The future of research into rotavirus vaccine
BMJ 2000; 321 doi: https://doi.org/10.1136/bmj.321.7260.525 (Published 02 September 2000) Cite this as: BMJ 2000;321:525
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Editor
Weijer states that, "Benefits of [rotavirus] vaccine may outweigh
risks for children in developing countries".(1) We agree and believe that
the issue of cost-effectiveness is therefore central to the choice whether
developing countries should adopt a rotavirus vaccine. We are involved in
a UK Department for International Development funded project that will
model the impact and incremental cost-effectiveness of introducing a
rotavirus vaccine into routine infant immunisation programmes in
Bangladesh and Peru.
Frequently, poor families in developing countries must sell assets at
a loss, or take out loans at high interest rates, to pay for care.(2)
Hence, optimising the use of vaccines will increase the potential for
economic development of the poorest groups by reducing their out-of-pocket
costs of obtaining treatment, especially for more severe disease.
Governments also stand to benefit through reducing the burden on
frequently over-stretched health systems. In addition, gains will occur
at the societal level, as caregivers will require less time off work to
provide and seek care. These economic benefits will occur due to
reductions in morbidity and mortality. Yet, the introduction of new or
under-utilised vaccines in developing countries has been hindered by the
paucity of data related to the economic and epidemiological burden of
vaccine-preventable diseases.
Recently Miller and McCann conducted a cost-effectiveness analysis to
estimate the impact of vaccination against rotavirus in national
immunisation schedules.(3) They estimated the cost per life-year saved to
be between $16-31 in a low-income setting, assuming a cost per dose of $1
and vaccine efficacy of 60% - their results are encouraging. While they
failed to include potential savings from the reduction in hospitalisation
costs, a study from Argentina has illustrated the substantial burden
placed on some health systems due to rotavirus - in 1991 rotavirus led to
roughly 84,500 outpatient visits and 21,000 hospitalisations, each
averaging four days, with associated direct medical costs of US $27.7
million.(4)
It is also important to identify, measure and value the associated
costs of providing the vaccine, including the cost of treating adverse
events (including programmatic errors).(5) Therefore, further modelling
and economic analyses will enable an empirical measurement of the costs
and benefits of the rotavirus vaccine. The utility of the vaccine for low
-income settings should not be dismissed prematurely. We hope that our
research will help shed light on the appropriateness of the rotavirus
vaccine in developing countries, once it becomes available.
Damian Walker
Research Fellow in Health Economics,
Health Policy Unit, London School of
Hygiene & Tropical Medicine, Keppel Street, London, WC1E 7HT, UK
Email. damian.walker@lshtm.ac.uk
S. M. Akramuzzaman
Clinical Sciences Division, ICDDR,B: Centre for Health and Population
Research,
GPO Box 128, Dhaka 1000, Bangladesh
Email: azaman@icddrb.org
Claudio Lanata
Instituto de Investigación Nutricional, Apartado 18-0191, Lima, Peru
clanata@iin.sld.pe
References
1. Weijer C. The future of research into rotavirus vaccine. Benefits of
vaccine may outweigh risks for children in developing countries. BMJ
2000; 321: 525-526.
2. Andersson N, Paredes S, Legorreta J, Ledogar RJ. Who pays for measles?
The economic arguments for sustained immunization. Health Policy and
Planning 1992; 7(4): 352-363.
3. Miller M, McCann L. Policy analysis of the use of hepatitis B,
Haemophilus influenzae type b, Streptococcus pneumoniae conjugate and
rotavirus vaccines in national immunization schedules. Health Economics
2000; 9: 19-35.
4. Gomez J, Nates S, de-Castagnaro N, Espul C, Borsa A, Glass R.
Anticipating rotavirus vaccines: review of epidemiologic studies of
rotavirus diarrheoa in Argentina. Rev Panam Salud Publica 1998; 3(2): 69-
78.
5. Intussusception among recipients of rotavirus vaccine - United States,
1998-1999. MMWR 1999; 48: 577-581.
Competing interests: No competing interests
Editor - In the '50s and '60s intussusception in rural Nigeria in
small infants was rare, if seen intussusception occurred more commonly in
6 to 10 year olds.
If this is still the situation in West Africa and is repeated elsewhere in
rural Africa this should make for an ideal situation to test out the
rotavirus vaccine(BMJ 321 525 Sept 2nd 2,000). The same may not apply in
urban Africa where levels of hygiene and the diet may approach those in
Europe and America where intussusception occurs in this young age group.
David Morley
Emeritus Professor of Tropical Child Health, University of London.
51 Eastmoor Park, Harpenden, AL5 1BN. UK.
Competing interests: No competing interests
Rotavirus vaccine and intussusception
Editor: Response to The Future of research into rotavirus vaccine (BMJ 2000: 321).
As you point out in the editorial, it is the truth that some people assume that inaction is a morally neutral state. This is dramatically true for the developing world, such as Latin American countries, because our politicians and public health authorities have not become aware that both action or inaction have consequences with costs that are important to establish. Moreover, nobody wishes to be responsible for the cost of the decisions taken. Then, it is necessary to know the risks and benefits before taking a decision like withholding the tetravalent rhesus rotavirus vaccine.
On the other hand, there are few aspects in favor of initiating a randomized controlled trial with this vaccine:
First, it is necessary to know the efficacy/effectiveness of this vaccine in a country with high mortality rates.
Second, the information regarding epidemiology of intussusception (IS) in developing countries is scarce. Probably, rates are lower than in developed countries. Therefore, the risk of IS associated to this vaccine is not necessarily that observed in the United States.
Third, large effectiveness studies will give additional information about the potential risk of IS with the use of rotavirus vaccine.
Finally, assuming the worse scenario of a 25% fatality rate from IS, 2000 to 3000 of the deaths caused by the rotavirus vaccine will also occur without the vaccine.
Data from Venezuela, a country with low mortality rate for rotavirus diarrhea (1 in 6000 infants <1 year of age die each year due to rotavirus - unpublished data) indicate that in a cohort of 600,000 birth/year, there will be approximately 100 deaths caused by rotavirus in this population. Supposing that the risk of IS associated to the vaccine is 1/10,000, there will be 60 cases and 15 deaths (25% fatality rate) from IS. This means that withholding the vaccine, we will prevent 15 deaths due to IS but 80 (vaccine will prevent 80% of death) infants will die from rotavirus diarrhea. This is the kind of mathematics we should apply in order to take our own decisions in developing countries.
Irene Pérez-Schael
Chief of Enteric Disease Section, Instituto de Biomedicina, MSDS/UCV.
Iperez@telcel.net.ve
Competing interests: No competing interests