Module 1: The Safe and Effective Delivery of Immunizations

Worldwide, an estimated 27 million children and 40 million pregnant women do not receive the basic package of recommended immunizations, and approximately 2 to 3 million people die from vaccine-preventable diseases each year.  In less industrialized countries, low vaccination rates can be attributed to such problems as high absenteeism rates of healthcare providers, and insufficient and/or unreliable supplies of vaccines.  On the patient side, lack of understanding about the purpose and importance of vaccines or fear of governmental health services lower uptake of immunization services.(1)

Case Study: Factors Hindering the Uptake of the Human Papillomavirus (HPV) Vaccine

A diverse set of factors play into the uptake of vaccination campaigns.  While some are a matter of scientific innovation to increase efficacy and decrease cost, other factors are more nuanced, such as the sociocultural perceptions of a vaccine.

Epidemiological Factors

Lack of national data on HPV and cervical cancer incidence and prevalence are needed to determine which countries are in need of the HPV vaccine and to influence governments to adopt HPV vaccination policies.

Financial Factors

Affordability is a major factor in a country’s decision to distribute the vaccine, and the cost effectiveness of the HPV vaccine needs to be determined for each country.  The high cost of the HPV vaccine is prohibitive for most countries and individuals.  Scientific innovation could, and hopefully will soon, lower the vaccine’s cost.

Biological Factors

The vaccine protects against HPV types 16 and 18, which are thought to cause 70% of cervical cancer cases globally.  However, 30% - 40% of cancers are caused by other types of HPV, and the prevalence of these types may vary from country to country.  Data needs to be collected on the actual health impact that this vaccine could have in various countries.

Sociocultural Factors

A low proportion of the public in most countries is aware that HPV is a sexually transmitted infection (STI) and that it causes cervical cancer.  Awareness should be generated through campaigns and through healthcare visits.  In addition, because this vaccine targets an STI, it may be very controversial and may not be socially and culturally acceptable in many countries. This situation can be seen in the United States, as will be discussed below.  Moreover, some areas may believe that, since the vaccine targets only girls and concerns sexuality, it may affect fertility.(2)  Certain populations may be especially skeptical of mass vaccine campaigns because of unethical medical campaigns and experiments that have occurred in the past.

Case Study: Sociocultural Factors Influencing the Low HPV Immunization Rates in the U.S.

In the U.S., the rates of HPV vaccination are unexpectedly low for a variety of reasons.  All of the factors discussed above contribute to this situation.  The immunization is costly and inconvenient (requiring three shots), and there is a lack of awareness about HPV.  These problems could readily be overcome in the near future, but the real challenge is social acceptability.  Parents have reported that they are uncomfortable immunizing their young daughters against a disease transmitted through sexual activity, perhaps believing that giving the vaccine would encourage less inhibited and less safe sexual activity.  The HPV vaccine is not the first to target sexually transmitted infections. The vaccine for Hepatitis B (a virus transmitted through contact with infected bodily fluids) is given in three doses before babies are 18 months old, and there is no public outcry over its delivery.  In fact, in 2006, the National Immunization Survey found that 81.3% of teenagers had been fully immunized against Hepatitis B. The pharmaceutical industry is now working to develop an HPV vaccine for men who, though rarely, can develop penile, anal, head, and neck cancers from HPV.(3)  By learning from other vaccination efforts, officials promoting the HPV vaccine could overcome the sociocultural barriers to its uptake. 

Political and Socioeconomic Challenges to the Global Delivery and Efficacy of Polio Vaccination

Poliomyelitis (polio), a viral infectious disease, has been nearly eradicated around the world through mass immunization campaigns since the inactivated virus vaccine (IPV) was developed in 1955 and the oral virus vaccine (OPV) was developed in 1963. Since 1988, the number of polio cases has dropped from 350,000 worldwide to 2,917 in 2000.  Polio remains in only four countries: Nigeria, India, Pakistan, and Afghanistan. This can be partly attributed to the development of vaccine-derived polio and the large number of subclinical cases.  Political conflict and poverty present even more complex barriers to the eradication of polio in those countries.

Nigeria, for example, has presented political challenges to mass inoculations which have not only inhibited efforts to eliminate polio, but have further increased its prevalence in Nigeria.  In 2003, three states in northern Nigeria boycotted the Global Polio Eradication Initiative because political and religious leaders believed that Westerners were trying to kill Muslims through the vaccine. They believed that the vaccine had been laced with HIV and with cancerous and sterilizing agents.  As a result of this boycott, polio cases increased by 30% in Nigeria in 2004 and were detected in neighboring countries as well as in countries as far away as Indonesia.  Because of political conflict, a vaccine that could have prevented a debilitating disease was not being delivered. As a result, vaccination efforts worldwide have been threatened due to political strife.

In areas such as Uttar Pradesh and Bihar in India, polio persists most likely due to overcrowding and extreme poverty.  These conditions increase the likelihood of children having chronic enteric diseases, which interfere with vaccine efficacy.  Consequently, some children have developed acute flaccid paralysis, a symptom of polio, even after receiving ten doses of the vaccine.(4)  Socioeconomic conditions cannot be ignored in healthcare delivery, even in an intervention as straight forward as a vaccine.  Not only do poor living conditions contribute to increased risk of transmission, but they can impede the efficacy of preventive medicine. This situation provides a double incentive for improving living conditions to improve health.  National healthcare infrastructure must be strong to effectively deliver health services such as mass inoculations but the underlying problem of poverty must be addressed for the inoculations to be effective. 

Incentivizing Immunization of Children

Despite the availability of free vaccinations provided by the Indian government through the public health sector, the rate of immunization is still low.  The National Family Health survey found that 66% of one to two year-old children had not received the most basic immunizations.  For resource-poor areas, having basic and immediate needs such as food and income may take precedence over getting one’s children vaccinated, especially when the benefits of immunization are not understood.  Various strategies are being employed to promote the uptake of immunization and other health services in less industrialized countries.  For example, Conditional Cash Transfer (CCT) programs in many Latin American countries have proven effective in augmenting the utilization of preventive health care services and improving health outcomes for women and children. However, they have demonstrated little effect on immunization rates. 

Since there has been no research proving that non-financial incentives can increase immunization rates, researchers from Innovations for Poverty Action and the Poverty Action Lab at MIT carried out a study in Udaipur to assess the impact of both increased reliability of immunization services and the distribution of non-financial incentives on immunization rates.  In the first group of villages, mobile immunization camps were set up by a nurse and an assistant on a fixed date and time every month.  In addition, a social worker in each village identified children needing vaccinations and educated mothers about the camps and the benefits of immunization.  In the second set of villages, the same model was used, but the parents were also offered one kilogram of lentils per immunization administered and a set of metal plates after the course of five immunizations had been administered.  The lentils given to the second group amounted to less than one dollar in cost and to about three-quarters of an average daily wage.  The lentils were intended to offset the opportunity cost of spending valuable time to get a child immunized.  The third set of villages received no intervention as the control group.

This study found that, compared to the control group which showed a full immunization rate of 6.2%, increasing the reliability of immunization services in the first set of villages resulted in full immunization rates of 16.6%, while adding the incentive boosted that number to 38.3%.  The lentils and plates provided an impetus for parents to immunize their children that day and to return for the next doses rather than waiting until another date.  Moreover, in the first set of villages, the immunization rates increased only among those living in the target village, while the rates increased for neighboring villages as well when the camps offered incentives. Therefore, this study demonstrates an impact when non-financial incentives are added to reliable health services and educational programs.  In addition, the intervention with the incentive proved more cost effective since the increase in volume of children being immunized decreased the overall program cost per child immunized.  With the incentives, the cost of fully immunizing a child was $27.94 while the cost was $55.83 without incentives.(5) This evidence reveals that health care personnel and resources can be well utilized, and immunization campaigns can be more cost effective, ironically, by using money to provide non-financial incentives.   

Dangerous Immunizations

Without regard to the way immunizations are given, vaccines can prove to deliver more harm than good to some individuals. While vaccinations do save approximately 2 millions lives per year, unclean syringes cause about 30% of Hepatitis B and C infections and 1.3 millions deaths each year worldwide. Unfortunately, in countries with a high prevalence of infectious diseases and, thus a need for injectable vaccines, there is often inadequate health infrastructure and poor sanitation.  Moreover, the disposal of needles and other sharps is expensive and dangerous.  Along with these reasons, healthcare personnel may reuse needles due to lack of knowledge and resources.(6)

Through India’s public healthcare system, a mass vaccination program is being implemented to vaccinate 300,000 people. Out of 495 people already treated, 92 have died due to unclean syringes.(7) In fact, Marc Koska, founder of SafePoint Trust, notes that 62% of injections in India are unsafe.   In a video taken from a TED conference talk, he discussed the widespread reuse of needles and syringes in Indian hospitals. He noted that while malaria kills 1 million people per year, unsafe injections kill more - 1.3 million people per year as noted above.(8) While syringes enable the delivery of vaccinations and life-saving medications, in these cases the injections intended to protect patients from fatal illnesses are actually spreading them.

Unfortunately, many international organizations and Ministries of Health promote the mass distribution of vaccines and other essential medicines without evaluating their administration. Koska has launched a campaign in India to spread awareness about this situation, and he is making huge strides in pushing organizations and governments to act. In 2009, the World Health Organization (WHO) placed this problem of unclean syringes on its list of issues to address for the year, even though it has known about the situation for years.(9) These bodies need to ensure that not only are they providing vaccines, but also that they are providing adequate supplies of clean syringes and ensuring through close monitoring that the syringes are being used as intended. 

Alternatively, some organizations and researchers have been trying to develop innovative syringes to eliminate this public health hazard. Although sterilizable syringes are more environmentally friendly and less expensive, they require proper sterilization equipment and training in order to be effectively cleaned. Marc Koska has developed an auto-disable (AD) syringe which can only be used once, breaking if the plunger is pulled back after the initial depression. These syringes can neither be used again by health personnel nor can they be sold on the black market for reuse. However, these syringes are more expensive than standard syringes and require difficult and expensive disposal.(10) Furthermore, to ensure that immunizations are able to have their maximum positive impact on health, their delivery vehicles must be appropriately designed and used. 

Conclusion

While vaccines can yield extraordinary outcomes in the prevention of life-altering and life-threatening diseases, they are not a simple panacea. A variety of measures must be taken to not only augment a vaccine’s uptake, but also to ensure maximal positive impact. To improve rates of use, scientific innovation is needed to reduce the price and improve the efficacy of certain vaccines. On the patient level, research is needed on ways to influence individual uptake and to promote positive perceptions of the vaccine. In addition, more distant factors such as the political climate and socioeconomic conditions must be improved to increase both use and efficacy of the vaccine. Lastly, the vaccination delivery must be conducted safely with proper delivery mechanisms.  It is important to recognize that a variety of factors play into the success of a vaccination campaign.  While developing a vaccine is a significant first step in eradicating a disease, it is by no means the last. In order to maximize a vaccine’s positive impact, its delivery must be examined from a myriad of angles, including economic, political, behavioral, and sociocultural.

Footnotes

(1) Banerjee, Abhijit Vinayak, Esther Duflo, Rachel Glennerster, and Dhruva Kothari.  “Improving Immunization Coverage in Rural India: A Clustered Randomized Controlled Evaluation of Immunization Campaigns with and without Incentives.”  Innovations for Poverty Action.

(2) “Introducing HPV Vaccines in Developing Countries: Overcoming the Challenges.” PATH, September 2005. https://path.azureedge.net/media/documents/RH_hpv_intro.pdf.

(3) Springen, K. (Feb. 24, 2008). “HPV Vaccine: Why so Unpopular?” Newsweek. https://www.newsweek.com/hpv-vaccine-why-so-unpopular-93479.

(4) Jitratkosol, Marissa. “The Challenges that the Global Polio Eradication Initiative Faces.”  The Advanced Molecular Biology Laboratory: The Educational Facilities of the Michael Smith Labs, 2010.

(5) Banerjee, Abhijit Vinayak, Esther Duflo, Rachel Glennerster, and Dhruva Kothari.  “Improving Immunization Coverage in Rural India: A Clustered Randomized Controlled Evaluation of Immunization Campaigns with and without Incentives.”  Innovations for Poverty Action.

(6) Anahtar, Melis N. (Spring 2008). “Needle-Free Injectors as a Sustainable Alternative to Syringes.”  MIT International Review.  http://web.mit.edu/mitir/2008/spring/needle.html.

(7) “Modasa Hepatitis Outbreak.” Safe Point Trust. https://safepointtrust.tr-cam.com/.

(8) Koska, M. “1.3m Reasons to Re-Invent the Syringe.” Ted Talks, 2009. https://www.ted.com/talks/marc_koska_1_3m_reasons_to_re_invent_the_syringe?language=en.

(9) “SafePoint Trust.” https://safepointtrust.tr-cam.com/.

(10) Turner, A.  (Mar. 22, 2009). “Used needles are causing a health crisis in India.” The Sunday Times. https://www.truthaboutnursing.org/news/2009/mar/orig/sunday_times_india_needles.pdf