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COVID-19 Vaccine - Additional Doses
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Someone may require an “additional dose” of a vaccine when the immune response to the primary series was weak and provided limited protection.
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On August 13, the Advisory Committee on Immunization Practices (ACIP) recommended an additional dose of the mRNA COVID-19 vaccine for people whose immune systems are moderate to severely compromised. ACIP does not recommend additional doses for other populations at this time and there is currently insufficient data to support additional doses for people who received Janssen (Johnson & Johnson) as their primary series.
Resources and guidance to help your practice implement this update and advise your patients include:
More information will be provided by the Health Department as it becomes available.
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COVID-19 Vaccine - Booster Doses
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Someone may require a “booster dose” of vaccine when evidence indicates that protection from the primary series has declined over time.
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On August 18, public health and medical experts from the U.S. Department of Health and Human Services (HHS) released a statement on the Administration’s plans for mRNA COVID-19 vaccine booster shots. Booster doses for Janssen (Johnson & Johnson) vaccine recipients may be needed as well, but this is pending more data, and any recommendation will likely come after the recommendation for mRNA vaccines.
Planning for Vermont implementation is ongoing. Booster doses are currently not recommended, and FDA approval and ACIP recommendation is needed before Vermont can roll out a plan.
Please refer to the full media statement for more information. The below Morbidity and Mortality Weekly Reports (MMWRs) include data used to support the Vermont planning.
More information will be provided by the Health Department as it becomes available.
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FDA Licenses Comirnaty (Pfizer-BioNTech)
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On August 23, the FDA granted full approval for Comirnaty (co-MER-na-tee), Pfizer-BioNTech’s COVID-19 Vaccine for individuals 16 years of age or older. CDC’s Advisory Committee on Immunization Practices met Monday, August 30, 2021, to discuss its updated recommendation for this vaccine.
- Vaccination for 12-to-15-year-olds is still authorized through Emergency Use Authorization (EUA)
- The FDA has issued new consolidated fact sheets that address the vaccine's use under licensed and EUA status.
- No changes have been made to the storage, handling, or vaccine ordering requirements as a result of licensure. Clinicians should continue to administer this vaccine in accordance with current ACIP recommendations and CDC guidelines.
- Pfizer has received feedback about presentation, packaging, and minimum order quantities. The Immunization Program will share more information when it is available.
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Initial Influenza Vaccine Ordering
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Historically, the Immunization Program has placed initial flu vaccine orders for Primary Care Providers (PCPs) early in the vaccination season. This year Vermont Children/Adult Vaccine Program (VCVP/VAVP) practices may place orders on their own.
Flu vaccine is available to order beginning September 7. Your practice should determine your initial order quantity and review the flu-only reconciliation and flu-only ordering resources on our website.
The first flu vaccine order will require you to reconcile your full vaccine inventory. Subsequent orders can be done using the flu-only reconciliation option as needed. Please also remember to submit any adjustments before reconciling.
Guidance on determining initial order quantity
Vermont does not receive the entirety of the flu vaccine at the start of the season, so orders must be spread out over several shipments.
- If you anticipate using 50 doses or fewer for the whole season, you may place your full order.
- If 60 or more doses are needed for the season, split it up over two or more orders to ensure enough vaccine for others in the state. Consider ordering what you plan to administer within the first four-six weeks or about 25% of your seasonal need. Assure you have ample storage. Subsequent orders can be placed when needed.
Managing Multiple Types of Vaccine Orders
Some of you will be submitting routine vaccines, COVID-19-only, and flu-only reconciliations regularly. It is convenient to reconcile for only the vaccine you need, but due to the limitations of the VIMS system, it is essential to consider the timing of these reconciliations. Only one reconciliation can be open within the ordering system at a time. Plan to leave one full business day between the various reconciliations to avoid frustrations.
For practices intending to order flu vaccine on September 7, who also have COVID-19 vaccine and must reconcile on Wednesdays, we suggest completing a full reconciliation on Tuesday, September 7, that includes your COVID-19 doses administered. Then complete the flu-only order.
Plan to submit a COVID-19-only order (if needed) the next day on September 8. The previous day's reconciliation will still be valid as long as more than 48 hours have not elapsed.
Only the first flu vaccine order will require you to reconcile your full vaccine inventory. Subsequent orders can be done using the flu-only reconciliation option.
Types of Vaccines Available
- Inactive vaccines will be added to your VIMS catalog on September 7 based on your current Vermont Vaccine Program Enrollment. Flu vaccine for adults will not appear in a practice catalog if an umbrella organization opted to purchase adult flu vaccine privately.
- While offices can choose which brands they receive for other state-supplied vaccines, this is not possible for flu. A combination of single-dose vials and prefilled syringes may be available. See the vaccine availability sheet for more information.
- There will be a limited amount of FluMist available for the 2021/2022 season for patients age 2 through 18 years. FluMist will be included in the catalogs of all VCVP enrolled practices, but represents only 2% of our pediatric supply.
- Vermont will not supply high-dose or adjuvanted vaccines intended for older adults. These vaccines may be purchased privately or patients referred to a pharmacy.
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Offsite flu clinics are encouraged to increase access in your community. Similar to last season, there will be some restrictions around the transport and management of vaccines. See Vaccine Storage and Handling for Offsite Clinics for more information.
Vaccine Carrier Borrowing Program
The Immunization Program has qualified vaccine carriers available to assist practices in conducting offsite clinics safely and confidently. Practices can request vaccine carriers from the Immunization Program. These are for temporary use and should be returned when no longer needed. The Vaccine Depot will deliver your vaccine carrier with a manufacturer user guide and a digital data logger. See the Vaccine Carrier Borrowing Program Guide for more information.
Practices are expected to use this program for offsite clinics. Previous guidance provided by the CDC Packing Vaccine for Transport during Emergencies is now only appropriate for short transfers of vaccine between monitored units. For prolonged storage during clinics, please request a carrier from the Immunization Program.
Clinic Notification
It is no longer necessary to notify the Immunization Program of any offsite clinic activity. Although when conducting an offsite clinic, it is the practice’s responsibility to:
- Plan Ahead: request a vaccine carrier at least 10 business days before the time of the clinic. This gives the Immunization Program time to process your request and you time to practice with the carrier and data logger before use. Panels need to be conditioned in your refrigerator at least 24 hours before your planned clinic.
- Communicate Vaccine Need: Running clinics outside of regular operation will likely require additional vaccines. When placing a larger than normal vaccine order, always leave a comment in VIMS to ensure that it is not perceived as an error.
- Ask Questions: If you are not sure how to use the data logger, carrier, or paper temperature log contact the Immunization Program.
- Report: Follow the Temperature Excursion Protocol whenever any temperature issues occur during a clinic.
If planning to host a clinic at a school, the CDC has resources available on the Considerations for Planning School-Located Vaccination Clinics webpage.
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Coadministration of COVID-19 and Influenza Vaccines
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With influenza season approaching, the CDC recognizes there may be compelling logistical advantages to offering patients COVID-19 and influenza vaccines on the same day.
You may administer COVID-19 and influenza vaccines (both live, attenuated and non-live influenza vaccines) without regard to timing (on the same day or within any time interval). There are no safety concerns for coadministration.
When deciding whether to coadminister another vaccine(s) with COVID-19 vaccine, consider:
- Whether the patient is behind or at risk of becoming behind on recommended vaccines
- The patient’s risk of vaccine-preventable disease
- The reactogenicity profile of the vaccines
- The likelihood of avoiding a missed opportunity to vaccinate
Best practices for multiple injections include:
- Label each syringe with the name and the dosage (amount) of the vaccine, lot number, the initials of the preparer, and the exact beyond-use time, if applicable.
- Separate injection sites by 1 inch or more, if possible.
- Administer the COVID-19 vaccines and vaccines that may be more likely to cause a local reaction (i.e., adjuvanted influenza vaccines) in different limbs, if possible.
Refer to the CDC’s Interim Clinical Considerations for more information.
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Additional Funding for Flu / COVID-19 Clinics
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Many practices took advantage of additional funding available in the 2020/2021 flu season to increase vaccine access through enhanced clinic hours, offsite activities, increased staffing, and vaccine storage equipment purchases, among others. For all those who participated, thank you.
We know how valuable and effective this program was. We anticipate a similar program to what was implemented last year, and practices should plan with that in mind. The Immunization Program will communicate about financial assistance for Flu and/or COVID-19 clinics in the coming weeks, and we appreciate your patience. We are working to ensure it is an easy process with clear guidelines.
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COVID-19 Vaccine and Providers
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COVID-19 Provider Agreement
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COVID-19 enrolled providers must administer COVID-19 vaccines in accordance with all program requirements and recommendations of the CDC, the Advisory Committee on Immunization Practices, and the U.S Food and Drug Administration (FDA). This applies to both EUA and FDA-approved COVID-19 vaccines.
Use of COVID-19 vaccines outside of those that have been approved and authorized by the FDA (often referred to as “off-label use”) is not recommended. It would violate the provider agreement and could expose providers to the following risks:
- Administration of the product off-label may not be covered under the PREP Act or the PREP Act declaration; therefore, providers may not have immunity from claims.
- Individuals who receive an off-label dose may not be eligible for compensation under the Countermeasures Injury Compensation Program after a possible adverse event.
- Providers giving off-label doses would be in violation of the CDC Program provider agreement, potentially impacting their ability to remain a provider in the CDC program.
- Administration fees may not be reimbursable by payers.
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Encourage Second Doses of COVID-19 Vaccine
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For the vaccine to be the most effective, patients should get the second dose as close to the recommended schedule as possible. A second dose is valid four days before the recommended schedule, and it is okay to get it up to 42 days after the first dose. There is limited data on how effective the vaccine is if the second dose is given after 42 days.
The administering practice is responsible for following up with patients who received their first dose of Moderna or Pfizer. This is most likely part of your practice workflow already. It should also be a priority to follow up with patients who may have received their first dose at another location and do not have a record of completing the series.
We know it can be challenging to assess COVID-19 vaccination needs. Read the instructions for running reports through the Immunization Registry below. If you have questions, contact the registry directly at IMR@vermont.gov | 1-888-688-4667.
Reports:
Patients who have not received any COVID-19 vaccine doses
Patients who have missed or are late for a second dose
Patients who have received a COVID-19 vaccine dose
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We are anticipating a staffing decrease at the Vaccine Depot. Please be mindful of storage and expiration considerations when placing orders and consolidate orders as much as possible. Please try to order enough vaccines to last your practice 3-4 weeks. Orders should be placed on Wednesdays (when needed) after weekly reconciliation. Delivery will be scheduled for the following week.
Additionally, where possible, consolidated orders and transfers within your broader organization are preferred. See Receipt and Management of COVID-19 Vaccine and COVID-19 Vaccine Distribution Hubs for more information.
The Immunization Program now has vaccine carriers available to borrow, which may make this transfer process easier for your organization if you do decide to manage vaccines in this way. Please see the Vaccine Carrier Borrowing Program guide for more information.
You should continue to order vaccines as needed to serve your patient population. Apart from the Janssen vaccine, which is still limited, there is no concern with vaccine availability. In order to serve your patients, offices are allowed to order both mRNA vaccines to accommodate additional dose and future booster dose needs.
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COVID-19 Vaccine Expiration Dates
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COVID-19 vaccine stability data is still being collected, and expiration information updates frequently. The Immunization Program will always communicate these updates via e-mail, but if you have a COVID-19 vaccine you believe has expired, do NOT remove it from appropriate storage, mark the vaccine DO NOT USE, and contact the Immunization Program for more guidance.
Check your Dates:
Pfizer: Expiration dates are on the vials. The FDA has approved extending the expiration dates of vaccines stored in ultra-cold from six to nine months. This extension is for printed expirations only and does not impact the vaccines Beyond Use Date (BUD).
Please refer to the current EUA Fact Sheet and the below chart for information. Reach out to the Immunization Program with any questions.
Moderna: Lot Number Expiration Checker
Janssen: Lot Number Expiration Checker
If regularly assessing COVID-19 vaccine expirations, full lot number data is available by registering on the CDC COVID-19 Vaccine Lot Number And Expirations Dates website.
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Non-FDA Authorized Vaccines and Your Patients
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On Monday, August 23, a message from Commissioner of Health, Dr. Mark Levine, states that patients who have received a non-FDA approved COVID-19 vaccine (i.e. AstraZeneca) either abroad or through clinical trials may choose to receive the Pfizer or Moderna vaccine. See the full letter and Vermont Health Update for more information.
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COVID-19 vaccine administering locations are invited to attend bi-weekly office hours where the Immunization Program provides updates and allows time for questions and discussion. Past recordings of these office hours are on the COVID-19 Vaccine Information for Health Care Professionals webpage.
If you receive the COVID-19 vaccine and are not currently invited to these sessions, please email AHS.VDHImmunizationProgram@vermont.gov for more information.
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Enrollment is necessary for managing and administering vaccines through your primary care office. If you are a non-primary care office and interested in providing COVID-19 vaccines to your patients, reach out to the Immunization Program to learn about the requirements.
If you are unsure of your enrollment status, please contact the Immunization Program at AHS.VDHImmunizationProgram@vermont.gov.
For more information on the process, read the COVID-19 Vaccine Enrollment Process Guide and FAQs.
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COVID-19 Vaccine Availability
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- Pfizer-BioNTech – Available to order
- Moderna – Available to order
- Janssen (Johnson & Johnson) - The state cannot order new shipments of Janssen vaccine at this time. We anticipate being able to order more Janssen by early September. If you have a specific need that should be met with Janssen (reaching populations that may be transient like migrant workers, discharged from hospital ED, have insecure housing, or are incarcerated, etc.), please reach out to AHS.VDHCovidVaxDistribution@vermont.gov directly. We will attempt to coordinate a local transfer of the Janssen vaccine from existing inventory at one of our partner locations.
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Janssen (Johnson & Johnson)
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Interim Clinical Consideration
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Interim Clinical Considerations for Use of COVID-19 Vaccines Currently Authorized in the United States (CDC)
Summary of recent changes as of August 25, 2021:
- New section on people vaccinated for COVID-19 as part of a clinical trial in the United States
- Update considerations for use of an additional mRNA COVID-19 vaccine dose after an initial 2-dose COVID-19 mRNA vaccine series for immunocompromised people
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Immunization Action Coalition Special Edition
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IAC will periodically publish special editions, providing new and updated Ask the Experts questions and answers from IAC experts. This issue includes selected Q&As about the latest updates to CDC recommendations for the use of COVID-19 vaccines.
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Health Department Vaccine Information for Health Care Professionals
- Available Vaccines
- Vaccine Distribution in Vermont
- Vaccine Safety and Reporting Adverse Reactions
- Enrolling in the Vaccine Program
- Storage and Handling
- Inventory Management
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Educate Yourself and Patients
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Vaccine Recipient Education (CDC)
Quick references for COVID-19 vaccinators to give people who want more information. The information on this page will help you share clear and accurate information about COVID-19 vaccines, raise awareness about the benefits of vaccination, and address common questions and concerns about what to expect when getting vaccinated. This page includes:
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