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\u2019s life.<\/p>\n
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<\/a>.<\/p>\n \u201cIt is hugely remarkable,\u201d said Barbera, 35, whose son is slowly recovering. <\/p>\n The botulism outbreak<\/a> tied to ByHeart formula has sickened at least 39 babies across in 18 states since August<\/a> \u2014 and showed the value of the treatment made from blood plasma donated by a small group of scientists and other volunteers.<\/p>\n \u201cThis is almost like a miracle,\u201d said Dr. Vijay Viswanath, a pediatric neurologist at Children\u2019s Hospital Los Angeles, who has treated several children with botulism during his career \u2014 including one in the current outbreak. <\/p>\n \u201cPrior to the discovery of BabyBIG, some of these hospitalizations would take two or three months,\u201d Viswanath said, if infected children recovered at all.<\/p>\n 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. <\/p>\n Treatment relies on donors<\/p>\n 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 \u2014 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.<\/p>\n 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.<\/p>\n 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.<\/p>\n 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.<\/p>\n 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. <\/p>\n \u201cIt was not very pleasant to be vaccinated with,\u201d Shine recalled. \u201cThere were a lot of side effects, like big welts where you got vaccinated and a little bit of pain.\u201d<\/p>\n Still, Shine contributed to three batches of the antitoxin produced between 2008 and 2019. <\/p>\n \u201cIt\u2019s probably the highlight of my career that I actually was able to participate in this project and donate plasma,\u201d Shine said. \u201cWe made a product that could save infants\u2019 lives.\u201d<\/p>\n Development faced hurdles<\/p>\n