Allocations and Distribution of COVID-19 Vaccine Regarding Requirements and Enforcement

Notice to Local Health Officers:  Allocation and Distribution of COVID-19 Vaccine

This Notice is to provide guidance to Local Health Officers to ensure that the COVID-19 vaccines are administered according to federal and state requirements.

COVID-19 Vaccine Allocation and Distribution Process:

California’s shipments of COVID‑19 vaccines are delivered under the federal Centers for Disease Control and Prevention (CDC) COVID-19 Vaccination Program. Under the CDC program, vaccine and ancillary supplies are procured and distributed by the federal government at no cost to enrolled COVID-19 vaccination providers.  For administration to identified priority populations, COVID-19 vaccine is sent directly to vaccination provider locations or designated depots for secondary distribution to administration sites.

> Vaccination Providers Must Enroll in the CDC’s COVID-19 Vaccination Program, Sign the CDC Provider Agreement, and Adhere to All CDC Requirements

To receive the vaccine, vaccination providers must enroll in the CDC’s COVID-19 Vaccination Program and must sign and agree to the conditions in the CDC COVID-19 Vaccination Program Provider Agreement.

The Provider Agreement requirements include, among others, that providers:

  • Administer the vaccine in accordance with ACIP recommendations and FDA Emergency Use Authorization (EUA) requirements;
  • Not sell or seek reimbursement for the vaccine and any diluent, syringes, needles, or other constituent products and ancillary supplies provided by the federal government;
  • Administer the COVID-19 vaccine regardless of the vaccine recipient’s ability to pay; and
  • Comply with CDC requirements for vaccine management.

Failure of any enrolled COVID-19 vaccination provider to meet the conditions of the agreement may impact whether COVID-19 vaccine product orders are fulfilled and may result in legal action by the federal government. Per the Department of Consumer Affairs Notice to Licensees (link here), failure to adhere to these requirements may also subject a licensee who inappropriately distributes or administers the COVID-19 vaccine to discipline by the applicable California licensing board.

> Prioritization of COVID-19 Vaccine Allocation

On December 1, 2020, the Advisory Committee on Immunization Practices (ACIP) issued its Interim Recommendation for Allocating Initial Supplies of COVID-19 Vaccine.  The ACIP provides advice and guidance to the CDC regarding vaccine use for the control of vaccine-preventable diseases, like COVID-19.

The ACIP recommended that both (1) health care personnel and (2) residents of long-term care facilities be offered COVID-19 vaccine in the initial phase of the vaccination program.

On December 12, 2020, the ACIP issued its Interim Recommendation for Use of Pfizer-BioNTech COVID-19 Vaccine in persons aged 16 years and older.  And on December 19, 2020, the ACIP issued its Interim Recommendation for Use of Moderna COVID-19 Vaccine in persons aged 18 years and older. The Emergency Use Authorizations for these vaccines issued by the federal Food and Drug Administration and the CDC’s vaccine provider agreement require vaccine administrators to comply with CDC vaccine management requirements, including prioritization recommendations.

The ACIP recommends that all COVID-19 vaccines authorized pursuant to a federal Food and Drug Administration Emergency Use Authorization, including the Pfizer-BioNTech and Moderna vaccines, should be implemented in conjunction with ACIP’s December 1, 2020 Interim Recommendations for allocating initial supplies of COVID-19 vaccines.

Likewise, on December 5, 2020, the California Department of Public Health (CDPH) published Allocation Guidelines for COVID-19 Vaccine During Phase 1A: Recommendations.  Like the ACIP recommendations, CDPH recommends that COVID-19 vaccines be prioritized and allocated in Phase 1A as follows:

  1. Persons at risk of exposure to SARS-CoV-2 through their work in any role in direct health care or long-term care settings. This includes individuals that work in inpatient, outpatient, home-based, and community-based settings providing clinical care and non-clinical care services, such as environmental services, patient transport, interpreters, and laboratory workers.
  2. Residents of skilled nursing facilities, assisted living facilities, and similar long-term care settings for older or medically vulnerable individuals.

The CDPH Drafting Guidelines Workgroup is continuing to develop California-specific guidance for the prioritization and allocation of COVID-19 vaccines while supplies remain limited. Allocation guidelines for all future phases will be posted on the Drafting Guidelines Workgroup’s page here.

> Distribution of COVID-19 Vaccine

The process for vaccination providers to receive COVID-19 vaccine involves local, state and federal partners working together.  Local orders for vaccine are entered into CalVAX, California’s database for ordering COVID-19 vaccine, after approval from Local Health Officers, taking into consideration the needs of the local health jurisdiction and the priority groups.  After Local Health Officer approval, CDPH transmits all approved local orders to the CDC to distribute the vaccine according to the approved amounts and locations.  CDPH is tracking the doses allocated to Local Health Jurisdictions and multi-county entities, the most up-to-date information is publicly available here. As described above, during Phase 1A of vaccine allocation and distribution, COVID-19 vaccines will be administered only to healthcare workers and long-term care residents.

There may be circumstances where COVID-19 vaccine may need to be redistributed.  In these instances, vaccination providers may be allowed or required to redistribute vaccine, as approved by the Local Health Officer and CDPH. In order to redistribute the vaccine, the appropriate entity must have reviewed and signed the CDC Supplemental COVID-19 Vaccine Redistribution Agreement.

How Local Health Officers Can Assist to Ensure Proper Administration of the COVID-19 Vaccine:

Vaccination providers must administer the vaccine in accordance with federal and state requirements.  Vaccination providers must adhere to COVID-19 vaccine standards, and failure to do so may result in:

  • Disciplinary action by the Department of Consumer Affairs’ respective licensing boards;
  • Disenrollment from the COVID-19 Vaccination Program and/or CalVAX, preventing the ordering of additional COVID-19 vaccine;
  • Redistribution of COVID-19 vaccine to other compliant vaccination providers; and
  • Legal action by the federal government, state departments, and/or law enforcement agencies.

If the Local Health Officer knows or has reason to know that an enrolled vaccination provider is not adhering to federal and state requirements, the Local Health Officer must immediately report such violations to CDPH at