--- title: How a rare drug made from scientists’ blood saves babies from Botulism date: 2025-12-16T16:25:00-08:00 author: Julie Dueck canonical_url: "https://marlerclark.com/news_events/how-a-rare-drug-made-from-scientists-blood-saves-babies-from-botulism" section: News --- [All News](/news_events) / [Publications](https://marlerclark.com/news_events/publications) / # How a rare drug made from scientists’ blood saves babies from Botulism **Associated Press | By Jonel Aleccia | December 10, 2025** 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](https://apnews.com/article/byheart-formula-infant-botulism-recall-79edcb5ad02cfc5391f3e120cf7c9584). “It is hugely remarkable,” said Barbera, 35, whose son is slowly recovering. The [botulism outbreak](https://apnews.com/article/byheart-baby-formula-botulism-recall-98ad391ac5606c980a012d35f5f7637c) tied to ByHeart formula has sickened at least 39 babies across in 18 states [since August](https://apnews.com/article/byheart-infant-formula-botulism-recall-9971f57a2a218eac4fba53f305dcba3c) — 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 Vishwanath, 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. **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. ![](https://holistic-kudu.transforms.svdcdn.com/production/Nancy-Shine-a-retired-biochemist-in-California_2025-12-17-002417_gfgo.webp?w=1440&h=960&auto=compress%2Cformat&fit=crop&dm=1765931057&s=6b482e484df6399262bc4484e637abc8)Nancy Shine, a retired biochemist, helped develop the Botulism antitoxin, BabyBigThe 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.” **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](https://pubmed.ncbi.nlm.nih.gov/17403850/). 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.” ### Other Botulism Lawsuits [By Heart Infant Formula tied to Botulism Outbreak spikes to 51](https://marlerclark.com/by-heart-infant-formula-tied-to-botulism-outbreak) [Botulism Outbreak at Valley Oak Food and Fuel](https://marlerclark.com/botulism-outbreak-at-valley-oak-food-and-fuel) [Marler Clark Files Two Botulism Lawsuits](https://marlerclark.com/marler-clark-files-two-botulism-lawsuits) ### Lawsuit updates about foodborne illnesses [Reactive Arthritis Lawsuit Updates](/news_events/case-news?illness=reactive-arthritis&year=all) [E. coli Lawsuit Updates](/news_events/case-news?illness=e-coli&year=all) [Guillain-Barre Syndrome Lawsuit Updates](/news_events/case-news?illness=guillain-barre-syndrome&year=all) [Salmonella Lawsuit Updates](/news_events/case-news?illness=salmonella&year=all) [Hemolytic Uremic Syndrome Lawsuit Updates](/news_events/case-news?illness=hemolytic-uremic-syndrome&year=all) [Listeria Lawsuit Updates](/news_events/case-news?illness=listeria&year=all) [Irritable Bowel Syndrome Lawsuit Updates](/news_events/case-news?illness=irritable-bowel-syndrome&year=all) [Hepatitis A Lawsuit Updates](/news_events/case-news?illness=hepatitis-a&year=all) [Norovirus Lawsuit Updates](/news_events/case-news?illness=norovirus&year=all) [Botulism Lawsuit Updates](/news_events/case-news?illness=botulism&year=all) [Campylobacter Lawsuit Updates](/news_events/case-news?illness=campylobacter&year=all) [Shigella Lawsuit Updates](/news_events/case-news?illness=shigella&year=all) [Cyclospora Lawsuit Updates](/news_events/case-news?illness=cyclospora&year=all) ### Lawsuits updates by year [Foodborne Illness Lawsuits in 1998](https://marlerclark.com/news_events/case-news?illness=all&year=1998) [Foodborne Illness Lawsuits in 1999](https://marlerclark.com/news_events/case-news?illness=all&year=1999) [Foodborne Illness Lawsuits in 2000](https://marlerclark.com/news_events/case-news?illness=all&year=2000) [Foodborne Illness Lawsuits in 2001](https://marlerclark.com/news_events/case-news?illness=all&year=2001) [Foodborne Illness Lawsuits in 2002](https://marlerclark.com/news_events/case-news?illness=all&year=2002) [Foodborne Illness Lawsuits in 2003](https://marlerclark.com/news_events/case-news?illness=all&year=2003) [Foodborne Illness Lawsuits in 2004](https://marlerclark.com/news_events/case-news?illness=all&year=2004) [Foodborne Illness Lawsuits in 2005](https://marlerclark.com/news_events/case-news?illness=all&year=2005) [Foodborne Illness Lawsuits in 2006](https://marlerclark.com/news_events/case-news?illness=all&year=2006) [Foodborne Illness Lawsuits in 2007](https://marlerclark.com/news_events/case-news?illness=all&year=2007) [Foodborne Illness Lawsuits in 2008](https://marlerclark.com/news_events/case-news?illness=all&year=2008) [Foodborne Illness Lawsuits in 2009](https://marlerclark.com/news_events/case-news?illness=all&year=2009) [Foodborne Illness Lawsuits in 2010](https://marlerclark.com/news_events/case-news?illness=all&year=2010) [Foodborne Illness Lawsuits in 2011](https://marlerclark.com/news_events/case-news?illness=all&year=2011) [Foodborne Illness Lawsuits in 2012](https://marlerclark.com/news_events/case-news?illness=all&year=2012) [Foodborne Illness Lawsuits in 2013](https://marlerclark.com/news_events/case-news?illness=all&year=2013) [Foodborne Illness Lawsuits in 2014](https://marlerclark.com/news_events/case-news?illness=all&year=2014) [Foodborne Illness Lawsuits in 2015](https://marlerclark.com/news_events/case-news?illness=all&year=2015) [Foodborne Illness Lawsuits in 2016](https://marlerclark.com/news_events/case-news?illness=all&year=2016) [Foodborne Illness Lawsuits in 2017](https://marlerclark.com/news_events/case-news?illness=all&year=2017) [Foodborne Illness Lawsuits in 2018](https://marlerclark.com/news_events/case-news?illness=all&year=2018) [Foodborne Illness Lawsuits in 2019](https://marlerclark.com/news_events/case-news?illness=all&year=2019) [Foodborne Illness Lawsuits in 2020](https://marlerclark.com/news_events/case-news?illness=all&year=2020) [Foodborne Illness Lawsuits in 2021](https://marlerclark.com/news_events/case-news?illness=all&year=2021) [Foodborne Illness Lawsuits in 2022](https://marlerclark.com/news_events/case-news?illness=all&year=2022) [Foodborne Illness Lawsuits in 2023](https://marlerclark.com/news_events/case-news?illness=all&year=2023) [Foodborne Illness Lawsuits in 2024](https://marlerclark.com/news_events/case-news?illness=all&year=2024) [Foodborne Illness Lawsuits in 2025](https://marlerclark.com/news_events/case-news?illness=all&year=2025) [Foodborne Illness Lawsuits in 2026](https://marlerclark.com/news_events/case-news?illness=all&year=2026) ##### Get Help #### Affected by an outbreak or recall? The team at Marler Clark is here to answer all your questions. Find out if you’re eligible for a lawsuit, what questions to ask your doctor, and more. [ Get a free consultation ](https://marlerclark.com/contact) ##### Related Resources ###### [What is Botulism?](https://marlerclark.com/foodborne-illnesses/botulism/what-is-botulism) Botulism is a life-threatening paralytic illness caused by neurotoxins produced by an anaerobic, gram-positive, spore-forming bacterium—Clostridium botulinum. Botulism is a rare disease and only affects a few hundred persons each... ###### [Epidemiology and Microbiology of Botulism](https://marlerclark.com/foodborne-illnesses/botulism/epidemiology-and-microbiology-of-botulism) C. botulinum bacteria and spores are widely distributed in nature because they are indigenous to soils and waters. They occur in both cultivated and forest soils, bottom sediment of streams... ###### [Symptoms of Botulism](https://marlerclark.com/foodborne-illnesses/botulism/symptoms-of-botulism) After their ingestion, botulinum neurotoxins are absorbed primarily in the duodenum and jejunum, pass into the bloodstream, and travel to synapses in the nervous system. There, the neurotoxins cause flaccid... ###### [Detection and Treatment of Botulism](https://marlerclark.com/foodborne-illnesses/botulism/detection-and-treatment-of-botulism) Although botulism can be diagnosed based on clinical symptoms, distinguishing it from other diseases is often difficult, especially in the absence of other known persons affected by the condition. 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