Post-marketing surveillance study of the safety of the HPV-16/18 vaccine in Korea (2017-2021).

Human papillomavirus (HPV) infection is associated with the risk of developing certain cancers, including cancers of the cervix, vulva, vagina, penis, anus, rectum, and oropharynx. In 2016, the bivalent HPV-16/18 vaccine was included in the Korea National Immunization Program. This vaccine protects against HPV types 16 and 18 and other oncogenic HPV types predominant in cervical and anal cancers. This post-marketing surveillance (PMS) study assessed the safety of the HPV-16/18 vaccine in Korea. The study was conducted in males and females aged between 9 and 25 years, from 2017 to 2021. Safety was measured in terms of frequency and intensity of adverse events (AEs), adverse drug reactions (ADRs), and serious adverse events (SAEs) after each vaccine dose. The safety analysis included all participants who were vaccinated as per prescribing information and who completed a 30-day follow-up after at least one dose. Data were collected using individual case report forms. The total safety cohort included 662 participants. A total of 220 AEs were reported in 144 subjects (21.75%), and there were 158 ADRs in 111 subjects (16.77%), with the most common being injection site pain in all cases. No SAEs or serious ADRs were reported. Most AEs were reported after the first dose and were injection site reactions with mild intensity that recovered. No individuals required hospitalization or an emergency department visit. Safety results showed that the HPV-16/18 vaccine was generally well tolerated in the Korean population, and no safety concerns were identified.ClinicalTrials.gov Identifier: NCT03671369.

What is the context? Infection with human papillomavirus (HPV) is linked to the development of certain cancers.More specifically, HPV types 16 and 18 are predominant in cervical and anal cancers.In 2016, the HPV-16/18 vaccine was included in the National Immunization Program of Korea.What is new? The objective of this study was to evaluate the safety of the HPV-16/18 vaccine following its introduction in Korea.The study was conducted from 2017 to 2021 in young Korean men and women between 9 and 25 years of age.The study analyzed 662 participants, of whom: ∘ 144 reported 220 adverse events∘ 111 reported 158 adverse drug reactions∘ None reported serious adverse eventsThe safety of the vaccine was measured after each dose as the number and intensity of: ∘ Adverse events, which are side-effects or unwanted reactions that might be associated with the use of the vaccine∘ Adverse drug reactions, which are side-effects or unwanted reactions associated with the use of the vaccine∘ Serious adverse events, which are reactions resulting in death, disability, are life-threatening, or require hospitalization (or prolongation of it).Most adverse events occurred following the first dose, were mild in intensity, and the participants recovered after a few days. Injection site pain was the most common adverse event following vaccination.What is the impact?The study showed that the HPV-16/18 vaccine is safe and generally well tolerated in Korean participants.

Pneumonia hospitalizations of children aged <2 years in Poland before (2013-2016) and after (2017-2018) universal mass vaccination with 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine.

As infection with Streptococcus pneumoniae is an important cause of pneumonia in children, the World Health Organization recommends childhood pneumococcal conjugate vaccines (PCVs). In January 2017, PCV universal mass vaccination (UMV) was introduced in Poland for children aged <2 years. The objective of this study was to estimate and describe the trends in the incidences of various types of pneumonia hospitalizations in Poland before (2013-2016) and after (2017-2018) introduction of the UMV program. The study was conducted at the regional hospitals of Opole and Bialystok and included all hospitalized children aged <2 years with a primary or secondary diagnosis of pneumonia in their electronic medical records. Pneumonia diagnoses were identified based on International Classification of Diseases 10th revision (ICD-10) codes for bacterial, viral, and other/unknown-cause pneumonias. The effect of the implementation of PCV UMV was modeled via an inferential multivariate model. Among 4,168 children included in the study, 64.3% were admitted before PCV UMV. The number of radiograph-confirmed likely bacterial pneumonia cases varied between 55 and 176 cases per 100,000 person-years, and no trend was observed over time. However, inferential modeling showed statistically significant decreasing trends in the incidence rates of bacterial-coded pneumonia (28.48%), viral-coded pneumonia (35.36%), all-cause pneumonia (24.60%), and radiograph-confirmed likely non-bacterial pneumonia (24.98%) among children eligible for UMV. This might be the first indication of the impact of the PCV UMV program in Poland.

What is the context? Infection with the bacteria Streptococcus pneumoniae is a key cause of pneumonia in children worldwide.Pneumococcal vaccines are available to help prevent this infection.In 2017, a pneumococcal vaccination program was introduced in Poland, free of charge for children aged less than 2 years.The impact of this vaccination program on the incidence of pneumonia hospitalizations is unknown.What is new? This study evaluated the incidence of pneumonia hospitalizations in children following the implementation of the vaccination program (2017-2018) and compared it with the incidence before implementation (2013-2016).The study was carried out in two regional hospitals and included all children aged less than 2 years hospitalized with pneumonia.Pneumonia cases were identified using International Classification of Diseases codes and bacterial cases were confirmed with chest x-rays.During the 2 years after the vaccination program was introduced, we observed:No clear trend in the incidence of bacterial pneumonia confirmed by chest x-ray.A statistically significant decline in the likelihood of developing other types of pneumonia among children eligible for the pneumococcal vaccination program.The incidence of pneumonia was higher in children from the region of Opole and for those who were admitted to hospital in winter and at a younger age.What is the impact? Pneumococcal vaccination might reduce the number of pneumonia hospitalizations. However, more research is needed to confirm these results.

Descriptive Overview of Pertussis Epidemiology Among Older Adults in Europe During 2010-2020.

INTRODUCTION: Following the introduction of pertussis vaccination during infancy, the age-related demographics of pertussis epidemiology have changed. METHODS: To better understand the pertussis burden (defined here as number of cases and/or incidence rate [IR]) among older adults (OA; at least 50 years of age) in Europe, we collected data on the reported number of cases and IR in this population in Denmark, England and Scotland, Finland, Germany, the Netherlands, Norway and Sweden from 2010 to 2020. Additionally, we collected contextual epidemiological information on surveillance systems, case definitions, laboratory diagnostics and vaccination approaches. RESULTS: We observed large heterogeneity in the burden among OA between countries: annual IRs ranged from 0.4 (England, 2010) to 54.5 (Norway, 2011) per 100,000 population; 9% (Denmark, 2010) to 45% (England, 2017) of all reported cases occurred in OA. No clear impact of changes in contextual epidemiological information or common trends between countries could be observed, highlighting the need for standardised pertussis surveillance programmes across Europe. The epidemiological trends observed in OA were similar to those observed in 0-4-year-olds. CONCLUSION: This analysis showed that B. pertussis continues to circulate among OA in Europe, suggesting that current vaccination strategies are insufficient to decrease the disease burden in all age groups. This may indicate that improved monitoring of pertussis in OA and booster vaccination throughout adulthood are necessary to control the total pertussis burden.

Whooping cough is an infectious, vaccine-preventable disease that is primarily serious in unvaccinated infants but can also affect adults (at least 50 years old). While vaccination is well established in children, many countries do not routinely vaccinate older adults. Moreover, whooping cough infections in older adults can be difficult to identify for healthcare professionals because of the atypical and mild nature of symptoms. Consequently, the extent of whooping cough occurrence in this population is underestimated. To better understand the extent of disease occurrence, we studied whooping cough infections in Denmark, England and Scotland, Finland, Germany, the Netherlands, Norway and Sweden from 2010 to 2020. Our study was based on the number of laboratory-confirmed cases reported to relevant institutions. We also assessed whether we could identify links between disease occurrence among older adults and contextual epidemiological information, such as disease monitoring systems, methods used for laboratory confirmation, vaccination schedules and vaccination coverage rates. Our study confirmed that whooping cough affects older adults and disease occurrence follows similar trends to those in 0- to 4-year-old children. Because the contextual epidemiological information differed over time and between countries, we could not establish links with disease occurrence in older adults. These data may provide further evidence to authorities that whooping cough among older adults would be better controlled and its burden more accurately estimated with a reinforced comprehensive approach around vaccination and monitoring. Because adults can also infect children who are not yet fully vaccinated, such an approach might help further control the disease in children.