How a rare drug made from scientists' blood saves babies from botulism
[December 10, 2025]
By JONEL ALECCIA
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.
Treatment relies on donors
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.
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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)
 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.”
Development faced hurdles
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.”
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