Developing a Vaccine with New Technology
Around 10 January, Chinese scientists developed and shared a full genetic sequence of SARS-Cov2, the virus that causes COVID-19, colloquially called coronavirus. Several companies are using this information to develop vaccines that will contain a small amount of genetic code. Certain cells in the body will take up this genetic information and produce elements of the virus, not infecting the person but triggering the immune system to respond.
DNA or RNA based vaccines are not made with a weakened or deactivated virus, nor elements of the virus, so they can be produced in the lab. This approach is faster and more reliable than traditional vaccine processing, which uses virus grown in eggs or cell cultures. For example, Moderna, in collaboration with the National Institute of Allergy and Infectious Disease (USA), developed the first COVID-19 vaccine in clinical trials using a genetic platform called messenger RNA (mRNA). It took only 42 days to move from vaccine design to human testing – an industry record.
While genetic platforms are promising and fast, there are currently no such vaccines approved for human use. In addition to the many companies pursuing vaccines on this platform, other companies are exploring different vaccine approaches such as using a deactivated version of the virus. The benefit of developing and trying multiple potential vaccines is the increased chance that one of them will be approved for public use. First, however, they must go through clinical trials.
Safety, Efficacy and Approval
Vaccines are given to healthy people to prevent disease. While a COVID-19 vaccine is very much needed, a rush to market without appropriate testing could put healthy people at risk. One area of risk is vaccine enhancement, meaning the disease is more harmful to a vaccinated person.
The clinical trial process is designed to test whether new vaccines are both safe and effective before making them available to the public. The process typically involves several phases and takes approximately ten years, but governments and industry are making efforts to expedite the process, and even intersperse animal testing throughout, while maintaining safety and efficacy standards, as follows:
- Phase I: A small study in healthy people that evaluates the vaccine for safety and immune response at different doses. For COVID-19 trials, this is expected to take three months; it can typically take one to two years.
- Phase II: A randomized, double blind, placebo-controlled study of hundreds of people that further evaluates safety, assesses efficacy and informs optimal dose and vaccine schedule. For COVID-19 trials, this is expected to take eight months; it can typically take two to three years.
- Phase III: A randomized, double blind, placebo-controlled study of thousands of people that evaluates safety and efficacy. For COVID-19 trials, this may be combined with Phase II; it can typically take two to four years.
- Regulatory review: The governmental body that approves new vaccines reviews the trial data and other information in the licensing application. This typically takes one to two years but is likely to be expedited to take only a few months.
- Phase IV: Post approval studies that monitor effectiveness in real world conditions.
The final step in speeding up production of mass quantities of vaccine is early and robust manufacturing.If manufacturing begins during trials, then a vaccine will be available to the public upon approval.However, vaccines that are manufactured before they are approved are done so at risk.A manufacturer loses significant resources if approval does not come or a vaccine is no longer needed in the marketplace.The more vaccines produced, the more risk incurred.
To mitigate this risk and encourage manufacturing, governments, industry and international organizations are working together. CEPI, the Coalition for Epidemic Preparedness Innovations, made an urgent call for $2 billion in funding to support vaccine development, trials and enhanced manufacturing capacity. Gingko Bioworks committed capacity to manufacturing DNA or RNA based vaccines.Government officials are discussing funding support as well.
What does this mean for you?
The international community is working together like never before to produce a coronavirus vaccine. If a vaccine is developed in the timeline predicted, then people will have a preventative option should COVID-19 recirculate next year. Protection from the virus will save lives and help society return to functioning as normal.
If the virus fizzles out, the innovative and cooperative multistakeholder approaches taken to develop a vaccine will still have a lasting impact. They led to the fastest time from vaccine design to trial, and may lead to the first approvals of vaccines based on genetic platforms. This technology could fundamentally change how scientists are able to develop vaccines that protect people from new diseases – making discovery faster, production more reliable and vaccines potentially more cost effective.
Contributors: Professor Gareth Baynam. Clinical Geneticist, Head Western Australian Register of Developmental Anomalies; Program Director, Undiagnosed Diseases Program, Genetic Services of WA; Adjunct Genomic Policy Advisor, Office of Population Health Genomics, WA Health; Ministerial Council for Precision Health
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