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Minnesota Department of Health
April 30, 2021
Good afternoon,
Here are the COVID-19 vaccine provider updates for 4/23-4/29.
The pause for administering Janssen COVID-19 vaccine was recently lifted following evaluation of reports of Thrombosis with Thrombocytopenia (TTS), a rare and severe type of clotting syndrome. The FDA and CDC determined the use of this vaccine should be resumed in the U.S. for those 18 years and older. Both agencies have confidence the vaccine is safe and effective, and its known and potential benefits outweigh the potential risks. Available data suggests the TTS risk is very low.
Refer to the CDC: 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 for more information.
When resuming vaccination:
Providers should consult the CDC Health Alert Network (HAN) notification Cases of Cerebral Venous Sinus Thrombosis with Thrombocytopenia after Receipt of the Johnson & Johnson COVID-19 Vaccine published on April 13, 2021, and guidance from the American Society of Hematology Thrombosis with Thrombocytopenia Syndrome (also termed Vaccine-induced Thrombotic Thrombocytopenia) for information on the diagnosis and treatment of suspected cases of TTS.
On April 27, 2021, the CDC updated the Interim Clinical Considerations for Use of COVID-19 Vaccines Currently Authorized in the United States. This update includes new information for people vaccinated with COVID-19 vaccines not authorized in the United States, considerations for use of the Janssen COVID-19 vaccine in certain populations and patient counseling, and many more updates. The green box at the top of the page has a summary of the recent changes.
Moderna plans to ship multi-dose vials that contain (up to) 15 doses starting in early May. There will be two Moderna multi-dose vial options in circulation until the end of May when the 11-dose vials are phased out. During this transition, pay close attention to the volume vials on hand and make sure to withdraw the appropriate number of doses per vial. If a full 0.5mL dose cannot be withdrawn from the vial, discard the vial and contents. Never “pool” or combine excess vaccine from multiple vials to obtain a dose.
Moderna COVID-19 vaccine vials and labels
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Moderna multi-dose vial (maximum 11 doses of 0.5mL). Vaccination sites should continue to reliably extract 10 doses from the current volume vial.
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Moderna multi-dose vial (maximum 15 doses of 0.5mL), which has a new National Drug Code (NDC). Range of doses per vial is 13-15 doses. Based on overfill in the vial and the type of syringes used to administer the vaccine, it will not always be possible to extract the 15th dose. Vaccination sites should plan to extract 14 doses from the new larger volume vial using the ancillary kit supplies provided.
Reporting wastage
If you cannot extract a 15th dose from the Moderna 15-dose vial, or an 11th dose from an 11-dose vial, you do not need to report that dose as wasted.
The second dose of Pfizer-BioNTech and Moderna vaccines should be administered as close to the recommended interval as possible, but not earlier than recommended (i.e., 3 weeks for Pfizer-BioNTech or 1 month for Moderna). However, second doses administered within a grace period of 4 days earlier than the minimum interval date for the second dose are still considered valid. If it is not feasible to adhere to the recommended interval and a delay in vaccination is unavoidable, the second dose of Pfizer-BioNTech and Moderna COVID-19 vaccines should be administered at the earliest opportunity. The second dose may be administered up to six weeks (42 days) after the first dose. Currently, only limited data are available on efficacy of mRNA COVID-19 vaccines administered beyond this window.
CDC does not recommend restarting the series or giving additional doses if the interval is greater than six weeks.
Transfer COVID-19 vaccine at 2 to 8 degrees Celsius (36 to 46 degrees Fahrenheit), a refrigerated temperature. Monitor vaccine temperature during transit using a continuous temperature monitoring device in the transport cooler.
- If vaccine is frozen before transporting, it should still be packed in a cooler at refrigerated temperatures, time in transit can count as thawing time.
- Do not refreeze vaccines once thawed.
Try to minimize multiple transports. If a vial is unopened and unused one day after being transported, make sure to use that vial first the next day rather than transporting it again.
You must complete the REDCap: COVID-19 Vaccine Redistribution Form to report to MDH each time vaccine is redistributed and document temperature monitoring during transport. Use the COVID-19 Vaccine Temperature Monitoring and Documentation Form (PDF) if transporting vaccine for an offsite clinic.
Find the updated guide and appendices at COVID-19 Vaccine Providers.
- Main guide:
- Updated ordering and distribution language to reflect the suspension of the 72-hour rule (p. 5).
- Added new section with CDC resources to assist clinicians in possible COVID-19 vaccine-related adverse events (p. 18).
- Appendix B/Moderna: Updates to reflect the changes in vial sizes ( (p. 1 & 5).
- Appendix C/Janssen: Updates to the “Warnings” section regarding Thrombosis with Thrombocytopenia Syndrome (p.4).
- Appendices A and B have updated language for second doses.
As with licensed vaccines, vaccines under an Emergency Use Authorization have the same requirements to report to the Vaccine Adverse Event Report System (VAERS) any situations, including serious adverse events, that occurred after vaccination. This is regardless of determination of cause.
The CDC and FDA are monitoring VAERS reports about COVID-19 vaccines daily. They follow-up with providers to get any further information especially about severe or life-threatening events. This is what helped identify the clotting issues with the Janssen vaccine very early, despite it affecting a very small number of people.
To submit an event, go to VAERS: Report an Adverse Event. There is a checklist on this page to help gather information needed when submitting a report (VAERS 2.0_Checklist (PDF)).
Urgent consults
Health care providers can contact the CDC Emergency Operations Center at 770-488-7100 if they need an urgent COVID-19 vaccine safety consultation. In case of a health emergency, providers should call 911.
Complex health situations
Health care personnel or health departments in the United States can request a consultation from the CDC Clinical Immunization Safety Assessment (CISA) Project if they have complex COVID-19 vaccine safety questions not readily addressed by CDC guidance. For non-urgent concerns, providers may Contact CDC-INFO.
VaccineFinder is a federal tool that can direct people to COVID-19 vaccine providers that have vaccine available. Registering with VaccineFinder is optional. In an effort to help Minnesotans find vaccine in their community, we encourage you to display your location to the public if you choose to register.
Sites receive an automated invitation email from VaccineFinder to register every five days, so if you are interested but have not yet registered, look for an email from vaccinefinder@auth.castlighthealth.com. MDH will continue to report inventory on behalf of all sites.
Once your site is registered, please refer to the Quick Start Guide: VaccineFinder Public Display Administration Fields – Log Manually (PDF) for instructions on how to update your public display information.
Please note that this is a federal tool and is separate from the state’s Find Vaccine Locations map
Registered COVID-19 providers must report vaccine wastage in MIIC. Refer to Reporting Nonviable COVID-19 Vaccine to MIIC (PDF) for guidance.
When using MIIC to report, please disregard any automatic email responses you may get about shipping labels or expired or spoiled COVID-19 vials. COVID-19 vaccine doses are not being returned to the manufacturer or McKesson. Dispose of vials per recommendations found in the COVID-19 vaccine provider guide. Note that with the new Moderna NDC, failure to extract a 15th dose does not result in reportable waste.
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