07/19/2023
COVID Vaccine Information:
BULLETIN
What Massachusetts COVID-19 Vaccine Providers Need to Know
Week of 7/19/2023
Information related to the use of COVID-19 vaccines changes frequently. Please be sure to refer to the CDCâs Interim Clinical Considerations for Use of COVID-19 Vaccines Currently Authorized in the United States as your primary source for the most up-to-date information.
⢠COVID-19 Vaccination Recommendations Infographic (Updated 5/16/2023)
⢠COVID-19 Vaccination Recommendations Infographic (Immunocompromised) (Updated 5/16/2023)
⢠Bivalent Moderna COVID-19 Vaccine: When to use the pink versus blue-capped vial (Updated 6/12/2023)
⢠Interim COVID-19 Immunization Schedule (Updated 5/31/2023)
⢠FAQs for the Interim Clinical Considerations (Updated 6/14/2023)
⢠COVID-19 Vaccine Product Information (Updated 5/16/2023)
LATEST NUMBERS
⢠As of 7/19/2023 5,956,528 people in Massachusetts have completed a primary series. However, only 2,093,636 Massachusetts residents have received the recommended bivalent booster dose.
LATEST NEWS
Changes expected this fall
Plans are underway for the transition to routine commercial use of COVID-19 vaccines.
On June 15, 2023, independent experts on the Food and Drug Administrationâs (FDAâs) Vaccines and Related
Biological Products Advisory Committee (VRBPAC) met to publicly discuss whether a change to the current vaccine
strain composition of COVID-19 vaccines is necessary for the 2023-2024 fall/winter season. The VRBPAC voted to
update the vaccine composition, and FDA subsequently advised those manufacturers planning to offer COVID-19
vaccines that they should develop vaccines with a monovalent XBB.1.5 composition. These vaccines are currently being manufactured. They are not yet available or licensed/authorized.
Once these updated vaccines do become licensed or authorized by FDA, ACIP will review evidence and update its recommendations for all age groups.
These vaccines will be the first COVID-19 vaccines to be available directly from the manufacturers as part of the commercial market, rather than through the United States Government.
These vaccines will be available commercially at no out-of-pocket cost for adults with insurance (including Medicaid and Medicare). These vaccines will also be available at no out-of-pocket cost for all individuals under 19 years of age (regardless of insurance status) in Massachusetts through the Commonwealthâs universal pediatric vaccine program. The US Department of Health and Human Services is designing a special 1-year bridge program to create affordable access to the new COVID-19 vaccines for the 25 million uninsured adults residing in the US. More details of the bridge program will be forthcoming.
Current transitional phase
Currently, the COVID-19 Vaccination Program is in a unique, transitional position. Although we anticipate that commercialization, or the transition of vaccines to more traditional pathways for procurement, distribution, and payment, for adult providers will occur in the fall, (FAQ - Commercialization of COVID-19 Medical Countermeasures), at this time the COVID-19 Vaccine Program remains unchanged. The expiration of the federal PHE for COVID-19 on May 11, 2023, did NOT affect the requirements of the COVID-19 Vaccination Provider Agreement. In May, the Department of Health and Human Services (HHS) released the Fact Sheet: End of the COVID-19 Public Health Emergency | HHS.gov which stated
⢠âat the end of the COVID-19 PHE on May 11, Americans will continue to be able to access COVID-19 vaccines at no cost, just as they have during the COVID-19 PHE, due to the requirements of the CDC COVID-19 Vaccination Program Provider Agreement.â
During this transitional phase, it is important to understand the need to adhere to the COVID-19 Vaccination Provider Agreement, particularly as it pertains to patient access. CDC and MDPH want to ensure that providers in the COVID-19 Vaccination Program are not denying requests or turning away patients from obtaining COVID-19 vaccine. The COVID-19 Vaccination Provider Agreement requires that healthcare providers abide by the terms of the agreement, which states that COVID-19 vaccines are provided at 100% no cost to the vaccine recipient.
The COVID-19 Vaccination Provider Agreement requires that all organizations and providers participating in the Program:
⢠must administer COVID-19 Vaccine at no out-of-pocket cost to the recipient
⢠may not deny anyone vaccination based on the vaccine recipientâs coverage status or network status
⢠may not charge an office visit or other fee if COVID-19 vaccination is the sole medical service provided
⢠may not require additional medical services to receive COVID-19 vaccination
⢠may seek appropriate reimbursement from a program or plan that covers COVID-19 Vaccine administration fees for the vaccine recipient, such as:
o vaccine recipientâs private insurance company
o Medicare or Medicaid reimbursement
⢠may not seek any reimbursement, including through balance billing, from the vaccine recipient
CURRENT COVID-19 VACCINES
The following COVID-19 vaccines, categorized into three vaccine types, are currently authorized under an EUA by FDA and available for use in the United States:
⢠mRNA vaccines
o Moderna COVID-19 Vaccine, Bivalent
o Pfizer-BioNTech COVID-19 Vaccine, Bivalent
⢠Protein subunit vaccine
o Novavax COVID-19 Vaccine, Adjuvanted
The monovalent formulations of the two mRNA COVID-19 vaccines (COMIRNATY/Moderna COVID-19 Vaccine and SPIKEVAX/Pfizer-BioNTech COVID-19 Vaccine) should no longer be used for COVID-19 vaccination.
All currently available mRNA COVID-19 vaccines in the United States are formulated as a bivalent vaccine based on the original (ancestral) strain of SARS-CoV-2 and the Omicron BA.4 and BA.5 (BA.4/BA.5) variants of SARS-CoV-2.
Novavax COVID-19 Vaccine is formulated as a monovalent vaccine based on the original (ancestral strain) of SARS-CoV-2. Janssen COVID-19 Vaccine is no longer available in the United States.
None of the currently FDA-authorized COVID-19 vaccines are live-virus vaccines.
COVID-19 vaccine-specific FDA fact sheets and U.S. COVID-19 Vaccine Product Information can be consulted for a full list of ingredients and information on the conditions of use, storage and handling, preparation, and administration procedures.
WHO TO VACCINATE
COVID-19 vaccination is recommended for everyone ages 6 months and older in the United States for the prevention of COVID-19. There is currently no FDA-authorized COVID-19 vaccine for children younger than age 6 months. CDC recommends that people stay up to date with COVID-19 vaccination.
See Appendices A (People who received COVID-19 vaccine outside the United States) and B (People who received COVID-19 vaccine as part of a clinical trial) for recommendations for these populations.
VACCINE ADMINISTRATION RECOMMENDATIONS
CDC recommends that people ages 6 months and older receive at least 1 bivalent mRNA COVID-19 vaccine.
An overview of COVID-19 vaccination is summarized below; detailed schedules can be found in Table 1 for people who are not moderately or severely immunocompromised and in Table 2 for people who are moderately or severely immunocompromised.
Bivalent mRNA vaccines
The number of bivalent doses varies by age, vaccine, previous COVID-19 vaccines received, and the presence of moderate or severe immune compromise.
For people who are not moderately or severely immunocompromised:
⢠At the time of initial vaccination, depending on vaccine product, children ages 6 monthsâ4 years are recommended to receive 2 or 3 bivalent mRNA vaccine doses; children age 5 years are recommended to receive 1 or 2 bivalent mRNA vaccine doses
⢠People ages 6 years and older who are unvaccinated or previously received only monovalent vaccine doses are recommended to receive 1 bivalent mRNA vaccine dose
⢠People ages 65 years and older have the option to receive 1 additional bivalent mRNA vaccine dose
For people who are moderately or severely immunocompromised:
⢠At the time of initial vaccination, people ages 6 months and older are recommended to receive 3 bivalent mRNA doses
⢠People ages 6 months and older who previously received only monovalent doses are recommended to receive 1 or 2 bivalent mRNA vaccine doses, depending on age and vaccine product
⢠People who previously received a bivalent mRNA vaccine dose(s) have the option to receive 1 or more additional bivalent mRNA vaccine doses
Novavax COVID-19 Vaccine
People ages 12 years an older who previously received 1 or 2 monovalent Novavax primary series dose(s) are recommended to receive 1 bivalent mRNA vaccine dose. The monovalent Novavax COVID-19 Vaccine remains authorized for use as a 2-dose primary series and as a booster dose in certain limited situations.
Vaccine dosage and administration
In general, CDC recommends that people receive the age-appropriate vaccine product and dosage based on their age on the day of vaccination in accordance with the recommended intervals for that age group. However, for COVID-19 vaccination there are exceptions for children who receive the Pfizer-BioNTech COVID-19 Vaccine and transition from age 4 to 5 years during the 3-dose vaccination series and children who transition from age 5 years to 6 years during the Moderna COVID-19 vaccination series (see Transitioning from a younger to older age group).
COVID-19 vaccination schedule for people who are NOT moderately or severely immunocompromised
The COVID-19 vaccination schedule for people who are not moderately or severely immunocompromised is summarized in Table 1; see also COVID-19 Vaccination Recommendations Infographic.
The schedule is organized by age and COVID-19 vaccination history. It provides the number of bivalent mRNA vaccine doses an individual needs based on COVID-19 vaccine doses previously received, including the number of prior doses, whether the doses were monovalent or bivalent, and the vaccine manufacturer (Moderna, Novavax, or Pfizer-BioNTech).
Most people ages 6 years and older who are not moderately or severely immunocompromised and have received 1 dose of a bivalent mRNA vaccine do not need any further vaccine doses at this time. People ages 65 years and older who received 1 dose of a bivalent vaccine have the option to receive 1 additional dose at least 4 months after the first bivalent dose.
Considerations for people ages 65 years and older to receive an additional bivalent mRNA dose
People ages 65 years and older have the option to receive 1 additional bivalent mRNA vaccine dose if it has been at least 4 months after their first bivalent mRNA dose. The option to receive 1 additional bivalent mRNA dose may be informed by the clinical judgement of a healthcare provider, a personâs risk for severe COVID-19 due to the presence of underlying medial conditions and age, and personal preference and circumstances. If Moderna is used, administer 0.5 mL/50 ug (dark blue cap and label with a gray border); if Pfizer-BioNTech is used, administer 0.3 mL/30 ug (gray cap and label with a gray border).
COVID-19 vaccination guidance for people who ARE moderately or severely immunocompromised
To assist healthcare providers, the COVID-19 vaccination schedule for people who are moderately or severely immunocompromised (Table 2) provides detailed age-specific guidance; see also COVID-19 Vaccination Recommendations Infographic (Immunocompromised). However, the EUAs for Moderna and Pfizer-BioNTech COVID-19 vaccines allow healthcare providers flexibility for use of vaccine products, number of doses, dosage, and intervals between doses; alternative schedules within the parameters of the EUAs may be appropriate based on individual circumstances and clinical judgement.
People who are or who become moderately or severely immunocompromised should follow the COVID-19 vaccination schedule according to their age and immune status at the time of eligibility for that dose; see Considerations for timing of COVID-19 vaccination in relation to immunosuppressive therapies for vaccination of people who will shortly become moderately or severely immunocompromised (e.g., prior to organ transplant) and Considerations for COVID-19 revaccination.
CDCâs Clinical Considerations contain a description of moderate and severe immunocompromising conditions. It also affirms that people can self-attest to their moderately or severely immunocompromised status and receive COVID-19 vaccine doses wherever vaccines are offered. Vaccinators should not deny COVID-19 vaccination to a person due to lack of documentation.
Interchangeability of COVID-19 vaccines
The COVID vaccination schedules within the CDC Clinical Considerations should be consulted for age-specific information.
CDC recommends children ages 6 monthsâ5 years who are unvaccinated and recommended to receive more than 1 bivalent mRNA vaccine dose for initial vaccination receive all doses from the same manufacturer. However, as detailed below, FDA authorization allows for administration of a mixed product series for initial vaccination in some age groups.
Authorization to use COVID-19 vaccines interchangeably from different manufacturers varies by vaccination history, age, and product as follows:
⢠People ages 6 monthsâ4 years who are unvaccinated or previously received 1 or more doses of a monovalent mRNA vaccine are authorized to receive only bivalent mRNA vaccine dose(s) from the same vaccine manufacturer.
⢠People age 5 years who are unvaccinated or previously received 1 or more doses of monovalent Moderna COVID-19 Vaccine are authorized to receive either bivalent Moderna or bivalent Pfizer-BioNTech COVID-19 vaccine.
⢠People age 5 years who are unvaccinated or previously received 1 or more doses of monovalent Pfizer-BioNTech COVID-19 are authorized to receive only bivalent Pfizer-BioNTech COVID-19 Vaccine.
⢠People ages 6 years and older who are unvaccinated or previously received 1 or more doses of any monovalent COVID-19 vaccine are authorized to receive either bivalent Moderna or bivalent Pfizer-BioNTech COVID-19 vaccine.
A Vaccine Adverse Event Reporting System (VAERS) report is required following administration of a vaccine in an unauthorized manner.
In the following exceptional situations, a different age-appropriate COVID-19 vaccine may be administered when FDA authorization requires that a vaccine from the same manufacturer be used. A VAERS report is not required for these exceptional situations:
⢠Same vaccine not available
⢠Previous dose unknown
⢠Person would otherwise not complete the vaccination series
⢠Person starts but unable to complete a vaccination series with the same COVID-19 vaccine due to a contraindication
The COVID vaccination schedules for People who are not moderately or severely immunocompromised and People who are moderately or severely immunocompromised should be consulted for age-specific information; see Appendix C for recommended actions following interchangeability-related COVID-19 vaccine administration errors or deviations.
REPORTING OF VACCINE ADVERSE EVENTS
Adverse events that occur in a recipient following COVID-19 vaccination should be reported to VAERS. Vaccination providers are required by FDA and the provider agreement for the CDC COVID-19 Vaccination Program to report the following that occur after any COVID-19 vaccination:
⢠Vaccine administration errors whether or not associated with an adverse event
⢠Serious adverse events, irrespective of attribution to vaccination
⢠Cases of Multisystem Inflammatory Syndrome (MIS) in adults and children
⢠Cases of myocarditis
⢠Cases of pericarditis
⢠Cases of COVID-19 that result in hospitalization or death
Reporting is encouraged for any other clinically significant adverse event, even if it is uncertain whether the vaccine caused the event. Information on how to submit a report to VAERS is available at https://vaers.hhs.gov or by calling 1-800-822-7967.
VACCINE MANAGEMENT
Pfizer 12+ bivalent single dose vials continue to be available for ordering by Primary Care Provider (P*P) Sites
The Pfizer bivalent vaccine formulation for 12+ are available in single dose vials. Due to limited quantities of this formulation, it is available only to P*P sites (pediatricians, family practices, internal medicine offices, community health centers). To add this vaccine formulation/packaging click on the âadd a vaccineâ button in the lower left-hand corner of the ordering screen. SDVs will not include ancillary kits.
Expiry Date vs Beyond Use Date (BUD)
The expiration date is set by the manufacturer and is the date by which the vaccine should be used. The expiration date assumes that the vaccine has been stored and handled according to the manufacturerâs guidance. Expiration dates cannot change based on how vaccine is being stored or when a vial is punctured. However, on occasion, the expiration date may be updated by the manufacturer as additional stability data become available.
Beyond Use Date (BUD) is the date of when the vaccine can no longer be used due to a change in storage temperature, reconstitution, puncturing the vial, etc. It is recommended to place a label with the BUD and the initials of the person making the calculation whenever a vaccine vial or box is moved to a different temperature storage unit, reconstituted, or had a vial punctured resulting in a chance in the BUD.
You can find BUD guidance and labels for Moderna, Novavax, and Pfizer from the CDCâs U.S. COVID-19 Vaccine Product Information webpage.
COVID Vaccines Available for ordering in the MIIS
All providers enrolled Massachusetts COVID-19 Vaccine Program (MCVP) are able to place routine orders for all of the following COVID-19 vaccine formulations through the Massachusetts Immunization Information System (MIIS).
Brand
NDC
NDC Description
Minimum ordering size
-
59267-0304-02
COVID-19 (Pfizer);BIVALENT;MDV6; 10-pack
180
-
59267-1404-02
COVID-19(Pfizer);BIVALENT;SDV;10pk
50
-
59267-0565-02
COVID-19 (Pfizer);BIVALENT;(PED 5-11) MDV10;10pk
100
-
59267-0609-02
COVID-19 (Pfizer);BIVALENT;(PED 6m-4y) MDV10; 10-pack
100
-
80777-0282-99
COVID-19 (Moderna);BIVALENT;MDV5; 10-pack
100
-
80777-0283-99
COVID-19 (Moderna); BIVALENT;(PED 6m-5y) MDV2;10-pack
20
-
80631-0102-10
COVID-19 (Novavax); MDV5; 10-pack
50
There are 2 presentations of Moderna COVID-19 Vaccine, Bivalent. Even though vials and cartons of both presentations are labeled âBOOSTER DOSES ONLY,â doses from these vials are authorized ford for ALL doses for individuals 6 months of age and older.
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RESOURCES & LEARNING OPPORTUNITIES
Commercialization of COVID-19 products
HHS Commercialization Transition Guide (pdf available here)
HHS recently published a question-and-answer document with frequently asked questions on the commercialization of COVID-19 medical countermeasures.
Modernaâs medical updates
Moderna resources are posted here.
Pfizerâs medical updates
Pfizer has recordings of recent live medical update sessions available for viewing at https://www.pfizermedicalinformation.com/en-us/medical-updates
Pfizerâs Vaccine Formulation/Presentation Guide is a document from Pfizer-BioNTech with information about the formulations and presentations of the vaccines.
EUA Fact Sheets
Once a new EUA Fact Sheet is issued, it must be used. Previous ones no longer contain accurate information.
⢠Moderna EUAs can be found on the FDA website here
⢠Pfizer EUAs can be found on the FDA website here
⢠Novavax EUAs can be found on the FDA website here
Standing Orders
Standing orders can be found under the âAdministrationâ tab of each vaccine at: https://www.cdc.gov/vaccines/covid-19/info-by-product/index.html
Other Helpful Resources
⢠AAP Pediatric COVID-19 Vaccine Dosing Quick Reference Guide
⢠CDCâs Stay Up to Date with COVID-19 Vaccines
⢠CDCâs COVID-19 Vaccination Clinical & Professional Resources
⢠Immunize.org: Checklist of Current Versions of U.S. COVID-19 Vaccination Guidance and Clinic Support Tools (PDF)
⢠Immunize.org: Vaccines: COVID-19 main page
⢠Immunize.org: Ask the Experts: COVID-19 web page
⢠COVID-19 Vaccine Education and Equity Project - CVEEP
MDPH RESOURCES
Immunization Division Main Number
For questions about immunization recommendations, disease reporting, etc.
Phone: 617-983-6800 (24/7 MDPH Epi line)
Fax: 617-983-6840
Website: https://www.mass.gov/topics/immunization
MIIS Help Desk
Phone: 617-983-4335
Fax: 857-323-8321
Email questions to: [email protected]
Website: https://www.mass.gov/massachusetts-immunization-information-system-miis
MDPH Vaccine Unit
Phone: 617-983-6828
Email questions to: [email protected]
Website: https://www.mass.gov/service-details/vaccine-management
Color Help
Email questions to: [email protected]
Website: https://www.mass.gov/info-details/vaccine-clinic-management-platform
COVID-19 Email Box
Email questions to: [email protected]
The Massachusetts Department of Public Healthâs (MDPHâs) Vaccine Clinic Management Platform is a digital application that allows providers in the Commonwealth to streamline their vaccination clinics.
