Maryland, Massachusetts, and Michigan all follow the CDC’s storage and handling toolkit for COVID-19 vaccines which states that cold chain storage and handling requirements for COVID-19 vaccine products will vary in temperature from refrigerated (2°C to 8°C) to frozen (-15°C to -25°C) to ultra-cold (-60°C to -80°C) in the freezer or within the dry ice thermal shipper in which product was received.
- COVID-19 vaccine orders will be placed through ImmuNet, and then uploaded to the CDC Vaccine Tracking System (VTrckS) vaccine ordering system for shipping directly to the hospital or work site location within 48 hours of order approval by the immunization program. The Maryland Department of Health will oversee the tracking and administration of the vaccines via ImmuNet.
- Vaccines will be sent directly to the locations of the vaccination distributor for administration or designated secondary distribution depots to administration sites and the federal government will not redistribute the product until vaccine supplies have been delivered to a provider site.
- Jurisdictions will then be allowed to redistribute vaccines while maintaining the cold chain.
- In Maryland, COVID-19 storage practices follows the CDC’s storage and handling guidelines for COVID-19 vaccines. Cold chain storage and handling requirements for COVID-19 vaccine products will vary in temperature from refrigerated (2°C to 8°C) to frozen (-15°C to -25°C) to ultra-cold (-60°C to -80°C) in the freezer or within the dry ice thermal shipper in which product was received.
- The cold chain storage begins at the COVID-19 vaccine manufacturing plant and ends with administration of COVID-19 vaccine to a person; every vaccine storage unit/container must have a temperature monitoring device and CDC recommends a digital data loggers to register the temperatures.
- Due to limited amounts of vaccine initially available, vaccination will begin with three priority groups which includes healthcare personnel likely to be directly exposed to or treat people with suspected or confirmed COVID-19, people at increased risk for severe illness from COVID-19 and essential workers who are at more risk to exposure.
Data & Reporting
- Every 24 hours, jurisdictions will be expected to report data elements relating to vaccine administration. Vaccination providers will be expected to report and maintain on the CDC’s VaccinerFinder their COVID-19 vaccination records.
- Data Use Agreements (DUAs) will be required for data sharing through the IZ Gateway and other data sharing methods of vaccine administration with the CDC and will be coordinated by the immunization program of each jurisdiction.
- The MDH Center for Immunization (CFI) will lead the operational aspects of the plan implementation and the MDH Office of Preparedness and Response (OP&R) will assume planning and coordination and logistical responsibilities, with other MDH programs and agencies, including the Office of the Attorney General, Maryland Emergency Management Agency (MEMA), Maryland Institute for Emergency Medical Services Systems (MIEMSS), Maryland State Police (MSP), Local Health Departments (LHD), Public Health Emergency Planners (PHEPs), and Maryland Hospital Association (MHA), taking on roles and responsibilities as the operational needs evolve.
- ImmuNet will be used by providers to register to become a COVID-19 provider, order vaccines, track delivery, report and notify individuals of dosage administration.
- Gainwell Technologies is the support vendor for ImmuNet, responsible for keeping the systems up-to-date.
- PrepMod, a new online resource that will be used to schedule clinics, track equipment needs and report vaccination activity will be used to send email/text message on vaccination reminders.
- Maryland MyIR is the customer vaccination portal which will allow consumers access to their COVID-19 vaccination record and provide certification of COVID-19 specific vaccination.
- In accordance with security protocols to prevent theft and publicization, location of Phase 1 vaccines will be kept highly confidential.
- Phase 1 clinics would need to develop safety protocols to be approved by CFI before the arrival of the vaccine. The security protocols should address the location of storage and deliveries, site security, security protocols for unused doses.
- McKesson will distribute the COVID-19 vaccine for federally contracted vaccines directly to each MIIS-enrolled provider site assigned to the MDPH Immunization Division vaccine.
- The vaccine will be distributed at a minimum of 100 doses and the ultra-cold formulations will be distributed at 1,000 doses. Once an order is submitted to CDC, the order should be fulfilled within 48 hours.
- Storage and handling requirements for COVID-19 vaccine products will vary in temperature from refrigerated (2°C to 8°C) to frozen (-15°C to -25°C) to ultra-cold (-60°C to -80°C).
- Vaccines that require ultra-cold storage can be stored in their shipping containers with dry ice.
- Providers are required to continuously monitor COVID-19 vaccine with a Temperature Monitoring Device (TMD), also known as a Digital Data Logger (DDL).
- Due to limited amounts of vaccine initially available The MDPH will prioritize three population groups for initial administration; healthcare personnel (HCP) likely to be exposed to or treat people, with COVID-19, people at increased risk for severe illness from COVID-19 and other essential workers.
- When there is an adequate supply of COVID-19 vaccine, the MCVP will focus on ensuring equitable vaccination across the entire population including underserved areas or populations in the state.
Data & Reporting
- Providers will report COVID-19 vaccine doses administered to the Massachusetts Immunization Information System.
- The Massachusetts Department of Public Health (MDPH) will collect data elements like location, CVX, IIS recipient ID, name, sex, vaccine administered.
- Provider enrollment data will be submitted to CDC twice a week while the MDPH COVID-19 Vaccination Leadership Team and MDPH legal counsel will review any proposals to share MIIS data.
- The Massachusetts Department of Public Health (MDPH) regulates, licenses, and provides oversight of a wide range of healthcare-related professions and services, and focuses on preventing disease and promoting wellness and health equity for all people.
- The Bureau of Infectious Disease and Laboratory Sciences (BIDLS) is the lead for COVID-19 vaccination planning, distribution, and implementation efforts.
- The Bureau of Community Health and Prevention (BCHAP) will support the Immunization Division with communications planning.
- The Bureau of Health Care Safety and Quality (BHCSQ) will support the Immunization Division, providing outreach and coordination with health care facilities in support of MCVP implementation activities.
- The Bureau of Health Professions Licensure (BHPL) will support the Immunization Division with outreach and coordination with health care professionals and the Board of Registration in Pharmacy.
- The Office of Communications will develop and implement the MCVP Communications Plan.
- The Office of Local and Regional Health (OLRH) will support the Immunization Division with outreach and coordination with local boards of health in support of MCVP implementation activities.
- The Office of Population Health (OPH) will support the Immunization Division by providing guidance to assure the MCVP addresses health inequities.
- The Office of Preparedness and Emergency Management (OPEM) “will support the Immunization Division with COVID-19 Vaccination Plan development expertise, as well as the development of exercises in support of plan implementation and post-incident debriefs.”
- The Massachusetts Immunization Information System (MIIS) will be used to capture COVID-19 vaccine doses administered data.
- PrepMod System will be used to connect to the MIIS for real-time reporting and to assist with off-site vaccination clinic scheduling, billing, and IIS reporting.
- Electronic Health Records (EHR) system will be used by providers to send their immunization data via Health Level Seven (HL7) electronic messaging.
- “Massachusetts Department of Public Health (MDPH) staff is trained to respond to calls from providers and the public about COVID-19 vaccine safety and reporting of adverse events“
- During phase 1, the Division of Immunization will directly distribute COVID-19 vaccine to the facilities identified with in Michigan’s critical populations. CDC allocations will be distributed to local health departments following shipments directly to hospitals to prioritize vaccine to providers that have the capacity to administer vaccine to other critical populations.
- Allocations controlled by the LHDs will be routed to providers that can vaccinate the priority populations under their jurisdiction. LHDs will also distribute to pharmacies who have not received direct distribution from CDC.
- “Phase 2 vaccine distribution will be allocated through the local health jurisdictions. The LHDs will allocate to commercial sector settings such as retail pharmacies, private sector settings including private doctors’ offices, and public health sites including Federally Qualified Health Centers, temporary and off- site clinics, and additional locations to ensure equitable vaccine access to the critical and general populations.”
- Cold-chain procedures must be in accordance with manufacturer’s instructions and CDC’s guidance on COVID-19 vaccine storage and handling toolkit.
- According to the CDC’s COVID-19 vaccine storage and handling toolkit, cold chain storage and handling requirements for COVID-19 vaccine products will vary in temperature from refrigerated (2°C to 8°C) to frozen (-15°C to -25°C) to ultra-cold (-60°C to -80°C) in the freezer or within the dry ice thermal shipper in which product was received.
- Phase 1 of Michigan’s vaccination will be administered to its priority group due to limited supply doses. The priority groups are healthcare personnel, LTC staff and residents, critical infrastructure workers, individuals 65 years and over, and those with underlying medical conditions.
- As doses become more available in Phase 2, vaccination will be expanded to larger population group to ensure HCP, essential workers not covered in phase 1, and general populations are vaccinated.
- In the Phase 3 when the vaccine supply is plentiful, the target vaccination group will be the general population of Michigan.
Data & Reporting
- Based on CDC guidance and reporting requirements, Michigan will submit daily reports of all doses administered and provider enrollment data twice weekly to the CDC.
- The Michigan Care Improvement Registry (MCIR) will be used to collect all COVID vaccine doses administered within 24 hours.
- “Real-Time documentation from satellite, temporary, or off-site clinic settings will require the provider to resolve with their organization and/or EHR vendor how they will collect information in their EHR system for HL7 VXU submission to the IIS from that site.”
- COVID-19 Vaccine Administration Monitoring reports will be created and provided to the Division of Immunization Leadership regularly. The reports will include: Provider Name; Facility Type/Site: Calculation based on Date of Receipt, Date of Administration and date of report to public health.
- The Immunization Division works closely with the Communicable Disease Division and partner on outbreak control activities and temporarily reports to the State Epidemiologist within the Bureau of Epidemiology and Population Health.
- The State Chief Medical Executive, State Epidemiologist, Local Health Services, Legal, and Communications will mostly provide guidance and direction to the program.
- External stakeholder groups will act as advisory group to engage and educate a wide selection of partners. The groups will include MALPH/Local Public Health, Michigan Health and Hospital Association, Michigan Primary Care Association, Michigan Osteopathic Association, Michigan Academy of Family Physicians, Michigan State Medical Society, Michigan American Academy of Pediatrics, Michigan Pharmacy Association, among others
- MCIR will also be used to facilitate vaccine ordering and accountability. The system will also be used to generate a reminder based on when the second dose of COVID-19 vaccine is due.
- The Michigan Health Alert Network (MIHAN) will be used to get high alert communication message fast to public health, healthcare and public safety personnel.
- Surveillance for adverse events related to COVID-19 vaccination will be conducted through reports to the national VAERS.