1. Is there a cost to providers to receive and administer the vaccine?
There is no cost for the vaccine or ancillary kits. The U.S. Centers for Medicare and Medicaid Services (CMS) has approved reimbursement for the administration of the vaccine. While vaccine providers may not bill for the COVID-19 vaccine itself, many vaccine providers in the state have contracted with outside entities, such as Commonwealth Medicine, to assist with insurance billing for the costs of administering the vaccine. The Department is not a party to these agreements, but if your site has such an agreement you may wish to familiarize yourself with its terms.
2. Will there be funding to administer COVID-19 vaccine?
At this time, no funding for administration related costs is available through the federal government or from the state. Vaccine and some related supplies (syringes, needles) are being supplied by the federal government. Providers may bill Medicare, Medicaid, and private insurers for the cost of administering COVID-19 vaccine. For more information, please see COVID-19 Vaccine Coverage and Reimbursement Update from the Massachusetts Medical Society.
3. Is there a cost to vaccine recipients?
Providers must administer COVID-19 Vaccine regardless of the vaccine recipient’s ability to pay administration fees or the recipient’s insurance coverage status. Providers may seek appropriate reimbursement from a program or plan that covers COVID-19 Vaccine administration fees for the vaccine recipient. Providers may not seek co-payment, reimbursement or any form of cost sharing, including through balance billing, from the vaccine recipient.
4. Is the COVID-19 vaccine mandated by DPH?
No, the COVID-19 vaccine is not mandated by DPH. It is a voluntary vaccination program. The COVID-19 vaccine has been shown to be highly effective at preventing illness and it is an important tool in the fight against the pandemic.
5. Is written consent needed for COVID-19 vaccination?
Informed consent is a vital process prior to the administration of a vaccine. DPH does not require a written informed consent form from vaccine recipients. However, vaccine providers should consult with their legal counsel regarding an appropriate informed consent process and what documentation may be recommended or required by their particular organization.
6. What information do we need to provide vaccine recipients about the US FDA Emergency Use Authorization (EUA) of the Moderna and Pfizer-BioNTech COVID-19 Vaccines?
The Moderna COVID-19 Vaccine Letter of Authorization (Letter) which describes the terms of the EUA, Fact Sheet for Healthcare Providers Administering Vaccine (provider fact sheet), and Fact Sheet for Recipients and Care Givers (recipient fact sheet) in addition to other related documents and translations of the fact sheet are available here: Moderna COVID-19 Vaccine | FDA. The corresponding Letter and fact sheets for the Pfizer-BioNTech COVID-19 vaccine in addition to other related documents and translations of the fact sheet should be carefully reviewed and are available here: Pfizer-BioNTech COVID-19 Vaccine | FDA. This Letter also places obligations on vaccine providers. It is important to review the documents from the linked FDA site so that you have access to any updates or amendments.
Facilities, organizations, and healthcare providers holding vaccination clinics, as vaccination providers, should carefully review the Letter of Authorization and the provider and recipient fact sheets for the particular vaccine they will be administering. The Letter places obligations on vaccination providers including administering the vaccine in accordance with the EUA, making the recipient fact sheets available to each individual receiving the vaccine, and reporting certain information to the Vaccine Adverse Event Reporting System (VAERS).
Vaccine allocation and distribution
7. How will allocation be determined (Pfizer vs. Moderna)? Can a facility decide which one we want?
In the early phases of vaccine distribution, vaccine will be distributed to practices based on availability of each COVID-19 vaccine product. Practices will only receive Pfizer vaccine if they have ultra-cold storage capacity or are able to use 975 doses with 2-3 weeks. DPH will strive to supply only one vaccine formulation to practices where possible, but for certain larger facilities such as hospitals it is very likely that both vaccine formulations will be supplied.
8. Can the minimum 975 Pfizer doses in an order be divided between health centers, or will small health centers need to wait for the Moderna vaccine?
Pfizer vaccine is only being sent to facilities that either have ultra-cold storage capacity or are able to administer all doses within a 2-3 week period. The Moderna COVID-19 vaccine will be prioritized to facilities not eligible for the Pfizer vaccine since it is shipped in 100-dose increments and does not require ultra-cold storage.
9. Should we ask our sites to update their information stored in MIIS Vaccines module to be that of our central depot or will this be something we can address separately?
No, please do not ask sites to update their vaccine information in the vaccine module as that will result in all routine vaccines now being shipped to the new location. We will develop a separate mechanism to capture the necessary information we need for hospital networks that will be using a central depot model.
10. What preparations should universities be making regarding receiving and distributing the vaccine?
All sites planning to receive and administer COVID-19 vaccine must be enrolled in the Massachusetts COVID-19 Vaccination Program (MCVP) and registered and on-boarded to submit vaccine administration data to the Massachusetts Immunization Information System (MIIS). For more information, please see COVID-19 Vaccine Information for Providers | Mass.gov.
11. How do sites ask for more COVID-19 vaccine?
On a weekly basis, all provider sites will receive a link to a MCVP survey. Completing this survey will ensure that we understand providers vaccine needs, the phase they are currently vaccinating in, as well as other information. Additionally, there is an option for the provider to also request additional doses as part of this survey process. If you have not received the weekly survey, please email DPH-Vaccine-Management@massmail.state.ma.us.
12. Who can administer vaccine?
This COVID-19 Vaccinators chart lists the different groups of individuals who can possess and administer COVID-19 vaccines.
13. Will training be required for providers to be able to administer the vaccine?
DPH strongly encourages the primary and back-up vaccine coordinators at each site and providers administering COVID-19 vaccine to complete the trainings in vaccine storage and handling and administration found at COVID-19 Vaccine Information for Providers | Mass.gov. More information will be provided when additional trainings are available.
14. How will patients know which vaccine they receive and when they need the second dose?
The vaccine ancillary supply kits will come with vaccine record cards that can be given to the patients indicating what vaccine they received and that they need a second dose. Vaccine record cards may be reproduced, if necessary. In addition, there will be electronic reminder/recall systems in the MIIS that providers could use in addition to their own EHR systems to send reminders to patients about their second dose. More information about the v-safe app, which also includes a patient reminder recall, can be found in the Guidance on COVID-19 vaccine management and administration for healthcare providers & organizations. Providers should schedule the 2nd dose at the time the 1st dose is administered.
15. When is the 2nd dose due?
Both the Pfizer and Moderna COVID-19 vaccine require 2 doses.
- Pfizer-BioNTech (30 µg, 0.3 ml each): three weeks (21 days) apart
- Moderna (100 µg, 0.5 ml): one month (28 days) apart
Second doses administered within a grace period of ≤4 days from the recommended date for the second dose are considered valid; however, doses administered earlier do not need to be repeated. The second dose should be administered as close to the recommended interval as possible. However, there is no maximum interval between the first and second dose for either vaccine.
For COVID-19 vaccines requiring 2 doses, the 2nd dose must be the same vaccine product as the first dose. If two doses of different mRNA COVID-19 vaccine products are inadvertently administered, no additional doses of either vaccine are recommended at this time
Recommendations may be updated as further information becomes available or additional vaccine types authorized.
16. For both the Pfizer and Moderna vaccines, there may be enough extra in each vial for more than the standard 5 or 10 doses. Is it okay to administer additional doses from a vial?
Yes. After preparation, vials of Pfizer-BioNTech COVID-19 Vaccine contain up to six doses of 0.3 mL. Low dead-volume syringes and/or needles can be used to extract up to six doses from a single vial. If standard syringes and needles are used, there may not be sufficient volume to extract a sixth dose from a single vial. Irrespective of the type of syringe and needle:
- Each dose must contain 0.3 mL of vaccine.
- If the amount of vaccine remaining in the vial cannot provide a full dose of 0.3 mL, discard the vial and any excess volume.
- Do not pool excess vaccine from multiple vials.
As a reminder, use only the prescribed 1.8 ml of diluent when reconstituting a vial.
Vaccinators may also find that they can withdraw more than 10 doses of the Moderna COVID-19 vaccine from a single 10-dose vial.
- Extra vaccine fluid from more than one vial CANNOT be combined to produce extra doses.
- Use any extra vaccine that can easily be drawn into a syringe from one vial to meet the 0.5 ml dose requirement.
- Enter all vaccine doses administered into the MIIS.
17. Will providers receive second doses based on the total number of administered first doses?
Yes, the number of second doses distributed will be the same as the number of first doses distributed.
18. What should a site do with extra vaccine?
Sites can continue to vaccinate anyone in a currently eligible priority group in accordance with the Commonwealth’s COVID-19 Vaccine Plan. Vaccine can also be transferred to sites that have completed an MCVP Agreement. Please note that this does not apply to temporary off-site clinics. Such a transfer must be done in consultation with the Vaccine Unit. Visit Massachusetts COVID-19 Vaccine Program (MCVP) – Guidance for Vaccine Providers and Organizations | Mass.gov for more guidance on redistribution.
19. What should we do with unused doses in the Moderna COVID-19 vaccine multi-dose vial?
Once a vial of Moderna COVID-19 vaccine has been entered, it must be used within 6 hours. Be sure to note the time the vial was first entered on the vial. Any vaccine remaining in the vial after 6 hours must be discarded.
Careful planning is important to ensure that COVID-19 vaccine is not wasted. It is essential that you have 10 people confirmed for vaccination within 6 hours before entering a new vial for the first time. In the rare instance where you have COVID-19 vaccine that will expire and you have no one in the current priority groups to be vaccinated, you can use your clinical judgement to administer the vaccine to a person in another priority group who is closest to the current priority group being targeted for vaccination to avoid vaccine waste. It is important that you also ensure that this individual is now included in your reminder recall systems for the 2nd dose.
20. What is our obligation to follow the Emergency Use Authorization (EUA) terms and principles of non-discrimination in administration?
Providers must follow the EUA. Decisions about which eligible patients receive the COVID Vaccine should be based on the clinical judgment of hospitals and providers, consistent with the terms of the EUAs and with this guidance. Provider criteria for the COVID Vaccine use should be as clear, transparent, and objective as possible, and be based on biological factors related only to the likelihood and magnitude of benefit from the medical resources and should at all times minimize inequitable outcomes. Factors that have no bearing on the likelihood or magnitude of immunization benefit, include but are not limited to, race, disability, gender, sexual orientation, gender identity, ethnicity, ability to pay or insurance status, socioeconomic status, English language proficiency, perceived social worth, perceived quality of life, immigration status, incarceration status, homelessness, or past or future use of resources.
21. Can organizations such as nursing homes, hospitals, and shelters vaccinate workers who are not on staff full time?
Absolutely. Contractors, part-time staff, volunteers, students, and others reporting to a facility who are part of a priority group are also eligible for vaccination. For example, a travel nurse working at a hospital who is performing COVID-facing work would be categorized similarly to a full time employee doing the same work.
22. Should someone who is COVID-positive receive the vaccine?
Vaccination of persons with known current SARS-CoV-2 infection should be deferred until the person has recovered from the acute illness (if the person had symptoms). While there is otherwise no recommended minimum interval between infection and vaccination, current evidence suggests that reinfection is uncommon in the 90 days after initial infection.
23. Can healthcare providers, essential workers, and other priority populations who live in Massachusetts but work in another state receive vaccine in Massachusetts? How about those who work in Massachusetts but live in another state?
The Massachusetts COVID-19 Vaccination program is intended for individuals who live, work or study in the state. Individuals will get vaccinated either by their employer, primary care physician, pharmacy or public clinic depending on the phase of vaccination we are in.
24. Can the vaccine be given to people who are pregnant?
- There are no data on the safety of COVID-19 vaccines in people who are pregnant. Animal developmental and reproductive toxicity (DART) studies are ongoing. Studies in humans are also ongoing and more are planned.
- If a person is part of a group (e.g., healthcare personnel) who is recommended to receive a COVID-19 vaccine and is pregnant, that person may choose to be vaccinated and may wish to discuss with their healthcare provider.
- mRNA vaccines are not live vaccines. They are degraded quickly by normal cellular processes and don’t enter the nucleus of the cell.
- COVID-19 infection during pregnancy can result in an increased risk of severe illness (ICU admission, mechanical ventilation and death) and might result in an increased risk of adverse pregnancy outcomes, such as preterm birth.
- Consider the following when discussing COVID-19 vaccination with people who are pregnant:
- Level of COVID-19 community transmission, (risk of acquisition)
- Personal risk of contracting COVID-19, (by occupation or other activities)
- The risks of COVID-19 to the person who is pregnant and potential risks to the fetus
- The efficacy of the vaccine
- The known side effects of the vaccine
- The lack of data about the vaccine during pregnancy
- Pregnant people who experience fever following vaccination should be counseled to take acetaminophen as fever has been associated with adverse pregnancy outcomes.
- Routine testing for pregnancy prior to receipt of a COVID-19 vaccine is not recommended.
Vaccinating healthcare providers
25. How will people in Phase 1 that are not affiliated with a hospital (e.g. primary care providers, home-based healthcare workers, urgent care staff, school nurses) be vaccinated?
There are two options. If the healthcare provider is enrolled in the MCVP and has the capacity to administer the vaccine the provider and obtain a small number of doses from a hospital depot. Additional information can be found here.
Alternatively, these individuals can obtain the vaccination at a mass vaccination site, provider site or pharmacy site. Sites can be found here. Additional sites will continue to be added to the map.
26. How should a hospital or other health care facility determine whom among their health workers they can vaccinate?
Hospitals and other health care facilities know their employees and their situations best and are responsible for determining which COVID-19-facing health care personnel (HCP) in their facilities are vaccinated first. Eventually, there will be enough COVID-19 vaccine to vaccinate all HCP. HCP include paid or unpaid persons (both clinicians and non-clinicians) who have the potential for direct or indirect exposure to people with COVID-19 or infectious materials. They do not have to be a clinician to fall into the category of HCP in Phase 1. The definition of COVID-19 facing health care personnel includes staff who may be redeployed to meet staffing needs in response to the current COVID-19 surge. DPH encourages all employees and volunteers, including food and environmental services, who may have exposure to people or materials infected with COVID-19 be prioritized HCP for vaccination.
27. Many of our patients are first responders. Should these patients be immunized with their employers or PCP office?
First responders are the third priority group within Phase 1 of the Commonwealth’s vaccine distribution timeline slated to begin January 11. First responders will be vaccinated through several methods including clinics sponsored by local health departments and regional mass vaccination sites. Please visit mass.gov/FirstResponderVaccine for more information on first responder vaccination. We encourage you to vaccinate patients who are first responders, if you are able to identify them. This is true for patients who are home health aides or health care personnel, especially those that are not affiliated with a hospital.
28. How can we balance potential side effects of the vaccine with healthcare providers needing to be available to work?
Systemic signs and symptoms, such as fever, fatigue, headache, chills, myalgia, and arthralgia, can occur following COVID-19 vaccination. Preliminary data from mRNA COVID-19 vaccine trials indicate that most systemic post-vaccination signs and symptoms are mild to moderate in severity, occur within the first three days of vaccination (the day of vaccination and following two days, with most occurring the day after vaccination), resolve within 1-2 days of onset, and are more frequent and severe following the second dose and among younger persons compared to those who are older (>55 years). Cough, shortness of breath, rhinorrhea, sore throat, or loss of taste or smell are not consistent with post-vaccination symptoms, and instead may be symptoms of SARS-CoV-2 or another infection.
DPH guidance about Considerations for Health Care Personnel After COVID-19 Vaccination can be found here.
29. If we obtain capacity for storing at ultra-cold temperatures after we have submitted information to MIIS that we did not have capacity, what is the best way to update the system?
If there is any change in your storage capacity, please email the DPH Vaccine Unit at email@example.com to update your information.
30. Will the state provide support in accessing dry ice?
No. If your facility does not have ultra-cold storage or access to dry ice, your facility will be allocated vaccine that does not require ultra-cold storage.
31. We are planning as a system and exploring central storage for our entities. How should we fill out the DPH and CDC forms regarding capacity within each type of storage (i.e. ultra-cold)? Will it be possible for us to receive all at one storage location?
You must enroll each location and note “ultra-cold” storage capacity at each location. DPH can work with you to have all of your site’s supply forwarded to the central ultra-cold storage location.
32. Should vaccination sites have security for vaccine inventory?
Vaccination sites are responsible for maintaining vaccine inventory delivered to the site secure. However, armed security guards or special security details are not required.
33. What credentials are required of individuals responsible for receiving vaccine shipment, managing inventory, and serving as vaccine coordinators and backup coordinators?
No credentials are required, but the individual must participate in required trainings (see question 32). The vaccine coordinator and back-up coordinator should be employees or contractors of the entity that is enrolled in the MCVP and receiving the vaccine.
34. Are the refrigerators and freezers required to be pharmacy grade?
Pharmaceutical and purpose-built refrigerators are a vaccine storage and handling best practice but are not required for the storage of COVID-19 vaccine. Standalone freezers are strong recommended, as the freezer portion of a household combination unit may not reliably maintain temperatures. If that is not possible for your site, please contact the Vaccine Unit at DPH-Vaccine-Management@massmail.state.ma.us for further guidance to ensure maintenance of appropriate temperatures. All storage units must be monitored continuously. The best practice for monitoring temperatures is to use a digital data logger available from DPH.
MIIS registration, enrollment, and training
35. Can the MIIS be used for pulling patient lists for defined prioritization based on age and higher risk diagnoses, for ease of outreach?
Providers can use the MIIS to run two reports that list patients by age - the Practice Population Report and the Patients Vaccinated Report. The Practice Population Report allows you to enter an age range. You can sort by birthdate on the report output. On the Patients Vaccinated Report you can also enter an age range, or leave it blank to run it by administration date or by vaccines the patients have received, and then sort by birthdate on the output.
36. My site administers immunizations directly. Am I required to register with and report data to the MIIS?
Yes. Reporting of immunization data to the MIIS is required by state law for all MA health care provider practices. You should register with the MIIS at the following website: www.miisresourcecenter.com. Registration with the MIIS also requires an onboarding process to ensure capacity to complete the required reporting and place vaccine orders directly through the MIIS. In order to receive COVID-19 vaccine, your site should:
Confirm that your facility is fully registered and on-boarded to submit vaccine-administered data to the Massachusetts Immunization Information System (MIIS): firstname.lastname@example.org
Confirm that your facility has signed and electronically submitted the Massachusetts COVID-19 Program (MCVP) Enrollment Form: DPH Vaccine Unit, email@example.com
37. How can my facility confirm that we are listed as a vaccine provider with DPH and are able to receive vaccine once it is available?
Confirm that your facility is fully registered and on-boarded to submit data about administered vaccine to the MIIS by contacting the MIIS team MIIShelpdesk@state.ma.us. Confirm that your facility has signed and electronically submitted the Massachusetts COVID-19 Provider (MCVP) Enrollment Form in the MIIS by contacting the DPH Vaccine Unit at firstname.lastname@example.org.
38. If a hospital has an urgent care center, should each site enroll separately or just the hospital?
All individual locations will need to enroll separately but sites will be receiving invitations directly as MCVP enrollment rolls out to additional provider locations.