As COVID-19 contamination spreads around the globe, Moderna (in our biotechnology and healthcare M&A certificates) announced that its first vaccine would be tested in Phase I study.

COVID-19 has infected more than 80’000 people, according to official counts, in at least 33 countries. As of Monday evening, at least 2’696 patients have died.

Yesterday, the first batch of Moderna’s candidate, known as mRNA-1273, has been sent to the U.S. National Institute of Allergy and Infectious Diseases (NIAID), to conduct the first human tests.

Delivery of the first batch takes place only 42 days after the sequencing of the virus’ genome, which allowed the identification of the sequence used for the vaccine. This record speed between identification and human trials confirms the rapid adaptability of Moderna's RNA platform. The team's efforts are impressive, with a significant number of employees working seven days a week to deliver the vaccine. The first batch was already completed on 7 February, but it took two weeks to test it.

Juan Andres (Moderna CTO) said: The collaboration across Moderna, with NIAID, and with CEPI has allowed us to deliver a clinical batch in 42 days from sequence identification. This would not have been possible without our Norwood manufacturing site, which uses leading-edge technology to enable flexible operations and ensure high-quality standards are met for clinical-grade material.

Twenty to twenty-five healthy volunteers will be part of Phase I clinical trials, which are scheduled to begin in April. The first results are expected to be released in July/August. However, even if the human trials are successful, it will take several months after approval for the vaccine to be widely disseminated. Sanofi, which has also a candidate, declared that “three or four years would probably be the fastest the company could get to a licensed vaccine”, citing its experience with Ebola.

Manufacturing of Moderna’s batches (more than 100 batches already roducted and released) have been funded by the Coalition for Epidemic Preparedness Innovations (CEPI). On January 23, this non-profit organization, which promotes vaccine development, allocated approximately $9mn each to Moderna, Inovio Pharmaceuticals and the University of Queensland in Australia.

The Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services, supported the vaccine development of several companies without disclosing financial details.

The European Union (€232mn), and foundations such as the Gates Foundation ($100mn) are also raising funds to strengthen detection, protect vulnerable populations, and develop vaccines and diagnostic tools.

How does the vaccine work?

Moderna develops vaccines from the RNA messenger (mRNA). mRNA plays a vital role in protein synthesis. mRNA, a single-stranded molecule, carries the genetic information from DNA in the cell’s nucleus to ribosomes (the cell’s protein maker machine), located outside the nucleus. All functions inside the human body – whether normal or disease-related - are made possible by one or several proteins.

This method could maximize effectiveness while avoiding the undesirable immune reactions that are common when injecting a foreign protein. As it acts before the protein is made, RNA messenger drugs are more accurate than protein-based drugs. RNA messenger drugs are also less invasive than DNA-based therapies, which could lead to damaging side effects.

mRNA prophylactic vaccines

The company designs prophylactic vaccines to prevent and control infectious diseases. Virus vaccines aim to pre-expose the immune system to a small, harmless amount of a virus protein (antigen) to prepare it to fight that pathogen in the future.

Moderna inserts mRNA into the patient's cells to directly produce the antigen found in the COVID-19 virus. This "natural" infection will stimulate the immune response.

To date, Moderna has achieved positive results, in Phase I trials, for six of the nine prophylactic vaccines in development. In addition to this modality, the company has ongoing programs in oncology, immuno-oncology, rare diseases and cardiovascular diseases.

Moderna is not alone in this race against time. Nearly twenty groups including several research institutes and bio-pharma companies (e.g., Gilead, J&J, Inovio, Clover Pharmaceuticals, Sanofi Pasteur) compete for COVID-19 first vaccine.

Large bio-pharma companies have greater resources than Moderna due to their high manufacturing capabilities at global scale and experience. Despite this, we believe that the news is positive for Moderna. If the company manages to complete COVID-19’s clinical trials by showing efficacy and safety, it will validate its technological platform.

Moderna share price is up around 15% today.