Moderna Inc. and the US National Institute of Allergy and Infectious Diseases (NIAID) have reported the dosing of the first patient for a novel vaccine (mRNA-1273) at the Kaiser Permanente Washington Health Research Institute (KPWHRI) in Seattle.  The phase I clinical trial entitled, “Safety and Immunogenicity Study of 2019-nCoV Vaccine (mRNA-1273) for Prophylaxis SARS CoV-2 Infection” has been registered at Clinicaltrials.gov, under reference: NCT04283461.  The study is aiming to evaluate different doses of the experimental vaccine for safety, and its ability to induce an immune response in participants. This is the first of multiple steps in the clinical trial process for evaluating the potential benefit of the vaccine.  Moderna Inc. and NSAID are supported by the Coalition for Epidemic Preparedness Innovations (CEPI), a global alliance financing and coordinating the development of vaccines against emerging infectious diseases (https://cepi.net/).

At present there are a list of 52 other vaccine candidates now tracking the World Health Organization across multiple countries.  Vaccines are being developed by up to eight different “platforms” for design and preparation – some use traditional vaccines using inactivated or weakened whole viruses, or later genetically engineered proteins, and now newer messenger RNA (mRNA) technology, which provides the backbone of the current Moderna vaccine. According to scientists at NIAID’s Vaccine Research Center (VRC), the experimental vaccine was able to quickly develop mRNA-1273 because of prior studies of related coronaviruses that cause severe acute respiratory syndrome (SARS) and Middle East respiratory syndrome (MERS). Coronaviruses are spherical and have spikes protruding from their surface, giving the particles a crown-like appearance. The spike binds to human cells, allowing the virus to gain entry. Once the genome of SARS-CoV-2 became available, scientists were then able to select an mRNA sequence to express the stabilized spike protein of the virus. The mRNA-1273 vaccine uses the nucleic acid transcript to be dosed into the patient’s muscle and this will generate a protein spike outside the coat of the virus.  As such, there are no virus particles and therefore the protein spike made by the mRNA will safely trigger the immune system.  mRNA-1273 is a novel lipid nanoparticle (LNP)-encapsulated mRNA encoding the full-length, prefusion stabilized spike protein.  Phase I study will use a dose ranging trial in adult males and females (non-pregnant) to assess safety, reactogenicity and immunogenicity.  Commenting in the study, the NIAID Director, Anthony S. Fauci, M.D. said, “Finding a safe and effective vaccine to prevent infection with SARS-CoV-2 is an urgent public health priority.  This Phase 1 study, launched in record speed, is an important first step toward achieving that goal.”

The Coalition for Epidemic Preparedness Innovations (CEPI) (a non-profit) will work closely with Moderna Inc and the NDAID to coordinate R&D  and support which CEPI has invested nearly $30 million in vaccine development at Moderna, and six other groups. CEPI’s CEO Richard Hatchett stated that. “We have gone through a selective process to pick the ones that we think have the greatest likelihood of meeting our goals—which we think ought to be the world’s goals—of speed, scale, and access.  We don’t want to be in a situation where we have [one] successful vaccine and we have a contamination event [during manufacturing] and suddenly we don’t have any vaccine supply.  By doing things in parallel rather than in serial fashion, we hope to compress the overall timelines.”