Beijing, China: China’s National Health Commission said in a statement that it is investigating a case in which children in a northwestern province may have been vaccinated with expired products. The country’s top health authority sent an investigative team to Shangluo, Shaanxi province, on Sunday, it said.
Some parents whose children received an MMR vaccine at a hospital on Mar 1, checked an app that provides information on vaccines and found that the expiration date was July 14 last year, an online post said on Friday.
MMR prevents measles, mumps and rubella, three common infectious diseases.
Another parent whose child received a DTaP vaccine in April found the expiration date was March 6, the post said.
The vaccine prevents diphtheria, tetanus and whooping cough.
The vaccine was produced in 2016 by Changchun Changsheng Bio-tech Co, a pharmaceutical manufacturer in Jilin province that is under investigation for faking production records of rabies vaccines, a serious violation discovered by the State Drug Administration last month. It also produced a substandard DTaP vaccine that may not provide effective immunization.
Some other parents said they could find no information on vaccines that their children were given for preventing epidemic meningitis or encephalitis, according to the post.
The government of Shangluo responded in a statement on Sunday morning that the city has started an investigation, and all vaccines specified in the post were within their dates of expiration.
The city government said the confusion was caused by mistakes in recording vaccine information on receivers’ booklets.
The city government is investigating who may be responsible and will hold them accountable, it said.
Experts from the Shaanxi provincial health authority and center for disease control and prevention are verifying the initial conclusions of the city, it added.
Shangluo’s center for disease control and prevention did not buy any substandard DTaP vaccines produced by Changchun Changsheng Bio-tech Co, the city’s drug authority said last week.
An official with the city’s publicity department, who asked not to be named, told state media that the investigation team dispatched by the National Health Commission arrived in the city on Monday, but declined to give further details.
Tao Lina, a Shanghai-based public health expert, said experience has shown that vaccines less than six months past their expiration dates can still be effective and safe.
“Vaccines are not as fragile as many imagine,” he said.
It is not clear what, if any, damage long-expired vaccines can cause children, he said.
UPDATE : The Standing Committee of the Political Bureau of the Communist Party of China (CPC) Central Committee on Thursday held a meeting to hear reports on the investigation of the defective vaccine case involving Changchun Changsheng Life Sciences Limited.
The meeting was presided over by Xi Jinping, general secretary of the CPC Central Committee, who attaches great attention to the case and has made important instructions over it on multiple occasions. He stressed that those involved in the case should be held accountable and punished severely according to the law.
Xi also instructed all-out efforts to be made to ensure the bottom line of safety and safeguard the public interest and social stability, according to the meeting.
Under the leadership of the CPC Central Committee, the State Council has held several meetings and sent investigation teams to probe the case.
“So far, the facts of the case and the performance of duties of relevant departments and officials have been basically ascertained,” the meeting said.
“Vaccines are something that concerns public health and national security. The case is a serious offense, in which the vaccine producer violated the law and relevant standards and regulations in pursuit of profits and fabricated false production inspection records.
“A number of local government officials and supervisory departments were found in dereliction of duty. The case resulted in a negative impact and exposed many loopholes, such as inadequate supervision, and reflected institutional defects in the production, circulation and use of vaccines.”
Chinese leaders pledged concrete measures in response to the incident at the meeting.
Participants at the meeting stressed that it is important to improve laws and rules, define and implement regulatory duties, step up on-spot production inspection, and prompt companies to fulfill their own responsibilities. They also emphasized the necessity of establishing mechanisms to trace product quality and safety, and target product risks.
For vaccine production that contains high risks and requires expertise, the participants of the meeting also agreed that it was necessary to clarify the regulatory authority and special inspection agencies should be sent to assist local supervision. A more professional supervisory force will be formed.
Law-breaking companies will pay a much higher price for their illegal activities, according to the meeting. Those who dare to “challenge the bottom line of morality and conscience” will face severe punishment and crackdown, with zero tolerance.
People involved in cases that endanger public safety, such as defective vaccines, will receive severe punishment, including huge penalties and life-long bans in the sector.
Officials will be motivated to earnestly perform their duties, with those derelict in their duties held accountable.
The meeting stressed Party committees and governments at all levels should learn a lesson and take solid action to ensure vaccine quality and safety.
The follow-up work of the incident should be conducted in a proper and orderly manner, including re-vaccination and compensation. The long-term vaccine management system will be improved.
Participants at the meeting agreed to remove Jin Yuhui from his post as vice governor of Jilin Province, who was put in charge of supervisory work over food and drug administration in Jilin Provine since April 2017, and asked Li Jinxiu to resign from his post as vice chairman of the Jilin Provincial Committee of the Chinese People’s Political Consultative Conference. Li was vice governor responsible for supervisory work over food and drug administration in Jilin from December 2015 to April 2017.
The meeting asked Liu Changlong to resign from the post of mayor of Changchun, and Bi Jingquan to resign from the post of the Leading Party Members Group Secretary of the State Administration for Market Regulation and as deputy head of the administration. Bi served as the former head of the now defunct China Food and Drug Administration from February 2015 to March 2018.
It urged Jiang Zhiying, a standing committee member of the CPC Jilin Provincial Committee and secretary of the CPC Yanbian Korean Autonomous Prefecture Committee in Jilin, and Jiao Hong, head of the National Medical Products Administration (NMPA), to make profound self-examinations.
A total of 35 non-centrally-administered officials will be held accountable.
Wu Zhen, former deputy head of the now defunct China Food and Drug Administration and National Health and Family Planning Commission, will be investigated by the CPC Central Commission for Discipline Inspection and National Supervisory Commission, according to the meeting.
It also urged the CPC Jilin Provincial Committee, Jilin provincial government and NMPA to make profound self-examinations to the CPC Central Committee and the State Council.