\u201cIt is important to note that FDA\u2019s authorization and licensure standards for vaccines do not require demonstration of the prevention of infection or transmission,\u201d Dr. Peter Marks, a top official at the U.S. Food and Drug Administration (FDA), said in\u00a0the document<\/a>.<\/p>\n Marks was writing as he rejected nearly all recommendations from a group of experts that\u00a0advised the FDA<\/a>\u00a0to update the labels for the Pfizer and Moderna COVID-19 vaccines.<\/p>\n Vaccines are traditionally known as drugs that prevent an illness. The U.S. Centers for Disease Control and Prevention (CDC) for years said a vaccine is a product that \u201cproduces immunity\u201d while vaccination is an injection of an infectious organism \u201cin order to prevent the disease.\u201d The agency\u00a0changed its definitions<\/a>\u00a0after people correctly noted that COVID-19 vaccines do not prevent infection.<\/p>\n The\u00a0Coalition Advocating for Adequately Labeled Medicines, a group of experts, had called for the FDA to make clear that the COVID-19 vaccines don\u2019t prevent infection or transmission.<\/p>\n \u201cThere is a widespread (but inaccurate) notion that efficacy against infection and transmission have been established by substantial evidence, and that these vaccines contribute to herd immunity,\u201d 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.<\/p>\n Biden, for instance, falsely said in 2021 that \u201cyou\u2019re not going to get COVID if you have these vaccinations.\u201d<\/p>\n \u201cTo remedy this situation, language clarifying that phase III trials were not designed to determine and failed to provide substantial evidence of vaccine efficacy against SARS-CoV-2 transmission or death must be added to labels,\u201d the coalition said. SARS-CoV-2 causes COVID-19.<\/p>\n While it\u2019s uncommon to include in product labeling what a product has not been proven to do, there are cases where it\u2019s necessary due to inaccurate assumptions, the coalition said. They pointed to the FDA stating that the influenza medicine Tamiflu \u201chas not been shown to previous serious complications of influenza\u201d after the drug\u2019s manufacturer said it reduced complications by nearly half.<\/p>\n Marks rejected the request, writing that the petitioners included \u201cselected statements by U.S government officials suggesting that vaccination against COVID-19 may prevent infection or transmission\u201d but omitted statements from Fauci and others that later acknowledged vaccines don\u2019t prevent infection or transmission.<\/p>\n \u201cIn responding to your Petition, we are not agreeing or disagreeing with any of the statements that are selected in the Petition,\u201d Marks said. \u201cRather, we are observing that the statements referenced by the Petition do not demonstrate a commonly held belief that the clinical trials provided substantial evidence of efficacy against SARS-CoV-2 transmission. We are not convinced that there is any widespread misconception about this.\u201d<\/p>\n The head of the CDC, Dr. Rochelle Walensky, is among those\u00a0maintaining to the present day<\/a>\u00a0that the vaccines at one point completely prevented transmission and symptomatic illness.<\/p>\n Trial data showed high efficacy against symptomatic illness but not 100 percent efficacy. Real-world data has shown lower effectiveness. The trials were not designed to measure transmission, the FDA has said in various documents.<\/p>\n Marks also said that the FDA can authorize or approve a vaccine even if there\u2019s no \u201cdemonstration of the prevention of infection of transmission.\u201d<\/p>\n \u201cA vaccine can meet the licensure standard if the vaccine\u2019s benefits of protecting against disease outweigh the vaccine\u2019s risks for the licensed use,\u201d he added. \u201cThere is no requirement that the vaccine also prevents infection with the pathogen that can cause the disease or transmission of that pathogen to others.\u201d<\/p>\n Emergency use authorization (EUA) can be granted \u201cwithout any evidence that the vaccine prevents infection or transmission,\u201d he also said.<\/p>\n EUAs were given to the Pfizer and Moderna COVID-19 vaccines in late 2020 due to a March 2020 declaration by then-Health Secretary Alex Azar under the Public Readiness and Emergency Preparedness (PREP Act) Act. The vaccines were later approved, though the FDA\u00a0reverted to emergency authorization<\/a>\u00a0this month when it switched all existing COVID-19 vaccines from the companies to the updated, unproven bivalent formulations.<\/p>\n Linda Wastila, a professor in the Department of Practice, Sciences, and Health Outcomes Research at the University of Maryland School of Pharmacy, said she was surprised by Marks\u2019 assertion.<\/p>\n \u201cI am totally flabbergasted that the FDA responded that proof of prevention of infection and transmission is not necessary for an EUA vaccine,\u201d Wastila, who is part of the coalition, told The Epoch Times via email. The comment \u201cmakes me wonder if the FDA has ANY standards of safety and efficacy of the EUA vaccines,\u201d she added.<\/p>\n Under the PREP Act, an emergency authorization can be given for a product used to diagnose, treat, or prevent a disease or condition when officials conclude that the product \u201cmay be effective\u201d in diagnosing, treating, or preventing the disease or condition and \u201cthe known and potential benefits of the product, when used to diagnose, prevent, or treat such disease or condition, outweigh the known and potential risks of the product.\u201d<\/p>\n That assessment is based on \u201cthe totality of scientific evidence available \u2026 including data from adequate and well-controlled clinical trials.\u201d<\/p>\n No clinical trial efficacy data has been made public for the bivalent vaccines.<\/p>\n The FDA did not respond to a request for comment. Marks noted that the FDA cleared the vaccines \u201cfor active immunization to prevent coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2.\u201d<\/p>\n \u201cThe 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,\u201d he said.<\/p>\n Other proposed changes that were rejected, included making clear that the FDA authorized a new Pfizer vaccine formulation with a different buffer without requiring studies to evaluate the efficacy or safety.<\/p>\n Kim Witczak, founder of Woodymatters and another member of the coalition, criticized the response letter.<\/p>\n \u201cHonest communication and transparency is key to trusting our regulatory agencies. However, the FDA\u2019s response to the citizen petition shows they are not really interested in transparency and sharing more information with the public,\u201d she told The Epoch Times in an email. \u201cWith an experimental rushed product, safety is paramount and the public deserves the good, the bad and ugly in real time.\u201d<\/p>\n The FDA only accepted a single proposal. It added some\u00a0data from a trial to the labeling for the new Pfizer bivalent vaccine.<\/p>\n Before this month, the labels did not include any data from trials, because the FDA authorized the new vaccines as boosters\u00a0without any trial data<\/a>.<\/p>\n After the fall 2022 authorizations, Pfizer and Moderna announced that trials showed the bivalent triggered higher levels of neutralizing antibodies than the old vaccines. Antibodies are thought to protect against COVID-19. Pfizer\u00a0said<\/a>\u00a0the data showed a favorable \u201csafety profile\u201d while Moderna\u00a0said<\/a>\u00a0that \u201cno new safety concerns were identified.\u201d The coalition said the labeling \u201cshould be updated to reflect current data.\u201d<\/p>\n While granting authorization for the bivalents as regular shots, the FDA updated the health care provider and recipient fact sheets for Pfizer\u2019s bivalent to include the safety data Pfizer announced. But it did not include any immunogenicity data or any data on Moderna\u2019s vaccine.<\/p>\n \u201cFDA has not conducted an evaluation of the data that is referenced in the press release,\u201d Marks said.<\/p>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\nAuthorization Standards<\/h2>\n
Lack of Safety Data<\/h2>\n
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