During the week of April 12th, The Center for Disease Control and Prevention (CDC) release a recommendation to pause use of the Johnson and Johnson vaccine to investigate a specific adverse event to the vaccine. Later in the month of April, the CDC recommended to resume using the vaccine, effective on April 23rd.
Why was there a pause in the use of the vaccine?
- There were 6 reported US cases of a rare adverse event after receiving the vaccine.
- 6.8 million doses of the vaccine had already been given at this point.
- The rare adverse event was a serious type of blood clot called cerebral venous sinus thrombosis (CVST) found in combination with low levels of blood platelets (thrombocytopenia).
- This event is dangerous as the treatment is different than traditional blood clots.
- All 6 cases occurred among women between the ages of 18 and 48.
- Symptoms occurred 6 to 13 days after vaccination
What did the CDC and the FDA aim to do?
- Recommend a pause in the vaccine until the events could be investigated.
- Schedule a meeting of the Advisory Committee on Immunization Practices (ACIP) that week to review the cases and provide an analysis.
- Review the analysis as well as investigate the cases.
What did they conclude after the investigation?
- The events suggest an increased risk of a rare adverse event, however, nearly all reports have been in adult women younger than 50 years old.
- The CDC's statement says:
- "The review of all available data at this time shows that the J&J/Janssen COVID-19 Vaccine's known and potential benefits outweigh its known and potential risks"
- The CDC and the FDA recommended to resume use of the vaccine, effective on April 23, 2021.
- The CDC attached to their statement a suggestion that women younger than 50 years old should be aware of the event and any symptoms they experience after receiving the Johnson & Johnson vaccine.
- They also suggest talking to your doctor if you have significant concerns for this, and that the other vaccines are also an option.
- The following signs and symptoms are on the list that was released by the CDC of what to look for for three weeks after receiving the vaccine:
- Severe or persistent headaches or blurred vision
- Shortness of breath
- Chest pain
- Leg swelling
- Persistent abdominal pain
- Easy bruising or tiny blood spots under the skin beyond the injection site
As of April 23, 2021, more than 8 million doses of the Johnson and Johnson vaccine had been given in the United States. Of these more than 8 million doses, experts reviewing safety reports have only found 15 women who developed this adverse event, so the event is a rare occurrence.
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