The Agriculture Department is taking a methodical approach to the question of whether cows should be inoculated against avian flu even as vaccine developers are seeing substantial demand from dairy farmers who want a vaccine.

One company, Medgene Therapeutics, Brookings, S.D., says it’s ready to go with a vaccine.

“We've got just under a million doses that have been pre-ordered by cattle producers that are concerned about the spread of this because it's impacting their milk production,” Medgene CEO Mark Luecke says. “They want to have the option of a vaccine.”

Central to the debate is the impact of the virus on milk production. USDA has maintained that infected cows generally recover and return to full production a few weeks after the onset, but reports from farmers indicate a small percentage of cows do not recover.

“Milk production is down up to 20% at infected farms," Luecke says. “We hear anecdotally that it doesn't quite come back all the way.”

He also says transport restrictions on dairy cows are “paralyzing producers, and so they need more options than 'better biosecurity' to be able to get their cattle moving again.”  

Jamie Jonker, chief science officer at the National Milk Producers Federation, has said some cows — it’s not clear how many — lose the ability to produce milk after recovering from the virus.

The number of cows so affected appears to be a “small amount,” he said last month, adding that the long-term impact of the H5N1 virus on production also is unknown at this point.

“We’re probably not going to understand until this fall if there's any lasting impacts for those cows that have essentially been dried off because of the H5N1 infection,” Jonker told Agri-Pulse.

NMPF is in the process of developing a survey for dairy farmers to get a better handle on the economic impact of H5N1 on milk production.

“I think that our dairy farmers are probably, well, why don't we just have a vaccine for this?” But in the next breath he acknowledges that there are “larger policy questions” that involve trade. “It's a little more complex than just, hey, let's get a vaccine out there.”

Secretary of Agriculture Tom Vilsack, when questioned on recent press calls, has said repeatedly that any decision on vaccines must take account of potential impacts on trade. Said a USDA spokesperson: “Many countries, including the U.S., do not currently allow the import of poultry (including live poultry, poultry products and poultry byproducts) from countries that vaccinate for HPAI [high pathogenic avian influenza] because vaccination may lead to subclinical infection and thus, the export of infected live animals or virus-contaminated products.”

The International Dairy Foods Association would like to see a vaccine available.

“We have continued to urge USDA to work as expeditiously as possible to develop a vaccine to address bovine H5N1,” says IDFA Senior Vice President Matt Herrick. “The industry and individual farmers can determine if or how they plan to deploy such a vaccine once it is available, but it is absolutely essential that USDA move with more urgency to have it available.”

Medgene joined with another large veterinary vaccine manufacturer to respond in May to a formal Request for Information (RFI) from USDA's Animal and Plant Health Inspection Service (APHIS) Center for Veterinary Biologics. 

APHIS “reviewed 21 inquiries from 20 manufacturers,” a USDA spokesperson said. “We will continue to engage with these developers to better understand their vaccine development, the efficacy of potential vaccines, as well as the cost of development and production.”

The agency made clear in its RFI that no decision has been made on whether to proceed with vaccine production by issuing a Request for Proposals (RFP). “This request is exploratory only and should not be interpreted as a decision to use vaccine in U.S. dairy cattle,” the RFI said.

USDA’s Agricultural Research Service is doing vaccine work of its own in Ames, Iowa, and has been supporting research at the University of Pennsylvania that involves testing a vaccine on calves. Other companies, including Merck and Zoetis, also are working on vaccines.

The USDA official says the ARS work is “very early in the development process and it is difficult to predict how long development might take, as many outstanding questions remain about the transmission to cattle, characterizations of the infection, etc. In addition, there are trade implications that would need to be considered once we are further into the development process.”

Medgene’s Luecke, however, says the company has developed its vaccine using a USDA-licensed prescription platform technology that has been employed to develop and distribute a vaccine for Influenza D in cattle.

“Influenza D is a different strain of influenza from bird flu, which is influenza A,” Luecke notes. Ideally, if a vaccine for Influenza A were approved, producers could simply inoculate cows in the fall at the same time (and in the same dose) they inoculate for Influenza D.

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Fred Gingrich, executive director of the American Association of Bovine Practitioners, says his members “support all vaccine technologies that can be used to prevent or control disease. And so certainly, if there was an effective and safe vaccine available for cows that would help against this disease outbreak, our organization and our members would certainly be supportive of that.”

But he and Jonker acknowledge trade as an issue. 

“If we use a vaccine in dairy cattle, some of our trading partners will want reassurances there's not a small circulating level of virus within our dairy sector that could potentially continue to have spread back into poultry operations and/or have the ability to adapt and cause an even larger issue in poultry farms,” Jonker says.

But, he adds, “designing reassurances for trading partners can be challenging.”

Gingrich notes that 18% of dairy products is exported, adding, “We would have some difficulties supporting a vaccine that destroyed the price of milk in the U.S. due to loss of export markets.”

USDA recently said that producers who have lost milk production because of the virus could qualify for aid under an emergency livestock program. To qualify, cows must be tested for the virus, and AABP and NMPF are concerned the aid is not enough to get producers to apply for it.

Gingrich says USDA’s formula for assistance uses a National Agricultural Statistics Service (NASS) estimate for milk production that’s below what most dairies get. In addition, some affected operations are “pretty large operations that [have] suffered a million and a half dollars worth of loss, and they're going to get $150,000. That's nice, but it doesn't come close to cover what actually happened.”

He contrasts the situation with that of poultry operations hit by the bird flu. “They get paid for the number of birds they depopulate — same virus.”

Luecke says Medgene is “advocating for our customers, cattle owners and their veterinarians. Because the USDA has put movement restrictions on, our customers need options, and one of those options is vaccination."

"Given the upcoming fall season, when cattle would typically get vaccinated, we are encouraging them to move quickly,” he says.

Luecke calls attention to recent announcements of $176 million in federal funding to develop a bird flu vaccine for humans and a USDA National Institute of Food and Agriculture request for applications for grants under a $10 million program for research on bird flu in animals.

"The contrasting efforts of $176 million in human vaccine development and stockpiling by HHS v. $10 million in basic research by USDA for a disease originating in agricultural animals is confounding," Luecke says. "Meanwhile, the disease continues to spread in animals with more herds and farmworkers testing positive and producers expressing that government payments do not come close to compensating for productivity losses, all leading to food supply shortages, higher grocery prices, and a zoonotic disease that is not contained. Without a veterinary vaccine, the wrong animal will contract the disease, the virus will mutate, and it will lead to the prognosticated human pandemic."

Eric Bohl of Bockorny Group, a consultant for Medgene, says a vaccine for cows would help prevent the spread of H5N1 to the human population.

“The only way you could ever end up having a human outbreak is if the animal outbreak got out of control,” he says. “So why wouldn't you want to put more emphasis and resources into making sure that doesn't happen in the first place, so we never get to the point where it bleeds over into the human population?”

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