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BMJ Global Health May 2021Previous studies identified factors influencing regulatory approval to introduction timelines for individual vaccines. However, introduction and uptake timelines have...
BACKGROUND
Previous studies identified factors influencing regulatory approval to introduction timelines for individual vaccines. However, introduction and uptake timelines have not been comprehensively assessed across the portfolio of Gavi-supported vaccines.
METHODS
We analysed median times between introduction milestones from vaccine licensure to country introduction and uptake across six vaccine-preventable diseases (VPDs), three delivery platforms and 69 Gavi-supported countries. Data were gathered from public, partner and manufacturer records. VPDs and prequalified vaccines analysed included type b (DTwP-HepB-Hib, pentavalent), pneumococcal disease (pneumococcal conjugate vaccine, PCV), rotavirus diarrhoea (rotavirus vaccine, RVV), cervical cancer (human papillomavirus vaccine, HPV), polio (inactivated polio vaccine, IPV) and meningococcal meningitis (meningococcal group A conjugate vaccine, MenA).
RESULTS
Median time from first vaccine licensure to first Gavi-supported country introduction across VPDs at a 'global level' (Gavi-supported countries) was 5.4 years. Once licensed, MenA vaccines reached first introduction fastest (campaign=0.6 years; routine immunisation (RI)=1.7 years). Most introductions were delayed. Country uptake following first introduction was accelerated for more recently Gavi-supported RI vaccines compared with older ones.
CONCLUSION
Factors accelerating timelines across delivery platforms included rapid product prequalifications by WHO, strong initial recommendations by the WHO Strategic Advisory Group of Experts (SAGE) on Immunization, achieving target product profiles on first vaccine licensure within a VPD and completing several VPD milestones at a global level prior to licensure. Milestones required for introduction in Gavi-supported countries should start prior or in parallel to licensure to accelerate uptake of vaccines delivered through diverse delivery platforms.
Topics: Humans; Rotavirus Vaccines; Vaccination
PubMed: 34045183
DOI: 10.1136/bmjgh-2021-005032 -
Emerging Infectious Diseases Apr 2023New Zealand (Aotearoa) experienced a Neisseria meningitidis serogroup B epidemic during 1991-2006, and incidence remains twice that of other high-income countries. We... (Review)
Review
New Zealand (Aotearoa) experienced a Neisseria meningitidis serogroup B epidemic during 1991-2006, and incidence remains twice that of other high-income countries. We reviewed clinical, laboratory, and immunization data for children <15 years of age with laboratory-confirmed invasive meningococcal disease in Auckland, New Zealand, during January 1, 2004-December 31, 2020. Of 319 cases in 318 children, 4.1% died, and 23.6% with follow-up data experienced sequelae. Children of Māori and Pacific ethnicity and those living in the most deprived areas were overrepresented. Eighty-one percent were positive for N. meningitidis serogroup B, 8.6% for serogroup W, 6.3% for serogroup C, and 3.7% for serogroup Y. Seventy-nine percent had bacteremia, and 63.9% had meningitis. In New Zealand, Māori and Pacific children are disproportionately affected by this preventable disease. N. meningitidis serogroup B vaccine should be included in the New Zealand National Immunization Schedule to address this persistent health inequity.
Topics: Child; Humans; New Zealand; Meningococcal Infections; Neisseria meningitidis; Neisseria meningitidis, Serogroup B; Serogroup; Meningococcal Vaccines
PubMed: 36957984
DOI: 10.3201/eid2904.221397 -
Human Vaccines & Immunotherapeutics Apr 2021Although China's Expanded Program on Immunization (EPI) provides two doses of group A meningococcal polysaccharide vaccine (MPV-A) for children younger than 2 y, more...
BACKGROUND
Although China's Expanded Program on Immunization (EPI) provides two doses of group A meningococcal polysaccharide vaccine (MPV-A) for children younger than 2 y, more self-paying group A and group C meningococcal polysaccharide conjugate vaccine (MCV-AC) has been used as an alternative to MPV-A, to prevent Neisseria meningitidis serogroup C (Men-C) earlier. We evaluated the pattern of MPV-A and MCV-AC utilization to provide evidence for China to upgrade the national meningococcal meningitis vaccination strategy.
METHODS
Children born between 2008 and 2017 registered in Hangzhou's Immunization Information System (HZIIS) were included. Descriptive epidemiological methods were used to characterize the data. Adverse event following immunization (AEFI) was collected from Chinese national adverse event following immunization information system (CNAEFIIS) to compare the safety of MPV-A and MCV-AC.
RESULTS
Data of 1149,027 children from HZIIS were analyzed. The average immunization rate of meningococcal meningitis vaccine (MenV) was 97.50%. Percentages of children using MPV-A-only, MCV-AC-only, and MPV-A/MCV-AC sequential schedules were 68.20%, 29.73%, and 2.07%, respectively. The vaccination rate of MCV-AC-only increased by age and it was higher in resident children than migration children. The incidence rate of AEFI of MPV-A and MCV-AC was 53.36 per 100,000 and 62.13 per 100,000, respectively.
CONCLUSION
Children in Hangzhou had high MenV coverage. MCV-AC-only schedule use increased by year and was higher in urban areas among locally born children. Both MPV-A and MCV-AC were safe for children, while MCV-AC could protect against Men-C more effectively. This supports the rationale to introduce MCV-AC into China's EPI system for free instead of MPV-A.
Topics: Child; China; Humans; Immunization; Immunization Programs; Male; Meningitis, Meningococcal; Meningococcal Infections; Meningococcal Vaccines; Neisseria meningitidis; Vaccination; Vaccines, Conjugate
PubMed: 32961071
DOI: 10.1080/21645515.2020.1809264 -
Anales de Pediatria Jan 2023As 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...
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.
Topics: Pregnancy; Infant; Adolescent; Child; Humans; Infant, Newborn; Female; Immunization Schedule; Meningococcal Vaccines; COVID-19 Vaccines; Meningococcal Infections; Infant, Premature; COVID-19; SARS-CoV-2; Bacterial Vaccines; Rotavirus Vaccines; Vaccines, Combined
PubMed: 36599520
DOI: 10.1016/j.anpede.2022.11.002 -
Human Vaccines & Immunotherapeutics Dec 2023This 2-stage Phase III study (NCT04142242) of a recently licensed quadrivalent meningococcal tetanus toxoid-conjugate vaccine (MenACYW-TT) assessed the safety and... (Randomized Controlled Trial)
Randomized Controlled Trial
Immunogenicity and safety of a quadrivalent meningococcal conjugate vaccine (MenACYW-TT) administered as a booster to adults aged ≥59 years: A phase III randomized study.
This 2-stage Phase III study (NCT04142242) of a recently licensed quadrivalent meningococcal tetanus toxoid-conjugate vaccine (MenACYW-TT) assessed the safety and immunogenicity of a booster dose in older adults (≥59 years) primed with either MenACYW-TT or a quadrivalent meningococcal polysaccharide vaccine (MPSV4). Immune persistence of MenACYW-TT and MPSV4 after primary vaccination was also evaluated. During Stage I, the participants administered MPSV4 (n = 165) or MenACYW-TT (n = 236) 3 years previously were randomized 9:2 to receive either a MenACYW-TT booster or to have blood drawn for persistence only. Participants primed with MPSV4 or MenACYW-TT 6-7 years previously had blood drawn for antibody persistence only. A serum bactericidal assay using human complement was used to measure functional antibodies against each serogroup at baseline and, for those receiving a booster, 30 days post-vaccination (D30). Proportions of participants with seroresponse (post-vaccination titers ≥1:16 when baseline titers <1:8 or ≥ 4-fold increase when baseline titers ≥1:8) were determined. Safety data were collected up to D30. Seroresponse rates for all serogroups at D30 ranged from 49.2% to 60.8% in the MPSV4-primed group, and 79.3-93.1% in the MenACYW-TT-primed group. MenACYW-TT induced sufficient seroresponses in each primed group. Geometric mean titers (GMTs) for serogroups C, W, and Y remained or trended higher than pre-vaccination levels at both 3 and 6-7 years after primary vaccination, indicating immune persistence. Safety outcomes were comparable between groups. A MenACYW-TT booster was immunogenic and well tolerated in participants aged ≥59 years regardless of previous quadrivalent meningococcal vaccine received. The greatest immune responses occurred in those primed with MenACYW-TT.
Topics: Aged; Humans; Antibodies, Bacterial; Meningococcal Infections; Meningococcal Vaccines; Neisseria meningitidis; Vaccination; Vaccines, Combined; Vaccines, Conjugate; Middle Aged
PubMed: 36632042
DOI: 10.1080/21645515.2022.2160600 -
Human Vaccines & Immunotherapeutics Nov 2020Globally, there is an increasing number of international migrants. The majority are forced displaced refugees and children unaccompanied by a caregiver, and have limited...
Globally, there is an increasing number of international migrants. The majority are forced displaced refugees and children unaccompanied by a caregiver, and have limited access to essential public health interventions. Routine vaccination might be interrupted or be incomplete due to conflict areas with limited public health services or a long-unplanned journey. Refugees and migrants may bring infectious disease risks to their country of destination and may be exposed to new risk factors during transit or at their destination. There are lessons learned strategies among refugees and asylum seekers in different countries (vaccination campaign during outbreak, maintain vaccination systems for refugees and medical screening and/or vaccination on arrival) against vaccine-preventable diseases - other than meningococcal infections. Since the 1980s, invasive meningococcal disease (IMD) has been reported as a critical healthcare issue in places of humanitarian crisis such as Thailand and African's meningitis belt. Refugees and migrants are at increased risk of IMD compared with the overall population due to sero-epidemiology in their country of origin, specific characteristics of the IMD, and a number of contacts during the journey. Recently, IMD cases due to serogroups X and W have been reported and are an emerging health threat for persons arriving from Africa to refugee camps in Italy. There have been sporadic case reports of IMD due to serogroup B in Turkey; however, there has not yet been increased disease activity in this population and no outbreaks have been observed. Outbreaks of IMD in refugee camps have been and could be successfully controlled through the implementation of timely and high-coverage vaccination campaigns, and individual cases of IMD can be treated with antibiotics. Research is needed to determine the prevalence of meningococcal carriage and serogroup distribution among refugees and migrants to inform vaccine recommendations. There is no official recommendation for meningococcal vaccination of refugees. Further strategies for prevention and treatment of human immunodeficiency virus, tuberculosis and antibiotic resistance among refugees are directly related to potential prevention methods for IMD. Meningococcal vaccines have been administered only to risk groups in most host countries Thus, further strategies for the definition of new/emerging risk factors for IMD would be helpful to guide vaccine implementation for refugees and immigrants.
Topics: Africa; Child; Emigrants and Immigrants; Humans; Italy; Meningitis, Meningococcal; Meningococcal Infections; Meningococcal Vaccines; Refugees; Thailand; Turkey
PubMed: 32347773
DOI: 10.1080/21645515.2020.1744979 -
Delaware Journal of Public Health Mar 2022Neisseria meningitidis is an aerobic, gram-negative, diplococcus bacterium that is a leading cause of meningitis and sepsis in the United States. Particularly at-risk...
Neisseria meningitidis is an aerobic, gram-negative, diplococcus bacterium that is a leading cause of meningitis and sepsis in the United States. Particularly at-risk groups include those with complement deficiencies, people using complement inhibitors, individuals with anatomic or functional asplenia, patients with HIV infection and travelers to endemic countries. There are currently three quadrivalent meningococcal vaccines (Serogroups A, C, W, Y) and two recombinant serogroup B vaccines available for use in the United States, and recommendations for vaccine use have changed rapidly in the past 10-15 years. This article summarizes updated ACIP recommendations for meningococcal vaccination for the primary care provider.
PubMed: 35402923
DOI: 10.32481/djph.2022.03.012 -
Human Vaccines & Immunotherapeutics Apr 2020Invasive meningococcal disease (IMD) caused by the bacteria is rare but potentially fatal. For healthy adolescents, the US Advisory Committee on Immunization Practices...
Invasive meningococcal disease (IMD) caused by the bacteria is rare but potentially fatal. For healthy adolescents, the US Advisory Committee on Immunization Practices (ACIP) recommends routine vaccination with MenACWY and recommends MenB vaccination under shared clinical decision-making (previously "Category B"). The recommendation for MenB vaccination was the first category B recommendation in adolescents, and it is unclear how healthcare providers (HCPs) implement these guidelines. This 2017 web-based survey of US HCPs explored characteristics associated with prescribing or receiving MenB and MenACWY vaccines, HCP knowledge of vaccine recommendations, and real-world practice patterns. Of 529 respondents, 436 prescribed MenB vaccines to their eligible adolescent/young adult patients and 93 prescribed MenACWY vaccines only. MenB vaccine prescribers were more likely to be pediatricians compared with MenACWY vaccine only prescribers, and patients who received MenB vaccines were more likely to be non-Hispanic whites living in shared spaces (eg, college dormitories) than those not receiving the vaccine. Seventy-seven percent of HCPs indicated that they prescribe MenACWY vaccines consistently with ACIP recommendations (to all members of an age group), whereas only 7% indicated that they prescribe MenB vaccines consistently with ACIP recommendations (individual clinical decision making). Patient-related factors, disease-related factors, and guidelines all influenced HCP decisions to prescribe meningococcal vaccines. Providing HCPs with clear guidance on how to initiate discussion of MenB vaccines with patients and their caregivers may aid in fully protecting US adolescents against meningococcal disease caused by 5 of the disease-causing serogroups.
Topics: Adolescent; Humans; Immunization; Meningococcal Infections; Meningococcal Vaccines; Neisseria meningitidis, Serogroup B; Pediatricians; Vaccination; Young Adult
PubMed: 31634035
DOI: 10.1080/21645515.2019.1682845 -
JAMA Network Open Aug 2023
Topics: Humans; Gonorrhea; Incidence; Meningococcal Vaccines; Universities; Students
PubMed: 37651146
DOI: 10.1001/jamanetworkopen.2023.31742 -
Infectious Diseases and Therapy Sep 2019Neisseria meningitidis is a major cause of meningitis and septicemia with cases, outbreaks, and epidemics reported globally in industrialized and non-industrialized... (Review)
Review
Neisseria meningitidis is a major cause of meningitis and septicemia with cases, outbreaks, and epidemics reported globally in industrialized and non-industrialized countries. N. meningitidis is categorized into 12 serogroups; however, only 5 serogroups (A, B, C, W, Y) are responsible for the majority of disease. Invasive meningococcal disease (IMD) occurs unpredictably; protection is therefore best achieved by initiating proactive vaccination strategies. Vaccines are currently available for the five main disease-causing serogroups. With the evolution of meningococcal vaccines and changes in IMD epidemiology, different vaccination strategies have been used. Recently, the rapid clonal expansion of meningococcal serogroup W (MenW) has been associated with a change in the national and regional vaccination recommendations from monovalent meningococcal serogroup C vaccines to meningococcal serogroup A, C, W, Y (MenACWY) vaccines in several countries. This review highlights these and other changes in IMD epidemiology and meningococcal vaccination recommendations, summarizes information available for currently available conjugate MenACWY vaccines, and focuses on clinical study data for the most recently approved MenACWY conjugate vaccine, MenACWY vaccine conjugated to tetanus toxoid (MenACWY-TT). MenACWY-TT studies spanned multiple age groups and generally demonstrated safety and immunogenicity in comparison with other meningococcal vaccines and under concomitant administration of other routine vaccines. Continuous updates to meningococcal vaccine recommendations in response to changing epidemiology, as have been undertaken for MenW, are necessary to ensure optimal population protection. FUNDING: Pfizer, Inc.
PubMed: 31347097
DOI: 10.1007/s40121-019-0254-1