Vaccines don't have to prevent infection or transmission to be cleared in the United States, the country's top regulatory agency said in a new document.
The U.S. Centers for Disease Control and Prevention for years said a vaccine is a product that "Produces immunity" while vaccination is an injection of an infectious organism "In order to prevent the disease." The agency changed its definitions after people correctly noted that COVID-19 vaccines do not prevent infection.
The Coalition Advocating for Adequately Labeled Medicines, a group of experts, had called for the FDA to make clear that the COVID-19 vaccines don't prevent infection or transmission.
"There is a widespread notion that efficacy against infection and transmission have been established by substantial evidence, and that these vaccines contribute to herd immunity," the group said, pointing to claims from President Joe Biden, the head of the CDC, and Dr. Anthony Fauci that vaccinated people would not get sick or infected.
Marks rejected the request, writing that the petitioners included "Selected statements by U.S government officials suggesting that vaccination against COVID-19 may prevent infection or transmission" but omitted statements from Fauci and others that later acknowledged vaccines don't prevent infection or transmission.
The vaccines were later approved, though the FDA reverted to emergency authorization this month when it switched all existing COVID-19 vaccines from the companies to the updated, unproven bivalent formulations.
"The vaccines are not licensed or authorized for prevention of infection with the SARS-CoV-2 virus or for prevention of transmission of the virus, nor were the clinical trials supporting the approvals and authorizations designed to assess whether the vaccines prevent infection or transmission of the virus," he said.
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