What evidence of vaccine effectiveness — balanced by what assurance of safety — would prompt you to seek a dose of one of these novel vaccines to protect an elderly family member or for yourself?
Optimal use of these Covid-19 vaccines will depend on the confidence of the American people in the processes leading up to the vaccines’ release. The Food and Drug Administration’s (FDA) Biologics License Application (BLA) is the standard path to vaccine licensing. The rigor and transparency of this process ensures clinician and public confidence in vaccine safety and efficacy.
To foster trust in the expertise and integrity of those who review the vaccine and make recommendations to the public, there must be frequent communication from a group of HHS experts, such as leaders of Operation Warp Speed, the FDA and the Centers for Disease Control and Prevention, with only limited input from pharmaceutical representatives.
The public knowledge that the vaccine’s safety is being closely monitored even after EUA licensure would be especially important in building public trust. All vaccines are routinely checked and studied for safety after they become available to the public, and the novelty of this vaccine makes that process all the more important.
A federal Covid-19 vaccine safety task force should be established and, along with a group of independent experts, be charged with conducting rapid reviews of data from the federal safety monitoring systems and reporting to the public. To sustain public confidence, Covid-19 vaccine safety surveillance must continue for the foreseeable future to fully define the safety profile of these novel vaccines.
Engagement with the most-affected communities
It is, therefore, imperative that public health personnel engage with communities and groups disproportionately affected by Covid-19 to listen to their concerns, understand their values and leverage their knowledge and expertise to inform policy and practice decisions.
Gaining the confidence of American people in the processes and systems that lead to the development and distribution of Covid-19 vaccines is essential. Only then will we have any hope of realizing the full potential of these vaccines to control this pandemic.