Authorized and Recommended Vaccines

• Scientists and doctors have been working on vaccines since the beginning of the COVID pandemic. Around the world, there are over two hundred currently in development.
• Currently, only the Pfizer vaccine has received authorized and recommended to prevent COVID-19. We will provide information on who is and is not recommended to receive each vaccine and what to expect after vaccination, as well as ingredients, safety, and effectiveness.

Clinical Trials

• Currently, clinical trials are evaluating investigational COVID-19 vaccines in many thousands of study participants to generate scientific data and other information for the Food and Drug Administration (FDA) to determine their safety and effectiveness.
• These clinical trials are being conducted according to the rigorous standards set forth by FDA in their June 2020 guidance document, Development and Licensure of Vaccines to Prevent COVID-19.  
• If FDA determines that a vaccine meets its safety and effectiveness standards, it can make these vaccines available for use in the United States by approval or emergency use authorization.
• After FDA makes its determination, the Advisory Committee on Immunization Practices (ACIP) will review available data before making vaccine recommendations to CDC.

CDC definition of phase 3 clinical trial

COVID-19 Vaccine Status

• The Food and Drug Administration (FDA) granted Emergency Use Authorization (EUA) to the Moderna COVID-19 vaccine on December 18, 2020.
• On December 19, 2020, the Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) voted to recommend the vaccine for ages 18 years and above.
• The FDA has posted meeting materials for the Vaccines and Related Biological Products Advisory Committee Meeting on December 17, 2020 to review the Moderna COVID-19 vaccine EUA application.
• The FDA has posted meeting materials for the Vaccines and Related Biological Products Advisory Committee Meeting on December 10, 2020 to review the Pfizer-BioNTech COVID-19 vaccine EUA application.
• Multiple COVID-19 vaccines are under development and in various stages of approval. 

CDC definition of phase 3 clinical trial

• On November 20, 2020, Pfizer applied to FDA for emergency use authorization (EUA) for their COVID-19 vaccine. Earlier Pfizer announced that its Phase 3 trial efficacy analysis has found its vaccine candidate is 95% effective. The study enrolled over 43,000 participants and has not uncovered any serious safety concerns.
• Moderna’s phase 3 trial includes 30,000 participants and has not uncovered any serious safety concerns. On November 30, 2020, Moderna applied to FDA for emergency use authorization (EUA) for their COVID-19 vaccine. Primary efficacy analysis of the Phase 3 study found vaccine efficacy against COVID-19 was 94.1%.
• As of November 20, 2020, two additional vaccines are in the last stage of clinical trials in the U.S.
• AstraZeneca recently reported results from its Phase III clinical trial in Brazil and the United Kingdom indicating strong vaccine effectiveness among participants in their Phase 3 clinical trials.
• Diversity in clinical trials is important to demonstrate the vaccine is safe and effective for all persons. Diversity in current clinical trials:
  • 28% of Moderna trial participants are from “diverse communities”
  • 75% of UIC’s Moderna trial participants from racial/ethnic minorities
  • 26% of Pfizer/BioNTech trial participants have “diverse backgrounds”
• Most vaccine products will be provided in 2-dose series, and some vaccine products will require special storage and handling (e.g., ultra-cold storage).

Vaccine Rollout

At first, there will be a limited supply of COVID-19 vaccine. The federal government plans to ship the first vaccine doses out for distribution once a vaccine is authorized or approved and recommended. As more vaccines are available, federal planners will ship additional vaccine doses. For more information see COVID-19 Vaccine Planning in Chicago.