Since the first moments of the coronavirus outbreak, pharmaceutical companies have maintained one ultimate goal: to develop a successful COVID-19 vaccine.
U.S.-based pharmaceutical giant Pfizer, in partnership with German drugmaker BioNTech, announced at the end of April that the first human participants in the United States have been dosed with a potential vaccine known as BNT162.
Here’s everything you need to know about the vaccine, its clinical trial, and where development goes from here.
How Does Vaccine BNT162 Work?
Vaccine candidate BNT162 contains genetic material called messenger RNA, or mRNA. This genetic code sends cells a message that helps them build an immune response to the COVID-19 virus. BNT162 actually exists in four different forms, each representing different mRNA formats and target antigens.
Who Received the First Doses?
On April 29, 12 study participants were dosed with vaccine candidate BNT162 in Germany. By early May, Americans were being dosed with the vaccine candidate at sites including the University of Maryland School of Medicine and the NYU Grossman School of Medicine. Altogether, about 200 healthy adults between the ages of 18 and 55 will receive this initial dose of the potential vaccine.
These doses are part of a Phase 1/2 trial designed to determine the optimal dose for further studies and evaluate the “safety and immunogenicity of the vaccine,” according to a statement from Pfizer.
“With our unique and robust clinical study program underway, starting in Europe and now the U.S., we look forward to advancing quickly and collaboratively with our partners at BioNTech and regulatory authorities to bring a safe and efficacious vaccine to the patients who need it most,” Pfizer Chairman and CEO Albert Bourla said in a statement.
How Will the Clinical Trials Be Performed?
It was only four months ago, during the initial outbreak of the coronavirus, that Pfizer began preclinical lab studies. The pharmaceutical company moved on a highly accelerated time table to begin human testing at the end of April.
Following the successful completion of the Phase 1/2 trial, “the selected vaccine candidate will be administered to several thousands of subjects,” as explained by BioNTech. This larger-scale study is expected to launch in September with more than 7,000 participants.
According to Pfizer’s chief scientific officer, Dr. Mikael Dolsten, Pfizer hopes to shatter the 12-18 month waiting period for a COVID-19 vaccine by making millions of doses of BNT162 available by the end of 2020, with “hundreds of millions” of doses distributed in 2021.
Pfizer and BioNTech are in close competition with Moderna, another pharmaceutical giant also in the process of developing a vaccine based on mRNA. Moderna began its first human trial testing back in March, giving them a head start.