Currently there are more than 140 research teams working from around the world to develop a safe and effective vaccine against SARS-CoV-2, the virus causing COVID-19. From small start-ups out of university labs to large industry leaders, the race is on to provide a global solution to a problem that has had devastating health and economic ramifications. Even with fast tracked vaccine development, it is still not clear exactly how long it could take to speed a successful product to market. However scientists are hoping to develop a COVID-19 vaccine within 12 to 18 months.
Where do we currently stand?
According to the World Health Organisation (WHO) as of the 31st July 2020, there were 26 candidate vaccines under clinical evaluation and 139 candidate vaccines under preclinical evaluation.
What does this mean?
New vaccines under clinical evaluation have previously progressed through the mandatory pre-clinical stage. This involves researches have given the vaccines to animals to confirm any immune response. Subsequently the vaccines enter 3 phases of human clinical trials.
Phase I
The vaccines are tested on a small number of healthy volunteers in order to establish safety and any immune response. As a result of its first use in humans. The results are statistically analysed. The significance of the study results are compared against a control.
Phase II
The vaccines are tested on a much larger group of participants. These participants share similar characteristics to the group the vaccine is intended for. This exposes the vaccine to a more diverse population. Providing more information on the best dosage range and give a better understanding of the immune response. The data is used to inform the design and sizing of the subsequent Phase III trial.
Phase III
The vaccines are administered to a much larger population of intended recipients. The safety, effectiveness and risk-benefit balance of the product are assessed. Following a successful phase III trial, the vaccine can be submitted for regulatory approval, in the chosen jurisdiction.
How are trials being accelerated?
Due to the urgency of the pandemic and the requirement to establish a vaccine in the shortest time. Researchers are running trials whilst simultaneously recruiting for the next phase. Taking lessons from the Ebola epidemic, they are attempting to further reduce the length of time to develop a successful vaccine.
Currently there are a number of COVID-19 vaccine products which have moved in to phase III clinical trials. Including a vaccine developed by a joint venture between the University of Oxford and Astra Zeneca. Trials have started in the UK, South African and Brazil. If successful this could be the first vaccine that makes it to market.
What are the some of the logistical and political issues around producing a COVID-19 vaccine during a pandemic?
Ensuring that there is sufficient infrastructure in place to effectively produce, store and distribute billions of doses of COVID-19 vaccines could be an issue. Particularly when this is coupled with the need to produce many other vaccines annually.
In previous pandemics, such as swine flu in 2009. Wealthy countries like Australia somewhat monopolised the H1N1 Swine flu vaccine. Contracts were entered into with big pharmaceutical companies in developed nations, at the expense of poorer countries. The use of the vaccine was controlled by the local governments. Limiting availability in other countries.
Could this happen with a COVID-19 vaccine?
Possibly. Although through the formation of the groups like the Coalition for Epidemic Preparedness Innovations (CEPI), the playing field has been somewhat levelled. CEPI is already working with a range of companies researching and developing COVID-19 vaccines, including Novavax. They are looking to increase equality in supply. It is hoped that through these collaborations vaccines can be supplied to developing nations as quickly as they are in developed countries.
There are some concerns that if a country heavily afflicted by COVID-19 produces a vaccine in-country. It could take much longer for the vaccine to be shared with the rest of the world. Leading to possible politically driven supply shortages of COVID-19 vaccines. It will be interesting to see what measures WHO may introduce to avoid this from happening.
When can we look forward to receiving a COVID-19 vaccine
Although we are now seeing Vaccines in clinical trials. A mass produced and effective vaccine is still a long way away. Even with the shortened time frames and increase push for production it is unlikely that we will see a working vaccine available to the general public in 2020. Hopefully 2021 will be the year that we see a COVID-19 vaccine available.