NYU Langone to Enroll Patients in US Clinical Trial for COVID-19 mRNA Vaccine

The first U.S. patients have been dosed in a clinical trial testing whether four experimental mRNA vaccine candidates can prevent infection with the virus that causes COVID-19 disease.

Pfizer and BioNTech announced the trial's start, with NYU Grossman School of Medicine and the University of Maryland as the first centers to enroll patients in the United States. The randomized phase 1/2 clinical trial will seek to enroll healthy patients to receive either one or two doses of one of the vaccines or a placebo (saline solution). The vaccines are being developed by Pfizer and BioNTech SE, which recently launched a similar, first-in-human trial in Germany.

Vaccine designers at BioNTech sought to determine which protein components of SARS-CoV-2 were "most noticed by" the human immune system. Successful vaccine ingredients "teach" the immune system which microbial invaders to attack upon future encounters, providing protection for a period of time, researchers say.

"We are excited to work with industry leaders to rapidly, carefully test state-of-the art vaccine candidates, with goal of providing protection against this pandemic that has taken such a tremendous toll," said Mark J. Mulligan, MD, director of the Division of Infectious Diseases and Immunology and director of the Vaccine Center at NYU Langone Health. "Vaccines have always been our most effective weapons to protect the health of the public from infectious disease threats, which is why it's so important to study these candidates closely."

The study vaccines are part of the class called "mRNA vaccines" that with recent advances can quickly be computer-designed, fabricated, and scaled up into millions of doses if successful and pending regulatory approval using high-speed machines. RNA-based vaccines also by nature avert risks of infection and immune challenges that come with older vaccine types based on live, weakened versions of a virus.

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