As the world races to find a vaccine for Covid-19, we must remember the safety precautions necessary for new medications.
Many races have been held over time in the world, from the competitions held during the ancient Olympic Games in Greece, to the race to the moon. Who knew there would be a race in which dozens of countries would fight not to overcome each other, but to overcome a virus? This is our current reality.
Scientists and researchers around the world are working to get a vaccine up and running as soon as possible. To develop a new vaccine, researchers need to excessively test it to ensure its safety. Vaccine development is a long and complicated process: in most cases, developing a vaccine takes about 10-15 years. Nevertheless, the world is trying its hardest to get a vaccine within two years. What is it that enables us to develop it so much faster than usual?
Vaccines need to go through different tests as well as a multi-stage clinical trial process before they can be widely distributed. The preclinical stage of testing involves using individual cells and small animals such as mice to check its safety, and whether the vaccine triggers an immune response. If this is successful, they go onto the next step: clinical testing.
The first phase of this process is carried out on a small group of healthy humans to examine whether there are no safety concerns in humans, and to see what the correct dosage should be.
In the second phase, the group on which the vaccine gets tested will be expanded to include people who might have the disease or are more vulnerable to it. They will examine how effective and consistent the vaccine is, and how the immune system responds to it. This will further determine the optimal dose.
In the third phase, they administer the vaccine to thousands, to confirm its safety, efficacy, and to once again see whether it provokes any rare side effects. Giving the vaccine to large groups of people is especially important as the immune response can vary by factors such as age and underlying health conditions. These trials often include a control group that will be given a placebo.
After this, the vaccine goes to regulatory agencies for approval. You would think that this would be the last hindrance. However, the truth is that even after approval, the vaccine faces potential hurdles once it comes to the phase of manufacturing and distribution, where discussions are held on topics such as which populations should get it first.
The clinical trials often come with a hiccup or two. One concerning instance occurred during the Covid-19 vaccine trial, developed by AstraZeneca, the University of Oxford, and dozens of companies across the United States, with a participant in the United Kingdom having a serious reaction to the vaccine. Even though the information about the illness has not been officially disclosed, multiple people who were involved in the trial mentioned that the symptoms were in line with transverse myelitis, a serious condition involving inflammation of the spinal cord that can cause muscle weakness, paralysis, and bladder problems. A review by the trial’s independent safety review committee and national regulators concluded that it was safe to continue with the trial.
Developing a vaccine generally takes a very long time. Yet, the researchers are trying to develop the vaccine in under two years - a record. One of the reasons why this can be accomplished is that at the beginning of the pandemic, China made the effort to sequence the genetic material of Sars-CoV-2, which is the cause of Covid-19. This made it possible for researchers around the globe to grow the live virus to study how it works.
Another reason for the rapid progress is that vaccinologists had already been working on "prototype" pathogens. Coronaviruses were also the cause of two other rather recent epidemics, and in both cases, they had already been working on a vaccine. Richard Hatchett, CEO of the Oslo-based nonprofit, the Coalition for Epidemic Preparedness Innovations (CEPI), said: ‘"The speed with which we have produced these candidates builds very much on the investment in understanding how to develop vaccines for other coronaviruses.’’
Nevertheless, it is still important to learn from the past and not to forget what happened to the thousands of babies in the 1950s and 60s, when thalidomide was prescribed to pregnant women to treat their morning sickness. The drug was approved and brought onto the market in 1957, even though thalidomide was never tested on pregnant women. It is estimated that over 10,000 babies were affected, and about half of whom died within months of birth. This tragedy led to many changes in the way drugs were brought onto the market, tested and approved in the UK, as well as the rest of the world.
With what we have gained from the past and with what we are working on in the present, we can build towards a new future. It truly is a hectic time in which a lot is asked of us all, and it will still be a while longer until the world can slowly revert to how it was before the pandemic. Until then, the best we can do is to slow the spread of the disease by adhering to measures and to keep running until we have reached the finish line, united.
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