Global production capacity of seasonal and pandemic influenza vaccines in 2019

Vaccines will be an important element in mitigating the impact of an influenza pandemic. While research towards developing universal influenza vaccines is ongoing, the current strategy for vaccine supply in a pandemic relies on seasonal influenza vaccine production to be switched over to pandemic vaccines. Understanding how much vaccine could be produced, in which regions of the world and in what timeframe is critical to informing influenza pandemic preparedness. Through the Global Action Plan for Influenza Vaccines, 2006–2016, WHO promoted an increase in vaccine production capacity and monitors the landscape through periodically surveying influenza vaccine manufacturers. This study compares global capacity for production of influenza vaccines in 2019 with estimates from previous surveys; provides an overview of countries with established production facilities; presents vaccine production by type and manufacturing process; and discusses limitations to these estimates. Results of the current survey show that estimated annual seasonal influenza vaccine production capacity changed little since 2015 increasing from 1.47 billion to 1.48 billion doses with potential maximum annual influenza pandemic vaccine production capacity increasing from 6.37 billion to 8.31 billion doses. However, this figure should be interpreted with caution as it presents a best-case scenario with several assumptions which may impact supply. Further, pandemic vaccines would not be immediately available and could take four to six months for first supplies with several more months needed to reach maximum capacity. A moderate-case scenario is also presented of 4.15 billion doses of pandemic vaccine in 12 months. It is important to note that two doses of pandemic vaccine are likely to be required to elicit an adequate immune response. Continued efforts are needed to ensure the sustainability of this production and to conduct research for vaccines that are faster to produce and more broadly protective taking into account lessons learned from COVID-19 vaccine development.     

A decade of adaptation: Regulatory contributions of the World Health Organization to the Global Action Plan for Influenza Vaccines (2006–2016)

The Global Action Plan (GAP) for Influenza Vaccines is a decade-long initiative that brings together a diverse range of stakeholders to work towards reducing anticipated global shortage of influenza vaccines and ensuring more equitable access to vaccines during the next influenza pandemic. Since its inception in 2006, significant progress has been made towards all the main objectives of GAP, namely: (1) an increase in seasonal vaccine use, (2) an increase in vaccine production, and (3) progress in research and development of more effective vaccines. The Technology Transfer Initiative (TTI), conceived and managed by WHO under the GAP, contributed to increasing regional influenza vaccine production capacity. This was achieved by facilitating technology transfer in 14 low- and middle-income countries, through grants to manufacturers to establish or strengthen influenza vaccine production capacity and support to their national regulatory authorities. Five of the countries subsequently licensed locally produced influenza vaccines; two pandemic and three seasonal vaccines received WHO prequalification. The success of GAP can be largely attributed to the regulatory support provided by WHO to both manufacturers and regulators. This support had two components: (1) direct regulatory support to GAP/TTI, and (2) support to GAP-related WHO programmes, such as the Pandemic Influenza Vaccine Deployment Initiative in 2010 and the Pandemic Influenza Preparedness Framework since 2013, especially in non-vaccine-producing countries. Temporary adaptation of the assessment process for influenza vaccines in the WHO Vaccine Prequalification Programme to the A(H1N1) pandemic situation in 2009 was instrumental to the success of the WHO Pandemic Influenza Vaccine Deployment Initiative in its attempt to meet the demand for pandemic vaccines in countries that received donated vaccines.     

Meeting Summary: Global Vaccine and Immunization Research Forum, 2021

The 2021 Global Vaccine and Immunization Research Forum highlighted the considerable advances and recent progress in research and development for vaccines and immunization, critically reviewed lessons learned from COVID-19 vaccine programs, and looked ahead to opportunities for this decade.For COVID-19, decades of investments in basic and translational research, new technology platforms, and vaccines targeting prototype pathogens enabled a rapid, global response. Unprecedented global coordination and partnership have played an essential role in creating and delivering COVID-19 vaccines. More improvement is needed in product attributes such as deliverability, and in equitable access to vaccines.Developments in other priority areas included: the halting of two human immunodeficiency virus vaccine trials due to lack of efficacy in preventing infection; promising efficacy results in Phase 2 trials of two tuberculosis vaccines; pilot implementation of the most advanced malaria vaccine candidate in three countries; trials of human papillomavirus vaccines given in single-dose regimens; and emergency use listing of a novel, oral poliomyelitis type 2 vaccine. More systematic, proactive approaches are being developed for fostering vaccine uptake and demand, aligning on priorities for investment by the public and private sectors, and accelerating policy making.Participants emphasized that addressing endemic disease is intertwined with emergency preparedness and pandemic response, so that advances in one area create opportunities in the other. In this decade, advances made in response to the COVID-19 pandemic should accelerate availability of vaccines for other diseases, contribute to preparedness for future pandemics, and help to achieve impact and equity under Immunization Agenda 2030.     

Influenza vaccine viruses and the development of seasonal vaccines: A Japanese perspective

In Japan, the Ministry of Health, Labour and Welfare (MHLW) designates one specific virus strain for each component of the quadrivalent seasonal influenza vaccine, and four domestic manufacturers produce egg-based influenza vaccines with the same formulation (inactivated, split-virus) using uniform vaccine strains. Thus, discussions of the development of effective seasonal influenza vaccines so far has focused solely on the antigenic match between the vaccine strains and epidemic viruses. However, in 2017, the Japanese selection system of vaccine viruses demonstrated that even a candidate vaccine virus that is antigenically similar to the predicted circulating viruses is not necessarily suitable for vaccine production, given lower productivity of the vaccine. Taking this experience into account, the MHLW reformed the scheme of vaccine strain selection in 2018, and instructed the Vaccine Epidemiology Research Group created by the MHLW to probe how the virus strains for the seasonal influenza vaccine should be selected in Japan. In this context, a symposium, entitled “Issues of the Present Seasonal Influenza Vaccines and Future Prospects”, was held as part of the 22nd Annual Meeting of the Japanese Society for Vaccinology in 2018, and subjects related to the influenza vaccine viruses were discussed among relevant administrators, manufacturers, and researchers. This report summarizes the presentations given at that symposium in order to convey the present scheme of vaccine virus selection, the evaluation of the resulting vaccines, and the efforts at new vaccine formulation in Japan. Notably, from March 2022, the MHLW has launched a discussion of the merits of the seasonal influenza vaccines produced by foreign manufacturers.     

Barriers and activities to implementing or expanding influenza vaccination programs in low- and middle-income countries: A global survey

IntroductionDespite considerable global burden of influenza, few low- and middle-income countries (LMICs) have national influenza vaccination programs. This report provides a systematic assessment of barriers to and activities that support initiating or expanding influenza vaccination programs from the perspective of in-country public health officials.MethodsPublic health officials in LMICs were sent a web-based survey to provide information on barriers and activities to initiating, expanding, or maintaining national influenza vaccination programs. The survey primarily included Likert-scale questions asking respondents to rank barriers and activities in five categories.ResultsOf 109 eligible countries, 62% participated. Barriers to influenza vaccination programs included lack of data on cost-effectiveness of influenza vaccination programs (87%) and on influenza disease burden (84%), competing health priorities (80%), lack of public perceived risk from influenza (79%), need for better risk communication tools (77%), lack of financial support for influenza vaccine programs (75%), a requirement to use only WHO-prequalified vaccines (62%), and young children require two vaccine doses (60%). Activities for advancing influenza vaccination programs included educating healthcare workers (97%) and decision-makers (91%) on the benefits of influenza vaccination, better estimates of influenza disease burden (91%) and cost of influenza vaccination programs (89%), simplifying vaccine introduction by focusing on selected high-risk groups (82%), developing tools to prioritize target populations (80%), improving availability of influenza diagnostic testing (79%), and developing collaborations with neighboring countries for vaccine procurement (74%) and regulatory approval (73%). Responses varied by country region and income status.ConclusionsLocal governments and key international stakeholders can use the results of this survey to improve influenza vaccination programs in LMICs, which is a critical component of global pandemic preparedness for influenza and other pathogens such as coronaviruses. Additionally, strategies to improve global influenza vaccination coverage should be tailored to country income level and geographic location.     

Influenza in Latin America: A report from the Global Influenza Initiative (GII)

The Global Influenza Initiative (GII) is a global expert group that aims to raise acceptance and uptake of influenza vaccines globally and provides recommendations and strategies to address challenges at local, national, regional, and global levels. This article provides a consolidated estimation of disease burden in Latin America, currently lacking in published literature, and delivers the GII recommendations specific to Latin America that provide guidance to combat existing vaccination challenges.While many countries worldwide, especially in the tropics and subtropics, do not have a seasonal influenza policy, 90% of Latin American countries have a seasonal influenza policy in place. Local governments in the Latin American countries and The Pan American Health Organization’s Technical Advisory Group on Vaccine-preventable Diseases play a major role in improving the vaccination coverage and reducing the overall disease burden. Influenza seasonality poses the biggest challenge in deciding on optimal timing for vaccination in Latin America, as in temperate climates seasonal influenza activity peaks during the winter months (November–February and May–October) in the northern and southern hemispheres, respectively, while in the tropics and subtropical regions it usually occurs throughout the year, but especially during the rainy season. Besides this, vaccine mismatch with circulating strains, misconception concerning influenza vaccine effectiveness, and poor disease and vaccine awareness among the public are also key challenges that need to be overcome. Standardization of clinical case definitions is important across all Latin American countries. Surveillance (mostly passive) has improved substantially in the Latin American countries over the past decade, but more is still required to better understand the disease burden and help inform policies.     

Changes and remaining challenges for the Japanese immunization program: Closing the vaccine gap

The Japanese immunization program has made considerable progress since 2009: several new vaccines have been introduced and most are included in the National Immunization Program (NIP). In October 2020, the Japanese law on immunization was revised, which resulted in a few laudable achievements. First, rotavirus vaccines were added to the NIP, 10 years after their introduction, and noteworthy studies of vaccine effectiveness and the incidence of intussusception in Japanese children were published. Second, rules on vaccine intervals—which had been a longstanding concern—were withdrawn. In addition to this revision of the law, the Japanese version of the Vaccine Information Statement (VIS) was released by the Japan Pediatric Society in 2018. The VIS provides useful caregiver information on general immunization concepts and individual vaccines. Further challenges for the Japanese immunization program include (1) administering a booster dose of pertussis-containing vaccine to preschool children or teenagers, (2) reestablishing the active recommendation for human papilloma virus vaccines, (3) adding the mumps and influenza vaccines to the NIP, and (4) ensuring optimal dosing of seasonal influenza vaccines. During the current coronavirus disease 2019 (COVID-19) pandemic, vaccination rates among children have been decreasing in many countries. In Japan, vaccination rates have been stable in infants, but declining among toddlers and school-aged children, despite public awareness of the need for timely administration of vaccines during the pandemic. Clearly, further action is needed if we are to adequately protect children living in Japan from vaccine-preventable diseases.     

Inactivated whole influenza virus particle vaccines induce neutralizing antibodies with an increase in immunoglobulin gene subclones of B-lymphocytes in cynomolgus macaques

The All-Japan Influenza Vaccine Study Group has been developing a more effective vaccine than the current split vaccines for seasonal influenza virus infection. In the present study, the efficacy of formalin- and/or β-propiolactone-inactivated whole virus particle vaccines for seasonal influenza was compared to that of the current ether-treated split vaccines in a nonhuman primate model. The monovalent whole virus particle vaccines or split vaccines of influenza A virus (H1N1) and influenza B virus (Victoria lineage) were injected subcutaneously into naïve cynomolgus macaques twice. The whole virus particle vaccines induced higher titers of neutralizing antibodies against H1N1 influenza A virus and influenza B virus in the plasma of macaques than did the split vaccines. At challenge with H1N1 influenza A virus or influenza B virus, the virus titers in nasal swabs and the increases in body temperatures were lower in the macaques immunized with the whole virus particle vaccine than in those immunized with the split vaccine. Repertoire analyses of immunoglobulin heavy chain genes demonstrated that the number of B-lymphocyte subclones was increased in macaques after the 1st vaccination with the whole virus particle vaccine, but not with the split vaccine, indicating that the whole virus particle vaccine induced the activation of vaccine antigen-specific B-lymphocytes more vigorously than did the split vaccine at priming. Thus, the present findings suggest that the superior antibody induction ability of the whole virus particle vaccine as compared to the split vaccine is attributable to its stimulatory properties on the subclonal differentiation of antigen-specific B-lymphocytes.     

A Research and Development (R&D) roadmap for influenza vaccines: Looking toward the future

Improved influenza vaccines are urgently needed to reduce the burden of seasonal influenza and to ensure a rapid and effective public-health response to future influenza pandemics. The Influenza Vaccines Research and Development (R&D) Roadmap (IVR) was created, through an extensive international stakeholder engagement process, to promote influenza vaccine R&D. The roadmap covers a 10-year timeframe and is organized into six sections: virology; immunology; vaccinology for seasonal influenza vaccines; vaccinology for universal influenza vaccines; animal and human influenza virus infection models; and policy, finance, and regulation. Each section identifies barriers, gaps, strategic goals, milestones, and additional R&D priorities germane to that area. The roadmap includes 113 specific R&D milestones, 37 of which have been designated high priority by the IVR expert taskforce. This report summarizes the major issues and priority areas of research outlined in the IVR. By identifying the key issues and steps to address them, the roadmap not only encourages research aimed at new solutions, but also provides guidance on the use of innovative tools to drive breakthroughs in influenza vaccine R&D.     

Cost-effectiveness of introducing an MF59-adjuvanted trivalent influenza vaccine for older adults in Argentina

IntroductionInfluenza surveillance in Argentina reported influenza-like illness at a rate of 3500/100,000, a hospitalization rate of 15.5/100,000, and a death rate of 0.32/100,000 annually in adults aged over 65 years. The high burden of disease may be due to a combination of immunosenescence and the suboptimal clinical effectiveness of conventional, non-adjuvanted influenza vaccines in this age group. There is a clinical need for more effective influenza vaccines in this population. This study evaluated the cost-effectiveness of an MF59®-adjuvanted trivalent influenza vaccine (aTIV) in adults aged over 65 years in Argentina compared with the non-adjuvanted trivalent influenza vaccine (TIV) used under the current national vaccination policy.MethodsA decision tree cost-effectiveness model was developed to estimate the cost-effectiveness of switching from TIV to aTIV in Argentinian older adults. The model compared cost and health benefits of vaccination in one influenza season from the payer perspective. The main predictions included survival, quality-adjusted survival, and costs. Model inputs were sourced from Argentina or internationally where local data was considered inaccurate. Vaccine efficacy assumptions were extracted from recently published, peer-reviewed scientific literature.ResultsSwitching from TIV to aTIV would result in 170 deaths averted and 1310 incremental quality-adjusted life years (QALYs) gained. The incremental cost-effectiveness ratio per QALY was US $2660.59 from the payer perspective. In all sensitivity analyses, aTIV remained highly cost-effective. The probabilistic sensitivity analyses showed a 95% CI per QALY of US $113.74–7721.67.ConclusionIntroducing an adjuvanted influenza vaccine in Argentina is potentially beneficial and cost-effective relative to the currently-used TIV through the reduction of disease burden and utilization of healthcare resources.     

Survey of influenza vaccine knowledge,attitudes, and beliefs among pregnant women in the 2016–17 season

ObjectivesInfluenza vaccination coverage among pregnant women in the United States is suboptimal. We surveyed women who were pregnant during the 2016–17 influenza season to assess knowledge and attitudes regarding influenza vaccination.MethodsWe identified and sampled pregnant women to include approximately equal numbers of vaccinated and unvaccinated women from strata defined by vaccination status and trimester from four integrated health systems in the Vaccine Safety Datalink (VSD). Potential participants were contacted via mail and telephone to complete a standardized survey. Characteristics and responses of women vaccinated and unvaccinated during pregnancy were compared.ResultsThe survey was completed by 510 (48%) of 1062 contacted women; 500 were included in the analysis. Vaccine receipt while pregnant was associated with primigravida status (p = 0.02), college degree (p = 0.01), employment in health care (p < 0.01), and history of routine annual influenza vaccination (p < 0.01). Among 330 vaccinated women, the primary reasons for vaccination included protection of self and baby from influenza (n = 233, 71%), and medical professional recommendation (n = 46, 14%). Multiple reasons were given for nonvaccination, but concern about ‘negative effects’ was cited most often (n = 44, 29%). Vaccinated women were significantly more likely to believe that influenza vaccines are safe and effective, and to recognize the potential for harm from influenza infection. Nearly all women reported receiving at least one influenza vaccination recommendation from a healthcare provider.ConclusionsVaccinated pregnant women were more likely to receive routine annual influenza vaccine compared to those not vaccinated. Recommendations by obstetric providers should be supplemented with efforts to encourage women of childbearing age to receive annual vaccination.     

Using classification and regression tree analysis to explore parental influenza vaccine decisions

Background and objectivesInfluenza poses a public health threat for children and adults. The CDC recommends annual influenza vaccination for children <18 years, yet vaccine uptake remains low for children (57.9%) and adults (37.1%). Given that parental decision-making is key in childhood vaccine uptake, there is a critical need to understand vaccine hesitancy among parents who decide not to vaccinate their children. This study aims to explore predictors of children’s influenza vaccine status given parental vaccination status and examine the factors that contribute to concordance or discordance between parental and children’s vaccine uptake.MethodsClassification and regression tree (CART) analyses were used to identify drivers of parental decisions to vaccinate their children against influenza. Hierarchy and interactions of these variables in predicting children’s vaccination status were explored.ResultsFrom a nationally representative sample of non-Hispanic Black and White parents who completed an online survey (n = 328), the main factors influencing parents’ decisions to vaccinate their children were vaccine behavior following physician recommendation, knowledge of influenza recommendations for children, influenza vaccine confidence and disease risk. Among unvaccinated parents, the greatest concordance was observed among parents who usually do not get vaccinated following physician recommendation and had lower knowledge of recommendations for influenza vaccination for children. The greatest discordance was observed among unvaccinated parents who had lower hesitancy about recommended vaccines.ConclusionsUnderstanding drivers of parental decisions to vaccinate themselves and their children can provide insights on health communication and provider approaches to increase influenza vaccine coverage and prevent influenza related mortality.     

Differences and disparities in seasonal influenza vaccine,acceptance, adverse reactions,and coverage by age,sex, gender,and race

BackgroundInfluenza is a significant threat to public health worldwide. Despite the widespread availability of effective and generally safe vaccines, the acceptance and coverage of influenza vaccines are significantly lower than recommended. Sociodemographic variables are known to be potential predictors of differential influenza vaccine uptake and outcomes.ObjectivesThis review aims to (1) identify how sociodemographic characteristics such as age, sex, gender, and race may influence seasonal influenza vaccine acceptance and coverage; and (2) evaluate the role of these sociodemographic characteristics in differential adverse reactions among vaccinated individuals.MethodsPubMed was used as the database to search for published literature in three thematic areas related to the seasonal influenza vaccine - vaccine acceptance, adverse reactions, and vaccine coverage.ResultsA total of 3249 articles published between 2010 and 2020 were screened and reviewed, of which 39 studies were included in this literature review. By the three thematic areas, 17 studies assessed vaccine acceptance, 8 studies focused on adverse reactions, and 14 examined coverage of the seasonal influenza vaccine. There were also two studies that focused on more than one of the areas of interest.ConclusionEach of the four sociodemographic predictors – age, sex, race, and gender – were found to significantly influence vaccine acceptance, receipt and outcomes in this review.     

Does having a seasonal influenza program facilitate pandemic preparedness? An analysis of vaccine deployment during the 2009 pandemic

BackgroundNational seasonal influenza programs have been recommended as a foundation for pandemic preparedness. During the 2009 pandemic, WHO aimed to increase Member States’ equitable access to influenza vaccines through pandemic vaccine donation.MethodsThis analysis explores whether the presence of a seasonal influenza program contributed to more rapid national submission of requirements to receive vaccine during the 2009 influenza pandemic. Data from 2009 influenza vaccine donation, deployment, and surveillance initiatives were collected during May-September 2018 from WHO archival material. Data about the presence of seasonal influenza vaccine programs prior to 2009 were gathered from the WHO-UNICEF Joint Reporting Form. Cox proportional hazards models were used to assess the relationship between presence of a seasonal influenza program and time to submission of a national deployment and vaccination plan and to vaccine delivery.FindingOf 97 countries eligible to receive WHO-donated vaccine, 83 (86%) submitted national deployment and vaccination plans and 77 (79%) received vaccine. Countries with a seasonal influenza vaccine program were more likely to submit a national deployment and vaccination plan (hazards ratio [HR] 2.1; 95% confidence interval [CI]. Countries with regulatory delays were less likely to receive vaccine than those without these delays (HR 0.4, 95% CI: 0.2–0.6).InterpretationDuring the 2009 pandemic, eligible countries with a seasonal influenza vaccine program were more ready to receive and use donated vaccines than those without a program. Our findings suggest that robust seasonal influenza vaccine programs increase national familiarity with the management of influenza vaccines and therefore enhance pandemic preparedness.FundingN/A.     

Vaccine innovation prioritisation strategy: Findings from three country-stakeholder consultations on vaccine product innovations

As part of the Vaccine Innovation Prioritisation Strategy (VIPS), three immunization-stakeholder consultations were conducted between September 2018 and February 2020 to ensure that countries’ needs drove the prioritization of vaccine product innovations.All consultations targeted respondents with immunization program experience. They included: (1) an online survey to identify immunization implementation barriers and desired vaccine attributes in three use settings, (2) an online survey to identify and evaluate the most important immunization challenges for ten exemplar vaccines, and (3) in-depth interviews to better understand the perceived programmatic benefits and challenges that could be addressed by nine innovations and to rank the innovations that could best address current challenges.The first consultation included responses from 442 participants in 61 countries, representing 89% of the 496 respondents who correctly completed at least one section of the online survey. For facility-based settings, missed opportunities for vaccination due to reluctance to open multidose vaccine vials was the barrier most frequently selected by respondents. In community-based (outreach) and campaign settings, limited access to immunization services due to geographic barriers was most frequently selected. Multidose presentations with preservative or single-dose presentations were most frequently selected as desired vaccine attributes for facility-based settings while improved thermostability was most frequently selected for outreach and campaign settings. The second online survey was completed by 220 respondents in 54 countries. For the exemplar vaccines, vaccine ineffectiveness or wastage due to heat or freeze exposure and missed opportunities due to multidose vial presentations were identified as the greatest vaccine-specific challenges. In-depth interviews with 84 respondents in six countries ranked microarray patches, dual-chamber delivery devices, and heat-stable/controlled temperature chain qualified liquid vaccines as the three innovations that could have the greatest impact in helping address current immunization program challenges.These findings informed the VIPS prioritization and provided broader application to designing immunization interventions to better meet country needs.     

The v-safe after vaccination health checker: Active vaccine safety monitoring during CDC’s COVID-19 pandemic response

The Centers for Disease Control and Prevention (CDC) developed and implemented the v-safe after vaccination health checker (v-safe) to monitor COVID-19 vaccine safety and as an active surveillance supplement to existing CDC vaccine safety monitoring programs. V-safe allows persons who received COVID-19 vaccines to report on post-vaccination experiences and how symptoms affected their health at daily, weekly, and monthly timepoints after vaccination. Text message reminders are sent linking to Internet-based health check-in surveys. Surveys include questions to identify v-safe participants who may be eligible to enroll in a separate pregnancy registry activity that evaluates maternal and infant outcomes in those pregnant at the time of vaccination or receiving vaccine in the periconception period.We describe the development of and enhancements to v-safe, data management, promotion and communication to vaccination sites and partners, publications, strengths and limitations, and implications for future systems. We also describe enrollment in v-safe over time and demographics of persons participating in v-safe during the first year of operation (December 14, 2020 – December 13, 2021). During this time, 9,342,582 persons submitted 131,543,087 v-safe surveys. The majority of participants were female (62.3 %) and non-Hispanic White (61.2 %); median age was 49.0 years. Most participants reported receiving an mRNA COVID-19 vaccine as their first recorded dose (95.0 %).V-safe contributed to CDC’s vaccine safety assessments for FDA-authorized COVID-19 vaccines by enabling near real-time reporting of reactogenicity once the COVID-19 vaccination program began in the community, encouraging reports to the Vaccine Adverse Event Reporting System and facilitating enrollment in a large post-vaccination pregnancy registry. Given that v-safe is an integral component of the most comprehensive safety monitoring program in U.S. history, we believe that this approach has promise as a potential application for future pandemic response activities as well as rollout of novel vaccines in a non-pandemic context.     

Influenza virus vaccine compliance among pregnant women during the COVID-19 pandemic (pre-vaccine era) in Israel and future intention to uptake BNT162b2 mRNA COVID-19 vaccine

The influenza virus vaccine, used worldwide as an annual preventive measure, is especially recommended for at-risk populations. Older adults and pregnant women are therefore offered the flu shot free of charge in Israel. The Israel Ministry of Health’s rationale for giving the influenza vaccine to pregnant women is to avoid serious complications that could harm both mother and foetus. In Israel, the winter of 2020/2021 was marked by a third surge of COVID-19, raising the risk of contracting the SARS-CoV-2 virus and the level of fear among the population. The influenza vaccine protects individuals from the flu and thus helps prevent an additional burden on medical centres treating COVID-19 patients. The aim of the present study was to assess compliance of pregnant and postpartum women to influenza vaccine uptake during winter 20/21 period. A survey questionnaire was distributed to examine factors predicting women’s attitudes toward the influenza vaccine. Questionnaire items based on the Heath Belief Model examined participants’ perceptions regarding influenza and the vaccine. The questionnaire also evaluated participants’ hypothetical willingness to get immunized with the Pfizer COVID-19 vaccine upon its arrival in Israel. The results showed a higher prevalence of influenza vaccine uptake among Jewish women than Arab women, while level of trust in healthcare providers was stronger among Arab participants than among Jewish participants. The findings indicate that the pregnant and postpartum community needs better information dissemination and education regarding the importance of the influenza vaccine. Decisions regarding uptake of the COVID-19 vaccine upon future availability were found to be unrelated to influenza vaccine perceptions. The results call for raising public awareness regarding influenza immunization in addition to offering the vaccine at routine pregnancy follow-up appointments.     

Estimating the number of averted illnesses and deaths as a result of vaccination against an influenza pandemic in nine low- and middle-income countries

BackgroundDuring the 2009 influenza A(H1N1)pdm09 pandemic, 77 countries received donated monovalent A(H1N1)pdm09 vaccine through the WHO Pandemic Influenza A(H1N1) Vaccine Deployment Initiative. However, 47% did not receive their first shipment until after the first wave of virus circulation, and 8% did not receive their first shipment until after the WHO declared the end of the pandemic. Arguably, these shipments were too late into the pandemic to have a substantial effect on virus transmission or disease burden during the first waves of the pandemic.ObjectivesIn order to evaluate the potential benefits of earlier vaccine availability, we estimated the number of illnesses and deaths that could be averted during a 2009-like influenza pandemic under five different vaccine-availability timing scenarios.MethodsWe adapted a model originally developed to estimate annual influenza morbidity and mortality burden averted through US seasonal vaccination and ran it for five vaccine availability timing scenarios in nine low- and middle-income countries that received donated vaccine.ResultsAmong nine study countries, we estimated that the number of averted cases was 61–216,197 for actual vaccine receipt, increasing to 2,914–283,916 had vaccine been available simultaneously with the United States.ConclusionsEarlier delivery of vaccines can reduce influenza case counts during a simulated 2009-like pandemic in some low- and middle-income countries. For others, increasing the number of cases and deaths prevented through vaccination may be dependent on factors other than timely initiation of vaccine administration, such as distribution and administration capacity.     

Meeting report: CEPI consultation on accelerating access to novel vaccines against emerging infectious diseases for pregnant and lactating women,London, 12–13 February 2020

Infectious diseases may cause serious morbidity and mortality in pregnant women, their foetuses, and infants; the risk associated with any newly emerging infectious disease (EID) is likely unknown at the time of its emergence. While the ongoing SARS-CoV-2 pandemic shows that the development of vaccines against new pathogens can be considerably accelerated, the immunization of pregnant women generally lags behind the general population. Guided by the priority pathogen list for WHO’s R&D Blueprint for Action to Prevent Epidemics, this workshop sought to define the evidence needed for use of vaccines against EIDs in pregnant and lactating women, using Lassa fever as a model. Close to 60 maternal immunization (MI) and vaccine safety experts, regulators, vaccine developers, Lassa fever experts, and investigators from Lassa-affected countries examined the critical steps for vaccine development and immunization decisions for pregnant and lactating women. This paper reports on key themes and recommendations from the workshop.Current practice still assumes the exclusion of pregnant women from early vaccine trials. A shift in paradigm is needed to progress towards initial inclusion of pregnant women in Phase 2 and 3 trials. Several practical avenues were delineated. Participants agreed that vaccine platforms should be assessed early for their suitability for maternal immunization. It was noted that, in some cases, nonclinical data derived from assessing a given platform using other antigens may be adequate evidence to proceed to a first clinical evaluation and that concurrence from regulators may be sought with supporting rationale. For clinical trials, essential prerequisites such as documenting the disease burden in pregnant women, study site infrastructure, capabilities, and staff experience were noted. Early and sustained communication with the local community was considered paramount in any program for the conduct of MI trials and planned vaccine introduction.