July 31, 2018
3 min read

Chinese vaccine manufacturer blunder could increase vaccine hesitancy in US

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Paul Offit
Paul A. Offit

Changchun Changshen Life Sciences Ltd., a vaccine developer located in Changchun, China, has distributed approximately 250,000 substandard vaccines intended for the prevention of diphtheria, tetanus and pertussis in children, according to the Chinese state media outlet CGTN .

Additional reports revealed that the company — the second-largest developer of rabies immunizations in the country — falsified documents related to the production and inspection of approximately 113,000 rabies vaccinations. The company has ceased all production of the rabies vaccine and issued a recall of all substandard doses. No injuries have been reported.

“We will resolutely crack down on illegal and criminal acts that endanger the safety of peoples’ lives, resolutely punish lawbreakers according to the law, and resolutely and severely criticize dereliction of duty in supervision,” Chinese Premier Li Keqiang wrote in a statement. He said the actions taken by the company “crossed a moral line.”

The company has issued an apology for its actions, acknowledging their guilt and embarrassment. They have agreed to cooperate with regulatory agencies to complete a full internal investigation.

Although vaccines from Changchun Changshen Life Sciences Ltd. are not used in the United States, parents may have concerns about the contents of vaccines in this country and the regulatory process by which they are approved, according to Paul A. Offit, MD, director of the Vaccine Education Center and attending physician in the division of infectious diseases at Children’s Hospital of Philadelphia.

“Vaccines are a victim of their own success,” Offit told Infectious Diseases in Children. “It is not surprising that parents of young children today are hesitant to give their children vaccines in the first few years of life to prevent diseases that we do not see anymore using biological fluids that most people do not understand.”

Offit believes that the Chinese manufacturer’s concerns are related to potency, not safety.

The U.S. FDA states on their website that because biological products undergo complex manufacturing processes, every lot of vaccines is examined by their manufacturer using tests outlined in their license application. The manufacturer then supplies the FDA with a sample of every licensed vaccines lot and results of the testing, which include information on potency, safety and sterility. Once the lot has been approved by the Consumer Affairs Branch of the FDA, it can then be released for distribution.

“[U.S.] vaccines are the safest, best-tested things that we put into our body,” Offit said. “They are invariably tested in prospective, placebo-controlled trials in tens of thousands of children before licensure. After licensure, they are subject to the Vaccine Safety Datalink, which is a linked, computerized medical record system that involves about 9% of the U.S. population. As vaccines roll into this country, we know very quickly who has gotten them, who has not, and if there is a safety problem related to them.”

Offit mentioned that in addition to the safety of vaccines distributed within the U.S., the regulatory process that these products go through is strict because they are intended for healthy children and adults. He said that people who are hesitant to have their child vaccinated tend to be less hesitant to use products that do not have as thorough a regulatory process.

“It amazes me to some extent that people can pick up a bottle of vitamins, which are not regulated by the FDA, and have a full sense of security with these products. For whatever reason, people are frightened by products that are regulated,” Offit said. “I understand that it is frightening to watch your child be injected with a biological fluid, but they should know that those are highly regulated products.” – by Katherine Bortz


BBC: Chinese Premier Li Keqiang calls for crackdown on vaccine industry. https://www.bbc.com/news/world-asia-china-44920193. Accessed July 30, 2018.

TIME: Outrage in China over latest vaccine safety scandal. http://time.com/5345677/china-rabies-vaccine-changsheng-outcry/. Accessed July 30, 2018.

U.S. FDA: Vaccines Licensed for Use in the United States. https://www.fda.gov/biologicsbloodvaccines/vaccines/approvedproducts/ucm093833.htm. Accessed July 30, 2018.

U.S. FDA: Vaccine Safety Questions and Answers. https://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/VaccineSafety/ucm133806.htm. Accessed July 30, 2018.

Disclosure: Offit reports no relevant financial disclosures.