05/05/2020 - 12:09
- Clarín.com
- The New York Times International Weekly
By Knvul Sheikh
Pfizer and German pharmaceutical company BioNTech announced that their potential coronavirus vaccine began human testing in the United States on Monday. If the tests are successful, the vaccine could be ready for emergency use here as early as September.
The two firms are jointly developing a vaccine candidate 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 potentially tell cells how to make the coronavirus spike protein without actually making a person sick.
Because the virus typically uses this protein as a key to open and take control of lung cells, the vaccine could train a healthy immune system to produce 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 world market.
New York-based Pfizer and BioNTech injected the first human volunteers in Germany last month with their candidate vaccine, called BNT162. The experimental injection was administered to only 12 healthy adults, although the trial will eventually be extended to 200 participants .
In the United States, pharmaceutical companies plan to test the vaccine on 360 healthy volunteers for the first stage of the study, adding 8,000 volunteers at 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 machinery of the leading protein. Doctors will closely monitor participants' antibody levels , liver enzymes, and other indicators of possible side effects.
c.2020 The New York Times Company
