As countries around the world begin their return to a new normal, the importance of a vaccine against SARS-Covid-2 becomes more prevalent. Therefore, it is the perfect time to discuss the progress that the world has made with the vaccine.  

In a usual process, a vaccine takes about an average of 10 years to be created. However, since this vaccine is needed quickly, this process has been fast-tracked. This process includes; Preclinical testing, where scientists give the vaccine to see if animals produce an immune response; Phase I when scientists conduct safety trials in which a small number of people are given the vaccine to ensure an immune response will occur; Phase II, which involves expanded trials with the testing of many people from various age groups;  and Phase III, where the vaccine is distributed to thousands of people and the results are compared to those who receive a placebo. It should be noted that during phase II, a certain amount of the test population must experience an immune reaction for the vaccine to be considered effective. For example, a COVID-19 vaccine in the United States must demonstrate an immune response in 50% of the population to be deemed effective.  Once a vaccine has gone through this process, it can then be approved for use.  

Despite the extensive testing process, there are already many vaccines in the beginning stages of this process. There are currently 142 vaccines in pre-clinical evaluation, twenty-four in phase I, fifteen in phase II, and four in phase III. These vaccines have various mechanisms of action, which are controlled by the type of virus included in the vaccine. The virus in the vaccine could be the full inactivated virus, a live attenuated virus, or parts of the virus such as protein, DNA, or a non-replicating viral vector. A list of the types of vaccines and their stages can be found here.  

Recently, the most promising vaccine appears to be one from the University of Oxford that is licensed to AstraZeneca. The vaccine has demonstrated efficacy in early stage testing. Although there seems to be a front runner, it is very possible that multiple vaccines with different mechanisms will be successful and distributed. This will help meet demand and help us return to our usual lives faster.  

For more information, please contact Focal Point Research Inc. We are leading North American Regulatory and New Product Consultants for Medical DevicesNatural Health ProductsOTC DrugsCosmetics, and other consumer products regulated by Health Canada and the U.S. FDA