Johnson & Johnson (Janssen) Vaccine Receives Emergency Use Authorization
On Saturday, February 27, 2021, The Food and Drug Administration (FDA) granted Emergency Use Authorization (EUA) to the Johnson & Johnson vaccine product, also known as Janssen. This is an important development in the continued public health response to the COVID-19 pandemic.
Johnson & Johnson’s COVID-19 vaccine is:
- A single-dose vaccine.
- Transported and stored at refrigerated temperatures (2 to 8 degrees C).
- Authorized for people 18 years of age and older for the prevention of COVID-19 infection.
- Administered intramuscularly.
It is the third COVID-19 vaccine to receive EUA. The addition of this vaccine will greatly help increase vaccine supply in Wisconsin.
The CDC's Advisory Committee on Immunization Practices (ACIP) Recommendation
On Sunday, February 28, 2021, the expert committee members of the Advisory Committee on Immunization Practices (ACIP) issued an interim recommendation for the use of the Johnson & Johnson COVID-19 vaccine. The director of the Centers for Disease Control and Prevention (CDC) accepted those recommendations.
Clinical Resources
Prior to starting vaccine administration, ensure that your staff are familiar with the EUA fact sheet for clinicians. The patient fact sheet must be given to the patient or their caregiver in lieu of a vaccine information statement.
Ensure your clinicians are familiar with the Morbidity and Mortality Weekly Report (MMWR), outlining ACIP’s vaccine interim recommendations for use of Johnson and Johnson COVID-19 vaccine.
The Johnson & Johnson COVID-19 vaccine is a viral vector COVID-19 vaccine. CDC has released a webpage to help with Understanding Viral Vector COVID-19 Vaccines and Johnson & Johnson created a health care provider webpage with resources.
You may begin administering the product to patients once your staff are trained and corresponding standing orders, policies, and procedures reflect Johnson & Johnson COVID-19 vaccine clinical guidelines, including administration, storage, and handling.
Contraindications
Do not administer the Johnson & Johnson COVID-19 vaccine to individuals with a known history of a severe allergic reaction (e.g., anaphylaxis) to any component of the Johnson & Johnson COVID-19 vaccine (see full EUA Prescribing Information).
Anaphylaxis management
Ensure that appropriate medical treatment for managing immediate allergic reactions is immediately available in the event of an acute anaphylactic reaction occurring following COVID-19 vaccine administration. See CDC's Interim Considerations: Preparing for the Potential Management of Anaphylaxis at COVID-19 Vaccination Sites for more guidance.
Monitoring vaccine safety
Remember to submit all vaccine administration errors and adverse events to VAERS. Be sure to familiarize yourself with the specific EUA reporting requirements including:
- Vaccine administration errors whether or not associated with an adverse event
- Serious adverse events (irrespective of attribution to vaccination)
- Cases of Multisystem Inflammatory Syndrome (MIS) in adults and children
- Cases of COVID-19 that result in hospitalization or death.
Ensure all of your patients are aware of and receive a QR code for the V-safe program.
Product-specific resources
Johnson & Johnson, Pfizer, and Moderna COVID-19 vaccine products are not interchangeable.The same COVID-19 product must be administered for both doses of the mRNA COVID-19 vaccine series. ACIP does not state a product preference. A person may receive any recommended COVID-19 vaccine series.
More information will be coming in the upcoming days on this CDC webpage on administration of the vaccine and resources to assist providers in storing and handling.
Johnson & Johnson COVID-19 Allocation to Wisconsin Vaccination Sites
The Johnson & Johnson COVID-19 vaccines are now available to ship to Wisconsin. Wisconsin will receive an initial 48, 000 doses. These 48,000 doses will be allocated for vaccination of K-12 educators and child care workers, and should arrive next week.
After the initial shipments, DHS does not expect additional doses of Johnson & Johnson until the end of March. At that time, the Johnson & Johnson product will be available as part of regular allocations to all vaccinators. Vaccinators will not be able to choose which vaccine they are allocated.
Information about the Johnson & Johnson vaccine will be available in WIR in the upcoming days.
We will keep you updated on the timeline.
Eligible Groups Reminder
As was the case for Moderna and Pfizer COVID-19 vaccines, the new Johnson & Johnson COVID-19 vaccine should be used to only vaccinate groups Wisconsin DHS has identified as eligible. As of March 1, the following groups are eligible for COVID-19 vaccination (listed in priority order):
- Adults age 65 and older
- Front line health care personnel
- Residents of long-term care
- Police and fire personnel, correctional staff
- Education and child care
- Individuals enrolled in Medicaid long-term care programs
- Some public-facing essential workers
- Non-front line essential health care personnel
- Facility staff and residents in congregate living settings
What does this mean for vaccinators?
- You should continue to focus on vaccinating those ages 65 years and older and front line health care workers.
- Those vaccinators who either have completed vaccinating or do not serve those ages 65 years and older or front line health care workers, may begin to vaccinate the newly eligible groups.
- Among the newly eligible groups, education and child care workers are the top priority.
- There will not be enough vaccine to vaccinate everyone in the eligibility groups in the beginning of March. We ask for everyone’s patience and ask our partners to communicate this via your networks.
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