In Seattle, the fight against SARS-CoV2 coronavirus is taking a positive step forward. The new potential vaccine, mRNA-1273, entered a new phase 1 clinical trial last Monday and was administered to the first human.
43-year-old Jennifer Haller enrolled in the clinical trial which is being conducted at Kaiser Permanente Washington Health Research Institute in Seattle. Haller, who is an Operations Manager and mother of two, says “This is an amazing opportunity for me to do something.” She was the first of 45 volunteers who will be administered two doses given 28 days apart.
The vaccine was developed by biotechnology company, Moderna, alongside researchers from the National Institutes of Health. The current phase 1 study was achieved in record-breaking time. Entering the trial took just 65 days after Chinese authorities shared the genetic sequence of the SARS-Cov2 coronavirus. The vaccine’s design was finalized within two days and begun manufacturing right away. The first batch of vaccines was reportedly finished on February 7 and was shipped to NIH on February 24.
The phase 1 clinical trial will evaluate both the safety and immunogenicity of the vaccine in patients. Immunogenicity tests how well the vaccine stimulates an immune response to a protein on the coronavirus’ surface. Participants will be observed over the course of 12 months after the second vaccination.
It’s been declared that the vaccine cannot cause COVID-19. Instead of using the virus, a small piece of genetic code, mRNA, was extracted and then expanded in the laboratory. It works by conditioning the immune system to fight and block the virus from attaching to a person’s lung. If it can’t attach to the lungs, it cannot form the disease.
The accelerated pacing of the development of the vaccine is not without its sacrifices. Due to the urgency of the situation, the vaccine was not as extensively tested in mice before switching to human trials. Some experts express their concern regarding the matter and worry that it may put the volunteers at a greater risk.
“Finding a safe and effective vaccine to prevent infection with SARS-CoV-2 is an urgent public health priority,” said Anthony S. Fauci, M.D., head of the National Institute of Allergy and Infectious Diseases, at the NIH. Moderna is already simultaneously arranging for phase 2 trials which will include working with the FDA, government, and non-government organizations. The phase 2 trials will call for a larger volunteer pool.
Unfortunately, it will take a while for the vaccine to be available to the general public. Since participants need to be observed for a length of time, this part of the development process cannot be rushed.