![]() They may also suggest a safe starting dose for the next phase of research, as well as a safe method of administering the vaccine. These studies give researchers an idea of the cellular responses they might expect in humans. Animal subjects may include mice and monkeys. Pre-clinical studies use tissue-culture or cell-culture systems and animal testing to assess the safety of the candidate vaccine and its immunogenicity, or ability to provoke an immune response. These antigens could include virus-like particles, weakened viruses or bacteria, weakened bacterial toxins, or other substances derived from pathogens. Federally funded academic and governmental scientists identify natural or synthetic antigens that could help prevent or treat a disease. This stage involves basic laboratory research and often lasts 2-4 years. First Steps: Laboratory and Animal Studies Regulation and oversight increase as the candidate vaccine makes its way through the process. The first stages are exploratory in nature. In the United States, vaccine development and testing follow a standard set of steps. Stages of Vaccine Development and Testing Many countries have adopted the WHO standards. A committee of the World Health Organization makes recommendations for biological products used internationally. In the European Union, the European Medicines Agency supervises regulation of vaccines and other drugs. It is now known as the Center for Biologics Evaluation and Research. Later, the DBS was renamed the Bureau of Biologics, and became part of the Food and Drug Administration. After a poliovirus vaccine accident in 1954 (known as the Cutter incident), the Division of Biologics Standards was formed to oversee vaccine safety and regulation. ![]() The United States Public Service Act of 1944 mandated that the federal government issue licenses for biological products, including vaccines. The Act established the government’s right to control the establishments where vaccines were made. The Hygienic Laboratory eventually became the National Institutes of Health. Public Health Service to oversee the manufacture of biological drugs. The Act created the Hygienic Laboratory of the U.S. This act emerged in part as a response to, which involved smallpox vaccine and diphtheria antitoxin. This was the first modern federal legislation to control the quality of drugs. Congress passed "An act to regulate the sale of viruses, serums, toxins, and analogous products," later referred to as the (even though "biologics" appears nowhere in the law). However, no regulation of vaccine production existed. They were smallpox, rabies, plague, cholera, and typhoid vaccines. ![]() ![]() Government Oversight In the United StatesĪt the end of the 19th century, several vaccines for humans were developed. ![]() The current system for developing, testing, and regulating vaccines developed during the 20th century, as the groups involved standardized their procedures and regulations. Vaccine development is a long, complex process, often lasting 10-15 years, and involves a combination of public and private involvement. Please see the section on the COVID-19 pandemic and Operation Warp Speed for information on the COVID-19 vaccines. The article below mostly covers vaccines before the current COVID-19 pandemic. EDITOR'S NOTE ( ): Many anti-vaccine people and organizations are not presenting the information in this article in full context. ![]()
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