The international community is working together like never before to produce a coronavirus vaccine.
The 12-18 month timeline feels long, but it is actually condensing a 10-year process.
Around Jan 10 (2020), Chinese scientists developed and shared a full genetic sequence of SARS-CoV-2, the virus that causes Covid-19.
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 enough to infect the person, but enough to trigger 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, biotech company Moderna, in collaboration with the US National Institute of Allergy and Infectious Disease, 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.
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 that the disease is more harmful to a vaccinated person.
The clinical trial process typically involves several phases and takes approximately ten years, but governments and industry are making efforts to expedite the process.
- 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; typically, it takes one to two years.
- Phase II: A randomised, 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; typically, it takes two to three years.
- Phase III: A randomised, 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; typically, it takes another 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.
This is likely to go on as usual.
If manufacturing begins during the trials, then a vaccine will be available to the public straight away upon approval.
To mitigate this risk and encourage manufacturing, governments, industry and international organisations are working together.
CEPI, the Coalition for Epidemic Preparedness Innovations, made an urgent call for US$2bil (RM8.66bil) in funding to support vaccine development, trials and enhanced manufacturing capacity.
Biotech company Gingko Bioworks has committed capacity to manufacturing DNA- or RNA-based vaccines.
Government officials are discussing funding support as well.
The innovative and cooperative approach taken for this vaccine could change how scientists develop future ones.
This could make discovery faster, production more reliable and vaccines potentially more cost-effective.
Elissa Prichep is the Precision Medicine lead at the World Economic Forum.
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