April 29, 2021
Whitmer Unveils Plan to Get ‘MI Vacc to Normal’ 
Gov. Gretchen Whitmer today unveiled the ‘MI Vacc to Normal’ plan as the state continues to push toward its goal of vaccinating 70 percent of Michiganders ages 16 years or older. To facilitate this goal, the Michigan Department of Health and Human Services (MDHHS) will base future epidemic order actions on four vaccination-based milestones that, once achieved, will enable Michigan to take a step toward normalcy. 
 
The ‘MI Vacc to Normal’ plan will use four vaccination-based milestones – using data for Michiganders 16 years or older who’ve received their first dose – to guide future steps required to get back to normal: 
 
  • 55 percent of Michiganders (4,453,304 residents), plus two weeks 
  • Allows in-person work for all sectors of business. 
  • 60 percent of Michiganders (4,858,150 residents), plus two weeks 
  • Increases indoor capacity at sports stadiums to 25 percent. 
  • Increases indoor capacity at conference centers/banquet halls/funeral homes to 25 percent. 
  • Increases capacity at exercise facilities and gyms to 50 percent. 
  • Lifts the curfew on restaurants and bars.   
  • 65 percent of Michiganders (5,262,996 residents), plus two weeks 
  • Lifts all indoor capacity limits, requiring only social distancing between parties. 
  • Further relaxes limits on residential social gatherings.   
  • 70 percent of Michiganders (5,667,842 residents), plus two weeks 
  • Lifts the Gatherings and Face Masks Order such that MDHHS will no longer employ broad mitigation measures unless unanticipated circumstances arise, such as the spread of vaccine-resistant variants.   

To date, Michigan has administered 6,657,997 vaccines. Currently, 48.8 percent of Michiganders ages 16 and older have received at least one dose, with 35.9 percent percent of Michiganders ages 16 and older being fully vaccinated. Although progress has been made, it is crucial that Michiganders continue to mask up and socially distance as the state takes steps to get back to normal. It is also crucial for everyone to get their second doses of the Moderna and Pfizer vaccines, which Michiganders have been doing at a rate of 96.4 percent, above the national average. 


If new cases remain greater than 250 daily/million as a 7-day average in a Michigan Economic Recovery Committee (MERC) region at the time of implementing steps 2 through 3, MDHHS may delay implementation in that MERC region.  
Also today MDHHS announced that the department and Protect Michigan Commission are launching new television spots this week featuring stories from Michiganders on why they chose to get the COVID-19 vaccine. The new ads are part of the next phase of the “Spread Hope, Not COVID” campaign that MDHHS launched last fall.  
 
The spots were recorded Friday, April 16, outside the Ford Field vaccination site in Detroit. Additional spots were recorded outside a Detroit Medical Center vaccination location at the Northwest Activity Center in Detroit on Friday, April 23. 
New Moderna Vaccine Guidance, Including Storage and Handling
The Michigan Department of Health and Human Services (MDHHS) has provided an update regarding Moderna COVID-19 vaccine. Recent changes include vaccine vial fill volume, updated labeling, and storage and handling modifications. The key updates are below.

  • Recent emergency use authorization (EUA) revision includes that the Moderna vaccine will be available in two different vials by early May. Shipments of the new vials could occur as early as May 3.
  • The current maximum 11-dose vial and a new maximum 15-dose vial.
  • The vial will remain the same size but will be filled to the higher volume.
  • Each vial is clearly marked as either a maximum of 11 doses or a maximum of 15 doses.
  • The label for the maximum of 15-dose vial also has distinctive blue shading on the bottom half of the label.
  • Moderna is planning to transition all manufacturing to the new vial during May.
  • The recently updated Moderna COVID-19 Vaccine EUA Fact Sheet for Health Care Providers includes the maximum 15-dose vial information.
  • A new National Drug Code (NDC) has been issued for the larger volume Moderna vial, which has been given a range of 13-15 doses in the EUA.
  • Carton NDC: 80777-273-98
  • Vial NDC: 80777-273-15
  • Ancillary kits will be reconfigured to extract a maximum of 14 doses per vial, plus a 5 percent surplus.
  • Minimum order quantity: 140 doses
  • An unextracted 15th dose from the larger volume vial does NOT result in reportable waste.
  • Updated storage and handling guidance for Moderna COVID-19 vaccine. Time frames have been changed; see updated storage time frames below. MDHHS also verified with the manufacturer, Moderna, to clarify vaccine temperatures and storage timeframes.
  • Frozen: Moderna vaccine vials may be stored in the freezer between -50° to -15°C (-58° to 5°F).
  • Refrigerated/Unpunctured vials: An unpunctured Moderna vaccine vial may be stored between 8° to 25°C (46° to 77°F) for a total of 24 hours. This is an increase from 12 hours.
  • Punctured Vials: A punctured Moderna vaccine vial may be stored between 2° to 25°C (36° to 77°F) for up to 12 hours. Vials should be discarded 12 hours after the first puncture. This is an increase from six hours.
  • Updates are reflected on the Moderna S&H Summary and the Moderna COVID-19 Vaccine Preparation and Administration Summary.

Moderna COVID-19 Vaccine Storage and Handling Question and Answer:
"During a clinic, we had an unpunctured vial of Moderna move from a refrigerated state cool cube into room temperature. The vaccine thawed, but we ended up not using the vial (it was at room temperature for about two hours). Can we place the unpunctured vial back into the cool cube at refrigerated temperatures? If we do this, will it “pause” the 24-hour guideline?"

Per Moderna (response as of 4/27/21) — One should refrain from mixing and matching temperature. So, for example, unpunctured refrigerated vials can be stored in the refrigerator for 30 days at 2 to 8°C, and the unpunctured vial can be stored at 8 to 25°C for a total of 24 hours. If it is kept at refrigerated temperatures, it can be stored under those conditions for 30 days. If the vial is thawed and at room temperature, then it really should stay at room temperature and needs to be used within 24 hours. (Do not mix and match temperatures). The 24-hour countdown starts as soon as the vial is removed from the refrigerator and DOES NOT stop if the vial is returned to the refrigerator. There is no “pause.”
 
Additionally, clinical materials for healthcare workers will be updated and available on the web the first week of May.

Resources:
COVID-19 Vaccine Breakthrough Case
Investigation and Reporting
The Centers for Disease Control and Prevention (CDC) has recently provided guidance on COVID-19 breakthrough case investigation and reporting on their website, according to an update from the Michigan Department of Health and Human Services (MDHHS) sent through the Michigan Health Alert Network (MIHAN).
 
Key Points
  • Vaccine breakthrough cases are expected. COVID-19 vaccines are effective and are a critical tool to bring the pandemic under control. However, no vaccines are 100 percent effective at preventing illness. There will be a small percentage of people who are fully vaccinated who still get sick, require hospitalization, or die from COVID-19.
  • More than 87 million people in the United States had been fully vaccinated as of April 20, 2021. Like with other vaccines, symptomatic vaccine breakthrough cases will occur, even though the vaccines are working as expected. Asymptomatic infections among vaccinated people also will occur.
  • There is evidence that vaccination may make illness less severe (see reference a).
  • Current data suggest that COVID-19 vaccines authorized for use in the United States offer protection against most SARS-CoV-2 variants circulating in the United States. However, variants will cause some of these vaccine breakthrough cases (see reference b).
  • Beginning May 1, 2021, CDC will transition vaccine breakthrough surveillance activity to focus on identifying and investigating only those vaccine breakthrough infections that result in hospitalization or death. This shift is intended to allow public health to maximize the quality of data collected on cases of greatest clinical and public health surveillance. MDHHS will continue to monitor trends of all vaccine breakthrough cases reported in Michigan through the Michigan Disease Surveillance System (MDSS) and the Michigan Care Improvement Registry (MCIR). However, as of May 1, data uploaded to CDC will be limited to cases that resulted in hospitalization or death.
 
CDC vaccine breakthrough case definition
An individual who has: 
  1. Completed the primary series of a U.S. Food and Drug Administration (FDA)-authorized vaccine, AND   
  2. Tested positive for SARS-CoV-2 RNA or antigen on a specimen collected ≥14 days after the final dose of vaccine, AND  
  3. Not tested positive by PCR or antigen in the 45 days prior to the most recent positive PCR or antigen test. 
Note: this definition includes asymptomatic and symptomatic infections.
 
COVID-19 vaccine breakthrough infections reported to CDC
  • As of April 20, 2021, CDC received 7,157 reports of vaccine breakthrough infections meeting CDC case criteria from 45 U.S. states and territories.
  • Vaccine breakthrough infections were reported among people of all ages eligible for vaccination.
  • 3,265 (46 percent) of the reported infections were among people ≥60 years of age.
  • 4,580 (64 percent) of the people experiencing a breakthrough infection were female.
  • 2,078 (31 percent) of the vaccine breakthrough infections were reported as asymptomatic.
  • 498 (7 percent) people with breakthrough infections were known to be hospitalized and 88 (1 percent) died.
  • Of the 498 hospitalized patients, 167 (34 percent) were reported as asymptomatic or hospitalized for a reason not related to COVID-19.
  • Of the 88 deaths, 11 (13 percent) were reported as asymptomatic or the patient died due to a cause not related to COVID-19.
  • Hospitalizations and deaths that are not a direct result of COVID-19 are still considered vaccine breakthrough cases if the person was fully vaccinated and subsequently tested positive for COVID-19.
 
Michigan COVID-19 vaccine breakthrough infections
  • Vaccine breakthrough cases were identified through reviews of Michigan Disease Surveillance System (MDSS) and MCIR data.
  • As of April 20, 2021, MDHHS has identified 2,108 cases of vaccine breakthrough infections meeting CDC case criteria based on a positive COVID-19 test 14 or more days after being fully vaccinated and no positive COVID-19 PCR or antigen tests in the prior 45 days.
  • Less than 1 percent of people who were fully vaccinated met this case definition.
  • 41 (2 percent) of the people with breakthrough infections were known to be hospitalized.
  • 22 (1 percent) of the people with breakthrough infections died.
  • Of the 22 deaths, 21 (95 percent) were among persons aged 65 years or older and one individual had a prior PCR positive test greater than 45 days prior.
  • Additional resource: CDC COVID Vaccine Breakthrough Case
 
For healthcare providers who identify a potential breakthrough case:
  1. Contact the laboratory where the positive COVID-19 specimen was sent and ask them to forward any residual respiratory specimens from the positive test to the MDHHS Bureau of Laboratories (BOL) to perform whole genome sequencing. The MDHHS BOL COVID-19 (SARS-CoV-2) Sequencing Requisition form 5905 must be included.
  2. Unless specifically requested, collection of additional new specimens is not necessary.
  3. Notify the local health department of the patient’s residence about the case. If the patient’s residence is unknown, notify the local health department associated with the healthcare facility.
  4. Breakthrough cases that result in hospitalization or death should be reported to the Vaccine Adverse Event Reporting System (VAERS).
 
For Local Health Departments who identify a potential breakthrough case:
  1. Confirm the COVID-19 vaccination dates using the MCIR. To import an individual’s MCIR immunization record within MDSS, go to the Notes tab of the MDSS COVID-19 case and select “MCIR vaccine retrieval”. Click here for additional instructions on how to query MCIR from MDSS.
  2. Complete the vaccination history and clinical information sections, including the Pre-existing Health Status section, in the MDSS case detail form with any available information.
  3. Add “FULLVAC” to the MDSS Outbreak Name field. If the case is already part of a named outbreak, add “FULLVAC” to the end of the current outbreak name.
  4. If the respiratory specimen from a PCR test is still available, request that it be sent for sequencing at MDHHS BOL with the MDHHS BOL COVID-19 (SARS-CoV-2) Sequencing Requisition form 5905.
  5. It is not necessary to pursue collection of additional specimens (e.g., serum or an additional respiratory specimen).
  6. Although there may be an occasional request for more information, LHDs do not need to routinely complete a supplemental form (e.g., the CDC breakthrough investigation form) at this time.
  7. If possible, please ask the case (or proxy) about awareness of non-response to any other vaccinations (e.g., MMR, Tdap). Notes on vaccine non-response or additional information on pre-existing or underlying conditions can be added to the comments section of the MDSS case report form.
 
MDHHS Actions
  • MDHHS staff will routinely match MDSS case data with MCIR COVID-19 vaccination data to assist in identifying vaccine breakthrough cases.
  • If breakthrough cases are identified that warrant additional follow-up, MDHHS will contact the LHD.
  • MDHHS staff will extract vaccine breakthrough case data from MDSS to report to CDC.
References:
a) Teran RA, Walblay KA, Shane EL, et al. Postvaccination SARS-CoV-2 Infections Among Skilled Nursing Facility Residents and Staff Members — Chicago, Illinois, December 2020–March 2021. MMWR Morb Mortal Wkly Rep. ePub: 21 April 2021. DOI: http://dx.doi.org/10.15585/mmwr.mm7017e1.
 
b) Cavanaugh AM, Fortier S, Lewis P, et al. COVID-19 Outbreak Associated with a SARS-CoV-2 R.1 Lineage Variant in a Skilled Nursing Facility After Vaccination Program — Kentucky, March 2021. MMWR Morb Mortal Wkly Rep. ePub: 21 April 2021. DOI: http://dx.doi.org/10.15585/mmwr.mm7017e2.