When Alessandro Barbera was rushed to a California hospital last October, suffering from infant botulism, his father, Tony, had little knowledge of the rare and potentially deadly disease. Now, however, he expresses profound gratitude for BabyBIG, the sole antidote that likely saved his newborn son’s life.
"It is hugely remarkable," said Barbera, 35, whose son is now slowly recovering. Alessandro’s case is one of at least 39 infant botulism infections across 18 U.S. states since August, linked to contaminated ByHeart infant formula.
This outbreak has underscored the critical value of BabyBIG, a treatment derived from blood plasma donated by a dedicated group of scientists and volunteers.
"This is almost like a miracle," stated Dr. Vijay Viswanath, a pediatric neurologist at Children’s Hospital Los Angeles, who has treated several children with botulism, including one in the current outbreak.
He added, "Prior to the discovery of BabyBIG, some of these hospitalisations would take two or three months," if infected children recovered at all.
Licensed in 2003, BabyBIG is the brand name for human botulism immune globulin, an intravenous medication that uses antibodies from volunteers vaccinated against botulism to aid babies too young to fight the disease independently.
The treatment was the brainchild of the late Dr. Stephen Arnon, a scientist with the California Department of Public Health. In 1976, Arnon and his colleagues identified the rare form of botulism affecting infants younger than one year old, dedicating his 45-year career to finding a cure.
The disease occurs when babies ingest botulism spores that germinate in the intestine, producing a dangerous toxin that attacks the nervous system.
More than 3,700 children worldwide have received BabyBIG since Arnon’s team conducted a pivotal clinical trial in California in 1997. This trial demonstrated the medication’s ability to 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 exclusively used to fund the botulism program.
The medication relies heavily on donors such as Nancy Shine, a 76-year-old retired biochemist in California. Shine was vaccinated against botulism due to her work with the lethal germ in a laboratory. Arnon first recruited her and other scientists for the BabyBIG project two decades ago, recognising their blood produced high levels of antibodies – the blood proteins that neutralise the botulism toxin.
The early protocol required volunteers to receive booster doses of an investigational botulism vaccine, also used by the US military, followed by a procedure to harvest the blood plasma containing 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." Despite this, 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," she said. "We made a product that could save infants’ lives."
Developing BabyBIG faced substantial hurdles. Infant botulism is rare, with fewer than 200 cases reported in the US each year, meaning securing funding and resources took nearly 15 years and $10.6m, as Arnon noted in a 2007 article.
Today, approximately 30 individuals on average provide plasma for each batch of BabyBIG, California health officials confirmed. Batch 8, the latest edition, is currently being manufactured at a Takeda Pharmaceutical Co. plant near Los Angeles.
Giles Platford, president of the company’s plasma-derived therapies unit, stated that Takeda contracts with California officials to produce BabyBIG on a "not-for-profit basis."
Some of the earliest donors, like Shine, have aged out of the BabyBIG programme, which collects blood from adult volunteers up to 70 years old.
New donors are accepted, but they must enrol 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.
However, the ByHeart outbreak is part of a worrying rise of at least 107 infant botulism cases treated in the US since August, according to Dr Jessica Khouri, senior medical officer for the state programme.
Ms Shine recently received a booklet filled with photos and letters from families whose children 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."
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