There are some hard limits to the vaccine development process that mean we are not going to see any preventative immune therapies to fight the new coronavirus for at least a year to 18 months. But Moderna, which is behind the first potential vaccine to enter human clinical trials in the U.S., provided new info on Monday that indicates it will seek to provide access to the vaccine to a limited group, likely consisting of healthcare workers, by as early as this fall.
The company will look at possibly doing so under an emergency use authorization from the Food and Drug Administration, which is similar to how certain testing procedures are being granted approval for use now, bypassing the typical process under which such diagnostic tools are given the go-ahead. Moderna’s solution, which was developed in partnership with the National Institute of Allergy and Infectious Diseases, is already the fastest potential vaccine to enter the human clinical trial phase.
Their proposed vaccine makes use of messenger RNA, rather than relying on either a small or inactive sample of the COVID-19 virus itself — the source of most existing effective vaccines. The mRNA method means there is no actual virus introduced to subjects who receive it, which in turn means that they are not at risk of actually contracting the virus from the vaccine itself, which can be an issue in the testing and development phase of any traditional virus-based immune therapy.
Last Monday, Moderna began providing the vaccine to volunteer participants in the first phase of its human clinical trial in Washington state. Despite the speed with which it entered human testing, and the unconventional bypass of the animal testing phase, commercial availability is still at least a year away. But select, limited use for healthcare professionals at an accelerated timetable could help provide additional protection for frontline workers who are risking greater exposure — provided Moderna’s vaccine is effective, and proves safe in its current human testing.
Moderna’s solution works by convincing the body to generate proteins that resemble the virus but that are harmless, and provoke antibodies that are effective both in fighting off the protein and the actual virus itself. There are other RNA-based vaccines in development, as well as other types of immune treatments, but only Moderna’s has reached the clinical trial phase thus far. The Boston-based company has been working on mRNA-based treatments for cancer cells, and went public in December 2018.
