HOLLY SPRINGS, N.C. ‒ A quiet effort to prevent the next global pandemic began on a production line this summer, behind the gates of an office building just outside Raleigh.
In this vast facility surrounded by dense pine forests, CSL Sequilas workers are bottling millions of doses of a new vaccine targeting the H5N1 avian influenza virus.
The virus first emerged in wild birds around 1997 and has spread this year to dairy and poultry farms across the United States.
Thirteen farm workers have contracted the virus this year, some of whom developed red eyes and coughs, but none have become seriously ill enough to require hospitalization, although in other countries about half of those diagnosed with H5N1 in past years have died.
The virus is not transmitted from person to person, which is why public health officials aren’t panicking: Because the risk to the general public remains low, the federal government doesn’t think it’s worth vaccinating anyone against H5N1 yet, even farmworkers who are at highest risk of contracting the virus from infected chickens and cows.
But behind the scenes, people are preparing at Sequiras’ advanced facility in Holly Springs, a hub for biomanufacturing.
Already, 4.8 million doses of the potential vaccine are stored at an undisclosed distribution center run by Sequiras, ready to be distributed if needed.
“Exercises like this give our partners the opportunity to step up and make sure that manufacturing is happening reliably,” Dawn O’Connell, assistant secretary for preparedness and response at the U.S. Department of Health and Human Services, told USA Today during an exclusive tour of a vaccine plant in late July.
In past disease outbreaks, producing enough vaccine in time to stop individual infections and slow the spread of the disease has been the government’s “Achilles heel,” she said.
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So here, in the heart of North Carolina’s popular Research Triangle, winding conveyor belts and hanging robotic arms are filling thumb-sized glass vials with doses, one at a time, in an effort to prevent the next global pandemic.
Real success would mean that, at some point, we’d be able to essentially flush the contents of those vials down the toilet, because bird flu would theoretically no longer pose a threat to human health.
But at a time when the virus seems to be spreading to new farms on a weekly basis, when the U.S. health care system and treatment of farmworkers means infections are likely going undetected, and with the fall flu season fast approaching, public health officials say you can’t be too cautious.
“We want to prepare for the worst,” said Dr. Raj Punjabi, who oversaw the White House pandemic response as special assistant to President Joe Biden from 2021 to 2023. “This gets the engine going.”
On the production line
Through several security doors at the Sequiras plant, dozens of workers in white zip-up plastic suits, hairnets and goggles worked along conveyor belts carrying small tubes along a packaging line.
Sequilas’ packaging lines can produce 2 million doses of flu vaccine every two weeks, said Jonathan Kegerlis, vice president of manufacturing and site manager at the Holly Springs plant. The 4.8 million doses of H5N1 vaccine were delivered in between seasonal flu shots, so vaccine production was not affected.
A robotic arm fills and caps the vials, while workers stand guard and prepare the machine for the next batch. Along the way, cameras take pictures of the vials and lights flash for quality control. The vials undergo additional inspection before being packaged and prepared for shipment if the federal government decides it needs an H5N1 vaccine.
The liquid was primarily divided into vials containing 10 doses each, and Seqirus manufactured an additional 250,000 pre-filled, single-dose syringes in case opening the 10-dose vials would be wasteful.
The H5N1 vaccine is already being produced at the same Sequelas facility and is stored at temperatures between 35.6 and 46.4 degrees Fahrenheit. Concentrated vaccine will be pre-produced as part of the national stockpile.
The vaccine is now being pumped into vials, allowing public health officials to more easily distribute it as needed.
It takes about a month to make the substance needed for a dose, then a day to compound the batch, another day to fill the vials, and finally a day to inspect and package them.
Sequilas said it is producing 4.8 million doses of the vaccine under a $22 million contract with the federal government..
Two vaccines are being prepared to protect against the H5N1 virus: In addition to the one being prepared in Holly Springs, the government in July awarded Moderna $176 million to develop an mRNA flu vaccine that includes H5N1.
The two vaccines use different technologies: mRNA can be produced more quickly in case of a rapidly spreading pandemic, while the more traditional cell-based vaccines that roll off these assembly lines take longer to make.
Dr. Nahid Bhadelia, founding director of the Center for Emerging Infectious Diseases at Boston University, said it makes sense to perfect the cell-based vaccines already in the national stockpile now, telling USA Today that an mRNA vaccine could be useful if the virus changes enough that a new vaccine must be developed.
Still, Bhadelia, who worked in the Biden administration during the COVID-19 outbreak, is concerned that Congress hasn’t allocated enough funding to get ahead of the avian flu virus.
“Without money, nothing happens,” she said.
The vaccines we currently have
Scientists hope that the vaccine being pumped into vials here will protect people against severe H5N1 infection, but they’re not sure.
So far, the vaccine has only been tested in ferrets, animals commonly used in laboratories to test influenza vaccines. Sekirus already produces an H5N1 vaccine that the FDA has determined to be safe and effective. The new avian flu vaccine replaces the H5N1 strain with the circulating virus.
The first clinical trials of the new vaccine will begin in healthy people to see if the vaccine has the desired effect on the immune system, with results expected later this year.
For now, researchers believe the vaccine coming off the line will be effective, but that’s not guaranteed, Bhadelia said.
Dr. Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia and an expert on infectious diseases and vaccines, said that by the time the virus mutates to become truly dangerous to large numbers of people, it may have changed enough that a vaccine prepared here would no longer work.
Even if a vaccine works, there’s the problem of scaling up production and getting it to enough people quickly enough.
To be effective, the vaccine requires two doses, spaced at least three weeks apart. It’s unclear how much protection the first dose provides. In an emailed response, Sekiras declined to say when the vaccine will expire or when it should be replaced.
It will also be difficult to get it to people.
In the case of the COVID-19 vaccine, getting the doses from warehouses to vaccination clinics and administering them proved to be more difficult than expected: refrigeration, bottle size and other factors posed problems that had to be solved quickly.
of National Biodefense ProgramThe program, overseen by Punjabi, was launched in 2022 with the goal of providing enough vaccines for all at-risk people within four months of the pandemic’s start.
If avian flu could be tackled early — contained before it spreads beyond farmworkers and their families and into the general public — it would be much easier to produce enough vaccine and get it to the right people within four months.
That’s why some public health experts believe agricultural workers should be offered the vaccine before the virus becomes more dangerous.
While vaccinating farm workers would not reduce the number of people who become seriously ill with bird flu, Bhadelia believes they should be given the shot as part of research trials. “Vaccination could help reduce the severity of illness and help us advance our scientific understanding,” he said.
Still, Dr. Nirav Shah, principal deputy director of the Centers for Disease Control, doesn’t think it’s the right time to start vaccinating anyone.
H5N1 does not cause severe illness, is not transmissible from person to person and its genetic makeup has not changed significantly since the vaccine was developed, and for now, readily available antiviral drugs are a better option than a vaccine for those infected or exposed to the virus, he told reporters in late July.
“Right now, the H5 vaccine is not doing what we really need it to do,” Shah said.
Another vaccination
Finland made a different decision. In June, Finnish authorities have begun distributing 20,000 vaccine doses The government has recommended that people aged 18 and over who have had contact with animals thought to be infected with avian flu, including mink industry workers, be given a different strain of the Securas vaccine.
Mia Kontio, chief expert on infectious disease control and vaccination at the Finnish Institute of Health and Welfare, said fewer than 200 people had been vaccinated in Finland as of late July, and the vaccine needs to be used before it expires in mid-September. With many Finns on summer holidays, August will be “very busy” to get the two-dose vaccine administered quickly, she added.
The urgency increases in the fall when wild migratory birds return and may be carrying the virus, she said.
“We felt it was our responsibility to actually do something if we could,” Contio told USA Today, “because things can change quickly.”
Where are we now?
In the United States, federal officials in recent months have expanded restrictions on transporting livestock between state lines. They added warnings about products such as unpasteurized milk and warned that sharing equipment can spread the virus between animals.
It also provided personal protective equipment such as N95 masks, goggles and gloves to avian flu-affected states.
Federal officials recently began an effort to vaccinate livestock workers against seasonal influenza, but the CDC’s Shah said the vaccine doesn’t work against another strain of influenza, H5N1.
But the seasonal vaccine can protect you from getting both the highly contagious seasonal flu and the extremely deadly H5N1 flu virus at the same time — a worst-case scenario, Shah said, would be a combination of the two.
Influenza viruses are known to exchange genes with each other, so such combinations are possible all the time.
“Viruses are smart,” Mei Chu, clinical professor of epidemiology at the Colorado School of Public Health, told USA Today. “Our bodies provide a place for the virus to grow, so if we don’t put the virus in our bodies, we’re not contributing to the genetic growth of this virus. We want to stop that, because the more people that are infected, the more the virus can grow and the more likely it is to develop genetic mutations that have harmful effects.”
She stressed that such a combination would be “bad for us.”
