FDA Releases New Details on Postmarket COVID-19 Vaccine Monitoring

The FDA has unveiled new details on its postmarket safety monitoring of COVID-19 vaccines, including its surveillance for adverse events, that should help vaccine sponsors comply with the agency’s requirements under Emergency Use Authorizations (EUAs).

Pfizer and Moderna, whose vaccines received EUAs in December, are required to provide postmarket safety data and to track a pre-identified set of 15 adverse events (DID, Feb. 8). And the standard protocol for late-stage vaccine trials also calls for two years of safety monitoring.

Moderna said it relies on both government reporting systems and its own database to track adverse events. Specifically, the company looks at “all data sources, including ongoing clinical trials and national adverse event reporting systems,” such as the federal Vaccine Adverse Event Reporting System (VAERS), along with “adverse events reported to our global safety database,” a Moderna spokesperson told FDAnews.

The company’s phase 3 trial protocol calls for monitoring of participants to continue for more than two years, and the company routinely shares safety information with regulatory agencies, the spokesperson said.

Pfizer’s EUA states that post-authorization safety studies “should be conducted in large-scale databases,” and the company said it captures serious adverse events for two years “whether related or not to the vaccine.”

AstraZeneca, which has not yet filed for an EUA, writes in its global phase 3 study protocol that all participants are to be “assessed for efficacy and safety for two years following the first dose.” And Johnson & Johnson, which filed for an EUA last week with an FDA decision expected by month’s end (DID, Feb. 5), also has a trial protocol calling for two years of follow-up safety monitoring.

In addition to passive safety monitoring via the VAERS system or the Centers for Disease Control and Prevention’s new mobile survey platform V-Safe, the FDA carries out active surveillance through its Sentinel electronic safety monitoring system, specifically the program’s Biologics Effectiveness and Safety (BEST) system. BEST uses large-scale claims data and electronic health records (EHRs) to identify adverse event data and to conduct studies on vaccine safety.

The agency said its linked claims-EHR database allows for targeted analysis of older patients, immune-compromised individuals, pregnant women, those with severe allergic reactions or pre-existing conditions, or any of the other groups in its adverse-events tracking list. The FDA is also working with the Centers for Medicare and Medicaid Services to monitor vaccine adverse events in adults over 65 years old using the Medicare Claims database. ― Jason Scott