vaccine incident is an important issue related to the future of children in the motherland. A while ago, it aroused strong concern and condemnation from the society. So what's the latest progress? Follow Xiaobian to get to know it.
According to the spokesman, in 2017, the former CFDA China food and Drug Control Institute found that the potency index of pertussis vaccine with batch number of 201607050-2 produced in Wuhan biological production did not meet the standard, while that of diphtheria and tetanus did. Relevant information was released to the public on November 3, 2017. Through on-site inspection and retrospective analysis of the enterprise, the main reason for the unqualified titer of this batch of vaccine of Wuhan Biological Engineering Co., Ltd. is the short-term failure of the subpackage equipment, resulting in the uneven suspension of the products to be subpackaged, which belongs to sporadic.
What measures have been taken after finding that the titer index of Wuhan biological DPT vaccine is unqualified? The spokesman said that after finding that the titer is unqualified, the former State Food and Drug Administration will send an inspection team to conduct a comprehensive on-site inspection of the enterprise, and work together with the former national health and family planning Commission to deploy the disposal of unqualified DPT vaccine. Hubei food and Drug Administration will enter Wuhan biological The enterprise timely sealed and recalled unqualified vaccines. It is found that in 2016, Wuhan Bio Technology Co., Ltd. produced 201607050-2 batches of substandard vaccines with a total titer of 400520, sold 190520 to Chongqing Center for Disease Control and prevention, and sold 210000 to Hebei Center for Disease Control and prevention. The enterprise recalled all unused vaccines and destroyed them under the supervision of Wuhan food and Drug Administration on May 4, 2018.
According to the introduction, according to the requirements of the former State Food and drug administration, Hubei food and Drug Administration supervised the rectification of enterprises, Wuhan biology strengthened the maintenance of key process equipment, ensured the normal operation of the equipment, revised the sub packaging procedures, strengthened the quality control of the sub packaging process, strengthened personnel training, improved personnel quality awareness, and ensured the effective operation of the quality management system. CFDA conducted sampling inspection on other batches of DPT vaccine within the validity period of the enterprise, and the inspection results met the requirements. In the subsequent batch issuing work, the titer of 30 batches of DPT vaccine produced continuously by the enterprise was tested, and the results all met the requirements. In March 2018, the former State Food and Drug Administration sent another inspection team to inspect the rectification of Wuhan biological diphtheria vaccine. The enterprise has completed the rectification, which conforms to the GMP.
In terms of punishment, the spokesman said that the former State Food and Drug Administration required the local food and drug administration to punish Wuhan bio in accordance with laws and procedures. On May 29, 2018, Wuhan food and Drug Administration decided to confiscate illegal income and fine Wuhan bio in accordance with relevant laws and regulations of the drug administration law.