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1 1 (March 22, 2021)

handle is hein.crs/govecub0001 and id is 1 raw text is: S Congressional ______ SResearchService Compensation Programs for Potential COVID-19 Vaccine Injuries March 22, 2021 Following the Food and Drug Administration's (FDA) emergency authorization of the Pfizer/BioNTech, Moderna, and Janssen Biotech/Johnson & Johnson vaccines against COVID-19, millions of Americans have received at least one dose of a COVID-19 vaccine regimen. Based on months-long clinical trials (including safety monitoring) of each vaccine candidate involving tens of thousands of participants, FDA did not identify any safety concerns for these vaccines that would preclude FDA emergency use authorization. As with most vaccines, however, a very small percentage of inoculated individuals experienced adverse reactions to a COVID-19 vaccine. Anecdotal reports from early in the COVID-19 vaccination campaign include several cases of anaphylaxis-a severe and potentially life-threatening allergic reaction-following vaccination. According to a joint study by scientists at the Centers for Disease Control and Prevention (CDC) and FDA, there were 21 reported cases of anaphylaxis from the first 1.9 million Pfizer/BioNTech vaccinations. Nearly all of these individuals (19 of 21) received epinephrine as treatment. Although some of these individuals were hospitalized, all have recovered and were discharged; no deaths were reported. The most recent evidence available indicates serious allergic reactions to COVID-19 vaccines occur in approximately two to five people per million doses administered. Although these serious adverse events are rare, the CDC recommends that all individuals be monitored for at least 15 minutes following their vaccinations, and that all vaccination sites have epinephrine available for treatment of anaphylaxis. Federal law has two distinct vaccination compensation regimes that may compensate individuals harmed by adverse reactions. In general, the National Vaccine Injury Compensation Program (VICP) may provide compensation for injuries or deaths associated with most vaccines routinely administered in the United States (such as pediatric and seasonal influenza vaccines). During certain public health emergencies, the Countermeasures Injury Compensation Program (CICP) may provide compensation for injuries and deaths resulting from the administration of covered countermeasures under the Public Readiness and Emergency Preparedness Act (PREP Act), which may include vaccines. Under the Secretary of Health and Human Services's (HHS) PREP Act Declaration for COVID-19 (and its amendments), COVID-19 vaccines are considered covered countermeasures within the PREP Act's scope. As a result, CICP-and not VICP-will apply to injuries resulting from COVID-19 vaccinations while the public health emergency persists and the Declaration remains in force. Compensation through Congressional Research Service https://crsreports.congress.gov LSB10584 CRS Legal Sidebar Prepared for Members and Committees of Congress

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