Development process for new vaccine

Alexa Stolyarov and Brooke Falk

The following information outlines the general process for developing a new vaccine. Information was provided by William Hartman, principal investigator for the University of Wisconsin-Madison AstraZeneca COVID-19 vaccine trial, and Jennifer Pancorbo, director of industry programs and research at the Biomanufacturing Training and Education Center at North Carolina State University. 

Exploratory stage 

This is the research stage in which a number of different methods to help tackle the virus are created. The part of the virus that needs to be attacked via the vaccine is identified. The vaccine has to be able to show the body a part of the virus so that antibodies can be formed to attack the real virus in case a person were to ever contract it. 

Preclinical stage

Preclinical testing begins once a vaccine model and good vaccine candidate are established. Cells are tested in a lab to ensure the vaccine can get into them and do what it is designed to do. The vaccine is also tested on animals, and animals are checked for symptoms and examined to see if they are developing antibodies, which are cells in the immune system that help protect the body against the virus the vaccine targets. 

Clinical development stage 

If the vaccine candidate is not toxic with animal models and produces some kind of immune reaction, then it goes through three clinical testing phases. In phase one, the vaccine is tested primarily for safety in a small group of people. In phase two, safety is again tested in a slightly larger group, but the cell is also examined to see if it is making or expressing the viral piece that allows for the generation of antibodies once the vaccine gets inside the cell. In phase three, which has an even larger testing group, the vaccine is tested for safety and effectiveness. The testing group includes different races, ethnicities and ages. Some trial participants receive a placebo, and the rest receive the actual vaccine. Data is compared between the two groups to see who developed the virus and to check the vaccine’s effectiveness.

Regulatory review and approval

Once testing is complete, companies apply for regular approval or Emergency Use Authorization, a way to get medicines and vaccines to people more quickly. During this stage, the vaccine is reviewed by the Data Safety Monitoring Board, composed of independent vaccine experts. The board looks at data to determine if the vaccine is safe, was developed safely and is effective. The vaccine then goes under review of the Food and Drug Administration, which makes the final decision to approve the vaccine. The FDA, government and manufacturers of the vaccine do continuous quality control even after the vaccine’s approval to ensure proper production, shipment and storage of the vaccine.