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Updated: September 24, 2013 02:07 IST

The sad story of a good vaccine

Mohuya Chaudhuri
Comment (9)   ·   print   ·   T  T  
Illustration: Satwik Gade
Illustration: Satwik Gade

Lax monitoring, poor public engagement and inadequate training to vaccinators have dealt a serious blow to the crucial pentavalent immunisation programme

The Pentavalent vaccine, the Ministry of Health and Family Welfare’s latest addition to the immunisation programme, has run into a storm. The Supreme Court has sent a notice to the Ministry asking why the vaccine should not be banned in the country.

The vaccine is no stranger to controversy. A mix of five vaccines to fight childhood diseases like diphtheria, pertussis, tetanus, Hepatitis B, pneumonia and meningitis caused by Haemophilus influenzae Type B, its roll-out in nine States has been opposed after infant deaths were reported post vaccination.

Adverse events

So far, 82.72 lakh doses have been administered in the country and 29 serious cases of Adverse Events Following Immunization (AEFI) have occurred following immunisation. Kerala reported 15 deaths; of these, six children had co-morbidity such as congenital heart disease, eight were Sudden Infant Death Syndrome (SID), where the cause of death is unknown, and one infant probably died due to the vaccine. Haryana reported five deaths, Tamil Nadu four, Karnataka three and Gujarat and Jammu and Kashmir one each.

“There is no clear evidence that these deaths were related to the vaccine,” says Dr Ajay Khera, Deputy Commissioner, Child Health and Immunisation. “All AEFI cases were investigated and the findings of the team of experts ruled out any linkage of cause of these deaths with the vaccine.” He also says information of causality is limited since autopsies are not being permitted by many families.

But there are concerns, says a senior paediatrician. “Out of 15 deaths, only six were clearly established to be not related to the vaccine. That is not good enough in a vaccination programme. It is not a question of safety alone but also of the delivery system. Families need answers. The follow-up to these deaths needs to be more meticulous to understand what caused these deaths.”

Other Asian experiences

The vaccine was introduced in India after intense deliberations between the Health Ministry and the National Technical Advisory Group on Immunisation (NTAGI). Its report states that the vaccine is safe and recommended that it be introduced in all States to combat a large but preventable burden of disease.

Vietnam, Sri Lanka, Pakistan and Bhutan faced a similar predicament when adverse events were reported following which the vaccine was suspended. After it was found that there was no obvious link between AEFIs and the vaccine, it was reintroduced in the immunisation programmes. Indonesia has done the same recently.

Dr. Cyrus S. Poonawalla, Chairman, Poonawalla Group, who owns the Serum Institute that manufactures the vaccine, contests these charges. He says: “India is not the only country to use pentavalent vaccine … 170 countries have introduced the vaccine. Not a single child has died due to the administration of the vaccine anywhere in the world. Each container has 10 doses and if there was something wrong with the vaccine then all 10 children who received the vaccine should have shown adverse reactions; but nine others were not affected. This is clear proof that the vaccine is all right. In most of the cases, there are other causes, say the injection delivered in unhygienic environment or there are underlying medical conditions, which are not identified.”

Dr. Yogesh Jain of Jan Swasthya Sahyog, who filed the petition in the Supreme Court demanding that the pentavalent vaccine be banned in India says, “We are not against vaccines, it is an important public health tool. What prompted us to file the petition was the death of children within 24 hours of administering the vaccine. We wanted to know the cause of death of these children but the report is not available. Also, the effects of administering a combination of too many vaccines need to investigated and shared with us as well.”

According to experts, when a new vaccine is introduced, it is imperative that the procedures that merit caution are followed. It is also mandatory that all AEFI should be looked into and then reported to the Drug Controller General of India (DCGI). But this practice has not been followed. He says, “Is there an acceptable rate of death for vaccines? When a child has a congenital heart disease, is there a need to vaccinate the child? These are programmatic errors that need to be addressed. We filed the petition because we believe that judicial oversight is necessary in this case.”

Vaccines are known to be safe and one of the best preventive tools to protect children from disease. In India, nearly three-and-a-half lakh children die of pneumonia and meningitis every year and the best way to save these lives is a vaccine.

Dr. N.K. Ganguly, Advisor, Translational Health Science and Technology Institute (THSTI), says that the benefits of the vaccine outweighs the risks. “The system has been strengthened so a larger number of serious adverse events and deaths are being reported. Every case must be monitored after immunisation. In case deaths occur, autopsies must be done to establish the cause of death. Children with co-morbidity should be provided care and with better follow-up of every child. It is an injectable vaccine, so the delivery mechanism, maintenance of cold chain must also be monitored to ensure better case management,” he adds.

Currently, the government’s AEFI guidelines do emphasise post-vaccination monitoring and protocols for examination of AEFI cases but they do not have any instructions on how health workers and local medical officers should track and monitor the pre-vaccination medical status of children and the appropriate steps that should taken in cases underlying morbidity.

Model worth considering

Immunisation is done by health-care providers like auxiliary nurse midwives, who are often not trained enough to recognise clinical symptoms prior to administering the vaccine and the ability to provide support in case of adverse events. Vaccinators need to be well trained in the importance of identifying underlying conditions of the child before vaccinating, make parents understand the risks of vaccinating in case of any underlying condition and ensure post-vaccination care if there is any event of crying, fever and convulsions.

In Christian Medical College and Hospital, Vellore, around 31,200 infants receive the vaccine annually. So far no deaths have been reported. Prior to immunisation, every child’s medical history is evaluated in detail. Post vaccination, the child is followed up closely to address any side effects or adverse events, reducing any risk to the child. In short, an ideal delivery model that can prevent or reduce infant deaths and morbidity and build confidence in the vaccine.

In Sri Lanka, where it was found that infant deaths after immunisation were due to congenital heart disease, infants are now immunised under medical supervision, especially if there are underlying health conditions. Paediatricians say that this should be made mandatory in India as well.

Communication

Another loophole in the programme is poor public engagement. It is a tough ask for parents to reconcile with the death of their newborn baby, who was apparently healthy before the vaccine was delivered. With growing awareness about the value of vaccines and rising demand for better health for their children, families place their trust in the system. But if a child dies and the cause of death is unknown, parents lose faith in the system and the product, no matter how safe it may be. It was only after medical experts bulldozed the government, that some answers are emerging.

For the 27 million children born every year, each life counts. So far, millions of lives have been saved through vaccination, but for the pentavalent to be truly accepted, it is essential that the government is more transparent and rapid in its response following adverse events.

If the public health system provides quality immunisation services and ideal case management AEFI, cases can be minimised. This is the government’s own promise, which it needs to keep for children to remain healthy and safe.

(Mohuya Chaudhuri is an independent journalist. She was formerly health editor at NDTV. E-mail: mohuya.chaudhuri@gmail.com)

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Causes of death could not be clearly ascertained in all cases except 6. The number may
appear small with respect to 89 lakh babies but for a parent loss of a child is monumental.
We also need to answer the question regarding why this vaccine is banned in some
developed countries like US. There can be deeper issues as well as pentavalent vaccine
costs Rs.455 per unit as compared to earlier DPT vaccine which costs only Rs.5 .

from:  Supriya
Posted on: Sep 25, 2013 at 14:17 IST

The risks of vaccinating get discussed in the article but then quickly get whitewashed by stating that "the deaths were not related to the vaccine", because of some comorbidity. That's like saying a child died from eating peanut butter but it was not the peanut butter, it was the fact that the child was allergic to it. The underlying cause still remains the peanut butter.

from:  jody
Posted on: Sep 25, 2013 at 02:48 IST

I find Mr. Poonawalla's comment cynical that "no death has occurred in
any country due to the vaccine", when the investigations are
suggesting that morbidity may occur when infants suffering from other
undiagnosed conditions such as congenital heart disease are
administered the vaccine.
Obviously, this points to need for regular check-ups for all infants. Likewise, there may have been instances of allergic reactions or vaccine contamination etc. Any new medical procedure needs to be introduced after thorough testing and all procedures need regular monitoring. There are many instances where one cannot conclusively prove causality, or maybe one does not want. This does not mean that
there isn't a link. Vaccinations are one of the most important tools in our fight against infant mortality. We would do well to maintain public faith in these.
This cannot be done by bold claims and empty boasts made by those selling the product. The medical board needs to look into the matter.

from:  Vivek
Posted on: Sep 24, 2013 at 15:03 IST

Like private hospitals,govt hospitals should keep a record of the childs health. It should keep post vaccination track. Vaccinators should be well trained. All these are very necessary in our country.

from:  nutan panda
Posted on: Sep 24, 2013 at 12:57 IST

Can the HINDU follow-up on the Vellore vaccination and report whether that was part of a clinical trial? NO Medical facility does a follow-up for the simple reason of cost. For such a large program there should have been clinical trials done and if so whether it was done with the consent of the parents of the children who received the vaccination.

from:  Bala
Posted on: Sep 24, 2013 at 12:52 IST

Vaccine should be provided only after adequate medical checkup.Health
department can certify vaccination centers based on facilities

from:  varghese
Posted on: Sep 24, 2013 at 11:23 IST

Private hospitals all over the country use pentavalent vaccination. Even my child was administered pentavalent vaccine from a private hospital. I don't know why the hue and cry when private hospitals are using the same without any issue.

from:  Senthilkumar K B
Posted on: Sep 24, 2013 at 10:54 IST

Is this report verified by health ministry ? We should go only with the official government report on these kiind of things. We all believe Govt of India is responsible and are taking full care towards its citizens.
Let us not publish reports from other sources.

from:  Vinoo
Posted on: Sep 24, 2013 at 09:17 IST

are you trying to justify & portray a failing & clearly proved fraud vaccine campaign as a sad story ?

from:  sanjay mehta
Posted on: Sep 24, 2013 at 08:42 IST
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