Mary Madison, RN, RAC-CT, CDP
Clinical Consultant – Briggs Healthcare
“Following a thorough safety review, including two meetings of the CDC’s Advisory Committee on Immunization Practices, the U.S. Food and Drug Administration and the U.S. Centers for Disease Control and Prevention have determined that the recommended pause regarding the use of the Johnson & Johnson (Janssen) COVID-19 Vaccine in the U.S. should be lifted and use of the vaccine should resume.” This statement leads the April 23, 2021 FDA News Release.
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.
- Health care providers administering the vaccine and vaccine recipients or caregivers should review the Janssen COVID-19 Vaccine Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) and Fact Sheet for Recipients and Caregivers, which have been revised to include information about the risk of this syndrome, which has occurred in a very small number of people who have received the Janssen COVID-19 Vaccine.
The Johnson & Johnson Granting EUA Amendment (April 23, 2021) letter re-authorizes the emergency use of Janssen COVID‑19 Vaccine.
“Minor editorial changes to the EUA Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) were made for clarity and consistency. In addition, other changes consistent with those described above were made to the Short Version of the Fact Sheet.
In addition, the EUA Fact Sheet for Recipients and Caregivers has been updated: to include information about the remote risk of blood clots that involve blood vessels in the brain, abdomen, and legs, along with low levels of platelets; to note that most people who developed these blood clots and low levels of platelets were females ages 18 through 49 years; to note that for people who have developed blood clots and low levels of platelets following vaccination, symptoms began approximately one to two-weeks following vaccination; and to inform vaccine recipients that they should seek medical attention right away if they have any of the following symptoms after receiving Janssen COVID-19 Vaccine: shortness of breath, chest pain, leg swelling, persistent abdominal pain, severe or persistent headaches or blurred vision, or easy bruising or tiny blood spots under the skin beyond the site of the injection.”