Pólio: baixa cobertura vacinal e o risco iminente de novas infecções / Polio: low vaccination coverage and the imminent risk of new infections

A poliomielite, comumente chamada de pólio ou paralisia infantil, é uma doença viral altamente infecciosa que afeta principalmente crianças menores de 5 anos de idade. O vírus é transmitido de pessoa para pessoa, disseminado principalmente pela via fecal-oral ou, menos frequentemente, por fômites (água ou alimentos contaminados); sendo que o agente etiológico pode se espalhar rapidamente em áreas cujos sistemas de higiene e saneamento são precários. Também pode haver transmissão por meio de gotículas de secreções da garganta durante a fala, tosse ou espirro ( WHO, 20 22 a ; SBIm, 2022)

Polio, commonly called polio or infantile paralysis, is a highly infectious viral disease that primarily affects children under 5 years of age. The virus is transmitted from person to person, spread mainly by the fecal-oral route or, less frequently, by fomites (contaminated water or food); being that the agent etiologic disease can spread rapidly in areas where hygiene and sanitation systems are precarious. There may also be transmission through droplets of secretions from the throat during speech, coughing or sneezing (WHO, 20 22 a ; SBIm, 2022)

Routine Vaccination Coverage - Worldwide, 2020.

Endorsed by the World Health Assembly in 2020, the Immunization Agenda 2030 (IA2030) strives to reduce morbidity and mortality from vaccine-preventable diseases across the life course (1). This report, which updates a previous report (2), presents global, regional,* and national vaccination coverage estimates and trends as of 2020. Changes are described in vaccination coverage and the numbers of unvaccinated and undervaccinated children as measured by receipt of the first and third doses of diphtheria, tetanus, and pertussis-containing vaccine (DTP) in 2020, when the COVID-19 pandemic began, compared with 2019. Global estimates of coverage with the third dose of DTP (DTP3) and a polio vaccine (Pol3) decreased from 86% in 2019 to 83% in 2020. Similarly, coverage with the first dose of measles-containing vaccine (MCV1) dropped from 86% in 2019 to 84% in 2020. The last year that coverage estimates were at 2020 levels was 2009 for DTP3 and 2014 for both MCV1 and Pol3. Worldwide, 22.7 million children (17% of the target population) were not vaccinated with DTP3 in 2020 compared with 19.0 million (14%) in 2019. Children who did not receive the first DTP dose (DTP1) by age 12 months (zero-dose children) accounted for 95% of the increased number. Among those who did not receive DTP3 in 2020, approximately 17.1 million (75%) were zero-dose children. Global coverage decreased in 2020 compared with 2019 estimates for the completed series of Haemophilus influenzae type b (Hib), hepatitis B vaccine (HepB), human papillomavirus vaccine (HPV), and rubella-containing vaccine (RCV). Full recovery from COVID-19-associated disruptions will require targeted, context-specific strategies to identify and catch up zero-dose and undervaccinated children, introduce interventions to minimize missed vaccinations, monitor coverage, and respond to program setbacks (3).

Immunization Against Poliomyelitis and the Challenges to Worldwide Poliomyelitis Eradication.

Both inactivated poliovirus vaccine (IPV) and oral poliovirus vaccine (OPV) have contributed to the rapid disappearance of paralytic poliomyelitis from developed countries despite possessing different vaccine properties. Due to cost, ease of use, and other properties, the Expanded Programme on Immunization added OPV to the routine infant immunization schedule for low-income countries in 1974, but variable vaccine uptake and impaired immune responses due to poor sanitation limited the impact. Following launch of the Global Polio Eradication Initiative in 1988, poliomyelitis incidence has been reduced by >99% and types 2 and 3 wild polioviruses are now eradicated, but progress against type 1 polioviruses which are now confined to Afghanistan and Pakistan has slowed due to insecurity, poor access, and other problems. A strategic, globally coordinated replacement of trivalent OPV with bivalent 1, 3 OPV in 2016 reduced the incidence of vaccine-associated paralytic poliomyelitis (VAPP) but allowed the escape of type 2 vaccine-derived polioviruses (VDPV2) in areas with low immunization rates and use of monovalent OPV2 in response seeded new VDPV2 outbreaks and reestablishment of type 2 endemicity. A novel, more genetically stable type 2 OPV vaccine is undergoing clinical evaluation and may soon be deployed prevent or reduce VDPV2 emergences.

Neurologic Safety Monitoring of COVID-19 Vaccines: Lessons From the Past to Inform the Present.

The spread of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has triggered a global effort to rapidly develop and deploy effective and safe coronavirus disease 2019 (COVID-19) vaccinations. Vaccination has been one of the most effective medical interventions in human history, although potential safety risks of novel vaccines must be monitored, identified, and quantified. Adverse events must be carefully assessed to define whether they are causally associated with vaccination or coincidence. Neurologic adverse events following immunizations are overall rare but with significant morbidity and mortality when they occur. Here, we review neurologic conditions seen in the context of prior vaccinations and the current data to date on select COVID-19 vaccines including mRNA vaccines and the adenovirus-vector COVID-19 vaccines, ChAdOx1 nCOV-19 (AstraZeneca) and Ad26.COV2.S Johnson & Johnson (Janssen/J&J).

Progress Toward Polio Eradication - Worldwide, January 2019-June 2021.

In 1988, when the Global Polio Eradication Initiative (GPEI) began, polio paralyzed >350,000 children across 125 countries. Today, only one of three wild poliovirus serotypes, type 1 (WPV1), remains in circulation in only two countries, Afghanistan and Pakistan. This report summarizes progress toward global polio eradication during January 1, 2019-June 30, 2021 and updates previous reports (1,2). In 2020, 140 cases of WPV1 were reported, including 56 in Afghanistan (a 93% increase from 29 cases in 2019) and 84 in Pakistan (a 43% decrease from 147 cases in 2019). As GPEI focuses on the last endemic WPV reservoirs, poliomyelitis outbreaks caused by circulating vaccine-derived poliovirus (cVDPV) have emerged as a result of attenuated oral poliovirus vaccine (OPV) virus regaining neurovirulence after prolonged circulation in underimmunized populations (3). In 2020, 32 countries reported cVDPV outbreaks (four type 1 [cVDPV1], 26 type 2 [cVDPV2] and two with outbreaks of both); 13 of these countries reported new outbreaks. The updated GPEI Polio Eradication Strategy 2022-2026 (4) includes expanded use of the type 2 novel oral poliovirus vaccine (nOPV2) to avoid new emergences of cVDPV2 during outbreak responses (3). The new strategy deploys other tactics, such as increased national accountability, and focused investments for overcoming the remaining barriers to eradication, including program disruptions and setbacks caused by the COVID-19 pandemic.

Polio eradication at the crossroads.

The Global Polio Eradication Initiative, launched in 1988 with anticipated completion by 2000, has yet to reach its ultimate goal. The recent surge of polio cases urgently calls for a reassessment of the programme's current strategy and a new design for the way forward. We propose that the sustainable protection of the world population against paralytic polio cannot be achieved simply by stopping the circulation of poliovirus but must also include maintaining high rates of population immunity indefinitely, which can be created and maintained by implementing global immunisation programmes with improved poliovirus vaccines that create comprehensive immunity without spawning new virulent viruses. The proposed new strategic goal of eradicating the disease rather than the virus would lead to a sustainable eradication of poliomyelitis while simultaneously promoting immunisation against other vaccine-preventable diseases.

Mobile nudges and financial incentives to improve coverage of timely neonatal vaccination in rural areas (GEVaP trial): A 3-armed cluster randomized controlled trial in Northern Ghana.

BACKGROUND: Despite progress in vaccination coverage, timeliness of childhood vaccination remains a challenge in many settings. We aimed to assess if mobile phone-based reminders and incentives to health workers and caregivers could increase timely neonatal vaccination in a rural, low-resource setting. METHODS: We conducted an open-label cluster randomized controlled 1:1:1 trial with three arms in 15 communities in Northern Ghana. Communities were randomized to 1) a voice call reminder intervention; 2) a community health volunteer (CHV) intervention with incentivized rewards; 3) control. In the voice call reminder arm, a study staff member made voice calls to mothers shortly after birth to encourage vaccination and provide personalized information about available vaccination services. In the incentive arm, CHVs promoted infant vaccination and informed women with recent births about available vaccination opportunities. Both CHVs and women were provided small monetary incentives for on-time early infant vaccination in this arm, delivered using mobile phone-based banking applications. No study activities were conducted in control communities. A population-based survey compared vaccination coverage across arms in the pre-intervention and intervention periods. The primary endpoint was completion of at least one dose of Polio vaccine within 14 days of life and BCG vaccination within 28 days of life. RESULTS: Six-hundred ninety births were identified; 106, 88, and 88 from pre-intervention and 150, 135, and 123 in the intervention period, in the control, voice call reminder and CHV incentive arms, respectively. In adjusted intent-to-treat analysis, voice call reminders were associated with 10.5 percentage point (95% CI: 4.0, 17.1) higher coverage of on-time vaccination, while mobile phone-based incentives were associated with 49.5 percentage point (95% CI: 26.4, 72.5) higher coverage. CONCLUSION: Community-based interventions using mobile phone technologies can improve timely early vaccination coverage. A CHV approach with incentives to community workers and caregivers was a more effective strategy than voice call reminders. The impact of vaccination "nudges" via voice calls may be constrained in settings where network coverage and phone ownership are limited. TRIAL REGISTRATION: This trial was registered at ClinicalTrials.gov; NCT03797950.

Impact of COVID-19 Pandemic on Global Poliovirus Surveillance.

On January 30, 2020, the World Health Organization (WHO) declared coronavirus disease 2019 (COVID-19) a Public Health Emergency of International Concern (1). On March 24, 2020, the Global Polio Eradication Initiative (GPEI) suspended all polio supplementary immunization activities and recommended the continuation of polio surveillance (2). In April 2020, GPEI shared revised polio surveillance guidelines in the context of the COVID-19 pandemic, which focused on reducing the risk for transmission of SARS-CoV-2, the virus that causes COVID-19, to health care workers and communities by modifying activities that required person-to-person contact, improving hand hygiene and personal protective equipment use practices, and overcoming challenges related to movement restrictions, while continuing essential polio surveillance functions (3). GPEI assessed the impact of the COVID-19 pandemic on polio surveillance by comparing data from January to September 2019 to the same period in 2020. Globally, the number of acute flaccid paralysis (AFP) cases reported declined 33% and the mean number of days between the second stool collected and receipt by the laboratory increased by 70%. Continued analysis of AFP case reporting and stool collection is critical to ensure timely detection and response to interruptions of polio surveillance.

Developing a three-dimensional narrative to counter polio vaccine refusal in Charsadda.

BACKGROUND: Endemic polio in Pakistan is threatening the Global Polio Eradication Initiative (PEI). In recent years, vaccine refusals have surged, spiking polio cases. The current study was conducted to understand the ethnic, religious and cultural roots of vaccine refusals in Charsadda District and explore the remedial options. METHODS: We conducted 43 in-depth interviews with parents who had refused polio vaccines for their children and the PEI staff. Interviews were audio-recorded, written in verbatim and analysed with Atlis.ti. We conducted a thematic analysis of our data. RESULTS: The fear of American and Jewish conspiracies was the primary cause of vaccine refusals. Militant groups like Tehrek-i-Taliban Pakistan capitalised on this fear, through social media. The Pashtun ethnic group considers itself at the centre of conspiracies. They are suspicious of mass investment and mobilisation behind the polio campaign. Our respondents feared that polio vaccines were making children vulgar. They also feared a reduction in the male to female ratio in childbirth. In Pashtun communities, the iconic conventional community gatherings ["Hujras"] are being replaced by provocative digital Hujra [social media], which the PEI and the Government of Pakistan (GOP) are failing to influence or regulate. The PEI uses the misleading term 'religious refusal'. Some factions in the clergy are maligning people from vaccinations, but not through religious dictum. The anti-state elements have stirred sentiments to weaken the state initiative. Fear of adverse effects, attitudinal barriers of health care providers, unmet basic needs and alleged haram composition of the vaccine were among the reasons for vaccine refusals. The PEI needs to revise its misleading nomenclature and ensue open discussion to dispel the myths of infertility, vulgarity and gender ratio related to the vaccines. Simultaneously, the GOP should stop disinformation on social media and rebrand polio vaccination with popular initiatives like the government-sponsored health insurance schemes. CONCLUSIONS: The ethnic, cultural and religious dispositions of community members shape polio vaccine refusals in Charsadda District, in different ways. In synch with existing conspiracy theories and medical misconceptions, these three factors make refusals harder to counter. Awareness campaigns with content addressing these three dimensions can improve the situation.

Lessons learned from the polio eradication initiative in the Democratic Republic of Congo and Ethiopia: analysis of implementation barriers and strategies.

BACKGROUND: Since its inception in 1988, the Global Polio Eradication Initiative (GPEI) has partnered with 200 countries to vaccinate over 2.5 billion children against poliomyelitis. The polio eradication approach has adapted to emerging challenges and diverse contexts. Knowledge assets gained from these experiences can inform implementation of future health programs, but only if efforts are made to systematically map barriers, identify strategies to overcome them, identify unintended consequences, and compare experiences across country contexts. METHODS: A sequential explanatory mixed methods design, including an online survey followed by key informant interviews (KIIs), was utilized to map tacit knowledge derived from the polio eradication experience from 1988 to 2019. The survey and KIIs were conducted between September 2018 and March 2019. A cross-case comparison was conducted of two study countries, the Democratic Republic of Congo (DRC) and Ethiopia, which fit similar epidemiological profiles for polio. The variables of interest (implementation barriers, strategies, unintended consequences) were compared for consistencies and inconsistencies within and across the two country cases. RESULTS: Surveys were conducted with 499 and 101 respondents, followed by 23 and 30 KIIs in the DRC and Ethiopia, respectively. Common implementation barriers included accessibility issues caused by political insecurity, population movement, and geography; gaps in human resources, supply chain, finance and governance; and community hesitancy. Strategies for addressing these barriers included adapting service delivery approaches, investing in health systems capacity, establishing mechanisms for planning and accountability, and social mobilization. These investments improved system infrastructure and service delivery; however, resources were often focused on the polio program rather than strengthening routine services, causing community mistrust and limiting sustainability. CONCLUSIONS: The polio program investments in the DRC and Ethiopia facilitated program implementation despite environmental, system, and community-level barriers. There were, however, missed opportunities for integration. Remaining pockets of low immunization coverage and gaps in surveillance must be addressed in order to prevent importation of wild poliovirus and minimize circulating vaccine-derived poliovirus. Studying these implementation processes is critical for informing future health programs, including identifying implementation tools, strategies, and principles which can be adopted from polio eradication to ensure health service delivery among hard-to-reach populations. Future disease control or eradication programs should also consider strategies which reduce parallel structures and define a clear transition strategy to limit long-term external dependency.

Progress Toward Poliomyelitis Eradication - Pakistan, January 2019-September 2020.

Pakistan and Afghanistan are the only countries where wild poliovirus type 1 (WPV1) is endemic (1,2). In 2019, Pakistan reported 147 WPV1 cases, approximately 12 times the number reported in 2018. As of September 15, 72 cases had been reported in 2020. Since 2019, WPV1 transmission has also spread from Pakistan's core poliovirus reservoirs (Karachi, Peshawar, and Quetta block) to southern districts of Khyber Pakhtunkhwa (KP), Punjab, and Sindh provinces. Further, an outbreak of circulating vaccine-derived poliovirus type 2 (cVDPV2), first detected in July 2019, has caused 22 paralytic cases in 2019 and 59 as of September 15, 2020, throughout the country. The coronavirus disease 2019 (COVID-19) pandemic has substantially reduced delivery of polio vaccines through essential immunization (formerly routine immunization) and prevented implementation of polio supplementary immunization activities (SIAs)* during March-July 2020. This report describes Pakistan's progress in polio eradication during January 2019-September 2020 and updates previous reports (1,3,4). The Pakistan polio program has reinitiated SIAs and will need large, intensive, high-quality campaigns with strategic use of available oral poliovirus vaccines (OPVs)† to control the surge and widespread transmission of WPV1 and cVDPV2.

Polio in Afghanistan: The Current Situation amid COVID-19.

Polio is a deadly viral disease that has been paralyzing many children in Afghanistan. Despite fundamental efforts, primarily vaccination, to reduce the number of cases in Afghanistan, there are still many children who are deprived of the vaccine every year. Afghanistan is one of the two remaining countries endemic for polio, and the country has undergone various challenges that have hampered the eradication of this disease. The underlying challenges include inaccessibility of unsecured areas, illiteracy, refusal, and, most recently, COVID-19. The country is in the midst of a battle against COVID-19, and polio has almost entirely been neglected. Sadly, polio cases are increasing in the country, particularly in polio-free provinces. After an initial lockdown, many businesses have been allowed to resume, but the mass polio vaccination campaign has not restarted. New cases of polio will surge if endemic regions remain unvaccinated or inaccessible. To curb the further spread of polio, Afghanistan needs to resume nationwide house-to-house vaccination as restrictions due to COVID-19 are loosened.

Review of poliovirus modeling performed from 2000 to 2019 to support global polio eradication.

INTRODUCTION: Over the last 20 years (2000-2019) the partners of the Global Polio Eradication Initiative (GPEI) invested in the development and application of mathematical models of poliovirus transmission as well as economics, policy, and risk analyses of polio endgame risk management options, including policies related to poliovirus vaccine use during the polio endgame. AREAS COVERED: This review provides a historical record of the polio studies published by the three modeling groups that primarily performed the bulk of this work. This review also systematically evaluates the polio transmission and health economic modeling papers published in English in peer-reviewed journals from 2000 to 2019, highlights differences in approaches and methods, shows the geographic coverage of the transmission modeling performed, identified common themes, and discusses instances of similar or conflicting insights or recommendations. EXPERT OPINION: Polio modeling performed during the last 20 years substantially impacted polio vaccine choices, immunization policies, and the polio eradication pathway. As the polio endgame continues, national preferences for polio vaccine formulations and immunization strategies will likely continue to change. Future modeling will likely provide important insights about their cost-effectiveness and their relative benefits with respect to controlling polio and potentially achieving and maintaining eradication.

Progress Toward Polio Eradication - Worldwide, January 2018-March 2020.

Since the Global Polio Eradication Initiative (GPEI) was established in 1988, two of the three wild poliovirus (WPV) serotypes (types 2 and 3) have been eradicated.* Transmission of WPV type 1 (WPV1) remains uninterrupted only in Afghanistan and Pakistan. This report summarizes progress toward global polio eradication during January 1, 2018-March 31, 2020 and updates previous reports (1,2). In 2019, Afghanistan and Pakistan reported the highest number of WPV1 cases (176) since 2014. During January 1-March 31, 2020 (as of June 19), 54 WPV1 cases were reported, an approximate fourfold increase from 12 cases during the corresponding period in 2019. Paralytic poliomyelitis can also be caused by circulating vaccine-derived poliovirus (cVDPV), which emerges when attenuated oral poliovirus vaccine (OPV) virus reverts to neurovirulence following prolonged circulation in underimmunized populations (3). Since the global withdrawal of type 2-containing OPV (OPV2) in April 2016, cVDPV type 2 (cVDPV2) outbreaks have increased in number and geographic extent (4). During January 2018-March 2020, 21 countries reported 547 cVDPV2 cases. Complicating increased poliovirus transmission during 2020, the coronavirus disease 2019 (COVID-19) pandemic and mitigation efforts have resulted in suspension of immunization activities and disruptions to poliovirus surveillance. When the COVID-19 emergency subsides, enhanced support will be needed to resume polio eradication field activities.

A comparative assessment of cold chain management using the outbreak of circulating vaccine-derived polio virus type 2 as a surrogate marker in Oyo State, Nigeria-2019.

INTRODUCTION: inspite of the demonstrable evidence of the preventive and protective ability of vaccines to reduce the outbreak of vaccine-preventable diseases, there are still some significant disease outbreaks recorded in our communities. In some settings, these outbreaks have been linked with poor vaccine management. Therefore, this study was conducted to compare the cold chain practices in Oyo State, Nigeria. METHODS: we conducted a cross-sectional survey among health workers in the local government areas of Oyo State between October and November 2019. Using purposive sampling, we recruited all the 84 routine immunization focal persons for the study. A self-administered questionnaire was used to collect data on cold chain management. Data were analyzed using SPSS version 24 and bivariate analysis was done using Chi-square. Statistical significance was set at p < 0.05. RESULTS: the mean age of the respondents was 46.4 ± 6.7 years. Most prevalent cadre in the rural facilities was health assistants (87.5%) while Community Extension Health Workers (54.8%) were prevalent in the urban (p = 0.002). The proportion of respondents with adequate cold chain equipment was significantly higher in the urban compared with the rural area. The cold boxes were the only adequate cold chain equipment found in the rural health facilities compared with the urban (p = 0.036). CONCLUSION: there was a low proportion of qualified health workers and inadequate cold chain equipment in the rural area compared with the urban facilities. Engagement of skilled health workers and supply of the cold chain equipment are recommended.

Routine Childhood Vaccines Given in the First 11 Months of Life.

The US Advisory Committee on Immunization Practices recommends that infants beginning at birth receive several vaccines directed against a variety of infectious diseases that currently pose threats of morbidity and mortality to infants and those around them, including the 3-dose hepatitis B (HepB) series. The first dose is due at birth. This series protects against maternal-infant transmission of the HepB virus and against exposure the rest of the infant's life. At age 2 months infants are to receive not only their second dose of HepB vaccine but also a series of vaccines directed against diphtheria, tetanus, pertussis, pneumococcus, rotavirus, poliovirus, and Haemophilus influenzae type b. At 4 months, infants are to repeat those vaccines except for the HepB vaccine. At age 6 months infants are to finish the HepB series and receive the third doses of the other vaccines received at 2 and 4 months except for the rotavirus vaccine, depending on the brand used. Also, starting at 6 months, depending on the time of year, infants are to begin a 2-dose series against influenza separated by 28 days. Each of these vaccines is due at a time when the vaccine works to protect against an immediate risk and to provide long-term protection. These vaccine-preventable diseases vary in terms of the nature of exposure, the form of the morbidity, the risk of mortality, and the ability of routine vaccination to prevent or ameliorate harm.

[Update on vaccines: 2018 recommendations]. / Actualización sobre vacunas: recomendaciones de 2018.

Beginning in 1974, the date on which the Expanded Program on Immunization was established in the Americas, the number of deaths and disabilities due to certain infectious diseases decreased considerably thanks to universally applied vaccines. A program that initially included four vaccines that protected against six diseases (tuberculosis, diphtheria, pertussis, tetanus, polio and measles) was consolidated, over the years, by incorporating new vaccines and significantly raising coverage rates. The Sociedad Argentina de Pediatría (Argentine Society of Pediatrics), as a leader of opinion, played a leading role in the incorporation of new vaccines, currently reaching one of the most complete vaccination calendars in the world, which improves the levels of inequality and inequity in public health. Taking into account the significant role of the pediatrician in decision-making, the National Committee of Infectious Diseases, together with the Subsidiary Committees, prepared a document on updates and recommendations for 2018 on Polio, Rotavirus, Pneumococcus, Meningococcus, Human Papillomavirus, Chickenpox, Flu, Dengue vaccines and Whooping Cough.

A partir del año 1974, cuando se estableció el Programa Ampliado de Inmunizaciones en las Américas, la cantidad de muertes y discapacidades por enfermedades infecciosas disminuyó de manera considerable gracias a las vacunas aplicadas. Inicialmente, se incluyeron cuatro vacunas que protegían contra seis enfermedades (tuberculosis, difteria, coqueluche, tétanos, polio y sarampión), y, a través de los años, al incorporar nuevas vacunas, aumentaron considerablemente las tasas de cobertura. La Sociedad Argentina de Pediatría tuvo un rol destacado en la incorporación de nuevas vacunas y, en la actualidad, hay uno de los calendarios de vacunación más completos del mundo, lo que permite mejorar los niveles de desigualdad e inequidad en salud pública. Teniendo en cuenta el rol que tiene el pediatra en la toma de decisiones, el Comité Nacional de Infectología, junto con comités de filiales, elaboró un documento sobre actualizaciones y recomendaciones de 2018 acerca de polio, rotavirus, neumococo, meningococo, virus del papiloma humano, varicela, gripe, dengue y coqueluche.

Effect of mobile phone text message reminders on improving completeness and timeliness of routine childhood vaccinations in North-West, Ethiopia: a study protocol for randomised controlled trial.

INTRODUCTION: Non-attendance and delay in vaccination schedules remain a big challenge to healthcare workers. With the continuous growth of mobile network coverage and exponential penetration of mobile devices in the developing world, adoption of short message service has been shown to increase attendance for health services by targeting participant characteristics such as forgetfulness. Therefore, the aim of this trial is to determine the effect of mobile text message reminders on completeness and timeliness of childhood vaccination in North-West, Ethiopia. METHODS AND ANALYSIS: A two-arm, parallel, superiority, randomised controlled trial study will be employed. The study arms are the intervention group (text message reminders plus routine care) and the control group (routine care only). Mother-infant pairs will be randomised to one of the groups during enrolment. The trial will consider a sample size of 434 mother-infant pairs with 1:1 allocation ratio. Mothers assigned to the intervention group will receive text message reminder 1 day before the scheduled vaccination visit at 6 weeks, 10 weeks, 14 weeks and at 9 months. Initially, descriptive statistics will be computed. For the primary outcome log-binomial regression model will be used to identify associated factors, and relative risk with 95% CI will be reported. Primarily, iIntention-to-treat analysis principle will be applied. STATA V.14 software will be used for the analysis. ETHICS AND DISSEMINATION: This study obtained ethical approval from the University of Gondar Institutional Ethical Review Board. The trial findings on the effectiveness of mobile text message reminders in improving vaccination uptake will help to inform decision makers on the use of mobile health interventions in developing countries like Ethiopia. The scientific findings of the trial will also be published in reputable journals. TRIAL REGISTRATION NUMBER: PACTR201901533237287.