Novavax Is Beginning Clinical Trials Of Its Coronavirus Vaccine
by Alex Knapp
Novavax, a biotech company focused on developing vaccines against infectious diseases, announced Monday that it is beginning a phase 1 clinical trial of its Covid-19 vaccine candidate in Australia. Results of the trial are expected in July 2020.
“Administering our vaccine in the first participants of this clinical trial is a significant achievement, bringing us one step closer toward addressing the fundamental need for a vaccine in the fight against the global Covid‑19 pandemic,” Stanley C. Erck, the company’s CEO and president, said in a statement.
Maryland-based Novavax is one of several biotech companies racing to develop a vaccine against SARS-CoV-2, the virus that causes Covid-19. Two other companies, Moderna and BioNTech (in a partnership with Pfizer) have already begun clinical trials of vaccines.
However, those other two companies are developing mRNA vaccines, a new type of vaccine that’s still unproven - though there are several mRNA vaccine candidates, none have yet been approved to go to market. Those vaccines use mRNA to stimulate the body to produce copies of the coronaviruses “spike protein” in order to stimulate an immune response.
By contrast, Novavax is developing a “subunit” vaccine - which sends copies of the virus’s spike protein directly into the body to stimulate an immune response. This is an established vaccine technology currently already being used against diseases such as HPV, Hepatitis B and shingles.
During this vaccine trial, 130 healthy people between the ages of 18-59 will undergo a randomized controlled trial. Some participants will receive a placebo while others receive Novavax’s vaccine candidate. The trial will test two different dosages of the vaccine, and will also test doses both with and without a vaccine adjuvant - a compound that can help boost the immune response from a vaccine. If the results are positive, the company says it will immediately move into the next phase of testing at sites around the world.
Last month, Novavax announced that it will be receiving up to $388 million from the Coalition for Epidemic Preparedness (CEPI) to aid in the development and manufacturing of the vaccine. That was based on success that its vaccine candidate had seen in animal models, and the company says part of that funding will be used to support the next clinical trial tests. The other funding is primarily devoted to manufacutring. Novavax says it aims to have 100 million doses of its vaccine ready by the end of this year, and one billion by the end of 2021.
“Our investment in Novavax allows us to focus on manufacturing in parallel with the clinical development of the vaccine,” Dr. Richard Hatchett, CEPI’s CEO said in a statement. “So that if the vaccine is proven to be safe and effective, we can make doses available to those who need them without delay.”