Recently rumors have been circulating that Community Medical Center did not apply for the COVID vaccine. CMC took to social media and cleared up the misinformation that has been circulating regarding vaccine distribution.
Community Medical Center and rural health clinics fully support the distribution of the COVID vaccines when they become available.
The first doses in our area are expected to be delivered sometime in the next few weeks. The vaccine will be distributed according to the State of Nebraska’s phased distribution plan.
There has been great collaboration locally between the Southeast District Health Department, County Emergency Management agencies, local health boards, hospital, schools and clinics to get plans in place once the vaccine arrives.
Ryan Larsen, CMC Administer said, the Hospital has “absolutely been involved and wants to be ready at a moments notice,” when the vaccine becomes available.
The Nebraska COVID-19 Vaccine Plan states: The purpose of the COVID-19 Vaccine Plan is to assist partners in a shared understanding of pandemic response that includes planning assumptions, roles and responsibilities, ordering and reporting, and mass vaccination tools for local providers to substantially reduce morbidity and mortality from COVID- 19.
Limited COVID-19 vaccine could be available possibly as early November 2020, but COVID-19 vaccine supply will increase substantially in 2021. Current planning is in three phases.
Initial COVID-19 vaccination efforts should focus on those in the critical workforce who provide healthcare and maintain essential functions of society, as well as those at highest risk of developing complications from COVID-19, depending on supply availability and type.
Final decisions will be made on the use of initially available supplies of COVID-19 vaccines and partially informed by proven efficacy.
Initial doses of COVID-19 vaccine may be authorized for use under an “Emergency Use Authorization (EUA)” based upon available safety and efficacy data.
Two doses of COVID-19 vaccine, separated by > 21 or > 28 days, will be needed for immunity. Second-dose reminders for patients will be necessary. Both doses will need to be with the same product, which will require strategies to ensure the correct match of COVID-19 vaccine products and dosing intervals such as reminder/recall. As vaccine is made available, a reserve will be held at the federal level to ensure access to a second dose.
Routine immunization programs will continue.
Recommendations on populations of focus will be based on Federal Drug Administration (FDA),
Public demand for COVID-19 vaccination will likely be high, especially when there is limited supply and if there is severe disease in the community.
Assuming COVID-19 will continue to spread in the community in the fall of 2020 and into 2021, vaccination plans must ensure vaccine clinics will not put patients at risk for COVID-19, which in the setting of mass vaccination may need to include considerations for personal protective equipment (PPE), social distancing or spacing of persons vaccinated and staff, and scheduling individual vaccination appointment times, among other approaches.
COVID-19 vaccine providers must complete a COVID-19 Vaccination Program Provider Agreement.
COVID-19 vaccine will be allocated either proportionally to each state’s population size or by the amount of people within the critical population groups in each state. Vaccine will be centrally maintained and directly distributed by CDC’s distributor to COVID-19 vaccination providers.
Additional allocation consideration for COVID-19 vaccine is based on multiple factors, including: Populations recommended by Advisory Committee on Immunization Practices (ACIP) and National Academy of Medicine.
COVID-19 vaccine production and availability; COVID-19 vaccine, adjuvant, and ancillary kits will be procured and distributed by the federal government at no cost to enrolled COVID-19 vaccination providers and their patients.
Nebraska Phase Plans
Nebraska is planning a phased approach to COVID-19 Vaccination distribution, beginning with Phase 1 where the volume of doses is low and supply is constricted. During this phase, vaccines will only be available for Phase 1 providers to order and receive, and only Phase 1 target populations will receive vaccination. Nebraska is additionally breaking Phase 1 into two sections, Phase 1a and Phase 1b, providing even greater separation between target populations to ensure that initial doses are given to critical portions of the population. Phase 2 assumes a larger availability of vaccine, likely sufficient to meet demand, and requires expansion of the provider network to vaccinate a larger portion of the population. Finally,Phase3representsashifttowardsongoingvaccinationwherethereisopenaccess to the product via the more traditional network of vaccination.
Phase 1 Providers will include current Vaccine for Children (VFC) partners already connected to NESIIS for ordering vaccine and reporting data, and those able to administer vaccine in closed setting specific to Phase 1, such as: Local Health Departments; FQHCs, Community Based Clinics, Tribal Healthcare o Hospitals–closed settings.
The federal government will determine the amount of COVID-19 vaccine designated for each jurisdiction, however Nebraska is responsible for managing and approving orders from enrolled providers.
As the amounts allotted changes overtime, NDHHS will be ready for this shift based on the following: ACIP recommendations; Estimated number of doses allocated and timing of availability; Distribution considerations will include all of Nebraska; Providers ability to secure appropriate vaccine storage and handling/minimizing waste of all vaccine supplies.
Allocation consideration include
Priority populations; provider capabilities; vaccine product type, temperament, and availability o provider partnership and state and local data.
If there is insufficient vaccine, NDHHS will prioritize subsets of critical populations by analyzing a number of factors, including but not limited to (1) COVID county positivity rates, (2) hospitalization rates, and (3) throughput of local health department Points Of Dispensing (POD). Allocation decisions will include factors such as: Provider vaccine administration capacity, location, reporting and vaccination abilities, and staffing; Proximity to priority populations and community contacts/connectivity; Ability to maintain the cold chain, temperature excursions, adverse events.
Nebraska Department of Health and Human Services will continue to clearly and effectively communicate COVID-19 vaccine messaging as it becomes available. Messaging should be proactive, transparent, informative, culturally diverse and available in multiple languages. Information shared must be evidence-based, truthful/credible, respectful, and shared with a sense of urgency.
Communications objectives are to: Educate the public; Vaccine distribution (phases), development, authorization; Vaccine confidence that includes data, safety, efficacy; Work with internal and external partners to understand needs and concerns; Provide tool kits, resources and guidance to local providers; Monitor public perception, address hesitancy and vaccine population uptake.
Target Key Audiences; Healthcare personnel/associations; Urban/rural employers; Nebraskans from diverse populations in general; Priority populations; Groups at risk of severe outcomes or increased chance of acquisition or transmission; Public/consumers; Those with limited access; Provide messaging that addresses myths, cultural/historic mistrust, and/or product hesitancy.
Prevaccine; General vaccine education; Product safety; Populations identified as priority populations; Vaccine availability; limited supply; increasing in availability as vaccine production progresses; how to find a COVID-19 provider.
The NDHHS Communications team meets with the COVID-19 planning group, participates in program webinars, and updates the program of any newly identify strategies for effectively communicating with Nebraskans. Communications has proposed the following: Conduct a state-wide survey asking consumers vaccine survey; Create messaging that addresses consumer concerns and questions. Utilize various avenue of communication Social media; Churches; Cultural community centers; Print ad; Robo Calls; Box trucks; Public Service Announcements; Facebook live; Electronic billboards/gas station video messages; Modify CDC materials; Share CDC material with local levels to create local messaging; NDHHS Communication staff will continue to establish points of contacts with organizations, employers, and leaders within critical population groups by having a coordinated public information campaign. Information will be shared publicly, as well as through multiple local partnerships including VFC providers, local health departments, healthcare coalitions, etc. in order to leverage pre-existing relationships and communication pathways.
In Nebraska, local health departments function as the local public health authority and voice within their communities. NDHHS will support these efforts by providing and coordinating messaging across the state and will provide support to local health departments when needed.
Regulatory Considerations. Emergency Use Authorization (EUA) Fact Sheets. The EUA authority allows FDA to authorize either (a) the use of an unapproved medical product (e.g., drug, vaccine, or diagnostic device) or (b) the unapproved use of an approved medical product during an emergency based on certain criteria. The EUA will outline how the COVID-19 vaccine should be used and any conditions that must be met to use the vaccine. FDA will coordinate with CDC to confirm these “conditions of authorization.” Vaccine conditions of authorization are expected to include distribution requirements, reporting requirements, and safety and monitoring requirements. The EUA will be authorized for a specific time period to meet response needs (i.e., for the duration of the COVID-19 pandemic). Additional information on EUAs, including guidance and frequently asked questions, is located on the FDA website.
Adverse Reaction Reporting
VAERS is a passive reporting system, meaning it relies on individuals to send in reports of their experiences to CDC and FDA. VAERS is not designed to determine if a vaccine caused a health problem, but is especially useful for detecting unusual or unexpected patterns of adverse event reporting that might indicate a possible safety problem with a vaccine. This way, VAERS can provide CDC and FDA with valuable information that additional work and evaluation is necessary to further assess a possible safety concern.
Providers will need to be vigilant as identifying and reporting any “signals” that might indicate possible safety problems. Provider reporting will help CDC detect new or unusual adverse events, will help monitor the increase of known side effects, and identify patient risks related to particular health problems.
Continual adverse reaction support and education will be provided to providers, throughout COVID-19 vaccination phases, as well as frequent program website updates when made available.
CDC will implement v-safe, a new smartphone-based tool that uses text messaging and web surveys to check in with vaccinated individuals for adverse events after a COVID-19 vaccination. v-safe will also provide second-dose reminders (if needed) and live telephone follow up by CDC if vaccinated individuals report a medically significant event during a v-safe check-in. v-safe asks questions that help CDC monitor the safety of COVID-19 vaccines. The v-safe information sheet and counseling script are in development and will be made available electronically when competed. It is critically important for vaccine safety monitoring and assessment that healthcare professionals give each patient a v-safe information sheet at the time of vaccination and encourage patients to enroll.
Nebraska will monitor progress in COVID-19 Vaccination Program implementation by tracking provider enrollment, the population’s access to vaccination services, NESIIS performance, reporting, vaccine ordering and distribution, and vaccination coverage. Nebraska is tracking provider enrollment by transferring data captured on the Provider Agreement forms to a spreadsheet, which can then be utilized to create maps showing where enrolled providers are located and thus access to vaccination services, as well as translated to a CSV file for submission to CDC twice weekly.
HS Immunization Program has a variety of ways to communicate with enrolled providers, including email, fax, phone, and the ability to post messages on the front-facing page within NESIIS – ensuring that providers see communication when looking to order product or enter administration data. Additionally, resources will be posted online – a provider specific page that will include COVID-19 specific resources as well as a page for the public containing more general information (http://dhhs.ne.gov/Pages/Coronavirus.aspx).
Nebraska will continue to utilize the existing COVID-19 Information Line (phone: (402) 552-6645, Toll Free (833) 998-2275) at least initially to ensure that Nebraskans have a way to get accurate, reliable information regarding COVID-19 vaccination services across the state.
To read the complete State of Nebraska COVID-19 Vaccination Planby Dannette R. Smith, Chief Executive Officer Department of Health and Human Services, Governor Pete Ricketts, Jeri Weberg-Bryce and Sara Morgan, go to http://dhhs.ne.gov/Pages/COVID-19-Vaccine-Information-For-Health-Care-Providers.aspx.