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Ban sought on pentavalent vaccine

New Delhi: A leading Indian journal of medical ethics has charged the World Health Organization (WHO) with promoting a vaccine whose use has been discontinued in some countries following adverse reactions and deaths in children.

Dr Jacob Puliyel

In a hard-hitting editorial, the Indian Journal of Medical Ethics (IJME) has accused the WHO of promoting pentavalent vaccine “by stating falsely that no adverse event following immunisation (AEFI) has ever been reported with the vaccine.” The journal says this is contrary to facts.

The IJME editorial by Dr Jacob Puliyel, head of paediatrics at St Stephens Hospital in New Delhi, is based on his detailed investigation into the deaths of children in Bhutan, Sri Lanka, India and Vietnam following use of pentavalent vaccine. This vaccine combines the Diphtheria, Pertussis, Tetanus or DPT vaccine — long used in national immunization programmes — with Hepatitis-B and H influenza-b or Hib vaccine.

The IJME editorial says that on 4th May 2013 the Ministry of Health of Vietnam suspended Quinvaxem — the pentavalent combination used in that country — after 12 deaths and 9 other non-fatal serious adverse events. According to local news reports, all the babies who died were in good health prior to vaccination and had serious trouble breathing before dying shortly afterwards.

The WHO, which investigated the incident, said the deaths were not vaccine-related and asserted that “Quinvaxem was prequalified by WHO and no fatal adverse event following immunization has ever been associated with this vaccine.”

The editorial points out that the WHO had not disputed the death of 12 children soon after immunization and “therefore it is patently wrong and misleading for it to conclude that no fatal AEFI have ever been associated with the vaccine.”

This combination vaccine is not licensed for use by the US Food and Drug Administration (FDA) nor is it used in other developed countries, the editorial says. But the WHO recommends this pentavalent vaccine in developing countries, by piggy backing the Hepatitis-B and Hib vaccines on the well accepted DPT to increase uptake of Hepatitis B and Hib according to a write up on the GAVI website.

Serious adverse reactions and deaths have now been reported with pentavalent vaccine produced by other manufacturers and in a number of countries, the journal says. Bhutan, Sri Lanka and Pakistan have stopped using the vaccine, “following unexplained deaths soon after immunization.”

Bhutan stopped the immunization programme after four deaths but was later persuaded to restart immunization by the WHO. Reintroduction of the vaccine was followed by a further four deaths and Bhutan is not using this vaccine any longer, the journal says.

The deaths in Sri Lanka also resulted in the suspension of the immunization drive there. A WHO committee that investigated the deaths reported that the deaths were not due to the vaccine but could find no alternate cause for the deaths.

In Pakistan too — where one child died within half an hour of receiving the vaccine and two others died within 12 to 14 hours — the vaccine was not blamed but no alternate cause of death was found for any of the cases, the IJME article says.

In India, according to IJME, 21 have so far died in a limited experiment with the vaccine introduced in 2011 in the immunization programme of Tamil Nadu and Kerala. India had announced plans to roll out the vaccine to other states after monitoring its impact in these two states.

“In all the deaths being discussed in this editorial, the common factor has been that the children had received pentavalent vaccine and in most of them, this was followed by high fever, excessive crying and in some, there were convulsions before the child died,” the journal says expressing surprise at how the WHO “failed to see the unifying connection between the deaths” in the different countries.

The majority of deaths after pentavalent vaccine have followed the first dose of the vaccine. This pattern of the adverse events taking place predominantly after the first dose, also suggests that these are not random events, the editorial says.

The journal has also questioned the very rationale for introducing Hib vaccination in India where the incidence of Hib disease is very low. The editorial estimates that vaccinating 25 million babies could at best save 350 children from Hib meningitis and Hib pneumonia but “3125 children will die from vaccine adverse effects.”

The journal warns that when countries like Bhutan and Vietnam have taken action, it is imperative that India acts to protect the lives of its children. “To trivialize all these deaths as ‘coincidental deaths’ is hiding the real picture.”

AFPI and the pentavalent vaccine – looking for a composite picture

4 Comments

  1. geetika geetika Friday, July 26, 2013

    I would like to know what is the opinion of IAP on this issue.

  2. Dr Jayant Shah Dr Jayant Shah Thursday, July 25, 2013

    Are similar adverse effects also seen with Pentavac or EasyFive? If yes, can we know how many serious side effects have been seen compared with the total number of doses? Also, they should be compared with the side effect incidence of DTwP alone. If the incidence of adverse effects with DTwP alone and that of pentavalent vaccines is same, then the combination is not to be blamed; but if there is statistically significant increase, then action is needed.

  3. Dr. Shivaraj B M Dr. Shivaraj B M Thursday, July 25, 2013

    Though articles is an eye opener for AEFI issue, simply you cant attribute all the deaths to pentavalent vaccine.
    Hep B going to be serious issue in near future…
    There should be detailed study on AEFI to prove the dangers of this pentavalent vaccine.

  4. Dr R Ramakrishnan Dr R Ramakrishnan Thursday, July 25, 2013

    Its a very interesting article. The risk-benefit analysis is very much tilting towards risk. WHO must enlighten the public with proper explanation for its policy on this issue.

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