vaccine planning work group - maine.gov
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Maine Department of Health and Human Services
1
In order to keep an accurate roll call, we ask that everyone joining this meeting rename
themselves to include the following information:
• First Name
• Last Name
• Organization
Please type all questions into the chat box.
Presentations slides will be posted on the Maine Immunization Program website at:https://www.maine.gov/dhhs/mecdc/infectious-disease/immunization/covid-19-
providers/communications.shtml
We appreciate the time and effort taken by everyone joining to help the Maine CDC with
COVID-19 vaccine planning.
Vaccine Planning
Work Group
All information in this presentation is subject to change.
Information shared in these slides are assumptions
as of 11/4/2020.
This presentation is being recorded.
If there are any objections, please disconnect now.
Disclaimer
3Maine Department of Health and Human Services
• Pre-Positioning of Vaccine
• Vaccinate with Confidence
• U.S. CDC Website Resources
• Next weeks Topic: Storage and Handling from Pfizer
Agenda
4Maine Department of Health and Human Services
• OWS may pre-position vaccine to ensure that supply is closer to
the administration sites where vaccine is needed once FDA
issues an EUA and ACIP recommendations are made.
• This pre-positioning is a onetime effort intended to shorten the
timeline between EUA release and the initiation of vaccine
administration (e.g., if initial prioritization focuses on
administration of vaccine to healthcare providers).
• Ultra Cold Storage for Vaccine Candidate “A”
Pre-Positioning of Vaccine
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Formative Research: Methods
• Focus Groups Methodology
– 49 groups – 43 completed to date
• Two primary audiences – 6 segments
– African American and Mixed Ethnicity
– Older adults, parents, young adults, essential workers and nurses
• Quota sampling of participants via professional recruitment company
• Conducted online via Zoom – 60 minutes
– 8 participants recruited for each group – goal to seat 6
• Led by trained moderators following established guide
• Findings today from notes-based analysis
Vaccinate with Confidence
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A new pandemic, a new vaccine, and a new adult-focused platform
means shifting tactics
• Individuals across the continuum will have concerns. These concerns are
understandable and need to be addressed with empathy and transparency.
• Concerns among healthcare providers is a risk for overall vaccine
confidence. Healthcare providers are the most trusted source for health
information.
• Communities will have unique experiences informing COVID-19 vaccine
perceptions. Engagement with community organizations and leaders will
expand access to clear and accurate information on COVID-19 vaccines.
Vaccinate with Confidence
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Intentions to Get Vaccinated
• Participants generally open to getting the COVID-19 vaccine eventually
• Many participants hesitant to get the COVID-19 vaccine when first available
• Concerns included:
– Safety and Side effects (both short and long term)
• No specific consequences expressed, but just “side effects”
– Effectiveness
– Sufficient testing in their group (age, race, ethnicity, underlying health conditions)
– Rapid development process
• Participants wanted more information, would “wait and see” before deciding
• 6 months commonly cited as a reasonable time frame
Vaccinate with Confidence
12Maine Department of Health and Human Services
Reasons to Get Vaccinated or Not
• YES
• Desire to get back to a normal life
• Trust in vaccines and the scientific process
• NO
• I don’t get vaccines
• I’m healthy
• Don’t trust it
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Priority Group - Health Care Workers
• Doctors, nurses, hospital workers (and occasionally paramedics/EMTs)
• Consistently mentioned as group to get COVID-19 vaccine first
• Usually mentioned first/early in discussion
– Every group mentioned they should be first
• Why first?
– High exposure to COVID-19 (risking their health/life)
– Interact with the public
– Keep everyone healthy
Vaccinate with Confidence
14Maine Department of Health and Human Services
Priority Group – First Responders
• First Responders
– Fire, police, paramedics/EMTs
– Widely agreed that they should be first/among first
• Why among the first?
– Frequent interaction with public, exposure to people with COVID-19
– Keep people safe
• Mixed response on whether first responders should get vaccine first along with
healthcare workers:
– Should get vaccine first along with health care workers (Older Adult groups)
– Should get vaccine after health care workers along with essential workers
– Often no direct comparison of who is first among “high priority” occupations
Vaccinate with Confidence
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8 Things to Know about Vaccine Planning
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1. The safety of COVID-19 vaccines is a top priority
2. Many vaccines are being developed and tested, but some might be ready before
others. CDC is planning for many possibilities.
3. At least at first, COVID-19 vaccines might be used under an Emergency Use
Authorization (EUA from the U.S. Food and Drug Administration (FDA)
4. There may be limited supply of COVID-19 vaccines before the end of 2020, but
supply will continually increase in the weeks and months that follow.
5. If there is limited supply, some groups may be recommended to get COVID-19
vaccine first.
6. At first, covid-19 vaccines may not be recommended for children.
7. Cost will not be an obstacle to getting vaccinated against COVID-19.
8. COVID-19 planning is being updated as new information becomes available.
https://www.cdc.gov/coronavirus/2019-ncov/vaccines/8-things.html
How is the Emergency Use Authorization (EUA) Fact Sheet for
Recipients different from a vaccine information statement (VIS)?
When FDA authorizes a vaccine for use under an EUA, providers and public health
entities involved in vaccine administration are legally required to provide the FDA-
authorized EUA Fact Sheet for Recipients to individuals receiving vaccine or their
guardians, similar to VIS’s that are also required by law for certain licensed vaccines.
The EUA Fact Sheet for Recipients, like the VIS, explains the benefits and risks
associated with the vaccine. But unlike a VIS, the EUA fact sheet also provides vaccine
product-specific information, including the vaccine’s authorized use, dose/dose-series,
and known information or experience with the vaccine from clinical trials that support
issuance of the EUA by FDA.
Emergency Use Authorization
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What is the difference between an EUA, an EUA Fact Sheet for Healthcare
Providers and an EUA Fact Sheet for Patients?
– The legal authority of FDA to authorize emergency use of an investigational medical product
(e.g., vaccines prior to licensure, drugs prior to approval) or an unapproved use of an approved
medical product to diagnose, treat, or prevent a serious or life-threatening disease is referred to
as Emergency Use Authorization (EUA). The term “EUA” can refer to either the legal authority
itself or to the regulatory status of a medical product, such as COVID-19 vaccine. For example,
one could say “FDA issued an EUA” or “an EUA is in place.”
– When FDA authorizes emergency use of a medical product such as an anticipated COVID-19
vaccine, an EUA Fact Sheet for Healthcare Providers (in place of a package insert typical of a
licensed vaccine) and an EUA Fact Sheet for Recipients (akin to product information for patients
or a CDC-provided VIS for a licensed vaccine) must be provided to the healthcare providers
prescribing and/or administering the authorized medical product. The healthcare providers, in
turn, provide the EUA Fact Sheet for Recipients to vaccine recipients or their guardians.
Emergency Use Authorization
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Can the EUA Fact Sheet for Recipients or VIS be provided to
vaccine recipients electronically or is a hard copy required?
The EUA Fact Sheet for Healthcare Providers and EUA Fact Sheet for
Recipients can be offered in an accessible form (e.g., printable as a hard copy)
or through mass media (including print, broadcast, radio, satellite, internet, or
other electronic means of dissemination), videos/DVDs, or direct
communication from public health agencies.
Emergency Use Authorization
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About COVID-19 Vaccines
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Benefits of Getting a COVID-19 Vaccine
• COVID-19 vaccination will help keep you from getting COVID-19
• COVID-19 vaccination will be a safer way to help build protection
• COVID-19 vaccination will be an important tool to help stop the
pandemic
How COVID-19 Vaccines Work
• The Immunize System
• Types of Vaccines
• The Bottom Line
Myths and Misconceptions about COVID-19 Vaccines
COVID-19 Vaccine Recommendations
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CDC is making coronavirus disease 2019 (COVID-19) vaccination
recommendations for the United States based on input from the Advisory
Committee on Immunization Practices (ACIP). ACIP is a federal advisory
committee made of up of medical and public health experts who develop
recommendations on the use of vaccines in the U.S. public. ACIP holds regular
meetings, which are open to the public and provide opportunity for public
comment.
• Goals for vaccination if supply is limited
• Ethical Principles
• Groups considered for early vaccination if supply is limited
https://www.cdc.gov/coronavirus/2019-ncov/vaccines/recommendations-
process.html
Ensuring COVID-19 Vaccine Safety
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• Clinical Trials
– These clinical trials are being conducted according to the rigorous standards set forth by
FDA
• Vaccine Safety Monitoring
– CDC is working to expand safety surveillance through new systems and additional
information sources, as well as by scaling up existing safety monitoring systems.
• Expanded Safety Monitoring Systems– CDC: V-SAFE pdf icon[644 KB, 21 pages] — A new smartphone-based, after-vaccination health
checker for people who receive COVID-19 vaccines. V-SAFE will use text messaging and web
surveys from CDC to check in with vaccine recipients for health problems following COVID-19
vaccination. The system also will provide telephone follow up to anyone who reports medically
significant (important) adverse events.
– CDC: National Healthcare Safety Network (NHSN) — An acute care and long-term care facility
monitoring system with reporting to the Vaccine Adverse Event Reporting System or VAERS
– FDA: Other large insurer/payer databases — A system of administrative and claims-based data for
surveillance and research
• Existing Safety Monitoring System
https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety.html
C19Vaccine.MECDC@maine.gov
For questions regarding vaccine planning for COVID-19:
• Provider Enrollment Requirements
• CDC COVID-19 Vaccination Program Provider Agreement
• Any follow-up questions to these weekly Vaccine Planning Work Group Meetings
C19PA.MECDC@maine.gov
To submit documents for COVID-19 vaccine enrollment:
• CDC COVID-19 Vaccination Program Provider Agreement
• Storage & handling documentation if required
Contact Information
25Maine Department of Health and Human Services
ImmunizeME.org
Website Information
26Maine Department of Health and Human Services
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