America has started the phase I clinical trial of coronavirus vaccine, mRNA-1273, at Kaiser Permanente Washington Health Research Institute (KPWHRI), Seattle, in the leadership of Lisa A Jackson, MD, Senior Investigator at KPWHRI.
Moderna, a biotechnology company, along with the researchers of the National Institutes of Health (NIH), has developed this vaccine using a genetic platform – messenger RNA (mRNA). As per NIH, the manufacturing of the vaccine has been supported by the Coalition for Epidemic Preparedness Innovations (CEPI) and the National Institue of Allergy and Infection Diseases (NIAID), a part of NIH, is funding its trial.
Anthony S Fauci, the Director of NIAID, has called the prevention of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) an urgent priority. As a big step towards fighting this battle against COVID – 19, four healthy volunteers have been vaccinated in the US with initial shots of mRNA-1273. Jennifer Haller, 48, has become the first human to be injected with the trial coronavirus vaccine.
Though NIH has claimed the success of coronavirus vaccine on animal models, its effects are yet to be tested on humans.
As mentioned on the website of NIH, the vaccine will be tested on 45 male and non-pregnant female volunteers, age between 18 and 55. The volunteers will be given two doses of the vaccine at an interval of approximately 28 days. These doses will be injected in the upper arm of the receiver through intramuscular injection.
Based on the quantity of vaccine, the 45 volunteers will be divided into three groups. Each of these groups will be assigned for receiving one of the three doses of vaccination – 250 micrograms (mcg), 100 micrograms, or 25 micrograms. The purpose of different treatments is to evaluate the nature of the immune response generated by the vaccine in volunteers.
Initially, an injection of the lower dose will be given to the first four volunteers, followed by a dose of 100 micrograms to the next four. The safety of these eight volunteers will be reviewed intensively before vaccinating the remaining participants of 25 mcg and 100 mcg groups. The decision of the second vaccination will also depend on the results of this review. The 250 mcg group will be vaccinated only after having a second successful safety review.
mRNA-1273 developed quite quickly because of the prior studies of related coronaviruses. The syndromes of these viruses, Severe Acute Respiratory Syndrome (SARS) and Middle East Respiratory Syndrome (MERS), were quite similar to that of COVID – 19.
Even after such a fast development and manufacturing, it will take almost a year to confirm if the vaccine is safe and effective on humans.