The word cloud for language used around the world in 2020 will probably have ‘virus’ and ‘vaccine’ in the biggest font, centre stage. As soon as we adapted to the knowledge that COVID-19 was going to threaten and then change our lives, the public hunt for information on a vaccine was on. Scientists were already well underway by the time civilians were looking for updates, and it has been the most widely anticipated vaccine development process of our lifetime due to the global, simultaneous nature of this pandemic.
We are fascinated by the trials and research, and proud to be doing our part by sourcing and stocking some virus specific technology. We now carry the new Timestrip VST series, which can play a valuable role in vaccine development. These indicators monitor when specimens, including coronavirus, have been stored for too long outside the required temperature range for reliable testing.
At present, there are potential vaccines in all stages of trial. A successful vaccine protects us against a virus by mimicking it, or a part of it, to stimulate our immune system into creating antibodies. These provide immunity against the virus if we are later exposed to it. The testing stages ensure that initially no humans are exposed to the potential vaccine until it was gone through a significant pre-clinical stage. There are currently 138 COVID-19 vaccines at this stage.
In the first stage of testing, the vaccine is given to animals to see if it triggers an immune response. If this pre-clinical stage is successful, and an immune response is triggered, the vaccine enters phase 1 of clinical testing. Here, it is given to a small group of people. The aims of this stage are to determine that the vaccine is safe for humans, and to learn about the immune response it creates from their bodies. There are 25 COVID-19 vaccines in phase 1, being used in small scale safety trials, at present.
For vaccines which successfully pass through phase 2, it is then into expanded safety trials. There are currently 15 COVID-19 vaccines at this point. Here the vaccine is given to hundreds of people. The intention is to learn more about the correct dosage, and gather further proof of safety or observations on side effects.
Phase 3 involves testing on thousands of people. At this stage, significant proof of the safety, efficacy and approach of the vaccine must have been obtained by the scientists. These trials also involve a control group who are given a placebo. There are currently 7 COVID-19 vaccines in large scale efficacy trials.
Following this, vaccines can be approved for general use. It is only when they have successfully passed through pre clinical and three stages of clinical trials that this can happen. No COVID-19 vaccines have yet reached this point. Through each of these stages, specimens are vital for research and data gathering. By holding and testing the virus, scientists can learn about all aspects of potential vaccines, including about appropriate dosages. The new Timestrip VST range of indicators ensure that specimens are appropriately stored and handled to protect the integrity of test results.
The above trials are happening around the world, simultaneously. Despite less than 2.5% of all clinical trials in the world taking place in Africa, South Africa is currently involved in COVID-19 vaccine trials. This is crucial because studies show that vaccines don’t necessarily work similarly across different populations. For South Africa to stand a chance of being an early adopter of any COVID-19 vaccination, it’s therefore crucial that we have testing in country, and do not simply rely on testing data from overseas.
Professor Shabir Madhi is leading a South African trial of a COVID-19 vaccine which has been developed by the Jenner Institute at the University of Oxford in England. They are currently recruiting 2000 volunteer participants to test the vaccine. The hope is to determine an efficacy of at least 60%; meaning that your chance of developing COVID-19 is reduced by 60% or more having had the vaccination.
These trials include people who are HIV+, which is an important factor for any vaccine to be used on a South African population. There are three international trials now taking place in South Africa. All three are on the WHO’s list of the 26 most viable candidate vaccines. The Johnson & Johnson trial which will begin in South Africa in September will be a phase 3 trial, whereas the Oxford and Novavax trials are in the latter stages of phase 2.
We’re proud to stock the new Timestrip VST range of indicators at this time, when they can be real game changers in the hunt for a vaccine. As Timestrip’s Commerical Director Nora Murphy explains, by monitoring specimens from collection through to testing, and providing notice if their optimum temperature range has been breached, these indicators will give “confidence in the integrity of the specimen, and thus the test results.”
It is hugely positive that South Africa is playing such an active role in vaccine testing. It offers is great hope both in the fight against COVID-19, and in our position amidst global medicine and science moving forwards. However, though there are some 200 COVID-19 vaccines at various stages of testing around the world, it is important to remember that only 10% of vaccines which enter clinical trials are ever licensed for use.