On Monday, participants’ arm muscles were injected with a COVID-19 mRNA-based vaccine in one of America’s first clinical trials for preventing the deadly virus. The candidates were dosed at trial centers at the University of Maryland and at NYU Langone Health. The trial is being done in cooperation with Pfizer and BioNTech SE, which are developing the vaccines. A similar trial with Pfizer was also just launched in Germany. In both countries, the trials enroll healthy patients to receive two doses of one of the four experimental vaccines or a saline solution, as a placebo.
Should the vaccines prove successful and receive regulatory approval, experts say they can be quickly scaled to millions of doses.Pfizer is hopeful that it will receive emergency authorization from the US Food and Drug Administration as soon as October, and be able to distribute some 20 million doses of the vaccine by the the end of 2020, Reuters reports.That nine-month timeline, if achieved, would be record-breaking for vaccine development, which often takes a decade. “This is the equivalent of doing Phases 1, 2 and 3 of a typical clinical trial but all compressed into the May-through-October time frame,” Kirsten Lyke, a director at the University of Maryland’s Center for Vaccine Development and Global Health, tells Reuters.
New York has been a hot spot for vaccine trials similar to this one — at NYU Langone, for instance, its vaccine center yielded vaccine candidates for HIV and other viruses. The center’s director, Dr. Mark J. Mulligan, says they’re hoping to wrap up the trial as quickly as they can.“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,” Mulligan says in a statement.
The current stage of the trial is called “dose escalation phase,” and involves gathering evidence based on the reactions of 360 subjects in two groups: those ages 18 to 55 and those ages 65 to 85, all of whom are healthy and coronavirus-free. The older set will only be tested once the younger adults have proved a vaccine to be safe.
A similar trial has begun with an investigation al vaccine made by Moderna, but involves fewer patients.