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Prevaccine and Vaccine-Era Disease Estimates

Hepatitis a, hepatitis b, haemophilus influenzae type b, measles, mumps, and rubella, streptococcus pneumoniae, conclusions, acknowledgments, impact of routine childhood immunization in reducing vaccine-preventable diseases in the united states.

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Sandra E. Talbird , Justin Carrico , Elizabeth M. La , Cristina Carias , Gary S. Marshall , Craig S. Roberts , Ya-Ting Chen , Mawuli K. Nyaku; Impact of Routine Childhood Immunization in Reducing Vaccine-Preventable Diseases in the United States. Pediatrics August 2022; 150 (3): e2021056013. 10.1542/peds.2021-056013

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Current routine immunizations for children aged ≤10 years in the United States in 2019 cover 14 vaccine-preventable diseases. We characterize the public-health impact of vaccination by providing updated estimates of disease incidence with and without universally recommended pediatric vaccines.

Prevaccine disease incidence was obtained from published data or calculated using annual case estimates from the prevaccine period and United States population estimates during the same period. Vaccine-era incidence was calculated as the average incidence over the most recent 5 years of available surveillance data or obtained from published estimates (if surveillance data were not available). We adjusted for underreporting and calculated the percent reduction in overall and age-specific incidence for each disease. We multiplied prevaccine and vaccine-era incidence rates by 2019 United States population estimates to calculate annual number of cases averted by vaccination.

Routine immunization reduced the incidence of all targeted diseases, leading to reductions in incidence ranging from 17% (influenza) to 100% (diphtheria, Haemophilus influenzae type b, measles, mumps, polio, and rubella). For the 2019 United States population of 328 million people, these reductions equate to >24 million cases of vaccine-preventable disease averted. Vaccine-era disease incidence estimates remained highest for influenza (13 412 per 100 000) and Streptococcus pneumoniae -related acute otitis media (2756 per 100 000).

Routine childhood immunization in the United States continues to yield considerable sustained reductions in incidence across all targeted diseases. Efforts to maintain and improve vaccination coverage are necessary to continue experiencing low incidence levels of vaccine-preventable diseases.

The United States childhood vaccination program has dramatically reduced morbidity, mortality, and disability for targeted diseases. Updated estimates of disease incidence and cases averted, reflecting changes in disease epidemiology, vaccine utilization, and vaccine recommendations (based on the 2017 to 2021 schedule), are needed.

The childhood vaccination program reduced the incidence of all targeted diseases—with reductions ranging from 17% (influenza) to 100% (diphtheria, Haemophilus influenzae type b, measles, mumps, polio, and rubella)—and averted >24 million disease cases for the 2019 United States population.

Childhood vaccination has dramatically reduced morbidity, mortality, and disability caused by vaccine-preventable diseases, with ∼21 million hospitalizations, 732 000 deaths, and 322 million cases of disease averted in the United States between 1994 and 2013. 1   Among diseases targeted by vaccines recommended before 1980, 3—polio, measles, and rubella—have achieved elimination status as defined by the World Health Organization 2   and 1—smallpox—has been eradicated. 3   Diphtheria and tetanus have declined markedly in incidence with routine immunization and are well controlled, 2   whereas the incidence of pertussis and mumps has declined when compared with prevaccine levels but still fluctuates given periodic outbreaks since vaccination was introduced. 3   The public health burden of diseases targeted in the childhood immunization program between 1980 and 2005, including hepatitis A, hepatitis B, invasive Haemophilus influenzae type b (Hib), varicella, and invasive pneumococcal disease (IPD), has decreased by more than 80% 3   ; reductions in related nontargeted diseases (eg, acute otitis media caused by Streptococcus pneumoniae ) have also been observed. 4   After 2005, the routine immunization schedule 5   for United States children ≤10 years of age targeted additional pathogens, such as rotavirus and further pneumococcal serotypes. 5  

This study updates estimates of the reduction in overall and age-specific disease incidence associated with the routine childhood immunization program in the United States (based on the 2017 to 2021 vaccination schedule). This update incorporates changes in vaccine utilization rates and observed incidence of the targeted vaccine-preventable diseases since previous evaluations. 3 , 6   The present analysis will be of interest to policy makers, public health decision makers, and modelers concerned with public health interventions to minimize the burden of vaccine-preventable diseases. A companion study evaluated the value of the childhood immunization program for the 2017 United States birth cohort. 7  

We estimated the epidemiologic impact of the United States routine childhood immunization program (ages ≤10 years) by calculating the percent reduction in overall and age-specific disease incidence rates for each disease targeted by the program. We multiplied the prevaccine and vaccine-era incidence rates (using age-specific data, where available) by 2019 United States population estimates, 8   accounting for underreporting where necessary, to calculate the 2019 clinical disease burden with and without childhood immunization and to estimate the cases averted by vaccination. As in previous studies, we assumed that the difference between incidence rates during these periods was entirely attributable to the childhood immunization program. 3 , 6  

For the prevaccine period, we estimated disease incidence using published incidence estimates or calculated incidence using published annual case estimates and United States population data from the same period. For the vaccine era, we calculated incidence as the average incidence over the most recent 5 years of available surveillance data; we used published incidence estimates if surveillance data were not available. For both periods, we accounted for underreporting where necessary.

Table 1 summarizes the prevaccine and vaccine-era disease incidence sources. Age-specific incidence data were used for all diseases except diphtheria, polio, tetanus, and rotavirus. Incidence of Hib and rotavirus was limited to ages <5 years and diphtheria to ages ≤10 years, given lack of data in older age groups in the prevaccine period and the fact that clinical burden was largely limited to those age groups in both periods. Incidence of measles, mumps, and rubella was included only up to age 40 years, as prevaccine incidence data in ages ≥40 years was unavailable. For pneumococcal pneumonia, pneumococcal acute otitis media (AOM), and rotavirus, resource use estimates (ie, hospitalizations, emergency department [ED] visits, and outpatient visits) are reported instead of incidence and disease cases because of limitations in the source data.

Summary of Prevaccine and Vaccine-Era Disease Incidence Sources

ABC, Active Bacterial Core; AOM, acute otitis media; CDC, Centers for Disease Control and Prevention; ED, emergency department; IPD, invasive pneumococcal disease; NNDSS, National Notifiable Diseases Surveillance System.

Dates of immunization program initiation correspond to dates of vaccine licensure and/or routine recommended use. 3 , 96   For additional details on vaccines with multiple dates listed, please see Roush and Murphy 3   and Widdowson et al. 76  

Prevaccine pertussis incidence estimates for ages >10 y were estimated from all cases reported by Roush and Murphy, 3   adjusted to account for the estimate from Cherry 95   that approximately 93% of pertussis infections in the first half of the 20th century were among ages <10 y.

An underreporting factor of 10 was taken from economic evaluations and burden-of-illness studies 53 – 55   and was multiplied by prevaccine pertussis incidence in ages >10 y and vaccine-era pertussis incidence for all ages; prevaccine incidence from birth to age 10 y (taken from Zhou et al) already accounted for underreporting. 9   This underreporting factor is conservative compared with previous studies that have tested underreporting of pertussis up to 100 to 200 times reported cases among adolescents and adults. 53 , 55 , 56  

A prevaccine underreporting factor was calculated based on an estimated 48% of notifiable polio cases being paralytic in 1954. 74   This implied underreporting factor (1 of 0.48 = 2.1 cases per reported case) was used to calculate the estimated total number of notifiable polio cases (both paralytic and nonparalytic) based on the incidence of paralytic polio reported by Baicus. 75  

The prevaccine underreporting factor (22.2) was calculated from the 1994 NNDSS report, 20   which reported that approximately 3.7 million cases of varicella occurred annually prevaccine, with 4% to 5% of cases reported. 11 – 15  

Because cases of varicella were not reported by age in 2014 and 2015, the total cases were distributed by age using the same age distribution of cases from 2016 when calculating the age-specific 5-year incidence rate. The vaccine-era underreporting factor (10.4) was calculated based on the underreporting factor used by Roush and Murphy 3   (12.7 = 612 768 cases estimated of 48 445 cases reported by 33 states in 2006), adjusted for 40 states reporting varicella cases in 2015 versus 33 states in 2006 (12.7 × 33/40 = 10.4).

We obtained prevaccine diphtheria disease incidence for children aged ≤10 years from an economic evaluation by Zhou et al, 9   which estimated incidence from a 1916 to 1919 survey of childhood vaccine-preventable diseases in 31 353 United States children and physician-reported data. 10   We assumed the incidence reported by Zhou et al 9   for ages 5 to 9 years uniformly applied to all children ≤10 years. We calculated vaccine-era incidence among children aged ≤10 years as the average value over the most recent 5 years (2014 to 2018) of available data from the Centers for Disease Control and Prevention (CDC) National Notifiable Disease Surveillance System (NNDSS) reports. 11 – 15  

We calculated prevaccine hepatitis A incidence using the average number of reported cases between 1990 and 1994 from the NNDSS 16 – 20   divided by the 1994 United States population for each respective age group. 21   We calculated vaccine-era incidence as the average value over the most recent 5 years (2014 to 2018) of available data from the NNDSS. 11 – 15   A systematic review and meta-analysis of underreporting of hepatitis A in nonendemic countries found that reported hepatitis A cases ranged from 4% to 97% of total estimated cases across 8 included studies, with a pooled proportion of 59%. 22   As a result, an underreporting factor of 1.7 (1/59% = 1.7) was applied for prevaccine and vaccine-era estimates, 22   which is similar to underreporting factors found in other studies. 23  

We estimated prevaccine hepatitis B incidence as the average number of reported cases between 1976 and 1980 from the NNDSS 24 – 28   and calculated vaccine-era incidence as the average value over the most recent 5 years (2014 to 2018) of available data from the NNDSS. 11 – 15   The underreporting factor for hepatitis B (6.5) was obtained from a probabilistic model estimating underreporting of hepatitis A, B, and C. 23  

We obtained prevaccine disease incidence for Hib for children aged <5 years for 1976 to 1984 from an economic analysis by Zhou et al. 29   We calculated overall incidence by summing the incidence values reported separately for Hib-related meningitis, epiglottitis, bacteremia, pneumonia, cellulitis, arthritis, and other invasive diseases reported in Zhou et al. 29   We calculated vaccine-era incidence among children aged <5 years as the average value over the most recent 5 years (2013–2017) of available data from CDC Active Bacterial Core (ABC) surveillance reports. 30 – 34  

For influenza, instead of using data from the period before influenza vaccines were routinely recommended, we estimated prevaccine incidence among children aged ≤10 years by using the number of cases and averted cases estimated by the CDC, assuming all averted cases would have occurred without vaccination. 35 – 42   Specifically, we summed the number of reported cases to the cases averted by vaccination among children <5 years and children aged 5 to 10 years for 5 recent influenza seasons (2014–2015 to 2018–2019) and then divided the total number of cases by the number of children in the United States in each respective age group for the same period. 8   An average incidence across the 5 years was then calculated for both age groups. For vaccine-era incidence, we used the same source and calculated the average incidence over the same 5 recent seasons (2014–2015 to 2018–2019). Our analyses did not account for the impact of adolescent and adult influenza vaccination or herd immunity in older age groups; therefore, incidence of influenza was restricted to ages ≤10 years, and we attributed all changes in incidence to vaccination in this age cohort.

For measles, mumps, and rubella, we obtained prevaccine disease incidence from Zhou et al. 43 – 47   For the vaccine era, we calculated incidence as the average value over the most recent 5 years (2014 to 2018) of available data from the NNDSS. 11 – 15  

We estimated prevaccine pertussis incidence for birth to 10 years from 2 economic evaluations of diphtheria, tetanus, and acellular pertussis vaccine, which derived age-specific risk of pertussis from United States data in the 1920s and from Sweden in the 1980s. 9 , 48   Prevaccine incidence for ages >10 years was calculated using the number of reported pertussis cases estimated by Roush and Murphy 3   for ages >10 years during 1934 to 1943 (before the start of routine pertussis vaccination in the late 1940s) divided by the size of the United States population >10 years old over the same period. 49 , 50   We calculated vaccine-era incidence as the average value over the most recent 5 years (2014 to 2018) of available data from the NNDSS. 11 – 15   An underreporting factor of 10 was applied in the prevaccine and vaccine eras ( Table 1 ). 51 – 56  

For IPD, we calculated prevaccine disease incidence as the average value from the 1997 to 1999 ABC surveillance reports 57 – 59   and calculated vaccine-era incidence as the average value from the 2013 to 2017 ABC surveillance reports. 60 – 64  

For pneumococcal pneumonia, we obtained prevaccine, age-specific, all-cause pneumonia hospitalization rates per 100 000 for the period 1997 to 1999 65   and all-cause outpatient visit rates per 100 000 for the period 1998 to 2000 66 , 67   ( Table 1 ). For the vaccine era, we used the incidence of all-cause pneumonia from 2014 based on an analysis of a large convenience insurance claims dataset (MarketScan) multiplied by the percentage hospitalized or treated in an outpatient or ED setting taken from the same study. 68   We multiplied the all-cause rates by the prevaccine 69 , 70   and postvaccine 71 , 72   percentage of all-cause pneumonia caused by pneumococcus ( Table 1 ).

For pneumococcal AOM, we used prevaccine, age-specific incidence from 1997 to 1999 and vaccine-era incidence from 2012 to 2014 from a retrospective analysis of the National Ambulatory Medical Care Survey comparing ambulatory visit rates before the introduction of 7-valent and following 13-valent pneumococcal conjugate vaccine. 4   We summed annual rates of physician office, hospital outpatient, and hospital ED visits to calculate a total annual ambulatory visit rate per 1000 children. To calculate pneumococcal AOM burden for each period, we multiplied all-cause rates by the percentage of AOM caused by pneumococcus in the prevaccine period (1995 to 2001) (44%) and vaccine era (2010 to 2016) (21%). 73  

For polio, we obtained the average number of paralytic poliomyelitis cases for the period 1951 to 1954 (before the introduction of the first polio vaccine in 1955) from Roush and Murphy 3   . We divided the total number of cases by the average United States population size from 1951 to 1954 to estimate an overall incidence rate. 49   Age-specific data were not available in the prevaccine period; therefore, the same incidence rate was used for all ages. A prevaccine underreporting factor of 2.1 was applied ( Table 1 ). 74 , 75   We calculated vaccine-era incidence as the average value over the most recent 5 years (2014 to 2018) of available data from the NNDSS. 11 – 15  

We calculated prevaccine estimates of rotavirus-related burden among children aged <5 years using 1993 to 2002 data on the cumulative individual risk of event by age 59 months for events including hospitalizations, ED visits, and hospital or ambulatory outpatient visits. 76   The median values were used to calculate annual probabilities of each type of rotavirus-related resource use. We further assumed rotavirus events were uniformly distributed from birth to age 5 years ( Supplemental Table 3 ). In the vaccine era, we calculated rotavirus-related burden by multiplying prevaccine event rates by the estimated reduction in hospitalizations 77   and reduction in ED and outpatient visits. 78  

We calculated prevaccine tetanus incidence based on the number of cases reported during 1947 to 1949 (before routine vaccination began in the late 1940s 3   ) divided by the average size of the United States population during that same period. 49   Data were not available by age in the prevaccine period; therefore, the same incidence rate was used across all ages in the model. We calculated vaccine-era incidence as the average value over the most recent 5 years (2014 to 2018) of available data from the NNDSS. 11 – 15  

We calculated prevaccine varicella incidence using the average number of reported varicella cases between 1990 and 1994 (before vaccine introduction in 1995) from the NNDSS 16 – 20   divided by the 1994 United States population for each respective age group. 20 , 21   We calculated vaccine-era incidence as the average value over the most recent 5 years (2014 to 2018) of available data from the NNDSS. 11 – 15   Underreporting factors of 22.2 and 10.4 were applied to prevaccine and vaccine-era incidence, respectively ( Table 1 ). 3 , 20  

We report calculated incidence overall and by age for both the prevaccine and 2019 vaccine-era periods. We calculated the percent reduction in incidence overall and by age group for each disease by comparing the 2 periods. Using 2019 United States population estimates from the United States Census Bureau, we calculated the number of cases of each disease that would be expected in 2019 without and with the routine childhood immunization program and the number of cases of disease averted.

For infants (<1 year), prevaccine annual incidence per 100 000 was highest for pneumococcal AOM (49 324), influenza (18 903), measles (9200), and pertussis (4720) ( Supplemental Tables 3 – 5 ). For young children (ages 1 to 4 years), as for infants, incidence in the prevaccine period was highest for pneumococcal AOM (15 004–49 324), influenza (18 903), measles (10 641–11 503), and pertussis (4720), as well as for varicella (4519). For school-aged children (ages 5–18 years), prevaccine incidence varied by age group but was highest for influenza (14 066), varicella (389–6480), pneumococcal AOM (4840), and pertussis (131–4720). For adults, prevaccine incidence was highest for pneumococcal pneumonia (29–1553), rubella (300), mumps (99–256), and pertussis (131).

After vaccines were introduced, incidence decreased for all diseases evaluated ( Fig 1 ; Table 2 ). Incidence was reduced to less than 1 per 100 000 for 6 of the diseases: diphtheria, Hib, measles, polio, rubella, and tetanus. The incidence of mumps was reduced by >99% and varicella by 98%. The incidence of rotavirus-related hospitalizations among children aged <5 years was reduced by 91%; a lower reduction was observed for rotavirus-related ED visits (61%) and outpatient visits (45%). The incidence of pertussis was reduced by 91%, hepatitis A by 87%, hepatitis B by 86%, and IPD by 60%. Pneumococcal pneumonia hospitalization rates and outpatient visit rates decreased by 84% and 69%, respectively, and incidence of pneumococcal AOM decreased by 75%. The incidence of influenza among people aged <11 years was reduced by 17%.

Percentage reduction in disease incidence in the vaccine era by disease. Percentage reduction for rotavirus is hospitalizations. IPD does not include pneumococcal pneumonia or acute otitis media. Percentage reductions in disease incidence round up to 100% for several diseases, although there are still some cases in the vaccine era ( Table 2 ). IPD, invasive pneumococcal disease.

Prevaccine and Vaccine-Era Disease Incidence Estimates, Annual Cases, and 2019 Cases Averted in the United States by Disease

Annual cases are rounded to the nearest thousand. AOM, acute otitis media; ED, emergency department; IPD, invasive pneumococcal disease.

Incidence estimates are adjusted by underreporting factors of 1.7 for hepatitis A, 6.5 for hepatitis B, 10.0 for pertussis (in ages 11 y and older prevaccine and all ages in the vaccine era), 2.1 for polio prevaccine (to capture paralytic and nonparalytic cases), 22.2 for varicella prevaccine, and 10.4 for varicella in the vaccine era (with all other diseases assumed fully reported and/or already adjusted to account for underreporting from the source data).

Prevaccine and vaccine-era case estimates are calculated using 2019 United States population estimates and are rounded to the nearest thousand. For Haemophilus influenzae type b and rotavirus, the population size for ages <5 y ( n = 19 576 683) was used to calculate annual cases. Annual cases for diphtheria and influenza were calculated using the population size for ages ≤10 y ( n = 43 833 518). The population size for ages <40 y ( n = 170 936 198) was used to calculate annual cases for measles, mumps, and rubella. For all other diseases, the total United States population size ( n = 328 239 523) was used to calculate annual prevaccine and vaccine-era cases.

Rotavirus and pneumococcal disease results are shown separately by healthcare resource use because of a lack of incidence data.

The calculated value for cases averted may not precisely equal the difference between the number of cases in the “with immunization” and “without immunization” period because of rounding.

For the 2019 United States population of 328 million people, the number of cases of each disease without and with the childhood immunization program and the estimated number of cases averted are shown in Table 2 . In the vaccine era with routine immunization, the annual number of cases of disease was 0 for polio, <10 cases per year for diphtheria and rubella, and <100 cases per year for Hib and tetanus. Pneumococcal AOM and influenza represented the largest clinical burden annually (>1 000 000 cases per year), followed by pertussis, pneumococcal pneumonia, outpatient rotavirus gastroenteritis, and outpatient varicella (between 100 000 and 1 million cases per year).

Routine immunization was estimated to avert over 24 million cases of vaccine-preventable disease in 2019 across all age groups, ranging from approximately 1000 cases of tetanus averted to more than 4.2 million varicella cases averted ( Table 2 ). Cases averted were greatest (>1 000 000) for influenza, measles, mumps, rubella, pertussis, varicella, and outpatient visits for pneumococcal AOM.

This analysis found that routine childhood immunization in the United States has continued to reduce the incidence of all targeted diseases. Landmark achievements have been the reduction in incidence of diphtheria, Hib, measles, polio, rubella, and tetanus to negligible levels (<1 case per 100 000 population annually); and >90% reduction in incidence for 10 diseases targeted by the routine childhood immunization program for children ≤10 years of age. These reductions equate to the prevention of over 24 million cases of disease for the 2019 US population.

Roush and Murphy 3   evaluated the impact of routine childhood immunization on vaccine-preventable diseases for which recommendations were in place before 2005, using 2006 disease data. Our estimates were generally consistent with the previous results and other published studies, 79   although we estimated a greater reduction in incidence of IPD (60% versus 34%) and of varicella (98% versus 85%). A potential explanation for these differences may be that our analysis used vaccine-era incidence from 2013 to 2017 for pneumococcal disease and from 2014 to 2018 for varicella, capturing the greater impact of the 13-valent pneumococcal conjugate vaccine (recommended in 2010 for infants) compared with the 7-valent pneumococcal conjugate vaccine and capturing the greater impact of 2-dose varicella vaccine compared with 1 dose (second dose added to recommendations in 2007). 80  

With sustained vaccine coverage at levels greater than 80% for most pediatric vaccines (with the exception of hepatitis A, rotavirus, and annual influenza vaccine), many vaccine-preventable diseases are now controlled as a public health problem or eliminated in the United States. However, despite significant impact of vaccines, continued risk from these vaccine-preventable diseases remains. When whole-cell pertussis vaccine was withdrawn in Sweden in 1979 because of concerns about safety and efficacy, incidence rates of pertussis similar to those observed in the prevaccine era returned in Sweden within a few years; after introduction of the diphtheria, tetanus, and acellular pertussis vaccine in 1996, incidence rates decreased markedly compared with the 1986 to 1995 10-year period. 81 , 82   Similarly, despite elimination status being declared for measles in 2000, under-vaccination has led to continued measles outbreaks in the United States, jeopardizing elimination status for the disease. 83 – 85   Diphtheria outbreaks continue to occur where vaccination rates are low, particularly in areas of social disruption, and are often associated with high rates of mortality. 86 , 87   The most recent large outbreak occurred in Russia from 1990 to 1997, resulting in ∼115 000 cases and 3000 deaths across the population. 88   These experiences underscore the importance of continued immunization in sustaining reductions in incidence of infectious diseases.

This analysis includes some limitations. First, consistent with previous studies, 3 , 6   the analysis does not directly account for other public health measures (eg, better sanitation, healthcare access, and improved standards of care) that have been introduced over the past 70 years and likely contributed to the reduction in vaccine-preventable diseases. Furthermore, this analysis did not account for random error in the parameter estimates or account for the proportion of disease incidence reduction that may be attributed to adolescent and adult vaccines or to booster doses. As a result, the analysis may overestimate reductions in burden directly attributable to childhood immunization. Future analyses could address these methodological limitations using time-series analysis to identify and adjust for trends to explore the extent to which adolescent and adult vaccination programs, which have expanded since 2005, 80 , 89 , 90   contribute to reduction in disease incidence.

Second, owing to limited data on differences among racial and ethnic groups, this analysis did not account for racial or ethnic disparities in vaccine coverage and incidence of vaccine-preventable diseases. Evaluating the public health impact of routine immunization among racial and ethnic groups is an important direction for future research. Moreover, this analysis was limited in scope to vaccine-preventable disease for vaccines included in the United States routine childhood immunization program for children ages ≤10 years. Expansion of this analysis to include vaccine-preventable diseases, such as meningococcus and human papillomavirus targeted by routine adolescent vaccines, is another potential area of future research.

Third, because annual incidence varies substantially from year to year for many vaccine-preventable diseases, we have calculated prevaccine and vaccine-era incidence as averages across multiple years, where data allowed. Despite our efforts to estimate average incidence values in both periods, significant epidemics or outbreaks occurred for some diseases that may not be reflected in the annual averages used in this analysis. 91   For the vaccine era, data used to derive disease incidence were for years preceding the coronavirus disease 2019 (COVID-19) pandemic. There are multiple factors that may influence the impact of COVID-19 on the incidence of vaccine-preventable diseases. For example, behavior changes caused by nonpharmaceutical interventions, including lockdowns, face-covering use, and other social distancing measures may reduce the transmission of some diseases, while simultaneously causing disruptions to vaccine uptake and coverage for the pediatric population that may adversely impact the prevention of vaccine-preventable diseases. 92 – 94   Future surveillance and survey data will help to understand the impact of the COVID-19 pandemic and other potential “shocks” to the immunization program on the transmission of other vaccine-preventable diseases.

Routine childhood immunization in the United States has continued to reduce the incidence of all targeted vaccine-preventable diseases. In the vaccine era, the incidence of diphtheria, Hib, measles, polio, rubella, and tetanus has been reduced to <1 per 100 000; across all targeted diseases, ∼24 million cases have been averted because of vaccination for the 2019 United States population. Routine immunization remains an effective public health intervention to avert disease; maintenance of high rates of vaccination coverage is necessary for sustained impact.

We thank Kate Lothman of RTI Health Solutions, who provided medical writing support for the development of this manuscript and whose services were funded by Merck Sharp & Dohme LLC, a subsidiary of Merck & Co, Inc, Rahway, NJ, USA.

Ms Talbird, Mr Carrico, and Dr La conceptualized and designed the study, reviewed the literature, interpreted the results, and drafted the initial manuscript; Drs Chen, Nyaku, Carias, and Roberts conceptualized the study and provided input on the study design, secured funding, and interpreted the results; Dr Marshall interpreted the results; and all authors reviewed and revised the manuscript, approved the final manuscript as submitted, and agree to be accountable for all aspects of the work.

COMPANION PAPERS: companions to this article can be found online at http://www.pediatrics.org/cgi/doi/10.1542/peds.2021-056007 and http://www.pediatrics.org/cgi/doi/10.1542/peds.2022-057831 .

Dr La’s current affiliation is GSK, Philadelphia, Pennsylvania.

FUNDING: This study was funded by Merck Sharp & Dohme LLC, a subsidiary of Merck & Co, Inc, Rahway, NJ, USA.

CONFLICT OF INTEREST DISCLOSURES: Ms Talbird and Mr Carrico are employed by RTI Health Solutions, which received funding for the conduct of this study. Dr La was an employee of RTI Health Solutions when this study was conducted and is now an employee and shareholder in the GSK group of companies. Drs Chen, Carias, and Roberts are employees of Merck Sharp and Dohme LLC, a subsidiary of Merck & Co, Inc, Rahway, NJ, and are shareholders in Merck & Co, Inc. Rahway, NJ. Dr Nyaku was an employee of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co, Inc, Rahway, NJ and a shareholder in Merck & Co, Inc, Rahway, NJ when this study was conducted. Dr Marshall has been an investigator on clinical trials funded by GlaxoSmithKline, Merck, Pfizer, Sanofi Pasteur, and Seqirus, and he has received honoraria from these companies for service on advisory boards and/or nonbranded presentations.

active bacterial core

acute otitis media

Centers for Disease Control and Prevention

coronavirus disease 2019

emergency department

Haemophilus influenzae type b

invasive pneumococcal disease

National Notifiable Disease Surveillance System

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In this randomized, controlled integrated phase 1/2/3a/3b clinical trial, the authors show that the self-amplifying mRNA COVID-19 vaccine ARCT-154 shows good immunogenicity and is safe and efficient against COVID-19 (57% against any COVID-19, and 95% against severe COVID-19).

• Nhân Thị Hồ
• Steven G. Hughes
• Xuan-Hung Nguyen

News and Comment

UTIs make life miserable — scientists are finding new ways to tackle them

Researchers are developing vaccines and fresh drug approaches to prevent and treat recurring infections without antibiotics.

• Carissa Wong

Scientists tried to give people COVID — and failed

Researchers deliberately infect participants with SARS-CoV-2 in ‘challenge’ trials — but high levels of immunity complicate efforts to test vaccines and treatments.

• Ewen Callaway

Harnessing our lived experience for science communication

Adrian Liston, professor of pathology at the University of Cambridge, UK, has published several illustrated children’s books on the topic of vaccination and has developed a computer game called ‘VirusFighter’. Here, he shares his thoughts on how to become an effective science communicator.

• Adrian Liston

The role of correlates of protection in overcoming barriers to vaccine development and demonstrating efficacy

• Charlotte Weller

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How Americans View the Coronavirus, COVID-19 Vaccines Amid Declining Levels of Concern

Just 20% of the public views the coronavirus as a major threat to the health of the U.S. population and only 10% are very concerned about getting a serious case themselves. In addition, a relatively small share of U.S. adults (28%) say they’ve received an updated COVID-19 vaccine since last fall.

Americans’ Largely Positive Views of Childhood Vaccines Hold Steady

About nine-in-ten (88%) Americans say, overall, the benefits of childhood vaccines for measles, mumps and rubella outweigh the risks, identical to the share who said this before the coronavirus outbreak. U.S. adults are less confident in COVID-19 vaccines: Fewer than half rate them as having high health benefits and a low risk of side effects.

About half of recent online daters in U.S. say it’s important to see COVID-19 vaccination status on profiles

Online dating users who are Democrats are far more likely their Republican counterparts to say someone’s vaccination status is important for them to see.

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Just 20% of the public views the coronavirus as a major threat to the health of the U.S. population and only 10% are very concerned about getting a serious case themselves. In addition, a relatively small share of U.S. adults (28%) say they’ve received an updated COVID-19 vaccine since last fall.

Lack of Preparedness Among Top Reactions Americans Have to Public Health Officials’ COVID-19 Response

Overall, 46% of Americans say the statement “public health officials were unprepared for the outbreak” describes their views extremely or very well, including similar shares of Republicans and Democrats.

Gay or bisexual men express concern about monkeypox, are critical of government’s response

Men who describe themselves as gay or bisexual are more likely to say they have received or intend to get a monkeypox vaccine.

Partisan differences are common in the lessons Americans take away from COVID-19

Here’s what Americans said they learned about the development of vaccines and medical treatments and their advice for handling a future outbreak.

Americans Reflect on Nation’s COVID-19 Response

Americans offer a lackluster evaluation of how the country has balanced priorities during the coronavirus outbreak. Fewer than half say the country has given the right amount of priority to the needs of K-12 students, public health or quality of life.

Americans skeptical about religious objections to COVID-19 vaccines, but oppose employer mandates

Most U.S. adults do not believe that requests for religious exemptions from the COVID-19 vaccine are sincere.

Two Years Into the Pandemic, Americans Inch Closer to a New Normal

Americans in 2022 find themselves in an environment that is at once greatly improved and frustratingly familiar.

COVID-19 Pandemic Continues To Reshape Work in America

Nearly two years into the COVID-19 pandemic, roughly six-in-ten U.S. workers who say their jobs can mainly be done from home (59%) are working from home all or most of the time.

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Vaccine FAQ

Top 20 Questions about Vaccination

Last updated 22 April 2022

Our most frequently asked questions. Expand for detailed answers from experts.

Vaccines work to prime your immune system against future “attacks” by a particular disease. There are vaccines against both viral and bacterial pathogens, or disease-causing agents.

When a pathogen enters your body, your immune system generates antibodies to try to fight it off. Depending on the strength of your immune response and how effectively the antibodies fight off the pathogen, you may or may not get sick.

If you do fall ill, however, some of the antibodies that are created will remain in your body playing watchdog after you’re no longer sick. If you’re exposed to the same pathogen in the future, the antibodies will “recognize” it and fight it off.

Vaccines work because of this function of the immune system. They’re made from a killed, weakened, or partial version of a pathogen. When you get a vaccine, whatever version of the pathogen it contains isn’t strong or plentiful enough to make you sick, but it’s enough for your immune system to generate antibodies against it. As a result, you gain future immunity against the disease without having gotten sick: if you’re exposed to the pathogen again, your immune system will recognize it and be able to fight it off.

Some vaccines against bacteria are made with a form of the bacteria itself. In other cases, they may be made with a modified form of a toxin generated by the bacteria. Tetanus, for example, is not directly caused by the Clostridium tetani bacteria. Instead, its symptoms are primarily caused by tetanospasmin, a toxin generated by that bacterium. Some bacterial vaccines are therefore made with a weakened or inactivated version of the toxin that actually produces symptoms of illness. This weakened or inactivated toxin is called a toxoid. A tetanus immunization, for example, is made with tetanospasmin toxoid.

Vaccines are designed to generate an immune response that will protect the vaccinated individual during future exposures to the disease. Individual immune systems, however, are different enough that in some cases, a person’s immune system will not generate an adequate response. Therefore, he or she will not be effectively protected after immunization.

That said, the effectiveness of most vaccines is high. After receiving the second dose of the MMR vaccine (measles, mumps and rubella) or the standalone measles vaccine, 99.7% of vaccinated individuals are immune to measles. The inactivated polio vaccine offers 99% effectiveness after three doses. The varicella (chickenpox) vaccine is between 85% and 90% effective in preventing all varicella infections, but 100% effective in preventing moderate and severe chicken pox.

Currently, the U.S. childhood vaccination schedule for children between birth and six years of age recommends immunizations for 14 different diseases. Some parents worry this number seems high, particularly since some vaccine-preventable diseases are now extremely rare in the United States.

Each disease for which vaccinations are recommended can cause serious illness or death in unvaccinated populations, and could quickly begin to appear again if vaccination rates dropped. The United States has seen mumps outbreaks in recent years, since vaccination rates have dropped, with severe complications and hospitalizations required for some patients. And before the introduction of the Hib (Haemophilus Influenzae Type b) vaccine, Hib meningitis affected more than 12,000 American children annually, killing 600 and leaving many others with seizures, deafness, and developmental disabilities. After the vaccine was introduced, the number of deaths from Hib dropped to fewer than 10 per year.

Each vaccine on the schedule continues to be recommended because of the risks posed by wild infection.

In some cases, natural immunity is longer-lasting than the immunity gained from vaccination. The risks of natural infection, however, outweigh the risks of immunization for every recommended vaccine. For example, wild measles infection causes encephalitis (inflammation of the brain) for one in 1,000 infected individuals. Overall, measles infection kills two of every 1,000 infected individuals. In contrast, the combination MMR (measles, mumps and rubella) vaccine results in a severe allergic reaction only once in every million vaccinated individuals, while preventing measles infection. The benefits of vaccine-acquired immunity extraordinarily outweigh the serious risks of natural infection. (For more on this topic, see our  .)

Additionally, the Hib ( Haemophilus influenzae type b) and tetanus vaccines actually provide more effective immunity than natural infection.

It is unclear why the length of acquired immunity varies with different vaccines. Some offer lifelong immunity with only one dose, while others require boosters to maintain immunity. Recent research has suggested that the persistence of immunity against a particular disease may depend on the speed with which that disease typically progresses through the body. If a disease progresses rapidly, the immune system’s memory response (that is, the “watchdog antibodies” generated after a previous infection or vaccination) may not respond quickly enough to prevent infection—unless they’ve been “reminded” about the disease fairly recently and are already watching for it. Boosters serve as a “reminder” to your immune system.

Research continues on the persistence of immunity generated by vaccines.

The idea of “pox parties” is generally tied to the perception of chickenpox as a harmless illness. Before the varicella vaccine became available, however, chickenpox infections required 10,000 hospitalizations and caused more than 100 deaths each year in the United States. Exposing a child to wild chickenpox puts him at risk for a severe case of the disease.

Even uncomplicated cases of chickenpox cause children to miss a week or more of school, with a caregiver missing work to care for the sick child.  Natural infection also means a risk of infecting others: while successful vaccination protects a child against chickenpox without this risk, children infected with chickenpox naturally are contagious. They can spread the disease to other people—not just other children, but also adults, who have a higher risk of complications from the disease.

Meanwhile, vaccination for chickenpox typically prevents future infection with the disease. In rare cases where individuals do not develop adequate protection from vaccination to prevent future infection, chickenpox infection is typically mild, results in fewer symptoms, and ends more quickly than natural infection. (People with this mild form are contagious, however, and should take care not to expose others to the virus.)

Vaccines made with killed versions of pathogens—or with only a part of the pathogen—are not able to cause illness. When a person receives these vaccines, it is impossible for him or her to become ill with the disease.

Live, attenuated (or weakened) vaccines are theoretically capable of causing illness: because they can still replicate (though not well), mutation is possible, which can lead to a virulent form of the pathogen. However, they are designed with this in mind, and attenuated to minimize this possibility. Reversion to virulent form is a problem with some forms of the oral polio vaccine (OPV), which is why only the inactivated form (IPV) is now used in the United States.

It is important to note that attenuated vaccines can cause serious problems for individuals with weakened immune systems, such as cancer patients. These individuals may receive a killed form of the vaccine if one is available. If not, their doctors may recommend against vaccination. In such cases, individuals rely on herd immunity for protection.

Why some vaccines contain live pathogens and others contain killed pathogens, the reasons vary by illness. However, live, attenuated vaccines generally generate longer-lasting immunity than killed vaccines. Thus, killed vaccines are more likely to require boosters to maintain immunity. Killed vaccines, however, tend to be more stable for storage purposes, and can’t cause illness. The medical community must weigh these trade-offs in deciding which approach to use against a particular disease.

Yes. Studies demonstrate that infants’ immune systems can handle receiving many vaccines simultaneously—more than the number currently recommended. The immunization schedule is based on infants’ ability to generate immune responses, as well as when they are at risk of certain illnesses. For example, the immunity passed from mother to child at birth is only temporary, and typically does not include immunity against polio, hepatitis B, Haemophilus influenzae type b, and other diseases that can be prevented by vaccination.

Unlike most vaccines, which contain the most common strains of a given pathogen (if more than one exists) and are rarely changed, the seasonal flu vaccine changes frequently, though one or more flu strains in the vaccine may be retained from one year to the next. This is because the strains of influenza viruses that circulate are constantly changing. Each year, researchers choose viruses for the vaccine based on which ones are likely to circulate over the coming flu season, providing protection against the most prevalent strains. So when you get a seasonal flu vaccine, you’re usually not getting another “dose” of the same flu vaccine you were given before. Instead, you’re usually getting protection against a whole new batch of flu viruses.

Herd immunity, also known as community immunity, refers to the protection offered to everyone in a community by high vaccination rates. With enough people immunized against a given disease, it’s difficult for the disease to gain a foothold in the community. This offers some protection to those who are unable to receive vaccinations—including newborns and individuals with chronic illnesses—by reducing the likelihood of an outbreak that could expose them to the disease.

Some vaccines, including most vaccines against influenza, are cultured in chicken eggs. During the process of creating the vaccine, most egg protein is removed, but there is some concern that these vaccines could generate an allergic reaction in individuals with an egg allergy.

A recent report found that most children with egg allergies who were given a flu shot had no adverse reactions. About 5% of children in the studied group developed relatively minor reactions, such as hives, which resolved without treatment.  Additional research is underway to study this issue further.

In most cases, only people with a severe (life-threatening) allergy to eggs are recommended against receiving egg-based vaccines. Your doctor can provide specific information.

No. Vaccines do not cause autism. This possibility was publicized after a 1998 paper by a British physician who claimed to have evidence that the MMR (measles, mumps and rubella) vaccine was linked to autism. The potential link has been thoroughly explored; study after study has found no such link, and , which had originally published it. Studies were also done regarding the possibility of a link between the preservative thimerosal, which is used in some vaccines, and autism; again, no such link was found.

It’s likely that this misconception persists because of the coincidence of timing between early childhood vaccinations and the first appearance of symptoms of autism.

All vaccines have possible side effects. Most, however, are mild and temporary. Adverse effects from vaccines are thoroughly monitored via multiple reporting systems, and there is no evidence from these systems to support these claims.

Every vaccine has potential side effects. Typically they are mild: soreness at the injection site (for a vaccine delivered via a shot), headaches, and low-grade fevers are examples of common vaccine side effects. Serious side effects are possible, including severe allergic reactions. However, these side effects are rare. (Your doctor can explain the risks for individual vaccines in detail; .)

When considering possible side effects from vaccination, it’s important to do so in context. While some possible side effects are serious, they are rare. It’s important to remember that choosing not to vaccinate also has serious risks. Vaccines protect against potentially fatal infectious diseases. Avoiding vaccination raises the risk of contracting those diseases and spreading them to others.

Vaccines are tested repeatedly before being approved, and continue to be monitored for adverse reactions after their release. See our article on vaccine testing and safety for more information and details about this topic.

No. The rubella vaccine virus included in the MMR (measles, mumps and rubella) shot is cultured using human cell lines. The vaccine material is carefully separated from the cells in which it was grown before being used.

Some of these cell lines were generated from fetal tissue obtained in the 1960s from legal abortions. No new fetal tissue is required to generate the rubella vaccine.

Improved hygiene and nutrition, among other factors, can certainly lower the incidence of some diseases. Data documenting the number of cases of a disease before and after the introduction of a vaccine, however, demonstrate that vaccines are responsible for the largest drops in disease rates. Measles cases, for example, numbered anywhere from 300,000 to 800,000 a year in the United States between 1950 and 1963, when a newly licensed measles vaccine went into widespread use. By 1965, U.S. measles cases were beginning a dramatic drop. In 1968, about 22,000 cases were reported (a drop of 97.25% from the height of 800,000 cases in just three years). By 1998, the number of cases averaged about 100 per year or less. A similar post-vaccination drop occurred with most diseases for which vaccines are available.

Perhaps the best evidence that vaccines, not hygiene and nutrition, are responsible for the sharp drop in disease and death rates is chickenpox. If hygiene and nutrition alone were enough to prevent infectious diseases, chickenpox rates would have dropped long before the introduction of the varicella vaccine, which was not available until the mid-1990s. Instead, the number of chickenpox cases in the United States in the early 1990s, before the vaccine was introduced in 1995, was about four million a year. By 2004, the disease incidence had dropped by about 85%.

In theory, nearly any infectious disease for which an effective vaccine exists should be eradicable. With sufficient vaccination levels and coordination between public health organizations, a disease can be prevented from gaining a foothold anywhere. Without anyone to infect, it must die off. (A notable exception is tetanus, which is infectious but not contagious: it’s caused by a bacterium commonly found in animal feces, among other places. Thus, tetanus could not be eradicated without completely removing the  Clostridium tetani  bacterium from the planet.)

Smallpox is unusual, however, in the characteristics that made it susceptible to eradication. Unlike many other infectious diseases, smallpox has no animal reservoir. That is, it can’t “hide” in an animal population and re-emerge to infect humans, while some diseases can do exactly that (yellow fever, for example, can infect some primates; if a mosquito bites an infected primate, it can transmit the virus back to humans).

Another obstacle to eradication for many infectious diseases is visibility. People with smallpox were highly visible: the smallpox rash was easily recognizable, so that new cases could be detected quickly. Vaccination efforts could be focused on the location of the cases and potential exposure to other individuals. Polio, by contrast, causes no visible symptoms in about 90% of the people it infects. As a result, tracking the spread of the polio virus is extremely difficult, making it a difficult eradication target.

Perhaps most importantly, smallpox patients generally did not reach their highest level of infectivity (that is, their ability to infect others) until after the appearance of the smallpox rash. As a result, quick action to quarantine infected individuals upon the eruption of the rash usually left enough time to vaccinate anyone already exposed, and prevent additional exposures. Many infectious diseases do not allow for this type of reaction time. Measles patients, for example, can become infectious up to four days before the appearance of the measles rash. As a result, they can pass the virus on to many, many other people before anyone even knows they are infected.

Many people still think eradication is possible for certain diseases. Efforts are ongoing to eradicate polio and Guinea worm disease (Dracunculiasis), with both eliminated in many regions, but remaining endemic in several countries. Meanwhile, the Carter Center International Task Force for Disease Eradication has declared additional diseases potentially eradicable: lymphatic filariasis (Elephantiasis), mumps, pork tapeworm, and yaws. 

[For more about this topic, see our article on  .]

The polio vaccines developed by Jonas Salk and Albert Sabin in the mid-20th century were made with monkey cells. Years later, microbiologist Maurice Hilleman found a monkey virus in both vaccines—the 40th monkey virus to be discovered, which he called Simian Virus 40 (SV40). (Salk’s killed vaccine, which was treated with formaldehyde, had very small amounts of the virus; Sabin’s live vaccine was heavily contaminated.) Worried about the potential effects the virus could have on humans, Hilleman injected it into hamsters, finding that nearly all of them developed massive cancerous tumors. But the initial panic this caused gave way in the face of future studies.

First, hamsters that ingested SV40 instead of being injected with it didn’t get cancer. Sabin’s live vaccine (which contained more SV40 than Salk’s) was given orally. Additional studies showed that children given Sabin’s vaccine did not develop antibodies to SV40; it simply passed through their digestive system, never causing infection.

That left only Salk’s vaccine, which contained very little SV40, but was given by injection. Studies performed eight years, fifteen years, and thirty years after SV40-contaminated vaccines were given to children found they had the same cancer incidence as unvaccinated groups. No credible evidence suggests SV40 has ever caused cancer in humans.

For a discussion on why the polio vaccine is not associated with HIV, read our article discussing this proposed association:

The mRNA vaccines developed in response to the COVID-19 pandemic caused concern among many people who claimed the mRNA technology was “too new” to be considered safe, or that it would be a while before we would know all the risks.

First, the clinical trials to show the vaccine safety and efficacy were carried out in the same manner as other clinical trials for vaccines. They had the same number of participants, same steps, and same oversight. The only aspect of those trials that was different was the timeframe in which they were done. Because of the need for new vaccines to counter to the COVID-19 pandemic, the studies and vaccine development/manufacturing were done simultaneously, not subsequently. Those clinical trials showed that the mRNA vaccines were safe and effective in preventing severe disease.

Second, mRNA technology has been around since the 1990s. So why have they not been used in vaccines? Two reasons: Lack of funding to use them as vaccines against infectious agents, and lack of interest, since the existing licensed vaccines worked well. In 2020, the Trump Administration authorized the use of funds for “Operation Warp Speed” to fund the rapid development of vaccines, taking care of the funding part. Once the mRNA vaccines were shown to be safe and effective against COVID-19, other infectious diseases were targeted for mRNA vaccine development.

• Gever, J.  . MedPage Today. (2010) Accessed 01/25/2018.
• Carroll-Pankhurst, C., Engels, E.A., Strickler, H.D., Goedert, J.J., Wagner, J., Mortimer Jr, E.A. . British Journal of Cancer . 2001 Nov;85(9):1295. Accessed 01/25/2018.
• The Carter Center.  . (20 KB PDF)  Accessed 01/25/2018.
• Centers for Disease Control and Prevention.  . Accessed 01/25/2018.
• CDC.  . Accessed 01/25/2018.
• Sharp, P.M., Hahn, B.H. . Philosophical Transactions of the Royal Society of London. Biological Sciences . 2010 Aug 27;365(1552):2487-94. Accessed 01/25/2018.
• Worobey, M., Santiago, M.L., Keele, B.F., Ndjango, J.B., Joy, J.B., Labama, B.L., Dhed'a, B.D., Rambaut, A., Sharp, P.M., Shaw, G.M., Hahn, B.H. Origin of AIDS: contaminated polio vaccine theory refuted. Nature. 2004 Apr 22;428(6985):820-.

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170 Vaccination Research Paper Topics For Stellar Students

Research papers are a monumental highlight in your academic journey. They are a critical milestone in your studies that must be tackled with the utmost care and stellar diligence. Vaccination topics are susceptible as you have to show complete mastery of all details.

If you are pursuing a medicine course, then vaccination research topics might be an excellent area of interest. A good research paper starts with a great topic, and we are here to help you nail that. We understand the significance of research papers, and that is why we have handpicked 170 out-of-the-box vaccination research paper topics, titles, and ideas to make your work seamless.

Debate Topics About Vaccination

• What is reverse vaccinology?
• Look at the ways of harnessing the participation of dendritic cells in tolerance and immunity
• What are some of the approaches to advance cancer vaccines to clinical utility?
• Highlight innovative therapeutic and vaccine approaches against respiratory pathogens
• Examine immunity to malaria and vaccine strategies
• Assess molecular vaccines against pathogens in the post-genomic era
• Comprehending the limitations of today’s influenza vaccine strategies and further development of more efficient therapeutic and preventative interventions
• Study HIV-associated persistent inflammation and immune activation
• Analyze recent advances in respiratory virus infection
• What is the novel approach for anti-tumor vaccines
• Unravel the challenges and progress in the development of a B cell-based hepatitis C virus vaccine
• What is the functional relevance of Tatraspanins in the immune system?
• Look at advanced immunization technologies for next-generation vaccines
• Evaluate epitope discovery and synthetic vaccine design
• In what ways can tuberculosis be treated by targeting host immunity
• What are the immunomodulatory effects of drugs in the treatment of immune-related diseases
• Highlight natural antibodies in health and disease
• Discuss different influenza virus vaccines and immunotherapy
• What are some of the shadows of cancer immunotherapy
• Understanding the therapeutical potential of extracellular vesicles
• A review of the ethical theories and problems associated with vaccination in America
• Do vaccines love the Darwinian fitness of immune cells

Vaccination Behavior Research Topics

• Unraveling demand and supply effects on the up-take of influenza vaccinations
• Point out new approaches to the seasonal flu vaccine
• Exploring the impact of vaccination
• Investigating patient experience with, and the use of, an electronic monitoring system to assess vaccination responses
• A meta-analysis of interventions that enhance the use of adult immunization and cancer screening services
• Do vaccines seem to work against bacterial and viral infections, and are they effective?
• Gathering the evidence for the introduction of typhoid vaccine: worldwide vaccine testing
• Explore molecular mimicry to broaden the immune response to carbohydrate antigens for vaccine development
• Tumor-associated glycan and immune surveillance
• Rational design and application of idiotope vaccines
• Assessing the effects of vaccines on immune-deficient people
• What are the impacts of rapid growth and deployment of high-volume vaccines for pandemic response

Anti-vaccination Research Paper Topics

• Should the state impose vaccinations, or should the choice be left up to the child’s parents?
• What is the connection between vaccination and autism?
• Is natural immunity better than immunity through immunization?
• Examining cultural perspectives on vaccination
• Are they worth it? adverse effects of vaccination on children
• To vaccinate or not against HPV? A content analysis of vocabularies of motives
• Vaccines: religious and cultural arguments from an Islamic perspective
• Anti-science populism or biomedicine’s unresolved knots? Comparing views on the movements against mandatory pediatric vaccines
• An anthropological commentary on vaccine hesitancy, decision-making, and interventionism among religious minorities
• Understanding attitudes to vaccination

Research Topics For Covid-19 Vaccination

• Medical mistrust in the context of Covid-19: implications for intended care-seeking and quarantine policy support in the United States
• What is the acceptability of the potential COVID-19 vaccine among smokers and non-smokers?
• COVID-19 vaccine hesitancy in healthcare personnel: are there any differences among classifications
• Discuss various options that one can use to convince people to get the covid-19 vaccine
• Examining COVID-19 vaccine efficacy after the first dose: Pfizer, Moderna, AstraZeneca
• Discuss the impacts of herd immunity during the covid-19 pandemic
• What are some of the effects of covid-19 vaccination on transmission of disease?
• Discuss whether antibodies generated through vaccination recognize all-new variants of covid-19
• Investigate how the intensity of lockdowns accelerate or influence mutation of the COVID virus
• Examine how the new covid-19 strain identified in England will affect the available vaccines.
• Outline which immunoglobulin types can be used as the markers for covid-19 vaccination
• Which is the best way to deal with swaps after completing vaccinations in nursing homes
• How do we curb vaccine hesitancy among healthcare providers?
• Which one is the more dangerous, covid-19 or covid-19 vaccine? What must be the individual decision?
• Analyzing Ebola and the evolving ethics of quarantine
• Break down some of the side effects of covid-19 vaccination
• How long will immunity last after receiving the covid-19 vaccination?
• Will, a covid-19 vaccine work for everyone? Are there people who cannot get vaccinated?
• Is bivalent OPV immunization capable of mitigating the impact of covid-19?
• What are the expected long-term side effects of the vaccination for covid-19?
• Evaluate differences between the first and second doses of the covid-19 mRNA vaccine?
• Examine the ingredients in the covid-19 mRNA vaccine
• Can a person’s DNA change through mRNA vaccines?
• Factors that stops the body from continuing to produce COVID-19 spike protein after getting a COVID-19 mRNA
• Discuss whether a person vaccinated against covid-19 will be able to spread the virus to susceptible people
• Investigating vaccination adverse outcomes and costs of vaccine injury claims(VICs): In the past, present, and during COVID-19.
• Who gets cured: Covid-19 and the development of critical sociology and anthropology of cure
• Development of perception and attitude scales related to COVID-19 pandemic
• Does the mutation of the coronavirus affect the capacity of the vaccines to prevent disease?
• A case-control study: finding a link between pre-existing antibodies got after the childhood vaccinations or past infections and COVID-19?
• Queue questions: ethics of COVID-19 vaccine prioritization
• Disparities between Black and White in H1N1 vaccination among adults in the U.S. in 2009: A cautionary tale for the COVID-19 pandemic
• Autonomy and refusal in pandemics: What to do with those who refuse COVID-19 vaccines
• Knowledge, attitude, and acceptance of a COVID-19 vaccine: a global cross-sectional study
• Prospects of COVID-19 vaccine implementation in the U.S.: Challenges and potential solutions
• What are the effects of COVID-19 vaccines on pregnant women?
• Compare and contrast the efficacy of different covid-19 vaccines.
• Ways to improve covid-19 vaccine acceptance
• Determination of causation between COVID-19 vaccines and potential adverse effects

Vaccination Of Children Topics

• What is the essence of increasing HPV vaccination among children?
• Analyze the primary diseases that vaccines prevent in children
• What will happen if a child’s vaccination schedule is delayed
• Look at the vaccination schedule for children in the U.S.
• Can children receive more than one vaccine at a time?
• Examine revaccination outcomes of children with proximate vaccine seizures
• What are the impacts of measles-containing vaccination in children with the severe underlying neurologic disease?
• Evaluate the challenges involved in measuring immunization activity coverage among measles zero-dose children
• What is the connection between the polio vaccine and the risk of cancer among children?
• Do multiple vaccines affect babies’ health and immune system in an adverse war, or can their bodies handle them?
• What are the various vaccination options available for children, and are they harmful to children’s overall health?
• The case for further research and development: assessing the potential cost-effectiveness of microneedle patches in childhood measles vaccination programs
• Evaluate the accuracy of parental recall of child immunization in an inner-city population
• Evaluating maternal acculturation and childhood immunization levels among children in African-American families in Florida
• Policy analysis: the impact of the vaccine for children’s program on child immunization delivery
• The effect of managed care: investigating access of infant immunizations for poor inner-city families
• Who takes up free flu shots? Investigating the effects of an expansion in coverage
• What are the societal and parental values for the risks and benefits of childhood combination vaccines?
• Looking into trends in vaccination intentions and risk perceptions: a longitudinal study of the first year of the H1N1 pandemic

Healthcare Topics About Vaccination

• Conscious consideration of herd immunity in influenza vaccination decisions
• A case study of ethnic or racial differences in Medicare experiences and immunization
• What preservatives are used in vaccines
• Discuss the relationship between vaccines and autism
• What is the role of epidemiology in infection control?
• How t design and select the most relevant immunogenic peptide sequences
• Discuss why the Zika virus has not had a significant impact in Africa as compared to America
• What are the advantages of using the phage display technology of antibodies versus hybridism technology?
• Analyzing the impact and cost-effectiveness of vaccination programs in a country using mathematical models
• Malaria vaccines: progress and problems
• Malaria: cloning genes for antigens of plasmodium falciparum
• Fighting profits on the pandemic: The fight for vaccines in today’s economic and geopolitical context
• Molecular and biotechnological approaches to fish vaccines
• Immunogenicity of a whole-cell pertussis vaccine with low lipopolysaccharide content in infants
• Immunogrid: an integrative environment for large-scale simulation of the immune system for vaccine discovery, design, and optimization

Thesis Topics In Vaccination

• Investigating challenges and opportunities in vaccine delivery, discovery, and development
• Discuss classic methods of vaccine development
• What are some of the current problems in vaccinology?
• Assess some of the latest tools for vaccine development
• Using cost-effectiveness analysis to support research and development portfolio prioritization for product innovations in measles vaccination
• Communicating vaccine safety during the introduction and development of vaccines
• Highlighting viral vectors for use in the development of biodefense vaccines
• What is the role of US. military research programs in the invention of USA-approved vaccines for naturally occurring infectious diseases
• Curbing outbreaks: utilizing international governmental risk pools to fund research and development of infectious disease medicines and vaccines
• Vaccine stabilization: research commercialization and likely impacts
• Exam the unequal interactions of the role of patient-centered care in the inequitable diffusion of medical innovation, the human papillomavirus(HPV) vaccine
• A case study of the status of development of vaccines and vaccine research for malaria
• Enteric infections vs vaccines: a public health and clinical research agenda for developing countries
• A review of research and vaccine development for industry animals in third world countries
• How the research-based industry approaches vaccine development and establishes priorities
• A look at the status of vaccine research and development of a vaccine for HIV-1
• Modeling a cost-effective vaccination strategy for the prevention of herpes zoster infection
• Using an adequate T.B. vaccination regiment to identify immune responses associated with protection in the murine model
• A systematic analysis of the link between vaccines and atopic dermatitis
• Do vaccines provide better immunity than natural infections?
• Is there a need to be vaccinated against a disease that is not available in your country or community
• How to strengthen adult immunization via coordinated action
• Using the general equilibrium method to assess the value of a malaria vaccine: An application to African countries
• Who should take up free flu shots?
• Evaluate the impact of vaccination among health care personnel
• Retail clinics and their impact on vaccination in the U.S.
• Discuss the societal values for the benefits and risks of childhood combination vaccines
• How safe and effective is the synovial vaccine for people above 60 years
• Evaluating vaccination effectiveness of group-specific fractional-dose strategies

Law Research Topics On Vaccination

• Explain why there are age restrictions for Rotavirus vaccination?
• Vaccination or hygiene : Which factor contributes to the decline of infectious diseases?
• Outline the main factors that cause vaccine failure
• Discuss why HIV is so hard to vaccinate in uninfected people?
• In what ways do maternal vaccinations affect the fetal nervous system development
• How to deliver malaria vaccine effectively and efficiently
• Highlight the vaccines that are specifically licensed in the U.S. for pregnant women
• How does an immune genetic algorithm work?
• Evaluate the relationship between the success of artificial insemination and vaccination
• Outline the reasons why vaccines underperform in low-income countries
• Discuss U.S. immigration and vaccination policy
• Assessing the effectiveness of compelled vaccination

Vaccination Ethical Topics

• What are the requirements for a strain to be used as a vaccine?
• What is the best way to administer vaccines in children?
• Assessing the benefits of maternal vaccination on breastfed infants
• Evaluating the pros and cons of intraperitoneal vaccination
• Examine ways to measure the pattern of vaccination acceptance
• Investigate Covid-19 transmission, vaccination rate, and the fate of resistant strains
• Look into dark web marketplaces and covid-19 vaccines.
• A close look at covid-19 vaccines and kidney diseases
• Contextualizing the impact of covid-19 vaccine misinformation on vaccination intent in the U.S.
• Examining behaviors and attitudes of medical students towards covid-19 vaccines

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• Immunization prevents deaths worldwide.
• 1 in 5 children globally do not have access to lifesaving vaccines.
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Vaccines save lives.‎.

• About 4 million deaths worldwide are prevented by childhood vaccination every year.
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1 in 5 children lack access to lifesaving vaccines.‎.

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A trial HIV vaccine triggered elusive and essential antibodies in humans

Finding points the way toward a successful vaccine that elicits broadly neutralizing antibodies.

An HIV vaccine candidate developed at the Duke Human Vaccine Institute triggered low levels of an elusive type of broadly neutralizing HIV antibodies among a small group of people enrolled in a 2019 clinical trial.

The finding, reported May 17 in the journal Cell , not only provides proof that a vaccine can elicit these antibodies to fight diverse strains of HIV, but that it can also initiate the process within weeks, setting in motion an essential immune response.

The vaccine candidate targets an area on the HIV-1 outer envelope called the membrane proximal external region (MPER), which remains stable even as the virus mutates. Antibodies against this stable region in the HIV outer coat can block infection by many different circulating strains of HIV.

"This work is a major step forward as it shows the feasibility of inducing antibodies with immunizations that neutralize the most difficult strains of HIV," said senior author Barton F. Haynes, M.D., director of the Duke Human Vaccine Institute (DHVI). "Our next steps are to induce more potent neutralizing antibodies against other sites on HIV to prevent virus escape. We are not there yet, but the way forward is now much clearer."

The research team analyzed data from a phase 1 clinical trial of a vaccine candidate developed by Haynes and S. Munir Alam, Ph.D., at DHVI.

Twenty healthy, HIV-negative people enrolled in the trial. Fifteen participants received two of four planned doses of the investigational vaccine, and five received three doses.

After just two immunizations, the vaccine had a 95% serum response rate and a 100% blood CD4+ T-cell response rate -- two key measurements that demonstrated strong immune activation. Most of the serum responses mapped to the portion of the virus targeted by the vaccine.

Importantly, broadly neutralizing antibodies were induced after just two doses.

The trial was halted when one participant experienced a non-life-threatening allergic reaction, similar to rare incidents reported with COVID-19 vaccinations. The team investigated the cause of the event, which was likely from an additive.

"To get a broadly neutralizing antibody, a series of events needs to happen, and it typically takes several years post-infection," said lead author Wilton Williams, Ph.D., associate professor in Duke's Department of Surgery and member of DHVI. "The challenge has always been to recreate the necessary events in a shorter space of time using a vaccine. It was very exciting to see that, with this vaccine molecule, we could actually get neutralizing antibodies to emerge within weeks."

Other features of the vaccine were also promising, most notably how the crucial immune cells remained in a state of development that allowed them to continue acquiring mutations, so they could evolve along with the ever-changing virus.

The researchers said there is more work to be done to create a more robust response, and to target more regions of the virus envelope. A successful HIV vaccine will likely have at least three components, all aimed at distinct regions of the virus.

"Ultimately, we will need to hit all the sites on the envelope that are vulnerable so that the virus cannot escape," Haynes said. "But this study demonstrates that broadly neutralizing antibodies can indeed be induced in humans by vaccination. Now that we know that induction is possible, we can replicate what we have done here with immunogens that target the other vulnerable sites on the virus envelope."

In addition to Haynes and Williams, study authors include S. Munir Alam, Gilad Ofek, Nathaniel Erdmann, David Montefiori, Michael S. Seaman, Kshitij Wagh, Bette Korber, Robert J. Edwards, Katayoun Mansouri, Amanda Eaton, Derek W. Cain, Mitchell Martin, Robert Parks, Maggie Barr, Andrew Foulger, Kara Anasti, Parth Patel, Salam Sammour, Ruth J. Parsons, Xiao Huang, Jared Lindenberger, Susan Fetics, Katarzyna Janowska, Aurelie Niyongabo, Benjamin M. Janus, Anagh Astavans, Christopher B. Fox, Ipsita Mohanty, Tyler Evangelous, Yue Chen, Madison Berry, Helene Kirshner, Elizabeth Van Itallie, Kevin Saunders, Kevin Wiehe, Kristen W. Cohen, M. Juliana McElrath, Lawrence Corey, Priyamvada Acharya, Stephen R. Walsh, and Lindsey R. Baden.

• HIV and AIDS
• Infectious Diseases
• Bird Flu Research
• Microbes and More
• Antiretroviral drug
• Flu vaccine
• MMR vaccine

Story Source:

Materials provided by Duke University Medical Center . Note: Content may be edited for style and length.

Journal Reference :

• Wilton B. Williams, S. Munir Alam, Gilad Ofek, Nathaniel Erdmann, David C. Montefiori, Michael S. Seaman, Kshitij Wagh, Bette Korber, Robert J. Edwards, Katayoun Mansouri, Amanda Eaton, Derek W. Cain, Mitchell Martin, JongIn Hwang, Aria Arus-Altuz, Xiaozhi Lu, Fangping Cai, Nolan Jamieson, Robert Parks, Maggie Barr, Andrew Foulger, Kara Anasti, Parth Patel, Salam Sammour, Ruth J. Parsons, Xiao Huang, Jared Lindenberger, Susan Fetics, Katarzyna Janowska, Aurelie Niyongabo, Benjamin M. Janus, Anagh Astavans, Christopher B. Fox, Ipsita Mohanty, Tyler Evangelous, Yue Chen, Madison Berry, Helene Kirshner, Elizabeth Van Itallie, Kevin O. Saunders, Kevin Wiehe, Kristen W. Cohen, M. Juliana McElrath, Lawrence Corey, Priyamvada Acharya, Stephen R. Walsh, Lindsey R. Baden, Barton F. Haynes. Vaccine induction of heterologous HIV-1-neutralizing antibody B cell lineages in humans . Cell , 2024; DOI: 10.1016/j.cell.2024.04.033

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Each year the Johns Hopkins Vaccine Initiative (JHVI) hosts Vaccine Day to highlight the advancements in vaccine research by inviting a distinguished scientist to deliver a keynote address on the current status of topics ranging from dengue, rotavirus, COVID-19, measles, and more.

The inaugural Vaccine Day held in 2008 officially launched the JHVI, and 14 Vaccine Day events have been hosted since. Led by Professor Ruth Karron , Vaccine Day works to promote and foster current vaccine research at the Bloomberg School. 

This year, Vaccine Day featured two keynote speakers. First Gabriela Paz-Bailey, MD, PhD, MSc, DTM&H, the Chief of the Dengue Branch in the Division of Vector-Borne Diseases from the National Center for Emerging and Zoonotic Infectious Diseases (NCEZID) at the CDC, discussed the basics of dengue transmission and pathogenesis, factors contributing to the increasing global burden of disease from dengue, current outbreak trends, and the current testing and treatments for dengue infections. 

Anna Durbin, MD, a professor and the Director of the Center for Immunization Research in the Department of International Health shared the history of dengue vaccine research, an overview of currently available dengue vaccines, her ongoing research developing new vaccines, and the challenges around vaccine implementation and surveillance.

A panel discussion followed with the keynote speakers and two additional vaccine experts, Rupali Limaye, PhD ’12, MPH, MA, an associate professor in the GDEC Program in the Department of International Health and 2nd year MSPH student Morghan Park . During the panel, attendees had the opportunities to ask questions about dengue vaccine research and implementation, issues around vaccine hesitancy, and the importance of improving communication and trust around vaccines within communities.

The event also hosts a poster session that showcases vaccine-related research by students and faculty at the Bloomberg School. Each year this session brings about a rich forum of discussions and knowledge sharing around ongoing research and awards the top 3 student poster presentations. This year over 40 posters were displayed by faculty, staff, and students. The 2024 poster winners are:

1st Place: Binh Nguyen, Zhengrong Li and Samandika Saparamadu – “To Subsidize or Not to Subsidize: The Cost-Effectiveness of RSV Vaccination Among Infants in the U.S.”

2nd Place: Molly Sauer and Prachi Singh – “Characterizing Potential Acceptability of Maternal RSV Vaccination in Kenya: A Latent Class Analysis Approach”

3rd Place: Laura St Clair – “mTOR Activation is associated with greater protective antibody responses following Influenza Vaccination in Young Adult Female compared to Male Mice”

Finally, the new cohort of PAVE Scholars was announced during the event. PAVE, Program in Applied Vaccine Experiences , supports vaccine-focused internships for Johns Hopkins students at international organizations that hold critical roles in global vaccine policy and delivery. Students spend 12 to 16 weeks working full time at one of the partner organizations, gaining valuable experience in vaccine research, policy, and programs of global importance. The outstanding PAVE Scholars 2024 cohort is:

Kedest Mathewos (PhD, Health Systems): Gavi, the Vaccine Alliance

Rithika Rajesh (MSPH, GDEC): Gavi, the Vaccine Alliance

Stella Dlamini (MSPH, GDEC): WHO, Immunization, Vaccines and Biologicals

Georgia Artzberger (MSPH, GDEC): WHO, Immunization, Vaccines and Biologicals

Wally Wennerberg (MSPH, GDEC): UNICEF

Haley Challgren (MSPH, GDEC): PAHO

Watch the recorded keynote addresses and panel session.

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Trial HIV vaccine triggers elusive and essential antibodies, pointing the way toward a successful vaccine

by Duke University Medical Center

An HIV vaccine candidate developed at the Duke Human Vaccine Institute triggered low levels of an elusive type of broadly neutralizing HIV antibodies among a small group of people enrolled in a 2019 clinical trial.

The finding , reported May 17 in the journal Cell , not only provides proof that a vaccine can elicit these antibodies to fight diverse strains of HIV, but that it can also initiate the process within weeks, setting in motion an essential immune response.

The vaccine candidate targets an area on the HIV-1 outer envelope called the membrane proximal external region (MPER), which remains stable even as the virus mutates. Antibodies against this stable region in the HIV outer coat can block infection by many different circulating strains of HIV.

"This work is a major step forward as it shows the feasibility of inducing antibodies with immunizations that neutralize the most difficult strains of HIV," said senior author Barton F. Haynes, M.D., director of the Duke Human Vaccine Institute (DHVI). "Our next steps are to induce more potent neutralizing antibodies against other sites on HIV to prevent virus escape. We are not there yet, but the way forward is now much clearer."

The research team analyzed data from a Phase I clinical trial of a vaccine candidate developed by Haynes and S. Munir Alam, Ph.D., at DHVI.

Twenty healthy, HIV-negative people enrolled in the trial. Fifteen participants received two of four planned doses of the investigational vaccine, and five received three doses.

After just two immunizations, the vaccine had a 95% serum response rate and a 100% blood CD4 + T-cell response rate—two key measurements that demonstrated strong immune activation. Most of the serum responses mapped to the portion of the virus targeted by the vaccine.

Importantly, broadly neutralizing antibodies were induced after just two doses.

The trial was halted when one participant experienced a non-life-threatening allergic reaction, similar to rare incidences reported with COVID-19 vaccinations. The team investigated the cause of the event, which was likely from an additive.

"To get a broadly neutralizing antibody, a series of events needs to happen, and it typically takes several years post-infection," said lead author Wilton Williams, Ph.D., associate professor in Duke's Department of Surgery and member of DHVI.

"The challenge has always been to recreate the necessary events in a shorter space of time using a vaccine. It was very exciting to see that, with this vaccine molecule, we could actually get neutralizing antibodies to emerge within weeks."

Other features of the vaccine were also promising, most notably how the crucial immune cells remained in a state of development that allowed them to continue acquiring mutations, so they could evolve along with the ever-changing virus.

The researchers said there is more work to be done to create a more robust response, and to target more regions of the virus envelope. A successful HIV vaccine will likely have at least three components, all aimed at distinct regions of the virus.

"Ultimately, we will need to hit all the sites on the envelope that are vulnerable so that the virus cannot escape," Haynes said.

"But this study demonstrates that broadly neutralizing antibodies can indeed be induced in humans by vaccination. Now that we know that induction is possible, we can replicate what we have done here with immunogens that target the other vulnerable sites on the virus envelope."

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Current topics in research ethics in vaccine studies

Prasad s. kulkarni.

Serum Institute of India Ltd, Pune, India

About 7.6 million children under the age of five die every year, according to 2010 figures,[ 1 ] out of these 2.4 million children die from vaccine preventable diseases.[ 2 ] The problem is compounded by the absence of effective therapies for many infectious diseases. Obviously, new, more cost-effective and improved vaccines are needed today and in the future.

Vaccines have some distinct features than drugs. Unlike therapeutic molecules, vaccines have preventive role against specific infectious diseases. The target population is healthy people, mostly children and infants; as a result, tolerability of adverse events is less. Additionally, vaccines are highly complex substances derived from living microorganisms and their quality and safety needs to be demonstrated on a lot-to-lot basis. Naturally, these factors have some bearing on the clinical trials of vaccines. Here we discuss some of the current ethical issues in vaccine clinical trials.

Pediatric trials

Most of the vaccine studies are conducted in children, some of them in infants and even in newborns because that is where you want to catch them for prevention of an infection. However, children by themselves are unable to consent, and the vaccinator has to accept a legal guardian's agreement. Also, one would expect children to experience more adverse reactions than adults. For these and many other reasons, it is generally agreed that vaccine studies are, at least primarily, unethical in children if the relevant investigation can be done among adults. The main problem here is, however, that many infections are characteristically only pediatric diseases, or at least, those infections are specially harmful to the youngest.

One therefore needs to seek for a difficult balance between the true and ostensible need of a vaccine in the pediatric population. The CIOMS rightly states that “Before undertaking research involving children, the investigator must ensure that-the research might not be equally well be carried out in adults; and the purpose of the research is to obtain knowledge relevant to the health needs of children.”[ 3 ]

Parental consent

More in developing countries than elsewhere, parents or guardians of children may have little or no understanding of research trials. They may be unfamiliar with concepts such as “informed consent” and “confidentiality” and may not understand the scientific terms and processes involved in trials, including the use of randomization and placebos. Yet these parents will be called upon to give consent on behalf of their small children, or to explain to their older heirs (children) what is happening in the trial.

Another concern is consent of an appropriate legal representative in the absence of parental consent. Recently a demonstration project on a vaccine was conducted in India. An investigation was prompted after press reports of some deaths. Though the deaths were not found caused by the vaccine, consent obtained from hostel wardens in some subjects living in hostels was questioned.[ 4 ]

Need for the trial

Before launching a trial in children one must show that there is compelling need to use children to establish safety, immunogenicity, effectiveness or efficacy of the vaccine. Such a trial would not be justified if the child comes from population in which that particular disease is not a problem. Malaria vaccine cannot be tested soon in Europe or North America.

An absolute care must be taken to ensure that socioeconomic inequalities between industrialized and developing countries are not exploited i.e., that children in a poor country are not asked to undertake risks to produce a vaccine that, for economic or other reasons, would primarily benefit their counterparts in industrialized countries. At the same time, research should not be impeded that aims to reduce the inequality of health care and to benefit pediatric populations in need in developing countries.

Selection of control

If a good vaccine is already in use in some other country or community which is more or less comparable to site where the trial is planned, that vaccine should be used as the comparator. If such a vaccine does not exist, a placebo “vaccine” may be used, provided the set-up is thoroughly explained to the participants, their families and the community. Placebo controls are ethically acceptable when there is no proven vaccine for the indication for which the candidate vaccine is to be tested.[ 5 , 6 ]

A modification of this setting is that the placebo recipients receive the true vaccine later–but all this has to be explained in understandable words to the participants.

An alternative to the use of placebo is to give another vaccine that provides comparable benefit against another disease, or more willingly, against similar disease caused by different agents. This was the approach in Finland in the 1970s, when the first vaccines against bacterial meningitis (due to Neisseria meningitidis and H. influenza) were tested in children.[ 7 ] Here it was important these two types of meningitis were equally common in that community. For some vaccines, the choice is not difficult since there are no effective interventions so far, e.g., malaria or HIV vaccines.

In Indonesia, an exceptional approach was taken on 1998-2002.[ 8 ] Half of children received traditional DTP (diphtheria-tetanus-pertussis) vaccine, whereas the other half of children got DTP with H. influenza type B (Hib) component. Thus, all children were not in an equivalent position, but the setup was considered justified because in the absence of disease burden data and vaccine efficacy data in the region, the trial was deemed helpful for the decision whether or not to introduce Hib vaccination in Indonesia and the whole region.

When, instead of clinical efficacy, “only” immunogenicity (antibody production) is measured, the rules of equipoise are looser. The comparator vaccine may function more as “compensation” to the child in the trial's control arm. For instance, meningococcal C conjugate vaccine in a pneumococcal vaccine trial, or rabies vaccine in a Japanese encephalitis vaccine trial does not restore equipoise but benefit the child who would not otherwise receive that vaccine.

Age de-escalation

Age de-escalation means that phase I and II trials are conducted first in adults, then in older children, and finally, if relevant, in small children. Epidemiology of the disease, the risks/benefits of the vaccine for each age group, and the safety profile are all factors to be taken into account in de-escalation.

However, if a new vaccine is only for infants, trials in older children may expose them to unnecessary risks without giving any benefit to these too “old” vaccinees. Rotavirus vaccines are good examples in this category. Sometimes adult participants can be used in the first trials, although they are of no help in the efficacy trials.

Sometimes there are grounds to use child participants already in phase I trials. This is the case if the new vaccine would likely cause problems in adults (but not in children) because of prior immunity in adults e.g., DTP vaccine.

Participation of adolescents

Only a few vaccines as targeted just for adolescents: examples are human papillomavirus (HPV) and herpes virus (HSV) vaccines. However, adolescents may be used in the de-escalation studies before progressing to small children. The participation of adolescents often involves complex legal, ethical issues and operational issues.

Informed consent is problematic, because adolescents often have the intellectual and emotional capacity to provide consent, but do not have the legal right to consent. Also their views may not be the same as their parents’ views, and appropriate confidentiality can be difficult to maintain. An extreme would be a situation in which the youth disagrees but the parents agree the trial, or in which a willing adolescent would be included in the absence of parental consent.

The participation of adolescent girls is further complicated by the potential or soon materializing pregnancy. Not only would it perhaps risk the young mother and the fetus, but also raise complex issues regarding the consent, confidentiality and legal liability. Routine pregnancy testing of adolescent girls prior to the inclusion in a trial would also have its cultural problems.

Limitations of informed consent

Obtaining informed consent in a developing country has its own problems and should be seen as a process which begins from the voluntary decision to participate in the study. The decision should be based on sufficient information prior to the trial entry. The informed consent form should be simple enough to be understood by the often not-too-educated individual, or in case of a child, by parents or legal guardian, but still comprehensive to explain the concepts, potential risks and benefits, implications of the use of a placebo or other comparator, care that will be provided, and the indemnity for injury or death arising from the trial. Importantly, it must be stated clearly that a withdrawal from study is allowed at any time without giving an explanation for the decision. If the circumstances of the trial change significantly, the consent form is to be changed accordingly, and the whole study warrant discussion with the already enrolled participants. Another consent is then to be obtained.

The problems in getting valid consent are heightened in developing countries where people may be unfamiliar with scientific research, concepts and vocabulary. Thus, the expectations may be unrealistic. Also the individual's full autonomy might become endangered because of the society's cultural and/or gender norms, or the family or spousal pressure. All of these challenges are further complicated when the trial deals with children.

Child's assent

In the case of a child, every effort should be made to explain to him/her also, in language that is understandable to the child, what the participation means, as regards to potential risks (discomfort, time spent, etc.) and benefits, The investigators should document the child's assent.

Community consent

Since an informed consent may be culturally sensitive, family or community discussions are sometimes necessary, albeit the community consent should not be considered as a substitute for the individual consent. There may also be tension between the ethical responsibility to maintain individual confidentiality, and cultural norms that press for “shared confidentiality”. Within appropriate boundaries of confidentiality, it may be useful to have an impartial witness/observer present during an oral consent particularly if verbal rather than signed consent is sought. Such witnessed consent must be recorded in the trial files.

Potential for inducement

The improved medical care provided during the trial may constitute an inducement and may impact on the willingness to participate. Indeed, trial participants often accept the trial in the belief that they will receive improved treatment. It is important to explain that participation will not necessarily ensure protection against disease. In case of a study using placebo, the entire set-up and the meaning of randomization should be explained, including the fact that the participant might fall in the placebo group. Any care or other benefits that perhaps are offered should be described.

Another concern is if the parents see an opportunity for economic benefits, they may encourage enrolling their and perhaps other children in trials in which those should not necessarily be included. All efforts should be made to avoid any exploitation, and to minimize all mental, emotional and physical harm.

Standard of care

In case of vaccine trials in developing countries, the situation is tricky because of a high burden of disease and low standards of health care in that community. With the contribution of local authorities, a standard of care should be offered. This means an improvement in the health conditions of participants, and that it is sustainable. These efforts need an approval from the local ethics committees.

Duration of follow-up

An active follow-up should extend at least to the end of the trial. In case of an adverse effect, the, follow-up should be continued for an additional six months. In high mortality populations, it may be desirable to analyse long-term mortality changes and to follow-up participants for a number of years. Passive follow-up is advisable even longer, and if existing mechanisms can be used for this purpose.

Long-term follow-up may complicate a trial substantially and greatly increase the costs. Therefore, gathering only passive data may suffice. Creative follow-up should be contemplated, both for safety and long-term protection. The high titer measles vaccine was studied in some African countries, however on a long term follow up, it was discovered that female mortality was higher following the vaccine,[ 9 ] which resulted in abandoning the use of the vaccine. This important finding was detected only because of long-term follow-up.

Screening of subjects

Vaccine trials need to be conducted in healthy people and hence, the screening for inclusion/exclusion criteria is very critical. Enrolment of children with underlying medical conditions can complicate the safety outcomes. A recent vaccine trial in India brought forth this issue. A death was reported in the study after an infant had received a licensed vaccine used as a control. The investigation revealed that the infant who died had a pre-existing medical condition.[ 10 ] It is recognized that physical screening of young infants has limitations; however, every effort should be made to ascertain the health status. In case of suspicious cases, it is better to err on the safer side.

CONCLUSIONS

Vaccine clinical research needs to deal with certain ethical issues because of the inherent nature of these trials. The issues are more complicated since the research mostly happens in pediatric populations in developing countries. Keeping in mind these issues while designing research on vaccines is critical.

Source of Support: Nil

Conflict of Interest: None declared

REVIEW article

This article is part of the research topic.

Pathogen-Induced Immunosenescence: Where do Vaccines Stand?

TB and HIV Induced Immunosenescence: Where do vaccines play a role? Provisionally Accepted

• 1 Western University of Health Sciences, United States
• 2 Chamberlain University, United States

The final, formatted version of the article will be published soon.

This paper tackles the complex interplay between Human Immunodeficiency virus (HIV-1) and Mycobacterium tuberculosis (M. tuberculosis) infections, particularly their contribution to immunosenescence, the age-related decline in immune function. Using the current literature, we discuss the immunological mechanisms behind TB and HIV-induced immunosenescence and critically evaluate the BCG (Bacillus Calmette-Guérin) vaccine's role. Both HIV-1 and M. tuberculosis demonstrably accelerate immunosenescence: M. tuberculosis through DNA modification and heightened inflammation, and HIV-1 through chronic immune activation and T cell production compromise. HIV-1 and M. tuberculosis co-infection further hastens immunosenescence by affecting T cell differentiation, underscoring the need for prevention and treatment. Furthermore, the use of the BCG tuberculosis vaccine is contraindicated in patients who are HIV positive and there is a lack of investigation regarding the use of this vaccine in patients who develop HIV co-infection with possible immunosenescence. As HIV does not currently have a vaccine, we focus our review more so on the BCG vaccine response as a result of immunosenescence. We found that there are overall limitations with the BCG vaccine, one of which is that it cannot necessarily prevent reoccurance of infection due to effects of immunosenescence or protect the elderly due to this reason. Overall, there is conflicting evidence to show the vaccine's usage due to factors involving its production and administration. Further research into developing a vaccine for HIV and improving the BCG vaccine is warranted to expand scientific understanding for public health and beyond.

Keywords: immunosenescence, M. tuberculosis, Vaccine3, BCG, HIV

Received: 14 Feb 2024; Accepted: 13 May 2024.

Copyright: © 2024 Singh, Patel, Seo, Ahn, Shen, Nakka, Kishore and Venketaraman. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY) . The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

* Correspondence: Mx. Vishwanath Venketaraman, Western University of Health Sciences, Pomona, 91766-1854, California, United States

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