BCHHS Public Health Provider Update: J&J COVID-19 vaccine update & clinician call

April 27, 2021

Please see the 4/23/2021 statement from the FDA and CDC on lifting the recommended pause on the Johnson & Johnson (Janssen) vaccine. NCDHHS recommends NC providers follow CDC and FDA guidance to resume vaccinating with the J&J vaccine. 

The CDC and FDA have determined the following:

·         Use of the J&J COVID-19 Vaccine should be resumed in the United States. The J&J COVID-19 vaccine is recommended for persons 18 years of age and older in the US population under the FDA's Emergency Use Authorization.

·         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 thrombosis-thrombocytopenia syndrome (TTS) occurring is very low, but the FDA and CDC will remain vigilant in continuing to investigate this risk.

o    On 4/23, the CDC stated that out of a total of 7.89 million doses of J&J vaccine administered, 15 cases of TTS following receipt of the J&J vaccine have been reported to VAERS, including the original six reported cases. All of these cases occurred in women between the ages of 18 and 59, with a median age of 37 years. Reports indicated symptom onset between 6 and 15 days after vaccination. Additional potential TTS cases were under review at that time, including potential male cases.

·         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. These fact sheets have been revised to include information about the risk of TTS, which has occurred in a very small number of people who have received the Janssen COVID-19 Vaccine.

o    The new information on the healthcare provider fact sheet includes the following:

§  Thrombosis with Thrombocytopenia

§  Reports of adverse events following use of the Janssen COVID-19 Vaccine under emergency use authorization suggest an increased risk of thrombosis involving the cerebral venous sinuses and other sites (including but not limited to the large blood vessels of the abdomen and the veins of the lower extremities) combined with thrombocytopenia and with onset of symptoms approximately one to two weeks after vaccination. Most cases of thrombosis with thrombocytopenia reported following the Janssen COVID-19 Vaccine have occurred in females ages 18 through 49 years; some have been fatal. The clinical course of these events shares features with autoimmune heparin-induced thrombocytopenia. In individuals with suspected thrombosis with thrombocytopenia following the Janssen COVID-19 Vaccine, the use of heparin may be harmful and alternative treatments may be needed. Consultation with hematology specialists is strongly recommended. The American Society of Hematology has published considerations relevant to the diagnosis and treatment of thrombosis with thrombocytopenia following the Janssen COVID-19 Vaccine.

§  Recipients of Janssen COVID-19 Vaccine should be instructed to seek immediate medical attention if they develop shortness of breath, chest pain, leg swelling, persistent abdominal pain, neurological symptoms (including severe or persistent headaches or blurred vision), or petechiae beyond the site of vaccination.

Consider listening to the CDC COCA Call, tomorrow, Tuesday, 4/27 from 2-3pm J&J COVID-19 Vaccine and Thrombosis with Thrombocytopenia Syndrome (TTS):  Update for Clinicians.

·         Slides and a recording of the call will be available at that link shortly afterwards.

Remember that reports of adverse events following any vaccination should be made to the Vaccine Adverse Event Reporting System

Buncombe County’s COVID-19 vaccine clinic at AB Tech provides Pfizer vaccine and has many appointments remaining this week. Individuals 16 and older who need their first dose can make an appointment online at www.buncombeready.org or by calling 828-419-0095 Monday-Friday 8a-8p. Information on other vaccine providers can be found at myspot.nc.gov.