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During the COVID-19 pandemic, the CDC’s Immunization Safety Office (ISO) succeeded overall in monitoring safety data and evaluating risks related to vaccination, according to a new report from the National Academies of Sciences, Engineering, and Medicine.

The ISO studies vaccine risks once vaccines are administered to the public. The National Academies convened an expert committee to assess the ISO’s performance related to COVID-19 vaccination at the request of the CDC, according to a press release announcing the report.

The committee reviewed the ISO’s statistical and epidemiological methods in vaccine risk monitoring and evaluation, including processes designed to detect, evaluate, and report potential problems associated with COVID vaccines. The committee also evaluated CDC’s external communication strategies and provided recommendations to sustain and enhance ISO’s vaccine risk monitoring and communication systems.

In the report, published online on October 7, the committee noted that that ISO managed risk monitoring systems under challenging circumstances and rapidly changing information about the SARS-CoV-2 virus and played a key role in informing public health decisions about vaccination.

However, the committee also concluded that trust in the ISO has been affected by the intersection with the CDC and other government authorities, and ISO needs to focus on providing evidence-backed information clearly to its three audiences: organizational health professionals, policy makers, and the public.

“In medicine and public health, behaviors are shaped by levels of trust in communications sources,” said Jane E. Henney, MD, chair of the committee, one of several members who presented the recommendations in a webinar announcing the release of the report.

Five Recommendations for the ISO

The committee identified five recommendations for the ISO that expanded on the need to maintaining public trust through scientific integrity, credibility, and independence.

Relevance. The committee recommended that the ISO not only develop a strategic plan and mission statement, but also establish a board of scientific counselors. This board could help inform mechanisms for communication with the public and health professionals, and outline steps to take in the event of a public health emergency, the committee wrote. “Transparent communication and regular updates will help ensure that all activities remain aligned with public health priorities,” they wrote.

Credibility. “This is the office that evaluates risk,” Henney said in the webinar. The committee recommended that the ISO communicate its activities in ways that “avoid overlap with policy making or promotion,” she said. Information about systems and protocols for research and evaluation should be shared with the public as clear language summaries of vaccine risk results, divided and standardized by risk groups if possible, according to the report.

Data stewardship. Rigorous protection of privacy is essential to maintaining trust, the committee members noted in the webinar. Proper management of data is needed to interpret and share vaccine risks; the committee members wrote. However, they recommended the ISO solicit information from researchers and the public about their agenda and how to make the data more accessible to external researchers.

Improvement and Innovation. Continuous quality improvement and innovation strategies include developing metrics, maintaining the current systems, and using communication research to inform communications, the committee noted.

Independence. The ISO needs to be free from internal and external influence to protect the scientific independence of the office, the committee noted. The ISO needs to be supported both administratively and financially, but should be kept out of the activities of policy making or promoting vaccine advocacy, they said. “Independence means being insulated, it does not mean being isolated,” Henney said in the webinar. Consultation with other agencies is important to the ISO’s work, but the final decision-making must be with the ISO, and the scientific content of risk communication must remain in this office and be articulated from them, Henney emphasized.

Data Sources Reviewed

The report noted the sources effectively used multiple existing vaccine safety monitoring systems to assess COVID-19 vaccine safety, including the Vaccine Adverse Event Reporting System, the Vaccine Safety Datalink, and the Clinical Immunization Safety Assessment. Two newer systems also were used: the COVID-19 Vaccine Pregnancy Registry, which collected data from pregnant women that are mainly unavailable in clinical trials, and V-safe, a program in which individuals use their smartphones to report symptoms or reactions after vaccinations that provides near- or real-time data on side effects.

Looking ahead, “We need to increase the understanding and the confidence in the studies of risk,” Perry N. Halkitis said in the webinar. “ISO merits the nation’s trust,” he added.

The work of vaccine monitoring could be enhanced by following the five recommendations, and by a commitment on the part of the CDC director to protect the independence of the office, the committee members emphasized in the webinar. Ideally, a robust and trusted ISO will lead to increased public confidence in vaccine programs, they concluded.

The report was commissioned by the CDC. The committee members had no financial conflicts to disclose.