CDC and FDA Green Light Use of Johnson & Johnson and in RI There Is a Workaround

CDC and FDA Green Light Use of Johnson & Johnson and in RI There Is a Workaround

The CDC and the FDA announced on Friday evening that following a thorough safety review, including two meetings of the CDC’s Advisory Committee on Immunization Practices has determined that the recommended pause regarding the use of the Janssen (Johnson & Johnson) COVID-19 Vaccine in the U.S. should be lifted and use of the vaccine should resume.

For Rhode Islanders uncomfortable taking Johnson and Johnson, the RI Department of Health tells GoLocal there is a workaround.

“When people register, they can see what vaccine will be offered for that slot. So someone can choose to get that vaccine at that time, or choose a different slot with a different vaccine,” said Joseph Wendelken, spokesperson for the RIDOH.

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According to the CDC, the pause was recommended after reports of six cases of a rare and severe type of blood clot in individuals following administration of the Janssen COVID-19 Vaccine. During the pause, medical and scientific teams at the FDA and CDC examined available data to assess the risk of thrombosis involving the cerebral venous sinuses, or CVST (large blood vessels in the brain), and other sites in the body (including but not limited to the large blood vessels of the abdomen and the veins of the legs) along with thrombocytopenia, or low blood platelet counts. The teams at FDA and CDC also conducted extensive outreach to providers and clinicians to ensure they were made aware of the potential for these adverse events and could properly manage and recognize these events due to the unique treatment required for these blood clots and low platelets, also known as thrombosis-thrombocytopenia syndrome (TTS).

The two agencies have determined the following:

- Use of the Janssen COVID-19 Vaccine should be resumed in the United States.
- The FDA and CDC have confidence that this vaccine is safe and effective in preventing COVID-19.
- The FDA has determined that the available data show that the vaccine’s known and potential benefits outweigh its known and potential risks in individuals 18 years of age and older.
- At this time, the available data suggest that the chance of TTS occurring is very low, but the FDA and CDC will remain vigilant in continuing to investigate this risk.