An Ames-based animal vaccine startup is on the path to getting U.S. Department of Agriculture conditional approval for a highly pathogenic avian influenza vaccine, its co-founder said recently.
Joel Harris, the CEO and co-founder of Genvax Technologies, said in mid-March the company is hoping to do more animal studies in the coming weeks.
“We’re generating the data, working closely with USDA and communicating with them on our progress,” he said, explaining that the process is an accelerated or emergency approval from the USDA.
Vaccine developers need to demonstrate safety and potency, which means they can manufacture a consistent product, and a reasonable expectation of efficacy, showing that they can stimulate an immune response or generate antibodies with their vaccine, Harris said.
Avian influenza has killed nearly 166.2 million birds since February 2022, according to USDA data released this month. It is blamed for surging egg prices. Iowa is the No. 1 state for egg production and is home to 45 million laying hens that produce about 15 billion eggs per year, according to the Iowa Egg Council.
In January 2024, the average price of a dozen Grade A large eggs in the U.S. was $2.52, according to the U.S. Department of Labor Statistics. A year later, the price had soared to $4.95, a record high, the Business Record reported earlier this month.
“I think it’s devastating,” Harris said of the avian influenza outbreak. “I think it’s economically devastating and emotionally devastating for these producers. It just feels like it’s not going away, and I think it’s really taking its toll on the producers.”
Harris said he’s not the only one developing a vaccine. The New Jersey-based Zoetis recently obtained a conditional license for its avian influenza vaccine for use in chickens. Germany-based Boehringer Ingelheim also has a vaccine, he said.
If everything continues, Harris said, his company could get conditional approval “within the year.”
The problem is that U.S. policy is to not vaccinate for avian influenza, he said. Chicken meat producers oppose vaccines because they are worried they could hurt meat exports. There are concerns “that vaccinating could allow the virus to linger undetected in flocks and mutate in ways that could make it more of a threat to humans and allow sick birds to get into the food supply,” reported the Associated Press. Still, if a person cooks a chicken to 165 degrees Fahrenheit, it will kill other diseases, along with the avian influenza, the AP reported.
In an email, USDA Secretary Brooke Rollins said there is currently no avian influenza vaccine authorized for use in U.S. poultry.
“As a result, vaccination against avian flu is not taking place at this time,” she said.
She pointed to the USDA’s approach to combating avian influenza and reducing egg prices, which includes efforts to explore vaccine use, as well as therapeutics and other strategies to protect egg-laying chickens and reduce depopulation.
“USDA is taking a targeted, science-driven approach to developing next-generation solutions and will invest up to $100 million to determine the best path forward,” Rollins said, adding that a formal public solicitation will be issued in the coming week.
Also, on March 11, the USDA Animal and Plant Health Inspection Service held its first call with state officials and industry stakeholders. Among the items discussed were potential vaccination, therapeutics strategy, logistics and surveillance, Rollins said.
Rollins announced in February a $1 billion strategy to curb avian influenza, lower egg prices and protect the U.S. poultry industry, which included $100 million for vaccine research, action to reduce regulatory burdens, and exploring temporary import options, according to the USDA website.
Harris said Genvax hopes to apply for USDA funding for vaccine research and continue to make progress.
The current vaccine is injected into day-old chicks, Harris said, adding that they are developing other delivery systems that could be part of the grant money they apply for. He said he’s hoping to show data in upcoming studies that shows how long the vaccine would last.
“We’re an Iowa company with technically skilled Iowans ready to provide a solution for this problem impacting Iowa,” he said.