Questions and Answers
Planning for the distribution and administration of COVID-19 vaccine is guided by several overarching principles: ensuring the COVID-19 vaccine meets safety requirements; ensuring that vaccines are distributed and administered equitably, especially given the limited vaccine initially available; and ensuring transparency in the process.
How will you ensure the goals outlined in the plan are met?
California has established an inter-agency COVID-19 California Governor's Vaccine Task Force and a COVID-19 Vaccine Task Force Working Group with state government leadership and subject matter expertise. Additionally, California will draw upon the knowledge of many, including:
- Scientific Safety Review Workgroup – comprised of immunization, public health, academic and other subject matter experts and charged with staying abreast of vaccine candidate(s) trials, evidence of safety and efficacy, and other information to independently provide recommendations to California leadership and vaccine planning efforts as well as ensure public confidence in vaccine safety, efficacy, and implementation efforts.
- Drafting Guidelines Workgroup – comprised of immunization, public health, ethicists, healthcare and academic experts and is charged with developing California specific guidance for the prioritization and allocation of vaccine when supplies are limited.
- Community Vaccine Advisory Committee – comprised of a broad range of community groups and is charged with providing input and feedback to the planning efforts and solving barriers of equitable vaccine implementation and decision-making.
Are you working with community organizations and others to prepare for the distribution of vaccines?
CDPH is working diligently with a variety of partners to prepare for the distribution and administration of COVID-19 vaccines in California. Planning has involved California's local public health departments, multiple state agencies, community-based organizations, and public and private immunizers.
How is California verifying vaccine safety?
California established a Scientific Safety Review Workgroup to closely monitor all available information about the candidate COVID-19 vaccines, including their Phase 3 trials, the FDA review process and any independent evaluations. California will need evidence that additional vaccine candidates have
received safety approvals and are effective before distributing them.
How will safety be tracked once a COVID-19 vaccine is made available to the public?
After a vaccine is licensed, scientists continue to monitor its use in post-licensure studies. In this way, they quickly become aware of any previously undetected issues of concern so that vaccinations can be halted if necessary. The Vaccine Safety Datalink in the United States, which monitors many immunizations in California, is designed to quickly pick up a safety problem in near real time so the public can be informed quickly of possible risks.
Who will get the initial vaccines given supplies are expected to be limited at first?
CDPH determined initial allocations for California counties in accordance to a prioritization framework based on guidance from the federal government. CDPH and community-based organizations and other partners are reviewing and incorporating national prioritization recommendations from the federal Advisory Committee on Immunization Practices and the National Academy of Medicine to guide prioritization for California.
Vaccines Approval Process
What will be needed to license COVID-19 vaccines in the United States? What is the role of the FDA?
The U.S. Food and Drug Administration's (FDA's) Center for Biologics Evaluation and Research (CBER) is responsible for regulating vaccines in the United States. The sponsor/manufacturer of a new vaccine product follows a multi-step approval process, which includes requirements to share information about how they determined that a vaccine is safe and that it works. They will need to provide data for review and information, so the FDA and other scientists can understand how the studies were designed, how many people participated in the study, and how the testing to obtain the data was done.
Once the FDA approves a vaccine, it continues to oversee its production to ensure it is safe. Monitoring of the vaccine and of production activities, including periodic facility inspections, must continue as long as the manufacturer holds a license for the vaccine product. FDA can require a manufacturer submit the results of their own tests for potency, safety, and purity for each vaccine lot. FDA can require each manufacturer submit samples of each vaccine lot for testing.
What are the different phases of clinical trials (phase I, II, III studies) for vaccines?
Clinical development is a three-phase process. During Phase I, small groups of people receive the trial vaccine. In Phase II, the clinical study is expanded, and the vaccine is given to people who have characteristics (such as age and physical health) similar to those for whom the new vaccine is intended. In Phase III, the vaccine is given to thousands of people and tested for efficacy and safety.
After a vaccine is licensed, scientists continue to monitor its use in "post-licensure studies." In this way, they quickly become aware of any previously undetected issues of concern, so that vaccinations can be halted if necessary. The Vaccine Safety Datalink in the United States, which monitors many immunizations in California, is designed to quickly pick up a safety problem in near real time so the public can be informed quickly of possible risks.
How can we be sure COVID-19 vaccines are safe since vaccine development and production are being expedited?
The FDA has issued assurances that it will not approve vaccines developed by sacrificing the standards for quality, safety, and efficacy that all vaccines meet. A group of vaccine manufacturers has also signed a pledge not to submit a COVID-19 vaccine before phase III studies have demonstrated that their candidate vaccine is safe and effective.
California's Scientific Safety Review Workgroup stays informed about each vaccine candidate's trials, evidence of safety and efficacy, and other information to independently provide recommendations to California leadership and vaccine planning efforts as well as ensure public confidence in vaccine safety, efficacy, and implementation efforts.