COVID-19 VACCINE16 May 2020 16:03
The public is repeatedly reminded that the finish line is at least 12 to 18 months away.
Vaccines are given to healthy people to prevent disease. While a COVID-19 vaccine is very much needed, a rush to market without appropriate testing could put healthy people at risk. One area of risk is vaccine enhancement, meaning the disease is more harmful to a vaccinated person.
The clinical trial process is designed to test whether new vaccines are both safe and effective before making them available to the public. The process typically involves several phases and takes approximately ten years, but governments and industry are making efforts to expedite the process, and even intersperse animal testing throughout, while maintaining safety and efficacy standards, as follows:
Phase I: A small study in healthy people that evaluates the vaccine for safety and immune response at different doses. For COVID-19 trials, this is expected to take three months; it can typically take one to two years.
Phase II: A randomized, double blind, placebo-controlled study of hundreds of people that further evaluates safety, assesses efficacy and informs optimal dose and vaccine schedule. For COVID-19 trials, this is expected to take eight months; it can typically take two to three years.
Phase III: A randomized, double blind, placebo-controlled study of thousands of people that evaluates safety and efficacy. For COVID-19 trials, this may be combined with Phase II; it can typically take two to four years.
Regulatory review: The governmental body that approves new vaccines reviews the trial data and other information in the licensing application. This typically takes one to two years but is likely to be expedited to take only a few months.
Phase IV: Post approval studies that monitor effectiveness in real world conditions.
https://www.weforum.org/agenda/2020/04/why-a-coronavirus-vaccine-takes-over-a-year-to-produce-and-why-that-is-incredibly-fast/
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