Vaccine safety analysis for COVID-19 not provided by FDA

In an effort to protect internal discussions protected by law, the US Food and Drug Administration is refusing to release key analyses of a COVID-19 vaccine safety database.

FDA and its partner laid out operating procedures in January 2021 and February 2022 for mining data "at least biweekly" in order to identify adverse events that occur more frequently than expected after vaccination with COVID-19 vaccines. Data will be mined based on the VAERS (Vaccine Adverse Event Reporting System).

Government agencies may withhold inter-agency and intra-agency memos and letters that would not otherwise be available to parties other than agencies engaged in litigation.

The agency cited an exemption to the Freedom of Information Act that lets the government withhold inter-agency and intra-agency memorandums and letters “that would not be available by law to a party other than an agency in litigation with the agency.”

10 Sep 2022