Two documents released Sept. 16 by the Department of Health and Human Services (HHS) and Department of Defense (DOD) outline the federal government’s plans for producing and distributing a COVID-19 vaccine.
The Operation Warp Speed (OWS) Strategic Overview summarizes distribution, administration, monitoring, and engagement strategies. OWS is a partnership among components of HHS and DOD to accelerate COVID-19 vaccine development.
The Centers for Disease Control and Prevention (CDC) is working with state, local, and tribal health departments to refine existing vaccine distribution and administration plans. A multi-agency team worked with five pilot jurisdictions — in California, Florida, Minnesota, North Dakota, and Philadelphia — to create an adaptable model administration plan.
CDC has contracted with McKesson, a centralized distributor that dispensed the H1N1 vaccine from 2009–2010. McKesson will deliver vaccines to designated locations around the country, which may serve as administration sites. Vaccines also can be transported from delivery sites to external administration sites or distributed through national retail pharmacy networks. McKesson also is capable of distributing refrigerated and frozen vaccines.
HHS will use its Vaccine Tracking System (VTrckS) for vaccine allocation, ordering, uptake, and management. The agency will onboard additional providers, including private partners (for example, pharmacy chains) and other federal entities, including the Indian Health Service.
Once a vaccine is authorized or approved by the Food and Drug Administration, a potential phased approach is outlined by OWS:
- phase 1 will aim to maximize vaccine acceptance;
- phase 2 will target vaccines to populations at high risk for severe outcomes from COVID-19; and
- phase 3 will integrate universal COVID-19 vaccines into routine vaccination programs.
CDC’s Advisory Committee on Immunization Practices (ACIP) will use the National Academies of Sciences, Engineering, and Medicine framework on equitable vaccine allocation to develop recommendations for COVID-19 vaccine policy.
Under the CARES Act, health insurance issuers and plans must cover any ACIP-recommended COVID-19 preventive service, including vaccines, without cost-sharing within 15 days of recommendation to the CDC. To support vaccine administration, OWS will provide 6.6 million ancillary supply kits that include needles, syringes, alcohol pads, vaccination cards, and limited personal protective equipment for vaccinators.
Administration sites in the initial phases of vaccine distribution might be limited to sites that pinpoint the target population. CDC will work with local partners to ensure rural populations receive the vaccine.
OWS will develop an integrated information technology system to monitor the vaccine’s efficacy and discover infrequent or rare side effects not identified in clinical trials.
CDC has developed an interim playbook for jurisdiction operations with more information about the vaccine distribution process, including steps jurisdictions should take to ensure equitable access to vaccination for each of the critical populations identified.
Visit the America’s Essential Hospitals coronavirus resource page for more information about the outbreak.
Contact Senior Director of Policy Erin O’Malley at email@example.com or 202.585.0127 with questions.