New COVID-19 vaccine goes into human trials: Details here
What's the story
As COVID-19 continues to batter different parts of the world, scientists are racing to find a way to fight the pandemic as soon as possible. US-based Moderna Therapeutics has already moved into the second phase of clinical trials, and now, Novavax, another American biotechnology company, has announced that its vaccine is also going into the human trial stage. Here's more about it.
Trials
Novavax's NVX‑CoV2373 candidate vaccine
Officially dubbed NVX‑CoV2373, the Novavax vaccine is a stable, prefusion protein that sends harmless copies of the coronavirus spike protein in the patient's body to train their immune system to fight off the actual infection when needed. According to the Associated Press, the company's scientists extracted the actual spike protein, purified it, and packaged it into virus-sized nanoparticles to create the delivery vaccine.
Results
Pre-clinical trials showed promising results
The vaccine technology used by Novavax is a proven one (also used against diseases such as HPV, Hepatitis B) and has already shown promising results in pre-clinical animal trials. Specifically, it was tested in giant vats of insect cells in a laboratory and was able to induce high immunogenicity and high levels of neutralizing antibodies required to fight off the deadly disease.
Clinical
Phase I of clinical human trials underway in Australia
Now, hoping that the vaccine would show similar immunogenic response in humans, Novavax has started Phase I clinical trials of NVX‑CoV2373 with 131 volunteers in the Australian cities of Melbourne and Brisbane. As part of this, volunteers will be administered with two doses of the vaccine, 5 micrograms and 25 micrograms, with and without the company's Matrix‑M™ adjuvant.
Results
Results expected in July
The results from the Phase I trial are expected in July. If it is proven to be safe and effective, the company will proceed with the Phase 2 trial, which will see the vaccine being administered on more number of people in multiple countries. The next test would assess immunity, safety, and disease reduction capabilities of the vaccine in a broader age range.
Quote
Closer to fight ongoing pandemic, says Novavax CEO Stanley Erck
"Administering our vaccine in the first participants is a significant achievement, bringing us one step closer toward addressing the fundamental need for a vaccine. We look forward to sharing the clinical results in July and, if promising, quickly initiating the Phase 2 of the trial."
Manufacturing
Novavax is also working on manufacturing
Along with moving through the trials, Novavax is also building manufacturing capabilities for the vaccine for quick distribution if it proves successful, the company's research chief Gregory Glenn said during a briefing. "We are in parallel making doses, making vaccine in anticipation that we'll be able to show it's working and be able to start deploying it by the year-end," he noted.
Work
As many as 124 COVID-19 vaccine candidates developed
At the time of writing, at least 124 COVID-19 vaccine candidates have been developed by biotech companies and research institutes around the world. Of these, 10, including the one by Novavax, are already in clinical trials, while the others are in the pre-clinical trial phase. The organizations testing these vaccines on humans include Moderna Therapeutics, Inovio Pharmaceuticals, BioNTech, Sinovac, CanSino Biological, and Oxford University.