January 10, 2012

It’s imperative to save our children against diseases, but does that justify mindless immunisation drives like the one involving pentavalent vaccine?  

On December 15, 2011, a girl child died in Kerala, within 24 hours of being administered the newly-introduced pentavalent vaccine. While authorities declared that the infant died of breathlessness probably due to breastfeeding, the tragic incident seems to have brought alive the worst fears of health activists opposing the introduction of this vaccine.

Pentavalent vaccine is grouping of the essential trivalent DPT vaccine for diphtheria, pertussis (whooping cough) and tetanus with vaccines for hepatitis B and Hib (Haemophilus influenzae Type B) bacteria, which causes meningitis and pneumonia.

Till recently, hepatitis B and Hib were not part of India’s universal immunisation programme (UIP) but on December 14, 2011, the pentavalent vaccine was introduced as a pilot in the state of Kerala, followed by introduction in Tamil Nadu three days later.

A public interest litigation (PIL) by a group of doctors and health activists, still pending before the Delhi High Court, claims there is no justification for introduction of hepatitis B and Hib vaccines in the universal immunisation because burdens of these diseases are fairly less.

It goes on to say that the vaccine is being introduced at the behest of World Health Organization (WHO) backed by international vaccine industry eyeing huge profits in India.

There is no justification for introduction of hepatitis B and Hib vaccines in the universal immunisation because burdens of these diseases are fairly less

Where are the numbers?

The merits of universal vaccination against hepatitis B and Influenza type B are highly debatable. While pushing for universal immunisation against hepatitis B, the medical bodies relied on a 1996 study by S P Thyagarajan and others, which calculated 19 previous studies to estimate the carrier rate of hepatitis B at 4.7% in India.

However, another study published in the Indian Journal of Medical Ethics pointed out that the figure is highly exaggerated and unscientific because most of the studies included data from blood bank donors, including professional blood donors, and dental professionals who are known to have a higher prevalence of infection. A more accurate estimate of the carrier rate using the same data after excluding high-risk groups was found to be 1.42 per cent.

In 2006, the Indian Medical Association held a national consultative meeting on hepatitis B and polio eradication. A review of various research papers on hepatitis B presented at this meeting indicated that the prevalence rate was as low as 2.1 among non-tribal populations in India. It was also pointed out that liver cancer only constituted 1.6 per cent of all cancers in India.

Also, not all cases of liver cancer are because of hepatitis B. Data from the Indian Council of Medical Research (ICMR) suggests the strain of hepatitis B in India causes liver cancer in only one out of 100 carriers of hepatitis B, which is too small to require universal immunisation.

Critics are of the opinion that instead of universal immunisation, selective vaccination of infants born to only hepatitis-B positive mothers should be done. “This will not only be cost effective but is also much more practical logistically because mothers of these babies would have been detected well in advance during antenatal check-ups and it would be much easier to track down and vaccinate the infants,” says Dr Gopal Dabade, president of non-profit Drug Action Forum, Karnataka.

For Hib vaccine, the WHO relies on a 2006 report by UNICEF, which claims that 14 out of every 1,000 children in India under the age of five die of pneumonia. In contrast, an ICMR study done in 2005 has shown that the incidence of all-cause pneumonia was 30 per 1,000 and mortality was just 0.3 per 1,000 children under five. This is 50 times lower than the UNICEF figure. Cases of meningitis were also pegged at 20 per 1,000, far too low than the criteria for universal immunisation.

UNICEF claims that 14 out of every 1,000 children in India under the age of five die of pneumonia. In contrast, an ICMR study found the mortality to be 50 times lower than the UNICEF figure

“There is something seriously amiss about the argument for a pentavalent vaccine. The story of how pharmaceutical companies influenced scientists and the WHO during the swine flu scare to push their medicines is well known. How can one be sure that no commercial interest is dictating this approach,” asks Dr Jacob Puliyel, the head of paediatrics department at St Stephen’s Hospital, Delhi. Dr Puliyel, who is also a member of National Technical Advisory Group on Immunisation (NTAGI), is one of the petitioners in the PIL against introduction of pentavalent vaccine.

In a supplementary affidavit submitted in the Delhi High Court, he maintains that NTAGI recommended introduction of pentavalent vaccine in two states under the influence of international agencies and other vested interests. What makes the scenario more worrisome is the fact that there are still doubts over safety of the pentavalent vaccine.

Whose life is it any way?

Five children died in Sri Lanka in 2008 and eight in Bhutan in 2009 after they were administered the pentavalent vaccine. In Pakistan, one child died within half-an-hour while two others passed away within 14 hours of the administration. However, in all these countries, the WHO claims there was no conclusive evidence linking vaccines to the deaths.

The health activists, however, don’t buy this. WHO has six classifications for adverse effects following immunization (AEFI)—certain, probable, possible, unlikely, unrelated and unclassifiable. The expert group removed two categories— possible and probable— while studying the deaths in Sri Lanka and put the deaths in the unlikely category. If the two classifications had not been eliminated, the incidents could have been put in the probable category, meaning they are probably linked to the vaccine. “The report gives the impression that the vaccine had nothing to do with the deaths, which is not true,” says Dr Dabade..

It is apparent that with introduction of the new vaccine, the trivalent DPT vaccine will be phased out, leaving no choice for parents but to go for the new and costlier pentavalent version. Switching to new vaccine also means that indigenous public sector units have to shut down since they don’t have expertise to develop pentavalent vaccine.

Even though this vaccine will be provided for free in government sector, the public money spent to acquire it will be very high. Currently, the government procures trivalent vaccine for around Rs 15 from Indian firms whereas the pentavalent vaccine from private companies will cost Rs 525 at UNICEF-negotiated prices. With overhead charges, it would cost around 35 times more than the trivalent vaccine.

Initially, Global Alliance for Vaccine Initiative (GAVI) will provide these vaccines for free but after three years, the Indian government has to bear the financial burden.

Switching to new vaccine also means that indigenous public sector units have to shut down since they don’t have expertise to develop pentavalent vaccine

“The production of these essential vaccines, inexpensively in our public sector undertakings, was a source of security for the country at a time when private manufacturers were dropping out of the market citing low profitability. However, the new national vaccine policy supports private companies by making advance marketing commitments. This means the government will to buy certain amount of vaccines at a given price even if it has poor efficacy or the market price is lesser,” says Dr Puliyel.

Around six months ago, certain companies offered reduced prices of vaccines to be distributed through GAVI. However, Dr Dabade is not impressed. “The question is will these lowered costs still be valid when GAVI’s support is not there? Moreover, the Bill and Melinda Gates Foundation, a major donor to GAVI, also has holdings in vaccine-manufacturing companies,” he points out. The Gates Foundation holdings are invested in Berkshire Hathaway, which has significant ownership in GlaxoSmithKline.

Jagannath Chatterjee, an Orissa-based public health activist, believes our national vaccine policy is being dictated by vested interests. “Blood money of pharmaceutical companies funds the election expenses of presidential candidates in the US and other developing countries. We are now seeing it happening in India too with because we have a vast subjugated population, and thus, a huge untapped market. We are guinea pigs now, all of us,” he says.

According to the National Family Health Survey (NFHS-3), we have not yet been able to provide DPT immunisation to 45% of children born in India. An obvious question to ask is: “Why are we making advanced commitments to push costlier, doubtful and avoidable pentavalent vaccine when the basic immunisation is far from satisfactory?”

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