COVID-19 Vaccine Provider Alert:
Monitoring For Myocarditis
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Myocarditis is the inflammation of the heart muscle and pericarditis is the inflammation of the lining outside the heart. In both cases, the body's immune system is causing inflammation in response to an infection or some other trigger. While myocarditis can be serious, it is frequently mild and self-limited. Symptoms can include abnormal heart rhythms, shortness of breath or chest pain.
To date, there has not been a safety signal identified in either VAERS or VSD. CDC will continue to evaluate reports of myocarditis/pericarditis occurring after COVID-19 vaccination and will share more information as it becomes available.
Healthcare providers should consider myocarditis in an evaluation of chest pain after vaccination and report all cases to VAERS. Reports to VAERS should be made using the VAERS website. As a reminder, it’s a requirement of the Emergency Use Authorization (EUA) that vaccine providers report adverse events to VAERS. Without this reporting, MDHHS and the CDC cannot know the scope of a potential issue, investigate it and provide you with tools on how to communicate about it.
CDC and MDHHS continue to recommend COVID-19 vaccination for people 12 years and older.
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Changes to Pfizer COVID-19 Vaccine Storage Guidance |
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Storage conditions have been expanded for refrigerated timeframes of Pfizer-BioNTech COVID-19 Vaccine – a change that can promote vaccine availability for even more vaccine providers in the community and thereby more residents across the state, according to the Michigan Department of Health and Human Services (MDHHS).
Please review the following updated information:
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The U.S. Food and Drug Administration (FDA) has authorized undiluted, thawed Pfizer-BioNTech COVID-19 vaccine vials to be stored in the refrigerator at 2°C to 8°C (35°F to 46°F) for up to one month.
- Previously, thawed, undiluted vials could be stored in the refrigerator for up to five days.
- Reminder about thawing: A carton of 25 vials or 195 vials may take up to two or three hours, respectively, to thaw in the refrigerator (whereas fewer vials will thaw in less time).
- This one-month refrigerated storage duration must be within the labeled expiration date.
- Do not re-freeze thawed vials.
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The Fact Sheet for Healthcare Providers Administering Vaccine has been updated to reflect this revised storage time.
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EUA Fact Sheets are also available on our COVID-19 Vaccine Provider Guidance website.
To review overall storage guidelines for Pfizer vaccine, below is a step-down review:
- Pfizer COVID-19 vaccine is shipped at ultra-cold temperatures
- Ultra-Cold Storage
- May be stored in an ultra-cold freezer between -80°C to -60°C (-112°F to -76°F) until the expiration date
- May be stored temporarily in the thermal shipper with dry ice replenishment for up to 30 days
- Frozen Storage
- May be stored at -25°C to -15°C (-13°F to 5°F) for up to two weeks
- Refrigerated Storage
- Undiluted, thawed vials may be stored in the refrigerator at 2°C to 8°C (35°F to 46°F) for up to one month.
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Note: The vaccine can be moved from two-week frozen storage to one-month refrigerated storage for a total storage timeframe up to but not exceeding 45 days.
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For Pfizer vaccine resources, visit the CDC Pfizer COVID-19 Vaccine Webpage and the Pfizer Manufacturer Website.
Previous storage requirements of this vaccine have been cited as a barrier for some providers, so this change may assist in alleviating such concerns. MDHHS encourages enrolled COVID-19 Vaccine Providers to utilize this change as an opportunity to engage in providing this vaccine (if not already). This may be accomplished via placing an E-Order in MCIR or seeking out redistributed vaccine (of smaller quantities) from a nearby provider with Pfizer vaccine, such as a Local Health Department. Ensuring Pfizer vaccine availability is an important step for adolescent vaccination efforts.
Additionally, Pfizer anticipates shipments of smaller order quantities to begin in early June with orders of 450 doses becoming available (the 1170-dose order quantities will also remain available). As more information on these smaller order quantities becomes available, we will share this with you.
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Memorial Day Shipping Changes for COVID-19 Vaccine |
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The Michigan Department of Health and Human Services (MDHHS) is asking providers to take note of the COVID-19 vaccine shipping holds for Memorial Day:
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Pfizer Vaccine: No vaccine deliveries will occur on Monday, May 31.
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Moderna Vaccine: No vaccine deliveries will occur on Monday, May 31, or Tuesday, June 1.
- However, providers may receive ancillary kits on June 1 for vaccine orders arriving Wednesday June 2.
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Janssen Vaccine: No vaccine deliveries will occur on Monday, May 31, or Tuesday, June 1.
- However, providers may receive ancillary kits on June 1 for vaccine orders arriving Wednesday, June 2.
Please take this into consideration for your planning efforts. If you need to place vaccine orders for clinics scheduled during the holiday weekend, they must be entered into the Michigan Care Improvement Registry (MCIR), approved by the local health department (LHD) and approved/processed by MDHHS by Tuesday, May 25, for Pfizer vaccine and by Wednesday, May 26, for Moderna or Janssen vaccine.
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MCIR E-Ordering Reminder: Required Shipping Hours Needed for COVID-19 Vaccine Orders |
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As E-Ordering has now launched through the Michigan Care Improvement Registry (MCIR), the Michigan Department of Health and Human Services (MDHHS) Division of immunizations is warning that providers need to ensure their shipping hours are compliant with Center for Disease Control and Prevention (CDC) requirements. MDHHS issued a communication emphasizing it is crucial to review shipping information in the provider's MCIR Vaccines for Children (VFC) tab prior to placing orders and to confirm the information at the time of orders. This includes confirming that your shipping hours are compliant with CDC requirements. Several sites have submitted orders with noncompliant shipping hours. Per CDC, shipping hours must comply with the following:
To support efficient distribution of vaccine, locations should offer full-day receiving hours to the extent possible. When that is not possible, COVID-19 Vaccine Providers must be available to receive shipments during a 4-hour window on a weekday other than Monday.
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Action Needed: All COVID-19 Vaccine providers must review shipping hours in your MCIR VFC tab and ensure they comply with CDC requirements by COB Friday, May 21.
Local Health Departments (LHDs), are advised not to approve orders with noncompliant shipping hours. Beginning Monday, May 24, MDHHS will reject any orders with noncompliant shipping hours.
As a reminder, several ordering tip sheets are available and posted online, including our webinar and tip sheet for How to Order COVID-19 Vaccine in MCIR (E-Ordering).
E-Ordering Now Used for All Vaccine Ordering
As a reminder, MCIR E-Ordering is to be used for all COVID-19 vaccine ordering, even for sites that previously had direct orders placed by MDHHS (LHDs, hospitals, etc.). MDHHS is no longer placing weekly orders for sites nor will second doses be automatically ordered. Instead, E-Ordering allows sites to initiate orders based on their need (and based on products available for order).
MDHHS has developed several resources for your support and will continue to create materials as we navigate this transition. See below:
How to Order COVID-19 Vaccine in MCIR (E-Ordering)
Other Tip Sheets on Orders & Shipments
Please note that orders are not automatically approved upon placement. They are reviewed by LHD staff who may approve, revise or reject orders and contact you for follow-up. Before approving requests for vaccine orders, LHDs may assess your site for readiness, request temperature logs or review other materials to assure COVID-19 vaccine is managed appropriately. Please defer to LHD guidance prior to placing an order in MCIR so that any necessary paperwork such as temperature logs can be provided at the time of ordering. Find your LHD here.
New Moderna Vials Available
Last week, MDHHS received an allocation of the 14-dose Moderna vials (max 15-dose). Therefore, when placing an order, providers will see the 10-dose and 14-dose presentations available (100-dose minimum order and 140-dose minimum order).
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Proper Disposal of COVID-19 Vaccine |
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Recently it has come to the attention of the Michigan Department of Health and Human Services (MDHHS) that there is a national concern regarding COVID-19 vaccine not being disposed of properly, in particular the Pfizer-BioNTech COVID-19 vaccine. MDHHS has previously sent out an email about the proper disposal of COVID-19 vaccine but released the following reminder as well.
Proper disposal of vaccines is everyone’s responsibility. There may be times when disposal of COVID-19 vaccine vials will need to occur even if the vial or syringe is not empty. COVID-19 vaccine should not be placed back in the shipping box and sent back to the manufacturer. Also, COVID-19 vaccine liquid should not be removed before disposing of the COVID-19 vaccine dose. We have heard rumors of vaccine liquid being removed via syringe and then “squirted” down the sink drain. This should not happen. If vaccine is still left in the vial, it must be disposed of in the Biohazard/Sharps container.
The document reviews the recommended actions suggested by the Department of Defense in relation to the increased threat of fake or counterfeit vaccines. It is recommended that vaccine administration sites dispose of wasted COVID-19 vaccines in accordance with their jurisdiction’s procedures and take appropriate steps to properly dispose of empty vaccine vials and product packaging.
Recommended actions to further protect COVID-19 vaccine empty vials and packaging are:
- Action 1 (Preferred method): Treat vials and packaging similarly to medical waste by placing in red sharps container; OR
- Action 2: Deface all or safely crush materials so it cannot be reintroduced or reproduced. After the products are sufficiently defaced, then dispose with regular waste.
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COVID-19 Vaccine Education Corner - MCIR |
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One of the many benefits of the Michigan Care Improvement Registry (MCIR) is the consolidation of immunization information from multiple providers into one comprehensive record. This consolidation strives to eliminate duplicate records and allows providers to view and assess up-to-date patient immunization records from one system.
In order for these benefits to occur, MDHHS must ensure that MCIR is utilized for accurate data reporting. This is not always easy during a busy COVID-19 clinic! MDHHS has received several reports of duplicate records being created for patients, which could lead to inaccurate assessment of vaccination needs. MDHHS wants to ensure appropriate assessment of records to insure accurate and complete documentation, as well as reduce potential vaccine administration errors. Therefore, MDHHS provided resources and guidance regarding the two questions below.
Question: Should I look my patient up in the MCIR before I administer a dose of COVID-19 vaccine?
YES! The most important step you can take prior to vaccine administration is to search for a patient or person in MCIR to verify their immunization status. This will ensure that you have the correct MCIR Immunization record and can verify if the patient has received a dose of COVID-19 vaccine. It also provides the opportunity to verify age as we are beginning to vaccinate those 12 years and older with the Pfizer BioNTech COVID-19 vaccine. This critical and essential step will help minimize and/or eliminate duplicate records. Two of the authorized COVID-19 vaccines are a two-dose series; this further emphasizes the importance of verifying a person’s immunization record to ensure proper intervals are met and that the same product is used.
Resources:
Question: What if the patient has lost, can’t find or never received their COVID-19 vaccination record card?
Remind your patient of these key things:
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Patients may contact the facility where they were vaccinated and request either a completed COVID-19 Vaccination Record Card or a printout of their current immunization record from the MCIR.
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Patients can also visit www.mcir.org/public to request an official immunization record, which will display proof they have received a COVID-19 vaccine.
- Both the record card and immunization record are official vaccination records.
Thank you for all your hard work to protect Michiganders from vaccine-preventable diseases!
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