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Electrical Device that “gives DNA vaccines the boost they need to work in humans” Receives $71M from U.S. Dept of Defense

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Electrical Device that “gives DNA vaccines the boost they need to work in humans” Receives $71M from U.S. Dept of Defense​


SEPTEMBER 12, 2021

NOVIO’S ELECTRICAL DEVICE ZAPS A COVID-19 VACCINE INTO THE BODY​

Can a handheld gadget usher in a new era of vaccines?

It took a global pandemic to accomplish one of the most significant advances in the history of vaccinology: widespread, commercial deployment of vaccines derived from nucleic acids. As of this writing, hundreds of millions of people have been vaccinated against SARS-CoV-2, the virus that causes COVID-19. And most of those shots have been the PfizerBioNTech and Moderna offerings, which are both of a type known as an mRNA (messenger RNA) vaccine.

Conceived decades ago but released to the public for the first time during the pandemic, mRNA vaccines so far are living up to their promise. Both the Pfizer and Moderna vaccines have proven to be about 95 percent effective against the novel coronavirus. In addition, this kind of vaccine can be tweaked with relative ease to target new variants of a virus, and its production does not rely on items that can be difficult to produce quickly in enormous quantities. And yet, a couple of drawbacks of mRNA vaccines have also been widely noted over the past six months: They depend on deep-freeze supply chains and storage, and they can produce significant side effects such as fever, chills, and muscle aches.

So hopes remain high for another kind of nucleic-acid vaccine, one that makes use of DNA rather than mRNA. DNA-based vaccines have most of the advantages of mRNA vaccines, yet they produce no significant side effects—and, crucially, they don’t need to be refrigerated. These attributes could make these vaccines a boon to rural and low-resource regions. “If we really have to vaccinate 7 billion people, we might just need every possible technology,” says Margaret Liu, chairman of the board of the International Society for Vaccines.

Inovio’s device uses a technique called electroporation to sneak a DNA vaccine into cells. Kate Broderick, Inovio’s senior vice president of R&D, has been working on this technique for years, but the pandemic provided both motivation and funding to accelerate development. Spencer Lowell

DNA vaccines come with a major challenge, however. When administered with an ordinary hypodermic needle, they’ve conferred only weak immunity, at best, in many human studies. But if a small, ambitious Pennsylvania company backed by the U.S. Department of Defense succeeds in its clinical trials, DNA vaccines—enabled by a new delivery technology—could soon join the fight against COVID-19, and a host of other viral illnesses.

The company, Inovio Pharmaceuticals, is using a technique known as electroporation, in which an electrical pulse applied to the skin briefly opens channels in cells to allow the vaccine to enter. After a standard vaccine injection, Inovio’s electroporation device, which looks like an electric toothbrush, is held against the skin. At the press of a button, a weak electric field pulses into the arm, opening channels into the cells. The tool gives DNA vaccines the boost they need to work in humans—or so the company says. It’s an engineering solution to a biological problem.

With its overseas warfighters in mind, the U.S. Department of Defense (DOD) has backed Inovio’s approach with a US $71 million contract to scale up the manufacturing of its electroporation device, and an undisclosed sum to cover phase 2 and 3 studies of the company’s COVID-19 vaccine. And the Bill and Melinda Gates Foundation gave the company $5 million as part of an effort to increase equitable access to COVID-19 vaccines.

Inovio is now finishing phase 2 studies that are testing the vaccine’s safety and efficacy on relatively small groups in the United States and China, and those results are imminent. In the meantime, the company has ramped up manufacturing with a plan to supply hundreds of millions of COVID-19 vaccine doses to the global population, should the vaccine prove successful.

But here’s the rub: The electroporation tool is essential to Inovio’s vaccine, but it also adds a layer of complication. It’s both an enabler and a handicap. Inovio must manufacture not only the vaccine but also the device and its disposable tips. Any vaccination site planning to administer Inovio’s vaccine will need not only the device but also people who know how to use it. The public will have to develop trust in a new apparatus. And all of this will have to happen during a pandemic and a frenzied vaccine rollout characterized by rampant misinformation and, in some quarters, an unwillingness to be vaccinated.

Given that backdrop, the idea of complicating mass vaccinations with an electric device has drawn skepticism. “This is not standard methodology for giving vaccines,” notes John Moore, an immunologist at Weill Cornell Medicine, in New York City. The technique might work, but “how practical it is is another question entirely,” he says.

Neither the skeptics nor tough questions from regulators have deterred Inovio. Nor has the fact that, despite more than a decade of research and development in other disease areas, the company has yet to bring a DNA vaccine to market. These are hardly normal times. The coronavirus has propelled many other novel technologies, medicines, and vaccines into the mainstream, and in the process has created massive business success stories. Inovio is betting that its technology will make it into that elite group of pandemic-era winners.

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nickndfl

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i wonder when they're going to change that Oath...