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 )
