An effective vaccine against Covid-19 remains both a chimera and the Holy Grail for the global biotech industry. But while the process of developing a vaccine, as well as antivirals and new tests, is a complex process, there is frenetic work under way to find a breakthrough.
The World Health Organisation announced the coronavirus pandemic on 11 March 2020.
follow. These are divided into a number of phases, namely Phase 0, I, II, III, and IV, during which the drug or vaccine is administered under ethically determined conditions to a group of volunteers, each of whom has submitted to a rigorous informed consent process. One or more of a combination of parameters including, but not limited to, safety and efficacy in humans, potential side-effects, and appropriate dosage are then studied.
To do this, the regulatory body reviews all the clinical trial data, assesses the conclusions drawn by the researchers, conducts clinical trial site inspections, and inspects the manufacturing facility to ensure that it is compliant with current Good Manufacturing Practices , etc.Regulators may require additional trials or studies to be conducted before market approval. The reality is that
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