In December 2020, the U.S. Food and Drug Administration (FDA) issued Emergency Use Authorizations (EUAs) for the Pfizer-BioNTech and Moderna vaccines to prevent COVID-19. Within twenty-four hours of each authorization, doses began shipping across the country to every state, marking significant milestones in the national response to the COVID-19 pandemic. Since then, over sixty-six million vaccine doses have been administered throughout the U.S. with another vaccine from Johnson & Johnson to be reviewed by the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) (i.e., the body that will review and evaluate the vaccine’s safety and efficacy) on February 26, 2021.
Once a vaccine is granted an EUA by the FDA, its safety and efficacy data are then shared with the Centers for Disease Control & Prevention (CDC) Advisory Committee on Immunization Practice (ACIP). ACIP provided advice and guidance to the director of the CDC regarding use of the Pfizer/BioNTech and Moderna vaccines among the U.S. general population in December 2020. The recommendations made by the ACIP were reviewed and approved by the CDC director as official CDC recommendations. States and territories could then choose to adopt or amend these recommendations as they made initial allocation decisions within their jurisdiction.
As the initial vaccine rollout has progressed, the federal government, states, and local health officials have adapted prioritization criteria in response to lower-than-expected vaccine uptake, as well as unpredictable and/or more limited supply than anticipated. While in some cases these priority changes have allowed for a more streamlined approach and guidance for providers and the general public, they have also dramatically increased demand for already quite limited supplies of vaccines and related resources (e.g., staff to administer the vaccines, syringes, personal protective equipment (PPE) for vaccinators). Efforts to ensure sufficient and equitable vaccine access will be critical throughout the vaccines’ rollout, particularly if demand continues to exceed supply.
Beyond the prioritization process, federal, state, and local governments have taken action to accelerate the vaccine rollout, including expanding the numbers and types of vaccine administration sites available. For example, on February 2, 2021, the White House announced that an initial one million doses of the vaccines will be shipped directly to pharmacies (e.g., CVS, Walgreens, Rite Aid) in addition to those allocated directly to states and territories. This will be modeled after the vaccine distribution partnership program between CVS and Walgreens and long-term care facilities and will be gradually scaled up in the coming weeks.
In the months ahead, members of the attorney general community should monitor and be aware of the following possible key events related to the vaccines’ rollout:
- New vaccines seeking EUAs in the U.S., including the single-dose Johnson & Johnson/Janssen vaccine, which the FDA will review and consider at the end of February 2021.
- Increased vaccine supply secured by the U.S. government via new or amended contracts with manufacturers. For example, efforts by the previous and current administrations to procure additional doses of the Pfizer/BioNTech and Moderna vaccines.
- Increased rates of vaccine production and distribution as vaccine manufacturers and state/local health departments ramp-up capacity and efficiencies. In addition, federal, state, and private partner actions proposed and taken to strengthen and expand on the production of vaccines and associated materials (e.g., personal protective equipment (PPE) for vaccine administration staff), including use of the Defense Production Act (DPA).
- Additional data gathered and published regarding the effects of COVID-19 variants on vaccine efficacy as well as rates of transmission and mortality.
- Additional data gathered and published regarding the long-term effectiveness of existing COVID-19 vaccines (i.e., when or if individuals will need to be revaccinated) and their ability to prevent transmission of COVID-19, including among asymptomatic cases.
Throughout 2021, NAAG will continue to provide informational updates and training opportunities to the attorney general community as COVID-19 vaccine distribution and related legal issues evolve. For more information on NAAG’s response to the COVID-19 pandemic, visit NAAG’s Members-Only COVID-19 Resource Page. Attorney general staff can request access to the page here. Additional public health-related updates from NAAG are available here.