NEW DELHI: Around 133 children died last year due to adverse effects following immunization (AEFI).

Minister of state for health Sudip Bandhopadhyay admitted on Friday said that six of those deaths occurred due to programme errors, while four others died of vaccine reaction.

Around 56 deaths have been termed “unclassifiable”, and 67 were termed “coincidental.”

In comparison, 138 children had died of AEFI in 2010. The death figures till last year had persistently risen. There were 111 and 116 deaths in 2008 and 2009, respectively.

India has one of the world’s largest universal immunization programme, targeting 2.6 crore children who are born every year. Each child is given four vaccinations in addition to vaccinations at birth. About 90 lakh vaccination sessions are held every year, where more than 25 crore vaccine doses of seven antigens like diphtheria, pertussis, tetanus, measles, BCG, Hepatitis B and polio are administered.

Bandhopadhyay said, “AEFI including deaths are being reported due to strengthening of the AEFI sdystem. AEFI are monitored by the government to build confidence of the community in the immunization programme as all serious AEFI including deaths following immunization may not be related to vaccination.”

Talking about measures being taken up by the ministry, the minister said, “guidelines for AEFI were revised in 2010 and have been disseminated. Training of officers associated with immunization have been carried out so that AEFI deaths due to programmatic errors are minimized.”

Vaccination programme is carried out both in health facilities and door-to-door outreach sessions in every village.

Booster doses are also given at the age of one and a half years and five years. Besides, supplementary immunization activities are carried out periodically.
http://articles.timesofindia.indiatimes.com/2012-08-25/india/33384932_1_vaccination-programme-aefi-immunization-programme
Source: Times of India, 25th August 2012.

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.

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