IDSA Response to HHS COVID-19 Vaccine Distribution Strategy

From the Factory to the Frontlines, the strategy for distributing a COVID-19 vaccine released by the Department of Health and Human Services Thursday, reflects commitment to important approaches to controlling this pandemic. The phased approach to distribution will help attain the essential goal of reaching populations disproportionately impacted by the virus and those at greatest risk of infection and serious illness, a goal that is pivotal to curtailing risks for all Americans. The strategy will also use and build on existing public health infrastructure, which will be important to strengthening and integrating our responses to the pandemic. In addition, the vaccine inventory tracking system should use existing infrastructure, including Vaccines for Children, and be integrated with electronic health records.

Success in delivering the vaccine, however, will rely on adequate funding to the Centers for Disease Control and Prevention and state and local health departments to enact jurisdictional distribution plans. Congress must provide the resources necessary to support this strategy.

In addition, education to help physicians, nurses and pharmacists who administer vaccines understand the safety and efficacy data underlying a vaccine’s authorization or licensure will be crucial to building confidence in the vaccine among health care providers, so that they in turn can build confidence among their patients.

A transparent evaluation, by FDA’s Center for Biologics Evaluation and Research Vaccines and Related Biological Products Advisory Committee and CDC’s Advisory Committee on Immunization Practices, of all data supporting a vaccine’s authorization or licensure of a vaccine will be imperative to the success of a vaccine rollout. That data, with VRBPAC and ACIP reviews and recommendations, should be publicly available, online.

After a vaccine is made available, the federal government must ensure continued data collection and reporting and full clinical trials. It is important to note that if a vaccine is made available through an Emergency Use Authorization, enrollment in the randomized controlled clinical trials that provide optimal data will face challenges. IDSA maintains that traditional licensure is preferable to the use of Emergency Use Authorization for a COVID-19 vaccine.

Swift and successful uptake and access to a COVID-19 vaccine could offer a turning point in this pandemic. The integrity of the process leading to a vaccine that has been proven safe and effective through all standard processes will be paramount for public confidence and acceptance of the vaccine. 

Thomas File, M.D., FIDSA – President, Infectious Diseases Society of America