Novavax has launched phase 3 clinical trials in the United States for its coronavirus vaccine candidate, making it the fifth company to launch a massive study to determine the safety and efficacy of the shots.
“The launch of this study — the fifth investigational COVID-19 vaccine candidate to be tested in a phase 3 trial in the United States — demonstrates our resolve to end the pandemic through development of multiple safe and effective vaccines,” said Dr. Anthony Fauci, the government’s top infectious disease expert and director of the National Institute of Allergy and Infectious Diseases.
The Maryland-based vaccine manufacturer will enroll up to 30,000 volunteers in the U.S. and Mexico, in sites “where transmission rates are currently high, to accelerate the accumulation of positive cases that could show efficacy,” the company said Monday.
“With the COVID-19 pandemic raging around the globe, this trial is a critical step in building the global portfolio of safe and effective vaccines to protect the world’s population,” said Stanley Erck, president and CEO of Novavax.
The sample will be broken into two cohorts, people ages 18 to 64 and people over 65, to test the safety of the two-dose vaccine and its effectiveness in preventing COVID-19. Novavax plans for 25% of the sample size to be made up of seniors over 65 and for at least 15% to be black, at least 10% to 20% Latino, and 1% to 2% American Indian.
The trial is funded by the Trump administration’s vaccine development initiative Operation Warp Speed, which awarded Novavax $1.6 billion in July to develop the shots.
Federal regulators have already authorized COVID-19 vaccines from Pfizer and Moderna for public use. Both use the same mRNA technology to instruct cells to create the same protein as the one found on the surface of the coronavirus. This teaches the body to launch an attack against the virus.
Vaccinations in the U.S. began on Dec. 14 with the distribution of the Pfizer vaccine, followed by the Moderna vaccine a week later. Already, roughly 2 million shots have been administered in the U.S., a monumental feat after just eight months of trials and development. Still, health experts said more effective vaccines will be needed to end the pandemic.
“We’ve come this far, this fast, but we need to get to the finish line,” said Dr. Francis Collins, director of the National Institutes of Health. “That will require multiple vaccines using different approaches to ensure everyone is protected safely and effectively from this deadly disease.”
AstraZeneca began phase 3 trials of its coronavirus vaccine in September. Johnson & Johnson plans to have efficacy results from the phase 3 trial of its single-shot vaccine by January or February.
To date, more than 19 million infections and roughly 333,000 deaths due to COVID-19 have been confirmed in the U.S.
