Vaccine development 10-20yrs11 Nov 2020 08:34
https://www.historyofvaccines.org/index.php/content/articles/vaccine-development-testing-and-regulation
Vaccine development is a long, complex process, often lasting 10-15 years and involving a combination of public and private involvement.
The current system for developing, testing, and regulating vaccines developed during the 20th century as the groups involved standardized their procedures and regulations.
Government Oversight
In the United States
At the end of the 19th century, several vaccines for humans had been developed. They were smallpox, rabies, plague, cholera, and typhoid vaccines. However, no regulation of vaccine production existed.
On July 1, 1902, the U.S. Congress passed "An act to regulate the sale of viruses, serums, toxins, and analogous products," later referred to as the Biologics Control Act (even though "biologics" appears nowhere in the law). This was the first modern federal legislation to control the quality of drugs. This act emerged in part as a response to 1901 contamination events in St. Louis and Camden involving smallpox vaccine and diphtheria antitoxin.
The Act created the Hygienic Laboratory of the U.S. Public Health Service to oversee manufacture of biological drugs. The Hygienic Laboratory eventually became the National Institutes of Health. The Act established the government’s right to control the establishments where vaccines were made.
The United States Public Service Act of 1944 mandated that the federal government issue licenses for biological products, including vaccines. 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. Later, the DBS was renamed the Bureau of Biologics, and it became part of the Food and Drug Administration. It is now know as the Center for Biologics Evaluation and Research.
Elsewhere
In the European Union, the European Medicines Agency supervises regulation of vaccines and other drugs. A committee of the World Health Organization makes recommendations for biological products used internationally. Many countries have adopted the WHO standards.
Stages of Vaccine Development and Testing
In the United States, vaccine development and testing follow a standard set of steps. The first stages are exploratory in nature. Regulation and oversight increase as the candidate vaccine makes its way through the process.
First Steps: Laboratory and Animal Studies
Exploratory Stage
This stage involves basic laboratory research and often lasts 2-4 years. Federally funded academic and governmental scientists identify natural or synthetic antigens that might help prevent or treat a disease. These antigens could include virus-like particles, weakened viruses or bacteria, weakened bacterial toxins, or other substances derived from pathogens.
Pre-Clinical Stage
Pre-clinical studies use tissue-culture or cell-culture systems and animal testing to assess the sa
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