Pfizer Starts Human Vaccine Trial in the US USA
and the German pharmaceutical company BioNTech announced that its potential vaccine began human trials in the United States Monday. If the tests are successful, the vaccine could be ready for emergency use here as early as September.
The two companies are jointly developing a candidate vaccine based on genetic material known as messenger RNA, which carries the instructions for cells to make proteins. By injecting a specially designed messenger RNA into the body, the vaccine could tell cells how to make the coronavirus spike protein without actually making a person sick.
Because the virus generally uses this protein as the key to unlocking and taking over lung cells, the vaccine could train a healthy immune system to make antibodies to fight an infection. The technology also has the advantage of being faster to produce and tends to be more stable than traditional vaccines, which use weakened virus strains.
Moderna, Inovio, CanSino and several other pharmaceutical companies are testing similar approaches, some of which started the first phase of human testing a few weeks ago. But no vaccine made with this technology for other viruses has reached the global market.
New York-based Pfizer and BioNTech injected the first human volunteers with their candidate vaccine, called BNT162, last month. The experimental injection was administered to only 12 healthy adults, although the trial will eventually be expanded to 200 participants.
In the United States , the drug companies plan to test the vaccine on 360 healthy volunteers for the first stage of the study, adding up to 8,000 volunteers by the end of the second stage. The study will be conducted at New york university Grossman School of Medicine, University of Maryland School of Medicine, University of Rochester Medical Center, and Cincinnati Children's Hospital Medical Center.
Participants will divide into groups to compare four variations of the vaccine, each representing a messenger RNA format with instructions to make a different piece of the spike protein machinery. Doctors will closely monitor participants' levels, liver enzymes, and other indicators of possible side effects.