China is currently facing a tragic vaccine scandal, where it was recently discovered that Chinese vaccine manufacturers provided hundreds of thousands of faulty and falsely documented vaccines to Chinese school children. The scandal has incited widespread fury both in China and abroad, prompting the country’s President, Xi Jinping, to describe the incidents as “vile and shocking.”
China’s Food and Drug Administration (CFDA) has launched an investigation into vaccine manufacturer Changchun Changsheng Biotechnology, revoking its license for human rabies vaccines and beginning a recall of all unused vaccines produced by the company.
Many of the defective vaccines were already on the market and being given to Chinese children, as part of the mandatory national vaccination program. A number have now been recalled, but there is no information at this stage as to how they could affect the health of those children who have already been injected.
Under China’s ‘Made in China 2025’ plan, pharmaceuticals are a target industry: President Xi has identified China’s reliance on imported drugs as an issue that can be resolved by overhauling the pharmaceutical industry and ultimately creating globally competitive firms.
Unfortunately, this is not the first time that China has faced scandals involving counterfeit vaccines. In 2015, Shandong Province authorities acknowledged the 2015 arrest of a mother and daughter accused of illegally selling $88m worth of vaccines across 20 provinces since 2011 including Beijing, Shenzhen, Guangzhou, and other big cities and provinces.
The details of the scandal illustrate the complexities of vaccine fraud. Main suspect Pang Hongwei, a former pharmacist at a hospital in Shandong, and her 21-year-old daughter were found illegally selling 12 different kinds of vaccines, two kinds of immune globulin and one kind of therapeutic product across the country. The investigation later found a trade ring surrounding Pang with 300 illegal distributors across 24 provinces and regions selling vaccines that were used in children and elderly.
The investigation noted that the illegal trade ring allegedly kept the vaccines at home, at temperatures of about 14 degree Celsius, much higher than the required 2 to 8 degree Celsius when storing and transporting vaccines. The storing of vaccines at improper temperatures can make them ineffective or even harmful when used.
As public outrage mounted over the scandal, top Chinese leaders stepped up their involvement. Chinese Premier Li Keqiang was quoted as saying Wednesday there would be “no leniency” for those involved.
As a result, 324 suspects were arrested, and 100 officials have been put under investigation under suspicion of taking bribes, abuse of power, and negligence, according to the authorities.
Notably, as these vaccine scandals ravaged much of China, Shanghai remained immune from such tragedies. The province’s inoculation to the vaccine scandal was not an accident. Shanghai is a leader in the regulation and monitoring of medical vaccines, and maintains high standards of quality control to ensure the safety and effectiveness of vaccines as they are manufactured and distributed.
In 2017, the Shanghai Municipal Commission of Commerce published ‘Shanghai Municipality Product Traceability System Construction Demonstration Support Project,’ which revealed that Shanghai’s success at assuring vaccine quality standard. Notably, VeChain’s traceability solution was the only blockchain project selected and supported by the Shanghai government.
DNV GL, an equity owner in VeChain, provides certification services for big pharma companies and hospitals in Shanghai, such as:
- Shanghai First Maternity and Infant Hospital
- Children’s Hospital of Shanghai
- American-Sino OB/GYN/Pediatrics Services
- Shanghai Redleaf International Women’s and Children’s Hospital
- Shanghai Jiaotong University Renji Hospital and
- Shanghai Pharma
The DNV GL Healthcare certifications issued cover a broad range of healthcare standards and include:
Provides a framework for healthcare providers looking to identify and control their environmental impact.
Improving quality and enhancing patient safety through the implementation of a quality management system is the best way to provide patient-centered care. ISO 9001 provides a model for a quality management system which focuses on the effectiveness of clinical, business and support processes to ensure high-quality care is provided. The standard promotes the adoption of a process approach emphasizing the requirements, added value, process performance and effectiveness, and continual improvement through objective measurements.
ISO/IEC 27001 is an internationally acknowledged management system standard for information security. By implementing an information security management system compliant with ISO/IEC 27001 you ensure that your organization identifies and mitigates the risks related to handling sensitive and vital data. A certified management system is compliant with applicable national legislation and international best practice. Certification assures patients, authorities and other stakeholders that you are handling all relevant information security aspects.
Drug and Vaccine Traceability Solution Developed by VeChain and DNV GL
VeChain, in partnership with DNV GL, is leveraging public blockchain technology to rapidly advance drug traceability, monitoring, security, and auditing. In 2016, the State Council issued the National Informatization Plan for the Thirteenth Five-Year Plan, in which blockchain technology was included. Now two years later, blockchain technology has developed under the support and guidance of state-provided resources and policy. VeChain is the only approved blockchain traceability provider in Shanghai and has been tasked to achieve the China traceability requirements by 2020. VeChain’s traceability solution is being developed and tested in Shanghai, and will soon be rolled out across China.
In VeChain’s drug and vaccine traceability solution, highly sensitive IoT devices capture and record to the VeChainThor Blockchain all data involved in vaccine manufacture and transport including getting vaccines from manufacturers, storage facilities, cold chain distribution, hospitals, and even usage. While ensuring the reliability of the data source, VeChain’s solution also eliminates the potential risks in the whole process and ensures that vaccine records are immutable and permanent.
The display system of VeChain’s intelligent temperature tracking platform
VeChain in-house developed temperature tracking IoT device (41mm*55mm*9mm)
The production data and transportation temperatures for vaccines need to be strictly monitored because vaccine composition and storage temperature directly affect vaccine effectiveness.
VeChain’s vaccine traceability solution will mitigate future vaccine manufacturing scandals through:
1. Accurate backtracking and accountability
In the event of a future manufacturing emergency, the verified data stored in the VeChainThor blockchain can help regulators backtrack data and provide evidence dictating responsible parties for any incident. At the same time, this solution helps compliant companies prove their innocence.
2. Targeted recall and disposal
Pinpoint and recall products in question and reduce unnecessary waste of resources.
3. Real data-based early warning and risk management to enable targeted monitoring of potentially responsible parties.
Find problems before they impact the public, and take measures before the crisis escalates, and focus on monitoring high-risk links.
4. An exclusive ID for each vaccine
Based on the VID on the VeChainThor blockchain, each dose of a vaccine will be labeled with a unique identifying code, and end users can scan the code retrieving a complete history of the product.
Blockchain technology can prevent, if not eliminate, future vaccine scandals, and most importantly offers a means to quickly lessen the damage by identifying and correcting the source of the problems. By using blockchain to record and review the data from medicine and manufacturing and delivery, the confidence of the Chinese people in their country’s medical products can be restored.
The VeChain vaccine traceability solution will be shown alongside other VeChainThor Powered solutions at the China International Import Expo — one of the highest-profile import/export conferences in the world. VeChain and DNV GL will participate in this event and showcase the blockchain assurance solutions developed together, such as cold chain logistics and MyStory. Their attendance is occuring at the specific request of the Chinese government, who wishes to highlight the state-backed collaboration with VeChain and DNV GL. President Xi Jinping will be in attendance.
DNV GL and VeChain have taken immense strides in advancing medical standards and security in China. The solutions created in their collaboration have been nurtured by the Chinese state, but they will not be isolated to China alone. The blockchain solutions engineered by DNV GL and VeChain will soon span the globe, as the products and solutions rolled out for China’s government and enterprises are only the initial components of a much larger plan.