Inovio Pharmaceuticals, along with the University of Pennsylvania's research facility and the Wistar Institute, has been working on the coronavirus vaccine early as January as reported by Fox News.
The Chinese government provided the genome sequencing of COVID-19 public three months ago and helped the vaccine process speed up. As of now, they started the first phase of testing, which Inovio researchers mentioned they were able to design their vaccine in just three hours.
About 40 people in Kansas City and the University of Pennsylvania will be tested for the first phase and results are expected by summer.
Dr. Kate Broderick, senior vice president, R&D at Inovio Pharmaceuticals, told Fox, "We immediately started testing the vaccine in the laboratory. And we're quite confident about the results that we've seen." She said the human trials just began last week and added, "We treated three people last week. But getting our vaccine into human beings is a huge step. But we did that in 83 days, which certainly in my career is absolutely an unprecedented level of speed."
Despite the quick start, she admitted that there are too many unknown variables that will influence the vaccine.
"In some patients, it looks like people who had the disease but now recovered have kind of these sort of low antibodies levels, but we don't know if that's a consistent result across everybody that's contracted the virus so far," she says. "So, we need to learn more about how the virus affects people and how people are affected by that infection before we can see too much about how that impacts vaccine design."
"What we don't know is that they contract the virus for a second time, which obviously would be very unlucky, but possible. Or is it just that they haven't fully recovered the first time around? So that's really what we're learning as we speak and as we move forward. And that's what kind of makes treating this virus very difficult because there's still so much we don't understand about it."
Dr. David Weiner, of the Wistar Institute, and one of the top researcher for this vaccine, told Fox News that "Phase one is supposed to be normal, healthy people. And in this case, they have not, as far as we know, they have not been infected with COVID-19."
"The first study is really just safety and tolerability in relatively low-risk people just to make sure the vaccine by itself, how well it's tolerated by people. You're watching that very closely, so you can figure how many people you can give it to and whether there's going to be issues."
Phase two will be followed after, which will test on the actual impacted population. Weiner says, "Phase two is really where you start to test out larger numbers and efficacy. And Inovio has already produced enough dosing for that several thousand doses in there because that process is so robust to get through that study as well. So, that's clearly on their radar."
Inovio got a $9 million grant from the Coalition for Epidemic Preparedness Innovations to speed up the testing process. The process is difficult work since they have to start over from scratch when there is a new outbreak. But, proprietary tech of digital mapping of DNA sequences supports them to work quicker.
Dr. Weiner also mentioned that it might take a very long time for the vaccine to actually be open to the market.
"When it goes to expanded efficacy studies, which are called phase three, this normally takes a very, very long time," Dr. Weiner said.
"That's why with vaccine development, all the proceeds normally take years to decades. So, to get to a licensed vaccine, a vaccine that would be available like that, we're talking about a year and a half to two years. Well, that would be all the way through."
But Dr. Weiner believes that there is a chance for the vaccine to be open for the public to use if emergency use authorization could be enacted. However, it is solely up to authorities.
"An emergency use authorization is not usually used, and that is where you get through early studies and show it's safe and you're given permission to start distributing it more widely," he says. " And there has been a lot of discussion from that from a group in Oxford, which is going to start their vaccine trial sometime in the summer. That has the positive in the sense that if the vaccine is safe, you're sort of using it already on lots of people."
"And that's really completely up to the authorities to decide those kinds of things. And I'm sure they'd be a lot of discussions. So that's something you're likely to hear about a lot."
