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.
Does the Massachusetts COVID-19 Vaccine Program provide up-front funding to administer COVID-19 vaccine?
At this time, there is no up-front funding for administration-related costs 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.
Does FEMA provide funding to cover vaccination costs?
Yes, eligible Applicants under the FEMA Public Assistance (PA) Program may seek 100% reimbursement for uncovered vaccination costs. Eligible Applicants include state, local, and tribal governments along with not-for-profit healthcare providers, Boards of Health, and other quasi-governmental agencies. The PA Program is administered through the Massachusetts Emergency Management Agency (MEMA). For more information you can visit MEMA’s website, or email your questions to firstname.lastname@example.org.
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.
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 even more effective at preventing severe disease leading to hospitalization or death; it is the single best tool in the fight against the pandemic.
Obtaining informed consent is a vital part of the vaccine administration process. 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. Information regarding informed consent for minors is provided below.
What procedure should a vaccine provider follow to obtain consent to administer a COVID-19 vaccine to someone who is under 18?
It is the responsibility of vaccine providers to obtain appropriate consent from patients before administering a vaccination. The expectation is that every vaccine provider in the Commonwealth will establish appropriate procedures which minimize hurdles to vaccination for minors, and make those requirements, including any required forms, easy to understand and accessible.
For minors, consent is obtained from a legally authorized representative on behalf of the child (usually a parent or guardian). The legally authorized representative does not need to accompany the minor to the vaccination appointment in order to provide consent for a vaccination. Vaccine providers are strongly encouraged to request written consent from the appropriate legally authorized representative, such as a written consent form, that the minor may then bring to their vaccine appointment. A model consent form is available here for providers to utilize for this purpose.
What liability protections do COVID-19 vaccinators have?
People or entities with liability or other legal questions should consult with their legal counsel. You and your legal counsel may wish to review the federal Public Readiness and Emergency Preparedness Act (PREP Act) and/or the Massachusetts Act to Provide Liability Protections for Health Care Workers and Facilities During the COVID-19 Pandemic.
Can people 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?
Yes. The Massachusetts COVID-19 Vaccination program is intended for individuals who live, work or study in the state.
What information do we need to provide vaccine recipients about the COVID-19 vaccines?
Currently, there is no Vaccine Information Sheet (VIS) for COVID-19 vaccines authorized under an Emergency Use Authorization (EUA). For each COVID-19 vaccine authorized under an EUA, the FDA requires that vaccine recipients or their caregivers are provided with certain vaccine-specific EUA information to help make an informed decision about vaccination. This is accomplished by providing an EUA Fact Sheet for Recipients and Caregivers. The Fact Sheet is similar in purpose and content to VISs for licensed vaccines but differs in that the EUA Fact Sheet is specific to each authorized COVID-19 vaccine, is developed by the manufacturer of the vaccine, and is authorized by the FDA. There is a separate EUA Fact Sheet for each formulation of a vaccine. For example, there are different Fact Sheets for each of the Pfizer-BioNTech COVID-19 Vaccine formulations. Once a new EUA Fact Sheet is issued, it must be used. Previous ones no longer contain accurate information.
CDC has also issued Emergency Use Instructions (EUI) for use of the COVID-19 vaccine by Pfizer-BioNTech and COVID-19 vaccine by Moderna. EUI provide information about emergency use of FDA-approved medical products that may not be included in or differ in some way from the information provided in the FDA-approved labeling (package insert). People vaccinated in accordance with these emergency use instructions should be given an EUI Fact Sheet at the time of vaccination.
Do we need a standing order for COVID-19 vaccine clinics?
Yes, you need to obtain a standing order for your program from a medical professional, such as a physician.
- State law, M.G.L. c. 94C, section 8 (7), requires a licensed provider with prescribing authority to issue an order for administration of a vaccine such as the COVID-19 vaccine.
- Authorized ordering provider types include: physician, chiropractor, surgeon, podiatrist, osteopath, nurse practitioner, dentist, or physician’s assistant. See MGL Ch. 94C; 105 CMR 700.00.
- A standing order is an order issued by a licensed provider, which is not specific to one person, and enables assessment and vaccination of patients without the need for clinician examination or direct order from the attending provider at the time of the interaction.
- Model standing orders developed by CDC for the Moderna COVID-19 vaccines, the Pfizer COVID-19 vaccines, the Novavax COVID-19 vaccine and for the Janssen COVID-19 vaccine.
- Other Emergency Treatment Standing order templates are available from the Immunization Action Coalition:
Who can administer vaccine?
This COVID-19 Vaccinators chart lists the different groups of individuals who can possess and administer COVID-19 vaccines.
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 Massachusetts COVID-19 Vaccine Program (MCVP) Overview | Mass.gov.
Answers to many questions can be found at:
What are the COVID-19 vaccine formulations currently approved or authorized for primary series and boosters?
For up-to-date information on the COVID-19 vaccine formulations currently approved or authorized for primary series and boosters consult the CDC Interim Clinical Considerations Use of COVID-19 Vaccines in the United States. Product specific storage and handling, administration and frequently asked questions (FAQ), information for Pfizer-BioNTech, Moderna, Novavax and Janssen is also available.
Who is eligible for COVID-19 vaccination?
All people age 6 months and older are recommended to receive age-appropriate COVID-19 vaccination.
Who is eligible to get a booster dose?
Booster dose recommendations vary based on age, COVID-19 vaccine product(s) received, time since last dose and immunocompetence. Detailed booster guidance can be found in the CDC Interim Clinical Considerations Use of COVID-19 Vaccines in the United States.
Are there specific recommendations for patients with moderate to severe immunocompromise?
Yes. People with immunocompromising conditions or people who take immunosuppressive medications or therapies are at increased risk for severe COVID-19. Because the immune response following COVID-19 vaccination may differ in moderately or severely immunocompromised people, specific guidance for this population is provided.
Are there vaccination recommendations for people previously vaccinated outside of the US?
Yes. The CDC Interim Clinical Considerations Use of COVID-19 Vaccines in the United States includes guidelines for individuals vaccinated outside of the US based on what vaccine product(s) the individual previously received.
What are the appropriate intervals between doses?
The appropriate interval between doses depends on a number of factors including age, COVID-19 vaccine product(s) received, and immunocompetence. Detailed vaccines schedules and interval guidance can be found in the CDC Interim Clinical Considerations Use of COVID-19 Vaccines in the United States.
What if a COVID-19 dose is administer outside the recommended interval?
If a reportable error occurred, report it to VAERS VAERS.hhs.gov.
What happens if a vaccine administration error occurs? For example, a vaccine recipient does not receive a full dose, or the dose is given subcutaneously (SC), not intramuscularly (IM)?
Report all COVID-19 vaccination errors to VAERS VAERS.hhs.gov.
How will patients know what vaccine doses they receive?
The vaccine ancillary supply kits will come with vaccine record cards that can be given to the patients indicating what vaccine(s) they received. 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 at V-safe After Vaccination Health Checker | CDC.
What should a site do if a vaccine recipient has lost or misplaced their COVID-19 Vaccination Record Card?
Consult the DPH Requesting a copy of your COVID-19 vaccination record for options.
What should a site do with extra vaccine?
Vaccine can 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.
What should we do with unused doses of COVID-19 vaccine in a multi-dose vial?
Vaccinators should withdraw only the authorized number of doses from each vial of COVID-19 vaccine. The number of authorized doses is indicated on the vaccine packaging in the provider EUA fact sheet for each vaccine. The actual number of doses that a vaccinator can get from each vial may be affected by the type of needle and syringe used. If less than the number of authorized doses is used by the Beyond Use Date (BUD), the vial and remaining vaccine must be discarded in a sharps container. With Pfizer, Novavax and Janssen (J&J) vaccine, any doses not used must be reported as wasted. For Moderna vaccine, an unextracted 15th dose in a maximum-15 dose vial does not count as waste.
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.
Will a person test positive for COVID-19 after getting the vaccine?
None of the recently authorized and recommended vaccines nor the other COVID-19 vaccines currently in clinical trials in the United States can cause you to test positive on viral tests, which are used to see if you have a current infection. Viral tests (molecular [e.g., PCR] or antigen) to detect current infection will still be accurate if you have been vaccinated.
COVID-19 vaccines teach the body to produce antibodies to fight infection from the virus that causes COVID-19. If a person gets an antibody test after receiving a vaccine, they might test positive by some (but not all) antibody tests. This depends on which type of antibody the specific test detects.
Should someone who is COVID-19-positive receive the vaccine?
People with known current SARS-CoV-2 infection should defer any COVID-19 vaccination, including booster vaccination, at least until recovery from the acute illness (if symptoms were present) and criteria to discontinue isolation have been met.
People who recently had SARS-CoV-2 infection may consider delaying a primary series dose or their first or second COVID-19 vaccine booster dose by 3 months from symptom onset or positive test (if infection was asymptomatic).
Is it safe for people to get a COVID-19 vaccine if they would like to have a baby one day?
Yes. CDC recommends that people who are trying to get pregnant now or might become pregnant in the future, as well as their partners, get vaccinated and stay up to date with their COVID-19 vaccines. There is currently no evidence that any vaccines, including COVID-19 vaccines, cause fertility problems in women or men.
Can the COVID-19 vaccines be given to people who are pregnant?
Yes. CDC recommends that people who are pregnant get vaccinated and stay up to date with their COVID-19 vaccines. CDC recommendations align with those from professional medical organizations serving people who are pregnant, including the American College of Obstetricians and Gynecologists, Society for Maternal Fetal Medicine, and the American Society for Reproductive Medicine, along with many other professional medical organizations.
Pregnant and recently pregnant individuals are more likely to get very sick from COVID-19 compared to people who are not pregnant. COVID-19 infection during pregnancy increases the risk of complications that can affect the pregnancy and developing baby.
Can COVID-19 vaccines be given to a person who is breastfeeding?
Yes. CDC recommends that people who are breastfeeding get vaccinated and stay up to date with their COVID-19 vaccines. COVID-19 vaccines cannot cause COVID-19 infection in anyone, including the mother or the baby.
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.
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.
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.
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 strongly 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
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.
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.
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
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 at MIISHelpdesk@mass.gov. 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.
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.