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With global cases of coronavirus disease approaching three million and more than 200,000 lives claimed, rapid monitoring of a vaccine is a priority for laboratories worldwide. While nothing is guaranteed, experts hope that a vaccine for COVID-19 can be developed. The process involves several phases and can often require years of research and development, although in the case of COVID-19 scientists hope that a vaccine can be rapidly accelerated.
Preclinical development
The first stage of vaccine development is preclinical development, which is carried out in laboratories and generally involves testing on animals. Identifying relevant antigens is one of the main steps, with the findings used to create an initial vaccine concept. The efficiency of the proposed vaccine is analyzed in test tubes and in animals. If these steps are successful, the vaccine is produced in accordance with Good Manufacturing Practice (GMP) standards.
Clinical development
The next stage is clinical development, which sees the new vaccine tested in humans. This can often last for several years, although scientists hope that the development of a possible COVID-19 vaccine will be faster. Clinical trials generally begin in Phase I and advance to Phase IV, also known as post-marketing surveillance. This is done after the vaccine has been commercialized and distributed on a large scale. The clinical development stage is based on strict ethical and safety principles, beginning with obtaining consensual volunteers for Phase I. Phase II expands the scope of clinical trials and assesses the effectiveness of the vaccine against simulated infections. The immune response and possible side effects are explored in this phase.
Moving on to Phase III clinical trials, a vaccine is tested on hundreds of participants in multiple locations, in hopes of evaluating efficacy against natural diseases. If all three phases are successful, the manufacturer can apply for a license to sell and market the vaccine for human use. Phase IV is carried out after the vaccine has been distributed and explores rare side effects as well as long-term effectiveness.
The challenges of vaccine development
One of the main challenges in vaccine development is extremely high costs. Only a small percentage of vaccines advance to the licensing stage, meaning that companies can often channel millions into research and development just to have the program complete before it reaches the licensing stage. For this reason, companies often explore a variety of different vaccines simultaneously.
From vaccine development to pharmaceutical research, advanced laboratory equipment is at the forefront of scientific research. For more information on the role and function of sterilization devices, don’t miss’ Energy Efficient Autoclaves: Misconceptions and Misunderstandings.
