An Emergency Use Authorization (EUA) is an authority granted to the Food and Drug Administration (FDA) to allow the use of unapproved medical products, or unapproved uses of approved medical products, to diagnose, treat or prevent serious or life-threatening diseases during a public health emergency, such as COVID-19 (watch video).
The FDA evaluates an EUA request for a medical product and reviews the scientific evidence to determine whether it meets legal standards.
All vaccines aim to expose the body to an antigen that won’t cause disease but will provoke an immune response that can block or kill the virus if a person becomes infected. At least eight types are being tried against the coronavirus, and they rely on different viruses or viral parts.
Traditional vaccine development is sequential, with one step not starting until the previous step was complete. However, due to the urgency of the pandemic, the government’s vaccine process was accelerated by Operation Warp Speed. The accelerated vaccine development has multiple activities (development, trials and manufacturing) work in parallel and the activities overlap on the timeline. This method shaved months off the schedule for delivery of vaccines.
To compare the typical process with the accelerated process, visit Operation Warp Speed.
For more general information, visit How Vaccines Are Developed.
It will take time for the vaccine to be available to everyone. But the goal is for everyone who wants a vaccine to be able to get a vaccine.
Since it will take several months to produce enough vaccinations for the U.S. population, the COVID-19 Vaccination Program will require a phased approach. The California Department of Public Health is working with the Centers for Disease Control to roll out the COVID-19 Vaccination Program in California. The program’s phases are still being determined at this time. The Shasta County Public Health Department will keep the community posted as each phase is determined.
Allocation is directed by federal, state and county guidance.
The federal Advisory Committee on Immunization Practices (ACIP) within the Centers for Disease Control and Prevention (CDC) provides advice and guidance on vaccine-preventable diseases.
On the state level, California refers to the ACIP’s ethical vaccine recommendations. Accordingly, California health officials appointed more than 65 advocacy, labor and business organizations to a new Community Vaccine Advisory Committee to ensure that the vaccine is distributed equitably. The committee remains mindful of our most vulnerable populations, as not to undermine efforts in controlling this pandemic.
To address the efficacy and safety of COVID-19 vaccine candidates, California formed a panel of public health and immunization experts—the Scientific Safety Review Workgroup. Neighboring states Washington, Oregon and Nevada are joining California’s effort to conduct independent reviews of any vaccine approved by the FDA.
Building on the state’s workgroup, California gathered experts from various fields—immunization, geriatrics, ethics, epidemiology, health equity and pharmacy practices—to form the COVID-19 Drafting Guidelines Workgroup. This workgroup developed California-specific guidance for the prioritization and allocation of a COVID-19 vaccine. The guidance is based on the framework for equitable allocation by National Academies of Sciences, Engineering, and Medicine (NASEM), and the Centers for Disease Control and Prevention (CDC). The state’s distribution plan will guide counties, which will oversee on-the-ground coordination.
Locally, Shasta County is closely monitoring the progress of the vaccine and developing guidelines for distribution depending on the number of doses we receive over the coming weeks and months. The Health and Human Services Agency created a task force of stakeholders to determine how the national and state recommendations will be applied to our vaccination plans.
The California Department of Public Health is working with local health departments to plan for and distribute COVID-19 vaccines. Some types of vaccines require ultra-cold freezers and are delivered in large quantities. Shasta County Public Health has acquired an ultra-cold freezer and is also working with other North State providers that can properly maintain and administer COVID-19 vaccine as well as meet additional federal and state requirements.