In late 2019, a novel coronavirus was identified in Wuhan Province, China, that caused a severe respiratory infection. The virus became known as SARS-CoV-2, the cause of COVID-19. About five months later, on March 11, 2020, the World Health Organization declared COVID-19 a global pandemic. The virus became prevalent in a remarkably short time. By the end of 2020, the number of cases was estimated at 83,832,334, with 1,824,590 deaths.
Even more remarkable was the pace at which clinical researchers developed effective mRNA vaccines against the new virus. The test vaccines were prepared between January and June 2020, and Pfizer and BioNTech initiated their landmark study in July. The clinical trials were enormous. Pfizer and BioNTech enrolled over 46,000 people in a single study launched in six countries and 153 research sites. And that only represents one study for one of the vaccine candidates.
An interim analysis of data from that study led to submission for approval and Emergency Use Authorization of the vaccine in December 2020. In August 2021, the FDA gave its first approval of a COVID-19 vaccine. A timeline accelerated to this degree is unheard of in pharmaceutical R&D.
Over the past two years, daily news broadcasts introduced the world to a new lexicon: mRNA, placebos, population diversity, epidemic, pandemic, endemic, data analyses, variants, efficacy rates, regulatory process, boosters and so on. The general public has been given a look into the new therapy development process. Public and private partnerships were developed and delivered on Operation Warp Speed, creating one of the best examples of how the government and pharmaceutical industry can work together to achieve a common goal and make technological leaps forward.
At IMA Clinical Research, we’re proud to have contributed significantly to several research studies across multiple sites that led to the development, approval and understanding of new COVID-19 vaccines. We’re very thankful and feel extraordinary pride for all the people in the communities around our clinics who volunteered their time to receive test vaccines and help make new vaccines possible. As COVID-19 continues to evolve, we stand ready to meet the new challenges of emerging variants and the next novel virus to threaten the world.
We’re conducting clinical trials to gather more data on virus progression and investigational treatments that will protect as many people as possible. Interested in learning more about COVID-19 Clinical Research Trials from IMA Clinical Research? Contact us.
Authors: Mike Minor, Dr. Robert Falcone and Dr. Charles Andrews