The Guangdong Provincial Food and Drug Administration (GDFDA) said that it has promptly instructed the Shenzhen Drug Administration to carry out on-site verification at the production enterprise, and has notified the provincial epidemic prevention and control centers (CDCs) in Guangdong, Hunan, and Guizhou to suspend the use of the same batch number of vaccine (which is a nationally-accounted immunization vaccine and is used through the CDC channel). The notification received from the State Food and Drug Administration on December 13, 2013 on the suspension of the use of the two approved vaccine numbers has also been forwarded to the Guangdong Health and Epidemiology Control Department. Any new investigation progress will be announced to the public in a timely manner.

Shenzhen Drug Administration: the vaccine was sold to Hunan and Guizhou. After a preliminary investigation, the recombinant hepatitis B vaccine (brewer's yeast) produced by Shenzhen Kangtai Biological Products Co., Ltd. with batch numbers C201207088 and C201207090 were sold to Hunan Province, Guizhou Province and Guangdong Provincial Center for Disease Control and Prevention, and the inventory is zero. Suspension of sales and use of the vaccine

Shenzhen has taken measures to suspend the sales and use of the vaccine batch in question and to verify its production inspection and sterility assurance after two deaths were reported in Hunan after the recombinant hepatitis B vaccine (brewer's yeast) produced by Kangtai Bio-Products Co.

The bureau has activated the emergency incident handling mechanism at the first time and went to the enterprise for on-site inspection. Shenzhen has followed the State Administration's request to Shenzhen Kangtai Biological Products Co., Ltd. to quickly find out the sales flow of the recombinant hepatitis B vaccines involved in the incident (Lot Nos. C201207088, C201207090), the quantity not yet used, and to take all measures to suspend the sales and use of the above batches.

Request for abnormal toxicity testing

On December 13, 2013, the Shenzhen Municipal Drug Administration said it had not yet found any violation of drug GMP and failure to carry out full testing in accordance with quality standards during the production process of the vaccine in question after inspection. At the same time, the company has been asked to immediately carry out abnormal toxicity checks on the recombinant hepatitis B vaccine (brewer's yeast) of the batch number in question.

The bureau said that in accordance with relevant state regulations, vaccine products must pass the test of the China Academy of Food and Drug Control and obtain a certificate of approval for the batch issuance of biological products before they are put on sale. The recombinant hepatitis B vaccine (brewer's yeast) with batch numbers C201207088 and C201207090 have obtained the batch-issuance certificates of biological products issued by the China Academy for Food and Drug Certification, the bureau said.

Administration of Food and Drug Administration calls for suspension of use of Kangtai's batch-numbered hepatitis B vaccines

The State Food and Drug Administration recently issued a notice calling on the Food and Drug Administration of Hunan, Guangdong, and Guizhou provinces to suspend the use of some of the batch-numbered recombinant hepatitis B vaccines (brewer's yeast) from Shenzhen Kangtai Bioproducts Co.

The notice said that in December 2013, two deaths occurred after the recombinant hepatitis B vaccine (brewer's yeast) produced by Shenzhen Kangtai Bio-products Co. was administered in Hunan province. The General Administration and local authorities are organizing an investigation into the matter. In order to control the risk of using the drug, it was decided to suspend the use of the recombinant hepatitis B vaccine (brewer's yeast) with lot numbers C201207088 and C201207090 from Shenzhen Kangtai Biological Products Co.

The notice said it was found that the products of the above two lot numbers were sold to Hunan, Guangdong and Guizhou provinces, and the relevant regulatory authorities were asked to immediately notify the relevant units under their jurisdictions to suspend their use to prevent similar incidents. The State Food and Drug Administration (SFDA) and the National Health and Family Planning Commission (NHFPC) jointly briefed on the on-site inspection of Shenzhen Kangtai Biological Products Co, Ltd, the results of the sampling and testing of two batches of the products sampled from Hunan, as well as the preliminary investigative and diagnostic opinions of the 18 cases, which are as follows:

I. Testing of the company's products

As of January 14, 2014, the China Food and Drug The China Academy of Food and Drug Administration (CAFDA) conducted tests on six batches of hepatitis B vaccine samples taken by the State Food and Drug Administration (SFDA), which were produced by Shenzhen Kangtai Biological Products Co. The six batches of samples were from Wuhua County Hospital of Traditional Chinese Medicine in Meizhou City, Guangdong Province (batch No. C201207076), Nanwan People's Hospital in Longgang District, Shenzhen City (batch No. C201207086), and Shenzhen Kangtai Biological Products Company Limited (batch Nos. C201205049, C201205051, C201207091, C201206065), with a total of 1315 pcs. The China Academy of Food and Drug Administration (CAFDA) conducted tests on all the items of the above 6 batches of samples, including: identification test, appearance, loading, pH value, aluminum content, in vitro relative potency determination, sterility check, abnormal toxicity check, and bacterial endotoxin check. The test results show that all the test items of the six batches of samples comply with the enterprise registration standards and the national pharmacopoeia standards. After comparison with the batch data, the test results of the six batches of samples are consistent with the results of the same batch of products issued, indicating that the product quality is stable.

Two, case investigation and diagnosis

Everywhere in the report of the 18 cases of Shenzhen Kangtai Biological Products Co., Ltd. hepatitis B vaccine suspected abnormal reaction cases have been completed the investigation and diagnosis of the work. 1 case of severe has recovered from the hospital, the case does not rule out the vaccine-induced anomalous reaction (anaphylactic shock is likely to be large); 17 deaths have been made clear that the vaccine has nothing to do with the vaccine, of which 3 cases of severe pneumonia, 3 cases of anaphylaxis, 3 cases of pneumonia, 1 case of anaphylaxis. Among them, there were 3 cases of severe pneumonia, 2 cases of asphyxia, 2 cases of infantile muffled fever syndrome, 1 case of acute hemorrhagic pulmonary edema and interstitial pneumonia, 1 case of amniotic fluid aspiration pneumonia and acute respiratory failure, 1 case of neonatal pneumonia and respiratory distress in newborns (fetal fecal aspiration syndrome), 1 case of congenital pulmonary small arterial hypertension and respiratory failure caused by amniotic fluid aspiration, 1 case of severe bilateral hydrocephalus and renal failure, 1 case of heavy pediatric diarrhea and severe dehydration, 1 case of severe pediatric diarrhea and severe dehydration, 1 case of severe pediatric diarrhea and severe dehydration, 1 case of severe pediatric diarrhea and severe dehydration, and 1 case of severe pediatric diarrhea. There were 1 case of severe pediatric diarrhea with severe dehydration, 1 case of necrotizing small bowel colitis with gastrointestinal perforation, 1 case of neonatal asphyxia with neonatal sepsis, 1 case of congenital heart disease, and 1 case of sudden infant death.

Comprehensive on-site inspection, product sampling results, quality retrospective analysis, as well as case investigation and diagnosis, did not find that the quality of hepatitis B vaccine produced by Shenzhen Kangtai Biological Products Co.