Why a coronavirus vaccine could take way longer than a year?

Ground Report | News Desk

As several companies race to develop a coronavirus vaccine, the public is repeatedly reminded that the finish line is at least 12 to 18 months away. This timeline feels excruciatingly long as the coronavirus pandemic continues to ravage the world around us.

Vaccines have historically taken two to five years to develop. But with a global effort, and learning from past efforts to develop coronavirus vaccines, researchers could potentially develop a vaccine in a much shorter time.

Here are the key steps in the path to developing a vaccine against coronavirus and an outline of what they mean for time saving and for you.

Vaccines reduce the risk of disease by preparing the immune system – the body’s natural defense network – to recognize, fight and destroy certain bacteria and viruses. While there are different types of vaccines, they work by introducing enough identifying information about a bacteria or virus to cause an immune response in the body without causing illness (though they sometimes cause symptoms). In response to a vaccine, the body sends immune cells to fight this foreign invader.

A vaccine provides a shortcut. Essentially, it helps your immune system learn to recognize a specific threat by tricking it into thinking it’s under attack. Then it can produce the antibodies it needs without having to face a real infection.

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.

What do you need to know about a virus to create a vaccine?

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.

The immune system learns how to fight a virus by studying its face the outside of the particle, including those telltale antigens. So a vaccine needs to give your body a snapshot of that face.

One classic technique involves injecting a person with a killed virus. Another uses live viruses that have been grown and deliberately weakened, typically by removing specific genes in their RNA or DNA.

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.

According to world economic Forum, 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.

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