HHS to Produce 4.8M Bird Flu Vaccines as 2 New Human Cases Identified

Guest Post by John-Michael Dumais

HHS is preparing 4.8 million H5N1 bird flu vaccine doses amid reports of two new human cases in Michigan and Australia. Meanwhile, the CDC this week urged health officials nationwide to ramp up flu surveillance.

Federal health officials are ramping up efforts to combat what they claim is the growing threat of H5N1 bird flu with plans to produce 4.8 million vaccine doses and increase influenza surveillance nationwide.

The move comes as two new human bird flu infection cases were identified — in Michigan and Australia — heightening concerns about the virus’s potential to spread among humans.

The new vaccine, currently in bulk form, will be filled and finished in multidose vials by one of the U.S. Department of Health and Human Services’ (HHS) manufacturing partners without disrupting seasonal flu vaccine production, according to the University of Minnesota’s Center for Infectious Disease Research and Policy (CIDRAP).

HHS Assistant Secretary for Preparedness and Response Dawn O’Connell on Wednesday said that active discussions are underway across federal agencies about the key triggers for deploying the H5N1 vaccine doses.

Triggers could include evidence the virus is spreading to people not employed on farms, or between humans rather than solely from animals to humans, or that the virus is causing more severe illness in those infected.

O’Connell also said HHS is in talks with Pfizer and Moderna about developing mRNA-based bird flu vaccines.

Reports of new human bird flu cases and plans for increased vaccine production sparked a surge in the value of vaccine-focused biotech companies’ stock on Wednesday, including Moderna, BioNTech, CureVac and Novavax, according to The Financial Times.

New human cases in Michigan, Australia

The Michigan Department of Health and Human Services reported that the H5 avian flu case in a dairy farm worker was identified through ongoing public health actions, which allowed farm workers to monitor and notify health officials if they developed symptoms, CIDRAP reported.

Reporting on only the second human case of bird flu infection this year, the Centers for Disease Control and Prevention (CDC) said the worker’s nasal swab tested negative for H5 influenza. But an eye swab tested positive, suggesting an eye infection similar to a previous case in Texas, reported in April.

Meanwhile, Michigan’s agriculture department reported another H5N1 avian flu outbreak in a dairy herd, bringing the total number of affected farms in the state to 19. The latest outbreak occurred in Gratiot County, where the virus was found at three other dairy farms earlier in the week.

On Tuesday, Australian health authorities reported the country’s first human case of H5N1. According to a report from the Victoria Department of Health, a child contracted the infection during a trip to India.

Although the report described the case as “severe,” it said the child had fully recovered. Contact tracing showed the infection did not spread to anyone else.

An outbreak of the H7 flu strain at a Victoria egg farm is not the same as the one fueling outbreaks in the U.S., according to Australian health officials. They noted that H5N1 was never detected in animals or people in Australia before this case.

Flu surveillance to scale up nationally

The CDC on Tuesday issued new recommendations urging state and local health officials to maintain enhanced levels of influenza testing over the summer to track potential human infections of bird flu, Newsweek reported.

During a call with health leaders, CDC Principal Deputy Director Nirav Shah emphasized the importance of keeping a “heightened awareness” of influenza transmission amid the ongoing H5N1 outbreak in poultry and U.S. dairy cattle.

Shah encouraged local health officials to collaborate with laboratories to increase submissions of positive flu virus samples for subtyping, determining whether an influenza sample is a common, seasonal flu virus or a novel virus like bird flu.

In a related development, an infectious disease-tracking sewage surveillance network began scaling up H5N1-specific testing of wastewater samples from its 190 sites at treatment plants across 36 states, according to STAT News.

The WastewaterSCAN network, led by Stanford University and Emory University in partnership with Verily Life Sciences, will share data with local public health officials and on its public dashboard in the coming weeks.

Marlene Wolfe, an environmental microbiologist and epidemiologist at Emory and one of the directors of WastewaterSCAN, emphasized the importance of testing wastewater for a genetic signature of the H5N1 virus to give officials “one extra piece of information” to help understand the outbreaks.

However, the CDC admitted that wastewater detection is an “evolving science” that cannot yet precisely determine the source of viral contamination.

This news follows the publication on April 29 of a preprint study by Wolfe and others describing the development of a novel polymerase chain reaction (PCR) test to detect the H5 subtype of influenza A virus in wastewater solids.

The researchers detected the H5 marker in samples from four treatment plants in Texas and North Carolina coinciding with areas reporting H5N1 outbreaks in dairy cattle.

Another preprint study published on May 10 by researchers at the University of Texas and Baylor University detailed their detection of H5N1 sequences in wastewater treated at 19 plants across nine Texas cities beginning on March 4.

The CDC has also begun releasing data from its influenza A-tracking efforts on a public wastewater dashboard, including data from 230 sites in 34 states.

While the agency is not conducting H5-specific testing, finding high levels of influenza A in wastewater over the next few months could indicate unusual activity before the higher seasonal flu levels return in the fall.

‘Relatively easy’ to ‘run a fear campaign’ to sell a vaccine

While expanding wastewater testing can be a tool for monitoring the spread of H5N1 bird flu, Dr. David Bell, a public health expert, warned against overinterpreting the results.

Bell told The Defender the presence of a pathogen’s genome in wastewater, including bird flu, does not necessarily indicate the presence of sick or infected humans.

“Birds poo rather widely,” he said, suggesting that finding the bird flu virus in wastewater is almost inevitable, regardless of the time period. “We would have found it if we had done this 20 years ago, 50 years ago or 100 years ago.”

Bell also expressed concern about the pressure to use new and more sensitive tests, incentivizing sales and use and yielding results that are “divorced from actual risk or the production of useful data.”

“It seems almost inevitable that we will find bird flu virus if we look for it in this way,” he said.

As an example of misplaced risk assessments, Bell said most deaths during the 1917-18 pandemic were not due to the virus but occurred because modern antibiotics for treating secondary bacterial infections were unavailable.

“It is relatively easy to demonstrate theoretical risk and run a fear campaign that may change behavior and sell a product such as a vaccine,” Bell said. “It is much harder to run a proportionate, evidence-based and sustainable public health policy.”

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