How a rare drug made from scientists' blood saves babies from botulism

When Alessandro Barbera was rushed to a California hospital with infant botulism in October, his father had barely heard of the disease, never mind the rare and costly treatment that likely saved the newborn’s life.

Now, however, Tony Barbera is deeply grateful for BabyBIG, the sole antidote to the paralyzing and potentially deadly illnesses linked to contaminated ByHeart infant formula.

“It is hugely remarkable,” said Barbera, 35, whose son is slowly recovering.

The botulism outbreak tied to ByHeart formula has sickened at least 39 babies across in 18 states since August — and showed the value of the treatment made from blood plasma donated by a small group of scientists and other volunteers.

“This is almost like a miracle,” said Dr. Vijay Viswanath, a pediatric neurologist at Children’s Hospital Los Angeles, who has treated several children with botulism during his career — including one in the current outbreak.

“Prior to the discovery of BabyBIG, some of these hospitalizations would take two or three months,” Viswanath said, if infected children recovered at all.

Licensed in 2003, BabyBIG is the brand name for human botulism immune globulin, an IV medication that uses antibodies from volunteers vaccinated against botulism to help babies too young to fight the disease on their own.

The treatment was the brainchild of the late Dr. Stephen Arnon, who was a scientist with the California Department of Public Health. In 1976, Arnon and colleagues identified the rare form of botulism that affects infants younger than 1 — and then spent his 45-year career figuring out how to treat it. The disease occurs when babies ingest botulism spores that germinate in the intestine and produce a dangerous toxin that attacks the nervous system.

More than 3,700 children worldwide have been treated with BabyBIG since Arnon and his team conducted a pivotal clinical trial in California in 1997 that showed the medication could shorten hospital stays and reduce the need for breathing machines.

Produced in small batches every five years, BabyBIG costs nearly $70,000 per treatment, according to the California Infant Botulism Treatment and Prevention Program, which Arnon founded. Under state law, fees from the sale of the drug are used only to fund the botulism program.

The medication relies on donors like Nancy Shine, a 76-year-old retired biochemist in California who was vaccinated against botulism because she worked with the lethal germ in a lab. Arnon first recruited Shine and other scientists for the BabyBIG project two decades ago because their blood produced high levels of antibodies, the blood proteins that neutralize the botulism toxin.

The early protocol required the volunteers to receive boosters doses of an investigational botulism vaccine also used by the U.S. military and then undergo a procedure that harvests the blood plasma that contains antibodies against botulism types A and B.

“It was not very pleasant to be vaccinated with,” Shine recalled. “There were a lot of side effects, like big welts where you got vaccinated and a little bit of pain.”

Still, Shine contributed to three batches of the antitoxin produced between 2008 and 2019.

“It’s probably the highlight of my career that I actually was able to participate in this project and donate plasma,” Shine said. “We made a product that could save infants’ lives.”

Because infant botulism is rare, with fewer than 200 cases reported in the U.S. each year, finding funding and other resources to develop the BabyBIG treatment took nearly 15 years and $10.6 million — and faced substantial hurdles, Arnon noted in a 2007 article.

Today, about 30 people on average provide plasma for each batch of BabyBIG, California health officials said. Batch 8, the latest edition, is being manufactured now at a Takeda Pharmaceutical Co. plant near Los Angeles, according to Giles Platford, president of the company's plasma-derived therapies unit. The company contracts with California officials to produce BabyBIG on a “not-for-profit basis,” Platford said.

Some of the earliest donors, like Shine, have aged out of the BabyBIG program, which collects blood from adult volunteers up to age 70. New donors are accepted, but they must enroll in a clinical study directed by the California health department and agree to receive a booster dose of a different investigational botulism vaccine.

California officials estimate they have enough BabyBIG in reserve to last until next summer, based on current projections. The ByHeart outbreak is part of a worrisome rise of at least 107 infant botulism cases treated in the U.S. since August, said Dr. Jessica Khouri, senior medical officer for the state program.

Shine recently received a booklet filled with photos and letters from families whose children have recovered from botulism after receiving BabyBIG.

“It's really wonderful. I read a couple each day," she said. “Every single one of them makes you want to cry.”

The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education and the Robert Wood Johnson Foundation. The AP is solely responsible for all content.

A glass case displaying a vial of BabyBIG, the treatment for infant botulism is shown on Nov. 21, 2025 in Aos Altos, Calif. (AP Photo/Terry Chea)

A glass case displaying a vial of BabyBIG, the treatment for infant botulism is shown on Nov. 21, 2025 in Aos Altos, Calif. (AP Photo/Terry Chea)

Nancy Shine at her home in Los Altos, Calif., on Nov. 21, 2025. Shine is a scientist who donated blood plasma that is used to create the treatment for infant botulism. (AP Photo/Terry Chea)

SIOUX FALLS, S.D. (AP) — Easter is around the corner, and it's time to start thinking about how to decorate your eggs.

Whether you're dying eggs for your table spread or planning to hide them for an egg hunt, it's important to follow food safety guidelines to minimize germs and maximize your egg quality.

Eggs are remarkably long lasting, so there needn't be a giant rush to eat them.

“Stores usually do turn over eggs pretty quickly, so the recommendations is you should consume eggs three to five weeks after you purchase them,” said Kara Lynch, food safety educator with Michigan State University Extension.

There is also a benefit in letting eggs age just a bit, as older eggs can be easier to peel. That's because eggs shrink over time within the shell, creating an air pocket between the egg and the shell.

Egg processors clean eggs before they reach store shelves, but it also is important to thoroughly cook eggs to reduce the risk of foodborne illness, especially salmonella. That bacteria lives naturally in the gastrointestinal and reproductive tracts of chickens, said Kimberly Baker, associate extension specialist at Clemson University.

To cook your eggs, place them in a saucepan, fill it with water and bring it to a boil. After that, put the lid on, turn the heat off and let it sit for about 12 minutes. Some also favor turning down the heat and simmering eggs.

You can vary the time in the hot water depending on a desire for harder boiled or slightly creamier eggs, but the yolk should be pretty solid to be safe. Boiling them for too long can risk creating green sulfur development on the outside of the yolk.

After that, Don Schaffner, food science department chair at Rutgers University, said there are two options.

You can run your eggs under cold water to reduce the temperature. From there, you can color them right away or place them back in the fridge until you're ready. Or, after you've boiled them, you can let them air dry until they've cooled.

The boiling process sanitizes the eggs, and as long as they are kept out of water, Schaffner said, they will remain safe to eat.

“You’ve boiled the egg, you’ve gotten rid of any bacteria that might be in the egg. And now you’ve air-cooled it, right? So it’s going to cool more slowly, it’s probably going to cook more,” he said. “But most importantly, you don’t have to worry about any bacteria from the water getting internalized into the egg.”

Either artificial or natural food dye is OK as long as the dye label says it's food grade. For those keeping track, the U.S. Food and Drug Administration has been updating its guidance and regulations regarding certain dyes.

And no, it's not a problem if the dye seeps through the shell.

“Eggs kind of naturally have their own abilities to absorb only so much,” Baker said.

As you're decorating the eggs and have the eggs outside, she suggested keeping your eggs in an ice bath, so they can stay at a cooler temperature while you're decorating.

Eggs should generally be kept at or below 40 degrees (4.4 degrees Celsius) to minimize the risk of contaminants.

Cooked eggs that weren't air-cooled should spend no more than two hours at room temperature. And that's cumulative, including the time spent decorating and the time spent hiding during the Easter egg hunt.

But if it's particularly warm, then that two-hour rule may be shortened to one hour, Lynch said.

Hard boiled eggs are generally good for about a week in the fridge.

Be careful with your eggs as you handle them.

One of the biggest concerns is making sure your eggs haven't cracked during an Easter egg hunt, making them vulnerable to contaminants. And once the egg has been hard boiled, there's no way to kill bacteria that get inside, Baker said.

“We don’t want to be putting them in the soil or in lawns where pets have gone to the bathroom,” she said.

Whether the eggs are hidden outdoors or in a corner of your home, you should rinse them in cool water before you peel them. And wash your hands, too, just in case the eggs have picked up something.

If the Easter egg hunt means your eggs will be at room temperature for longer than two hours, experts recommended using plastic eggs for the hunt instead of real ones to minimize food safety risk.

“If it’s an outdoor Easter egg hunt at any time, I would say go with the plastic eggs and be safe,” Baker said. “And use your dyed Easter eggs as your centerpiece on your table or your buffet, and enjoy them that way.”

FILE - Painted Easter eggs hang from an Easter Tree in Saalfeld, central Germany, March 30, 2018. (AP Photo/Jens Meyer, File)