China - Hunan provincial health suspends hepatitis B vaccine from one manufacturer after 2 infants reportedly die & 1 hospitalized

[sharon sanders]

machine translation

Hunan three infants after hepatitis B vaccine the accident two dead
2013-12-14 11:30 Changsha Evening News

　　Reporters on the 13th from the Hunan Provincial health, disease control, food and drug supervision departments that recently vaccinated infants Hunan three serious adverse reactions after hepatitis B vaccine, two of whom died. Medication for the control of risks arising from either the vaccine has now been suspended.

　　Recently, serious adverse reactions Changning, Hengshan County, Hanson County, Hunan Province, a total of three infants after hepatitis B vaccination. Among them, Chang Ning, Hengshan two babies died, Hanson baby still in the hospital intensive care unit for treatment. It is understood that someone's vaccine labeled Shenzhen Kangtai Biological Products Co., Ltd. production of recombinant hepatitis B vaccine (Saccharomyces cerevisiae).

　　Reporters from the Hunan Provincial Health Department and the Food and Drug Administration, Hunan Province was informed that at present, Hunan Province, Hunan Provincial Health Department and the CDC has organized a group of experts to investigate the matter, the result will be announced to the public as soon as possible. Medication to control risk, Hunan suspended Shenzhen Kangtai Biological Products Co., Ltd. and lot number C201207088 C201207090 recombinant hepatitis B vaccine (Saccharomyces cerevisiae). (Xinhua Changsha, December 13 electric reporters handsome before)

　　Recently, Chang Ning Hengyang, Hengshan County, Changde Hanson County three serious adverse reactions in infants after hepatitis B vaccination, which, Chang Ning, Hengshan County, two babies have died, Changde Hanson vaccinated infants still in intensive care unit rescue . Three babies, the biggest eight months, the youngest only a month. They are vaccinated with a hepatitis B vaccine manufacturers. Currently, the provincial CDC highly concerned about this incident, the expert group has been set up in the investigation.

　　8, Hengyang Zhou Chang Ning children vaccinated against influenza and hepatitis. December 9 in the morning, the family found only 8-month-old child has died. Family members suspect that the child's death related to vaccination. Changning CDC staff shows a sample was injected with hepatitis B vaccine - recombinant hepatitis B vaccine. Vaccine manufacturers Biological Products Co., Ltd. is a Shenzhen. Currently, Chang Ning CDC, health and public security departments have been involved in investigating the incident.

　　The accident Coincidentally, two ginkgo Hanson County town of Hengshan County and Prince miaozhen month-old boy also in the vaccinated after hepatitis B vaccine. Hengyang County boy died two days after vaccination, Hanson appeared in shock after infant vaccination, currently in the intensive care unit for treatment. The hepatitis B vaccine they use are Shenzhen, a biotechnology company's products.

　　Yesterday, the provincial CDC establishment of a panel to investigate the matter. Columbia, MD, director of CDC immunization programs Zhang Shujun introduction, Hengshan County children vaccinated after not feeling well, and after a day died suddenly. Chang Ning this case, when the child does not uncomfortable situation, there is no fever and other symptoms, Dec. 9 5:00 o'clock death. This case is Hanson after vaccination, appears pale purple symptoms within one hour.

　　CDC staff Province said that the current CDC expert group has been set up to investigate the matter, once found a problem with the vaccine is injected, immediately discontinue use and Responsibility. Meanwhile, the medical staff if there are irregularities in the injectable vaccine also under investigation. (Changsha Evening News)

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Re: China - Hunan provincial health suspends hepatitis B vaccine from one manufacturer after 2 infants reportedly die & 1 hospitalized

Two more infant Hep.B deaths in China

(Xinhua)
20:18, December 31,

JINAN, Dec. 31 -- Two more newborn babies have died after hepatitis B vaccinations in east China's Shandong Province, the provincial center for disease control and prevention said on Tuesday.

The two cases were in Tancheng and Juancheng counties, the center said.

Local health authorities have suspended use of the vaccines associated with the deaths.
...
At least a dozen newborns have died nationwide after receiving shots against Hepatitis B, arousing widespread concern over the safety of vaccines in China.
...

http://english.people.com.cn/90882/8500868.html

[Biological]

Re: China - Hunan provincial health suspends hepatitis B vaccine from one manufacturer after 2 infants reportedly die & 1 hospitalized

Guangdong Province, Shenzhen Kangtai jointly informed the hepatitis B vaccine distribution company in the province, use and stocks: As of December 23, 2013, the province's total procurement of 6.49 million, distributed to 21 prefecture-level city of Shenzhen Kangtai Company of 6,200,200 hepatitis B vaccine has been used 4,692,717, and the remaining 1,797,283 sealed in CDC vaccination levels and units.
How to determine the hepatitis B vaccine is safe before the
provincial CDC deputy director Deng Huihong introduced the use of the vaccine in our province, every batch has a lot release the State Food and Drug Administration certification.
Hepatitis B vaccine may occur after vaccination slight general reaction: If the pain and tenderness at the injection site, in most cases can disappear within 2-3 days; had a transient fever, swelling and pain, usually last 1-2 days after spontaneous remission; injection site induration generally is self-absorbed in 1-2 months. Extremely rare anaphylactic shock usually occurs within one hour after inoculation; allergic reactions generally occurs around 10 days after inoculation.
Province suspected abnormal reaction to vaccination monitoring shows that this year the province a total of 4,692,717 hepatitis B vaccination, vaccination abnormal reactions were diagnosed 53 cases (the vast majority of mild, severe abnormal reactions one case, severely abnormal reactions was 0.21/100 million); another three cases of suspected deaths in vaccine testing and autopsy results to be comprehensive judgment.
How the vaccine is regulated
Provincial Food and Drug Administration Office of Director Guo Yuhua introduction, food and drug regulatory department of the vaccine production, management implemented strict supervision. Vaccine manufacturers must strictly follow the "Good Manufacturing Practice" (GMP) production, vaccine wholesale enterprises and business units must be strictly in accordance with the use of "drug quality management specification" (GSP) and the "vaccine distribution and vaccination regulations" organization operation and use. Food and drug regulatory authorities as the vaccine regulatory focus species, the need for strict implementation of vaccine production factory batch release system for biological products, each batch of the product shall be subject to verification Institute of Chinese food and drug inspection and batch release certificate issued before listing; regulatory Department for circulating vaccine-site inspection operations more than 2 times per year, 100% coverage vaccine wholesale enterprises in recent years, Guangdong Province, the quality of the event because there is no vaccine circulation and lack of supervision occur.
Why should hepatitis B vaccine within 24 hours
邓惠鸿that neonatal hepatitis B vaccine within 24 hours, is the most effective way of mother to child transmission of hepatitis B block, and also the World Health Organization recommended a common practice in Europe and America and other countries. According to the National Health and Family Planning Commission "vaccination norms", the whole hepatitis B vaccine inoculation required three stitches, according to the 0,1,6-month vaccination program, the first one vaccinated as soon as possible within 24 hours after birth.
From a global point of view of public health practice, vaccination is the most effective prevention and control of infectious diseases means, is a powerful weapon to protect health. Deng Huihong urged the public to science and rational treatment.
Related News video link:
ministries respond vaccinated infants died after six questioned http://news.sina.com.cn/c/2013-12-25/021929072312.shtml Guangdong: Conde hepatitis B vaccine in the province informed the relevant circumstances http :/ / tv.cntv.cn/video/C10616/9c0f8b37a69d49a3a1e1f5b710d5e681 Guangdong Conde hepatitis B vaccine using flow situation in Guangdong http://video.sina.com.cn/p/news/v/20...763298881.html ? qq-pf-to = pcqq.group

http://www.gdwst.gov.cn/a/zwxw/2013122511176.html

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Province four cases of suspected fatal cases of hepatitis B vaccine has nothing to do with the vaccination
2014-01-04 10:07:51 Ministry of Health and Family Planning Commission
January 3, 2014, Jiangmen, Meizhou vaccination expert group investigating the diagnostic center according to Sun Yat-sen forensic autopsy results, combined with epidemiological, clinical data to make a diagnosis, clearly had Jiangmen, Meizhou occurred two cases of suspected Conde vaccinated with hepatitis B vaccine deaths exclude abnormal reaction to vaccination, regardless of vaccination. Jiangmen cause of death cases: 1, acute hemorrhagic pulmonary edema; 2, interstitial pneumonia; 3, cerebral edema. Meizhou cases the cause of death as: 1, acute respiratory failure; 2, amniotic fluid aspiration pneumonia.
Shenzhen, one case of suspected deaths unrelated to determine the initial vaccination, upon completion of the autopsy and other related work, will make the final diagnosis. Previously, Zhongshan one case of suspected deaths have been diagnosed exclude abnormal reaction to vaccination.

http://www.gdwst.gov.cn/a/zwxw/2014010411210.html

[Biological]

Re: China - Hunan provincial health suspends hepatitis B vaccine from one manufacturer after 2 infants reportedly die & 1 hospitalized

WHO: Hepatitis B vaccine immunization program should be fully implemented

Author: QIAO Ning Source: Health News Hits: 54 Update Time :2013-12-30

December 27, the State Food and Drug Administration to the World Health Organization reported on recent incidents of suspected hepatitis B vaccine to prevent the situation vaccination abnormal reactions. WHO emphasized that hepatitis B vaccination is the best way to prevent hepatitis B virus infection, hepatitis B vaccine is generally safe and effective. Hepatitis B Vaccine Immunization Program, China has made hepatitis B virus infection rate of children under five years of age dropped from over 9% to less than 1%. At the same time ensuring vaccine safety, should continue to fully implement planned projects hepatitis B vaccine.

　　WHO representative in China, Dr. Bernhard Schwartl?nder timely and effective reporting on the Chinese government to investigate fully affirmed the work, and expressed their willingness to investigate the incident provided the support and help. It is reported that the State Food and Drug Administration will invite experts to participate in the WHO survey analysis related work.

　　WHO declared its attention to China several suspected neonatal hepatitis B vaccination lethal event, the State Food and Drug Administration and the National Health and Family Planning Commission to suspend the use of hepatitis B vaccine and Shenzhen Kangtai disposal measures launched investigations into the incident support. Chinese government report on the incident and the investigation quickly, reflecting the health and drug regulatory system abnormal reactions and take action to prevent more problems strength.

http://www.hncdc.com/Article/ShowArticle.asp?ArticleID=5720

[Biological]

Re: China - Hunan provincial health suspends hepatitis B vaccine from one manufacturer after 2 infants reportedly die & 1 hospitalized

Prevention of Hepatitis B Frequently Asked Questions

Author: National guard meter ... Source: National Planning Commission website Methodist Hits: 83 Update Time :2013-12-23
First, the immunization program, vaccination contraindications and precautions
　　(a) hepatitis B vaccine immunization program?
　　Full immunization hepatitis B vaccine inoculation totaling 3 pin, immunization program as 0,1,6 months, ie within 24 hours after the first dose of hepatitis B vaccine birth dose, 1 month and 6 months vaccinated 2 and 3 doses of hepatitis B vaccine. First inoculation of hepatitis B vaccine and hepatitis B vaccine throughout the vaccination is critical to ensure that the protective effect. First dose of hepatitis B vaccine required within 24 hours after birth inoculation, and the sooner the better.
　　(B) What is hepatitis B vaccine contraindications?
　　Hepatitis B vaccination contraindications include: the vaccine contains no known ingredients, including excipients, formaldehyde and antibiotic allergies; suffering from acute illness, severe chronic illness, fever and acute exacerbation of chronic diseases; pregnant women; suffering is not Control of epilepsy and other progressive neurological diseases.
　　(C) The hepatitis B vaccine and other vaccines at the same time be able to use it?
　　Hepatitis B vaccine and meningitis vaccine, BCG, DPT, polio vaccine, Japanese encephalitis vaccine, measles-containing vaccine, hepatitis A vaccine inoculation. Hepatitis B vaccine and other vaccines simultaneously vaccinated in different parts to separate vaccination.
　　Second, the immune effect of hepatitis B vaccine
　　(a) protect the time of hepatitis B vaccine?
　　Hepatitis B antibody levels generated after vaccination decreased with time. The higher antibody titers, the longer duration. General vaccination, 1-3 months after injection of 3-pin 97 percent of people can be measured to hepatitis B surface antibody (anti-HBs); still maintain the same level at 1 year after seroconversion rate gradually decreased after the first free Three years can be reduced to about 74%, antibody titers also declined. Currently a lot of information, a protective effect of antibody responses were generally lasts for at least 20 years after hepatitis B vaccination.
　　(B) fully immunized three neonatal hepatitis B vaccine, the antibodies can be detected when?
Newborn fully immunized after 3 doses of hepatitis B vaccine, the general population can not be an antibody (anti-HBs) testing. If the mother is HBsAg positive, newborns need for antibody detection. Select 1 to 5 months after the completion of the hepatitis B vaccine inoculation when the whole blood, because then the highest titer of antibodies, such as anti-HBs <10 mIU / ml, can be inoculated again.
　　(C) the basis for the use of hepatitis B vaccine immunization process, after three doses of vaccine or vaccine production company type is not the same, what the problem work?
　　Different companies or different types of hepatitis B vaccine, different doses of the vaccine, replacing the use of the theoretical results are not affected. However, to ensure that practices, you should use the same brand, same forms of hepatitis B vaccine.
　　(D) after vaccination, the need to strengthen vaccination it?
　　after hepatitis B vaccine is protective antibody responses were better, the general population does not require monitoring or strengthen anti-HBs immunity. World Health Organization nor the hepatitis B vaccine recommendations to strengthen vaccination.
　　Third, hepatitis B two pairs of semi-common positive whether different combinations need to be vaccinated?
　　(A) anti-HBs and anti-HBc positive whether two hepatitis B vaccine?
　　Anti-HBs and anti-HBc positive description of two past infection with hepatitis B virus (HBV), and has produced a protective antibody (anti-HBs), have immunity against HBV, hepatitis B vaccination is not required.
　　(B) anti-HBs, anti-HBe, anti-HBc positive if there are three viral replication? Immunization can do?
　　Above three antibodies, indicating infection with hepatitis B virus (HBV), HBV replication has stopped, have immunity against HBV, hepatitis B vaccination is not required. However, for some patients with recurrent chronic hepatitis, although the present anti-HBs, anti-HBe, anti-HBc positive three still mutant HBV replication possibility exists.
　　(C) There is no need to fight hepatitis B patients with hepatitis B vaccine?
　　Hepatitis B and hepatitis B surface antigen of hepatitis B vaccine does not produce results, it does not require hepatitis B vaccination; against hepatitis B virus infection because the past and now has access to effective protection of natural antibodies by (hepatitis B, "two pairs of semi-" Check in hepatitis B surface antibody positive), there is no need to re-vaccination. But even for those infected with the hepatitis B vaccine inoculation, it will not cause adverse reactions.
　　(D) I was 7 months pregnant mothers, my husband and I are hepatitis B carriers, in which case you should ask after the birth How to prevent hepatitis B infection?
　　For maximum protection newborn child after birth should be vaccinated as soon as possible within 24 hours 100IU of hepatitis B vaccine and hepatitis B immune globulin, and in January and June to complete the full vaccination of hepatitis B vaccine.
　　Four adult focus groups and how the case of accidental exposure hepatitis B vaccine?
　　(A) hepatitis B vaccine priority groups are there?
　　Some focus on the adult population exposure opportunities, high risk of infection with hepatitis B virus, hepatitis B vaccination is recommended. World Health Organization and the U.S. CDC recommended hepatitis B vaccination of priority groups including the need for frequent use of blood or blood products, hemodialysis patients, solid organ transplant recipients, prison inmates, chronic liver disease, intravenous drug users, HIV infection persons with chronic HBV infection and sexual contact with the families of those who have multiple sexual partners, sexually transmitted disease clinic patients, diabetic patients, medical workers and other reasons may be due to occupational exposure to blood and blood products.
　　(B) in case of accidental exposure (eg, needle wounds were contaminated with blood containing the hepatitis B virus, hepatitis B virus or skin is contaminated with stab) How to hepatitis B vaccination?
Should be under different circumstances, take different measures:
　　(1) have not been vaccinated against hepatitis B vaccine were exposed: first injection of hepatitis B immune globulin 200 ~ 400IU (within 12 hours), the sooner the better, but in different parts of inoculation a hepatitis B vaccine, a six month intervals after inoculation doses of hepatitis B vaccine and 2,3. As in the past have had hepatitis B infection detection indicators appear positive for hepatitis B surface antigen, may not vaccinated.
　　(2) If the past has been vaccinated with hepatitis B vaccine, but did not complete the full immunization of exposure, should injection of hepatitis B immune globulin, hepatitis B vaccination program and then complete the three-pin full immunization.
　　(3) vaccinated with hepatitis B vaccine and hepatitis B surface antibody has been generated exposure, should be based on their antibody levels. If hepatitis B surface antibody levels ≥ 100 mIU / ml, can not handle; <100 mIU / ml who injected a dose of vaccine should be strengthened; If the primary immune response should be as soon as possible without injection of hepatitis B immune globulin, a dose of 200 ~ 400IU, while In different parts of the injection of the first dose of hepatitis B vaccine at intervals of 1 and 6 months after inoculation, 3 doses of hepatitis B vaccine.
　　Fifth, the use of hepatitis B immune globulin
　　hepatitis B immune globulin is isolated from healthy blood donors out of their plasma containing high titers of anti-HBs, made through the enrichment process, the better for hepatitis B virus immunization.
Generally in two situations:
　　(1) blocking the mother to child transmission, HBsAg-positive mothers newborns within 24 hours after birth injections of immunoglobulin 100IU ~ 200 IU, and in accordance with the completion of the hepatitis B vaccine immunization program 3 needle inoculation of mother to child transmission of hepatitis B virus blocking with good effect.
　　(2) such as doctors, nurses and other patients in treatment for hepatitis B, when nursing or blood, careless fingers are stained with the blood of hepatitis B virus piercing, inhaled, splashed into the wounds, mucous membranes, etc., should be immediately given by those exposed to hepatitis B Hepatitis B immunoglobulin 200 IU, spaced one month after the second dose, while hepatitis B vaccination three needle times, can play to prevent infection.

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