VAERS Has ‘A Proven Track Record’: FDA/CDC
CBER director Peter Marks and CDC National Center for Emerging and Zoonotic Infectious Diseases director Daniel Jernigan say the Vaccine Adverse Event Reporting System (VAERS) their agencies co-manage “works and has a track record that proves it.” The two wrote an online FDA Voices post that “explains how VAERS works, how successful it’s been, and addresses some of the common myths about the system.”
While it doesn’t say so directly, the post may be the agencies’ response to a recent BMJ investigative report that raised concerns that VAERS is not operating as planned and safety signals are likely being missed. The report alleged that VAERS staffing levels have not kept pace with the workload and said discussions with about a dozen people, including doctors and a state medical examiner, revealed cases in which adverse event reports were filed and the filers never received a response from the AERS experts.
In their explanation, Marks and Jernigan say “investigators may or may not reach out to the individual who submits a report to VAERS. VAERS experts may contact health systems or facilities for information related to a report to ensure they have all available information. This has sometimes led to confusion for individuals who have reported serious events, as they assume the ball was dropped. Even though the person who submitted a report may never hear from VAERS, without fail, work is happening to obtain more information about reported life-threatening events.”
While not specifically addressing the staffing question raised by BMJ, the agency post says “during the height of the Covid-19 pandemic, FDA and CDC had hundreds of people working on vaccine safety, and serious reports were followed up within five days. This includes reports of serious events that were in the original list identified during clinical trials or new potential safety concerns that warrant further review. The five-day timeline for follow-up remains true to this day. Not long after Covid-19 vaccines were authorized in late 2020, there was a backlog of reports, due in part to requirements under FDA’s emergency use authorizations that require manufacturers and vaccination providers to report any serious adverse event, regardless of whether it was believed the vaccine caused the event. During that initial time, a backlog of serious reports was cleared within a month and reports of non-serious events were cleared within three months.”
In its report, BMJ said that in response to questions raised in its investigation, FDA sent an e-mail that “appeared to dismiss the concerns.” In the e-mail, the agency said it “is actively engaged in safety surveillance of these vaccines to identify and address potential safety concerns” and that “physicians and epidemiologists from FDA and CDC continuously screen and analyze data from VAERS for Covid-19 vaccines to identify potential signals that would indicate the need for further study.”
In their post, Marks and Jernigan list all the successes they claim for VAERS and conclude the system “is constantly evolving, with ongoing efforts to enhance its data quality and analysis capabilities. While not without limitations, VAERS has proven to be vital in detecting both potential and actual safety issues and informing vaccine policy decisions that protect the health of the American public. That’s a job CDC and FDA take seriously. We know that failure to detect and communicate a serious health issue related to a vaccine could impact confidence not only in Covid-19 vaccines but in all vaccines.”