CDC Issues Covid-19 Vaccine Interim Plans
New Interim Plans for Covid-19 by Centers for Disease Control and Prevention
The CDC (Centers for Disease Control and Prevention) in the United States had just issued the Covid-19 vaccine interim plans, as many COVID-19 vaccine candidates are in development and clinical trials are being conducted simultaneously with large-scale manufacturing.
It is not known which vaccines may be approved or authorized for use by the United States FDA (Food and Drug Administration) or when such authorizations or approvals will take place. COVID-19 Vaccination Program plans must be flexible and accommodate multiple scenarios. For the purpose of initial planning, consider the following assumptions by the CDC:
COVID-19 VACCINE
- Limited COVID-19 vaccine doses may be available by early November 2020 if a COVID-19 vaccine is authorized or licensed by FDA by that time, but COVID-19 vaccine supply may increase substantially in 2021.
- Initially available COVID-19 vaccines will either be approved as licensed vaccines or authorized for use under an Emergency Use Authorization (EUA) issued by the U.S. Food and Drug Administration.
- Cold chain storage and handling requirements for each COVID-19 vaccine product will vary from refrigerated (2°C to 8°C) to frozen (-15°C to -25°C) to ultra-cold (-60°C to -80°C) temperatures, and ongoing stability testing may impact these requirements. Note: These temperatures are based on information available as of September 15, 2020. Updated information will be provided as it becomes available.
- Jurisdictions should develop strategies to ensure the correct match of COVID-19 vaccine products and dosing intervals. Once authorized or approved by the FDA, two doses of COVID-19 vaccine, separated by either 21 or 28 days, will be needed for most COVID-19 vaccine products, and second-dose reminders for patients will be necessary. Both doses will need to match each other (i.e., be the same vaccine product).
- Some COVID-19 vaccine products will likely require reconstitution with diluent or mixing adjuvant at the point of administration.
COVID-19 VACCINE ALLOCATION
The CDC said final decisions are being made about use of initially available supplies of COVID-19 vaccines. These decisions will be partially informed by the proven efficacy of the vaccines coming out of Phase 3 trials, but populations of focus for initial COVID-19 vaccination may include:
- Healthcare personnel likely to be exposed to or treat people with COVID-19.
- People at increased risk for severe illness from COVID-19, including those with underlying conditions and people 65 years of age and older.
- Other essential workers.
According to CDC allocation of COVID-19 vaccine to jurisdictions will be based on multiple factors, including:
- Critical populations recommended by the Advisory Committee on Immunization Practices (with input from the National Academies of Sciences, Engineering, and Medicine).
- Current local spread/prevalence of COVID-19.
- COVID-19 vaccine production and availability.
Jurisdictions should anticipate that allocations may shift during the response based on supply, demand, and risk. Each jurisdiction should plan for high-demand and low-demand scenarios, according to CDC.
PHASED APPROACH TO COVID-19 VACCINATION
Due to changing vaccine supply levels at various points during the COVID-19 Vaccination Program, planning needs to be flexible but as specific as possible to accommodate a variety of scenarios, according to CDC. A key point to consider is that vaccine supply will be limited at the beginning of the program, so the allocation of doses must focus on vaccination providers and settings for vaccination of limited critical populations as well as outreach to these populations.
The CDC said vaccine supply is projected to increase quickly over the proceeding months, allowing vaccination efforts to be expanded to additional critical populations and the general public. It is important to note that recommendations on the various population groups to receive initial doses of vaccine could change after vaccine is available, depending on each vaccine’s characteristics, vaccine supply, disease epidemiology, and local community factors.
According to CDC decisions are being made about use of initially available supplies of COVID-19 vaccines. These decisions will be partially informed by the proven efficacy of the vaccines coming out of Phase 3 trials, but populations of focus for initial COVID-19 vaccination may include:
- Healthcare personnel likely to be exposed to or treat people with COVID-19.
- People at increased risk for severe illness from COVID-19, including those with underlying medical conditions and people 65 years of age and older.
- Other essential workers.
According to the CDC, JURISDICTIONS SHOULD BE PLANNING IN TERMS OF 3 PHASES:
- Phase 1: Potentially limited supply of COVID-19 vaccine doses available
- Focus initial efforts on reaching the critical populations listed above. Ensure vaccination locations selected can reach populations, manage cold chain requirements, and meet reporting requirements for vaccine supply and uptake.
2. Phase 2: Large number of vaccine doses available
- Focus on ensuring access to vaccine for members of Phase 1 critical populations who were not yet vaccinated as well as for the general population; expand provider network.
3. Phase 3: Sufficient supply of vaccine doses for entire population (surplus of doses)
- Focus on ensuring equitable vaccination access across the entire population. Monitor vaccine uptake and coverage; reassess strategy to increase uptake in populations or communities with low coverage.
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Source: CDC
