President Joko “Jokowi” Widodo recently urged the Padjadjaran University research team to expedite the trial phase for a potential COVID-19 vaccine to just three months, but clinical trial coordinator professor Kusnandi Rusmil said it would be impossible, given the strict World Health Organization procedures that must be followed for safety and efficacy.
Almost all experts agree that even an 18-month target for a COVID-19 vaccine is too optimistic, so the best-case scenario could see a working vaccine in the second or third quarter of 2021. History shows it took 26 years to develop a vaccine for the human papillomavirus, and 25 years to secure one for the rotavirus.
As a rule, researchers don’t begin testing experimental vaccines on people until after rigorous safety checks. It starts with a preclinical toxicology study on a laboratory scale that assesses whether a drug is safe to use and is tested on animals. That usually takes three to six months depending on the study’s design.
If the evaluation is successful, the candidates go through to the three phases of testing in people, also known as clinical trials. Each phase has its special treatments, duration, and regulations.
The most time-consuming step is testing because researchers have to wait for enough volunteers to be exposed to a virus naturally. The vaccine must be given to a much larger group and compared to an unvaccinated control group to see whether it really prevents the disease. Such a test needs thousands of people to assess the safety and rare adverse events, while simultaneously, vaccine manufacturing consistency is confirmed.
The final part before the vaccine can be launched to the market is government approval. It sounds like a bureaucratic formality, but we need to keep in mind that its rubber stamp could cost lives. Typically, it takes scientists and advisory committees a full year to review the studies to make sure that the vaccine is really safe and effective as it is.
So, when the regulator expedites the process, manufacturers start to speed up the deployment and what’s next? It doesn’t mean we’re going to get it because millions of people could be in line before us. Otherwise, before it gets mass-produced, doctors, nurses, and other essential workers could get vaccinated right away.
We are dealing with a long, complex, and expensive process. Normally, less than 10 percent of drug trials are ultimately approved. The rest fail because of lower efficacy, wrong kind of immune response, too many side effects that weren’t previously noticed, and, sometimes, they can even exacerbate a disease.
The manufacturing task is overwhelming, costing at least three times in conventional pharmaceutical factories. That’s one of the reasons why most of the Phase 3 vaccine candidates all over the world chose to develop DNA or RNA vaccines. It’s because RNA vaccines don’t need to be cultured in large quantities and then purified; they are much cheaper, easier, and faster to produce.
However, they are riskier than other established strategies as not one has ever been made for humans before. The question about safety and efficacy then lingers.
Despite these various efforts, targets, and different approaches to developing the vaccines, we have one big goal together: to successfully eradicate COVID-19. Whichever company or university wins the race, it would be better to swiftly transfer its biotechnology across borders. It can lead to the production of more than one vaccine with different markets and prices.
As citizens, the simplest contribution we can give is to support the government, and remove our biases and stigma that prompt us to consider volunteers of vaccine trials “guinea pigs,” especially if vaccine trials do not live up to expectations. Such a result is very normal as developing biologic products has a 42-percent failure rate in Phase 3 of clinical trials.
As no vaccine will be available anytime soon, the most valuable thing that everyone can do right now is to follow public health recommendations. Therapeutic drugs might help fight COVID-19, at least they could lower the number of hospital admissions and help people recover faster. But still, it’s better to take as many precautions as we can to prevent ourselves from infection: Wear a mask, frequently wash your hands, and maintaining social distance.
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The writer is a pharmacist who formerly worked for a giant multinational pharmaceutical company as a safety data management specialist.
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