The COVID-19 pandemic has caused quite the fear to our community. Qualmedica Research has compiled information in a Q&A format to update you on current efforts to develop drug therapies and vaccines. We hope you find this information helpful.
Who is Qualmedica Research?
We are a multi-site clinical research company headquartered in Kentucky with research sites in Owensboro, Bowling Green and Evansville. We have extensive experience conducting phase II, III, and IV clinical trials across a large list of conditions. Our mission is to enable better health for patients that will benefit from new or improved drugs. We partner with physicians and sponsors to bring therapeutics to market that are safe, effective and meaningful to a patient’s quality of life. We are dedicated to improving health through research.
What is Coronavirus and COVID-19?
Coronavirus includes a large family of viruses. The disease COVID-19 is brought on by the coronavirus SARS-CoV-2. It was unknown before the outbreak began in Wuhan, China, in December 2019.
How does COVID-19 spread?
People can catch COVID-19 from others who have the virus. The disease can spread from person to person through small droplets from the nose or mouth which are spread when a person with COVID-19 coughs or exhales. These droplets land on objects and surfaces, then enter the body when people breathe in the droplets or touch their eyes, nose or mouth after touching a contaminated surface.
Are we making progress towards a treatment
Clinical trials play an important role in making safe and effective treatments available to the public. According to the World Health Organization there are more than 1700 active or completed COVID-19 clinical trials. Many of these are observational studies that in the long run will better inform us about the virus, but in the short term won’t quickly advance treatments. For that we need clinical trials. The normal drug-develop process takes six to 12 years. With the help of governmental agencies like the Food and Drug Administration (FDA) many drug companies are trying to compress this schedule into 6 – 12 months. That’s a tall order! As of May 2020, there were more than 20 drug companies working to find safe and effective therapies to treat COVID-19. A common strategy has been to test drugs that are already in the pipeline for other illnesses. For example, Remdesivir, manufactured by Gilead Sciences to fight Ebola, has been approved by the FDA in patients with severe COVID. Other drug companies are working on treatments that re-purpose anti-inflammatory drugs originally developed to treat inflammatory diseases like rheumatoid arthritis, psoriatic arthritis, severe eczema and even baldness. Another strategy is to collect and purify COVID-19 antibodies from infected people that have recovered from the virus and introduce those antibodies into people currently fighting the illness. This technique has worked before and there are active clinical trials to evaluate its effectiveness with COVID-19.
When can we expect a vaccine?
A vaccine is a substance used to stimulate the production of antibodies and provide immunity against a specific disease. As of May 2020, there were 12 drug companies working to find a safe and effective vaccine for COVID-19. A vaccine is the best way to achieve global protection against the COVID-19 virus. Unfortunately, vaccines require a lot of testing before they can be deemed safe and effective. The novelty of this virus adds to the challenge of developing a vaccine. We simply don’t know all of the virus’s defenses and how effective the patient’s immune response will be over time. Even if a safe and effective vaccine can be developed quickly, manufacturing and distribution will present a completely different set of challenges. There is a push to develop something that can be given to healthcare workers by the end of the year. An effective vaccine for the public may not be available until mid-2021. Several companies have progressed through early phase testing of a COVID vaccine and are planning on large, phase 3 studies beginning later this year. The government has provided funding to five companies to advance vaccine development. Of these companies there are three early leaders in vaccine development: Moderna’s mRNA-1273, Pfizer/BioNTec’s
BNT162, and Oxford University/AstraZeneca’s AZ1222. The technology behind these vaccines is relatively new and somewhat different than traditional vaccine formulation. That gives us hope that the right technology might produce a safe and effective vaccine in record speed. Of course, this novelty requires rigorous testing. Late stage testing will require large numbers of patient volunteers – in the range of 30,000 patients per study.
As vaccine development moves into later phases of testing, patient volunteers will play a critical role in helping to move that development along. Qualmedica Research is well positioned to bring one of these clinical trials to Bowling Green.
Volunteers Needed for New Pediatric Vaccine Study
We are accepting volunteers for a new pediatric trial in Bowling Green to evaluate an expanded pneumonia vaccine designed to protect against a broader range of germs that can cause pneumonia. The study is for infants and toddlers ranging from approximately one month up to 15 months of age. In addition to receiving the study vaccine, children entering the study will receive all age-appropriate pediatric vaccines. As with all our studies, there is no cost to participate and no insurance is required. Patients receive routine medical care and follow-up visits. Patient stipends are available to reimburse time and travel. Visit our web site for more information at QualmedicaResearch. com/Studies and look for infant vaccine studies in Bowling Green.