Researcher Distorts Facts on COVID-19 Vaccine Approval, Liability
SciCheck Digest
The Pfizer/BioNTech COVID-19 vaccine was fully approved by the Food and Drug Administration, though an emergency use authorization also remains in place. Dr. Robert Malone misleadingly said Americans are being offered the shot only under the latter and that it carried different liability ramifications. The liability protections, afforded under a public health law, are the same for the two.
The Food and Drug Administration expedited review of the vaccines because of the public health risks of the ongoing pandemic. All three vaccines in use in the U.S. were rolled out under an emergency use authorization, or EUA, which is typically less stringent than the full licensure, which is called a biologics license application, or BLA. However, the FDA added more rigorous requirements for a COVID-19 vaccine EUA. Under a standard EUA, regulators must determine that the product “may be effective” and the “known and potential benefits outweigh the known and potential risks.” For these EUAs, the FDA went further and required “at least one well-designed Phase 3 clinical trial that demonstrates the vaccine’s safety and efficacy in a clear and compelling manner.” The agency also wanted to see at least two months of follow-up data on half or more of the participants, and said it expected vaccine companies to continue to collect data to pursue full approval. The FDA full approval to the Pfizer/BioNTech COVID-19 vaccine for people 16 years of age and older on Aug. 23. The decision was based on additional data from the phase 3 clinical trials, in which more than half of participants were followed for at least four months after receiving a second dose, and a review of safety surveillance and manufacturing data, including inspections of production facilities.
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