Modeling the national pediatric vaccine stockpile: Supply shortages,health impacts and cost consequences

Pediatric vaccine stockpiles have been in place in the U.S. since 1983 to address the potential disruption in supply of routine pediatric vaccines. Increases in the number of vaccines recommended for pediatric and adolescent patients have increased the cost of stocking and maintaining the stockpile. Based on a spreadsheet-based model (VacStockpile) we developed, we estimated potential supply shortages of 14 stockpiled vaccines as of August 1, 2008 and its health and financial impacts under various shortage and stockpile scenarios. To illustrate the implications of policy options, we compared “high” to “low” stockpile scenarios. The high stockpile scenario ensures a 6-month vaccine supply to vaccinate all children according to recommended schedules. The low scenario comprised of 50% of the high scenario or existing stocks, whichever is smaller. For each vaccine, we used a weighted average of five shortage scenarios ranging from 0% to 100%, in 25% increments. Demand for each vaccine was based on current distribution or birth cohort size. The probabilities of shortages were based on number of manufacturers, market stability, history of manufacturing problems, and production complexity. CDC contract prices were used to estimate costs. Expert opinion and literature provided estimates of health impacts due to shortages. Applying the probabilities of shortages to all vaccines in a single year, the “low” scenario could cost $600 million, with 376,000 vaccine-preventable cases occurring and 1774 deaths. The “high” scenario could cost $2 billion, with an additional $1.6 billion initial stocking, and result in 7100 vaccine-preventable cases occurring and 508 deaths. Based on the assumptions in the model, there is the potential for large differences in outcomes between the scenarios although some outcomes could potentially be averted with measures such as catch-up campaigns after shortages. Using the VacStockpile policy makers can readily evaluate the implications of assumptions and decide which set of assumptions they wish to use in planning.     

Proteomic assessment of humoral immune responses in smallpox vaccine recipients

The availability of effective smallpox vaccines was a critical element of the successful eradication of smallpox in 1980. Antibody responses play a primary role in protective immunity and neutralizing antibody is an established correlate of protection against smallpox. In this study we used a poxvirus proteome array to assess the antibody response to individual viral proteins in a cohort of 1,037 smallpox vaccine recipients. Several statistically significant differences were observed in the antibody response to immunodominant proteins between men and women, including B5R—a major target of neutralizing antibody in vaccinia immune globulin, and the membrane proteins D8L and A27L, both of which have been used as vaccine antigens providing protection in animal models. We also noted differences across racial/ethnic groups. In this cohort, which consisted of both ACAM2000 and Dryvax recipients, we noted minute differences in the antibody responses to a restricted number of viral proteins, providing additional support for the use of ACAM2000 as a replacement smallpox vaccine. Furthermore, our data indicate that poxvirus proteome microarrays can be valuable for screening and monitoring smallpox vaccine-induced humoral immune responses in large-scale serologic surveillance studies and prove useful in the guidance of developing novel smallpox candidate vaccines.     

Safety and immunogenicity of IMVAMUNE smallpox vaccine using different strategies for a post event scenario

Introduction

Reintroduction of Variola major as an agent of bioterrorism remains a concern. A shortened dosing schedule of Bavarian Nordic's (BN) IMVAMUNE^® (modified vaccinia Ankara vaccine against smallpox) was compared to the currently recommended 0- and 28-day schedule for non-inferiority by evaluating the magnitude and kinetics of the immune responses.

Methods

Subjects were assigned to receive IMVAMUNE or placebo administered subcutaneously on Days 0 and 7, Days 0 and 28, or Day 0. Blood was collected for antibody and cell-mediated immune assays. Subjects were followed for safety for 12 months after last vaccination.

Results

The primary endpoint of this study was the geometric mean antibody titers (GMT) at 14 days post last vaccination. Of 208 subjects enrolled, 191 received vaccine (Group: 0 + 7, Group: 0 + 28 and Group: 0) and 17 received placebo. Moderate/severe systemic reactogenicity after any vaccination were reported by 31.1%, 25.4%, and 28.6% of the subjects for Group: 0 + 7, Group: 0 + 28, and Group: 0, respectively (Chi-square test, P = 0.77). Based on BN's Plaque Reduction Assay GMTs, Group: 0 + 7 was non-inferior to Group: 0 + 28 at Day 4, 180, and 365 after the second vaccination. On Day 14, Group: 0 + 7 and Group: 0 + 28 GMT were 10.8 (CI: 9.0, 12.9) and 30.2 (CI: 22.1, 41.1), respectively. Based on BN's Enzyme-linked immunosorbent assay, the proportion of subjects with positive titers for Group: 0 + 28 was significantly greater than that for Group: 0 + 7 after second vaccination at Days 4 and 180. By Day 14 after the second dose, the IFN-γ enzyme-linked immunosorbent spot (ELISPOT) responses were similar for Group: 0 + 28 and Group: 0 + 7.

Conclusion

Overall, a standard dose of IMVAMUNE (0.5 mL of 1 x 10⁸ TCID/mL) administered subcutaneously was safe and well tolerated. A second dose of IMVAMUNE at Day 28 compared to Day 7 provided greater antibody responses and the maximal number of responders. By Day 14 after the second dose, IFN-γ ELISPOT responses were similar for Group: 0 + 28 and Group: 0 + 7.     

Equination (inoculation of horsepox): An early alternative to vaccination (inoculation of cowpox) and the potential role of horsepox virus in the origin of the smallpox vaccine

For almost 150 years after Edward Jenner had published the “Inquiry” in 1798, it was generally assumed that the cowpox virus was the vaccine against smallpox. It was not until 1939 when it was shown that vaccinia, the smallpox vaccine virus, was serologically related but different from the cowpox virus. In the absence of a known natural host, vaccinia has been considered to be a laboratory virus that may have originated from mutational or recombinational events involving cowpox virus, variola viruses or some unknown ancestral Orthopoxvirus. A favorite candidate for a vaccinia ancestor has been the horsepox virus. Edward Jenner himself suspected that cowpox derived from horsepox and he also believed that “matter” obtained from either disease could be used as preventative of smallpox. During the 19th century, inoculation with cowpox (vaccination) was used in Europe alongside with inoculation with horsepox (equination) to prevent smallpox. Vaccine-manufacturing practices during the 19th century may have resulted in the use of virus mixtures, leading to different genetic modifications that resulted in present-day vaccinia strains. Horsepox, a disease previously reported only in Europe, has been disappearing on that continent since the beginning of the 20th century and now seems to have become extinct, although the virus perhaps remains circulating in an unknown reservoir. Genomic sequencing of a horsepox virus isolated in Mongolia in 1976 indicated that, while closely related to vaccinia, this horsepox virus contained additional, potentially ancestral sequences absent in vaccinia. Recent genetic analyses of extant vaccinia viruses have revealed that some strains contain ancestral horsepox virus genes or are phylogenetically related to horsepox virus. We have recently reported that a commercially produced smallpox vaccine, manufactured in the United States in 1902, is genetically highly similar to horsepox virus, providing a missing link in this 200-year-old mystery.     

Molecular smallpox vaccine delivered by alphavirus replicons elicits protective immunity in mice and non-human primates

Naturally occurring smallpox was eradicated as a result of successful vaccination campaigns during the 1960s and 1970s. Because of its highly contagious nature and high mortality rate, smallpox has significant potential as a biological weapon. Unfortunately, the current vaccine for orthopoxviruses is contraindicated for large portions of the population. Thus, there is a need for new, safe, and effective orthopoxvirus vaccines. Alphavirus replicon vectors, derived from strains of Venezuelan equine encephalitis virus, are being used to develop alternatives to the current smallpox vaccine. Here, we demonstrated that virus-like replicon particles (VRPs) expressing the vaccinia virus A33R, B5R, A27L, and L1R genes elicited protective immunity in mice comparable to vaccination with live-vaccinia virus. Furthermore, cynomolgus macaques vaccinated with a combination of the four poxvirus VRPs (4pox-VRP) developed antibody responses to each antigen. These antibody responses were able to neutralize and inhibit the spread of both vaccinia virus and monkeypox virus. Macaques vaccinated with 4pox-VRP, flu HA VRP (negative control), or live-vaccinia virus (positive control) were challenged intravenously with 5 × 10⁶ pfu of monkeypox virus 1 month after the second VRP vaccination. Four of the six negative control animals succumbed to monkeypox and the remaining two animals demonstrated either severe or grave disease. Importantly, all 10 macaques vaccinated with the 4pox-VRP vaccine survived without developing severe disease. These findings revealed that a single-boost VRP smallpox vaccine shows promise as a safe alternative to the currently licensed live-vaccinia virus smallpox vaccine.     

Combination of two candidate subunit vaccine antigens elicits protective immunity to ricin and anthrax toxin in mice

In an effort to develop combination vaccines for biodefense, we evaluated a ricin subunit antigen, RiVax, given in conjunction with an anthrax protective antigen, DNI. The combination led to high endpoint titer antibody response, neutralizing antibodies, and protective immunity against ricin and anthrax lethal toxin. This is a natural combination vaccine, since both antigens are recombinant subunit proteins that would be given to the same target population.     

A randomized phase II trial to compare safety and immunogenicity of the MVA-BN smallpox vaccine at various doses in adults with a history of AIDS

Traditional replicating smallpox vaccines are associated with serious safety concerns in the general population and are contraindicated in immunocompromised individuals. However, this very population remains at greatest risk for severe complications following viral infections, making vaccine prevention particularly relevant. MVA-BN was developed as a non-replicating smallpox vaccine that is potentially safer for people who are immunocompromised. In this phase II trial, 3 MVA-BN dosing regimens were evaluated for safety, tolerability, and immunogenicity in persons with HIV (PWH) who had a history of AIDS. Following randomization, 87 participants who were predominately male and African American received either 2 standard doses on weeks 0 and 4 in the standard dose (SD) group (N = 27), 2 double-standard doses on the same schedule in the double dose (DD) group (N = 29), or 3 standard doses on weeks 0, 4 and 12 in the booster dose (BD) group (N = 31). No safety concerns were identified, and injection site pain was the most commonly reported solicited adverse event (AE) in all groups (66.7%), with no meaningful differences between groups. The incidence of severe (Grade 3) AEs was low across groups and no serious AEs or AEs of special interest considered related to study vaccine were reported. Doubling the standard MVA-BN dose had no significant effect on induction of neutralizing antibodies, with 100% seroconversion and comparable GMTs at week 6 in the SD and DD groups (78.9 and 100.3, respectively). A booster dose significantly increased peak neutralizing titers in the BD group (GMT: 281.1), which remained elevated at 12 months (GMT: 45.3) compared to the SD (GMT: 6.2) and DD (GMT: 10.6) groups. However, based on the immune response previously reported for healthy participants, a third dose (booster) does not appear necessary, even for immunocompromised participants.Clinical Trial Registry Number: NCT02038881.     

Genomic differences of Vaccinia virus clones from Dryvax smallpox vaccine: the Dryvax-like ACAM2000 and the mouse neurovirulent Clone-3

Conventional vaccines used for smallpox eradication were often denoted one or another strain of Vaccinia virus (VACV), even though seed virus was sub-cultured multifariously, which rendered the virion population genetically heterogeneous. ACAM2000 cell culture vaccine, recently licensed in the U.S., consists of a biologically vaccine-like VACV homogeneous-sequence clone from the conventional smallpox vaccine Dryvax, which we verified from Dryvax sequence chromatograms is genetically heterogeneous. ACAM2000 VACV and CL3, a mouse-neurovirulent clone from Dryvax, differ by 572 single nucleotide polymorphisms and 53 insertions–deletions of varied size, including a 4.5-kbp deletion in ACAM2000 and a 6.2-kbp deletion in CL3. The sequence diversity between the two clones precludes precisely defining why CL3 is more pathogenic; however, four genes appear significantly dissimilar to account for virulence differences. CL3 encodes intact immunomodulators interferon-/β and tumor necrosis factor receptors, which are truncated in ACAM2000. CL3 specifies a Cowpox and Variola virus-like ankyrin-repeat protein that might be associated with proteolysis via ubiquitination. And, CL3 shows an elongated thymidylate kinase, similar to the enzyme of the mouse-neurovirulent VACV-WR, a derivative of the New York City Board of Health vaccine, the origin vaccine of Dryvax. Although ACAM2000 encodes most proteins associated with immunization protection, the cloning probably delimited the variant epitopes and other motifs produced by Dryvax due to its VACV genetic heterogeneity. The sequence information for ACAM2000 and CL3 could be significant for resolving the dynamics of their different proteomes and thereby aid development of safer, more effective vaccines.     

从供应链角度评介美国国家医药品战略储备体系及其对我国的启示

目的：应用供应链管理理论分析美国国家医药品战略储备供应体系的优缺点,提出适用于我国国家应急医药品有效供应的建议。方法：通过文献研究和比较研究方法,了解美国应急医药品战略性国家储备体系的供应链模式与中国的差异性。结果：从供应链的视角,美国战略性国家储备对应急医药品主要采取＂应急包预先储备＂、＂管理型库存＂和＂合同储备＂的应急准备方式;对应急医药品的物流调运采取＂地方—州—国家＂申报审批管理和分时间段供应模式;信息流的传递,利用大型数据库、模拟软件和技术咨询响应单元的建立,实现实时交流,便于准确与及时地调运应急医药品。结论：完善我国应急医药品的供应链体系,明确供应管理的主体与职责,建立分救灾时间段的应急医药品目录和采用第四方物流供应模式,提高我国应急医药品准备的系统化、规范化和信息化水平。     

Adventitious agents and live viral vectored vaccines: Considerations for archiving samples of biological materials for retrospective analysis

Vaccines are one of the most effective public health medicinal products with an excellent safety record. As vaccines are produced using biological materials, there is a need to safeguard against potential contamination with adventitious agents. Adventitious agents could be inadvertently introduced into a vaccine through starting materials used for production. Therefore, extensive testing has been recommended at specific stages of vaccine manufacture to demonstrate the absence of adventitious agents. Additionally, the incorporation of viral clearance steps in the manufacturing process can aid in reducing the risk of adventitious agent contamination. However, for live viral vaccines, aside from possible purification of the virus or vector, extensive adventitious agent clearance may not be feasible.In the event that an adventitious agent is detected in a vaccine, it is important to determine its origin, evaluate its potential for human infection and pathology, and discern which batches of vaccine may have been affected in order to take risk mitigation action. To achieve this, it is necessary to have archived samples of the vaccine and ancillary components, ideally from developmental through to current batches, as well as samples of the biological materials used in the manufacture of the vaccine, since these are the most likely sources of an adventitious agent. The need for formal guidance on such vaccine sample archiving has been recognized but not fulfilled. We summarize in this paper several prior major cases of vaccine contamination with adventitious agents and provide points for consideration on sample archiving of live recombinant viral vector vaccines for use in humans.     

Impaired innate,humoral, and cellular immunity despite a take in smallpox vaccine recipients

Smallpox vaccine is highly effective, inducing protective immunity to smallpox and diseases caused by related orthopoxviruses. Smallpox vaccine efficacy was historically defined by the appearance of a lesion or “take” at the vaccine site, which leaves behind a characteristic scar. Both the take and scar are readily recognizable and were used during the eradication effort to indicate successful vaccination and to categorize individuals as “protected.” However, the development of a typical vaccine take may not equate to the successful development of a robust, protective immune response. In this report, we examined two large (>1000) cohorts of recipients of either Dryvax^® or ACAM2000 using a testing and replication study design and identified subgroups of individuals who had documented vaccine takes, but who failed to develop robust neutralizing antibody titers. Examination of these individuals revealed that they had suboptimal cellular immune responses as well. Further testing indicated these low responders had a diminished innate antiviral gene expression pattern (IFNA1, CXCL10, CXCL11, OASL) upon in vitro stimulation with vaccinia virus, perhaps indicative of a dysregulated innate response. Our results suggest that poor activation of innate antiviral pathways may result in suboptimal immune responses to the smallpox vaccine. These genes and pathways may serve as suitable targets for adjuvants in new attenuated smallpox vaccines and/or effective antiviral therapy targets against poxvirus infections.     

纸质食品包装材料中荧光增白剂含量调查

摘要:目的　了解和掌握市售纸质食品包装材料中11种二苯乙烯型荧光增白剂的含量水平。方法　从河南各地市的市场、超市等采集纸质食品包装用品,采用“2014年国家食品污染和有害因素风险监测工作手册“中的“食品包装材料有害物监测的标准操作程序”检测,对检测结果进行分析。结果　检出8种荧光增白剂,其中C.I.85 的检出率和平均值最高,分别为12.9%和6.65 mg/kg;样品检出率为12.9%（15/116）,平均含量为13.2 mg/kg。结论　食品包装用纸存在违规添加使用荧光增白剂的情况,为减少其对人民健康的影响和危害,有关部门应加强监督管理。     

Safety and immunogenicity of modified vaccinia Ankara as a smallpox vaccine in people with atopic dermatitis

Background

Following vaccination with traditional smallpox vaccines or after exposure to vaccinated individuals, subjects with atopic dermatitis (AD) can develop eczema vaccinatum, a severe disease with disseminated eruption of pustular contagious lesions. Alternative smallpox vaccines with an improved safety profile would address this unmet medical need.

Methods

An open-label controlled Phase I clinical trial was conducted to investigate the safety and immunogenicity of modified vaccinia Ankara (MVA) in 15 healthy subjects compared to 45 subjects with either mild allergic rhinitis, a history of AD or presenting with mild active AD. MVA was given (Week 0 and 4) by a subcutaneous injection during a 28-week observation period.

Results

No serious adverse event was reported and vaccinations with MVA did not lead to any clinically relevant skin reactions in AD subjects. Unsolicited administration site reactions did not show any trends compared to the healthy subject group. The majority of adverse reactions were mild to moderate, and all reactions were transient and resolved without intervention. The majority of vaccinees had seroconverted by ELISA (80–93%) and PRNT (69–79%) already two weeks after the first vaccination, increasing to 100% after the second immunization, with peak GMT above 1000 and 145 for ELISA and PRNT, respectively.

Conclusions

MVA was equally well tolerated and immunogenic in all enrolled subjects with mild to moderate pain and redness at the injection site being the most frequent adverse reactions. There were no differences in the safety or immunogenicity profile of MVA in healthy subjects or those with AD or allergic rhinitis. The study has confirmed MVA as a promising smallpox vaccine candidate and demonstrated in a small study population that the vaccine has a similar safety and immunogenicity profile in healthy subjects and people with active AD.Clinical trials registration: NCT00189917.     

民族边远地区农村留守儿童个性分析

摘要:目的　探讨民族边远地区农村留守儿童的个性特征,为引导民族边远地区农村留守儿童健康心理的发展提供参考资料。方法　采用艾森克个性问卷（EPQ）（儿童版）对广西西部某市中小学的1298名留守儿童进行调查。结果　男女留守儿童、单亲与非单亲家庭的留守儿童在E、P、N、L 4个维度标准得分相比,差异均有统计学意义（P＜0.001）;与汉族相比,壮族留守儿童N维度得分较低,L维度得分较高,差异有统计学意义（P＜0.001）;居住在农村和县城的留守儿童P、N、L维度EPQ标准得分比较,差异均有统计学意义（P＜0.001）。结论　农村留守男性儿童情绪不稳,掩饰性强,女性儿童存在较高的精神质倾向;汉族、壮族留守儿童典型的情绪不稳,而且壮族留守儿童掩饰性强。农村的留守儿童情绪不稳定、存在更高的精神质和神经质倾向,但城镇的留守儿童掩饰程度高;单亲家庭儿童情绪典型的不稳定,但非单亲家庭留守儿童存在更高的精神质和神经质倾向,掩饰程度高。     

Estimated prevalence of smallpox vaccine contraindications in Israeli adolescents

BackgroundRoutine smallpox vaccination for military recruits was discontinued in Israel in 1996. However, Israeli guidelines recommend post-event mass-vaccination. This study aimed to estimate the rate of Israeli adolescents at risk of severe adverse events after vaccination during 1998−2013.MethodsThe study population included adolescents screened before military service in 1998−2013. Medical parameters correlating with contraindications to smallpox vaccination were retrieved from army databases, and were categorized by severity according to the Israeli post-event strategy.ResultsOf 1,180,964 individuals, 1.86% had vaccination contraindications in a post-event scenario. An additional 1.24% had contraindications in a pre-event scenario. There was an increase in the percentage of contraindications over time, attributed to the rising incidence of atopic-dermatitis.ConclusionsOnly a small percentage of the adolescent population is ineligible to receive the smallpox vaccine currently in use. This group may be protected by herd-immunity, or by new-generation vaccines designed to prevent severe adverse events.     

Safety and immunogenicity of influenza A(H5N1) vaccine stored up to twelve years in the National Pre-Pandemic Influenza Vaccine Stockpile (NPIVS)

Background

As part of the U.S. Department of Health and Human Services (HHS) Pandemic Influenza Plan preparedness and response strategy, the National Pre-Pandemic Influenza Vaccine Stockpile (NPIVS) program was established by the Biomedical Advanced Research and Development Authority (BARDA) in 2005 with the goal of building and maintaining a stockpile of vaccines for influenza viruses with pandemic potential to vaccinate 20 million people in the critical workforce in the event of a pandemic. The NPIVS program continuously monitors the integrity of influenza vaccine antigens and adjuvants stored within the stockpile. In addition to monitoring physical and chemical properties in stability studies, it is important to regularly assess the safety and immunogenicity of stockpiled vaccines and adjuvants to maintain preparedness for use in the event of an influenza pandemic.

疫苗冷链网络实时监测系统与人工监测效果比较

摘要:目的　“北京市顺义区疫苗冷链网络实时监测系统”与以往人工冷链设备监测效果比较。方法　采用Excel2010对资料进行统计分析。结果　疫苗冷链网络实时监测系统从温度监测频率、温度数据连续性、直观性方面,在发现温度异常的能力方面,在冷链系统管理水平方面,在群众满意度方面均优于人工监测系统。结论　疫苗冷链网络实时监测系统的监测效果远远高于人工监测系统,极大的提高了冷链系统管理水平,提升了群众对接种疫苗的信心和对预防接种单位的满意度,为评价疫苗冷链系统运行状况提供了客观的依据。     

A randomized,double-blind,controlled clinical trial to evaluate the efficacy and safety of CJ-50300, a newly developed cell culture-derived smallpox vaccine,in healthy volunteers

A randomized, double-blind, controlled clinical trial was conducted to evaluate the efficacy and safety of CJ-50300, a newly developed cell culture-derived smallpox vaccine, and to determine its minimum effective dose. The overall rates of cutaneous “take” reaction and humoral and cellular immunogenicity in CJ-50300 vaccinees were 100% (123/123), 99.2% (122/123), and 90.8% (109/120), respectively, and these rates did not differ significantly between the conventional-dose and the low-dose CJ-50300 (1.0 × 10⁸ and 1.0 × 10⁷ plaque-forming units/mL, respectively) (P > 0.05 for each). No serious adverse reaction was observed. However, one case of possible generalized vaccinia occurred in the conventionally dosed group [ClinicalTrials.gov Identifier: NCT00607243].     

北半球季节性甲型流感疫苗株HA抗原表位的分析

摘要:目的　分析近20年北半球甲型流感疫苗株血凝素（Hemagglutinin,HA）抗原的氨基酸和N-糖基化位点变异情况。方法　利用生物信息学软件分析1990-2012年季节性流感疫苗株H1N1的4个抗原决定簇Sa、Sb、Ca、Cb和H3N2的4个抗原决定簇A、B、C、D的氨基酸和N-糖基化位点变异情况。结果　（1）H1N1疫苗株Sb抗原决定簇28、40位氨基酸N-糖基化位点相对保守,而142位氨基酸发生改变。（2）Sb抗原决定簇上无N-糖基化位点。（3）H3N2疫苗株B、D抗原决定簇2、479、181、301位氨基酸N-糖基化位点相对保守,而149位氨基酸发生改变。（4）H3N2疫苗株的N-糖基化位点不在抗原位点上。结论　（1）流感疫苗株HA抗原氨基酸变异集中在HA1蛋白环状部位。（2）流感疫苗株的N-糖基化位点在相对保守的序列,并且相同亚型的流感疫苗株有相似的N-糖基化位点。（3）HA蛋白变异可以推测流感病毒基因的改变,为选择与之匹配的流行株提供参考。     

Successful introduction of an underutilized elderly pneumococcal vaccine in a national immunization program by integrating the pre-existing public health infrastructure

BackgroundAlthough pneumococcal vaccines had been recommended for the elderly population in South Korea for a considerable period of time, the coverage has been well below the optimal level. To increase the vaccination rate with integrating the pre-existing public health infrastructure and governmental funding, the Korean government introduced an elderly pneumococcal vaccination into the national immunization program with a 23-valent pneumococcal polysaccharide vaccine in May 2013.ObjectiveThe aim of this study was to assess the performance of the program in increasing the vaccine coverage rate and maintaining stable vaccine supply and safe vaccination during the 20 months of the program.MethodsWe qualitatively and quantitatively analyzed the process of introducing and the outcomes of the program in terms of the systematic organization, efficiency, and stability at the national level.ResultsA staggered introduction during the first year utilizing the public sector, with a target coverage of 60%, was implemented based on the public demand for an elderly pneumococcal vaccination, vaccine supply capacity, vaccine delivery capacity, safety, and sustainability. During the 20-month program period, the pneumococcal vaccine coverage rate among the population aged ≥65 years increased from 5.0% to 57.3% without a noticeable vaccine shortage or safety issues. A web-based integrated immunization information system, which includes the immunization registry, vaccine supply chain management, and surveillance of adverse events following immunization, reduced programmatic errors and harmonized the overall performance of the program.ConclusionIntroduction of an elderly pneumococcal vaccination in the national immunization program based on strong government commitment, meticulous preparation, financial support, and the pre-existing public health infrastructure resulted in an efficient, stable, and sustainable increase in vaccination coverage.