Tag Archives: Polio

IMA Recommendations on Polio

A National Consultative Meeting on the Polio Eradication Initiative (and Hepatitis-B) was held on 14th May 2006 by the Indian Medical Association (IMA).  While the complete report of this meeting is available on the IMA website (www.imanational.com), we reproduce here the Recommendations on Polio.

Polio Eradication: Current Status

Gains Achieved by the programme

  • Confirmed wild polio cases down significantly.
  • Number of `infected states’ has decreased.
  • Very focal transmission now.
  • P3 almost absent.
  • Less genetic bio-diversity now.
  • Coverage during pulse polio rounds is `improving’.
  • “Excellent” surveillance system in place.
  • Large scale social mobilization operation in India that cuts across several barriers (during pulse polio rounds).

The Costs

  • More than Rs 5000 crores have already been spent.
  • Higher priority health problems have receded to the background.
  • Even routine immunization has suffered, as evidenced by higher number of cases of traditional VPDs.
  • No mention of VAPP at all in the grand reports of covering 170 million per NID and 67 million per SNID.
  • Fatigue at all levels.
  • Confidence of public and professionals shaken.
  • A close look shows that with the current strategy “polio cannot be eradicated”.
  • No definite plan available for post eradication scenario or if there is a failure to achieve zero WPV status.

Conclusion 1: Continuing circulation of the wild polio virus in a few states, despite intensified pulse polio activities, with multiple changes in strategies and interventions, is a matter of serious concern.  At the same time a large number of states which have been free of WPV for last several years are being unnecessarily being exposed to hazards of VAPP due to OPV.

Recommendation: Strategies need to be reviewed by setting up a National Expert Group.  Possible use of IPV (alone or in combination with OPV) needs to be considered strongly. (See also Conclusion/Recommendation 4).

Conclusion 2: There is an alarming increase in number of clinical AFP cases, particularly in the states of UP and Bihar.  Such high incidence on non-polio AFP has not been reported from anywhere else in the world.

Recommendation: These reported cases need thorough evaluation, including clinical follow-up, to assess the possible causes and sequelae thereof.  There is also an urgent need of establishing an independent agency (separate from NPSP) for carrying out surveillance activities and their review.

Conclusion 3: Administration of multiple doses of mOPV1 in a pulse manner to a very large number of children in different states of the country is unprecedented.  It is alarming that the same is being done as phase IV clinical trial without following the established national guidelines for such trials.

Recommendation: There is a need to immediately evaluate the impact and side effects, if any, of the use of multiple doses of mOPV1.

Conclusion 4: At present there does not appear to be a coherent policy for the future keeping in mind the possibilities of: (a) pockets of continuing circulation of WPV; or (b) ultimate cessation of circulation of WPV.

Recommendation: There is a need for an independent National Expert Group to consider future strategies, which would be best, suited to our country within the overall objectives of the Global Polio Eradication Initiative.  The feasibility and desirability of introducing IPV and the suitable timing for the same also needs to be examined by this expert group.  There is urgency for deciding on these issues with a view to establish and achieve self-sufficiency in manufacturing of IPV in the country, if it is considered desirable to introduce IPV in the immunization programme.

Conclusion 5: The number of cases of VAPP is not available in the public domain.  It is not known whether any effort is even being made to delineate cases of VAPP.

Recommendation: District wise and state wise data on VAPP should be made available on a regular basis.  Efforts must also be made to assess VAPP among contacts of Vaccinnees.  It is also important that the state initiates a comprehensive programme of rehabilitation and possibly compensation for the victims of VAPP.

Global Polio Eradication Initiative in India (1995- 2006)

Prepared for IMA Conference by
Dr. Onkar Mittal. Dr. C. Sathyamala
Final Draft 4th May, 2006

Summary

Main Points

1. Circulation of Wild Polio Virus (WPV) continues despite 12 years of intensive efforts.
2. There has been a dramatic increase in the number of AFP cases in the last 2-3 years, with a national average rate of 6.3/1,00,000 and even higher incidence of 12-13 /1,00,000 in endemic states of UP and Bihar, against an international average of 1/1, 00, 000.
3. There is an urgent need for a complete epidemiologic investigation into the cases of AFP with a view to find out the reason for the rising incidence, to know the exact cases and nature of these AFP cases, and to provide appropriate treatment and rehabilitation.
4. Strategy of increasing the number of pulse polio rounds each year ( the NIDs and SNIDs) to meet the challenge of continuing transmission of WPV does not seem to be meeting the desired objective of stopping the transmission of WPV and needs to be reviewed.
5. The monovalent Oral Polio Vaccine-1 (mOPV1) has been introduced in India since last year, through the polio eradication programme. More than 5-6 pulse polio rounds have been undertaken in the selected districts of UP and Bihar with mOPV1, contrary to the recommended 1-2 doses. Impact of these multiple rounds of mOPV1 needs to be assessed.
6. Inactivated Polio Vaccine (IPV) has been introduced in many developed countries, to tackle the problem of Vaccine Associated Polio Paralysis (VAPP) due to OPV, while maintaining the immunity against wild polio virus. Desirability, feasibility and cost efficacy of this strategy needs to be discussed in the national context.
7. Strategies that need to be adopted, if we fail to stop the transmission of WPV, need to be discussed as much as the ‘post- eradication- strategies’ which would be required if we are somehow able make the achievement of stopping the wild polio virus transmission.

One Way Forward

1. The year 2006 should be the year of the phased withdrawal and closure of the National Pulse Polio Program.
2. Urgent investigation should be carried out on the actual incidence of Post Polio Residual Paralysis (PPRP) in the cases of reported AFP in the last 10 years.
3. The activities of the polio-immunization should be re-integrated into the Universal Immunization Program.
4. An expert committee should review the present evidence base on efficacy of the IPV and cost –benefit- ratio of substituting IPV for OPV and other issues related to the relative merits of these programs in the prevention of the transmission of WPV.
5. The improvement of sanitation and hygiene should be taken up as the highest priority, specially, in those urban and rural pockets of UP and Bihar, which have been reporting the cases of WPV in the last three years. Adequate funds are available under the ‘Rajiv Gandhi Drinking Water and Sanitation Mission’ for this purpose and more can be provided by the Central and State Governments. The public health professionals should put their time and energy for the effective implementation of this program.
6. An independent commission should be appointed to review all aspects of National Pulse Polio Program in the last ten years and appropriate lessons should be drawn for the health policy formulation, program implementation and health governance in this country.
7. A comprehensive policy and program for the rehabilitation of the children who have been paralyzed during the period of the polio eradication initiative should be worked out.

1. Background

The World Health Assembly had passed a resolution in 1988 for the WHO to take steps for the global eradication of poliomyelitis . Due to the strong advocacy of the WHO and UNICEF, Government of India (GOI) launched this program countrywide in the year 1995. The National Pulse-Polio Program was started by GOI in the year 1995 with the objective of eradication of the Wild Polio-Virus (WPV) transmission in the country. This program is an integral part of the Global Polio Eradication Initiative (GPEI). A vast sum of financial resources has been devoted by the Government of India on this program .

India’s expenditure on Pulse Polio Program

• These financial resources have been mobilized from the national budget, liberal grants from donors and loans from the World Bank.
The objectives of the program when it was launched were
• To stop transmission of wild polio virus,
• To decrease disability due to poliomyelitis
• Discontinue polio vaccination to save money,
• Establish global surveillance for polio virus and
• Strengthen the health systems in the developing countries.
• India has been forced to borrow from the World Bank, despite an impression being created that the entire program is grant funded. (data)
• The operational costs of hundreds of thousands of health workers, professionals and volunteers have not been calculated at all.

Three year program (2004-06) is expected to cost 482 million $ ( about 2000 cr rs) .

Box: World bank Loans by India for the Pulse Polio Program

1. Reproductive and Child Health Project (CR. NI 080-IN), and subsequently through the India Immunization Strengthening Project (Cr. 33400-IN) with an IDA credit of SDR 106.5 million (US$ 142.6 million equivalent).

700 cr.

2. Supplementary credit: India Immunisation
strengthening project: US$83.41 million-

400 cr.

3. The polio restructuring project- 96 $ Million

450 cr.

4. RCH-2: Project Component 3: Polio Eradication

1580 cr.

Total

3100 cr.

Table: Polio Eradication: Cost estimates and Financial Plan for India: 2004 – World bank

OPV

Operational expenses

Total

NIDs

35.04

31.00

66.04

SNIDs

40.29

32.40

72.69

Mop-ups

4.38

4.38

Buffer

0.77

0.77

Total

80.48

63.40

143.88

(data on expenditure on pulse polio as proportion of the Health & FW)

At the time of launching of the program, it was promised that polio eradication and its certification will be achieved in India and globally by the year 2000. This deadline was shifted to the year 2004 and then to the year 2007. However, due to continued detection of WPV in India and in several other countries, it is clear that the 2007 deadline will not be achieved.

In 2004, a status report presented to the World Health Assembly by WHO secretariat highlighted the following issues:

• WPV transmission was yet to be interrupted

• Concerns regarding the safety of OPV in certain countries were leading to opposition to the pulse polio drives.

• Importation of cases of poliomyelitis in polio-free areas/countries ( latest importation have been in Nepal and Bangladesh in SEA)

• Insufficient financing impelling cancellation or postponement of SIA activities

• Identification and management of vaccine derived poliovirus

• Post-eradication strategies – guidelines for national policy makers to underpin the decision they will need to make upon cessation of poliovirus vaccination

The WHO has recently ( in year 2005) published its guidelines for the post eradication strategies. It is now envisaged OPV will not be available any longer, once the global certification of the cessation of the transmission of the WPV is achieved. Abandoning the global perspective, these guidelines give the choice to the countries to either shift to IPV regime as routine immunization or stop polio immunization altogether. It is likely that the developed countries of the world which have already been using IPV will continue with that for routine immunization. The developing countries are meant to make their cost benefit analysis of shifting to the costly option of IPV or face the unknown danger of cVDPV, iVPDV or bio-safety or the reintroduction of WPV on cessation of OPV. The decision is now left with individual countries.

In 1997, the WHO had estimated that “once polio is eradicated and immunization halted, global savings from immunization, treatment costs, and rehabilitation will amount to over US$ 1.5 billion a year. It has been shown by the analysis done by WHO that continued use of IPV will make the goals of the entire global effort unfavorable on the cost benefit analysis and the program can be justified on these criteria only if the use of polio vaccine is stopped after the cessation of transmission.

In the meantime, the task of cessation of WPV transmission, the original goal of GPEI, is still unfinished. After demanding for intensification and increased number of SIAs in the remaining reservoirs of WPV in the years 2003 and 2004, the mOPV 1 was introduced into India in the year 2005. Even this has failed to achieve the zero polio status in India in the year 2006. Yet there is an assumption in statements made by NPSP and GPEI that wild polio virus transmission will somehow be stopped in India and globally. What will happen in the likely event of continued transmission of WPV, has not been made clear.

The failure to interrupt WPV transmission despite 12 years intensive efforts is a cause of concern. Questions have been raised, periodically, against the rationale and justification of this program by eminent public health experts in the country . According to these public health experts, several questions need to be answered by the proponents of the GPEI:

• How fair was it to impose the ambitious target of polio eradication on India (and other developing countries) particularly in the context of its low ranking priority in the country’s disease profile?
• How sound was the strategy adopted for the eradication programme?

• What are the interests and influences that have played the key role in pushing this over ambitious, an impossible, initiative onIndia and globally?
• What are the negative impact that the excessive demands of this program have made on the weak public health systems of this country ?

The present paper has been prepared as a background note for discussion in the expert group meeting convened by IMA in May 2006. The paper is based on the information made available on the program surveillance by the National Polio Surveillance Programme (NPSP), jointly managed by the WHO and Government of India and other available literature on the issue. The authors are grateful for the inputs provided by Prof. S.K. Mittal.

2. The survival of Wild Polio Virus (WPV)

2.1. The falling numbers of WPV as detected in the laboratories

The data for the polio viruses detected in the national laboratories from the stool samples of children suffering from AFP has been available since the year 1998. After the detection of polio virus, these are further classified as either wild virus or vaccine virus . The detection of the wild polio virus from **********Vaccine Virus

There has been an increasing trend in the vaccine virus cases since the year 2002. There were 500 cases in 2002, 474 in 2003, 894 in 2004, 1644 in 2005 and so far in the year 2006, 195 cases.

No statement has been issued by NPSP on the significance of these vaccine virus cases associated with AFP. No follow-up has been done to look for evidence of PPRP.

Cases of paralysis associated with OPV are usually caused by type 2 and 3. The overall risk of vaccine associated paralytic poliomyelitis is extremely low. The overall risk of VAPP is one case per 2.5 million doses of tOPV, with the highest risk being associated with the first dose. (Ref: Field Guide page 1)

Vaccine-Associated Paralytic Poliomyelitis ( ref: CDC. Progress toward interruption of wild poliovirus transmission—worldwide, January 2004–March 2005.MMWR 2005;54:408–12.)

Vaccine-associated paralytic polio is a rare adverse reaction following live oral poliovirus vaccine. Inactivated poliovirus vaccine does not contain live virus, so it cannot cause VAPP. The mechanism of VAPP is believed to be a mutation, or reversion, of the vaccine virus to a more neurotropic form. These mutated viruses are called revertants. Reversion is believed to occur in almost all vaccine recipients, but it only rarely results in paralytic disease. The paralysis that results is identical to that caused by wild virus, and may be permanent.VAPP is more likely to occur in persons 18 years of age and older than in children, and is much more likely to occur in immunodeficient children than in those who are immunologically normal. Compared with immunocompetent children, the risk of VAPP is almost 7,000 times higher for persons with certain types of immunodeficiencies, particularly B-lymphocyte disorders (e.g., agammaglobulinemia and hypogammaglobulinemia), which reduce the synthesis of immune globulins. There is no procedure available for identifying persons at risk of paralytic disease, except excluding older persons and screening for immunodeficiency.

From 1980 through 1998, 152 cases of paralytic polio were reported in the

United States; 144 (95%) of these cases were VAPP, and the remaining eight were in persons who acquired documented or presumed wild-virus polio outside the United States. Of the 144 VAPP cases, 59 (41%) occurred in healthy vaccine recipients (average age 3 months). Fortyfour (31%) occurred in healthy contacts of vaccine recipients (average age 26 years), and 7 (5%) were community acquired (i.e., vaccine virus was recovered but there was no known contact with a vaccine recipient). Thirty-four (24%) of VAPP cases occurred in persons with immunologic abnormalities (27 in vaccine recipients and 7 in contacts of vaccine recipients). None of the vaccine recipients were known to be immunologically abnormal prior to vaccination.

The risk of VAPP is not equal for all OPV doses in the vaccination series. The risk of VAPP is 7 to 21 times higher for the first dose than for any other dose in the OPV series. From 1980 through 1994, 303 million doses of OPV were distributed and 125 cases of VAPP were reported, for an overall risk of VAPP of one case per 2.4 million doses. Fortynine paralytic cases were reported among immunologically normal recipients of OPV during this period. The overall risk to these recipients was one VAPP case per 6.2 million

The stool samples of the reported AFP cases has been the mainstay assessing the transmission of the wild polio virus in the country. At present to survelliance of sewage or other environmental sources is being done, one a regular basis to detect the circulation of WPV in the environment.

As clear from the table below, the except for the year 2002 (when there was an apsurge), there was a declining trend in the detection foWPV from 1998 to 2006

OPV doses. However, 40 (82%) of these 49 cases occurred following receipt of the first dose, making the risk of VAPP one case per 1.4 million first doses. The risk for all other doses was one per 27.2 million doses. The reason for this difference by dose is not known with certainty, but it is probably because the vaccine virus is able to replicate longer in a completely nonimmune infant. This prolonged replication increases the chance of the emergence of a revertant virus that may cause paralysis. The situation is similar for contacts. A nonimmune child may shed virus longer, increasing the chance of exposure of a contact. The last case of VAPP acquired in the

United States was reported in 1999. As noted above a U.S. resident with VAPP was reported in 2005, but the vaccine virus infection was acquired in Costa Rica.

Table-1- The status of polio eradication in India (from 1997-2006) based on data from www.npspindia.org ( last date 1st May 2006)

Year

Total AFP cases

WPV cases

Infected Districts

Non-Polio AFP cases

Compatible cases ##

Stool Collection Within 14 days

Vaccine Virus cases#

NID/SNID/Mop Ups

1997

3047

1998

9461

1934

314

7527

59%

2 NID

1999

9587

1126

192

8461

71%

4 NID

2000

8103

265

89

7878

82%

2 NID
4 SNID

2001

7470

268

63

6916

286

84%

2NID
1SNID

2002

9705

1600

159

7424

681

82%

500

1 NID
2 SNID

2003

8505

225

87

7697

593

81%

474

2 NID
4SNID

2004

13274

134

43

12765

375

82%

894

5 NID
1SNID
1 mop Up

2005

27050

66

35

26351

366

81%

1644##

2 NID
6 SNID

2006

5947

22

12

4194 (904 pending)

5

86%

308

2 SNID
1NID in April
1in May
Moreplanned

# : through the virological scheme, NPSP started reporting WPV cases in the year 1998. The data for the vaccine virus cases is available to us only since the year 2002. We do not have the data before that. The vaccine virus cases are included in the category of the discarded or the non-polio AFP, column V in this table. The NPSP does not say anything on whether these cases are of VAPP or not. The data has been constructed from the tables on virological analysis of the polio positive cases given by the NPSP in its regular bulletins.

2.2. The Variations among the states in detection of WPV cases India being a large and diverse country, the status of polio cases presents a variegated picture, in different states.

The transmission of WPV has been uneven in India, as detected by the NPSP. UP and Bihar have not been polio free in any of the year since the beginning of the program. The areas of Western U.P and Bihar, which have been WPV free in one year, have shown the transmission again in the next year. It should also be be noted that Gujarat, Haryana and Punjab had not reported any cases in 2004 but the WPV cases have reappeared in 2005. There is no information available from NPSP whether this is local transmission or imported cases.

The following tables give the year wise status of the last case detected in the different states of the country:

Table-2 Status of last WPV case detected in different states

Last case detected in the year

States

2006

UP and Bihar

2005

Gujarat, Haryana, Punjab, Jharkhand, Uttranchal, Delhi

2004

Maharashtra, West Bengal, Andhra Pradesh, Tamilnadu and Karnataka

2003

Madhya Pradesh, Assam, Rajasthan, Chattisgarh

2002

Jammu and Kashmir, Chandigarh, Chattisgarh

2000

Kerala

1998 or earlier

NE states other than Assam, Goa, Pondicherry

Ref: constructed from the data given in www.npspindia.org .

These cases are a reflection of large number of resistant pockets of ongoing transmission in the country, particularly in the states of U.P. and Bihar.

2.3. The districts appearing to be reservoirs

Thirteen districts in the country are reporting cases repeatedly in the country and these have been called the reservoir of WPV by the NPSP. The NPSP has not made available in the public domain the names of these districts.

2.4. Immunity Gap 7

( immunity gap-defined as the number of non-polio AFP cases which had received 3 or less number of doses of OPV- ref: )

All along strong impression has been created that the low coverage of vaccine is the reason for the persistence of WPV and only if we could deliver the vaccine to all the children, the WPV will be wiped out. This is the basis on which the public campaign of the NPSP and GOI is based. Nothing can be further from the truth.

Paul states that “Committee of IAP has overlooked two vital issues: (a) vaccine failure with OPV and (b) misclassification of AFP cases. The members of the committee are not correct in their assessment that failure to eradicate wild polio virus is due to inadequate vaccine coverage only. Wild polio virus elimination cannot be achieved by the end of year 2003. The committee is trying to raise false hopes. There are many cases where children have developed polio even after taking more than 8 doses of OPV. Unless reasons for vaccine failure are found and appropriate measures taken, wild virus elimination cannot be achieved. ( Paul Y. 1100: 40; 2003. Indian Pediatrics)

In response John states “According to Dr. Paul, the success of eradication depends on the answer to the question: has any child developed polio after taking age appropriate number of OPV doses? If answer is yes, he would want us to believe that the program in its present form cannot eradicate polio. Of course the answer is yes. The fact of the matter is that eradication is the answer to this problem. ( ref: John T.J. 1102:40; 2003. Indian Pediatrics; emphasis added )”.

Can the immunity gap in the UP and Bihar (low coverage of under five children with vaccine virus during the pulse polio drives) be blamed for the persistent circulation of WPV ?

The intensification of the Pulse Polio program has led to an enhancement of coverage OPV and the immunity gap had largely been plugged in the so called high risk districts of U.P and

Bihar in the year 2004. Yet, the IEAG report (ref.) has attributed the continued transmission of WPV in western UP to poor quality of SIAs in the 13 high risk districts, in December 2004. No objective evidence has been provided.

In contrast, according to a communiqué issued by the WHO in 2004 ( see end note), “ in India, for the first time, minority populations are being reached with a higher number of vaccine doses. In the key state of Uttar Pradesh, data show at least 87% of children from minority populations had received at least four doses of polio vaccine in 2003, compared to only 58% in 2002.”

Based on the data received from the Lucknow office of NPSP (by one of the authors of this paper), most of the children in UP suffering from non-polio AFP had received more than three doses of Oral Polio Vaccine at the end of year 2004. The immunity gap was only 8% in the year 2003 and 2% in the year 2004. 93% of the 82 WPV cases had received four or more doses of OPV. ( This data should be made available publicly, to enable informed debate. ) Yet the wild polio virus transmission persists in these areas.

Table-3 : The immunity gap in children in U.P. at the end of year 2005#

Year

WPV cases

Infected districts

% AFP 0-3 doses (immunity gap)

WPV cases 4+ doses

Muslim WPV % cases

Hindu WPV%cases

1998

845

58

49%

32%

1999

757

56

36%

44%

2000

178

45

13%

62%

62%

38%

2001

216

28

10%

61%

74%

26%

2002

1242

65

27%

47%

59%

41%

2003

88

25

08%

69%

68%

32%

2004

82

15

02%

93%

78%

22%

2005

04

03

# data received from the Lucknow office of the NPSP in March 2005.

However, commenting on the large number of cases in Moradabad district this year, GPEI has issued a release in April 2006,

• Moradabad is one among several critical districts where data suggests fewer children are being immunized than in previous rounds. Some 50 Surveillance Medical Officers will be re-deployed to support the activities in these areas in western Uttar Pradesh and

Bihar.

This is a vague statement does not give actual figures. Due to the lack of access to the data, it is not possible to comment on the above statement. It is difficult to say whether the immunity gap has actually increased in the districts in the years 2005 and 2006.

2.5. The repeated rounds of pulse polio

The GOI and NPSP is using a slogan to motivate people to participate in the campaign: “ Once again, it is time for two drops; this time our success is sure.”

Do boodon ki phir

bari hai abke pakki jit hamari hai
Pulse polio round; 25th September 2005

Repeated rounds of pulse polio campaigns are being organized particularly in UP and

Bihar.

Number of Pulse Polio Rounds-2005

Bihar and UP- 8-9 rounds
• West Bengal, Delhi – 6 rounds
• Jharkhand, Uttranchal, Part of Maharashtra- -4 rounds
• Large parts of the country- 2 rounds.

2.6. WPV despite multiple doses of OPV

The IEAG in one of the report of the proceedings of its meetings gives the following explanation (ref: IEAG)

• If a few children do not receive OPV during NIDs/SNIDs, they maintain the circulation of wild poliovirus and this virus can then attack any child and produce paralysis in children that are not fully protected.

• Unless we reach uniformly high coverage without pockets of children being left out, there will always be a risk that some children who have been vaccinated could be affected by polio since they can still come into contact with virus.

• Thus the only way to assure 100% protection from polio is to eliminate the poliovirus and thus stop it from circulating from child to child.

• It is therefore even more important that every child under 5 years of age receives polio drops on every pulse polio day, in addition to their routine immunizations.

The question then is “ to demand that every child in every round should get vaccination, is this not against the principle of herd immunity” in any case, as per Jocob John8, OPV provides neither hard immunity nor gut immunity and we must try to administer at least 10 doses to all infants before 2 yrs of age to ensure stoppage of transmission of WPO

2.6. The use of mOPV1 since the year 2005

The polio-free status was achieved by different regions of the WHO (

Americas, Europe, SEAsia, etc.) with the tOPV only without the need for mOPV. The same was expected to happen in India and the SEARO region too. However, suddenly in the year 2005, WHO advised India to use mOPV1, as a new measure, to stop the transmission of WPV.

In April and November 2005, the thirteen alleged three reservoir districts of UP and

Bihar have received 4-6 mOPV1 rounds ( ref: IEAG findings, power point presentation, 5-6 December 2005; www.polioeradication.org . ). The IEAG group has summarized that introduction of mOPV1 and innovative SIA approaches have reduced the WPV cases to lowest incidence and geographical extent ever and that enhanced impact of mOPV1 during low season could stop all polio in early -2006. However IEAG’s optimism was misplaced once again, this time, since cases have been reported from these very reservoir districts despite 4-6 rounds of mOPV1.

Technical information on the MOPV1

One of the alleged reason for promotion of mOPV1 is that it fits the definition of an ideal oral polio vaccine, that needs to be administered orally once are at a maximum twice only.

“By general consensus amongst experts, prevention and eradication of type 1 infection would not be achieved by ordinary immunisation efforts using the currently available Sabin tOPV. The vaccine (tOPV) has proven insufficiently immunogenic to eradicate the type 1 form of the disease. A more specific and highly effective vaccine would be required. The fact that poliomyelitis expresses in the populations concerned as type 1 disease only suggests that the current immunisation regimen with tOPV is inadequate for prevention of type 1.”

“The WHO Technical Advisory Group on Poliomyelitis Eradication advised that mOPV1 should be used as a key tool in the last phase of polio eradication. This is because of the superiority of mOPV1 to tOPV in achieving rapid seroconversion and in boosting intestinal immunity in young children. Because of the consensus of the superior immunogenic and safety profiles of Sabin strains over others, and because the Sabin strains have been most widely used and tested, Sabin mOPV is the preferred product for this eradication programme.”

“ An Indian Phase IV study has been built in to implementation of mOPV1 that addresses the following: immunogenic of the vaccine in all vaccines receiving it; study of virus excretion in the stool in recipient, that will indicate the extent of virus infection; and comparision of the response and the sero-conversion rate following administration of one dose of mOPV1 with a response to one dose of tOPV. The Indian study would need to meet the following specification in order to serve as a basis for definitive registration approval and licensure by the NRA in

India itself, and subsequently by the NRAs of other countries. Chatterjee A & Chawla A: Monovlent Polio Immunization – A strategy for India, JIMA 2005)” This shows that introduction of monovalent OPV1 is in experimental stage in India. This raises questions of ethics and informed consent.

2.7. Issues arising from the experiences of the Polio Eradication Initiative in India
It is clear that this goal of stopping the transmission of WPV is yet to be achieved in India (and in several other countries in the world). Following issues needs to be considered in this context:

A. Continuous shifts in the strategy
Since the launch of polio eradication program in the country, WHO has recommended several shifts in polio eradication strategies, without clear rationale. Blame continues to be put on “lack of political will” or “so called resistant community” for failure to achieve eradication.” There has however not been an honest appraisal of the different strategies followed since the year 1995 and of the justification of the shifts in the strategies. The reality is that we are still left with ongoing transmission of WPV in

India (and in other parts of the world), despite implementing the advise of WHO in letter and spirit. The following shifts were made by the WHO advisers to achieve the goal of eradication within the given time framework, each time assuring success:
• NIDs will be sufficient to stop polio virus transmission.
• Intensification of Pulse Polio Immunisation and , SIAs
• Further intensification after 2002 upsurge in India, several rounds in the year
• The introduction of mOPV1 to finish the task of remaining reservoir
• IPV vaccination will have to continue in the developed countries of the world, (earlier, the stopping of polio vaccination and savings to the developed world was the main justification of the program).

B. Forcing a no-win strategy

The pulse-strategy for polio vaccination was not meant to be an incremental strategy but a kind of ‘one -off’. It was promised in the year 1995 that the task will be finished in one to two years and the certification will be done in five years, after three years of intensive surveillance. The promised eradication by the year 2000 failed to happen. The dates were then pushed to the year 2005 and then to year 2008, after the great setback of the year 2002. During these critical years, an absolute faith in an uni-focal strategy of ‘war between the vaccine and virus’ has been maintained leading to a demand for more and more pulse-polio rounds and house to house visits by the health workers. During the last 10 years the children have been administered several doses of the oral live polio vaccine in the national and sub-national rounds of pulse polio. The children borne in the year 1997 in the states of UP and

Bihar may have received 25-30 doses of polio vaccine by their fifth birthday, as against the previous wisdom of three doses under the routine immunization program. The star campaigner Amitabh Bachchan has been deployed to convince the women on the national media, not to worry about the number of doses. This is very much against the whole logic of pulse-strategy whereby even 80-90 percent coverage was promised to stop transmission due to herd effect of the vaccine virus. Two impossible targets have been put for the not very robust health systems of the country:

• A target that ‘not even a single child should be missed in any pulse round, otherwise the whole protection cover will break’. Ek bhi baccha chut

gaya, suraksha chrkra toot gaya.

• To ensure the zero dose to all newborn children.

C. How significant is the consistent drop in that WPV cases since the year 2003:
• The number of cases detected of WPV should not treated as equivalent to the measure of WPV transmission in the country. Too much should not be made out of decreasing number of cases being detected since 1998 (except upsurge of 2002). Even the 22 cases detected this year does not mean that these are residual cases.

• Each case of AFP caused by WPV may be equivalent of 1000 polio virus infection in the community, since majority of the infections remain either sub-clinical or do not manifest any paralytic symptoms. Therefore 66 detected cases in the year 2005, and 22 cases detected in the year 2006, do not reflect the last vestiges of the wild virus transmission.

• There is a a need to carry out the surveillance of sewage and environmental services to define cessation of WPV, is required to be taken into consideration

• Particularly in the case of UP the cases are concentrated in the ganga-yamuma Doab which has formed a reservoir of polio transmission in the country. The districts which have not reported cases in a particular year have reported case in the subsequent year. The polio certification program itself would require that a region should not report cases for three years continuously for it to be certified polio free.

• The filling of immunity gap has not really helped as cases continue to occur despite narrowing of the immunity gap.

D. Introduction of monovalent vaccine

• It is not clear whether mOPV1 has brought in any extra benefits or it has caused harm? The use of mOPV1 has been associated with alarming rise in number of AFP cases in UP and

Bihar. This may be a pure coincidence or there may be more substance in this (see next section).

E. Sanitation Issue in Eradication of WPV

• Several of the ‘resistant’ pockets in UP and

Bihar, which are now being called reservoir of WPV, particularly the urban and peri-urban areas, suffer from abysmally poor sanitation conditions. The sanitation and hygiene improvement should have been the foremost priority here.

3. The Rising numbers of AFP Cases in UP and

Bihar

3.1. The Trends in rising number of AFP Cases

• From the year 1998, to the year 2003, the AFP cases, as recorded by NPSP had remained around 8-9 thousand every year.

• However, the number of AFP cases, as recorded by NPSP has started rising in the year 2004 and the rise has assumed an alarming dimension in the year 2005. The trend seems to be continuing in the year 2006 also.

• In 2004, there were 13,274 AFP cases reported in 2004, 27050 cases in 2005 and 5947 cases in 2006, till the end of March.

• This shows that there has been three fold rise in the reported AFP cases in the country between the year 2003 and 2005.

• The trend of rise of AFP cases has been uneven in the different parts of the country which is also reflected in the AFP rate.

Table -4: The AFP rates in different states:

AFP Rate 2005

AFP Rate 2006

National

6.53

4.26

UP

14.12

10.36

Bihar

14.38

9.45

Jharkhand

7.78

4.30

Uttranchal

7.45

3.23

Delhi

2.51

1.94

West Bengal

5.70

3.32

MP

4.28

2.78

Haryana

4.53

2.70

3.2. Can it be due to better surveillance:

NPSP and IEAG has made only a passing reference to very high rates of AFP reporting from UP and

Bihar. As reflected from the minutes of their meetings in the year 2004 and 2005. “ High AFP detection rates have been maintained and consistency of surveillance has improved (i.e. more districts are achieving basic quality indicators); The surveillance system is operating at a very high level of sensitivity. While noting concerns about very high rates of AFP reporting from UP and Bihar in particular, the IEAG considers that at this stage of eradication process in India, it is critical to achieve high sensitivity even at the expense of specificity, ie. risk of including cases that may not be AFP . The evidence is clear that by improving the sensitivity of the system, transmission has been detected in several districts where it otherwise would not have been found. The IEAG reaffirms that the surveillance is reliable and high quality. “ : 14th Board meeting on 5-6 December in Delhi).

The NPSP has no valid explanation for such a large number of Non-Polio AFP cases in the country and more particularly the higher numbers in UP and Bihar The reasons why this cannot be explained by better surveillance alone are the following:

• We are not aware of any change in instructions for improved surveillance available in the public domain.
• In 20% of the AFP cases, the stool samples are not being collected within the stipulated period of 14 days. This figure has almost been constant since the year 2000. If the NPSP had issued any special directives to improve surveillance in the year 2004, it should have reflected in improvement in stool collection also, as shown by nearly 100 percent stool collection. Hence on the basis of this indicator, the claim of better surveillance cannot hold ground.
• Since the NPSP has not kept any record of the AFP cases that they had not included in the surveillance in the previous years, there is no basis for the NPSP to assert that there were similar numbers of cases in the previous years also.
• No district-wise, dis-aggregated data has been made available by the NPSP on the AFP cases. However, the distribution of these rising AFP
cases is non-random , in other words, some districts are showing very large number of cases compared to other districts (data received from the

Lucknow office of NPSP in March 2005).
• To unravel the mystery of increased number of AFP cases as well as to know their nature, despite the clear instruction in the AFP surveillance guidelines issued by the Department of Family Welfare, Government of India, a detailed analysis of AFP ases including 60 days follow up, is not being carried out by the NPSP.

An Overview of Compatible cases

The case records of the AFP cases, where the stool samples are not collected in time, are examined by the National Experts Review Committee (NERC). Those case records which resemble the polio-paralyses are labeled as ‘compatible’, even when no Wild Polio -Virus is detected.

The situation from 1998-2000

The stool samples collected within 14 days in these years were 59%, 71% and 82%. In absolute terms it means that stool samples were not collected within 14 days for 3760, 2850 cases and 1620 AFP cases in these years. There is no figures given for compatible cases for these years, as this definition came in use only in 2000-01. We have no figures available for how many of these cases were included in the confirmed category from these and how many of AFP cases was WPV actually detected. It may be a conjecture that the drop in number of cases from 1998-2000 was due to more cases being submitted for laboratory examination and less number of cases being put into confirmed category on the clinical criteria.

The situation in 2001-05

The following figures give the number of cases where the stool sample was not collected in time and the %ge of cases labeled as compatible:

Year

Estimated AFP cases where stool sample was not collected in time

Number of compatible cases

%ge of cases which have been labeled as compatible by the NERC

2001

1494

286

20%

2002

1940

681

35%

2003

1700

593

35%

2004

2654

375

15%

2005

9806

327

3%

Issues:

• No explanation has been provided for whether the cases were labeled compatible whether due to death, or due to loss to follow up or due to residual paralysis?

• The steep fall in % of cases labeled compatible in the year 2004 and 2005 (15% and 3%) is also required further probing.

• If in a very significant percentage of cases, the expert committee found evidence of residual paralysis to label these as compatible with post -polio-residual -paralyses (PPRP), the same can be projected on to the rest of the cases of AFP to give a different picture of the reduction in number of cases of paralysed children, than is being claimed by the NPSP on the basis of data on WPV.

• The data on number of deaths, following AFP, would also be another significant issue.

3.3. The Possible causes

In our understanding The Possible Causes for the rise of AFP cases could be following:

• Mis-classification, inadequate maintenance of the reverse cold chain and wrong laboratory diagnosis. Some of these cases could actually be due to polio virus, either wild or vaccine which has not been detected in the laboratory. No data is made available by NPSP on these parameters.

• The NPSP is not carrying out any clinical follow-up of the cases of AFP to detect the residual paralysis after 60 days. However this is being done for the cases where stool sample is not collected in time. Some of these cases have been labeled as compatible cases. A further analysis of this category may be projected on to the other AFP cases to throw some light on this riddle. ( see end note )

• The OPV is a live virus vaccine and repeated doses of any live virus can cause unforeseen damages. According to the data from

USA, OPV can cause paralysis- VAPP ( one case per 2.5 million doses for the first dose and one case per 6.5. million subsequent doses).

• However, in case of

India, it has simply been assumed that repeated doses of this vaccine are absolutely safe, without having an effective surveillance for any possible side effects of the vaccine. This kind of surveillance is an integral component of the vaccination program in U.S.A. With the theoretical possibility that the attenuated polio virus can form new recombinant strains with other enteric viruses and cause polio like symptoms or even encephalitis, such surveillance becomes critical. (ref. .. ).

• Polio like symptoms can be caused by the Non-Enteric Polio Viruses also. The NPSP has been detecting these viruses in the laboratories and in some of the districts of U.P. these viruses are associated with as much as 50% of the AFP cases. Moreover, there seems to be a substantial increase over the incidence of 25% reported in earlier years (2000-2003) of AFP surveillance. Most of the districts reporting repeated WPV cases have also reported more than 40% AFP cases associated with NPEV. It may be possible to link this to poor sanitation and poor immunity of the vaccinated children. There were 8172 AFP cases which detected NPEV in the year 2005 and 1188 AFP cases which detected NPEV in the year 2006. ( the data on NPEV ). It is

• Table List of the districts reporting

• WPV cases in UP in 2004 and percentage of AFP cases reporting NPEV

(ref: data received from Lucknow Office of NPSP)

• possible that the rising numbers of cases of AFP are being caused by rising number of NPEV cases and needs to be discussed.

• A small component of these AFP cases is constituted by the vaccine virus. In the year 2005, this figure was 1644 or about 6% of all AFP cases.

Increase in non-polio AFP rates, thus mandates explaining causes of such cases as this might have “perplexing implications for immunization program” (ref: Neogi S. B. 186: 43; 2006. Indian Pediatrics)

1

Moradabad

50%

2

Shahazanpur

46.6

3

Badaun

47.56%

4

Muzaffarnagar

48%

5

Bareilly

49.58%

6

Ghaziabad

47%

7

Shaharanpur

28%

8

Bijnor

41%

9

Meerut

38%

10

Baghpat

44%

11

Hathras

43%

12

Aligarh

35.48%

13

Bulandshahar

41.40%

14

Gautam Budh Nagar

61.8

15

Jyotiba Phule Nagar

47%

16

Mathura

34.35

17

Rampur

18

Etah

46.24%

19

Mau

45%

20

Chandauli

16.2

21

Azamgarh

23

22

Balrampur

12.8

23

Barabanki

26.8

24

Faizabad

21

25

Farukhabad

30

26

Hardoi

30

27

Lalitpur

21

28

Maharjganj

19

29

Sitapur

19

30

Varanasi

21.2

Total

State av. 31.90

3.4. Is there a decline in the childhood disability due to polio-paralyses

The GPEI on different occasions has come out with hyped up statements on the contribution that this program has made in preventing the paralyses amongst children. In fact, since the vaccination will not be continued now, the claim in prevention of paralyses in children remains the sole justification for this program

Before the advent of GPEI, poliomyelitis cases were diagnosed clinically. The above table gives the reported cases of poliomyelitis in the country since 1988. It is clear that there was a gradual decline in the number of reported cases of poliomyelitis from the year 1988 to 1994. During these years the immunization coverage had not increased dramatically despite EPI and UIP, and therefore it could not have been a major reason for this decline. Besides, this was not the era of pulse-polio strategy in

India, and therefore any reduction in reported polio cases during this period cannot be attributed to the successful implementation of the GPEI.

Table-5 : Number of reported cases of Polio before the launch of Pulse Polio

Year

Number of reported cases

1988

24,257

1989

13, 866

1990

10, 408

1991

6028

1992

9440

1994

4,793

Source: Park (1995)

The NPSP, despite its extensive monitoring network, has not undertaken any clinical investigation and follow-up of the cases of AFP for the Post-Polio-Residual Paralysis (PPRP), which was the basis for identification of the polio cases before the laboratory era introduced under the GPEI.

Limiting stool samples to AFP cases : Abandoning PPRP tracking

• The virological classification scheme of AFP based on clinical and laboratory data, any case of AFP associated with wild polio virus isolation from the stool should be classified as polio. The scheme hinges on the importance of two adequate specimens from all cases of AFP and the follow-up of the AFP cases 60 days after the onset of paralysis. Despite being discarded as not being polio, all non-polio AFP cases must be reported with their final diagnoses, such as GBS, TM, TN or tumour. This is important to document the background AFP reporting rate, which indirectly measures the sensitivity of the surveillance system. ( page – 7)

• Polio compatible cases indicate surveillance failure. The experts will look at clustering of such cases in space and time both during expert review of AFP cases with inadequate stool specimens and also in much greater detail during the certification process. (page 7)

• Follow-up of cases: All AFP cases (100%) should be followed up at 60 days ( and before 70 days) after paralysis onset to establish whether residual weakness is present. (page 18)

• Case investigation form- 100% of cases should have a completed case investigation form with identification, clinical findings, OPI and laboratory information.

Ref: surveillance of acute flaccid paralysis –field guide second edition of the child health division of department of family welfare, January 2000-

• The claim of fall in cases is dependent on the changed definition of the polio, since the year 1998, based on the detection of WPV in the stool sample of the child.

• We have no data of the previous years (before 1998) regarding WPV cases, since no laboratory investigations were being done in the country at that time, of the cases which were reported as polio. So there is no baseline to compare with.

• If all the Non-Polio- AFP cases are followed up for the evidence of PPRP, and their case records prepared, irrespective of the fact that whether stool samples have been collected or not, the actual number of polio paralytic (‘compatible’) cases could be much larger.

Table-6: Some issues in the Profile of AFP cases, NPSP classification and Post-Polio-Residual Paralysis (PPRP)

SN

NPSP classification

Issues

1.

WPV

These cases may recover after AFP or after follow-up, there may be possibility of PPRP. We do not know, whether NPSP is doing any follow-up to make this assessment.

2.

Compatible cases

Cases where the stool sample has not been collected and NERC has certified them as compatible with polio paralysis, despite finding no virus in the stool

3.

Vaccine Virus

Finding of vaccine virus in the stool. These are put in the category of discarded. These cases may recover after AFP or after follow-up, there may be possibility of PPRP. We do not know, whether NPSP is doing any follow-up to make this assessment.

4.

Discarded cases or Non-Polio AFP cases

These include the NPAFP, NPEV as well as Vaccine virus. This data needs to be segregated, otherwise it is a misleading nomenclature.

5.

Non-Polio –Enteric Virus

This is being used as an indicator of the quality of reverse cold chain and the quality of laboratory investigation. However there is no follow-up of these cases for PPRP. We do not know the extent of disability due to these cases.

Study of AFP line list of year 2002 from Rajasthan showed that some AFP cases had been discarded as non polio cases even without 60 days follow up because stool samples were negative for wild polioviruses. There might be similar misclassification from other parts of the country also. Thus, according to Paul, there is under reporting of cases. ( Paul Y. 1100: 40; 2003. Indian Pediatrics)

However this is contradicted by Dr. T. J. John. To quote: “ Dr. Paul says – some AFP cases had been discarded as non-polio cases even without 60 days follow-up because stool samples were negative for wild polioviruses. In the current virological classification of cases, reliance is on tests conducted on adequate stool samples collected in time. As pediatricians we know that 60 days residual paralysis is neither sensitive nor specific for polio. The focus is not on a syndrome of AFP with residual paralysis, but on AFP caused specifically by poliovirus. ( ref: John T.J. 1102:40; 2003. Indian Pediatrics)”.

“ It would be relevant to state that many polio cases are being missed because of the following reasons (i) AFP cases where vaccine polio viruses are found in stool are discarded as non-polio. (ii) Wild Polio Viruses not detected in stool samples of AFP cases. Many such cases are discarded as non-polio even without 60 days follow up. (ref: Paul Y. 728: 42, 2005. Indian Pediatrics).

3.5. Issues pertaining to human rights

• This program has expected and continues to expect that billions of people all over the world, year after year for decades, should be only passive recipient of the polio drops.

• In fact, where there was resistance, coercion, often in the form of direct force was exercised, to give polio drops even to unwilling families. ( ref: field visit by one of the authors)

• Critical information about polio vaccine was never shared with the people: that these two drops may not protect a child from polio.

• Dangers of injections during the transmission seasons fever or during the phase of vaccination was never presented. It should have been mandatory that during the pulse rounds, all unnecessary injections should be avoided as it may cause paralysis.

• The possibility of VAPP was never brought into public domain. Even the scientific community has not been taken into confidence.

• There is a 2-10% case fatality rate with poliomyelitis. Deaths due to poliomyelitis have been reported in children who have been administered large number of OPV doses ( ref. Paul: 2004; letter to the editor; Vaccine 23: 280). This has been reported from one state –Rajasthan. Yet they do not figure in the data presented by NPSP.

Introduction of mOPV1 in the pulse polio rounds as a “State IV clinical Trial without parental consent, is the most blatant misuse of human rights. This has also been done without any special monitoring for side effects (like VAPP) in those exposed to multiple doses of an Exprimental Vaccine”

The paralytic illnesses of the child hood and needs for prevention and rehabilitation

In this battle, the real issue of the viral (polio and other non-polio enteric viruses) and non-viral causes of the childhood paralyses and disability do not appear to matter. The program managers are un concerned about the fate of nearly 85,000 cases of non-polio-virus -Acute Flaccid paralyses detected since the year 1998. No effort has been made to find out whether these children have been left with any residual paralyses or other morbidities and what are their care and rehabilitation needs, as they grow up.

4. The Global concerns for the Global Polio Eradication Initiative The post-eradication strategy- the cessation of OPV and use of IPV in the post certification era:

4.1. The Overall Concerns

Tenth Meeting of Health Secretaries ( ref: Regional Committee, Provisional Agenda item 13 Fifty-eighth Session SEA/RC58/9 Colombo, Sri Lanka 6-10 September 2005 18 July 2005) of countries of the SEA Region, held in Dhaka on 3-4 July 2005 deliberated on the following issues:

• Interrupting the Final Chains of Wild-type Poliovirus Transmission in India
• Strengthening Surveillance for Polio Cases and Polioviruses
• Preparing for the Synchronous Cessation of Oral Poliomyelitis Vaccine Use
• Ensuring Sufficient Financing
• Inactivated Polio Vaccine (IPV)

4.2. Justification for OPV cessation after polio eradication:

OPV cessation after polio eradication.

Since 2000, WHO advisory committees have reviewed the risks associated with continued OPV use after eradication and have concluded that routine OPV use must be stopped globally after interruption of wild poliovirus transmission and at a time when population immunity and surveillance sensitivity will still be high. To reduce the risks associated with OPV cessation, six prerequisites must be met:

(i) confirmation of interruption of wild poliovirus transmission globally and appropriate bio-containment of wild polioviruses;
(ii) maintenance of the global surveillance and notification capacity;
(iii) establishment of a global stockpile of mOPVs and a global response mechanism;
(iv) implementation of IPV requirements in countries that retain poliovirus for research and/or vaccine production;
(v) synchronization of OPV cessation globally, and
(vi) appropriate bio-containment of Sabin polioviruses. Details on the status of each prerequisite are available (www.polioeradication.org).

Risks associated with continued use of OPV.

Continued use of OPV (assuming current vaccination policies) after worldwide interruption of wild poliovirus transmission would be associated with: (i) approximately 250–500 cases of vaccine-associated paralytic poliomyelitis (VAPP) per year; (ii) annual polio outbreaks caused by circulating vaccine- derived polio viruses (cVDPVs) ; at least 6 cVDPV outbreaks have been detected since 2000 in Hispaniola (Haiti and Dominican Republic, 2000), the Philippines (2001), Madagascar (2003 and 2005), China (2004) and Indonesia (2005); (iii) the generation of new long-term excretors of polioviruses among cases with immuno-deficient excreters of vaccine-derived polio viruses (iVDPV). The WHO registry contains 28 iVDPV cases from 1961– 2005, of whom 6 have excreted virus for more than 5 years; of these, 2 are known to be currently excreting poliovirus.The cVDPV outbreaks underscore the potential of OPVderived polioviruses to mutate and acquire the neurovirulence and transmission characteristics of wild polioviruses. Because of this well-described “reversion potential”, continued routine use of OPV is ultimately incompatible with eradication of polio.

Issue: How justified and accurate is the assessment of risk by WHO

4.3. Post polio eradication strategy: dividing the world into two:

In the post eradication era, the proposal of WHO strategy implies that the countries of the world will be divided into two broad groups: One deciding to continue the use the IPV in the post OPV cessation era and others not deciding to do so.

The following statement on IPV, presented in the background note of the meeting ( ref: see above)

• Each OPV-using country must decide whether or not it will stop all routine immunization against polio after OPV cessation ( after polio-free certification).

At that time, the inactivated polio vaccine (IPV) would be the only option available for such countries.

• WHO recommends that OPV-using countries do not routinely introduce IPV.

• However, if a country decides to continue routine immunization with IPV5, the following factors should be taken into consideration:

• costs and benefits,

• the impact on other disease control programmes,

• manufacture and availability of IPV (added)

• major programmatic implications of IPV introduction – such as the need to increase cold chain capacity( does IPV require cold chain, added ) , changing the pertussis component of combination vaccines, use of vaccine with a different preservative, and the marginal reduction of the already-small risks associated with OPV cessation.

• WHO is currently assisting some polio-free countries in evaluating the potential role of IPV in their national immunization programme, and will continue to review the role of IPV as additional data are collected on the risks associated with OPV cessation.

According to WHO post eradication strategy ( position on IPV following OPV cessation- Ref: WHO, Weekly Epidemiological record

14th april 2006, No 15 81, 137–144 , http://www.who.int)

The WHO supplementary statement on the IPV is more elaborate in this regard. To quote directly from the document:

• Having evaluated the risks and benefits of continued polio vaccination after eradication, WHO will not recommend a policy of universal immunization with IPV (emphasis added), except for those countries constituting an international biohazard because they have retained wild or Sabin viruses or VDPVs and potentially adjoining areas, but will continue to facilitate country-specific decision-making.

• Some industrialized countries have already made decisions to continue or initiate IPV immunization for security or other reasons of national interests. Continued immunization requires continued IPV production. Countries that store, handle or amplify polioviruses pose an international bio-safety risk for the release or reintroduction of poliovirus. Countries that retain poliovirus for use in IPV production and in poliovirus research facilities must meet all containment requirements and implement routine IPV vaccination activities to maintain appropriate population immunity. WHO is recommending, from an international bio-safety perspective, that such countries achieve and maintain very high population immunity through a routine IPV childhood immunization programme, with a preschool booster dose, to induce high population immunity against polioviruses (achieving >90% coverage).

• Countries that do not retain poliovirus will have the option of stopping polio vaccination and relying on the WHO stockpile and response capacity to control any release or reintroduction of poliovirus in the post-OPV era. These countries constitute a minimal international bio-safety risk for poliovirus introduction and will not be required to maintain polio population immunity in the post-OPV era. WHO has prepared a framework for national policymakers in OPV-using countries to facilitate national decision- making that outlines the prerequisites for OPV cessation and provides the current thinking on a stockpile and response capacity. Existing models for managing international vaccine stockpiles are being examined to inform the final decisions regarding the management and use of the mOPV stockpile for the post-OPV era.

• Countries that do not retain poliovirus but that perceive themselves at risk for poliovirus release or reintroduction, because of proximity to virus facilities in neighbouring countries, concerns about intentional use or a wish to further minimize the consequences of such release, may decide to introduce IPV. WHO will revise this supplement to the IPV position paper, as appropriate, to reflect the most current programmatic and scientific data.

4.4. The dilemmas of the post-eradication strategy:

Consequences of poliovirus release/introduction in the post-OPV era.

A background document (SEA/HSM/Meet.10/5) prepared for the 10th meeting of the Health Secretaries of the countries of the SEA region held in Dhaka, on 3-4 July, 2005 has analysed information on the potential consequences of release or reintroduction of poliovirus in the range of settings that are envisioned for the “post-OPV” era (based on income, sanitation and climate). Primary factors affecting subsequent transmission include the nature of the virus (wild, Sabin-like,VDPV), the population immunity status and the climate and sanitation. The assessment demonstrates that the highest risk for re-establishment of poliovirus transmission following release or reintroduction, regardless of the nature of the virus, is in low-income, low-hygiene and tropical settings. These settings experience the highest force of poliovirus infection and have been the most difficult in which to interrupt wild poliovirus transmission. These data have international biosafety implications for the location of laboratories or IPV production sites.

That the WHO was already of the mind to abandon the eradication goal had been pointed out by the authors of this paper in another paper published in

2005: “The promise that we will not need to continue polio vaccination once eradication has been achieved also seems to be misplaced. As several recent events indicate, polio immunization is unlikely to be discontinued in the future, if at all…….. That the WHO is well aware of the impossibility of achieving its goal of global eradication can be seen from a note circulated at the recent World Health Assembly, in May 2004 (5). It states clearly that in the new strategic “Global Polio Eradication Strategic Plan” for the period 2004–2008, the specific goal will be to cease oral polio vaccination after global certification. The WHO, for the first time, is silent about cessation of all vaccination in the future. (ref: IJHS Volume 35 No 2,pages 361-383, 2005)”

Bompart ( ref: F. 163: 42, 2005. Indian Pediatrics) concludes “– After global eradication is declared, the risk of seeing a resurgence of polio are real. Countries such as

India represent very large populations among which there are almost certainly undiagnosed immuno- depressed patients excreting OPV-derived polio viruses, where it will be difficult to maintain high-quality virological surveillance overtime, and where control of all wild polio viruses containing laboratory materials will be complex. It will be critical, therefore, to maintain population immunity over the long term, to prevent circulation of reemerging viruses. Once OPV is discontinued IPV will present the only option to maintain individual and collective immunity against polio. However in the face of the more burning health priorities funding of routine IPV vaccination will be justified only if the costs ( in the broadest sense of the term) of vaccination with IPV over long term are lower than the costs of not vaccinating with IPV at all and instance to maintain a “surveillance and response approach”. India and all other countries will have to gather data to assess the risks and advantage of each option and make a decision. Nevertheless, since viruses know no border, decision made by each country will have an impact on the global community. These dilemmas are the last challenges that international community must overcome, if it wants to ensure the long term success of global eradication initiative and to use the words of Dr. David Heymmann of WHO, to protect the investment that all countries have made in their fight against poliomyelitis.”

5. Future Options

5.1. Should eradication be the Goal

The first conference on “what next do we eradicate”- my answer was the word, “eradication”. ( D. A. Henderson; 2003)

“Eradication, as defined by WHO, is the ‘achievement of a status whereby no further cases of a disease occur anywhere, and continued control measures are unnecessary’. By definition, in a “post-eradication” scenario, there will be no more need for any strategy against either poliomyelitis or polio virus. If, however, poliomyelitis is controlled but polio virus is not completely eradicated, the control measures will have to be continued-but this scenario is clearly not “post eradication”. In short, there is no such thing as “post eradication immunization policy”. The term misleads lay people and professional alike by implying that the polio eradication initiative will soon come to a successful ending, an interpretation in line with the needs of the donor agencies. The implicit concession that there is a need for continued control measures, however, confirms the very opposite, that we are far from achieving polio eradication. In an attempt to solve this contradiction, it has even been suggested to redefine the meaning of eradication as ‘the extinction of a pathogen in the human population world wide, though not.. necessarily followed by the cessation of all control measures such as vaccination. “Post eradication immunization policy” thus is a particularly unfortunate example of double think. Confusing an unclear language of this kind should be avoided in a scientific approach to Public Health.” ( ref: Rajum et al. Language used in public health , correspondence, Lancet 363, P 9427, 2004.)

5.2. Need to de-link ourselves from the global initiative

The three issues ( survival of WPV, the rising numbers of AFP and the prospects of continuing with a newer costly vaccine rather than stopping the vaccination against polio altogether, obviously puts a complex challenge before the public health experts and the decision makers in a developing country like India.

We have to remind ourselves and everybody else that the National Pulse Polio Program, beginning with two annual NIDs and later transforming into

several rounds of SIAs, were never intended to be a ‘never-ending strategy’. Since the year 2003, every year the hope has been built by the IEAG that transmission would stop if the SIAs are further intensified, yet this has not happened. The enormous financial costs and opportunity cost of the time of health workers, seems to be no consideration for the IEAG and for them no cost and no sacrifice seems to be too great to achieve the ever elusive goal.

The global eradication of polio leading to cessation of the vaccination was the overriding goal that was pushing this program and determining its paradigm and direction. This is no longer a possibility even according to the proponents of GPEI. The WHO built an aggressive campaign in the year 2004, ‘the do or die year’, as according to them, if this chance was lost this year, the battle is lost forever. Yet the WHO has found reasons to persist with this aggressive strategy beyond 2004 to even up to 2006.

The complete cessation of the vaccination against the polio was the main goal of the polio eradication programme. Now that this is no longer possible, there remains no justification for spending more and more energies and resources in rooting out the remaining ‘reservoirs’ of WPV transmission. Therefore this can no longer be the part of the deliberations. The necessity of continuing the program needs to be reassessed for its cost benefit analysis and potential adverse effects.

This implies that time has come for us to de link from the post eradication strategy proposed by the WHO: a strategy that will leave the developing nations at the mercy of the WHO (and other global institutions, including the GAVI) and the vaccine manufacturers, for the management of outbreaks of poliomyelitis in the post eradication era.

5.3. Call a Halt to the Intensified SIAs

Therefore, in our view, the time has come to put a halt to the present program.

5..3.1 The factors that go in favor of a withdrawal strategy:

• The increasing resistance of the public,

• the flagging morale of the staff and

• costs to the health systems

• No possibility of rooting out the WPV from the reservoir solely on the unifocal strategy of war between vaccine and virus and mOPV1 has failed to deliver.

5.3.2. Risks of a withdrawal strategy:

• The reversal faced due to upsurge of WPV in the year 2002 may be a concern the experts and decision makers will have to consider while weighing their options in the year 2006.

• This decision may be opposed by the WHO bureaucracy as it goes counter to them and they may pressurize us in more than one way.

5.3..3. Risk Mitigation strategy:

• Public and nation should be taken into confidence and the positive gains of the program should be given due publicity.

• There should be a phased withdrawal and in the meantime a more energy should be spent in strengthening the routine immunization.

• Sanitation and safe water should be given its due importance.

India should forge alliance with other countries which hold similar views on this program. We should ask for an independent international commission to investigate of this program, a commission which will have the potential not to be influenced by the global players like the WHO, UNICEF and CDC Atlanta.

5.4. . OPV vs IPV

• With the assumption that WPV transmission will be stopped in near future, the WHO has said that the OPV will no longer be available. This is a questionable recommendation as the OPV will need to be available for handling the re-emergence of polio virus transmission, which seems to be real possibility in the future.

• Whether we should use IPV or OPV in future, should be solely determined by our national realities, and this is a different issue altogether which need not be dealt with here.

• In the past, the issue of the self –sufficiency in vaccine production has been raised. This should be a issue of deliberation again.

5.5. One Way Forward

• The year 2006 should be the year of the phased withdrawal and closure of the National Pulse Polio Program.

• Urgent investigation should be carried out on the actual incidence of PPRP in the cases of AFP in the last 10 years.

• The activities of the polio-immunization should be re-integrated into the Universal Immunization Program.

• An expert committee should review the present evidence base on efficacy of the IPV and cost benefit ration of substituting IPV for OPV.

• The improvement of sanitation and hygiene should be taken up as the highest priority in the pockets which have been reporting cases of WPV in the last three years. Adequate funds are available under the ‘Rajiv Gandhi Drinking Water and Sanitation Mission’ for this purpose and more can be provided by the Central and State Governments. The public health professionals should put their time and energy to the effective implementation of this program.

• An independent commission should be appointed to review all aspects of National Pulse Polio Program in the last ten years and appropriate lessons should be drawn for the health policy formulation, program implementation and health governance in this country.

• A comprehensive policy for the rehabilitation of the children who have suffered from paralyses during this period of the initiative should be worked out.

Financial Issues: the Cost benefit debates

The WHO estimates that “once polio is eradicated and immunization halted, global savings from immunization, treatment costs, and rehabilitation will amount to over US$ 1.5 billion a year…. At face value, the financial savings will be greatest in the countries where the costs of polio immunization, treatment , and long-term rehabilitation are highest. The European Union countries, for example, will together save an estimated US$ 333 million a year once polio has been eradicated. In the Netherlands, the cost of controlling the 1991-92 outbreak of polio involving over 70 members of a religious community, amounted to US$ 10 million – without taking into account the long-term costs of hospital care and rehabilitation for the 66 survivors. Meanwhile in the United States, three years after polio eradication was certified in the Americas, the Government continues to spend over US$ 230 million a year maintaining high levels of routine immunization coverage to prevent the reintroduction of poliovirus from polio endemic countries. The supply of polio vaccine alone costs over US$ 105 million a year. In addition, the US government is still contributing towards the cost of treatment and rehabilitation for polio survivors – including many who contracted the disease during the epidemics of 1940s and 1950s.

The United States will be a major beneficiary once the disease has been eradicated globally and polio immunization can be stopped. And there is a precedent for this. It has been estimated that, ever since the global eradication of smallpox was certified in 1979, the united States – the largest donor –has recouped its entire contribution every 26 days”. (WHO, 1997)

( Quoted in Polio Eradication Initiative at what cost in the book- securing health for all; dimensions and challenges, ed. Prasad and Sathyamala , pages 269 to 286. )

The WHO and World Bank have made a clear admission that polio eradication is not an epidemiological priority for the developing countries and program is to provide a saving of about $ 1 billion per year in vaccine production and delivery cost to the developed countries. For this reason, massive grants running into millions of dollars have been provided to the developing countries and WHO. It is now clear that this aim will not be achieved. ( the down load from the GPGH)

(ref: Deodhar –N.S. Poliomyelitis Eradication: An impracticable task and Pulse Polio program can never do it, Pune, School of Health Sciences. University of Poona, 2003; Global Prorgam of Polio Eradication in India – Debabar Banerjii, The study commissioned by West Bengal Volunatry Health Association. Is Polio Eradication really possible? Akhil Bhartiya Grahak Panchayat – Kale 2003; Memorandum to the WHO, UNICEF, GOI on 7th April 2004 on the GPEI in India -Banerjee et.al ).

The Impact assessment study of the RCH-1 by World bank

Reprodutive and Child health program phase 1 was implemented from 1997 to 2004.

Section VI- Project Impact: Page 66: The immunization performance is a cause of worry. As per RHS data, full immunization coverage declined 52.0 in 1998-99 to 44.6 % in 2002-03. Disaggregated data show decline of 7.1 % in coverage with 3 doses of DPT and 9.1 % in that of polio. This has to be viewed against the fact that alongside an initiative for improvement of immunization program ran also including the supporting polio eradication activities (World Bank Credit IN 3340), which aimed at increasing full immunization coverage by 5 %. Probably deteriorating outreach is a cause as may be low profile of routine immunization. The proportion of women visited by any health worker during 3 months prior to survey has declined by 9.6 % to 10.1 % during this period.

Polio incidence has come down from come down from 1931 in 1998 to 133 in 2004. From being spread allover India, it has been localized to some pockets in Bihar and UP, although eradication target slipped by. A variety of factors including socio-cultural belief, health system weaknesses and overdose of polio IEC may have been responsible for this.

The awareness of diarrhea management and ARI danger signs have also gone down slightly (2.3 % and 4.8 % respectively) reflecting lack of emphasis. Lack of due attention may again have been the cause.

Section IX: Major factors affecting the project

Page 68: “ Intensive polio operations and such other campaigns run by programs like HIV/AIDS also affected program performance. Because of continuing high level of wild virus, states, particularly in northern parts had to take up as many as 8 rounds of polio, each needing huge mobilization of resources and health personnel extending to weeks. All this diverted management attention, personnel and resources etc. especially from child health services. Even as country could not have avoided supporting polio eradication operations, attention thereon was disproportionate to its epidemiological impact.

Family Welfare is a part of overall health sector. The personnel for the large part are funded by the states. States budget crunch reduced funding for the health infrastructure, thus post of male workers or IEC personnel etc. were not filled up, funding for operational expenses of facilities got reduced and infrastructure deteriorated for want of
maintenance. This coupled with lack of work-culture, unfriendly attitude and poor image have led to underutilization of public services. General lack of trust of private sector also came in way of more use of their services.”

[ Ref: Document of The World Bank FOR OFFICIAL USE ONLY Report No: 30479-IN IMPLEMENTATION COMPLETION REPORT (IF-N0180 IF-N0181) ON A CREDIT IN THE AMOUNT OF SDR 179.5 million TO INDIA FOR A REPRODUCTIVE AND CHILD HEALTH PROJECT May 27, 2005 This document has a restricted distribution and may be used by recipients only in the performance of their official duties. Its contents may not otherwise be disclosed without World Bank authorization.]

Joint press release
31 October 2003
Location: Kutail Gamri, Haryana, India

Prince of Wales Backs India’s Fight Against Polio

HRH The Prince of Wales will visit a north Indian village today to meet children being immunised against polio as part of a targeted national campaign to eradicate the disease in India by the end of next year.

The Prince’s visit to Kutail Gamri in Haryana state aims to raise crucial awareness of the 9 November immunization campaign, when more than 100 million children will be vaccinated against polio in just six days across northern India.

Further campaigns will be launched in January and February to reach all 165 million of India’s under five year old children and eliminate polio ahead of the global end-2004 target. India is one of the key remaining polio-endemic countries in the world and together with Nigeria and Pakistan accounts for 96 percent of global cases.

The Prince will welcome the UK Department for International Development (DFID) commitment of more than £275 million to the global effort to rid the world of polio, including £100 million to the Government of India and WHO in the sub-continent alone. In the current year DFID-India is spending £43 million on health-related projects in India.

Joanna Reid, DFID-I senior health adviser, said:

“We are grateful that the Prince of Wales has chosen to support the campaign to immunise more than 100 million children in India as part of an ongoing programme to eradicate polio in India. The Prince’s support will remind children and parents in India of the importance of being vaccinated against this debilitating disease.

“DFID-I is committed to supporting WHO and the Government of India in their efforts to deliver polio immunisation programmes and rapid responses to emergency outbreaks to help eradicate polio in India and the rest of the world by the end of next year.”

Fewer than 170 cases of polio were reported in India this year, showing that the Government’s efforts to eliminate polio are working, despite an epidemic of new polio cases in 2002.

“We’re leaving the polio virus no place to hide,” said Dr Jay Wenger, Project Manager of the joint World Health Organization/Government of India National Polio Surveillance Project.

“If the upcoming campaigns are successful and we can reach all children with the polio vaccine, this disease will be consigned to history.”

Wenger paid tribute to the Government of India’s tremendous response to last year’s epidemic, dramatically scaling up eradication efforts throughout 2003.

“India’s accelerated immunization schedule this year has brought impressive results. If the quality of this accelerated schedule can be maintained for the upcoming
campaigns and into next year, no Indian child will ever again need to know the pain of polio-paralysis.

“It is vital that all communities mobilise now to ensure that every child under the age of five receives the polio vaccine.”

According to John, one of the foremost experts in this field and member of the IEAG has raised doubts on the very belief of the herd immunity produced by the use of OPV in the community . “ Inspite of 96.5% coverage with 2-18 doses of OPV, gaps in immunity remained in the vaccinated and unvaccinated showing that vaccine viruses did not spread extensively among children. The continued wild virus transmission has also questioned the theory that gut immunity induced by OPV would interrupt transmission rapidly. If 100 % children must be individually vaccinated for interrupting transmission, gut immunity (and herd immunity, added) is not operative in a significant measure. If so, either OPV does not induce adequate gut immunity or fecal oral route is not the measure route of wild virus transmission. As OPV does induce gut immunity, the conclusion is that major route of wild virus transmission is not fecal oral. The very young age of poliomyelitis ( median age 12-18 months) suggests high force of transmission reminiscent of measles, the route of transmission being probably oral-nasal and pharyngeal. Fecal oral transmission may be less important. Even when millions of viruses are fed in OPV, bypassing the naso-pharynx, infecting rate remains poor. If these arguments are valid, then IPV, which induces better pharyngeal mucosal immunity than OPV, is a valid tool for interrupting the wild virus transmission. However, this choice ( to use both vaccine as needed) should have been made in 1988, today we must try our best to eliminate wild viruses in the endemic districts by applying intense vaccine pressure by immunizing infants critical virus amplifiers with 10 doses of OPV or as near as 10 as possible (ref: John T.J. 2005 Indian Pediatrics, emphasis added).

POLIO AND SANITATION

In 1952, there were 57,879 reported cases of polio in the United States, including 21,269 cases of paralytic polio that resulted in more than 3000 deaths, with similar epidemic reported in Europe. These epidemics appeared to affect mostly adolescents and young adults and were growing at a steady pace, which spurred development of SALK inactivated vaccines. The universal use of Salk and Sabine vaccines has resulted in the almost complete global eradication of polio.

The most devastating result of poliovirus infection is paralysis, but more than 90% of infections are asymptomatic or inapparent but do induce protective immunity. Clinically apparent but non paralytic illness in about 5% of all infections, with paralytic polio occurring in about 1 out of 1000 infections among infants to about 1 out of 100 infections amongst adolescents. Prior to introduction of vaccines in United States and Europe, improvement in sanitation had limited the fecal- oral spread of polioviruses, resulting in epidemic of infection occurring later in life, when 1 in every 100 infections resulted in paralysis. Thus in developed countries prior to universal vaccinations, epidemics of paralyitic poliomyelitis were observed among adolescents. Conversely in developing countries where sanitation was and continues to be poor, infection in early life results in infantile paralysis. Undoubtedly, good sanitation explains the virtual eradication of polio as a disease from United States in early 1960s, when only about two third of population was immunized with Salk vaccine, and subsequent absence of circulating wild-type poliovirus in US and Europe. In contrast, poor sanitation and crowding have permitted the continued transmission of polio virus in certain poor countries in Asia and Africa, despite massive global efforts to eradicate polio, in some areas with an average of 12-13 doses of polio vaccine administered to children younger than 5 years of age.
Nelson’s Text Book of Pediatrics- 17th edition page….

Pseudo paralysis: Certain conditions present with “pseudo” paralysis, which may be confused with AFP. These conditions are not AFP and should not be reported as AFP. Unrecognised trauma from contusisons, sprains or fracture are common sources of confusion. Others- children with hypokalemia, nonspecific toxic synovitis, acute osteomyelitis, scurvy, acute rheumatic fever, congenital syphilitic osteomyelitis, meningitis or meningoencephalitis” ( page 25 surveillance guide).

Lessons from the polio campaign


DR. JACOB M. PULIYEL

(Source: Magazine, THE HINDU, Sunday, November, 19, 2006)

The National Polio Eradication Programme is not working according to plan. What went wrong and what can be done?

Controversial choice:

IT is now being acknowledged that the National Polio Eradication Programme did not work according to plan. The failure of this magic bullet approach (repeated doses of oral polio vaccine) to solve what is essentially a water and sanitation problem was predictable. Yet, that did not mitigate the sadness its failure caused among many of us who have worked tirelessly to make it succeed. The Indian Medical Association (IMA) Sub-Committee on Immunisation debated on whether to go public with its findings about the failure of this initiative. In August 2006, it concluded that it was its duty to do so.

The need to publicise dissent

Dr. Pushpa Bhargava, who is presently the Vice-Chairperson of the National Knowledge Commission, had written an article, “Fighting the polio virus”, published on December 12, 1999 in The Hindu. In 1988, he had attended a meeting where it was decided to use injectable polio vaccine (IPV) in India because of the poor efficacy of the alternate vaccine, oral polio vaccine (OPV). A factory to manufacture IPV was set up in Gurgaon. Four years later, in 1992, on advice from the WHO, these plans were shelved and it was decided to use OPV. Dr. Bhargava wrote letters to the then Prime Minister (Mr. Narasimha Rao), the Health Minister and to the Health Secretary at different stages. Having been party to the earlier meeting that suggested the OPV was unsuitable for India, he asked for the evidence on which the government decided to switch in favour of OPV. He also demanded to know how the Rs. 50 crores spent by Indian Vaccine Corporation Ltd. to produce IPV would be justified. His letters were not answered. In the end he wrote this article to the press. He concluded the article saying, “No one will be more delighted and satisfied than me if it can be shown indisputably that OPV has worked in this country. Unfortunately all the evidence available today goes against that view. It is therefore not unlikely that polio will meet the same fate as BCG with valuable time and money lost.” Events have proved the prophetic nature of that statement.

Pubic accountability

Thanks to this publication, we now have some form of a paper trail. There is a need for public accountability and this applies to faceless mandarins in the WHO as also to officials of the Government of India who have been named in the article. Decisions based on judgment can go wrong but unless this is acknowledged, we are bound to repeat these mistakes over and over again.

The IMA Sub-Committee was also placed in a somewhat similar predicament as Dr. Bhargava. It was alarmed by the number of vaccine induced polio cases (1,600 last year) that repeated doses of OPV were producing. More alarming were the 27,000 cases of polio-like paralysis in children in whom the polio virus was not cultured in the stools. The government was not willing to even enquire how many were left with residual paralysis in this group. There was also clear evidence that many who were already vaccinated, were getting polio paralysis, suggesting the vaccine was not efficacious. In the face of a bureaucracy that would not even acknowledge the problem, the IMA Sub-Committee was left with the unpleasant task of exposing this farce.

It is to the credit of the maturity of this Government that they have not set out to castigate the messenger and discredit the IMA. Unfortunately the knee-jerk reaction of the government has been to start another programme which will aggravate rather than remedy this situation. This essay will conclude with suggesting a mechanism to avoid these innumerable cycles of folly.

Before we go into the bigger issues, readers need to understand the disease which started all this fuss. Polio is a virus that can cause paralysis. The virus multiplies in the gut and is spread by contaminated water. Improvements in water and sanitation can control the disease. Routine immunisation would help hasten the eradication of polio. The polio control programme was working well with routine immunisation before the stepped up polio eradication programme was started. The incidence of polio fell from 24,000 in 1988 to 4,800 in 1994, well before pulse-polio started.

However in 1998, the WHO and other international bodies started this grand plan to eliminate the disease worldwide through repeated use of vaccines. Initial funding, to the tune of Rs. 400 crores a year, came from international agencies (including Rotary International). Inevitably, a couple of years after the programme started, these agencies claimed donor fatigue and withdrew funding. The Government of India spent Rs. 1,000 crores on this programme last year. Expenditure on all other immunisation (five diseases) was Rs. 300 crores.

A pattern with external funding — countries are lured into a debt trap.

With international funding initiatives the government is made to look foolish, refusing to accept a donation made for the benefit of its people. Once the programme is introduced on the basis of the external funding, overseas support is withdrawn. Poor countries fall for this ploy and vaccines are introduced without the mandatory cost-effectiveness study.

We have no way of knowing what influence the offer of overseas funding had on this decision, but the fact is that, in the end, the GOI was landed with unprecedented bills for a programme that was destined to fail .

No lessons learnt

But unfortunately we haven’t learnt from our mistakes. In the aftermath of the failure of OPV polio eradication programme, the government has accepted an overseas offer of “free” injectable polio vaccine (IPV) to be given in the high endemic areas.

The imported injectable vaccine is 25 times more costly than the oral vaccine. One lot of near-expiry injectable vaccines is being provided free, but we cannot base a national immunisation programme on this. Furthermore, the costs of delivery of this injectable vaccine from door to door will be staggering. If this money were spent on improving water and sanitation in these areas, we will have a permanent solution to the problem. Injectable vaccine must be given to every child, and if we have not succeeded in getting OPV to 100 per cent of the population, the uptake will be much less with the injectable vaccine. So failure is guaranteed once again!

The IMA Sub-Committee had in fact suggested that that the government cool down this entire campaign and get back to strengthening routine immunisation along with concerted efforts to improve the water and sanitation in affected areas. We need a permanent mechanism to make such intricate decisions related to introduction of vaccines. A solution could be the setting up of an independent body similar to the “National Institute of Clinical Excellence” (NICE) in the U.K., to decide these matters. A professional body of health professionals, technical experts, health economists and public representatives should be formed. The government must publicise the vaccine under consideration. All stake holders, such as patient groups, health professionals, academic institutions, industry producing the vaccine, trade unions and international organisations like the WHO and GAVI must register their interest.

The body should assess the clinical evidence and the economic data of benefits. They should put up draft guidelines, to be assessed by the registered stakeholders, and a citizen’s council (which provide the social values that underpin the work of group). Based on their input, the panel should then revise the guidelines. Finally an independent panel should review the guidelines, to decide if all stakeholder comments have been taken into account. The final guidelines should then be issued so that the government has clear and unbiased advice on which to base decisions.

The writer is Vice Chairman, the IMA Sub-Committee on Immunisation. The opinions expressed here are his own. Email: puliyel@vsnl.com

Memorandum on Pulse Polio

Submitted to the World Health Organization, UNICEF, and the Government of India, on 7 April 2004, The World Health Day.

We are a group of public health professionals from India who wish to register our concern at the manner in which the entire polio eradication ‘initiative’ has been thrust on our country by the World Health Organization (WHO), the UNICEF, the American Centers for Disease Control and Prevention, Atlanta, and the Rotary International. The Polio Eradication Initiative in India launched in 1995, as part of the Global Polio Eradication Initiative (GPEI), promised eradication by the year 2000 and the ‘certification’ of eradication by 2005. The target is now postponed to 2004-07. It is time to take stock and see what has been the achievement of GPEI in our country in the nine years of intense effort beginning from 1995. It is our contention that the goal of GPEI was flawed from the time of its conception and is unlikely to achieve its stated objectives this year or in the coming years.

The scientific organizations spearheading the initiative are aware of the flaws but are misleading our government and the world that the strategy adopted is scientifically sound and all that would be required to achieve it is ‘political will’. Instead of admitting to the programme’s failure, on January 15 this year, a ‘clarion’ call, “2004 –Now More than Ever: End Polio Forever”, was issued from the WHO Head Quarters at Geneva. On the same day, a ‘Declaration’[1] was signed on behalf of the Health Ministers representing the Government of Afghanistan, Egypt, India, Niger, Nigeria, and Pakistan, allegedly “…the six countries of highest priority for stopping the transmission of poliovirus globally”. These governments, were made to note “…with grave concern that the poliovirus is being exported from endemic countries and is infecting children in previously polio-free areas” thereby implicating themselves in an international ‘crime’ which they are being accused of.

It is our contention that:

  • The WHO inflated the numbers of paralytic polio cases for the pre-programme period to justify GPEI;
  • Repeated changes in ‘case definition’ have led to claims of a far greater impact of the programme than what it is in reality;
  • An ‘Elimination’ strategy is being passed off as an ‘Eradication’ strategy when it is clear that poliovirus cannot be eradicated in India by relying on vaccination alone;
  • Significant proportion of the polio cases in the country, including the epidemic in 2002 in UP, is iatrogenic[2];
  • Significant proportion of the children with confirmed wild polio paralysis in the post GPEI are immunized children[3]; and
  • A number of children have developed vaccine-associated paralytic poliomyelitis (VAPP) in the last nine years of GPEI[4].

The polio eradication campaign has failed to achieve its goal. In fact, in 2002, there was a serious upsurge in the number of paralytic polio cases and the cases were spread in 16 states.  Not just that, in 2003, four states (Karnataka, Assam, Andhra Pradesh and Tamil Nadu) which had been previously polio free also had cases of polio. The states of Andaman & Nicobar, Arunachal Pradesh, Lakshadeep, Manipur, Mizoram, and Sikkim are the only six states that have not reported polio cases since 1997.

We note with concern:

  • The excessive dosing of our children with OPV, at times exceeding more than 25 doses in the first five years of age which is unheard of in the history of polio eradication in the West[5];
  • The potential for future outbreaks due both to wild and vaccine-derived virus as a consequence of the impact on the natural history of polio.
  • The arbitrary decision to do away with all universally held contraindications of OPV for our children[6];
  • The resurgence of other vaccine-preventable diseases, due to the adverse impact of pulse polio on routine immunization programme;
  • That a disease of lower public health importance in the country[7] has been justified on the grounds of some small savings for the developed nations[8];
  • The over-loading of an already weak health care system of our country by the meaningless and expensive pulse polio initiative;
  • That an impossible and unnecessary case is being made for the eradication of wild poliovirus as the objective, thereby trapping the country in the unrealizable success criteria imposed by WHO[9];
  • That the stage is now being set for an exorbitantly expensive IPV for routine immunisation in the coming years[10];
  • That more than Rs 2500 crores have already been spent on this misadventure and that more than Rs 400 crores/year has been allocated in the Tenth plan[11];
  • That the promises made by the international fraternity that the country will not have to borrow, has been belied by the government quietly borrowing US $ 180 million from the World Bank for the pulse polio programme thereby adding to our debt[12];
  • That UNICEF has changed its role from being only a technical advisor to also a procurer of vaccines for the Government of India leading to conflict of interests[13];
  • That three recent events — the discovery of revertant strain of vaccine to ‘wild’ virus, the discovery of long-term carriers of vaccine virus and conflict situations in several parts of the world, make worldwide cessation of polio vaccinations in future an empty claim.

We Demand:

  • An independent inquiry be held on the polio eradication ‘initiative’ in India with due consideration to the relevant epidemiology as well as health-care priorities in the country. A white paper on why this ‘initiative’ was advised when the ‘experts’ knew that even after a successful campaign of full coverage was achieved, polio vaccination cannot be discontinued; a full database on the entire programme; the vaccine procurement policy; and the consequences of GPEI for public health including that for polio, be released. The independent enquiry committee should also charter the way forward.
  • The right of compensation and rehabilitation for children affected by both wild polio and vaccine induced paralytic polio since 1995; and
  • The right of rehabilitation of those suffering from non-polio AFP since 1995.

The GPEI is yet another negative exercise in mismanaging the health priorities and programs in developing countries in the time of globalization. We recognize the efforts of thousands of well-meaning health personnel in reaching out to lakhs of children under difficult circumstances. However, it is unfortunate that the enormous energy and goodwill that the programme generated was misguided and wasted. The failure of the eradication campaign is not because of lack of proper implementation but because of a basic flaw in the strategy itself. Instead of placing the blame where it rightfully belongs, the parents are being blamed with continuous bombardment of the propaganda machinery. We view the UN institutions, their corporate philanthropic partners and the gullible health bureaucracies, technocracies and political leaderships of the developing countries, as equal partners in this questionable venture. The WHO and UNICEF were set up with a mandate of providing scientifically sound technical advice to their member States. We are disappointed at their abdication of this responsibility. We write this memorandum with the hope that it will initiate a national level debate and allow the Government of India to take corrective measures.

This statement is endorsed by:

Dr. D. Banerji, Professor Emeritus, Centre of Social Medicine & Community Health (CSMCH), JNU, New Delhi.

Dr. N.S. Deodhar, Former Director, All India Institute of Health  & Public Hygiene, Kolkata and presently Consultant in Health Sciences, Services, Management and Research.

Dr. I. Qadeer, Professor, CSMCH, JNU, New Delhi.

Dr. C. Sathyamala, Visiting Professor, CSMCH, JNU, New Delhi.

Dr. Onkar Mittal, Secretary, Society for Action in Community Health, New Delhi.

Dr. Ritu Priya, Associate Professor, CSMCH, JNU, New Delhi.

Dr. Rajib Dasgupta, Assistant Professor, CSMCH, JNU, New Delhi.

Dr. Anant Phadke, CEHAT, Pune.

Mr. S. Srinivasan, Managing Trustee, Low Cost Standard Therapeutics, Baroda.

Dr. K.R.Nayar, Professor, CSMCH, JNU, New Delhi.

Dr. Mohan Rao, Associate Professor, CSMCH, JNU, New Delhi.

Dr. Kamla Ganesh, Retd. Professor, Obs. & Gynae., Maulana Azad Medical College, New Delhi.

Dr. Alpana Sagar, Assistant Professor, CSMCH, JNU, New Delhi.

Dr. Rama Baru, Associate Professor, CSMCH, JNU, New Delhi.

Dr. Sanghamitra Acharya, Associate Professor, CSMCH, JNU, New Delhi.

Mr. K.B.Saxena, Former Health Secretary and member of the Planning Commission, Government of India.


[1] “Geneva Declaration for the Eradication of Poliomyelitis” dated 15 January, 2004, Geneva, Switzerland.

[2] Provocative paralysis due to intramuscular injection, ineffectiveness of cold chain and reduction of circulating wild poliovirus due to partial and incomplete vaccination which paradoxically increases probability of paralytic poliomyelitis. We note with concern that none of the IEC material issued in the pulse polio programme in India indicts intramuscular injections as a key risk factor for paralysis with poliovirus.

[3] Personal communication from the WHO dated 5.3.2004 in response to a letter written jointly by Drs Onkar Mittal and C Sathyamala dated Jan 31, 2004, addressed to Dr Brent Burkholder, Regional Advisor, Immunization and Vaccine Development, WHO/SEARO, New Delhi.

[4]http:// npspindia.org/t5.htm

[5] For instance, a child born in Jan 1999 in some of the “high risk” states and districts would have received more than 25 doses of OPV during the many NIDs, SNIDs, and “Mop-up” operations by Jan 2004.

[6] The risk of VAPP (Vaccine Associated Paralytic Poliomyelitis) among immunodeficient infants is 3,200-fold to 6,800-fold higher than among immunocompetent infants (Sutter RW, Prevots DR, Vaccine-associated paralytic poliomyelitis among immunodeficient persons. Infect Med 1994;11:426,429-30,435-8, as quoted in Centers for Disease Control and Prevention. Poliomyelitis Prevention in the United States: updated recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR 2000;49(No. RR-5):7. The Operational Guide 2003-04 on Pulse Polio Immunization in India (GOI, June 2003) does not mention even a single contraindication for OPV.

[7] Paralytic polio is only a small fraction of all childhood paralysis and a polio eradication strategy will impact only marginally on childhood paralysis.

[8]WHO (1997). Polio: The Beginning of the End. p84.

[9] That even if one case is reported from a population of one billion, the entire programme would be treated as a failure.

[10]Planning Commission, (undated) Tenth Five Year Plan (2002-2007) Volume II: Sectoral Policies and Programmes Family Welfare, GOI, New Delhi p196.

[11] Planning Commission, (undated) Tenth Five Year Plan (2002-2007) Volume II: Sectoral Policies and Programmes Family Welfare, GOI, New Delhi, p213.

[12] World Bank (2000) Project Appraisal Document on a proposed IDA credit in the Amount of SDR 106.5 million (US$ 142.6 million equivalent) to India for an Immunization strengthening project, March 30,2000, Health, Nutrition and Population Sector Unit, South Asia Region, p32. World Bank (2003) Supplemental Credit Document, International Development Association, Proposed Supplemental credit of SDR 59.5 Million (US$83.4 Million equivalent) to India for the Immunization Strengthening Project, Nov 18, 2003, Human Development Unit, South Asia Region.

[13] One of the conditionalities of the World Bank loan is that the GOI will purchase polio vaccines only through the UNICEF.

Issues involved in Pulse Polio

  1. There has been an alarming increase in the number of cases of AFP (acute flaccid paralysis) in the country since 2003 – from 8505 to 27,050 (figures from http://www.npspindia.org). As against an international average of 1/100,000, the national average is 6.3/100,000, and even higher in case of the endemic states of UP and Bihar, with 12-13/100,000.
  2. Immunized children form a significant proportion of the children with confirmed wild poliovirus in the post-GPEI period. As per WHO data (cited in Sathyamala et al 2005), except for the outbreak in 2002, between 2000 and 2003, more than 50 per cent of the children with paralysis due to wild poliovirus, both confirmed and compatible, had received more than three doses of OPV.  Similar findings have been reported also in the pre-GPEI period (John 2004).
  3. It is clear that there is an alarmingly high incidence of vaccine associated paralytic polio cases (VAPP) in the country, though the NPSP has refrained from the publishing the number of VAPP cases. The number of “vaccine virus cases” has more than tripled between 2002-2005, from 500 to 1645 in 2005.
  4. The Pulse Polio Programme has adversely affected the functioning of the already declining public health care system in India. Immunization coverage has decreased between 188 to 2003, from 54 per cent to 48 per cent, as shown by the District Level Household Survey 2002-2004.
  5. There is a gross mismatch between public health needs and actual resource allocations. For instance: the 2006-2007 health budget of the central government has the following provisions:

Pulse polio- Rs 1004 crores; All routine immunizations – Rs 327 crores; TB control – Rs 184 crores.

When compared with their prevalence and mortality – about 1.5 crore TB cases and 4 lakh annual deaths due to TB, as compared to estimated 20,000 polio cases and less than 500 deaths when the polio eradication programme was launched in 1995, it points to complete mismatch between national need and choice of priority.

In addition we would like to point out that:

1.  For every clinical case of paralytic polio, there are about 100-1000 sub-clinical cases (GoI 2000), which too allow the virus to replicate. Hence even if there is no case of paralytic polio, the wild virus will continue to circulate and replicate because of the pool of sub-clinical infections. Moreover, it is impossible to ensure 100 % sero-conversion even if we ensure 100 % coverage, which means that there will always be a pool of sub-clinical infection even if overt paralysis does not occur.

2.  The majority of the oral vaccine viruses given to children revert to the virulent form within a month (WHO 1958; Melnick et al 1967; Guillot et al 1994). Hence, though OPV reduces the incidence of paralytic polio, it adds to the pool of virulent polioviruses. Hence, vaccination with OPV cannot be discontinued even if the incidence of paralytic polio is reduced to zero.  The aim of cessation of vaccination was the reason why the eradication programme was launched in the first place.

3.  There have been changes in the definition of polio case between the pre-GPEI and post-GPEI period, from clinical classification to virologic classification of AFP cases. In addition, there have been changes in the wild polio virus classification scheme also.  The dramatic reduction in polio cases from 1994 to 2005 can thus be attributed in large measure to this change in definition (Sathyamala et al 2005).

REFERENCES

John, J.T. (2004) End-stage challenges: Vaccine associated paralytic poliomyelitis.  Bulletin of the World Health Organisation, 82 (1).

Sathyamala, C., Mittal, O., Dasgupta, R., and Ritu Priya (2005) Polio Eradication Initiative in India: Deconstructing the GPEI. International Journal of Health Services, 35(2), 361-383.

Government of India (2000) Child Health Division, Department of Family Welfare, Surveillance of Acute Flaccid Paralysis, Field Guide, Ed.2, New Delhi.

WHO-TRS (1958) No. 145: Expert Committee on Poliomyelitis.

Melnick et al (1967) Studies of the immunogenicity , communicability and genetic stabiliy of oral polio vaccine administered during winter.  American Journal of Epidemiology, 86, 112-135.

Guillot et al (1994) Point Mutations Involved in the Attenuation/Neuro-virulence Alternation in Type 1 and 2 Oral Polio Vaccine Strains Detected by site specific polymerase chain reaction.  Vaccine, 12(6), 503.