In an interview with Pfizer’s Senior Vice President and Chief Scientific Officer Bacterial Vaccines, Annaleisa Anderson said that the company was geared toward making the Covid-19 vaccine more easily accessible. The company wanted to address and nip the Covid-19 issue in the bud but they had to make sure that everyone had access to these vaccines. A new drug, from the introductory stage to appeal can take about 12 years, but obviously, time was ticking. The discovery team at Pfizer made every possible effort to identify a promising molecule and move it into production.
The team at Pfizer had to get the drug out as soon as possible without compromising on its safety of it. They conducted several tests in parallel where experiments are completed before the next test would begin. This obviously required Pfizer to make a huge investment to make sure all tests could run parallelly while also designing new clinical trials all while working with the very high possibility that neither of these tests might be approved.
A flexible and amendable clinical study protocol was designed to expedite the process.
During Phase 1 of the trial, the team wanted to maximize the concentration of the medicine in the body to be confident that it would achieve efficacy and minimize resistance mutations in healthy volunteers. As a result, they evaluated the molecule alone and administered it with a pharmacokinetic booster, which helps the compound stay in the body longer, enabling higher concentrations.
Pfizer, in order to save time, used a new technology in the field. This technology helped them model and simulate clinical trials in place of the traditional Phase 2 trials. Viral Kenetic Model were developed and used in place of the traditional models. The Viral Kinetic Models simulates virus replication un humans and also simulate the way the drug would inhibit that replication in people with COVID-19. This new modelling data, along with the data from the trial that used healthy volunteers, informed the dose that would be focused on in the subsequent Phase 2/3 studies
Around 2,500 people participated in the Phase 2 and 3 trials. EPIC-HR(Evaluation of Protease Inhibition for COVID-19 in High-Risk Patients) trials were used to test the effectiveness of the vaccines. In the trials; 41% came from the US and 59% came from around the world, with representation in South Africa, Western Europe, Eastern Europe, Thailand, Malaysia, Japan, Argentina, Mexico, and beyond.6 The results were striking: in non-hospitalized adults with COVID-19 and at least one risk factor for progression to severe disease, the oral therapy was found to reduce the risk of hospitalization or death by 89% compared to a placebo when treated within three days of symptom onset.
Arthur Bergman, who is Group Head of Clinical Pharmacology in Pfizer’s Anti-Infectives Early Clinical DevelopmentBergman gets emotional when he reflects on the moment he learned the results. “It still brings a tear to my eye today, thinking about how all the hard work from this team came together to create something with such potential to impact patients’ lives,” he says. “You know, that’s something that I’ll never forget.”