FDA Revises Moderna EUA to Increase Number of
Vaccine Doses Available
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With vaccination efforts ramping up, the U.S. Food and Drug Administration (FDA) has announced two revisions for the Emergency Use Authorization (EUA) of Moderna COVID-19 vaccine. The fact sheet for healthcare providers administering Moderna COVID-19 vaccine now reflects these changes.
The first revision adds clarity that the maximum number of extractable doses is 11, with a range of 10-11 doses. The second revision authorized the availability of an additional multi-dose vial in which each vial contains a maximum of 15 doses, with a range of 13-15 doses that can potentially be extracted. With both of these changes, it is important to note that the amount of doses extracted still depends on the type of syringes and needles being used to extract doses.
Partial doses should not be administered to patients, nor should they be pooled with partial doses from other multiuse vials to make a full dose. This poses a contamination risk, since the vaccine does not contain a preservative.
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COVID-19 Vaccine Ancillary Kit:
Syringe and Needle Deficiency Reporting
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Reports of defects in the ancillary supply kits for COVID-19 vaccine have prompted the Michigan Department of Health and Human Services (MDHHS) to issue guidance on how to report any deficiencies in syringes and needles in the kits.
Vaccination providers are encouraged to report any issues with syringes and needles contained in the ancillary kits that are shipped with their federal vaccine orders. The reporting process outlined below does not cover supplies obtained outside the federal system.
Reporting Process:
Prior to reporting, please take a picture of the deficiency, so that it can be used to support the report and possible investigation. Here and below, find sample photos of different types of deficiencies.
1. Report deficiencies to your Local Health Department (LHD) who will then report to MDHHS.
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For LHD contact information please visit: www.michigan.gov/lhdmap.
- When reporting, please have pictures available to submit.
- You must provide your VFC PIN, delivery date, lot number and all details regarding the deficiency identified.
3. Because syringes and needles are classified as medical devices, providers and facilities are encouraged to report any deficiencies by completing FDA form 3500:
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- Per U.S. Food and Drug Administration (FDA) guidelines: If the case report involves more than one faulty medical device, please prepare a complete copy of Form FDA 3500 that identifies one device then attach an additional copy of Form FDA 3500, with only Section E filled in, for each additional device.
- For more information on how to file the report, click the button below.
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Rising COVID-19 Rates and Variant Spread:
Updates in Case Investigation, Contact Tracing and Quarantine
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Due to increasing case rates and variant spread in Michigan, the Michigan Department of Health and Human Services (MDHHS) has two important updates for case investigation and contact tracing guidance, effective today. These changes are being implemented to best leverage available public health resources to better define the scope of the outbreak and limit spread.
Key updates in this document are as follows:
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A focus on confirmed and probable cases, to address the spread of the epidemic in younger age groups who are frequently testing via antigen tests
- A prioritization of case investigations among younger versus older age groups
- A continued focus on timely investigation of cases associated with congregate settings and outbreaks
- Recommendations on the use of technology (like PEG) to notify patients of their result, provide them health education and guidance, and to electronically capture case report form data from cases
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An emphasis on the collection of household and non-household contacts
- Guidance on abbreviated interviews using traditional case investigation methods
Secondly, effective today, Michigan will reinstitute a standard 14-day quarantine for close contacts of COVID-19 cases. This will remove the option of a 10-day quarantine for non-variant cases. As a reminder, a “test out of quarantine” strategy has never been adopted in the state of Michigan.
Changes to Traceforce to implement this change will occur as soon as possible.
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Vaccine Eligibility Expands to Everyone Age 16 and Older |
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Starting today, all Michiganders age 16 and older are eligible for the COVID-19 vaccine, per the Michigan Department of Health and Human Services. As the state is working to expand access to create equitable and efficient distribution, MDHHS has also announced a new goal: to get 100,000 shots in Michiganders' arms every day.
All residents are encouraged to sign up for the vaccine:
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Check the website of your local health department or hospital to find out their process or for registration forms (map of local health departments);
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Check additional vaccination sites, such as local pharmacies like CVS, Kroger, Meijer, RiteAid, Walmart (Mid/Central and Northern MI) or Snyder Drugs (U.P. residents);
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To register for the West Michigan Vaccine Clinic at DeVos Place in Grand Rapids, go to West Michigan Vaccine Clinic (spectrumhealth.org).
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To register for the Regional Community Vaccination Site at Ford Field in Detroit go to https://clinic.meijer.com/register/CL2021 or text EndCOVID to 75049.
- Residents who don't have access to the internet or who need assistance navigating the vaccine scheduling process can call the COVID-19 Hotline at 888-535-6136 (press 1) Monday through Friday from 8 a.m. to 5 p.m. Saturday and Sunday 8 a.m. to 1 p.m.
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State Employees to Continue Working from Home until July 12 |
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State employees that are currently working remotely should plan on doing so until at least July 12, according to a report by Gongwer News Service. Remote work was last set to end on May 1, but will now be extended until July, Office of the State Employer Acting Director Cheryl Schmittdiel said in a Friday email.
"State employees currently working from home should not expect to return to a state office building until that time," Ms. Schmittdiel wrote.
The email said while there is positive news when it comes the state's vaccination efforts and "incremental steps" toward normalcy, there is still concern about coronavirus case counts.
"Which means we must remain vigilant when it comes to wearing masks, maintaining social distance and washing hands frequently. New variants of the virus continue to occur, and we can't let our guard down now," she wrote. "There is light at the end of the tunnel – but we are still in the tunnel and everyone must remain committed to the safety protocols that are proven to work."
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