Hexavalent Vaccine Research Articles

Calendario de inmunizaciones de la Asociación Española de Pediatría: recomendaciones 2023

As it does every year, the CAV-AEP publishes the update of its recommendations for the use of vaccines in children, adolescents and pregnant women residing in Spain.The 2 + 1 schedule is maintained in infants (at 2, 4 and 11 months), including preterm infants, with the hexavalent vaccine (DTaP-IPV-Hib-HB) and the pneumococcal 13-valent conjugate vaccine.A booster dose with DTaP-IPV is needed at 6 years for those who received the 2 + 1 series with hexavalent vaccine as infants, in addition to 1 dose of dTap in adolescence. Routine vaccination of pregnant women with a dose of dTap is recommended in each pregnancy, preferably between weeks 27 and 32 of gestation, although can be given from 20 weeks if there is risk of preterm delivery.All infants should receive the rotavirus vaccine (2–3 doses) and the 4 CMenB vaccine (2 + 1 series).All children aged 6–59 months should be vaccinated against influenza each year, in addition to risk groups from 6 months.The MenACWY vaccine should be given routinely at 12 months of age and in adolescence between ages 12 and 18 years.The recommendations for the MMR vaccine (12 months and 3–4 years) and varicella vaccine (15 months and 3–4 years) also remain unchanged, using the MMRV vaccine for the second dose.Recommendations for the use of SARS-CoV-2 vaccines in the paediatric age group will be updated periodically on the CAV-AEP website.The HPV vaccine is indicated in all adolescents, regardless of sex, at age 12 years.Novelties include the recommendation of routine administration of nirsevimab to neonates and infants aged less than 6 months for passive immunization against RSV, and the recommendations regarding the hexavalent vaccine are consolidated in a single section.

Immunisation schedule of the Spanish Association of Paediatrics: 2023 Recommendations

As it does every year, the CAV-AEP publishes the update of its recommendations for the use of vaccines in children, adolescents and pregnant women residing in Spain.The 2 + 1 schedule is maintained in infants (at 2, 4 and 11 months), including preterm infants, with the hexavalent vaccine (DTaP-IPV-Hib-HB) and the pneumococcal 13-valent conjugate vaccine.A booster dose with DTaP-IPV is needed at 6 years for those who received the 2 + 1 series with hexavalent vaccine as infants, in addition to 1 dose of dTap in adolescence. Routine vaccination of pregnant women with a dose of dTap is recommended in each pregnancy, preferably between weeks 27 and 32 of gestation, although can be given from 20 weeks if there is risk of preterm delivery.All infants should receive the rotavirus vaccine (2–3 doses) and the 4CMenB vaccine (2 + 1 series).All children aged 6–59 months should be vaccinated against influenza each year.The MenACWY vaccine should be given routinely at 12 months of age and in adolescence between ages 12 and 18 years.The recommendations for the MMR vaccine (12 months and 3–4 years) and varicella vaccine (15 months and 3–4 years) also remain unchanged, using the MMRV vaccine for the second dose.Recommendations for the use of SARS-CoV-2 vaccines in the paediatric age group will be updated periodically on the CAV-AEP website.The HPV vaccine is indicated in all adolescents, regardless of sex, at age 12 years.Novelties include the recommendation of routine administration of nirsevimab to neonates and infants aged less than 6 months for passive immunization against RSV, and the recommendations regarding the hexavalent vaccine are consolidated in a single section.

Cost-effectiveness modelling of birth and infant dose vaccination against hepatitis B virus in Ontario from 2020 to 2050.

The World Health Organization recommends universal birth dose vaccination for hepatitis B virus (HBV), yet only 3 provinces and territories in Canada provide birth dose vaccination, and Canadian-born children in Ontario are acquiring HBV before adolescent vaccination. We sought to determine whether birth and/or infant HBV vaccination is cost-effective. We used a dynamic HBV model that incorporates population by year, disease stage, sex and the influence of immigration to quantify the disease and economic burden of chronic HBV infection in Ontario from 2020 to 2050. We compared 4 vaccination scenarios, which included a birth dose vaccine and variations of the 2 subsequent doses (either alone or as a part of the hexavalent vaccine) and a hexavalent-only strategy in infancy with the current adolescent vaccination strategy. Our costing estimates were based on values from 2020. All 4 infant vaccination approaches prevented an additional 550-560 acute and 160 chronic pediatric HBV infections from 2020 to 2050 compared with adolescent vaccination. Whereas birth dose could be cost-effective, incorporating vaccination into a hexavalent vaccine was cost saving. By 2050, the hexavalent approach led to $428 000 in cost savings per disability-adjusted life years averted. At the current prevalence in Ontario, a switch to birth dose or infant dose will be cost-effective or even cost saving. Introducing any form of infant HBV immunization in Ontario will prevent acute and chronic pediatric HBV infections.

Non-immunization associated with increased risk of sudden unexpected death in infancy: A national case-control study.

In the context of vaccine scepticism, our study aimed to analyse the association between immunization status and the occurrence of sudden unexpected death in infancy (SUDI). A multi-centre case-control study was conducted between May 2015 and June 2017 with data from the French national SUDI registry (OMIN) for 35 French regional SUDI centres. Cases were infants under age 1year who died from SUDI and who were registered in OMIN. Controls, matched to cases by age and sex at a 2:1 ratio, were infants admitted to Nantes University Hospital. All immunization data for diphtheria (D), tetanus (T), acellular pertussis (aP), inactivated poliovirus (IPV), Haemophilus influenzae b (Hib), hepatitis B (HB) and 13-valent pneumococcal conjugate vaccine (PCV13) were collected by a physician. Cases and controls were considered immunized if at least one dose of vaccine was administered. A total of 91 cases and 182 controls were included. The median age was 131days (interquartile range 98-200.0) and the sex ratio (M/F) was about 1.1. For all vaccines combined (D-T-aP-IPV-Hib and PCV13), 22% of SUDI cases versus 12% of controls were non-immunized, which was significantly associated with SUDI after adjustment for potential adjustment factors (adjusted odds ratio 2.01 [95% confidence interval 1.01-3.98, p=0,047]). Non-immunization for D-T-aP-IPV-Hib-HB and PCV13 was associated with increased risk of SUDI. This result can be used to inform the general public and health professionals about this risk of SUDI in case of vaccine hesitancy.

A review of the DTaP-IPV-HB-PRP-T Hexavalent vaccine in pediatric patients

ABSTRACTIntroductionHexaxim is a hexavalent vaccine approved as primary and booster vaccination in infants 6 weeks and older, protecting against diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B and Haemophilus influenzae type b.Areas CoveredTo evaluate the immunogenicity and reactogenicity (safety) of Hexaxim (Hexyon, Hexacima) in primary and booster vaccine schedules; long-term antibody persistence; concomitant use with other childhood vaccines and use in immunocompromised infants. Hexaxim was found to be noninferior to other licensed hexavalent vaccines, being highly immunogenic for all toxoids/antigens and with an acceptable safety profile. It can be administered concomitantly with other childhood vaccines. Hexaxim can be given as a booster for infants primed with Infanrix Hexa and given in a pentavalent-hexavalent-pentavalent series. Hexaxim elicits a similar immune response and safety profile in human immunodeficiency virus (HIV) positive infants. It has the benefit of being a ready-to-use liquid formulation, minimizing dosage errors and preparation time.Expert OpinionHexaxim has an acceptable safety profile and provides immunity against all six targeted diseases. It is an acceptable alternative to other hexavalent vaccines on the market. Further studies are required on the use of immunocompromised patients as well as the antibody persistence of each of the vaccine components.

2134. A Phase 2 Study to Evaluate the Safety, Tolerability, and Immunogenicity of a Booster Dose of a Group B Streptococcus 6-Valent Polysaccharide Conjugate Vaccine (GBS6)

Abstract Background Group B streptococcus (GBS) is a leading cause of invasive bacterial infections in young infants and pregnant women. Pfizer is developing a hexavalent GBS vaccine (GBS6) as a maternal vaccine to prevent invasive GBS disease due to the 6 most prevalent serotypes in young infants. We previously reported Phase 1 safety and immunogenicity data for GBS6. There is precedent for repeat doses of vaccines to augment or sustain circulating antibodies available for placental transfer with each pregnancy; thus, data to inform GBS6 booster strategies were required. Methods This was a Phase 2 open-label extension study to evaluate the safety and immunogenicity of a booster dose of GBS6 (20 μg capsular polysaccharide (CPS)/serotype/dose) with or without AlPO4, given ∼2 years after primary vaccination in 151 healthy nonpregnant adults. Sera taken before and 1-month postbooster were assessed for anti-CPS IgG using a direct Luminex immunoassay. Participants recorded solicited local and systemic events for 14 days after vaccination and unsolicited safety events through 6 months after vaccination. Immunogenicity time points from the Phase 1 study are referred to as primary dose. Results Immunogenicity results For all serotypes, serotype-specific IgG geometric mean concentrations (GMCs) remained elevated compared to baseline at the prebooster time point and were higher 1-month postbooster than 1 month post primary. The 1-month postbooster IgG GMCs were 10- to 59-fold higher than at the prebooster time point. There were similar responses between the 2 formulations. Safety and tolerability results The most frequently reported local reaction was mild to moderate pain at the injection site. Greater pain was associated with AlPO4 formulation. The most frequently reported systemic events were mild to moderate headache and fatigue. The frequency of adverse events was low. Figure 1Antibody Response Line Plot of IgG GMCs by Vaccine Group - All SerotypesFigure 2.Reverse Cumulative Distribution Curves (RCDCs) for IgG 1 Month After Primary and Booster Vaccination, by Vaccine Group – All SerotypesFigure 3.IgG Geometric Mean Fold Rises (GMFRs) at 1 Month Postbooster Vaccination Conclusion A booster dose of GBS6 given ∼2 years after a primary dose to healthy nonpregnant adults was safe and elicited robust immune responses that were also consistently higher than after primary dose. This study suggests that repeat vaccination with GBS6 may confer additional benefit in pregnant women in subsequent pregnancies. Disclosures Babalwa Jongihlati, MD, MBA, Pfizer: Stocks/Bonds Judith Absalon, MD, MPH, Pfizer: Stocks/Bonds Samantha Munson, MPH, MBA, Pfizer: Stocks/Bonds Yasmin Sanchez-Pearson, PhD, Pfizer: Stocks/Bonds Raphael Simon, PhD, Pfizer: Stocks/Bonds Natalie Silmon de Monerri, PhD, Pfizer: Stocks/Bonds David Radley, MS, Pfizer: Employee|Pfizer: Stocks/Bonds Emily A. Gomme, Ph.D., Pfizer: Stocks/Bonds Michelle Gaylord, PhD, Pfizer: Stocks/Bonds William C. Gruber, MD, Pfizer, Inc.: Salary|Pfizer, Inc.: Stocks/Bonds Kathrin U. Jansen, PhD, Pfizer: Stocks/Bonds Daniel A. Scott, MD, Pfizer: Employee|Pfizer: Stocks/Bonds Annaliesa S. Anderson, PhD, Pfizer: Stocks/Bonds.

EE631 Cost Minimization Analysis of the Switch to a New Immunization Schedule With a Hexavalent (DTAP-HBV-HIB-IPV) Vaccine in Algeria

EE631 Cost Minimization Analysis of the Switch to a New Immunization Schedule With a Hexavalent (DTAP-HBV-HIB-IPV) Vaccine in Algeria

EPH104 Valuing the Impact of Incorporating an Acellular Hexavalent Vaccine in the National Vaccination Scheme of Peru in the Context of COVID-19

EPH104 Valuing the Impact of Incorporating an Acellular Hexavalent Vaccine in the National Vaccination Scheme of Peru in the Context of COVID-19

EE337 An Economic Assessment of Incorporating an Acellular Hexavalent Vaccine as Part of the National Immunization Program of Peru

EE337 An Economic Assessment of Incorporating an Acellular Hexavalent Vaccine as Part of the National Immunization Program of Peru

A phase I, open label, clinical study to assess the safety and immunogenicity of indigenously developed liquid (DTwP-HepB-IPV-Hib) hexavalent combination vaccine in healthy toddlers aged 16–24 months

ABSTRACT This first in human study was designed as an open label clinical trial to assess the safety and immunogenicity of SIIPL DTwP-HepB-IPV-Hib (Hexavalent) combination vaccine in healthy toddlers, aged 16–24 months. A total of 24 healthy toddlers were administered a 0.5 ml single dose of SIIPL DTwP-HepB-IPV-Hib vaccine intramuscularly, and followed for 28 days for safety outcomes viz. immediate, solicited, unsolicited and serious adverse events. Blood samples were collected immediately prior to and 28 days after vaccination to assess the immunogenicity. Twenty four completed the study in compliance with the study protocol. None of the participants experienced any immediate or any serious adverse event. In terms of the frequency and intensity, the adverse events were comparable to DTwP-based combination vaccines. The vaccine elicited a strong booster response as demonstrated by a large increase in antibodies against all vaccine antigens. One month post booster vaccination seroprotection for diphtheria, tetanus, Hepatitis B, Haemophilus influenzae type b and polio virus type 1 and 3 was 100%. The percentage sero-response for pertussis was 75%. Four-fold increase in antibody concentration for pertussis was achieved in 87.5% subjects. Indigenously developed DTwP-HepB-IPV-Hib vaccine by Serum Institute of India Pvt. Ltd. was found to be safe, well tolerated and showed a robust immune response in toddlers. It was concluded that this vaccine should be assessed in the next phases of clinical development in the target population. Clinical Trial Registration – CTRI/2018/10/015875.

Real life hexavalent vaccination among children as a practical guide for public health professionals: Four years (from 2016 to 2019) of clinical practice in Sicily, Italy

ABSTRACT Hexavalent (HV) vaccination is a priority for newborn protection and in Italy is included in the National Immunization Plan with a three doses cycle at 61, 121 and 301 days of age. A retrospective clinical study has been conducted to evaluate real life clinical practice of HV vaccination in the fourth most populous Italian Region. Data on the completion of the HV cycle, on the interchangeability between the two HV adopted in 2016–2017 (DTaP3-IPV-HB/Hib) and 2018–2019 (DTaP5-IPV-HB-Hib) and on the use above the established age, were collected in five Sicilian Local Health Authorities. Data showed an average 91.5% completion of the vaccination cycle at 24 months of age. The average age of administration was significantly higher in children who switched between the two hexavalent vaccines compared to those who completed the vaccination cycle with the same product (p-value <.01). Interchangeability with one or two doses of HV was also documented in 17.8% (2018) and 16% (2019) of vaccinated infants. Co-administration with other vaccines included in the Sicilian Vaccination Schedule was 85% with anti-pneumococcal vaccination and 65% with anti-rotavirus vaccination. Children vaccinated above recommended age (from 15 to >36 months) significantly after the introduction of mandatory vaccination in Italy (p-value <.001). This retrospective analysis will contribute to manage potential disruptions due to missed routine immunization opportunities, as the pandemic has caused, with strategies such as catch up above recommended age as well as interchangeability. Data could also help to demonstrate the need to optimize vaccine sessions through co-administration, that strongly contribute to increase vaccination coverage rates and respect of timing of vaccination schedules.

Vaccine Coverage in Children Younger Than 1 Year of Age during Periods of High Epidemiological Risk: Are We Preparing for New Outbreaks?

Background: According to WHO, infectious disease control can be achieved if the vaccine coverage (VC) exceeds 90%. In recent years there has been a declining trend in VC which could lead to the recurrence of infectious diseases. Objectives: The study analyzed the determinants of VC and of parental decisions regarding immunization in children aged 0–1 year monitored during two high-risk epidemiological periods (the measles epidemic and the COVID-19 pandemic period). Methods: A retrospective observational cohort study-data regarding vaccination of children younger than 1 year of age during the periods January 2019–June 2019 (measles epidemic) and January 2020–June 2020 (COVID-19 pandemic) were analyzed. 2.850 children from 2019 and 2.823 children from 2020 were enrolled. Family physicians interacted with 2840 parents or legal guardians in 2019 and with 2800 parents or legal guardians in 2020, during the infants’ consults providing medical information and answer to their questions and worries regarding their immunization. Data on immunization schedules on the determinants of parents’ decisions regarding vaccination were evaluated. Results: During 2019–2020, VC has followed a declining trend for each type of vaccine included in the Romanian National Immunization Program; the most affected were infants aged 9–12 months during both periods: in 9-month aged infants, the MMR vaccine VC was 67.49% in 2019 vs. 59.04% in 2020 (p < 0.004). In the 12 months aged infants, the MMR VC was 64.29% in 2019 vs. 55.88% in 2020 (p < 0.005). For the Hexavalent vaccine administered at the age of 11 months, the VC was 71.59% in 2019 vs. 62.08% in 2020 (p < 0.001). The determinants of parents’ decisions regarding vaccination included parental hesitance 2019—25% vs. 2020—35%, fear on side effects 2019—32% vs. 2020—45%, vaccination denial 2019—7% vs. 2020—10%. Conclusion: We found a declining trend in the VC in Romania during the epidemic and pandemic periods. The decrease in VC for MMR generated a major risk for new measles outbreaks Permanent awareness educational campaigns regarding infectious disease risk are needed, accompanied by the empowerment of primary care and the emergence of an immunization management program based on national regulatory legislation.

Efficacy, safety and immunogenicity of hexavalent rotavirus vaccine in Chinese infants.

A randomized, double-blind, placebo-controlled multicenter trial was conducted in healthy Chinese infants to assess the efficacy and safety of a hexavalent live human-bovine reassortant rotavirus vaccine (HRV) against rotavirus gastroenteritis (RVGE). A total of 6400 participants aged 6–12 weeks were enrolled and randomly assigned to either HRV (n ​= ​3200) or placebo (n ​= ​3200) group. All the subjects received three oral doses of vaccine four weeks apart. The vaccine efficacy (VE) against RVGE caused by rotavirus serotypes contained in HRV was evaluated from 14 days after three doses of administration up until the end of the second rotavirus season. VE against severe RVGE, VE against RVGE hospitalization caused by serotypes contained in HRV, and VE against RVGE, severe RVGE, and RVGE hospitalization caused by natural infection of any serotype of rotavirus were also investigated. All adverse events (AEs) were collected for 30 days after each dose. Serious AEs (SAEs) and intussusception cases were collected during the entire study. Our data showed that VE against RVGE caused by serotypes contained in HRV was 69.21% (95%CI: 53.31–79.69). VE against severe RVGE and RVGE hospitalization caused by serotypes contained in HRV were 91.36% (95%CI: 78.45–96.53) and 89.21% (95%CI: 64.51–96.72) respectively. VE against RVGE, severe RVGE, and RVGE hospitalization caused by natural infection of any serotype of rotavirus were 62.88% (95%CI: 49.11–72.92), 85.51% (95%CI: 72.74–92.30) and 83.68% (95%CI: 61.34–93.11). Incidences of AEs from the first dose to one month post the third dose in HRV and placebo groups were comparable. There was no significant difference in incidences of SAEs in HRV and placebo groups. This study shows that this hexavalent reassortant rotavirus vaccine is an effective, well-tolerated, and safe vaccine for Chinese infants.

EPH89 An Individual Patient Data-Based Meta-Analysis of the Relative Reactogenicity of the Infant Doses of Two Licensed Dtap-Backboned Hexavalent Vaccines

The most robust way to assess the relative safety profile of vaccines data obtained from multiple randomized clinical trials is to run individual patient data meta-analyses (IPD-MA). Having access to individual subject data of six randomized head-to-head controlled trials of two hexavalent vaccines [DTaP-IPV-HB-PRP∼T (Hexaxim) and DTaP-IPV-HB//PRP∼T (Infanrix-Hexa)] we ran an IPD-MA to describe the relative safety profile of the two hexavalent vaccines based on a list of specific safety endpoints.

EE488 Solve Study: Costs Related to Logistics and Storage of Fully Liquid Acellular Hexavalent Vaccine in Brazil

This study aims to evaluate the storage and logistics costs of diphtheria, tetanus, whole-cell pertussis [DTwP] / hepatitis B [HB]/ Haemophilus influenzae type b [Hib] plus inactivated polio vaccine [IPV], and oral polio vaccine [OPV] (current scenario) versus the introduction of a fully liquid hexavalent acellular vaccine diphtheria, tetanus, and acellular pertussis [DTaP]-IPV/HB/Hib (alternative scenario) in the National Immunization Program (NIP) in Brazil.

Epidemiology, Antimicrobial Resistance, and Virulence Determinants of Group B Streptococcus in an Australian Setting.

Streptococcus agalactiae [group B Streptococcus (GBS)] is a major neonatal pathogen and also causes invasive disease in non-pregnant adults. One hundred GBS isolates (n = 50 invasive disease and n = 50 colonizing pregnant women) were characterized using capsular serotyping by latex agglutination, antimicrobial susceptibility testing, and whole genome sequencing (WGS). All isolates were susceptible to penicillin, 32% were resistant to clindamycin. Of these, two isolates had reduced susceptibility to ceftriaxone (MIC 0.75 mg/L) and were found to have unique alleles at pbp2X and pbp1A. Capsular serotypes Ia (18%), III (18%), Ib (14%), V (12%), and VI (11%) were most common and comparison of latex agglutination and capsular genotyping by WGS showed 71% agreement. Less common capsular genotypes VI–VIII represented 15% of isolates, indicating that a significant proportion may not be targeted by the proposed pentavalent or hexavalent vaccines under development. WGS is a useful aid in GBS surveillance and shows correlation to phenotypic serotyping and antimicrobial susceptibility data.

Demonstration of durable hepatitis B immune memory in children vaccinated with a DTaP5-IPV-HepB-Hib infant-toddler series 7 to 8 years previously

ABSTRACT Vaccination against hepatitis B (HepB) provides long-term protection against infection. This is despite a reduction in HepB surface antibody (anti-HBs) concentrations over time to levels below the well-accepted correlate of protection of ≥10 mIU/mL. Continued evidence of immune memory and protection despite declined anti-HBs concentrations can be demonstrated by HepB virus surface antigen challenge studies. Long-term immune memory and protection against HepB infection has not been demonstrated previously for the pediatric hexavalent vaccine DTaP5-IPV-HepB-Hib. This phase 3, multicenter, single-group, open-label challenge study (NCT04490499; EudraCT: 2020–000126–26) evaluated immune memory against HepB infection in children who had received DTaP5-IPV-HepB-Hib at 2, 4, and 11–12 months of age, or at 2, 3, 4, and 12 months of age. At age 8–9 years, they were each challenged with 5 μg of monovalent HepB vaccine. Anti-HBs levels were measured on pre-challenge day 1 and post-challenge day 30. At baseline, 45.4% (93 of 205) had anti-HBs levels ≥10 mIU/mL. On post-challenge day 30, 99.5% (201 of 202) had anti-HBs levels ≥10 mIU/mL, regardless of initial vaccination schedule. Post-challenge, geometric mean concentrations increased 71-fold over baseline and 96.0% of children had a ≥4-fold rise in anti-HBs concentrations with similar results across both dosing schedules. The challenge dose was well tolerated. The robust anti-HBs responses after a single 5-μg dose of HepB vaccine confirm the persistence of a HepB immune memory and demonstrate that DTaP5-IPV-HepB-Hib provides long-term protection against HepB.

Economic assessment of incorporating the hexavalent vaccine as part of the National Immunization Program of Peru

BackgroundThis study aimed to estimate the economic impact of replacing the current Peruvian primary immunization scheme for infants under 1 year old with an alternative scheme with similar efficacy, based on a hexavalent vaccine.MethodsA cost-minimization analysis compared the costs associated with vaccine administration, adverse reactions medical treatment, logistical activities, and indirect social costs associated with time spent by parents in both schemes. A budgetary impact analysis assessed the financial impact of the alternative scheme on healthcare budget.ResultsIncorporating the hexavalent vaccine would result in a 15.5% net increase in healthcare budget expenditure ($48,281,706 vs $55,744,653). Vaccination costs would increase by 54.1%, whereas logistical and adverse reaction costs would be reduced by 59.8% and 33.1%, respectively. When including indirect social costs in the analysis, the budgetary impact was reduced to 8.7%. Furthermore, the alternative scheme would enable the liberation of 17.5% of national vaccines storage capacity.ConclusionsDespite of the significant reduction of logistical and adverse reaction costs, including the hexavalent vaccine into the National Immunization Program of Peru in place of the current vaccination scheme for infants under 1 year of age would increase the public financial budget of the government as it would represent larger vaccine acquisition costs. Incorporating the indirect costs would reduce the budgetary impact demonstrating the social value of the alternative scheme. This merits consideration by government bodies, and future studies investigating such benefits would be informative.

A 5-year look-back at the notification and management of vaccine supply shortages in Germany.

BackgroundUnavailability of vaccines endangers the overall goal to protect individuals and whole populations against infections.MethodsThe German notification system includes the publication of vaccine supply shortages reported by marketing authorisation holders (MAH), information on the availability of alternative vaccine products, guidance for physicians providing vaccinations and an unavailability reporting tool to monitor regional distribution issues.AimThis study provides a retrospective analysis of supply issues and measures in the context of European and global vaccine supply constraints.Resultsbetween October 2015 and December 2020, the 250 notifications concerned all types of vaccines (54 products). Most shortages were caused by increased demand associated with immigration in Germany in 2015 and 2016, new or extended vaccine recommendations, increased awareness, or changes in global immunisation programmes. Shortages of a duration up to 30 days were mitigated using existing storage capacities. Longer shortages, triggered by high demand on a national level, were mitigated using alternative products and re-allocation; in a few cases, vaccines were imported. However, for long lasting supply shortages associated with increased global demand, often occurring in combination with manufacturing issues, few compensatory mechanisms were available. Nevertheless, only few critical incidents were identified: (i) shortage of hexavalent vaccines endangering neonatal immunisation programmes in 2015;(ii) distribution issues with influenza vaccines in 2018; and (iii) unmet demand for pneumococcal and influenza vaccines during the coronavirus disease (COVID)-19 pandemic.ConclusionVaccine product shortages in Germany resemble those present in neighbouring EU states and often reflect increased global demand not matched by manufacturing capacities.

Immunity against hepatitis B in a selected child population in Gampaha district, Sri Lanka, ten years after vaccination at two, four and six months of age

Background: Hepatitis B (HB) infections are a global public health concern, which carry high morbidity and mortality. Immunization is the safe and effective intervention to prevent transmission. Currently, the Hepatitis B vaccine is given to children at two, four and six months of age in Sri Lanka. However, the capability of this regimen in providing long term protection up to adolescence and beyond remains a concern. The current study was conducted to assess the HB immune status of children, ten years after vaccination during infancy. Methods: Antibody status of 150 children who received HB vaccine at two, four and six months of age was assessed 10 years after the last dose of vaccination. Some of these children had received liquid monovalent HB vaccine, while others were vaccinated with the Hexavalent vaccine. Children with HB antibody levels below the protective level were given a booster dose of monovalent recombinant HB vaccine, and antibody levels were reassessed in one month. Results: At the initial assessment, 128 children (85%) had protective levels of antibodies. Type of vaccine and gender had no significant effect on the prevalence of HB antibody levels (p&gt;0.05). All children who received the booster dose developed protective levels of antibodies. Conclusions: Most of the children immunized against HB during infancy maintain protective antibody levels at 10 years of age. Children with antibody levels below protective levels produced a rapid anamnestic response following a booster dose.