Many friends have asked for my perspective on the COVID vaccine. Answering this requires both an explanation of clinical trials and an understanding of what normally slows down pharmaceutical development. Importantly, COVID vaccines are required to go through the same process as every other pharmaceutical. These include the following: Preclinical trials. In this stage, researchers conduct animal testing to see if the vaccine can produce an immune response. If the vaccine is working in the animal model, and no unanticipated negative events happen, then the FDA approves for the vaccine to move into clinical trials. Clinical trials. There are four phases of clinical trials in humans. After each phase, companies must submit their data for review before advancing to the next required step. The four phases include: Phase 1: The vaccines are tested in a small group of volunteers (20-100) to ensure that it is safe in humans. Although it may have been safe in animals, we always also first test on a small group of humans for added safety. Phase 2: The trial is expanded to hundreds of volunteers to see if the vaccine actually prevents infection in a meaningful way. Phase 3: In this phase, tens of thousands of volunteers are enrolled to see if the vaccine works within diverse populations and to look for uncommon side effects. After the data is analyzed for phase 3, the FDA reviews it for official approval. Emergency Use Authorization requires a two-month volunteer follow-up before consideration. If the data is compelling, and human trials show its safety, the FDA approves the vaccine. Phase 4: After any approval, the studied pharmaceutical continues to be monitored. This is when rare or very long-term effects are reported so that therapeutics can be improved over time. For example, we technically are still in phase 4 for many HIV drugs since the oldest drug, AZT, is only 33 years old. The most advanced COVID vaccine candidates in the United States have just completed phase 3 clinical trials (ex the Pfizer vaccine). Pending FDA approval, they should begin to be distributed within the month, which is exciting! The follow-up question to this is usually: “How could we have possibly developed a COVID vaccine so quickly?” To answer this, we need to understand what typically slows down vaccine development. These include background research, funding, motivation, failed clinical trial phases, and bureaucracy. These are addressed below. Background research. Although COVID 19 is frequently discussed in the media as a “new” virus, there is a difference between COVID 19 and “coronavirus.” Coronaviruses are not new. You can think of coronavirus as the “family” from which COVID-19 came. As an analogy, just like most human families have similarities in how they look/behave, the same is true of different strains of viruses that arise from the same viral “family.” The viruses SARS and MERS actually come from the same “family” as COVID-19. These viruses were researched extensively for vaccine development. This is great news for us because it means that researchers had a head start in already knowing a lot about how to target COVID-19 potentially. Funding. At the end of the day, pharmaceutical companies are a business, and they don’t want to spend a lot of money developing something unless they know that there is a market for it. This is why many rare diseases do not have very good treatments, while common diseases tend to have better treatments. Not only that, but companies normally do not mass produce pharmaceuticals ahead of government approval because they don’t want to waste resources if their product is not ultimately approved. In this case, there is an enormous demand for a COVID-19 vaccine because it is a new viral strain. This creates a high market incentive for companies to invest time and resources into developing a vaccine. Beyond this, governments and nonprofits worldwide have invested billions into vaccine development since this is a public health crisis. The government has taken away the financial risk that pharmaceutical companies normally face by paying for phase 3 trials and mass production of vaccines before FDA approval. Motivation. From my explanation of the last point, it is fairly self-explanatory why companies are highly motivated to prioritize developing a COVID-19 vaccine over other research projects. They not only have a moral imperative but a financial incentive. Additionally, the people who work for these companies have the same worries that you or I have. They are worried about what might happen to their parents or themselves if they get sick with COVID, and they also want to return to normal life. Failed clinical trial phases. There are currently over 180 vaccines in clinical trials in the United States alone. So far, very few have made it through the first three phases to be assessed by the FDA for approval. More candidates equal greater odds that someone will make it to the finish line quickly. Bureaucracy. The most boring thing about clinical trial research is that it normally involves an incredible wait time. Picture this problem as the “waiting in line at the DMV” issue. The time it actually takes you to get your car registered is only a few minutes, but you might be stuck waiting around a government office all day just to get seen. This constantly happens in clinical trials. The FDA oversees hundreds of different therapeutics in phase 1-3 clinical trials, and everyone has to wait in line. The exception to this rule is during an emergency. If it is a healthcare emergency, then those studies can cut the line, thus saving time. Vaccination is a personal choice, but I 100 percent recommend it. Personally, I can’t wait to get vaccinated and am so grateful to the thousands of heroes who made this possible. Alexandra Fairchok is a medical student. Source
