Johnson & Johnson Vaccine Updates
After an 11-day pause to review the scientific information around rare blood clots, the U.S. Food and Drug Administration (U.S. FDA) and U.S. Centers for Disease Control and Prevention (U.S. CDC) announced that vaccine providers could resume use of the J&J vaccine.
On April 23, the Advisory Committee on Immunization Practices concluded that the benefits of resuming Janssen COVID-19 vaccination among persons aged ≥18 years outweighed the risks and reaffirmed its interim recommendation under FDA’s Emergency Use Authorization, which includes a new warning for rare clotting events among women aged 18–49 years.
Updated Recommendations from the Advisory Committee on Immunization Practices for Use of the Janssen (Johnson & Johnson) COVID-19 Vaccine After Reports of Thrombosis with Thrombocytopenia Syndrome Among Vaccine Recipients — United States, April 2021 | MMWR (cdc.gov)
FAQ on Resumption of J&J COVID-19 Vaccine
CDC offers webinar archive for clinicians titled “Johnson & Johnson/Janssen COVID-19 Vaccine and Thrombosis with Thrombocytopenia Syndrome (TTS): Update for Clinicians”
CDC is offering an archive of its Clinical Outreach and Communication Activity (COCA) webinar which originally aired on April 27, 2021. Titled Johnson & Johnson/Janssen COVID-19 Vaccine and Thrombosis with Thrombocytopenia Syndrome (TTS): Update for Clinicians, CDC has provided the following description of this session: This COCA Call will present the latest evidence on thrombosis with thrombocytopenia syndrome (TTS) after administration of the Johnson & Johnson/Janssen COVID-19 vaccine. Speakers will discuss information on TTS and updated vaccine recommendations. Access more information about this webinar: Johnson & Johnson/Janssen COVID-19 Vaccine and Thrombosis with Thrombocytopenia Syndrome (TTS): Update for Clinicians
Vaccination Clinics for Workplaces and Higher Education
The State of Maine will now support closed point-of-distribution (POD) clinics for workers, especially those with increased risk of contracting or transmitting COVID-19. Such workers include but are not limited to: hospitality workers (e.g., restaurant, hotel, summer amusement workers); agricultural, seafood, and food processing workers; grocery store workers; and workers at sites where physical distancing is challenging (e.g., shipbuilding, construction, transportation, public benefits workers).
Maine Immunization Program (MIP) providers may work with employers or industry groups directly to arrange for such clinics.
MIP providers may also work with higher education institutions to offer special hours, on-site clinics, or other means of high-throughput vaccination of their students and staff.
At this time, MIP has limited ability to allocate additional or specific types of vaccine doses to such clinics, so providers should consider how such clinics may be accommodated with their regular supply.
For more information, please see the full communication on the MIP website.
How to report an adverse event to VAERS
- Go to VAERS
- Submit a report online
- For help:
- Please sent records to VAERS ASAP if contacted and asked
- HIPPA permits reporting of protected health information to public health authorities, including CDC and FDA
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It is not too early to start preparing for Back-to-School in the Fall
The American Cancer Society has released a "call to action" to bring in school-age children between April and May of 2021 to catch up on missed vaccinations and provide newly due vaccines.
If the COVID-19 vaccines are approved for children as young as 12 years old, as anticipated, there will be the possibility of competing priorities during the usual back-to-school vaccination season.
Recommendations with COVID-19 administration state that no other vaccines should be provided two weeks before, during, or after the series. This would create a "blackout" period when adolescents may not be able to be vaccinated with routine vaccinations for a 6-8 week period.
It is important to start planning now to get any patients who may be due or overdue scheduled for immunizations.
Please read the American Cancer Society's Call to Action.
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Updates to Moderna COVID-19 Vaccine
Presentation information for the Moderna vaccine has been updated to:
Storage and Handling updates:
- Keep the vaccine between 2°C and 25°C (36°F and 77°F) for up to 12 hours. Discard any unused vaccine after 12 hours.
- If storing in a freezer:
- Vaccine may be stored in a freezer between -50°C and -15°C (-58°F and 5°F).
- If storing in a refrigerator:
- Vaccine vials may be stored in the refrigerator between 2°C and 8°C (36°F and 46°F) for up to 30 days before vials are punctured.
- After 30 days, contact the manufacturer for guidance on viability.
- If instructed to dispose of the vaccine, dispose of the vial(s) and packaging as medical waste according to local and state regulations. Refer to your jurisdiction’s immunization program for guidance.
Updates were made to the following documents to reflect these changes.
For more information, please visit the CDC's COVID-19 Product Information webpage.
Be Safe After you Vaccinate
The Maine Immunization Program has a new one-page resource that providers and the public can use to ensure that precautions are still being taken post-vaccination.
Moderna COVID-19 Temperature Excursion Tool
Moderna has a new Temperature Excursion Tool that allows you to see what to do with vials of the Moderna COVID-19 vaccine that may have experienced a temperature excursion prior to administering. They will provide you with an instant recommendation or, for more complex cases, a way to contact their specialized team directly.
You may use this online tool, but please continue to contact the Maine Immunization Program regarding the excursion at 207-287-3746.
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