vaccine planning work group - maine.gov

Maine Department of Health and Human Services

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• 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

https://www.maine.gov/dhhs/mecdc/infectious-disease/immunization/covid-19-providers/communications.shtml

Vaccine Planning

Work Group

Tonya Philbrick

Maine Immunization Program

November 5, 2020

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


• 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


Vaccinate with Confidence


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



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.



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



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

Maine Department of Health and Human Services 13

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



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




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8 Things to Know about Vaccine Planning


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

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


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.



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.



About COVID-19 Vaccines


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


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

https://www.cdc.gov/coronavirus/2019-ncov/vaccines/recommendations-process.html

Ensuring COVID-19 Vaccine Safety


• 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

https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2020-09/COVID-03-Shimabukuro.pdf

https://www.cdc.gov/nhsn/index.html

https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety.html

[email protected]

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

[email protected]

To submit documents for COVID-19 vaccine enrollment:

• CDC COVID-19 Vaccination Program Provider Agreement

• Storage & handling documentation if required

Contact Information


mailto:[email protected]

mailto:[email protected]

ImmunizeME.org

Website Information


https://www.maine.gov/dhhs/mecdc/infectious-disease/immunization/

Tonya Philbrick

Director

Maine Immunization Program


Questions?

vaccine planning work group - maine.gov

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