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Vaccine Timeliness Amy Mckay Senior Lecturer (London South Bank University) Family Nurse (SEPT) Co-Writer Edward Purssell Kings College London University Aims • To identify the importance of vaccine timeliness • To discuss research in relation to vaccine timeliness • To consider recommendations for practice Vaccination • Challenging an individual with antigens to stimulate an adaptive immune response • Provides immunological memory • Aim is to prime the immune system in an effort to protect against natural infection at a later date thus preventing the disease (DoH 2010) Immulogical memory (Hofmeyr 1997) UK vaccination schedule Age Vaccine 2 months DTaP/IPV/Hib (diptheria, tetanus, pertussis, polio, Hib) Pneumoccocal 3 months DTaP/IPV/Hib Meningitis C 4 months DTaP/IPV/Hib Pneumoccocal Meningitis C Between 12 and 13 months MMR (measles, mumps and rubella) DtaP/IPV (diptheria, tetanus, pertussis and polio) DoH 2010 12 -13 years HPV (cervical cancer) 13-18 years Td/IPV (diptheria, tetanus and polio) Importance of vaccine timeliness • Cost-effective • Global appropriately timed vaccinations have saved over 20 million lives in the last two decades via preventing disease outbreak (Unicef 2010) Early vaccination • Suboptimal immune response due to immaturity of the immune system • Transient protection against a disease (European Centres for Disease Prevention and Control 2009). Delayed vaccination • Early protection is particularly important for Hib and Pertussis where morbidity is high in infancy (Crowstoft et al 2003, Pertola 2000) • Increased individual susceptibility • Reduced herd immunity Vaccine intervals • Vaccines administered at intervals less than the recommended schedule can produce increased rates of local or systemic reactions • Robust immune response requires adequate spacing British guidance • No UK policies or guidelines stipulating what constitutes vaccine timeliness – Age – Spacing • Unspecific in relation to how many days constitutes a month Space between the ending of the 2nd month and beginning of the 3rd month Birth to 2 months Birth 2 months 3 months Start of appropriately timed first dose End of appropriately timed first dose 62 days: maximum possible amount of days (two months with 31 days; December and January OR 59 days: least possible amount of days (February (28 days), March (31 days) OR 56 Days (8 weeksweek constituting 7 days) 86 days: least possible amount of days (February (28 days), March (31 days) April (30 days)) OR 91 days (12 weeksweek constituting 7 days) OR 92 days: maximum possible amount of days (November (30 days), December (31 days) January (31 days)) 4 months onwards Start of the timing of the second dose of the primary vaccination course Classification of vaccine timeliness Timeliness Classification Dayan et al (2006) Akmatov et al (2008) Months constitute 30.5 days Hull et al (2006) Months constitute 30 days (delay counting from 31 days) Luman et al (2005a, 2005b) Months constitute maximum/minimum amount of calendar days. Luman et al (2008) Months constitute maximum/minimum calendar amount of days using ACIP guidelines (CDCP 2006). Delay= maximum amount of days + 4 days Early= minimum amount of days- 4 days Coverage vs Timeliness • COVER collects coverage data at one, two and five years (HPA 2010b) • Data for every child with whom the PCT have responsibility is collected • Benefits are that it is quick, comprehensive and easily understood • COVER is unable to identify the length of time infants are delayed or early in receiving their vaccines. • COVER provides no information regarding the proportions of infants vaccinated at specific time points (vaccine uptake rates) Vaccine timeliness study • Aims: to assess the timeliness of the primary vaccination course for a cohort of infants born between 1st April 2008 and 31st March 2009, and to assess this as a method of vaccine surveillance that can be used to complement the 1, 2 and 5 year coverage levels monitored through the COVER programme. Research Site • The PCT encompasses areas of affluence and deprivation • Approximately 3.8% of the population are under the age of one year • 93% uptake of the primary vaccinations as measured by COVER in 2008 (HPA 2008) Sample • Total population sample: 4,418 infants • Sampling frame – System One – All infants born between 1st April 2008 until 31st March 2009 who had completed their primary vaccination course Data • Provided anonymously • Data included – Child’s date of birth – Vaccination date – Ethnicity – Gender – Ward of residence Vaccine Timeliness Classification ACIP advice: Valid vaccine is one given on the day due +/- 4 days e.g. Child born on 10/04/08 2 month: 10/06/08 3 months: 10/07/08 Therefore: early vaccination would be classified as prior to 06/04/08 and late vaccination after 14/07/08 Pilot Study • 320 children • Born prior to the study cohort (March 2008) • Identified the need to collapse ward of living and ethnicity categories into smaller groups Findings: Bar graph displaying proportions vaccinated early, timely and late 90 80 70 p e r c e n ta g e 60 50 40 30 20 10 0 Early T imely Lat e Vaccine1 Early T imely Vaccine2 Lat e Early T imely Lat e Vaccine3 Findings: Kaplan-Meier survival curve, 1st dose 1.00 88 days 0.95 In s t an t an eo u s rat e o f v acci n at i o n u p t ak e 0.80 0.60 0.40 0.20 0.00 50 100 150 Days of Age 183 Findings: Kaplan-Meier survival curve, 1st dose 1.00 I n st a n t a n e o us r a t e o f v a c c in a t io n up t a k e 0.96 Delayed vaccination 0.80 0.60 0.40 0.20 Early vaccination 0.03 0.00 55 96 160 Days of Age Findings: Kaplan-Meier Survival Curve 3rd dose 221days In s t a n t a n e o u s ra t e o f v a c c in a t io n u p t a ke 1.00 0.80 0.60 0.40 0.20 0.06 0.00 100 116 157 200 250 Days of Age 300 350 365 Findings: Kaplan-Meier Survival Curve 3rd dose In s t a n t a n e o u s ra t e o f v a c c in a t io n u p t a ke 1.00 0.80 Delayed vaccination 0.60 0.40 Early vaccination 0.20 0.06 0.00 100 116 157 200 250 Days of Age 300 350 365 Findings: demographic analysis • Gender: No clinically significant findings were obtained • Ethnicity: Vaccine 1 (n= 4101) Vaccine 2 (n= 3948) Vaccine 3 (n=4050) Median days of vaccination: White Other 63 62 98 97 135 132 p value 0.027 <0.0005 <0.0005 Locality of living • 1st Vaccine dose: those living in areas of high IMD (Index of Multiple Deprivation) had the highest percentages of infants receiving their vaccines early and delayed • 3rd Vaccine dose: no association of vaccination early or late according to IMD. Recommendations • Vaccine timeliness using survival analysis is a useful tool to support COVER data • Consideration of policy and guidance regarding vaccine timeliness would be beneficial. Future research • The effect of suboptimal vaccination • Trialling of Kaplan-Meier Survival analysis utilisation within the UK • Consideration of the reason for suboptimal vaccination (parental and professional viewpoint) Recommendations • Need for professionals to be informing parents/guardians of not only the need to vaccinate but also the importance of this being timely • Flexibility of vaccination (drop-in clinics and opportunistic vaccination) Summary • Vaccine timeliness reporting is cost-effective and has health implications for infants. • Kaplan-Meier Survival analysis is a useful tool to complement current surveillance techniques adopted by COVER. • It is suggested that clarification in respect of policy/guidance is required in relation to vaccine timeliness References • • • • • Akmatov M, Kretzschmar M, Kramer A, Mikolajczyk R (2008) Timeliness of vaccination and its effects on fractions of vaccinated populations. Vaccine. 26: 3805-3811 Crowstoft N, Stein N, Duclos P, Birmingham M (2003) How best to estimate the global burden of pertussis? The Lancet: Infectious Diseases. 3: 413-418 Dayan G, Shaw K, Baughman A, Orellana L, Forlenza R, Ellis A, Chaui J, Kaplan S, Strebel P (2006) Assessment of delay in age-appropriate vaccination using survival analysis. American Journal of Epidemiology. 163 (6): 561-570 Department of Health (2010) Immunisations against infection diseases-‘The Green Book’. [Online] Available: http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicy AndGuidance/DH_079917 (accessed 09/10/10) European Centres for Disease Prevention and Control (2009) Scientific panel on childhood immunisation schedule: Diphtheria-tetanus-pertussis (DTP) vaccination. [Online] Available: http://ecdc.europa.eu/en/publications/Publications/0911_GUI_Scientific_Panel_o n_Childhood_Immunisation_DTP.pdf (accessed 11/11/10) References • • • • • • • • Health Protection Agency (2008) Health protection report; weekly report. [Online] Available: http://www.hpa.org.uk/hpr/archives/2008/hpr1908.pdf (accessed 06/06/10) Hofmeyr S (1997) Immune Memory. [Online] Available: http://www.cs.unm.edu/~immsec/html-imm/memory.html (accessed 07/11/10) Hull B, McIntyre P (2006) Timeliness of childhood immunisations in Australia. Vaccine. 24: 4403-4408 Luman E, Barker L, McCauley M, Drews-Botsch C (2005a) Timeliness of childhood immunizations: A state-specific Analysis. American Journal of Public Health. 95(8): 1367-1373 Luman E, Baker L, Shaw K (2005b) Timeliness of childhood Vaccination in the United States: Days Under vaccinated and number of vaccines delayed. Journal of the American Medical Association. 293(10): 1204-1211 Luman E, Shaw K, Stockley S (2008) Compliance with vaccination recommendations of U.S children. American Journal of Preventive Medicine. 34(6): 463-470 Pertola H (2000) Worldwide Haemophilius Influenza type b disease at the beginning of the 21st century: global analysis of the disease burden 25 years after the use of polysaccharide vaccine and a decade after the advent of conjugates. Clinical Microbiology Reviews. 13:302317 Unicef (2010) Expanding immunisation coverage. [Online] Available: http://www.unicef.org/immunization/index_coverage.html (accessed 20/10/10)