Key Points:• The international community is working together like never before to produce a coronavirus vaccine. The 12-18 month timeline feels long, but it is condensing a 10 year process.• New technologies combined with international cooperation to fight infectious diseases are enabling faster responses to new disease outbreaks, shaving several years from traditional vaccine development timelines.• 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.• While genetic platforms are promising and fast, there are currently no such vaccines approved for human use. Analysis:Here are the key steps in the path to developing a vaccine against coronavirus and an outline of what they mean.Around 10 January, Chinese scientists developed and shared a full genetic sequence of SARS-Cov2, 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 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. Speeding up clinical trialsWhile 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 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; 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 from the end of phase 3 trials. In the current context because phase 3 trials have end point after one year or two years after the vaccines are administered, the vaccines will need to be made available to population before a license is granted under Emergency Use Authorizations approval frameworks.
Phase IV: Post approval studies that monitor effectiveness in real world conditions. ManufacturingIf manufacturing begins during trials, then a vaccine will be available to the public upon approval. 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 and finally GAVI, CEPI and WHO are advancing a large Advance Purchase Commitment Facility (COVAX) that would if successful provide access to hundreds of millions of citizens in low and middle income countries. Faster discoveryThe 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.