ALBME

Providers Resume Use of the J&J/Janssen COVID-19 Vaccine

Alabama Department of Public Health (ADPH)
Alabama Emergency Response Technology (ALERT)
Health Alert Network (HAN)
April 30, 2021

Providers Resume Use of the J&J/Janssen COVID-19 Vaccine 

ADPH recommends resuming use of the J&J/Janssen COVID-19 vaccine to ensure flexibility, choice, and improved access. 

On April 13, 2021, CDC and the Food and Drug Administration (FDA) recommended pausing use of the J&J/Janssen COVID-19 vaccine following reports of thrombosis with thrombocytopenia syndrome (TTS) among vaccine recipients.

The Advisory Committee on Immunization Practices has concluded that the benefits of resuming J&J/Janssen COVID-19 vaccination among persons aged ≥18 years outweigh the risks of TTS and reaffirm its interim recommendation under FDA’s Emergency Use Authorization (EUA), which includes a new warning for rare clotting events among women aged 18–49 years. 

Education about TTS risk with J&J/Janssen COVID-19 vaccine is critical. 

 

Reporting of Adverse Events:

FDA requires that vaccine providers report vaccination administration errors, serious adverse events, cases of multisystem inflammatory syndrome, and cases of COVID-19 that result in hospitalization or death after administration of a COVID-19 vaccine under an EUA (10). Adverse events that occur after receipt of any COVID-19 vaccine should be reported to VAERS. Information on how to submit a report to VAERS is available at https://www.vaers.hhs.gov/index.html or 1-800-822-7967. Any person who administers or receives a COVID-19 vaccine is encouraged to report any clinically significant adverse event, whether or not it is clear that a vaccine caused the adverse event. In addition, CDC has developed a new, voluntary smartphone-based online tool (referred to as v-safe) that uses text messaging and online surveys to provide near real-time health check-ins after receipt of a COVID-19 vaccine. Please encourage patients to use the v-safe App or the link provided below to register.  The information is found on a hand out containing a Q code which should be given to any person vaccinated. In cases of v-safe reports that include possible medically attended significant health events, CDC’s v-safe call center follows up with the vaccine recipient to collect additional information for completion of a VAERS report. Information on v-safe is available at https://www.cdc.gov/vsafe.

 

Information concerning treatment:

The American Society of Hematology has published considerations relevant to the diagnosis and treatment of thrombosis with thrombocytopenia following the Janssen COVID-19 Vaccine (https://www.hematology.org/covid-19/vaccine-induced-immune-thrombotic-hrombocytopenia).

 

ADPH Encourages Medical Providers to Promote the COVID 19 Vaccine for Patients 

The Alabama Department of Public Health (ADPH) is asking all healthcare providers in Alabama to strongly recommend all age eligible patients take COVID 19 vaccine.  COVID 19 vaccine provides personal benefits to individuals, including reduction in severe illness, hospitalization, and death from COVID 19 disease.  Fully-vaccinated persons can resume many activities they stopped during the pandemic.  These activities are listed in the CDC link.  https://www.cdc.gov/coronavirus/2019-ncov/vaccines/fully-vaccinated.html#:~:text=After%20you've%20been%20fully,places%20until%20we%20know%20more

Dr. Scott Harris, State Health Officer, noted that, this week, Alabama's percent positive SARS-CoV-2 tests statewide increased to 5.5%, which is higher than this has been seen since March 6, 2021.  Further, ADPH has seen a 1% increase in COVID cases over the past two weeks, compared to the previous two weeks.  In addition, while influenza like illness had been low in Alabama this season, there has been an increase in influenza like activity for the past three weeks in a row.

Dr. Aruna Arora, President of the Medical Association of the State of Alabama joins Dr. Scott Harris, State Health Officer in urging Alabamians to be vaccinated against COVID 19.  Dr. Arora stated, “During this past year, we have seen patients suffer with chronic, long term COVID symptoms.  Hospitals and healthcare providers, throughout Alabama, have been under tremendous strain.  We, as physicians, know that we can control this pandemic, but our patients must help us by getting vaccinated.  Adequate vaccination is needed to have enough immune people and prevent an increase in variants, which can lead to another surge. We all want to return to normalcy.”

 

CDC Resources:


https://www.cdc.gov/mmwr/volumes/70/wr/pdfs/mm7017e4-H.pdf - Full MMWR for Use of the J&J/Janssen COVID-19 Vaccine

https://www.fda.gov/media/146305/download - Updated Emergency Use Authorization (EUA) of the J&J/Janssen COVID-19 Vaccine

https://www.fda.gov/media/146304/download - Updated Emergency Use Authorization (EUA) of the J&J/Janssen COVID-19 Vaccine