Key Provisions on Reporting ("Data Provisioning") in the 1986 NCVIA

The Act requires mandatory reporting of certain adverse events to HHS (implemented through VAERS starting in 1990). The core section is 42 U.S.C. § 300aa-25 (Section 2125 of the Public Health Service Act, as added by the NCVIA):

• Healthcare providers and vaccine administrators must report:

  • Any event listed in the vaccine manufacturer's package insert as a contraindication to additional doses of the vaccine.
  • Any adverse event specified in the VAERS Reportable Events Table (a table maintained and periodically updated by HHS/CDC) that occurs within the time period specified in the table after vaccination.

• Vaccine manufacturers must report:

  • All adverse events that come to their attention, with stricter requirements for serious events.

The law emphasizes that reports must be made regardless of whether the event is believed to be caused by the vaccine. This passive surveillance system serves as an early warning mechanism to detect potential safety signals.

Role of CDC (and FDA)

• The CDC and FDA jointly manage VAERS.
• The CDC handles public-sector reports, analyzes data for patterns, and investigates signals (often in coordination with other systems like the Vaccine Safety Datalink).
• The FDA focuses on regulatory aspects, such as manufacturer reports and potential labeling changes.
• The Act requires the Secretary of HHS (through CDC/FDA) to promote vaccine safety monitoring, including recordkeeping by providers and manufacturers (e.g., retaining vaccination records and reporting details like vaccine type, lot number, and event description).

Additional Context from the 1986 Law

• The reporting mandate supports the broader goals of the Act: stabilizing vaccine supply by limiting manufacturer liability through the no-fault National Vaccine Injury Compensation Program (NVICP) while ensuring ongoing safety monitoring.
• Providers must also record vaccinations in permanent medical records and report certain events as a condition of participating in the compensation program.
• Failure to report required events can have legal implications under federal law.