A little over a year ago, COVID-19 came into our lives, forever changing the way we knew it. Since then, many advancements continue, leveling the playing field between us and the virus. Vaccine distribution is slow, but it’s still happening. The hope of normalcy is within our grasp after a long-fought wait. While we continue to hope and celebrate progress thus far, we can’t lose focus on the road ahead. Yes, there is still more to do, and we’re still fighting COVID-19.
Emergency Use Authorizations Vs. Approval
Whether it be a drug, device, or lab test, any therapeutic method must have FDA approval before public use. When these are developed, they are first tested in a lab. If deemed safe, then they need to be studied in humans, called clinical trials. A new therapy will go through different phases of trials, and the data goes to the FDA to review its safety and effectiveness. Once complete, the FDA reviews the information and they approve or deny it. The trial process can take months, even years, from start to finish.
In emergencies, such as a pandemic, the FDA can essentially help things along in two main ways. They can fast track COVID-19 therapies, giving them priority review (not skipping steps) to speed things up. They can also provide limited approval of treatments based on data received until the trials can finalize. These are called emergency use authorizations (EUAs). EUAs typically start with specific populations such as those most at risk for severe symptoms or at the highest risk of infection.
As more data becomes available, authorizations receive updates, expanding access a little further. This is why you see vaccines going in phases. We are starting from scratch with COVID-19, so there are a lot of EUAs. In fact, the only therapy with full approval is Remdesivir.
Vaccine Trials and Beyond
Ongoing trials continue for vaccines so that the FDA can review the full data. Pediatric studies will also need to take place for children to get vaccinated as well. Moderna, Pfizer, and others plan to begin these trials over the next few months. However, vaccines are only a part of it. Since this is a new virus, we have learned so much in the first year, but we still have a ways to go. Observational and other types of studies can help us ascertain the long-term effects of the disease, how different populations are more at risk, etc.
Almost 4700 studies are in the database for COVID-19 alone. 2300 of those are actively enrolling with the hope to improve the way we detect, treat, and prevent this virus. Volunteers are still needed to participate. Without their contributions, medical advances would cease to exist. Endeavor Clinical Trials is committed to ending COVID-19 with our upcoming clinical research studies. To see how you can get involved, call us today at (210) 949-0807, or visit our website.