Exhibit 940 ยท Agency protocol
V-safe active surveillance for COVID-19 vaccine safety, protocol version 5
The purpose of v-safe surveillance is to rapidly characterize the safety profile of COVID-19 vaccines when given outside a clinical trial setting and to detect and evaluate clinically important adverse events and safety issues that might impact policy or regulatory decisions.
Protocol for V-safe, the CDC's smartphone-based system of text-message-initiated web surveys that follow vaccine recipients after vaccination, with telephone follow-up through the VAERS call center for medically attended events. It states the program's purpose and lists its limits: enrollment depends on providers and recipients, participants may differ from non-participants, vaccine type is self-reported, late enrollers may be a mixed group, and 3-, 6- and 12-month reports may suffer recall bias. It also states that a final deidentified aggregate data set would be made available through external requests or FOIA.
- Source
- Centers for Disease Control and Prevention
- Date
- 18 April 2022
- Quoted from
- Protocol summary, p. 5 (limits at pp. 14-15)
- Grade
- Primary record
- Document
- https://web.archive.org/web/20220817233556/https://www.cdc.gov/vaccinesafety/pdf/V-safe-Protocol-V5-508.pdf
- Accessed
- 2026-11-10
- Cited by
- Findings citing this exhibit
- Note
- Version 5 is the version the court cites in ECF No. 40 (item nd-tex-2024-freedom-coalition-v-cdc-vsafe-order). The cdc.gov URL is not reachable by automated fetch; the Wayback Machine capture of the CDC PDF is the copy read (the capture ends before the final attachments).