SAN DIEGO (KGTV) -- Early in the race for a COVID vaccine, a small drugmaker with ties to San Diego was getting a lot of attention. Then Inovio Pharmaceuticals had a setback.
In September, the Food and Drug Administration put the clinical trials of the company’s investigational DNA vaccine on hold. Inovio’s vaccine has still not undergone a large-scale Phase 3 trial with thousands of volunteers.
So does that mean the race is over for Inovio in the U.S.? President Joe Biden announced the country is on pace to have enough COVID-19 vaccines for every American adult by the end of May using supplies from Pfizer, Moderna and Johnson & Johnson.
Don’t count Inovio out yet, said Dr. Kate Broderick, who leads the company’s COVID-19 vaccine development from its San Diego office.
“Unfortunately, the virus is doing exactly what a virus does, which is mutate and change,” she said. “And so I think there might well be room for new vaccines, what we call next-generation vaccines, that are specifically tailored to these new strains of the virus.”
Inovio is already developing a next-generation vaccine with the help of artificial intelligence that it hopes can target multiple variants -- ones we know about now, and ones we don’t. By combining bits of genetic code from multiple variants and using predictive AI, the company hopes to create what it’s calling a “pan-variant vaccine.”
The Pennsylvania-based company is also hoping its originally formulated vaccine can be a major player on the world stage. The DNA-based vaccine does not require ultra-cold storage freezers that mRNA-based vaccines do.
Inovio signed an agreement with a Chinese drug manufacturer in January and is also pursuing trials in that country.
“I feel very confident that Inovio’s vaccines, be it our original vaccine or our potential pan-variant vaccine, is going to have a huge impact globally,” Dr. Broderick said.
But to have an impact, Inovio will first have to complete clinical trials. The FDA paused Inovio’s trials in September because of questions about its proprietary delivery device.
Instead of a needle and syringe, Inovio uses a AA battery-powered device that looks like an electric toothbrush to introduce tiny circles of DNA into cells. (DNA vaccines have been undergoing testing for decades, and no, they cannot modify your chromosomal DNA, Broderick says.)
Broderick said the FDA’s questions were related to the use of the device, not its safety.
Regulators allowed Inovio to move forward with a Phase 2 trial in November. The company plans to announce data from that trial next month.
The FDA will have to sign off before Inovio advances to the final, Phase 3 clinical stage. The company is hoping to begin those trials in the second quarter.
That means by the time Inovio finishes the required testing, the U.S. will likely already have enough doses for every American. The FDA requires a median of two months of follow-up after volunteers are vaccinated, then data must be analyzed and submitted for regulatory review.
However, Dr. Broderick is thinking about a longer timeline.
“I think we should maybe all be trying to wrap our heads around the fact that COVID is here to stay, potentially, and that we should view it more like the flu,” she said.
Broderick thinks the virus will become endemic, meaning we might need seasonal shots every year or so. And she says Inovio will be ready.
“I think, unfortunately, COVID-19 is not going anywhere. And we're going to need a lot of different types of vaccines,” she said.