The first U.S. patients are being dosed in a Phase 2/3 clinical trial testing whether a messenger RNA (mRNA) vaccine candidate can prevent infection with the virus that causes 2019 coronavirus disease (COVID-19).
NYU Grossman School of Medicine, under the auspices of its Vaccine Center, served as one of the sites for the initial stages of the same study that focused on the vaccine's safety. The 2/3 phase study, for which the NYU Grossman will also participate as one of 120 centers, may enroll up to 30,000 healthy participants between the ages of 18 and 85 globally. It is designed to measure whether the vaccine candidate can protect against COVID-19 infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
Pfizer and BioNTech announced the trial's transition into its final stage. Vaccine designers at BioNTech sought to determine which protein components of SARS-CoV-2 were "most noticed by" the human immune system, with the goal of teaching the system to further attack them upon any future encounter with the virus, researchers say.
"It is tremendously encouraging to see the early phase of this trial succeed, and to have a lead candidate emerge for global testing," said Mark J. Mulligan, MD, director of the Division of Infectious Diseases and Immunology and the Vaccine Center at NYU Langone Health. "We will continue to engage in rigorous scientific study to learn as soon as possible if this vaccine can be part of the public health solution to this terrible pandemic."
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NYU Langone Health was chosen as a trial center in part because of Dr. Mulligan's expertise in infectious disease research programs that have over decades assessed investigational vaccines for HIV, Zika, Ebola, and pandemic influenza.
The study vaccine is part of the class called "mRNA vaccines" that with recent advances can quickly be computer-designed, and scaled up into millions of doses if successful and pending regulatory approval using high-speed technologies. RNA-based vaccines also provide a level of safety since it is not possible to catch SARS-CoV-2 virus or COVID-19 disease from the RNA vaccines themselves.
mRNA vaccines are based on RNA, or ribonucleic acid, a form of genetic material similar to DNA. Human cells use mRNA to translate DNA instructions into proteins, the workhorse molecules that make up cell structures. In the pandemic coronavirus, RNA serves as the primary genetic material instead of DNA.