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1 1 (October 20, 2021)

handle is hein.crs/govegdm0001 and id is 1 raw text is: Congressional_______ ~ Research Service Compensation Programs for Potential COVID-19 Vaccine Injuries Updated October 20, 2021 More than 200 million Americans have received one or more doses of a Coronavirus Disease 2019 (COVID-19) vaccine, along with billions of people worldwide. The Food and Drug Administration's (FDA's) emergency use authorizations for the Pfizer-BioNTech, Moderna, and Johnson & Johnson COVID-19 vaccines were based on months-long clinical trials (including safety monitoring) of each vaccine, involving tens of thousands of participants. These trials did not identify any safety concerns that would preclude such authorization. (The Pfizer-BioNTech COVID-19 vaccine subsequently received full approval from FDA.) Post-authorization, the COVID-19 vaccines have been subject to safety monitoring requirements by FDA and the Centers for Disease Control and Prevention (CDC) to detect long-term or rare adverse health events. (For more information, see this CRS report.) The most common side effects of COVID-19 vaccines are mild-such as local pain around the injection side, tiredness, or fever-and usually resolve within a few days. As with most vaccines, however, a very small percentage of inoculated individuals experience serious adverse reactions to a COVID-19 vaccine. For example, approximately two to five people per million receiving mRNA COVID-19 vaccines experience anaphylaxis, a severe allergic reaction, following vaccination. (For this reason, 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.) Other serious adverse events reported following vaccination, such as myocarditis and Guillain-Barre Syndrome, are similarly rare and may be associated with COVID-19 vaccines. Federal law has two distinct compensation regimes that may compensate individuals harmed by adverse reactions to vaccines. 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' (HHS's) PREP Act Declaration for COVID-19 (and its amendments), COVID-19 vaccines are 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 Congressional Research Service https://crsreports.congress.gov LSB10584 CRS Legal Sidebar Prepared for Members and Committees of Congress