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Hepatitis B Vaccine Kills Baby and other Vaccine Death Cases

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Baby dies after injection of Hepatitis B vaccine

A 44-day-old baby, named Nguyen Ngoc Minh, died around 2 p.m. on Friday, six hours after having been injected with Hepatitis B vaccine at Ngoc Thuy Ward medical station in Hanoi’s Long Bien District.

According to Dr. Nguyen Thi Thuy, director of Long Bien District Preventive Health Center, the baby’s family agreed to let the Forensic Department conduct an autopsy on the infant to determine the cause of death.

The center also demanded the Bac Giang General Hospital to temporarily cease using the Euvax B vaccine, as well as requesting health officers monitor the health of the 193 babies who were also injected with the vaccine, produced by South Korean-based LG Co.

Source: Thanhniennews.com, news report, 6th January 2008.

Note, the ingredients of this children's vaccine are:


Aluminum hydroxide, Thimerosal , Yeast, Sodium chloride, Sodium phosphate-monobasic, Virus: Hepatitis B, Potassium phosphate.

Although thimerosal in children's vaccines was phased out in America in 2001, I have found Aventis Pasteur data sheets dated 2003 which list thimerosal in countries other than America.

Thimerosal is also used in the manufacturing process of most vaccinations and according to the manufacturer's, may still contain trace elements of the mercury derivative, even if it is labelled as mercury free.

Baby Girl Dies 12 Hours after Vaccination

A five-month-old infant, Surya, died nearly 12 hours after she was administered the first dose of the DPT, Oral Polio and Hepatitis B vaccines on Wednesday.

Authorities at the Institute of Child Health, Egmore, declared her dead on arrival last night. The parents chose not to file a police complaint and refused to allow post-mortem. Public health officials said it was unlikely to be a vaccine death because the most common cause, anaphylactic shock, would occur within an hour of vaccination.


Editor's Comment: the latent phase, where side-effects occur later is well documented in medical literature. For instance, professionals say that adverse reactions to MMR are more likely to happen 10 to 14 days after the shot.

Two Month Old Boy Dies after Vaccinations

A two-month-old boy died allegedly after being administered three immunisation injections at a government dispensary in Sonepat on Wednesday. The hospital authorities kept the body at the civil hospital's emergency room for post-mortem. Police have started investigations after receiving a complaint from Pooja, the victim's mother.

The police said Pooja alleged in her complaint that her son was administered three injections by an employee of the health department at the dispensary on Wednesday and as she reached home, the child started vomiting and bleeding through nose profusely.


She said when she took the child to a nearby nursing home, doctors declared him brought dead.
Sonepat SMO JS Poonia said: "Immunisation injections are administered for DPT, hepatitis and BCG, but in this case, real reason behind the death of the child would be known after the post-mortem reports are out."

Source: Hindustan Times, 19th September 2012.  http://www.hindustantimes.com/Punjab/Chandigarh/Two-month-old-boy-dies-after-vaccination/SP-Article1-932656.aspx

Vaccine Killed My Baby

I believe my only child, Samantha, died from childhood vaccinations. Her immune system gave in after she was given the shots.



Parents can waive those shots, citing their own religious convictions, if written on paper and given to the schools.


If parents had their children vaccinated, they should give them lots of vitamin C, since vaccinated children seem to be prone to lots of infections, asthma and SIDS, for example.


To learn more about the side effects of these shots, contact the National Vaccine Information Center, 407 Church St. Suite H, Vienna, VA 22180.


Beverly Trask.

Source: Kennebac Journal, 9th November 2012.  http://www.kjonline.com/opinion/learn-about-vaccines-before-children-get-them_2012-11-07.html

Indian Doctors Warn Against Mass Vaccination after Infant Deaths

A series of infant deaths after receiving the pentavalent vaccine had prompted doctors and academicians to write to the centre against its mass use. Now, the Indian Academy of Pediatrics (IAP) has issued a statement commending the government's efforts in providing free pentavalent vaccines and calling the fears as unfounded.

The pentavalent vaccine is supposed to provide protection against five life-threatening diseases - Diphtheria, Pertussis, Tetanus, Hepatitis B and Hib (Haemophilus influenza type b). While, the DPT (Diphtheria, Pertussis, Tetanus) and Hepatitis B are already part of the national routine immunization programme, the union government has recently added the protection against Hib. The combination together is called pentavalent. The centre had recently introduced the vaccine in Haryana, Goa, and Pondicherry after Tamil Nadu and Kerala.

Three infants had reportedly died in the past one month in Kerala after receiving the vaccine, while one death was also reported from Haryana this month.

Source: The Times of India, 25th January 2013.  http://articles.timesofindia.indiatimes.com/2013-01-25/mumbai/36547228_1_pentavalent-vaccine-hib-pneumonia-and-meningitis

Vaccine Suspected to Have Killed at Least 13 Infants

ON JANUARY 10, a day after a 42-day-old was administered pentavalent vaccine in Kerala, the infant developed fever and died. This was a repeat of what happened at Chalakudy Taluk Hospital on December 30. A 47-day-old was injected the same vaccine; it slept at night but did not wake up. Parents of both the infants suspect the vaccine caused the deaths. A doctor at the forensic department of Thrissur Medical College, where the post-mortems were conducted, said on condition of anonymity that the vaccine may be the cause as there was no other reason for the death.


At least 13 deaths have been reported from Kerala, Tamil Nadu and Haryana, all pointing towards pentavalent vaccine. Demanding analysis of mortality data from the two states, academicians, health activists and paediatricians wrote a letter to the health secretary, Ministry of Health and Family Welfare, on January 15. They pointed out that the National Technical Advisory Group on Immunization (NTAGI) had stated that the vaccine would be extended to other states only after data from Kerala and Tamil Nadu were reviewed and the vaccine was proved safe.

Source: Down to Earth, 15th February 2013 - http://www.downtoearth.org.in/content/pentavalent-takes-its-toll

Grandson Died after Vaccines

Testing for safety and effectiveness of vaccines leaves a lot to be desired.  2:  Vaccine makers are protected at the federal level from being sued over adverse vaccine reactions.  3.  Doctors don't like it when you ask them to sign a paper taking 100% responsibility for any and all adverse vaccine reactions.

Perhaps the lawmakers would like to take 100% responsibility for all adverse reactions that occur with this forced, one size fits all vaccine bill.  


I lost a grandson who's death was mis-relegated to SIDS; he was perfectly normal until well baby check, he got sick shortly after and within the month he was dead.  I  spoke with a nurse who's own grand-daughter was severely damaged by the shots given at well baby check.  She told me that she attends the doctors visits with her daughter and grand-daughter at Doernbecher's and has spoken with dozens of parents from all walks of life who say the same thing; "My baby was perfectly fine and healthy until well baby check."  


Neuro-toxins have no place in the human body, and aluminum and mercury are just two of many nasty ingredients that we are subjected to when getting vaccines.  I personally have had many serious issues because of mercury and aluminum; (mostly due to silver amalgam fillings, and vaccines in the service) the road to recovery is slow and long.  


It is my opinion that kids who are vaccinated should have their vitals checked before the jabs, and at regular intervals for thirty days following the jabs, and keep it independent from the vaccine makers.  That is the only way any real research is going to get done.

Source: Comment on 'Testimony Heard over Vaccine Exemptions for Children' article, Katu.com Politics, http://www.katu.com/politics/Testimony-heard-over-vaccination-exemptions-for-children-191958381.html#comments

Four-day-old baby dies after vaccination

A four-day-old baby girl died after allegedly being administered hepatitis vaccine at the Government hospital here, officials said today.


The baby's parents in a complaint to the Government College dean Soundararajan said the vaccine was given yesterday and the infant died within half-an-hour.

The spot where the vaccine was injected turned pale and the baby died, the parents said.
Officials are verifying if the vaccine was properly refrigerated or had expired.

Source: Deccan Herald, 16th February 2013.  http://www.deccanherald.com/content/312503/four-day-old-baby-dies.html

Month-old baby dies hrs after vaccination

High drama was witnessed at Thane Civil Hospital on Monday, after a month-old baby girl, Ayushi Gupta, died a few hours after she was administered oral pulse polio drops along with Hepatitis B vaccine and DPT (diphtheria, pertussis and tetanus) vaccine.

The baby’s parents, Amit and Lata, who reside at Mahagiri Koliwada in Thane, blamed the vaccination for her sudden death, and a complaint of negligence has been filed at the Thane Nagar Police Station.

A post-mortem was conducted, but doctors have reserved the cause of death and the deceased’s viscera have been sent for chemical analysis at Kalina’s Forensic Science Laboratory (FSL).

Amit Gupta, who is employed at a garment shop, said his baby was due for the first doses of vaccination, and was unwell when they took her to the hospital. “She was coughing but the doctor at Thane Civil Hospital who examined her said it was because of the change in weather,” Amit said.

The girl’s parents said she was administered two injections (Hepatitis B vaccine and DPT), and the polio vaccine was administered orally. “As soon as she was vaccinated, she started crying,” said Amit, adding that the doctors said she may cry the entire day due to the vaccination and that it was a “common side-effect”.

The nurse advised Ayushi’s mother to feed her after two hours. “We brought her home and fed her milk around two hours later. Around 7 pm, her eyes were shut and we assumed that she had fallen asleep,” Amit said, “When my wife tried to wake her up, she did not move.”

Ayushi was rushed to Maltibai Hospital where the doctors declared her dead on arrival. “They told us she had died more than an hour ago,” said an inconsolable Amit, who has another daughter, aged four.

Senior Inspector P Thorat from Thane Nagar Police Station said, “We have recorded statements of the doctors and the nurse who administered the vaccines. We have also checked the batch of the vaccination. However, Gupta’s complaint will be converted into FIR after we get the chemical analysis report, which may take up to amonth or even more.”

The hospital’s medical superintendent, Dr R B Kulkarni, said that 22 infants were administered vaccines on the same day as Ayushi. “None of them were brought in with any complaint. It seems to be an odd case where the baby may have had some health problems,” said Kulkarni.

Medical experts say adverse effects after routine immunisation are rare as the vaccines have been modified over the years. Dr Preetha Joshi, neonatologist from Kokilaben Ambani Hospital, said: “Fever, shivering and excessive crying are common. Death due to a vaccine is very rare.”


Source: Mumbai Mirror, 22nd February 2013.  http://www.mumbaimirror.com/article/2/20130222201302220404477967d807e2d/Monthold-baby-dies-hrs-after-vaccination.html

VAN UK's Comment: Death after vaccination is considered rare because whenever it happens doctors pass it off as 'coincidence' or say the child was suffering with something else.

Pentavalent vaccine: Doing more harm than good?

Jacob Puliyel, Head of Pediatrics, St Stephens Hospital Delhi, questions whether the time has come to stop using Pentavalent vaccine for immunisation


Immunisation with the new Pentavalent vaccine resulted in the recent death of two babies in Kerala. This combination vaccine was to replace the trivalent DPT (against diphtheria, whooping cough, tetanus vaccine) and additionally protects against Haemophilus influenzae type b and Hepatitis B. The post mortem certificate in both babies stated: “Based on the findings in the autopsy, preliminary reports of microbiological and histopathological findings, no definite opinion as to the cause of death can be furnished. Death due to natural disease, injury and aspiration pneumonia are ruled out. However, death as a result of post vaccination sequelae could not be ruled out.”1


Vaccines are administered to a large number of healthy children to protect against illness and death. The autopsy reports suggest that the vaccine was the most likely cause for the deaths but stopped short of saying the vaccine definitely caused the deaths.


All drugs have side effects, it has to be decided if the adverse effects are unacceptable. As children die from other reasons, unrelated to the vaccine there it is possible that coincidentally children may die of other disease on the day they were immunised. However for children noted as dying after pentavalent vaccine no ‘alternate and sufficient cause’ was found to explain the death in spite of diligent investigations. Even if no alternate cause of death is established the possibility of ‘Sudden Infant Deaths Syndrome’ (SIDS) exists where deaths happen without explanation.


Deaths in several countries where the vaccine is used


The two deaths whose autopsy reports are discussed above are not the only deaths associated with this vaccine. This vaccine is used mostly in developing countries. There were eight deaths in Bhutan.2 There were 25 instances of serious adverse events in Sri Lanka including five deaths.3 There were three deaths in Pakistan.4 There were 10 children who suffered serious adverse events of whom seven died in Vietnam.5 There were at least 15 deaths in Kerala6 and two in Tamil Nadu7 and one in Haryana8 making the total 18 deaths in India. These deaths, in different countries using vaccine from varied manufacturers, rules out defects in some specific batch of the vaccine, and also indicate that they are unlikely to be because of incorrect administration of the vaccine. The WHO considers two deaths due to vaccination as a cluster9 that mandates rapid evaluation of the risk to public safety.10 That there are 41 deaths are a matter of serious concern. Should the programme be now suspended?


Infant mortality rate and coincidental death on day of immunisation


Information obtained under the right to information suggests that in the first six months, when the vaccine was administered to 40,000 children in Kerala, five children died. If this is extrapolated and the 25 million babies in India born each year are vaccinated we can expect 3125 deaths.


These deaths from the vaccine would seem to outweigh any benefit that immunisation can yield. In Kerala 14 babies die before their first birthday per 1000 live births. This is called the infant mortality rate (IMR). Half of these deaths occur in the first month of life. The other seven deaths per 1000 occur in the remaining 11 months. Pentavalent vaccine is administered after six weeks of age, and so it is administered to babies who have survived the first month of life. Four out of five deaths occurred with the first dose of the vaccine and on the day or the next day of vaccination. The death of babies in the first day after vaccination works out to be four times higher than the expected number. The vaccine meant to save lives seems to be increasing mortality rather than reducing it.


Deaths from SIDS


Pentavalent vaccine is given to healthy babies. Mothers in Kerala don’t ordinarily bring very sick babies for immunisation. Each baby is examined by healthcare personnel before vaccination. So sick babies are unlikely to receive vaccination. Babies who die are usually severely ill. The deaths in these vaccinated babies are deaths in apparently healthy babies who no one anticipates will die in the next few hours. Another possibility is the rare SIDS, the death of an apparently healthy baby without explanation. SIDS may be the explanation for a very small number of deaths. Here the ‘unexplained deaths’ following immunisation, are four times the number that usually die after the first month of life. SIDS is very unlikely to be the explanation for these deaths following Pentavalent vaccination. Furthermore, the SIDS rate in the third month of life is higher than that in the second month, and if these deaths were merely coincidental with the Pentavalent vaccine there should be more deaths after the second dose rather than the first. However, four of the five deaths in the first six months in Kerala, were after the first dose. This also argues against all these deaths being SIDS deaths.


Lives lost to adverse events against lives saved by vaccination


One method to decide on continuing the programme would be to see if more harm is done than the benefits (reducing disease deaths in the community) by vaccination.


Pentavalent vaccine provides protection against Hib disease. Evidence from the World Health Organization studies in India suggests that seven children in 100,000 get Hib meningitis of which 10 per cent die. If the 25 million babies born each year are immunised it will prevent 8750 cases of Hib meningitis and 875 deaths over the next five years. Vaccination also protects children against pneumonia: more children get Hib pneumonia but few die of it. If we double the estimated deaths about 1750 children in the country die each year from HIb disease and these can be saved by immunisation. We cannot estimate the lives saved by Hepatitis B immunisation as they do not happen in childhood. The deaths from the vaccine (3125) seem to outweigh the benefits (1750 lives saved).


The parallels with Rotavirus vaccine withdrawal


In 1999 the newly introduced Rotavirus vaccine in the West was suspected of increasing 'intussusceptions' (a surgical condition of the small intestine). Ordinarily one in 10,000 children would get intussusception. This went upto 2/10,000 in the two weeks after the first dose of Rotavirus vaccine was administered. When 15 extra cases of intussusceptions were noticed (and when not even one baby had died) the vaccine was withdrawn.11 Product liability rules are so stringent in the West that the manufacturers voluntarily removed the vaccines before they were asked to.


Noel Narayanan Commission and underestimation of adverse events


Before starting the programme in Kerala the Government set up theNoel Narayanan Committee12. It recommended the Government collect data on each child immunised with the vaccine, for 48 hours after immunisation. A government affidavit to the Delhi High Court suggests this was not done in a systematic way but reporting of adverse events was left to voluntary ASHA workers13. They are given incentives depending on the number of children receiving Pentavalent vaccine in their area. This could be a disincentive for reporting adverse events as, such reports could reduce vaccine uptake and her earnings.


There are the Government Standard Operating Procedure (SOP) for adverse events following immunisation (AEFI)14. The numbers reported suggest severe under-reporting: while over 100 serious adverse reactions of various types would be expected with the standard DPT (triple antigen) vaccine in six months, only two were reported with Pentavalent vaccine that incorporates the DPT. In addition it appears there was an attempt to blame the parents of the first child who died following immunisation in Kerala. The press reported that the baby did not die of vaccine reaction but was smothered15 to death and later a spokesperson for the Health Department claimed the mother's breast-milk feeding killed the child.16 It took the post-mortem report to clear the parents of these accusations. Given these circumstances it is clear that adverse events are likely to be under-reported and we can anticipate that the 15 deaths reported from Kerala, is an underestimation.


Post-marketing surveillance and concluding remarks


Notwithstanding any deficiency in the Government reporting system, the vaccine manufacturer is obliged to provide the Drug Controller with a listing of all side effects in the first few years of marketing a newly licensed drug. The Drug Controller is the regulatory authority which has to ensure such reporting is made available.


Most of the information presented here pertains to the first six months of the programme in Kerala for which information was made available under the RTI. The public must insist that data for the 14 months the vaccine has been in use in Kerala and Tamil Nadu is carefully evaluated in a transparent manner before decisions are made for the health and safety of our children.


(Disclosure: In December 2009 a former Union Health Secretary Professor KB Saxena and eight others filed a public interest petition in the Delhi High Court to ask the Government of India to formulate an evidence-based rational vaccine policy for introducing new vaccines and to ensure that the basic EPI vaccines are provided to every child without discrimination or constraints of funds. The author is one of the petitioners. Since August 2010, he is a member of the National Advisory Group on Immunization. (NTAGI)).


The opinions expressed in this article are those of the author.


References:



  1.   http://articles.timesofindia.indiatimes.com/2013-02-25/thiruvananthapuram/37288777_1_pentavalent-vaccine-infant-deaths-mortem

  2.   http://bhutannews.blogspot.in /2010/07/pentavalent-killer-is-back.html

  3.   http://www.bmj.com/rapid-response/2011/11/02/sri-lankan-deaths-following-pentavalent-vaccine-acceptable-collateral-dama

  4.   http://www.bmj.com/rapid-response/2011/11/02/sudden-deaths-after-pentavalent-vaccination-vaccine-really-safe

  5.   http://www.thanhniennews.com /2010/pages/20130117-7-deaths-in-two-months-who-deems-vaccine-in-vietnam-safe.aspx

  6.   http://articles.timesofindia.indiatimes.com/2013-02-05/thiruvananthapuram/36764202_1_pentavalent-vaccine-immunization

  7.   http://articles.timesofindia.indiatimes.com/2012-07-13/chennai/32662981_1_pentavalent-vaccine-immunization-programme-aefi

  8.   http://articles.timesofindia.indiatimes.com/2013-01-12/chandigarh/36295667_1_pentavalent-vaccine-vaccination-programme-jhajjar#inbox

  9.   www.rho.org/HPV-vaccine-implementation.htm

  10.   http://www.who.int/bulletin /archives/78%282%29170.pdf

  11.   http://www.cdc.gov/mmwr/preview/mmwrhtml/mm4843a5.htm

  12.   http://jacob.puliyel.com /edit.php?id=264

  13.   http://jacob.puliyel.com /edit.php?id=278

  14.   http://jacob.puliyel.com/ edit.php?id=258

  15.   http://archive.asianage.com /india/kerala-infant-died-smothering-510

  16.   http://articles.timesofindia.indiatimes.com/2011-12-21/thiruvananthapuram/30542007_1_pentavalent-autopsy-report-expert-team

Source: Express Pharma, 1st April 2013. http://pharma.financialexpress.com/sections/res/1971-pentavalent-vaccine-doing-more-harm-than-good

Vietnam suspends Quinvaxem vaccine following 9 deaths

The Ministry of Health decided on May 4 to suspend the use of Quinvaxem, the made-in-Korea vaccine against five childhood deadly diseases, after nine deaths and dozens of cases of severe allergic reactions among local infants were reported over the past six months.



Since last November, nine newborns from different provinces died after being vaccinated with Quinvaxem, which is meant to prevent five common, potentially fatal childhood diseases: diphtheria (D), tetanus (T), pertussis (P, whooping cough), hepatitis B (HepB), and Haemophilus influenza type b (Hib).


All of the babies who died were in good health, but hours after receiving the vaccine they began wailing loudly, convulsed, and had serious trouble breathing, before passing away shortly after.


Despite several tests, no scientific evidence directly connecting the vaccine with the deaths or severe allergies has been provided, while health officials stressed that the vaccine batches involved were good quality and met all technical requirements.


However, no evidence has been produced to exclude the vaccine as a reason either.


According to Trinh Quang Huan, former deputy health minister, out of the 42 batches of Quinvaxem vaccine imported by Vietnam, over 20 resulted in minor to severe allergic post-injection reactions.


Huan also noted that whole-cell pertussis vaccines, like Quinvaxem, are among those that cause the most allergic reactions.


After severe reactions were reported in different provinces after immunization with Quinvaxem, provincial health departments halted the use of the vaccine.


Nguyen Nhat Cam, head of the Hanoi Preventive Health Center under the Ministry of Health, said that though tests on the vaccine batches suspected to have something to do with the deaths last January proved that the vaccine involved was fine and stored correctly, his center still halted the use of the vaccine, with some 3,000 remaining doses.

Source: Tuoitre News, 5th May 2013.  http://tuoitrenews.vn/society/9330/vietnam-suspends-quinvaxem-vaccine-following-9-deaths

Vietnam suspends use of Quinvaxem vaccine for children


HANOI, May 9 (Xinhua) -- The Vietnamese Ministry of Health instructed health centers across the country to suspend the use of Quinvaxem vaccine until the World Health Organization reports its final investigation conclusions, local media reported on Thursday.


The ministry released the instruction after local media reported that since November 2012, nine children died after receiving Quinvaxem vaccinations.


The vaccine, administered to children, is a preventative inoculation against diphtheria, tetanus, pertussis (whooping cough) , hepatitis B and H. and influenza Type B.


Quinvaxem is manufactured by the Berna Biotech Korea Corporation and was licensed for use in Vietnam's national expanded immunization program sponsored by the Global Alliance for Vaccines and Immunization.


According to the ministry, since June 2010, Vietnam has imported 16.2 million doses of Quinvaxem, 15.2 million doses of which have already been distributed, state-run Voice of Vietnam reported on its website.


The World Health Organization has sent experts to Vietnam to investigate the alleged serious side-effects of Quinvaxem, a 5-in- 1 vaccine for children, following some suspected deaths in the country, according to the report.


Batches of Quinvaxem have also been sent to the United Kingdom for further testing.


Source: http://news.xinhuanet.com/english/health/2013-05/09/c_132371052.htm 


Eight Babies Dead in China After Hep B Vaccination

The number of babies who have died in China after being vaccinated against hepatitis B has risen to eight, state news agency Xinhua reports.


A newborn baby died on Monday in a hospital in Sichuan province after being vaccinated on Sunday afternoon.


Chinese health experts are looking into the deaths of several babies who received the vaccination in a government immunisation programme.


Investigators have been sent to the company that produces the vaccines.


The investigation was launched after babies were reported to have died shortly after receiving the hepatitis B vaccine made by BioKangtai, a drug manufacturer in the southern city of Shenzhen.


Four babies reportedly died in the southern province of Guangdong, although one was said to have died from pneumonia, reports the Associated Press (AP) news agency.


The National Health and Family Planning Commission reported that two babies in Hunan province and another in Sichuan had also died in a similar way.


One more child in Meishan City, Sichuan, died on Monday, less than 24 hours after receiving a hepatitis B vaccine made by a different company, Xinhua said.

Source: BBC News China, Christmas Eve, 2013.

http://www.bbc.co.uk/news/world-asia-china-25505332






The unfortunate story of 37 deaths from a ‘good vaccine’

On October 11, two children died in Kashmir after receiving the Pentavalent vaccine, taking to six the total deaths there in one week and to eight the deaths over the last three weeks. According to reports appearing in local newspapers, the deaths were said to be an allergic reaction to the vaccine. These deaths come on the heels of a press release from the health ministry on October 10 that a committee that looked into the 15 deaths in Kerala after vaccinations has said they were not caused by the vaccine but were coincidental deaths. The press release also announced that the Pentavalent vaccine is to be rolled out nationwide. A week earlier, another ministry spokesperson had admitted there had been 29 deaths all over the country following the vaccine. The figure has now ballooned to 37.

The 29 deaths had happened when 82 lakh doses have been administered (and about 27 lakh children have been immunized). This works out to more than one death per 100,000 vaccinated and that 300 children would die each year from the vaccine when the birth cohort is vaccinated. It must be borne in mind that the adverse events are picked up by a system of passive surveillance which according to the US FDA picks up only a tenth of the real number of adverse events.


Co-morbidity as cause of death


It has been suggested that some of the deaths in Kerala had happened in children with an underlying heart disease. Many children who died in Sri Lanka after receiving the same vaccine also had a similar heart condition. Had they not been vaccinated, the death rate from the vaccine would have been less. 


However this is no practical proposition. Vaccinations are given in distant rural areas by health workers who are barely literate. The detection of heart murmurs by auscultation is a skill that many pediatricians have to hone over many years of training. In the absence of such training for all vaccinators, can we justify continuation of the vaccination programme? 


In Sri Lanka vaccination was stopped after five deaths. Under pressure from international organizations the programme was restarted. After that, there have been 12 more deaths. Dr. Yogesh Jain, who has filed a PIL in the Supreme Court, has sought the court’s oversight to prevent such pressures from influencing decision-making in India. 


The deaths from vaccine must be seen in the context of hard data from the best study on Hib (Haemophilus influenzae type b bacteria) in the country called the Minz study which suggested that some 175 children die from Hib meningitis in the birth cohort over five years and perhaps an equal number from Hib pneumonia. These figures from this large, meticulous community based study done in a population of 600,000 with house visits every two weeks and conducted over two years are clearly inconvenient. This is a case of the cure (vaccine deaths) being worse than the disease. The government seldom quotes the Minz study data, but relies instead on estimates that are not based on empirical evidence.

Source: The Health Site, 19th October 2013 - http://health.india.com/diseases-conditions/the-unfortunate-story-of-37-deaths-from-a-good-vaccine/

Vaccine-related deaths reach 11 in Vietnam

An infant in southern Vietnam's Lam Dong province has died after receiving Quinvaxem vaccine, bringing the total of such cases to 11 in the country since the begining of 2013, local press reported Friday.


A three-month-old boy died Wednesday, nearly 17 hours after being injected Quinvaxem vaccine. Local authorities are on their way to look into the cause of death, Tuoi Tre (Youth) online newspaper reported.


Former Deputy Minister of Health Trinh Quan Huan said that Quinvaxem is among the vaccines that caused the highest reaction rate, reports said.


Huan proposed that the government set aside more budget or to find more donors to replace Quinvaxem with a safer vaccine.


NIHE quoted Nguyen Nhat Cam, director of Vietnam's capital Hanoi Center for Preventive Medicine, as saying Friday that Quinvaxem is a South Korean-imported vaccine that protects children out of five deadly infectious diseases including diphtheria, pertussis, tetanus, hepatitis B and Hib.


Since it was included in Vietnamese National expanded Program on Immunization in June, 2010, the death toll resulting from Quinvaxem among kids has risen to 33 as of early 2014.


In late December 2013, World Health Organization and United Nations Children's Fund issued a joint announcement in Hanoi, saying there is no connection between the Quinvaxem vaccine and possible deaths among children after vaccinated.


However, recent deaths relating the vaccine triggered worries among Vietnamese parents about the links between the deaths or undesirable responses in some children and the "five in one" Quinvaxem vaccine.


Some refused to give vaccination for their children. Huynh Thai Phong, a reader, commented on VNExpress online newspaper on Friday that he wondered why Quinvaxem is still allowed to use after causing many deaths for kids.


An anonymous reader agreed with Phong, saying that he won't bring his kids to the national expanded program on immunization and will use paid vaccine instead.


A reader named "Mai Nguyen" commented in a rage as she advised the government to stop the vaccine immediately, adding that vaccination is for prevention, not for death.


Nonetheless, officials seem to hold a different viewpoint over the quality of Quinvaxem vaccine amid worries of local people.


In December 2013, Nguyen Tran Hien, director of NIHE cum chief of the National Expanded Program on Immunization, said in a press conference that there is no vaccine with 100 percent safety and the quality of Vietnamese vaccine is good.


Hien also admitted that the proportion of Vietnamese vaccinated children declined recently due to the decrease in the confidence of Vietnamese parents.

Source: English News, 17th January 2014 - http://news.xinhuanet.com/english/health/2014-01/17/c_133053223.htm










Deaths resume with return of Quinvaxem vaccine to Vietnam

In two months since a ban slapped on the Dutch-made vaccine was lifted, at least two more children have died after getting shots, but health officials say the vaccine was not to blame.


They have defended Quinvaxem despite an Indian doctor's accusation that the World Health Organization (WHO) was irresponsible for advising Vietnam to use it.


Tran My Ngoc, a five-month-old girl from the Mekong Delta province of Bac Lieu, became the latest victim on November 24, dying a few hours after being administered Quinvaxem.


She received the shot at a commune medical station with 17 other babies, and went into seizures on the way home, the family said.


Her eyes stopped moving, her mouth foamed, her body turned black and blue, and breathing became difficult.


She was rushed to the district general hospital, where she was given medicine and put on intravenous fluids, but sadly died.


The Ministry of Health, which sent experts to the province, said in a statement November 26 that the child had died of respiratory and cardiologic decline, "possibly due to anaphylactic shock after the vaccination. It is also unclear if the baby had other conditions that caused the death."


The ministry denied that the vaccine was responsible, saying the same batch had been used for nearly 400,000 shots nationwide since October.


Earlier Bui Quoc Nam, director of the Bac Lieu Department of Health, had said doctors had diagnosed the cause of death as vaccination shock.


The department has sealed the batch of vaccines and taken samples for testing, and has suspended the use of Quinvaxem in the province. It paid the family compensation of VND40 million (US$1,900). 


Deaths follow vaccine's reintroduction


Some parents prefer to pay VND500,000 ($24) per shot for their children to get shots of Pentaxim, an acellular five-in-one shot made by French drug company Sanofi Pasteur with purified antigens that are supposed to be safer than the whole-cell preparations found in the whooping cough component of Quinvaxem.


Quinvaxem, a liquid injection vaccine which has been pre-qualified by the WHO, is distributed in Vietnam by the Berna Biotech Korea Corporation and given to babies from two months old, three times over two months, to immunize them against diphtheria, tetanus, whooping cough, hepatitis B, and Hib (Haemophilus influenza Type B).


It costs VND77,000 a dose and has been pushed in low-income countries since it was introduced globally in 2006 by the Netherlands-based biopharmaceutical company Crucell.


Quinvaxem was temporarily banned in May after nine infants died since November last year, but the ban was lifted in October on the recommendation of the WHO, which said tests found no problem with the vaccine.


After it was reintroduced, a three-month-old boy in the north-central province of Quang Tri died November 10, five days after he got his first Quinvaxem shot.


The family said he started crying uncontrollably sixteen hours after the vaccination and refused to be breastfed. He turned black and blue and was taken to Quang Tri General Hospital.


After his death, an autopsy found pneumonia to be the cause, and the Ministry of Health issued a statement denying allegations that Quinvaxem was to blame.


In Hanoi, at least 37 babies have been admitted to hospital since October after being given Quinvaxem. They had high fevers, seizures, and rashes on their body. Hundreds of other similar cases have been reported nationwide, according to local media.


Thankfully, none of those cases have ended in death.


Of 47,000 kids who got the vaccine in Hanoi, 113 developed complications. But Nguyen Tran Hien, director of the National Extended Vaccination Program, said the rate of complications was acceptable based on WHO standards.

Source: http://www.thanhniennews.com/health/deaths-resume-with-return-of-quinvaxem-vaccine-to-vietnam-428.html

Vaccine Father Slams Official Report on Babies' Deaths

The father of one of 17 infants who died after receiving hepatitis B vaccine on Friday dismissed as "total rubbish" claims by Chinese officials that the deaths were unrelated to the inoculation.

Nine of the babies' deaths had nothing to do with the vaccines, the official news agency Xinhua quoted disease control and prevention official Yu Jingjin as saying on Friday.

Autopsies had yet to be carried out on the remaining eight infants, but a "preliminary analysis" also showed no link between the deaths and the vaccines, Yu said.

Shanxi-based Yang Wenlong, whose own child was among those who died, said the official account of the babies' deaths was groundless.

"They are talking absolute rubbish, and no one in China will believe it unless they are idiots," Yang said.

"I for one don't believe their results."

He said Yu's account had been roundly criticized by Chinese netizens, who are deeply suspicious of the government following a series of product safety and public health scandals in recent years.

"If you look at [chat site] QQ and online, you will see how many people are cursing him," Yang said. "I think they are afraid of affecting people's uptake of the vaccine."

"But I think that what they've done here will have the opposite effect to the one they intended."

Child deaths

The deaths were reported following inoculation with a hepatitis B vaccine, made by Shenzhen-based BioKangtai, between Dec. 13 and Dec. 31.

BioKangtai said in a statement last month that it has "rigorously" followed safety rules but that company is also testing the batches concerned.

On popular social media sites, many commentators agreed with Yang, however.

"Seventeen lives have been lost, and you still talk about your vaccine being viable?" wrote user @sz1961sy. "We call on relevant experts to carry out some research in the hospitals with a view to protecting young lives."

Parent activist Zhao Lianhai, whose child was made ill by melamine in the 2008 tainted milk formula scandal, said there had been well-documented cases of tainted vaccines before in China.

"This has been going on for years now," Zhao said. "We have met with the parents of children affected by tainted vaccines, but they have never won any sort of redress."

He called for an investigation into the source of the problem. "There should be an investigation in all areas [of vaccine production, storage and administration]," he said. "This cannot be tolerated."

"Is it with the vaccines themselves, or with the hospital?" he said.

"Some companies in China have common interests with certain government departments," Zhao said. "This is pretty much an open secret nowadays."

"If problems occur, they use their relationships [with government] or money to get around it."

Poor regulation

China's pharmaceutical industry is highly lucrative but poorly regulated, resulting in a string of fatalities blamed on counterfeit or shoddy medications in recent years.

An investigative report in the China Economic Observer newspaper in 2010 said that improperly stored vaccines administered by Shanxi health officials for encephalitis, hepatitis B, and rabies between 2006 and 2008 had killed four children and sickened more than 70 others, with tainted vaccines being used as late as March 2009.

Top investigative reporter Wang Keqin, who exposed the vaccine scandal among others, was forced out of his job at the newspaper in February 2013.

Parents who complain about mishaps linked to health and safety issues say they are frequently themselves targeted for official harassment and punishment.

In 2011, authorities in Beijing sentenced parent activist Yang Yukui to five months' "re-education through labor" on charges of "provoking disputes and causing trouble" after he complained that his son had been in and out of the hospital since being given a bacille Calmette-Guerin (BCG) tuberculosis vaccination shortly after birth.

Source: Radio Free Asia, 3rd January 2014 - http://www.rfa.org/english/news/china/vaccine-01032014164833.html

Baby Haylee Marie Dies 5 Hours After Hep B Shot

Haylee Marie passed away aged 10 months old, five hours after a shot for Hepatitis B. The government pathologist ruled it as SIDS (which is not a diagnosis, it just means 'the baby died suddenly and we don't know why') but the family didn't believe that their healthy baby could just suddenly drop dead a few hours after vaccinations and it just be a 'coincidence' so they had an independent pathologist examine her, who ruled she died as a result of an allergic reaction to the vaccine.



Fox 2 News Headlines

Court orders Rs 3 lakh for parents of child who died after vaccination

Meant to immunize an infant from fatal diseases, vaccines took away the life of a 42-day-old boy. Eleven years after the tragedy, the state consumer commission held an hospital and the doctor guilty of negligence, and awarded a compensation of 3 lakh to the child's parents.

K Dhanasekaran of Manali had admitted his wife in Dr Durga Nursing Home, Avadi, where she delivered a boy on January 26, 2003. The next day, she underwent a sterilisation operation and was discharged on January 30. As part of post-natal care, she took the infant to the hospital for vaccination. However, after the boy was administered Diptheria-Pertussis-Tetanus (DPT) and Oral Polio Vaccination (OPV), he died.

The same year, Dhanasekaran moved District Consumer Disputes Redressal Forum claiming the hospital had used expired medicines. The hospital doctor denied the claim and said the vaccine had been given after "observing necessary formalities." The boy died "unexpectedly due to sudden development," it said.

In 2011, the forum said the hospital was not equipped with a storage system to preserve the medicines and did not have the necessary gadgets. It also did not have an ambulance. In its verdict, the forum fined the hospital 1 lakh.

Against the order, both Dhanasekaran and the hospital approached the State Consumer Disputes Redressal Commission. While the hospital sought to quash the order, Dhanasekaran asked for enhancing the compensation.

The court said the hospital should have "arrangements to get immediate and emergency services from other capable and speciality institutions" in case of an emergency. It also said Dr A Vijaya Varma, who was managing the affairs of the hospital, too was liable for paying compensation.

Source: Times of India, 5th April 2014 - http://timesofindia.indiatimes.com/city/chennai/Court-orders-Rs-3-lakh-for-parents-of-child-who-died-after-vaccination/articleshow/33255146.cms

Leaked Confidential Report on Infantrix Hexa Vaccine Deaths

B0683335A (Netherlands):

Meningitis viral, Convulsion, Yellow skin, Cyanosis, Dehydration, Diarrhoea, Somnolence, Crying, Vomiting. This case was reported by a regulatory authority (NL-College ter Beoordeling van

Geneesmiddelen # NL-LRB-111158) and described the occurrence of meningitis in a 2- month-old male subject who was vaccinated with combined diphtheria, tetanus-acellular pertussis, hepatitis B, inactivated poliomyelitis and Haemophilus influenza type b vaccine (Infanrix hexa, GlaxoSmithKline), pneumococcal vaccines (non-gsk) (Prevenar) for prophylaxis. The subject had no medical history and no concomitant medication.

On 13 September 2010, the subject received 1st dose of Infanrix hexa (unknown route, unknown injection site), 1st dose of Prevenar (unknown route, unknown injection site). 3 minutes after vaccination, the subject experienced crying and sleepiness on the same day.

On 18 September 2010, 5 days after vaccination, the subject was found in bed with eyes half-opened and a blue mouth. His skin was yellow/pale. He vomited pink, foaming milk. No fever was observed (37 degrees C). The boy

was hospitalized, diarrhea aggravated and dehydration was diagnosed. Blood test and spinal tap were performed.The boy had several afebrile convulsions and a MRI showed severe damage of the brain.

No further treatment was given.

On 25 September 2010, 12 days after vaccination, the subject died from viral meningitis.

The regulatory authority considered the events were unlikely

to be related with vaccination with Infanrix hexa and Prevenar.

Additional information has been requested but could not be obtained from regulatory authority (new regulatory number: NL-LRB-116469).It was unknown whether an autopsy was performed.

Company comment:

Case of death due to viral meningitis in a 2-month-old male subject 12 days after 1st combined vaccination with Infanrix hexa and Prevenar.

There was severe brain damage on MRI.


It is unknown whether an autopsy was performed.


B0700040A (Sweden):

Meningitis, Sepsis, Shock, Pneumococcal infection, Renal impairment, Hepatic function abnormal, Pyrexia, Diarrhea, Vomiting


This case was reported by a consumer and described the occurrence of meningitis in a 9-month-old female subject who was vaccinated with synflorix (GlaxoSmithKline) and combined diphtheria,tetanus-acellular pertussis, hepatitis B, inactivated poliomyelitis and Haemophilus influenzae type b vaccine. (Infanrix hexa,GlaxoSmithKline) for prophylaxis. A physician or other health care professional has not verified this report.

Previous and/or concurrent vaccination included

Bacillus Calmette -Guerin vaccine (non-gsk) given on 28 October 2010; diphtheria and tetanus toxoids and acellular pertussis vaccine; GlaxoSmithKline given on 20 May 2010; hepatitis B vaccine recombinant; manufacturer unspecified given on 20 May 2010; synflorix; GlaxoSmithKline; given on 20 May 2010.

Concurrent medications included Paracetamol for her growing teeth.

On 17 August 2010, the subject received 2nd dose of Synflorix (administration site and route unknown, batch number not

provided). On 26 November 2010, 101 days after vaccination with Synflorix, the subject experienced fever, vomiting and diarrhea. This continued the whole day between 11 am to 6 pm. She suddenly got better and she was not vomiting and her fever went down.

She got fluid replacement and was able to urinate. On 27 November 2010, at 7 am, the subject was not breathing any longer.
At the hospital,they tried to save her during 40 minutes.

The subject died on 27 November 2010 from meningitis and sepsis. An autopsy was performed and showed abnormal renal function, hepatic function abnormal and possible pneumococcal infection. The body was in shock.


Company comment

:

Death of a 9 month-old female subject due to meningitis and sepsis 191 days after combined vaccination with Infanrix Hexa and Synflorix.




B0706503A (Thailand): Shock, Respiratory arrest, Cardiac arrest, Pyrexia, Somnolence, Hypotonia, Vomiting, Crying, Apnoea - Baby's Brother Killed by Vaccines Too


This case was reported by a physician and described the occurrence of fatal shock in a 2-month-old female subject who was vaccinated with combined diphtheria,tetanus-acellular pertussis, hepatitis B, inactivated poliomyelitis and Haemophilus influenzae type b vaccine (Infanrix hexa, GlaxoSmithKline)for prophylaxis. The subject was born by C-section. Apgar score was 10 at 0 and 5 min. Birth weight was 3.2 kg and experienced a normal growth and development. Medical condition included a possible genetic abnormality due to a family history of death after

vaccination (subject’s brother died 2 years ago after vaccination with DTwP). On 9 March 2011, the subject received unspecified dose of Infanrix hexa (.5 ml, unknown route of adminstration). The subject was normal before vaccination. On 10 March 2011, 24 hours after vaccination with Infanrix hexa, the subject experienced shock. She experienced low-grade fever, drowsiness and stopped breathing. The subject was floppy and had no heart rate. Cardiopulmonary resuscitation was performed during 3

hours but the subject did not respond to it. The physician considered the events were probably related to vaccination with Infanrix hexa. The subject died on 10 March 2011 from cardiorespiratory arrest. An autopsy was not performed. Follow-up received on 21 March 2011: The subject’s brother was 2 month-old when he died (11 years ago), after received DTwP which was EPI vaccine (no record available). After vaccination (no specific time available), the subject experienced vomiting (single ep

isode) and had colicky crying at home. On 10 March 2011, the subject was taken to the clinic due to fever and crying. After massive crying, the subject experienced apnea and no heart beat was detected after stimulation. Cardiopulmonary resuscitation was performed for 10 minutes and subject responded by crying. One hour later, the subject experienced apnea again and resuscitation was continued for 3 hours without any response.

Neither lab results nor autopsy results were available.



Company comment

: This case described a SUDI (Sudden Unexpected Death in Infancy)in a 2 month-old female subject 24 hours after vaccination with Infanrix

hexa. Autopsy or lab results were not provided. There is a notion of post-vaccine death in a sibling.

B0712016A (Italy): Hypotonia, Hyperhidrosis, Pyrexia - Contraindicated Baby Brain Damaged with Cerebral Palsy Given Further Shots that Kill Him



This case was reported by a regulatory authority (IT-Agenzia Italiana del Farmaco #137473) and described the occurrence of hypotonia nos in a 11-month-old male subject who was vaccinated with combined diphtheria, tetanus-acellular pertussis, hepatitis B, inactivated poliomyelitis and Haemophilus influenzae type b vaccine.


(Infanrix hexa, GlaxoSmithKline) and pneumococcal vaccines (non-gsk)(Prevenar13) for prophylaxis. The subject was born after 41 weeks + 3 days,normal pregnancy and spontaneous delivery. Concurrent medical conditions included severe respiratory distress at birth. He was reanimated and resigned from the prenatal intensive care on 20 May 2010. He was not able to feed spontaneously(dysphagia)so a nasogastric tube was inserted with pump infusion. According to the doctor, the subject had contraindication to the vaccine. He was hospitalised from 22 May 2010 to 25 May 2010 due to respiratory distress. From 14 to 21 July 2010 due to seizures. On 18 August 2010, diagnostic results showed cerebral palsy, gastroesophageal reflux, hypoxic-ischemic encephalopathy of grade 3, microcephaly, psychomotor retardation and spastic quadriplegia (mainly the upper limbs). Concurrent medications included Paracetamol (Tachipirina), Vitamin, Vigabatrin, Topiramate, Antibiotics (Antibiotic), Bronchodilator and Steroid. On 25 March 2011, the subject received 3rd dose of Infanrix hexa (intramuscular, right thigh) and 3rd dose of Prevenar 13 (intramuscular, left thigh). On 26 March 2011, 1 day after vaccination with Infanrix hexa and Prevenar 13, the subject experienced fever (38 to 38.5 deg.C).

On 27 March 2011, 2 days after vaccination with Infanrix hexa and Prevenar 13, the subject experienced hypotonia nos and crisis of sweating. The regulatory authority reported that the events were possibly related to vaccination with Infanrix hexa and Prevenar 13. The subject died on 28 March 2011, cause of death was not reported. It was unknown whether an autopsy was performed. Follow-up information receivedon 15 July 2011: As no additional information could be obtained, the case has been closed.

Company comment

: This case described death of an 11-month old male subject 48 hours after third combined vaccination with Infanrix hexa and Prevenar.  The subject died in the context of severe hypoxic-ischemic encephalopathy (cerebral palsy leading to quadriplegia and microcephaly).

B0727175A (France): Death


This case was reported by the French regulatory authority (FR-Agence Françaiss de Sécurité Sanitaire des Produits de Santé # NT20110388) and described the occurrence of unexplained death in a 18-month-old femalesubject who was vaccinated with combined diphtheria, tetanus acellular pertussis, hepatitis B, inactivated poliomyelitis and Haemophilus influenzae type b vaccine (Infanrix hexa,GlaxoSmithKline) for prophylaxis. The subject had no known and relevant medical history.

 On 26 October 2010, the subject received an unspecified dose of Infanrix hexa (batch A21CA724A, intramuscular, injection site unknown). On 27 October 2010, 1 day after vaccination with Infanrix hexa, the subject was found dead after her nap. Autopsy did not identify any cause of death.Respiratory aspiration was assessed as not very probable. No other information was available. According to the French method of assessment, the AFSSaPS considered the causal relationship between vaccination with I

nfanrix hexa and unexplained death as dubious. Autopsy (2010): no identified cause of death.

Company comment

: This case described a SIDS in an 18 month-old female subject 1 day after vaccination with Infanrix hexa.

No cause was found after autopsy.

B0735723A (Australia): Death


This case was reported by a consumer and described the occurrence of death unspecified in a 6- week-old male subject who was vaccinated with combined diphtheria, tetanus-acellular pertussis, hepatitis B, inactivated poliomyelitis and Haemophilus influenzae type b vaccine. (Infanrix hexa,GlaxoSmithKline), live attenuated human rotavirus vaccine (Rotarix) and pneumococcal vaccines (non-gsk) (Prevenar 13) for prophylaxis. A physician or other health care professional has not verified this report. On 20 July 2011, the subject received unspecified dose of Infanrix hexa (administration site and route unknown), an unspecified dose of Rotarix (route unknown) and an unspecified dose of Prevenar 13 (unknown). On 21

July 2011, 14 hours after vaccination with Infanrix hexa, Prevenar 13 and Rotarix, the subject died for unknown reasons. The subject died on 21July 2011, cause of death was not reported. An autopsy was performed. Autopsy

results are not ye tavailable. Further information has been expected.


Company comment

:This case reported a SUDI in a 6-week old male subject 14 hours after combined vaccination with Infanrix hexa, Prevenar and Rotarix.

An autopsy was performed but results are not available.


D0071496A (Germany): Death


This case was reported by a health professional via a regulatory authority (DE-Paul-Ehrlich-Institut # DE-PEI-PEI2011016343) and described death ofa 3-month-old female subject who was vaccinated with combined diphtheria,tetanus-acellularpertussis, hepatitis B,inactivated poliomyelitis and Haemophilus influenzae type b vaccine (Infanrix hexa, GlaxoSmithKline) and  pneumococcal vaccines (non-gsk,Prevenar 13) for prophylaxis.

Previous vaccinations with Infanrix hexa and Prevenar13 (on 14 April 2011) have been well tolerated. On 16 May 2011 the subject received the second dose of Infanrix hexa (intramuscular, unknown thigh) together with the second dose of Prevenar 13 (intramuscular, unknown thigh).

At this time the subject had suffered from a mild intestinal infection.

In the morning of the following day, on 17 May 2011,the subject was found dead .An autopsy was performed and a preliminary autopsy report was provided. According to the autopsy protocol very early in the morning of 17 May 2011 the subject had been found "cold and lifeless" by her parents. On

05:02 an emergency physician had been called. Cardiopulmonary resuscitation by the parents and later by the emergency personal failed and death was testified.

Policemen were involved at 06:20. Interrogation of the subject’s parents revealed that the subject and her four siblings had always been healthy.

Follow-up information was received from the institut of legal medicine Halle (Saale) on 04August 2011: The final autopsy report was provided.

The causes and mode of death could not be clarified. The infant had been suffering from an acute unilateral otitis media at the time of death

(smear from the left middle ear: proof of Haemophilus influenzae; smear from the right middle ear: no proof of  microorganisms). Within the

scope of additional examinations no alcohol (alcohol concentration 0.00 %) or other pharmacologic could be detected. There was neither evidence of an

allergic reaction.(total IgE 5.65 kU/l, reference <20kU/l) nor of a gastrointestinal infection. Nor was there any evidence of a postvaccinal disorder."According to the autopsy report, the onset date of the subject’s otitis media was "very recent", but it could not be clarified whether it had been prior to or following the vaccination. Although no evidence of a

relation of the event to the vaccination was found during the autopsy the close temporal relation might be seen as an indication that the subject’s death was possibly related to the vaccination with Infanrix hexa and Prevenar 13.
Company comment: This case described a SUDI in a 13 month-old female subject 1day after 2nd combined vaccination with Infanrix hexa and Prevenar .A recent acute haemophilus influenzae otitis media was diagnosed on autopsy.


D0072663A (Germany): Death -Poor 9 week old recieved so many vaccines, fluoride and radiation

This case was reported by a German regulatory authority (DE-PaulEhrlich Institut #DE-PEI-PEI2011029271) and described the occurrence of unexplained death in a 9-week-old male subject who was
vaccinated with combined diphtheria, tetanus-acellular pertussis, hepatitis B,inactivated poliomyelitis and Haemophilus influenza type b vaccine (Infanrix hexa, GlaxoSmithKline) for prophylaxis.Co-suspect

vaccinations included 13 valent pneumococcal conjugate vaccine (non-GSK)

(Prevenar 13, Pfizer Pharma).

Pregnancy and birth had been normal. The subject’s medical history

included neonatal jaundice.The subject was developing normal. Family history included no allergies.

Concurrent medical conditions included suspicion of congenital hip dysplasia. Hip ultrasonography, performed on 09 August 2011, showed type IIa left and type I right. Follow-up hip ultrasonography,performed on 05 September 2011, showed type Iboth sides. At the time of vaccination, on 05 September 2011,the subject was well.The subject showed small white plaques in oral mucus (oropharyngeal plaques) left but most likely no oral candidiasis.

Previous vaccination with Rotavirus vaccine (non-GSK) (RotaTeq; Sanofi Pasteur MSD),given orally at 2 ml on 09 August 2011, was well tolerated.

Concurrent medications included colecalciferol + sodium fluoride (D-Fluoretten) and paracetamol (Ben-u-ron).

On 05 September 2011 the subject received the first dose

of Infanrix hexa (0.5 ml,intramuscular, unknown thigh lateral) and the first dose of Prevenar 13 (.5 ml,intramuscular, unknown thigh lateral). Approximately two days post vaccination with Infanrix hexa and Prevenar 13, on 07 September 2011, the subject died. The cause of death was unknown (death unexplained).

The event had also been reported as life threatening. An autopsy was performed on 07 September 2011 at an institute for forensic pathology

 At the time of reporting, on 08 September 2011, examinations had not been finished and no autopsy results have been reported.

The German regulatory authority (DE-Paul-Ehrlich-Institut) has requested further information .Quality test result was received on 11 October 2011. A complete review of the batch records has been performed by Qualit yAssurance and Production. No deviation that could impact the quality of the product has been highlighted during th eGlaxoSmithKline Biologicals investigation.

Company Comment:


Since 12 September 2011 ,five cases linked to batch A21CB094A were reported to GSK (D0072663A, D0072852A, D0072638A, D0072908A, D0072920A). All five were serious reports and two had a fatal outcome).

D0072852A (Germany): Circulatory collapse, Sepsis, Shock, Crying, Pallor

This case was reported by a regulatory authority (DE-Paul-Ehrlich-Institut # DE-PEI-PEI2011030856) and described the occurrence of circulatory failure in a 5-month-old male subject who was vaccinated with combined diphtheria, tetanus-acellular pertussis, hepatitis B, inactivated poliomyelitis and Haemophilus influenzae type b vaccine (Infanrix hexa, GlaxoSmithKline) for prophylaxis.Co-suspect vaccination included 13-valent pneumococcal vaccine (non-GSK) (Prevenar 13, Pfizer). First vaccination with both vaccines on 23 August 2011 was well tolerated. Information about anamnesis was provided by a hospital report from intensive care treatment after birth The mother had been pregnant for the first time. The mother had former surgerybecause of false lung vein opening and received permanent treatment with bisoprolol.The subject was delivered prematurely in 31+4 weeks of gestation, by section from breech presentation after pathologic CTG. There was no premature rupture of the amnion andamniotic fluid was clear. The subject had an APGAR of 6/10/10, a weight of 1490 g, lengthof 39 cm, head circumference of 32.6 cm, navel artery pH was 7.16.After birth the subject had neonatal respiratory distress syndrome grade I with continuous positive airway pressure for 24 hours.The subject developed possible meconium ileus due to microcolon, transient intestinal transportation disorder, cholestatic hepatosis after parenteral nutrition, with increased transaminases (alanine aminotransferase 131 U/l, aspartate aminotransferase 100 U/l,creatine kinase 342 U/l, total bilirubin 3 mg/dl, direct bilirubin 2.75 mg/dl). Additional diagnoses after birth included neonatal anemia and iron deficiency, asymmetry from lying, small hemangioma right gluteal and dystrophic growth and weight increase. On the sixth day of life, the subject’s condition worsened and he was transferred to an intensive care unit for neonates. Intravenous antibiotics were given for seven days.


The subject had abdominal distension since birth and not yet passed meconium. Acute abdomen was suspected on the seventh day of life. The subject was transferred to a pediatric chirurgic unit for further intervention, but after conservative treatment the symptoms resolved.


Test results were normal for ions, blood gases, immune reactive trypsin (tested on 06 Mayand 06 June 2011), sonogram of head, abdomen and hip (Graf classification Ib) and hearing screening.


Cytomegalovirus (CMV) and toxoplasmosis IgM and IgG antibodies were negative. Initially increased Tyroid stimulating hormone normalised on control. Bile acid was increased (74.6 mcmol/l), pancreatic kinase was decreased (68 mcg/g). Eye examination showed vascularisation limit zone III at both sides.


The subject was discharged after 39 days in good condition and received rachitis prophylaxis and iron substitution.


On 20 September 2011 the subject received 2nd dose of Infanrix hexa (unknown route and application site), 2nd dose of Prevenar (unknown route and application site). On 20 September 2011 in the evening, less than one day after vaccination with Infanrix hexa and Prevenar, the subject had been crying and turned grey while lying in bed. The vaccinating physician was consulted and admitted the nfant to hospital, where thesubject died on 21 September 2011, from circulatory depression or possible sepsis. Different lot numbers were reported on follow-up. Approximately 20 hours after vaccination with Infanrix hexa and Prevenar 13, the subject experienced shock with circulatory failure. An emergency physician was called and the subject was hospitalized on emergency to an intensive care unit. Approximately 10 hours after onset of symptoms the subject died despite intensive care. According to follow-up information received on 07 October 2011 via the


German regulatory authority (PEI), the lot number A21CB094A was documented in vaccination certificate, while there was no documentation for the mentioned lot numbers A21CB105A and A21CB115A.


Quality test result was received on 11 October 2011. A complete review of the batch records has been performed by Quality Assurance and Production. No deviation that could


impact the quality of the product has been highlighted during the GlaxoSmithKline Biologicals investigation. An autopsy was performed. A duplicate case was reported bya physician, via a sales representative and no further details about the reported event were provided.


Since 12 September 2011, five cases linked to batch A21CB 094A were reported to GSK (D0072663A, D0072852A, D0072638A, D0072908A, D0072920A). All five were serious reports and two had a fatal outcome.















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