Tucked discreetly behind one of Smyrna’s busiest retail districts is a biotech lab where researchers in white coats and goggles are trying to develop the nation’s next COVID vaccine. They’re testing how effectively their new vaccine prototype will prevent infection.
The lab is part of GeoVax, one of two Georgia biotech companies that recently received a combined total of more than $60 million in federal funding from the U.S. Department of Health and Human Services’ Project NextGen initiative to study better ways to protect against the persistent COVID health threat.
The $5 billion Project NextGen is pushing new innovative vaccines that provide stronger protection against COVID than the original vaccines on the market, last longer without the need for frequent boosters, protect people with chronic conditions, and come in more forms than a standard injection, such as pills and nasal sprays. For instance, CyanVac in Athens, Georgia, is testing a COVID nasal spray.
COVID deaths and emergency room visits have dropped since early in the pandemic, and while infections from the current strains are milder, the number of cases continue to rise and fall in seasonal waves, including a summer surge that’s still underway.
The Food and Drug Administration (FDA) last week approved updated COVID vaccines arriving now at doctor’s offices and pharmacies and intended to protect against the currently circulating version of the virus. New vaccines under development through Project NextGen won’t be on the market for several years and it is still in the midst of testing in humans.
Credit: Jason Getz / Jason.Getz@ajc.com
Credit: Jason Getz / Jason.Getz@ajc.com
Project NextGen builds on the Operation Warp Speed effort early in the pandemic to bring COVID vaccines to market as fast as possible.
The first generation of vaccines developed during the pandemic contained messenger ribonucleic acid (mRNA), a molecule in human cells that triggers the body’s immune system to create antibodies, or proteins, to fight the virus. But an mRNA vaccine might not be as effective in people who have a weakened immune system, cancer or a history of cancer, according to the Cleveland Clinic.
An estimated 3% of Americans, or about 10 million people, have immunocompromised conditions or weakened immune systems that make them more vulnerable to illness, according to the National Institutes of Health. Some recent research pegs the vulnerable population as at least double that estimate.
Other drawbacks of the current mRNA vaccines include their short duration of protection against the virus. They only protect for several months, requiring frequent boosters to maintain protection against an evolving COVID virus, and can cause side effects.
Researchers at GeoVax hope their new vaccines can reduce the need for booster shots and might also be more adept at fending off new variants. GeoVax received $24 million for a clinical study to confirm its vaccine does both.
Like the earlier mRNA vaccine, GeoVax’s formula stimulates antibodies to fight the virus, but adds an additional protein to stimulate the T cells, which are white blood cells that protect against infection.
Credit: Jason Getz / Jason.Getz@ajc.com
Credit: Jason Getz / Jason.Getz@ajc.com
“One of the shortcomings of the first-generation vaccines is that those have to be reconfigured as new variants of concern arise,” GeoVax CEO David Dodd told The Atlanta Journal-Constitution after a tour of the Smyrna lab. “Our [early] clinical data has shown our vaccine offers 8 to 12 months of protective immunity without having to reformulate the vaccine.”
The original COVID vaccines were believed to be effective for about six months before their protection waned. The new vaccines could potentially extend that duration to a year, like current flu shots.
GeoVax began in 2001 as an outgrowth of the Emory Vaccine Center, initially focused on developing a HIV vaccine. It was based on the research of Harriet Latham Robinson, a former director of the division of microbiology and immunology at Yerkes National Primate Research Center at Emory. She is the company’s founder and chief scientific officer emeritus.
The company is also studying vaccines for Ebola, Marburg and Zika viruses, treatments for some cancers, and more recently, Mpox, formerly known as monkeypox. The World Health Organization has declared the spread of mpox in Africa a public health emergency.
Credit: Andrew Davis Tucker
Credit: Andrew Davis Tucker
Nasal spray vaccine studied
Meanwhile, startup CyanVac received $40 million to develop a COVID vaccine delivered through a nasal spray. The new vaccine was developed at the University of Georgia based on a respiratory virus used in a kennel cough vaccine for dogs.
“Because of my dislike of needles, I thought it would it be a great idea if we could use a simple spray to immunize instead of typical needle-based injection,” said company founder and CEO Biao He, a professor in UGA’s College of Veterinary Medicine who developed the vaccine.
That’s when he made the connection between the kennel cough vaccine given to dogs in a nasal spray for more than 50 years, and humans, who don’t develop side effects after being exposed to the vaccine through their dogs. He also figured some people may prefer a nasal spray to an injection, and delivering a vaccine through the nose may be more effective as it treats a respiratory virus in the place where infection usually develops.
CyanVac’s COVID vaccine candidate produces antibodies, T cells, and a nasal protection against the virus and reduces side effects, He said. Previous clinical studies with almost 300 people found that those who received the CyanVac nasal vaccine “almost never” developed side effects like fever or arm pain that could arise from the current mRNA vaccines, according to He.
The goal of the vaccine is also to provide longer protection against the virus and prevent its spread to others, He added.
The Georgia companies expect their clinical research partners to eachreceive about $400 million in federal funding to complete the next phase of clinical trials to test their vaccines, which would separately enroll 10,000 volunteers. The studies will compare the effectiveness of the new vaccines to those already on the market.
“While existing vaccines against COVID-19 are still very effective at preventing serious illness and death, they are less capable of reducing infection and transmission over time,” according to a spokesperson for the HHS Administration for Strategic Preparedness & Response, which announced the Project NextGen funding. The new vaccines should better address COVID variants and prepare for future ones, the spokesperson told the AJC.
About 80% of Americans have received at least one COVID vaccine, but about 22% of adults received the most recent COVID vaccine, according to the latest figures from the Centers for Disease Control and Prevention. GeoVax and CyanVac see opportunities to fill a gap in a shrinking COVID vaccine market that is no longer seeing the growth experienced early in the pandemic.
Meanwhile, the largest producers of first-generation vaccines, Pfizer and Moderna, are studying alternative uses for their vaccines or branching into treatments for other illnesses.
GeoVax’s Dodd still anticipates potential in the worldwide COVID market, particularly to provide an option for patients with weakened immune systems, such as those with cancer or leukemia. Biao He of CyanVac eyes the larger COVID market, the 22% of Americans who received the latest booster shot.
Both CEOs say it would be at least two years before their vaccines could be approved by the FDA for emergency use. “Normally it takes at least three years to get to market” after the second phase of clinical trials, He said. The speed to market will depend on whether the FDA requests additional testing, He explained. At this point, He and Dodd are just excited their companies are on the federal government’s radar for fast-track approval of potential new vaccines to help curb the relentless health hazard.
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