Coronavirus vaccine entering human trials after receiving FDA approval

Inovio has been well ahead of other pharmaceutical companies with regards to getting a working coronavirus vaccine into worldwide circulation.

By ZACHARY KEYSER
An employee of German biopharmaceutical company CureVac, demonstrates research workflow on a vaccine for the coronavirus (COVID-19) disease at a laboratory in Tuebingen, Germany (photo credit: REUTERS/ANDREAS GEBERT)
An employee of German biopharmaceutical company CureVac, demonstrates research workflow on a vaccine for the coronavirus (COVID-19) disease at a laboratory in Tuebingen, Germany
(photo credit: REUTERS/ANDREAS GEBERT)
A vaccine, funded by the Bill and Melinda Gates Foundation, designed to treat the disease caused by the coronavirus (COVID-19), has entered into the human stages of testing after the US Food and Drug Administration (FDA) approved its application to begin trials under the classification of an Investigational New Drug program following promising results achieved during animal testing.
Inovio Pharmaceuticals, the developers behind the INO-4800 DNA vaccine, began injecting volunteers with their first dose on Monday; the second dose will be administered four weeks later. Inovio is expecting the initial data from the trial results by late summer.
The methodology for the trial period will include 40 healthy adult volunteers, selected through screening processes carried out at Philadelphia’s Perelman School of Medicine at the University of Pennsylvania and the Center for Pharmaceutical Research in Kansas City. Each volunteer will receive two doses of INO-4800.
The first trial phase is intended to determine the safety and immunogenicity (ability to cause an immune response) of the vaccine. The second will be the clinical trials, which will test the effectiveness of the vaccine in treating COVID-19.
Inovio has been well ahead of other pharmaceutical companies with regards to getting a working coronavirus vaccine into worldwide circulation. A spokesperson for the company told reporters that the firm developed a vaccine construct for its coronavirus vaccine within three hours of the public release of the viral sequence of SARS-CoV-2 on January 10, adding that they have already manufactured the vaccine and begun pre-clinical trial.
The company has manufactured "thousands of doses" of its new vaccine in a few weeks time to support the trial periods – thanks to the support of the Bill and Melinda Gates Foundation, as well as other funding such as from the Coalition for Epidemic Preparedness Innovations.
CEPI has so far invested in the development of six vaccine candidates against COVID-19, including projects with the US firms CureVac, Inovio Pharmaceuticals, Moderna (which began trials in mid-March) and with the University of Queensland in Australia.
Depending on the success of their clinical trials, the pharmaceutical company could have a million doses available by December, for further testing and/or a potential emergency situation that garners official approval for use, according to Tech Crunch.
Approval for official use, however, will likely take about a year to a year-and-a-half.