The world continues to reel from the impact of the novel coronavirus – a massive, spanning crisis that is meeting almost all aspects of our lives in some capacity. Economies stutter, businesses suffer, and human lives are lost.
Amidst the pandemic, and the billions of lives in lockdown, there are companies and organizations looking for preventative methods to stop the virus from spreading any further.
Two weeks ago, ITNA reported that as many as 35 different companies around the world were working on a vaccine for the novel coronavirus. Many of these vaccines had been fast-tracked due to our current understanding of SARS-CoV-2, the novel virus that is causing the pandemic, yet very few had entered phase 1 of human testing.
Now, a new COVID-19 vaccine candidate has entered phase 1 clinical human trials, after the FDA (the US’ Food and Drug Administration) accepted an application from Inovio Pharmaceuticals under the regulator’s Investigational New Drug programme.
The Inovio vaccine candidate has several important partners and collaborators, most notably – The Bill and Melinda Gates Foundation, who have provided noteworthy support to the project, reports Tech Crunch.
Inovio plans to inject its first volunteer test subject with the INO-4800 DNA vaccine candidate it has developed following promising results from preclinical studies performed on animals that did indicate an increased immune response.
This vaccine begins to work when a specifically engineered plasmid, a tiny, independent genetic structure, is injected into a patient. The plasmid then provokes the human immune system to produce the correct antibodies to fight off the specific infection. If this INO-8400 candidate is successfully approved for human use, it will be the very first DNA vaccine to be given to humans.
DNA vaccines, while approved for a variety of animal infections in veterinary medicine, have never before been approved for human use.
Inovio itself has been able to quickly produce candidates, developing and producing “thousands of doses” of INO-4800 in just a few short weeks in order to undergo it’s phase 1 and phase 2 trials. The company has managed this, in part thanks to backing from the Bill and Melinda Gates Foundation, as well as funding from other non-profits and organizations.
If the INO-4800 clinical trials are a success, Inovio says it will be able to have up to 1-million doses of the vaccine ready by the end of the year, for use in additional trials and for potential emergency use pending authorization.
This is notably much sooner than the predicted timeline of 18-months, according to Annelies Wilder-Smith, professor of emerging infectious diseases at the London School of Hygiene and Tropical Medicine.