we will still conduct our vaccine clinics during this time but will only administer the Moderna vaccine to those 18 and over. We are also creating a list of 16- and 17-year-old patients who wish to receive the Pfizer vaccine. Both of which are still approved under their Emergency Use Authorization (EUA) from the FDA.

It is essential to realize that these adverse events appear to be extremely rare, and the response of the CDC and FDA is because vaccine safety is a top priority.

If you or someone you know received the Johnson & Johnson vaccine greater than a month ago, the risk is very low. Further, we report any adverse reactions to the Vaccine Adverse Event Reporting System, and so far we have not needed medical interventions at MHCC.

If you received the Johnson & Johnson vaccine within the last two weeks. Please monitor for these symptoms and seek medical attention if they occur:

  • Severe heart arrhythmia
  • Abdominal pain
  • Leg pain
  • Shortness of breath

More information from both agencies is planned for release later today at a media briefing. We will follow the recommendations set in place by the CDC and the Wyoming Department of Health policies. If you have any questions about the COVID-19 vaccines in our area, please do not hesitate to contact us at 307-358-2122.