Gavi’s 2022 progress report: rebounds and challenges

Gavi’s 2022 progress report: rebounds and challenges

In September 2023 Gavi announced the publication of its 2022 Annual Progress Report, which presents insights into a “year of recovery” for immunisation services thanks to “historic levels of investment” by lower-income countries. Just a few months ago the organisation celebrated the immunisation of over 1 billion children, a milestone that is highlighted in the report. Here we investigate the key themes and concerns of the report. 

The Chair and CEO weigh in 

Professor José Manuel Barroso, Chair of the Gavi Board, and CEO David Marlow open the publication by reflecting on the findings of the report and the goals it presents. They recognise that “nearly half of lower-income countries have recovered to or are above pre-pandemic DTP3 coverage levels”. This is a standard that refers to immunisations with the third dose of diphtheria, pertussis, and tetanus-containing vaccines. However, “some countries saw slower progress”.  

Although the number of so-called “zero-dose children” has fallen from 12.4 million to 10.2 million, this is higher than the estimated 9 million of 2019, with a reduction of 34% required to meet the target for 2025.  

“As we reflect on the important progress and urgent challenges that remain, the Vaccine Alliance nonetheless acknowledges the tremendous effort countries have made to get routine immunisation back on track.”  

Professor Barroso and Mr Marlow recognise that 2022 was “indeed complex and challenging for global health”; COVID-19 caused great suffering and undermined routine immunisations. Polio and diphtheria emerged in some countries for the first time in “decades”, Uganda “battled an outbreak of Sudan ebolavirus”, and mpox was declared a PHEIC. Thus, 2023 was “heralded” as a Year of Renewal.  

In December 2022, the Gavi Board approved “Gavi 5.1”, an “evolution” of the 5-year programme strategy with renewed focus on essential and COVID-19 vaccinations, reaching zero-dose children, introducing new vaccines, and strengthening the Alliance’s role in PPPR: pandemic prevention, preparedness, and response.  

“To make up the ground we lost during the pandemic, in December 2022 the Gavi Board approved a more than $600 million investment to protect 86 million girls [with HPV vaccines] by 2025.” 

With “climate change, deforestation, and migration” come increased risks of infectious disease outbreaks. This has been demonstrated in the “tragic turn” of cholera cases increasing globally. As these risks increase, the importance of Gavi’s commitment to vaccine equity is emphasised. An example of how vaccine equity is challenges it the “dearth of vaccine manufacturing in some regions”, such as across Africa. Gavi recognises its responsibility to “build healthier vaccine markets” by working with African countries and Africa CDC, establishing a greater manufacturing capacity in Africa.  

The foreword concludes with a reflection on the “six core values” that guide Gavi’s work: teamwork, respect, openness, accountability, innovation, and country-driven.  

Leaving no one behind 

Gavi’s “vision” is “leaving no one behind with immunisation”, which translates into the mission: “to save lives and protect people’s health by increasing equitable and sustainable use of vaccines”. This mission is supported with four strategic goals (below) with strategy indicators.  


The vaccine goal 

The report confirms that since 2000, Gavi has helped countries reach over 1 billion unique children with routine immunisation. It also highlights a range of other achievements, including the interesting fact that “children in Gavi-supported countries are better protected than children in other countries” due to the “breadth of protection” by vaccines in the Gavi portfolio. The growth of this portfolio is illustrated in the figure below: 


The other goals are explored through graphics and figures throughout the report, and we encourage you to access it here if you are interested! 

Learning from the report 

What can we take from the facts, figures, and findings of the report? Marlow emphasises that the data show that “immunisation really is a global success story in terms of the unprecedented levels of collaboration”.  

“At the same time, we must not lose sight of the challenges ahead, as countries face a very uncertain future as a result of deteriorating economic conditions, an uncertain geopolitical outlook, and the impact of climate change among other factors. The need for continued collaboration and innovation, today, is greater than ever.” 

Professor Barroso comments that the Alliance’s “priority” is to help countries “maintain this trajectory” of restoring immunisation, broadening coverage, and mobilising domestic resources.  

“The prospect for immunisation to deliver transformative societal and economic benefits is greater than ever, but only if we are collectively able to navigate the path ahead.”  

WHO Director-General Dr Tedros Adhanom Ghebreyesus is encouraged by the “global rebound” in immunisation, which he describes as a “tribute” to those who have worked on it. 

“But global and regional averages don’t tell the whole story, and they mask severe and persistent inequities. When countries and regions lag, children pay the price.” 

He is “proud to work with Gavi” to ensure that every child “benefits from the life-saving power of vaccines”. UNICEF Executive Director Catherine Russell agrees that “the job isn’t done yet”, with many countries “yet to recover the ground they lost during the pandemic”.  

“We must double down on our efforts to reach every child. The recovery has started, now let’s make sure it’s equitable and durable.”  

If you’ve read the report, what do think it means for the global vaccine community? How can Gavi-supported countries continue to recover, and what are the implications for countries that don’t receive support from Gavi?  

For more on equitable vaccine progress join us at the Congress next month in Barcelona or subscribe to our newsletter here.

CEPI and Global Affairs Canada collaborate on biosecurity

CEPI and Global Affairs Canada collaborate on biosecurity

In September 2023 CEPI announced a “renewed collaboration” with Global Affairs Canada, comprising CAD 1 million in funding to “accelerate the development of vaccines against emerging infectious disease”. The funding will support CEPI’s efforts to “manage the inherent biological security risks” of the century, encourage engagement with the security community, and “catalyse new and stronger health partnerships”. This collaboration also furthers progress on the 100 Days Mission.  

“As stewards of global public funds CEPI has a critical responsibility to ensure that CEPI-funded R&D is conducted safely and securely.” 
Weapons Threat Reduction 

CEPI reports that Global Affairs Canada’s Weapons Threat Reduction Programme (WTRP) is going to support the development and implementation of CEPI’s biosecurity strategy. Heading this up is inaugural Director of Biosecurity, Dr Andrew Hebbeler. Dr Hebbeler is a “globally recognised biosecurity expert” with experience leading “global policy and capacity-building efforts aimed at preventing, detecting, and responding to” biological events. These include natural, accidental, and deliberate events.  

To identify relevant initiatives within the sector, CEPI intends to “map the biosecurity landscape” and its “intersection with global health and health-security spaces”. From there the organisation hopes to understand how it can offer “opportunities for alignment and collaboration”.  

Trevor Smith, Canada’s Investor Council Representative, commented that the WTRP “recognises the critical role” of vaccines and medical countermeasures in the “fight against the deliberate use of disease”. The programme has been investing in CEPI’s “world-leading R&D since 2017. 

“We are proud to build on and further strengthen our collaborative partnership with CEPI through this biosecurity-focused contribution. In the global campaign to prevent, detect, and respond to biological health threats and to build sustainable health-security capacity, multi-sectoral cooperation is imperative.” 
Biosecurity meets health 

The 100 Days Mission “directly contributes” to health and security goals by contributing to pandemic prevention, regardless of an outbreak’s origin.  

“It is imperative that CEPI define the risks and opportunities underpinning expanded investments in the development of safe and effective vaccines and other biologic countermeasures.” 

Thus, CEPI can assume a “leadership role”, driving international norms and standards.  

Lessons from COVID-19 

In CEPI’s announcement in September we are reminded of the “devastating and destabilising effect” that infectious diseases have on society. COVID-19 had consequences for health, economies, and global security. Unfortunately, the risk of emerging infectious diseases is “increasing” thanks to a plethora of moving parts including climate change, urbanisation, and environmental degradation.  

Technology troubles 

Although emerging technology is exciting, creating “new and promising opportunities” to improve health, it also brings “new and evolving risks”. For example, as we explored in our summary of the Brown School of Public Health’s New Species of Trouble, there will be future outbreaks that may be triggered by accidental or deliberate pathogen release, as well as emerging technologies.  

“Addressing biosecurity is a key component of strengthening global health security, and ensuring the world is prepared for future epidemics and pandemics.”  

Dr Richard Hatchett, CEPI’s CEO, believes it is “vital” for countries to be ready to respond to biological threats “no matter the source or cause”.  

“Investing in the ability to rapidly develop and manufacture vaccines and other biologic countermeasures against a broad range of potentially dangerous pathogens enables governments to advance their security interests at home and abroad.” 

Dr Hatchett is “pleased to elevate the role of biosecurity in CEPI’s mission” and looks forward to the strengthened collaboration with Global Affairs Canada.  

For more from CEPI and other health leaders at the Congress in Barcelona, get your tickets to the event here. Or plan to join us in April in Washington! For weekly updates on global health and vaccine progress, subscribe to our newsletter here.  

Report: investigating vaccine manufacturing in Africa

Report: investigating vaccine manufacturing in Africa

We know from before and during the COVID-19 pandemic that Africa’s demand for vaccines exceeds its local supply: 99% of vaccines administered on the continent are imported. The pandemic highlighted an existing need, but did it also galvanise action to establish greater “local” manufacturing? A recent report by Africa CDC, the Clinton Health Access Initiative (CHAI), and PATH, examines “current and planned vaccine manufacturing in Africa”. Here we look at the findings and recommendations presented in the report.  

Why does Africa need manufacturing? 

Apart from the pressures placed on Africa during the COVID-19 pandemic, Chatham House suggested in 2022 that “seven of every ten vaccines” used in Africa are donated by Gavi. A year before that, WHO Africa reported on the “enormous challenges” to establishing sustainable vaccine industries. The imbalance in production contributes to “unequal access” and “enormous health disparities” suggests this latest report.  

In the report, Africa CDC, CHAI, and PATH analyse the current and planned manufacturing capacity in Africa, at a time of expected growth. The hope is that the paper will offer “insights into what is needed to develop a robust and sustainable vaccine manufacturing ecosystem”.  

The process behind the paper 

Although Africa needs a more effective vaccine manufacturing ecosystem, current capabilities are set to “expand dramatically” because of the COVID-19 pandemic. This highlight inequities and provoked a “surge in local political support for vaccine production”. So, what does the environment currently look like, and what might it turn into in the future? To answer these questions, a collaborative team engaged vaccine manufacturers across Africa between December 2022 and March 2023 on “current and planned production capacity, technical and commercial capabilities, and supporting functions”.  

19 manufacturers were engaged in total, including manufacturers with commercial scale production capacity and early-stage projects. The team also involved a “variety of originator companies” outside Africa that are interested in technology transfers. The goal of this involvement was to identify their perceived “opportunities, challenges, and considerations for collaboration”.  

The “benchmark” for vaccine demand was 2030, but 2040 is also considered in line with PAVM Framework for Action, which “sets the goal of manufacturing 60% of Africa’s routine immunisation needs on the continent by 2040”. The authors note that “other aspects of the vaccine manufacturing ecosystem” such as infrastructure development and improvement, regulatory authority strengthening, and market shaping, are not covered in the paper.  

Finding 1: too much form/fill/finish not enough antigen production 

The first finding in the paper identifies an “excess” of form/fill/finish” in contrast with a “dearth of antigen production”. The analysis explored two critical steps in the manufacturing process: 

  1. Drug substance production – the most cost-intensive and technically challenging step 
  2. Drug product production – including formulation, fill, and finish (form/fill/finish) 

The authors suggest that “current capacity”, including ordered capacity, to form/fill/finish vaccines with imported antigen is “around 2 billion doses”. This “far exceeds” the average annual demand of 1.3 billion doses, yet further capacity is planned to increase production by “2 billion-plus doses”.  

“The scale of overcapacity means there is a risk not every manufacturing project will be sustainable.” 

On the other hand, antigen production capacity is “very limited” and “well below” the capacity required for PAVM’s domestic production targets. Furthermore, a significant proportion of antigen production is now used for non-vaccine products. Unfortunately, plans to expand manufacturing are “not enough to close the gap between production and demand”.  

Finding 2: limited access to technology transfer 
“Africa is reliant on technology transfers…due to the complex nature of vaccine manufacturing and the urgency with which manufacturers needed to scale production on the continent.” 

At present, the research team identified “limited technology transfers”, which mean that African vaccine manufacturers may only be able to produce a “fraction of what they theoretically could”. They note that “technology transfer can be an important step in developing capacity to produce antigens locally”. Furthermore, “uncertain demand commitments” from governments for African-made vaccines add a complication.  

“Demand uncertainty creates a barrier for African vaccine manufacturers…even among those manufacturers that have been able to sign agreements, unclear demand is delaying implementation of those transfers.” 

Finally, a “single vaccine manufacturer” drives most current technology transfers to Africa. Thus, a “significant dependence” is established, making the “ecosystem vulnerable”. 

Finding 3: available capacity does not equal commercial success 

Although African manufacturers have “potential”, this does not guarantee “commercial success”. For example, despite “strong financial capabilities” for many manufacturers, commercial capabilities must be developed.  

“Success depends on commercial savvy, market access, and effective partnerships, among other important factors.” 

However, the “biggest obstacles” to the development of sustainable vaccine manufacturing capacity are “market access and demand materialisation”. Going global is easier intended than realised, and the report recognises “challenges breaking into the regional and global markets”.  

“Local government support has been a driving force behind many manufacturers’ plans, but it has also led to strategies that are aligned to local political decisions rather than global market requirements.”  
Recommendations and next steps 

As is often the case, the importance of “investor and donor support” is raised as “crucial to a healthy and sustainable vaccine manufacturing ecosystem”. However, “careful consideration” must be given to how each investment supports “the whole” and pandemic preparedness. Similarly, stakeholders in Africa should “focus on efforts that build the continental vaccine manufacturing ecosystem” over “efforts that only benefit a particular manufacturer or country”.  

Investors and donors should… 

  • Reconsider investments in form/fill/finish capacity building in favour of efforts that strengthen commercial viability 
  • Strengthen end-to-end manufacturing capabilities with investments that build capacity to manufacture antigens locally 
  • Fund technical support to achieve international standards for Good Manufacturing Practice and prepare for/secure WHO prequalification 

African manufacturers and governments should… 

  • Improve the likelihood that investments have the right effect by strengthening commercial strategies and business planning, determining a clear pathway to market access 
  • Diversify technology transfer partners to mitigate the risk of a market monopoly for antigen production 
  • Be more precise in demand commitments for African-made vaccines, to catalyse technology transfers and create a market 

These steps are a “multi-year, complex undertaking” and will require collaborative efforts. Thus, each of the partners outlines specific areas of commitment.  

PATHworking with partners to determine the conditions needed to achieve the planned capacity, referred to as “future state mapping”. 
CHAIworking with key stakeholders to develop a set of high-impact, market-shaping interventions and support in their execution, including addressing the strategic and commercial gaps identified through the landscaping exercise. 
Africa CDCworking with African Union Member States to agenda-set activities guided by the PAVM Framework for Action by developing initiatives to support the procurement of African-made vaccines.  

Do you agree with the findings and recommendations set out in the report? If you are based in Africa, how realistic is this? If you are in other areas, what lessons can you learn from this perspective?  

If you are interested in discussions about African manufacturing check out our interview with Professor Terblanche of Afrigen. For more on technology transfer, check out this conversation with Dr Ike James, Medicines Patent Pool.

We look forward to learning more about global manufacturing and African-made vaccines at our Congress in Barcelona next month as well as in Washington next year. Are you joining us? Don’t forget to subscribe for more like this.

COVID-19 vaccines and unexpected vaginal bleeding

COVID-19 vaccines and unexpected vaginal bleeding

Although insufficient attention has been directed towards the effects of vaccination on menstrual experiences, a study published in Science Advances in September 2023 presents research into the link between COVID-19 vaccination and “unexpected vaginal bleeding” in “nonmenstruating women”. The study, carried out in Norway, examines self-reported data from 2021 after spontaneous reporting systems revealed an increase in “menstrual disturbances” and “post-menopausal bleeding” (PMB).  

Who was affected? 

The study involved almost 22,000 participants and examined three main areas: 

  1. Vaginal bleeding in postmenopausal women 
  2. Unexpected vaginal bleeding in perimenopausal women 
  3. Breakthrough bleeding in nonmenstruating premenopausal women 

The latter group involves a “substantial proportion of the female population” that does not menstruate because they use long-term hormonal contraception.  

“While an altered bleeding pattern after COVID-19 vaccination has been frequently addressed among menstruating women, few studies have investigated such experiences in women who do not menstruate due to hormonal contraception.”  

This figure (below) from the paper presents the data cleaning and inclusion process involved: 


What did the team find? 

Study author Kristine Blix told Nature that the results were “surprising”: 252 postmenopausal women, 1,008 perimenopausal women, and 924 premenopausal women report instances of unexpected vaginal bleeding. Of these experiences, around 50% were reported within 28 of vaccination. In postmenopausal women, the risk of vaginal bleeding “was increased two to threefold in the 4 weeks after vaccination”, compared to the pre-vaccination period. By comparison, the association with vaccination was “slightly stronger” in peri- and pre-menopausal women; the risk was increased three to fivefold. 

Blix states that the “most important contribution” of their research could be that “female bleeding patterns are included as end points, or monitored, in clinical trials of new vaccines”.  

Why this is important 

Dr Kate Clancy from the University of Illinois told Nature that unexpected bleeding after menopause is “often very concerning”, but this link could allow health providers to “put their bleeding incidence into context’. However, she’s “so glad” to see attention on a “very underserved group”. 

“Hooray for another group looking at peri- and postmenopausal people!” 

If this study is of interest do click here to see the full paper or subscribe for more vaccine safety insights. We look forward to hearing more discussions about vaccine safety at the Congress in Barcelona next month. Join us there! 

Genomic surveillance strategies: WHO’s step-by-step guide

Genomic surveillance strategies: WHO’s step-by-step guide

In September 2023 WHO shared Considerations for developing a national genomic surveillance strategy or action plan for pathogens with pandemic and epidemic potential to support countries in the development of genomic surveillance strategies. This publication seeks to answer some questions that arise in the wake of surveillance gains from the pandemic, which highlighted the importance of genomics in public health toolkits. The guide establishes key considerations and an approach for developing a national strategy, and WHO recommends that all stakeholders can use it. 

Developing an effective health toolkit 

The introduction reflects that genomic surveillance has become a “priority” in public health systems, with genomic sequencing being used to characterise pathogens and monitor important public health priorities.  

“The decrease in cost and time of sequencing and the exponential development of bioinformatic pipelines have played a critical role in integrating pathogen genomics into routine public health surveillance.” 

During the COVID-19 pandemic, sequencing was emphasised as a useful tool in infectious disease surveillance, facilitating “earlier detection, more accurate investigation of outbreaks, closer real-time monitoring of pathogen evolution, and tailored development and evaluation of interventions”. Despite the importance of genomic sequencing, WHO identifies a need to “coordinate efforts, leverage and link existing surveillance and laboratory networks and capabilities, and systematically integrate genetic sequence data with clinical and epidemiological data”.  

In the spring of 2022 WHO launched a 10-year global genomic surveillance strategy for pathogens with pandemic and epidemic potential. The goal is to “strengthen and scale up” genomic surveillance to promote “quality, timely, and appropriate” actions. Furthermore, WHO developed 13 “foundational principles” to encourage global data sharing: 

  1. Capacity development 
  2. Collaboration and cooperation 
  3. High-quality, reproducible data 
  4. Global and regional representativeness 
  5. Timeliness 
  6. Acknowledgment and intellectual credit 
  7. Equitable access to health technologies as a benefit 
  8. As open as possible, and as closed as necessary 
  9. Interoperability and relevance for national, regional, and global decision-makers 
  10. Trustworthiness and ease of use 
  11. Transparency 
  12. Consistency with applicable law and ethical regulations 
  13. Compliance and enforcement 
Challenges and opportunities 

The report recognises “considerable” challenges and opportunities in terms of infrastructure, capacity and capability requirements, and “harmonisation across systems”. However, these vary depending on the national context. Thus, an “adequately resourced” strategy will enable countries to set goals, objectives, and priority strategic actions.  

The tool outlines key considerations and a stepwise approach, recommending that a national strategy should reflect the stages of the genomic surveillance value chain: 


Key considerations 

The guide suggests 5 “considerations” to inform strategy development: 

  1. Ensure strong national leadership, financial commitment, and governance framework 
  2. Focus on public health decision-making 
  3. Target all relevant pathogens with priority pathogen use cases 
  4. Strengthen data management 
  5. Promote data sharing and collaboration 
Stepwise approach 

Alongside the key considerations, the guide offers seven key steps with proposed actions for direct implementation. The duration and chronology, it suggests, can be adapted to national contexts.  


How do you think this guide can be used in your region?  

We look forward to hearing more on surveillance in the context of pandemic preparedness and prevention at the Congress in Barcelona next month. Are you joining us there? 

Don’t forget to subscribe to our newsletter here.  

“A New Species of Trouble”: pandemic preparation in Africa

“A New Species of Trouble”: pandemic preparation in Africa

In September 2023 the Pandemic Centre at Brown University School of Public Health shared a publication that emphasises the importance of “identification, attribution, and consequence management” of pathogen releases in Africa. The report offers a “roadmap” for the preparation for accidental or deliberate release, comprising “expert input” from “those on the frontlines”. In this piece we explore the guidance that is offered, which is intended for application “to a range of settings” apart from the specific geography that is used. To read the report in full click here, and don’t forget to let us know what you think! 

A roadmap for preparation  

The report begins with a foreword from Director, DrPH Jennifer Nuzzo, who comments on the “direct evidence” from COVID-19 that societies are vulnerable to biological threats.  

“As governments move on from the pandemic emergency, we should not forget how much we’ve lost during this crisis – a consequence of our lack of preparedness for biological threats.” 

DrPH Nuzzo emphasises that our preparedness for “future biological emergencies” depends on recognition of “other plausible disease scenarios” that could threaten “health, peace, and prosperity”. These scenarios include the two of the “most challenging”: accidental or deliberate release of a deadly biological agent. She suggests that the report will offer a “roadmap”; although it is addressed to a “particular geography in mind (Africa)”, the authors make it clear that the recommendations have relevance elsewhere. 

“We may hope that future biological crises don’t occur, but hope is not a strategy for being prepared.” 

The executive summary acknowledges that African countries are “by no means alone in lacking the tools” to respond to incidents caused by accidental or deliberate pathogen release. However, the policy brief is focused on Africa. 

The importance of origins 

Three types of outbreaks are presented as threats to public health: 

  1. Naturally occurring – those resulting from the transmission and spread of infectious diseases in the absence of human intervention of through human contact with wildlife 
  2. Those caused by accidental pathogen release – caused by laboratory mishap, unintended pathogen releases linked to lawful or illicit activities, or human error in handling dangerous materials 
  3. Those caused by deliberate pathogen release – intentional release or dissemination of pathogens to cause harm, instil fear, or disrupt societies 

The authors suggest that “recent growth in laboratory systems” and “widespread access to innovative but potentially dangerous technologies” create a “new species of trouble. This requires a “re-evaluation of the threat landscape”. African countries have protocols addressing naturally occurring outbreaks, but “fewer policy measures” to govern accidental or deliberate outbreaks.  

There are several reasons for the importance of determining the origin or an outbreak as identified in the report: 

  • Identify the source – this is crucial for implementing effective control measures to prevent the further spread of the disease 
  • Understand the epidemiology of the disease – this informs public health policies and interventions 
  • Identify potential risk factors for the disease – this can inform prevention strategies 
  • Alleviate public anxiety and fear (as demonstrated by the COVID-19 pandemic) 
  • Where accidental, identify which threat and risk reduction measures to take to build resilience in biosecurity and biodefence systems 
  • Where deliberate, and if possible, preserve the integrity of the crime scene and collect evidence to prevent further attacks, identify victims, and pursue and prosecute offenders 

The report serves as a “multi-sectoral complement” to Africa CDC’s Biosafety and Biosecurity Initiative’s Model Legal Framework. The Initiative was launched in April 2019 to improve outbreak assessment, facilitating appropriate responses. This was pushed forward with the development of a strategic plan (2021-2025), which outlined a coordinated approach to strengthen biosafety and biosecurity. Priority area 6 in the plan seeks to enhance infrastructure, training, and capacity building for the prevention, detection, and response to biological events. The report authors suggest that policies are needed to identify and manage pathogen releases.  

Protocols for naturally occurring pathogens 

According to the report, African countries do have a “range of protocols, strategies, policies, and systems” to address naturally occurring pathogens. These range from a framework for early detection to epidemic-prone diseases, to the creation of Africa CDC, or the establishment of a One Health programme and coordination group. From the stated protocols and policies, the authors infer: 

  • Natural outbreaks are those resulting from the transmission and spread of infectious disease in the absence of accidental or deliberate release.  
  • They can occur because of zoonotic infections, environmental changes, contamination food, water, and environment, or the emergence of new pathogens or re-emergence of agents.  
  • Understanding the characteristics and patterns of natural outbreaks is crucial for effective response and consequence management.  
  • Implementing several measures is vital to effectively manage a crisis or outbreak’s economic, social, and political consequences. 
Protocols for accidental release of pathogens 

Accidental outbreaks have “profound implications” for both public health and law enforcement. Thus, a “systematic approach” is needed. The authors state that there are several “essential factors” to consider. These include “characterising and documenting laboratory accidents and unintended releases and possessing the necessary expertise and technologies for identification and confirmation”.  

Effective threat-reduction measures can mitigate the accidental release of pathogens, including: 

  • Robust biosafety and biosecurity protocols 
  • Identification of country specific high priority pathogens and conducting risk assessments to check preparedness, response, and mitigation methods 
  • Adequate training and education 
  • Simulation exercises 
  • Robust facility design 
  • Regular inspections and audits 
  • Incident reporting and investigation 
  • Risk assessment and management 
  • International standards and collaboration 
  • Research into effective biosafety and biosecurity measures 

Implementing these measures can “significantly reduce” the risk of accidental releases.  

Protocols for deliberate release of pathogens 

Deliberate outbreaks can be caused to “cause harm, instil fear, or disrupt societies”. These can result from: 

  • Biocrime – threatening to release or using a disease-causing biological agent or toxin to harm or kill an individual or a small group motivated by revenge or the pursuit of monetary gain through extortion or other means. 
  • Bioterrorism – threats or intentional releases of viruses, bacteria, or other agents or toxins to cause illness or death in people, animals, or plants, driven by ideological, religious, or political beliefs and seeks to create casualties, instil fear, disrupt society, or cause economic losses. 
  • Biowarfare – using disease-causing agents as weapons, prohibited under the Biological and Toxin Weapon Convention. 
“The timely detection and confirmation of deliberate outbreaks requires specialised expertise and advanced technologies within public health and law enforcement.” 

The pursuit of next-generation sequencing technologies allows “unprecedented resolution” and “improved understanding” of pathogen transmission dynamics. Other techniques have also been used, and web-based surveillance tools, modelling, and epidemic intelligence methods are “crucial components” for outbreak detection and assessment.  

The examples of “consequence management” measures include: 

  • Public health emergency response 
  • Medical treatment and isolation 
  • Contract tracing and quarantine 
  • Mass vaccination or prophylaxis 
  • Risk communication and public awareness 
  • Decontamination and environmental remediation 
  • Psychological and social support 
  • Investigation and law enforcement 

The measures are “coordinated and multidisciplinary”, with the goal of minimising the effects of deliberate pathogen release outbreaks, protecting public health, and restoring “normal functioning within affected communities”.  

WOAH’s algorithm  

WOAH proposes an algorithm for handling a suspicious biological event, which can be divided into three main areas of importance:  

  1. Plan 
  2. Assess and respond 
  3. Recover 

One Health and multidisciplinary approaches 
“Using a One Health strategy, countries should foster collaboration and information sharing among national and regional public health agencies, research institutions, academia, veterinary, agricultural, and environmental services, and international partners.” 

This will demand the facilitation of joint investigations and data sharing as well as the establishment of communication channels and platforms for immediate exchange of “information, best practices, and lessons learned”.  

Going forward 

The brief outlines the importance of an outbreak assessment and consequence management framework to African public health. Such a framework would allow the continent to quickly detect and assess outbreaks, accurately determining their origins, and implementing consequence management pathways in response.  

“The increasing threat of accidental and deliberate release of biological agents constitutes a new species of trouble in global health. Governments, public health agencies, and relevant stakeholders must prioritise establishing this framework, allocating necessary resources, and collaborating effectively to ensure its successful implementation.”  

What key lessons did you identify in the brief, and how are they relevant to your region if you are not based in Africa? For more discussions on the importance and intricacies of outbreak prevention and management, don’t forget to get your tickets to the Congress in Barcelona next month, and subscribe to our weekly newsletter here.  

Tuberculosis goals: leaders reaffirm “collective commitment”

Tuberculosis goals: leaders reaffirm “collective commitment”

At the United Nations General Assembly high-level meeting on tuberculosis world leaders approved a political declaration “reaffirming their collective commitment” to end the infectious disease by 2030. In a move recognised by WHO, Member States committed to “urgently strengthen measures” to reduce deaths, continue support for the WHO Multisectoral Accountability Framework for tuberculosis, and implement national plans or strategies with “multisectoral approaches”. At the summit, calls for a new, improved vaccine were also heard.  

They put a man on the moon 

Dennis Francis, President of the General Assembly, opened the meeting with a comment on the lack of success against the disease: 

“Why, after all the progress we have made – from sending a man to the moon to bringing the world to our fingertips – have we been unable to defeat a preventable but curable disease that kills over 4,400 people a day?” 

Breaking into a chant of “end TB”, he called upon stakeholders to accelerate innovation towards a suitable vaccine. The importance of vaccine development was emphasised by Dr Tedros Adhanom Ghebreyesus, WHO Director-General, who recalled that the only licensed vaccine was developed over a century ago.  

“We have an opportunity that no generation in the history of humanity has had: the opportunity to write the final chapter in the story of TB.”  
Infectious environments 

Amina J. Mohammed, Deputy Secretary-General, suggested that armed conflict, economic upheavals, and climate disasters facilitate the spread of infectious diseases by creating a “breeding ground” and following a vicious cycle that perpetuates inequality. She urged Member States to prioritise the disease in their national agendas, reflecting on the sad death of her own father to tuberculosis.  

“What we need is a vaccine. Let’s end tuberculosis now. It’s possible.” 
Political commitment 

Paula Narváez, President of the Economic and Social Council, demanded “strong political commitment to the very highest levels”. She observed that the high-level meetings on health during the week demonstrated the links between universal health, pandemic preparedness, and ending tuberculosis. She highlighted the Council’s important role in these challenges.  

A powerful perspective was presented by tuberculosis survivor and author of Stigmatised: A Mongolian Girl’s Journey from Stigma & Illness to Empowerment, Handaa Enkh-Amgalan. She repeated the words of her doctor when she was diagnosed with the disease 12 years ago: “do not tell anyone”. She stated that “stigma costs lives”, drawing attention to the role of social expectations, particularly of women and girls, in delaying detection and treatment. She called on world leaders to prioritise the provision of support to affected populations to reduce this stigma.  

WHO weighs in 

In a release from WHO the magnitude of our current position was highlighted by the Director General. 

“For millennia, our ancestors have suffered and died with tuberculosis, without knowing what it was, what caused it, or how to stop it. Today, we have knowledge and tools they could only have dreamed of. The political declaration countries approved today, and the new targets they have set, are a commitment to use those tools, and develop new ones, to write the final chapter in the story of TB.”  

So, what are the targets set and tools available? WHO states that, although global efforts have saved “over 75 million lives”, we have fallen short of targets already. This is largely due to the disruptions caused by the COVID-19 pandemic. The new targets include reaching 90% of people with TB prevention and care services, using a WHO-recommended rapid test as a first diagnostic method, providing social benefit packages to all people with TB, licensing at least one new vaccine, and closing funding gaps by 2027.  

Dr Tereza Kaseva, Director of the WHO Global TB Programme, hopes the opportunity to unite on the response will “accelerate action and strengthen health systems” for TB and “broader health and well-being” concerns.  

“Averting TB-related financial hardship and preventing the development of the disease in vulnerable groups will help diminish inequities within and between countries.”  
Vaccine Accelerator Council 

In January 2023, Dr Tedros Adhanom Ghebreyesus announced plans to establish a “TB Vaccine Accelerator Council” to facilitate the “development, testing, authorisation, and use” of new TB vaccines. The Council convened for an establishment meeting on 20th September 2023. The Council is supported by the WHO secretariat, with subsidiary bodies to support its engagement and interaction with sectors and stakeholders.  

Do you think the latest updates from global leaders are enough to bring about adequate action, and will we succeed in meeting tuberculosis goals? For more on health targets don’t forget to subscribe to our newsletters here.  

UK government announces health security package at UNGA

UK government announces health security package at UNGA

The UK’s International Development Minister Andrew Mitchell and Health Minister Will Quince announced investments in “ground-breaking research and development” at the United Nations General Assembly (UNGA) 78th session in September 2023. The government describes these investments as an effort to “tackle the world’s most pressing health challenges”. UK scientific expertise is to be “harnessed to boost health security around the world”.  

Research and development  

The investment includes up to £103.5 million to develop affordable vaccines through the UK Vaccine Network, which unites industry, academia, and funding bodies in an advisory capacity for the Department of Health and Social Care. The funding will cover other health products and treatments that will “halt the spread of infectious diseases” and support programmes to protect sexual and reproductive health. 

The UK will also contribute to research and development into “cutting-edge technology” that enables quick responses to disease outbreaks and improves the health of vulnerable populations in low- and middle-income countries. £295 million will go towards the development of new methods of drug administration to ensure that life-saving care reaches remote areas.  

“This new package of R&D will bolster the world’s ability to respond swiftly and effectively to disease outbreaks.”  

Included are a previously announced pledge from the Foreign, Commonwealth, and Development Office to CEPI and £5 million of additional funding for the TB Alliance. An additional £95 million will go to the Tackling Deadly Diseases in Africa Programme II; this partners with Kenya, Ghana, Uganda, Malawi, Democratic Republic of Congo, WHO, and Africa CDC to “detect and tackle future epidemics, drug resistant infections, and climate change.  

Back on track for SDGs 

Andrew Mitchell commented that the UK is “committed to reinvigorating progress” towards the Sustainable Development Goals (SDGs).  

“The UK’s significant support for global health announced at the UN General Assembly this week will be truly transformational in creating more resilient and inclusive health systems worldwide.” 

Will Quince agreed that the investment is “vital for saving lives – both at home and abroad”.  

“This UK Vaccine Network investment will help deliver effective and accessible vaccines for populations threatened by infectious diseases and cements the UK’s status as a leader in global health research.”  

Do you think this is an adequate financial contribution to global health goals from the UK, or could more done to secure a return to progress towards SDGs? For more updates like this, don’t forget to subscribe.  

WHO “welcomes” UNGA landmark pandemic declaration

WHO “welcomes” UNGA landmark pandemic declaration

At the United Nations General Assembly (UNGA) 78th session in September 2023 a “landmark declaration” was adopted on pandemic prevention, preparedness, and response. This was the General Assembly’s first ever high-level meeting on the subject, which WHO welcomed. Describing the “historic commitment”, WHO recognised the need for “international cooperation, coordination, governance, and investment” to prevent a repeat of the COVID-19 experience. This declaration will also support efforts to “get back on track” with the Sustainable Development Goals (SDGs).  

“Making the world safer” 

The Assembly convened under the theme “Making the world safer: Creating and maintaining political momentum and solidarity for Pandemic Prevention, Preparedness, and Response”. The meeting began with comments from Assembly President Dennis Francis, who reflected on the COVID-19 pandemic as “one of the most pressing global challenges of our time”.  

“The reality is that we simply lacked preparation and responsiveness.”   

Further to the collective lack of preparation, Mr Francis noted the global inequalities that were highlighted. This concern was echoed by Member States in the Political Declaration, where “glaring inequalities” in access to vaccines were recorded.  

Political Declaration 

The Political Declaration outlines a range of recommendations including: 

  • Conclude negotiations on a WHO convention, agreement, or other international instrument on pandemic prevention, preparedness, and response (aka the Pandemic Accord).  
  • In line with the Pandemic Accord process, ensure the sustainable, affordable, fair, equitable, effective, efficient, and timely access to medical countermeasures. 
  • Take measures to counter and address the health-related misinformation, disinformation, hate speech, and stigmatisation. 
  • Invest in primary health care and other health system measures. 
Under-Secretary-General’s concerns 

UN Under-Secretary-General Amina J. Mohammed emphasised the need to follow these recommendations to prevent a repeat of vaccine hoarding by richer countries. The document also called for the promotion of equitable distribution of affordable and quality medicines, and the reaffirmation of the World Trade Organisation (WTO) Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). This agreement “plays a critical role” in encouraging trade in “knowledge and creativity”, resolving intellectual property trade disputes, and “assuring WTO members the latitude to achieve their domestic objectives”.  

Ms Mohammed also demanded reform of the international financial architecture to reduce the debt burden of developing countries. She requested long-term financing of more than $500 billion each year within the SDGs recovery plan. Another area of attention for Ms Mohammed was the need to fight misinformation about vaccines. She gave the example of a code of conduct on digital platforms and proposed the creation of an emergency coordination platform to respond to complex international shocks.  

WHO Director-General’s view 

Dr Tedros Adhanom Ghebreyesus commented that the adoption of this Political Declaration is “a historic milestone”. He urged the Member States to implement the commitments outlined in the document. Furthermore, he called for an agreement by May 2024 for the drafting of the WHO international instrument on prevention, preparedness, and response.  

“The lived experience of people who suffered through the COVID-19 pandemic must be at the forefront of our minds going forward in order to realise the clear direction provided by world leaders. We must learn how to protect our communities better and to engage, inform, and empower them to be part of the solution.” 

He remarked upon the need for “concrete actions” to promote equitable access to medical countermeasures, appropriate financing, “empowered and engaged communities”, and “robust, trained, and equipped health workers”.  

“The world needs a more collaborative, cohesive, and equitable approach to preventing, preparing for, and responding to pandemics.”  
Spend to save 

World Bank Senior Managing Director Axel Van Trotsenburg welcomed the first annniversary of the pandemic fund, which secured pledges from 133 countries of $2 billion. This is a “very good starting point”, but Mr Trotsenburg called for $10 billion.  The High-Level Champion for Pandemic Prevention, Preparedness, and Response, Helen Clark, called for a global financing system capable of immediately responding to pandemics. 

“Spending billions will save trillions.” 

She suggested that vaccines, diagnostics, and treatments should be considered “global common goods”.  

“Viruses that can cause pandemics will not wait for diplomacy to produce results.” 

During the meeting it was proposed that a dedicated global coordination body should be created. Ms Clarck emphasised that the “political choice” of Member States will determine if COVID-19 is the “last pandemic to cause such devastation”.  

For a keynote discussion on how we can get “ahead of the curve on pandemic preparedness” at the World Vaccine Congress in Barcelona next month, get your tickets here. Don’t forget to subscribe to our weekly newsletters for more like this.  

Report: how can the EU improve its vaccine industry appeal?

Report: how can the EU improve its vaccine industry appeal?

A study carried out by Charles River Associates (CRA) for Vaccines Europe (VE) in June 2023 investigates the state of the vaccines industry in the European Union (EU). The goal of the study was to “identify the factors affecting vaccine investment” throughout the value chain and “assess the attractiveness of the EU” compared to other global regions. The report, which can be accessed from the Vaccines Europe website, highlights challenges that the industry is facing and provides key policy recommendations for the future.  

Encouraging vaccine innovation 
“Vaccination brings significant value not only to public health but to the economy as well, and should be viewed as an investment, rather than a cost.”  

Vaccines Europe describes vaccination as “one of the most successful health prevention tools” for disease eradication and control. To mine the benefits that it offers, the right environment for innovation is needed. Sibilia Quilici, Vaccines Europe’s Executive Director, describes the EU as the “home of vaccine production and innovation before the COVID-19 pandemic”. During the pandemic, she suggests, the “footprint grew”. 

“Now, we can see potential for even more growth through the pipeline of new vaccine candidates. The vaccines industry is recognised as a key infrastructure for Europe. To ensure its sustainability and growth, we need this recognition to be translated into policy actions, maintaining the EU’s position as a leader within the vaccine ecosystem.” 

In this post we look at the findings of the report and explore the key recommendations presented.  

Lifting the rock 

The report claims that there has been a concerning “relative decline in Europe’s attractiveness as a centre for innovation and manufacturing” over recent years. A clear example of this is pharmaceutical R&D expenditure; in the US this exceeded that of Europe by over €20 billion. Unfortunately, the “gap is widening”: 20 years ago, the difference was “only” €2 billion.  

“Less attention has been paid to vaccines.” 

Despite the small share that the vaccines industry has in the overall pharmaceutical industry (recent data suggest it holds 3.6% of the total world market for pharmaceutical products), it is “particularly important for the EU”. The European Commission industry scorecard acknowledges the health industry at the second highest level of investment value in comparison with other innovative industries. In 2016 the vaccines industry contributed 122,000 jobs (indirectly and directly). Although the EU has “traditionally” been the home of investment in innovative vaccines, manufacturers have been seeking sites in other regions, such as Asia, to meet global demand. 

What factors affect decision-making? According to the report, the pandemic has influenced these. Before the pandemic, there was “concern” that the EU vaccines industry was facing “several challenges”. Although the pandemic emphasised the value of the innovative vaccine industry, the debate regarding attractiveness and competitiveness has focused on pharmaceuticals with “little specific consideration” of vaccines. Thus, with the “specificities and complexities” of the vaccine industry, the report highlights a need for analysis of “what would make the EU region more attractive”.  

“Only by understanding the challenges facing the vaccines industry in the EU is it possible to develop the priorities needed to secure the region as a worldwide leader in vaccine innovation and ensure a sustainable ecosystem.”  
The review at a glance 

The report considers the differences in the policy environment for therapeutic vaccines compared with prophylactic vaccines. As a review of Vaccine Europe members found that of 100 candidates in the pipeline in July 2022, 92 were prophylactic, the report focuses on prophylactic vaccines across “classical and next-generation technology platforms”. The research approach demanded three key steps: 

  1. A literature review identified the key drivers affecting investment and recent trends and policy challenges affecting the EU vaccines industry. 
  2. Quantitative evidence was collected on factors affecting investment decisions to see how the environment is changing.  
  3. An interview programme involving 11 VE members validated the investment drivers and challenges for vaccines and demonstrated the impact of the policy environment on investment decisions and revealed policy questions to improve attractiveness.  
Investment drivers 

The report connects the factors that drive investment with the policies that increase attractiveness. In the table below we summarise the key investment drivers across each phase of the value chain.  


Market attractiveness 

When considering market attractiveness in the EU, the report acknowledges that EU Member States are responsible for organising and delivering health services and care. Thus, the EU’s role in health policy is “complementary to national policies”. It aims to: 

  • Protect and improve the health of EU citizens 
  • Support the modernisation of health infrastructure 
  • Improve the efficiency of the EU’s health systems 
  • Strengthen preparedness and response measures to cross-border health threats 

Each phase of the value chain is reviewed to identify the policy challenges and implications for attractiveness.  


Many of the world’s largest vaccine companies have established research facilities within the region due to the persistence of “several key investment drivers” across certain countries. The COVID-19 pandemic revealed the research strength of the EU vaccines industry, when nearly half (47%) of patent applications for COVID-19 vaccines came from European companies.  

However, due to challenges to early-stage research, some companies are directing research investments in other regions. The report identifies this as of particular concern regarding the development of small and medium-sized enterprises (SMEs) investing in vaccine research. A key challenge that the industry faces is the difficulty early-stage actors encounter when trying to raise capital due to “limited exit opportunities”.  

“Vaccine development is highly complex and requires significant investments of both time and capital. These factors can create concerns about the return on investment, which in turn, can make it difficult to raise funding for vaccine research, particularly for SMEs that are heavily reliant on external funding.”  

The lack of exit opportunities reduces the availability of funding and creates a “barrier to innovation”, thus “hindering the development of new vaccines”. Another challenge identified is the “lack of sufficient incentivise to diversify vaccine technology platforms”. The “limited support” at EU and national levels discourages researchers from investing in new technologies and “risks preventing future innovation”.  

Furthermore, there are “significant barriers” to gaining EU-level funding. This creates an extra challenge before companies can secure investment. Finally, a shortage of skilled workers is highlighted. The complex and technical nature of vaccine research demands workers with “specialised skills and knowledge”.  

“The absence of skilled workers reduces the attractiveness of the EU as a region for vaccine research and forces companies to consider other regions for investment.”  

The EU has “traditionally” been a significant region for vaccine development; approximately 22% of global vaccine clinical trials have taken place in the EU over the last 20 years. This could be thanks to the “relatively advanced clinical trial infrastructure” in many EU countries, which offers a “solid foundation” for vaccine development. However, there are key issues associated with clinical development that are affecting the EU vaccines industry.  

A main challenge is that clinical trial requirements can be “extensive”. Although the report recognises that some requirements are “necessary to appropriately demonstrate the safety and efficacy of vaccines”, they can become “increasingly burdensome”. This prolongs the development process and delays access.  

“It is vital that processes are streamline and efficient to deliver innovation quickly.”  

Although the literature review found little supporting evidence for the notion that the speed of clinical trial timelines is “relatively slow” in the EU, it was “frequently reported” during the interview stage. Another stated issue is the “significant disparity” in clinical trial approval timelines across Member States. A recent analysis revealed that approval and establishment of a study could be 100 days quicker in the US than in some EU countries. Thus, developers may prioritise other EU countries or look outside the EU.  

A final challenge is the lack of real-world evidence (RWE) infrastructure to support development in the EU. RWE plays a “key role” in providing data on existing vaccines’ safety and efficacy, which can be used to optimise the development of innovative vaccines. It can also provide context on uptake and use, supporting developers to make informed decisions.  


Once again, the report highlights the role played by the EU in the COVID-19 pandemic response. However, the attractiveness of the industry is hampered by “key manufacturing challenges”. For a start, there is “limited funding support and effective engagement with public institutions”. There are also “minimal incentives” for expanding vaccine manufacturing infrastructure. These challenges prevent companies from improving or expanding their manufacturing capabilities.  

Another challenge is that manufacturing quality control processes and requirements are “suboptimal and lack harmonisation”. Variations and complexities cause delays and/or shortages, as well as increased production costs and inefficiencies. Furthermore, many national manufacturing infrastructures are “suboptimal”, and there are significant disparities between Member States. This indicates that the “EU ecosystem is not well-placed to support manufacturing”.  


The report suggests that the access environment is a Member State competency but that the EU can play a “supporting role” in improving uptake and equity.  

“Currently, the EU market access environment for vaccines is fragmented.” 

Central to this is the delay from national vaccine committees in making recommendations; this contributes to “significant disparities in reimbursement timelines”. Evidence suggests that in 30% of EU countries it can take over 6 years for a new vaccine to be reimbursed.  

“Immunisation programmes are slow and lack dynamicity to adopt innovative vaccines, resulting in considerable delays to population access.”  

Another challenge is associated with budgeting and “highly punitive” tendering practices. From the statistic that 77% of Member States spend less than 0.5% of their healthcare budget on immunisation it is clear that vaccines are given “relatively low prioritisation”. Funding challenges create uncertainty, which disincentivises future research. 

Vaccine hesitancy is still causing issues, with some countries, like Poland, having “notably higher hesitancy levels than global averages”. This negatively affects vaccine uptake and disincentivises development.  Finally, there are “considerable disparities in vaccine monitoring infrastructure” across Member States.  

Summary and recommendations 

The thematic challenges that affect the health and attractiveness of the EU ecosystem are laid out in figure from the report below.  

Based on these findings, the report presents policy priorities that align with each cross-cutting challenge.  


Do you agree with the findings and recommendations presented in the report? How might your region fare when examined? For more on supporting innovation and encouraging research, join us in Barcelona for the World Vaccine Congress next month. Don’t forget to subscribe to our weekly newsletter.  

WHO urges health commitment at 78th UN General Assembly

WHO urges health commitment at 78th UN General Assembly

Next week, from 18th to 26th September 2023, the United Nations General Assembly (UNGA) will take place in New York and virtually. This is the 78th event of this kind at a time described by the UN as defined by “unprecedented setbacks on global progress”. WHO has shared a message in advance of this meeting, calling for leaders to “put health for all on the highest political agenda”. Urging the application of lessons from the COVID-19 pandemic, the appeal coincides with “multiple humanitarian and climate-related crises”, which are converging to threaten lives and livelihoods around the world.  

“The Earth is getting hotter, faster. Poverty and food insecurity are worsening, amid war and inflation. Humanitarian needs are escalating in scale and cost. Inequality is deepening.”  
What’s on the agenda? 

The UN suggests that leaders will “discuss and debate” how we can “confront the global polycrisis” and accelerate actions on the 2030 Agenda for Sustainable Development. Central to the UNGA 78 event is the SDG Summit, taking place on 18th and 19th September. This marks the beginning of a “new phase of accelerated progress” towards the Sustainable Development Goals and draws on “high-level political guidance on transformative and accelerated actions” as we approach 2030.  


WHO’s call to action focuses on three main areas: strengthening pandemic prevention, preparedness, and response, delivering universal health coverage (UHC), and ending TB. WHO suggests that the convening leaders “have a chance to demonstrate that health is an investment, not a cost”.  

Dr Tedros Adhanom Ghebreyesus reflects that “if COVID-19 taught us nothing else, it’s that when health is at risk, everything is at risk”.  

“The pandemic caused enormous economic, social, and political upheaval, and stalled or reversed progress towards the health-related targets in the SDGs.”  

He describes the UNGA as “the moment” for leaders to show that “they have learned the painful lessons of the pandemic”, taking “concrete steps” towards a “healthier, safer, and fairer world for all”.  

WHO’s anniversary 

This year, 2023, the WHO celebrates 75 years of improving public health. Thus, the Director-General commented on the opportunity to remind the world of “what our founders affirmed”: 

“Health is not only a fundamental human right, but also the foundation of safe, peaceful, and prosperous societies.”  

Alongside senior leadership, the Director-General will participate in “high-level meetings” and other events.

For more on global health goals don’t forget to subscribe to our weekly newsletters here.

IVI and CEPI announce renewed vaccine collaboration

IVI and CEPI announce renewed vaccine collaboration

In September 2023 the Coalition for Epidemic Preparedness Innovations (CEPI) and the International Vaccine Institute (IVI) announced a “renewed collaboration” to “accelerate the development of vaccines against emerging infectious diseases”. This was marked by a signing ceremony between Dr Jerome Kim, Director General of IVI, and Dr Richard Hatchett, CEO of CEPI, in London.  

Implementing Partnership Agreement 

CEPI states that under the terms of the renewed agreement, IVI is to provide “technical services” for CEPI-funded projects, “leveraging IVI’s expertise and capabilities” both at their headquarters in Korea and around the world. The goal is the acceleration of vaccine development against pathogens with epidemic or pandemic potential and aligns with CEPI’s 100 Days Mission.  

IVI will provide support to CEPI across a “variety” of projects. This will include the provision of “strategic, technical, and scientific support” for “clinical development and manufacturing of vaccines, standards and assay development, and capacity-building initiatives”. This continued partnership develops previous “successful collaborations” between the two organisations.  

Fruitful collaboration: past and future 

Dr Richard Hatchet is “delighted” to reaffirm the partnership, which follows “several years of fruitful collaboration to advance vaccine R&D for better global health.” 

“As our organisations continue to work toward the joint goal of accelerating the development of safe, effective, and accessible vaccines against emerging infectious diseases, this ongoing partnership will play an important role in our work to ensure the world is better prepared to fight future outbreaks.”  

Dr Jerome Kim commented that the partnership is an “exemplary model” of a public-private partnership “with the vision, support, and capabilities to move innovative vaccine technology from need to impact”. The two organisation have “years of collaboration” behind them in areas of laboratory research, epidemiology, vaccine clinical development, and clinical research preparedness. Dr Kim highlights that their work has ranged from COVID-19 and MERS to chikungunya.  

“We are proud and looking forward to expanding IVI’s role as an implementing partner to advance vaccines against emerging and infectious diseases.”  

We were pleased to hear more from Dr Kim at last year’s Congress in Barcelona when he joined us for an interview and look forward to sharing interviews with representatives of CEPI from this year’s Congress over the coming months. Do join us in Barcelona in October, and subscribe to our newsletters in the meantime!

Partners approach human trials for drug overdose vaccines

Partners approach human trials for drug overdose vaccines

A partnership involving a team at the University of Montana, funded by NIH, suggests that it is “nearing human trials” for vaccines designed to prevent fentanyl and heroin drug overdoses. Expecting to begin testing in humans in early 2024, the researchers will target first heroin, then fentanyl, before attempting a combined multivalent vaccine against both.  

Drugs and overdose deaths 

The NIH suggests that over 106,000 US deaths were attributed to drug overdose in 2021. This is an increase from 2019 and was reflected in a rise in deaths involving “synthetic opioids” such as fentanyl. 70,601 synthetic opioid overdose deaths were reported in 2021. Fentanyl is a “powerful” synthetic opioid that, although FDA-approved for severe pain management, is “increasingly found in the drug supply” as illegally made and distributed. It is “about 50 to 100 times more potent than morphine”.  

The journey of vaccine development 

Dr Jay Evans directs the UM Centre for Translational Medicine and is co-founder of Inimmune, the corporate partner focused on scaling up vaccine components for manufacture. He suggests that the vaccines began with Dr Marco Pravetoni, professor of psychiatry and behavioural science and the University of Washington, and director of the Centre for Medication Development for Substance Use Disorders. His team designs haptens and drug conjugate vaccines to elicit the production of antibodies against target opioids.  

Dr Pravetoni has been tackling vaccines against opioids for “over a decade”.  

“Our vaccines are designed to neutralise the target opioid, while sparing critical medications such as methadone, buprenorphine, naltrexone, and lanoxone, which are used in treatment of opioid addiction and reversal of overdose.”  

Dr Evans and his team are bringing a patented adjuvant, INI-4001, to the mix. Having worked closely with other researchers, Dr Evans hopes to “optimise anti-opioid vaccines” to advance them to human clinical trials. 

“Our adjuvants improve the vaccine response, providing a stronger and more durable immunity.” 

With a $33.4 million contract to develop and advance two candidate anti-opioid vaccines through Phase I trials, and support from the NIH Helping to End Addiction Long-Term (HEAL) initiative, the team is prepared for further steps next year. So far mice, rats, and pigs have been tested in advance of human testing.  

Trials to begin 

Dr Evans believes that the heroin vaccine human trials will begin first and looks forward to finalising Investigational New Drug applications to the FDA later in the year. Phase I trials will be conducted with Dr Sandra Comer at Columbia University in New York City. Recruitment and enrolment could take over 6 months and will include a drug challenge to “evaluate both safety and efficacy”. Patients will then be followed for an evaluation of antibody persistence.  

The Phase I trials involve a gradual dose escalation, with the lowest dose possible not being effective. Dr Evans emphasised that these trials will be “focused on safety”.  

“When the first dose cohort is complete, a data safety monitoring board reviews the data and approves testing at the next dose level if the vaccine is safe. The process takes time until you reach dose levels that are both safe and effective.”  

Moving through later trials will take a “long time”, says Dr Evans, but thanks to preclinical data and established safety profiles in animal models, the team is “very hopeful”. 

With the potential to save and change thousands of lives in the US alone, these vaccines could be critical if successful in trial. For more on tackling pressing health issues with vaccine approaches don’t forget to subscribe to our newsletter here.

Misled America: KFF study tracks vaccine misinformation

Misled America: KFF study tracks vaccine misinformation

In August 2023 KFF shared the results of its Health Misinformation Tracking Poll Pilot as part of a wider effort provide accurate information to guide health policy in the US. This examines the public’s media use and trust in sources of health information and measures the reach of specific “false and inaccurate claims”. Of the three health-related topics, COVID-19 and vaccines, reproductive health, and gun violence, the first is pertinent to our community.  

KFF acknowledges that health misinformation and disinformation “long preceded the pandemic” but suggests that the “pervasiveness of false and inaccurate information” about COVID-19 and vaccines “brought into further focus” the damage that can be done. Previous KFF surveys found in 2021 and 2022 that “large shares of the public” either believed or were uncertain about false claims relating to COVID-19 vaccines and treatments. The studies also emphasised the roles of traditional and social media as “vehicles” for spreading or challenging misinformation.  

Testing false claims 

The following specific health-related claims were presented in the survey alongside 5 others: 



The study authors state that “health misinformation is widely prevalent in the US”. They suggest that 96% of adults said they had heard “at least one” of the ten items of health-related misinformation considered. The most widespread misinformation items in the survey were related to COVID-19 and vaccines. For example, 65% of people had heard or read that COVID-19 vaccines have caused thousands of deaths in otherwise healthy people, and 65% of people had heard or read that the MMR vaccines have been proven to cause autism.  

Regardless of whether the respondents had heard or read specific items of misinformation, the survey asked people whether they thought each claim was “definitely true”, “probably true”, “probably false”, or “definitely false”. For “most of the misinformation items” included, between one-fifth and one-third of the public selected “definitely true” or “probably true”.  

“While the most frequently heard claims are related to COVID-19 and vaccines, the most frequently believed claims were related to guns.” 
Who believes what? 

The study offers an insight into the profile of people who responded, revealing that across the five COVID-19 and vaccine related items (shown above) adults without a college degree were more likely than college graduates to suggest that these claims are “definitely true” or “probably true”. Additionally, “Black adults were at least ten percentage points more likely than White adults” to believe “some items of vaccine misinformation”. 

Black (29%) and Hispanic (24%) adults were more likely than White adults (17%) to claim that the statement “more people have died from the COVID-19 vaccine than have died from the COVID-19 virus” is “definitely true” or “probably true”. Political identity trends were also observed, as well as community types; rural residents were “more likely” than urban or suburban counterparts to believe that false claims related to COVID vaccines are “probably or definitely true”. 

Media: trusted messengers or misinformation pedlars? 

The authors indicate that “large shares of the public” are “unable to identify many health-related misinformation items as definitely false”. Therefore, “trusted messengers and sources” are responsible for countering the “proliferation of health misinformation”. An example of a trusted source is a patient’s personal doctor: 93% of the public have a “great deal” or a “fair amount” of trust in their own doctor to make suitable health recommendations.  

Not so for government agencies, predictably; although “most adults” have at least a “fair amount” of trust in the FDA and CDC to make the right recommendations, just one in four have a “great deal of trust” in the CDC and one in five have a “great deal of trust” in the FDA. Fewer still trust the Biden Administration on health issues.  

The media available to the public provide adults with a “varied media diet”, with local TV news, national network news, and digital and online news aggregators representing the “top news sources” for US adults. Over half of the respondents “regularly” engage with these sources. However, there are further variations in consumption of traditional news sources. Adults under 30 are less likely than “older adults” to say they regularly watch local news but are more likely to use digital or online news aggregators like Apple or Yahoo News.  

The results suggest that whether respondents were regular viewers or not, at least seven in ten would have at least “a little” trust in health information reported by their local TV news station, national network news, or local newspaper. However, fewer than three in ten adults would have “a lot” of trust in health information reported by each of the media sources asked about in the survey. Furthermore, regular users are “much more likely” to trust health information reported by each source.  

Social media 

Over half of adults who responded say that they use social media “at least once a week” including a third (33%) who use it daily. Roughly one in four (24%) suggested that they use social media at least weekly to find health information and advice, whereas four in ten would “never” do this. Of the platforms included, the most commonly used were YouTube and Facebook, with more than six in ten saying they use each of these at least weekly.  

“Social media use is also correlated with being exposed and inclined to believe health misinformation.” 

For example, a majority of those who use social media for health information and advice “at least weekly” have heard at least one of the false COVID-19 or vaccine claims tested in the survey and think it is “definitely or probably true”. This compares with four in ten of those who don’t use social media for health advice.  

Over the next few weeks, the organisation will release additional analysis, which examines media use and trust and exposure and susceptibility to health misinformation among “key subgroups”. 

What do you think of the results presented by KFF, and how can we address the clear susceptibility to misinformation in the US as well as abroad? For a workshop dedicated to these issues join us at The World Vaccine Congress in Barcelona in October. Or, subscribe for more updates like this! 

UK announces £210 million AMR investment from aid budget

UK announces £210 million AMR investment from aid budget

The UK Department of Health and Social Care announced in August 2023 that it was supporting “state-of-the-art laboratories”, “cutting-edge” disease surveillance, and a “bigger global workforce” to tackle antimicrobial resistance (AMR). Through funding of up to £210 million from the government’s UK aid budget, the Fleming Fund will continue activities to fight AMR in countries across Asia and Africa over three years.  

The burden of AMR continues to grow, with around 1.27 million people dying each year as a result. 1 in 5 of those deaths are children under 5. The problem is global, and although this investment focuses on the African and Asian regions, AMR was found to have caused between 7,000 and 35,000 deaths in the UK. The announcement coincides with the G20 Health Ministers’ meeting in India.  

Strengthening and building  

The funding will “bolster” surveillance capacity in up to 25 countries where the threat and burden of AMR is considered the highest. These include Indonesia, Ghana, Kenya, and Papua New Guinea. More than 250 laboratories will be upgraded with “state-of-the-art equipment”, including new genome sequencing technology to help track bacterial transmission between humans, animals, and the environment.  

The funds are also intended to “strengthen the international health workforce” by supporting 20,000 training sessions for laboratory staff, pharmacists, and hospital staff. Over 200 Fleming Fund scholarships will be covered, to boost expertise across microbiology, AMR policy, and One Health.  

Stopping the silent killer 

Steve Barclay, Secretary of State for Health and Social Care, emphasised that AMR is a “silent killer” that poses a “significant threat”.  

“It’s vital it is stopped in its tracks and this record funding will allow countries most at risk to tackle it and prevent it from taking more lives across the world, ultimately making us safer at home.”  

He also referred to a government effort to “incentivise drug companies to develop new antibiotics”, suggesting that other G20 countries are looking to implement the example set by the UK. PharmaPhorum describes this model as a “subscription-based system”, but notes that “other countries in the G20 have not followed suit”.  

UK Special Envoy on AMR, Dame Sally Davies, is “proud and delighted” that the Fleming Fund will “continue to create real impact to tackle AMR and build pandemic preparedness on the ground across the world”. Dame Davies believes that “using data” we will “drive action and catalyse investment”.  

“This world-leading investment in AMR laboratories, workforce, and systems is a vital contribution to realise our vision of a world free of drug-resistant infection.”

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Bovine TB: cattle pathway planning already underway

Bovine TB: cattle pathway planning already underway

In August 2023 Farmers Weekly reported on discussions to develop a pathway for approval of the export of cattle vaccinated with the “much-anticipated” bovine TB vaccine. The discussions are taking place two years before the vaccine is schedule to be deployed. The vaccine and accompanying Diva test are currently in the second phase of a trial regime, but Defra told Farmers Weekly that the government is “already engaging” with the World Organisation for Animal Health (WOAH), the EU Commission, and international trading partners. The hope is that these discussions can “mitigate the likelihood of any trade impacts” of the vaccine and skin test.  

More work ahead 

Current standards relating to exports of live vaccinated animals and their subsequent genetic material will be reviewed, but no further controls for fresh meat or meat products are expected. Defra explained to Farmers Weekly that, when field trials have been successfully completed, a “formal application” will be submitted to WOAH to validate the Diva skin test and update the WOAH Codes and Manuals.  

The deadline of 2025 can be met through the achievement of the following factors: 

  • Successful trials conducted by Eville and Jones 
  • Transfer of the Diva test technology to a suitable manufacturer 
  • Establishment of robust systems for official identification and traceability of vaccinated cattle 
  • Necessary UK marketing authorisations from the Veterinary Medicines Directorate 

Defra assured Farmers Weekly that progress is being made “at pace” but the vaccine will only be deployed “when we have all the right steps in place to enable the programme to be a success”. Dr Lindsay Heasman, project manager at Eville and Jones, understands how “crucial the project is for the future control of TB”, and how it may become “part of a suite of measures to help eradicate” the disease.  

A tool not a silver bullet 

In July a Defra-commissioned study emphasised that “no single control measure” will be a “silver bullet” for eradication. However, vaccination will be an essential tool. Defra reiterated to Farmers Weekly that vaccination will help “drive down the disease burden”. This will “significantly” contribute to the goal of achieving TB-free status in England by 2038.  

Vet and technical director for the TB Advisory Service, Sarah Tomlinson, commented that “England has come a long way” over 10 years. Although June saw a drop in cattle slaughter by “24%” since last year and the South-West is at the “lowest level of TB for 20 years”, we “still have a long way to go”. She emphasised that a strong grasp of local epidemiology will be critical.  

“Different tactics may be needed in different parts of England: enhanced cattle testing, badger control, engagement in TB biosecurity… Cattle vaccination needs to fit into policy alongside these ‘tools in the box’.” 

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The threat of the unknown: what is “Disease X”?

The threat of the unknown: what is “Disease X”?

In August 2023 the announcement of the newly unveiled Vaccine Development and Evaluation Centre in the UK provoked consternation on social media. Repeated reference to the threat of “Disease X” was identified and questioned. Disease X is the term used to describe the future threat presented by a currently unknown pathogen. Understandably, the public is susceptible to misinformation around this mysteriously named concern. However, the accurate information is out there and a quick google search can offer insight into what Disease X is, and how and why scientists are already preparing for it.  

What’s in a name? 

The rather science-fiction-sounding name was adopted by the WHO in 2018 for its list of priority diseases. WHO suggests that Disease X “represents the knowledge that a serious international epidemic could be caused by a pathogen currently unknown to cause human disease”. It can be considered, therefore, akin to the familiar algebraic foe “x”, representing the variable or unknown.  

What will it be? 

Disease X is “supposed to be caused by a pathogen X”, which itself is expected to be a zoonosis. It is predicted to emerge from an area where the “right mix of risk factors highly promotes the risk for sustained transmission”. If this all sounds terribly hypothetical or broad, it is. Indeed, CEPI states that 25 viral families are known to infect humans, and over 1.6 million undiscovered viral species within them are estimated to exist in mammal and bird hosts.  

However, Johns Hopkins Centre for Health Security suggests that 6 viral families capable of infecting humans (Adenoviridae, Coronaviridae, Orthomyxoviridae, Paramyxoviridae, Picornaviridae, and Poxviridae) have the following key traits to enable a pandemic: 

  • No immunity (no preexisting immunity in the global population) 
  • Airborne (spread via respiratory transmission) 
  • Silent (transmissible by infected people without symptoms) 
  • Harmful (without existing, effective therapeutics or vaccines) 
If we don’t know what it is why are we preparing? 

It might seem a bit hopeless to prepare ‘blindly’ for an unknown threat, but the need is great; infectious disease outbreaks now occur 3 times more frequently than they did 40 years ago. Furthermore, our experience with the COVID-19 pandemic and increasing outbreaks of diseases like mpox should demonstrate the importance of preparation. In fact, although we may have seemed tragically underprepared to meet COVID-19, the vaccine community set a record timeline of 326 days between discovery of the virus to the first emergency use of the vaccine.

Another lesson from the pandemic is how much damage can be done before a vaccine is ready, and even while it is being deployed. Thus, the need to arm the world as quickly as possible is a cause championed by many, including CEPI. CEPI outlined an ambitious goal to this end in 2022: 

“Vaccines should be ready for initial authorisation and manufacturing at scale within 100 days of recognition of a pandemic pathogen, when appropriate.”  

The hope is that, alongside “improved surveillance” and “swift and effective use of non-pharmaceutical interventions”, this goal would give us a better chance at “containing and controlling” future threats. CEPI’s Tom Mooney, Senior Communications and Advocacy Manager emphasises that this will require “the right level of financial commitment and political will” but is a “[credible] aim to eliminate the risk of epidemics and pandemics”.  

How are we preparing? 

If the 100 Days Mission is the guide, how is the vaccine community stepping up to the plate? CEPI outlines several stages: readiness, reaction, and rollout and review. Within these stages, CEPI is advocating the development of a “vaccine library” and is supporting the development of novel technologies with dedicated funding.  

A vaccine library comprises prototype vaccines created for each of the key virus families, and CEPI is prioritising the development of vaccine libraries for up to 10 high-risk virus families. These families are identified through potential for outbreak transmission or zoonotic spillover, ability to mutate, and mode of transmission among other factors. Within these families, vaccine candidates will be created for up to 15 different viruses depending on the complexity of the family.  

The vaccines in each library will be based on “rapid-response platforms”. These are systems that can be adapted for use against different pathogens through insertion of new genetic or protein sequences.  

“Building vaccine libraries is a mammoth task requiring major investment, so we anticipate it being a shared global project with CEPI playing a pivotal leadership and connecting role.”  

Other areas of focus for the vaccine community include establishing or improving manufacturing capabilities and ensuring that vaccine development is executed with access in mind. One of the unfortunate lessons of the COVID-19 pandemic, and indeed mpox, has been that equity was not the political priority it should be.  

Access is key 

The Lancet’s Aimee Ramgolam reflects on the COVID-19 pandemic in an article on Disease X, emphasising that “on a global scale, sharing is integral to preventing the proliferation of a pandemic”. This is easier collectively agreed upon than collectively enacted. Ramgolam recognises that elected officials “will always act in their own country’s best interests”, so we would be better using our time “making collaborative working politically beneficial to individual countries”. Thus, governments would find incentive to share.  

An example of effort to address this is presented by Ramgolam: WHO’s pandemic treaty. This would be a potentially legally binding agreement aiming to address the following key gaps: 

  • Global preparedness and response arrangements 
  • Sustained, predictable funding for health emergency preparedness and response 
  • Governance and oversight mechanisms 

Local manufacturing is also an area for development; we know that in 2021 Africa imported 99% of its vaccines. Going forward, Africa CDC and the African Union have set the goal of manufacturing, producing, and supplying over 60% of the total vaccine doses on the continent by 2040. How will this happen? Through the efforts and collaborations of organisations like Afrigen, led by Professor Petro Terblanche, Africa will should be able to “innovate with the world”. However, greater investment and policy reform are still needed.  

Politics and pounds 

The key drivers of preparation for Disease X are political will and financial investment. These often come together, or not at all. So, how can we encourage them? If, as Ramgolam suggests, elected officials are guided by their voters, a first step could be to educate the voters on the significance of Disease X, not by fear mongering, but by setting out the available facts and contrasting threats with tools.  

It’s taken us this long to mention Kate Kelland, author of Disease X: The 100 Days Mission to End Pandemics purely because we focused on freely available information online. However, in an interview with the World Economic Forum’s Radio Davos Podcast host Robin Pomeroy, she gave an insight into some of her recommendations. Relating to financing, she calls for a “pandemic fund already set up and populated with actual money” before it is needed. For political leaders, there is a need to balance “low-regret decisions” with greater risks: 

“If you delay, you will almost certainly be too late.”  

If you made it this far, don’t forget to subscribe for more like this. If you are interested in Disease X, check out our World Vaccine Congress agenda for Barcelona, featuring a “Biothreats and Disease X” workshop. We hope you will join us there!

International partnership targets parasitic worms in sheep

International partnership targets parasitic worms in sheep

In August 2023 Moredun Research Institute announced that it is leading an international partnership with the University of Glasgow and the University of New England to develop an effective vaccine for on-farm worm control. This project will also include colleagues at the James Hutton Institute. The vaccine will target parasitic worms in the gut, which cause severe consequences for infected animals and farmers.  

Gastrointestinal nematodes 

Gastrointestinal nematode infection is described as a “major problem in the small ruminant industry worldwide”. Species of nematode responsible for disease vary from region to region, but most affect the abomasum or small intestine. The greatest level of clinical disease occurs in “young, growing animals”.  

Moredun states that the cost of parasitism is estimated to be around £4 per lamb through reduced wait gain and treatment costs. The total cost to the Australian sheep and goat industry is estimated to be more than AU$ 450 million a year. Furthermore, the “inefficiency in production” exacerbates the problem of agricultural greenhouse gas emissions.  

Treatments and control 

Although chemical treatments are the “mainstay” of parasite control programmes for nematode infections, growing resistance to these treatments “severely undermines control options”. To encourage a sustainable future in sheep farming, Moredun identifies a need for vaccine development.  

Much of the progress in this area is being funded by “significant investment” from the Scottish Government, UKRI, and others and is a “long-term project”. However, through a combination of the team’s parasitology, immunology, and vaccine formulation experience and expertise, the partnership is hoping to “significantly increase the chances of success”.  

Dr Alasdair Nisbet is the project lead from Moredun Research Institute. 

“We are delighted to be able to lead this international team to develop our nematode vaccine technology further and push towards a commercial product to help control this major issue in the sheep industry.”  

The project is co-funded by the partners and funding is matched by the Australian Federal Government through the Meat and Livestock Australia Donor Company to a total of over £6 million over 5 years. Over half of this will go to the Scottish partners.  

Study: how effective are seasonal flu vaccines?

Study: how effective are seasonal flu vaccines?

A study in Vaccines special issue Vaccines against Influenza virus presents a systematic review and meta-analysis of randomised controlled trials (RCTs) and test-negative designs (TNDs) to assess the vaccine effectiveness (VE) of seasonal influenza vaccines (SIVs) for patients between the ages of 15 and 64. Influenza, a respiratory disease caused by the influenza virus, is “highly transmissible in humans”; it represents a “year-round disease burden” according to WHO. However, WHO also suggests that “the most effective way to prevent the disease is vaccination”, with safe and effective vaccines having been deployed for over 60 years. So, how effective are annual efforts to identify and target specific viruses, and how important is it to get this right? 

Vaccine values 

Influenza is most prevalent during cold periods, peaking in the Northern Hemisphere between November and April and in the Southern Hemisphere between June and October. WHO estimates that there are 1 billion cases of influenza every year, of which 3-5 million are “severe” cases. Roughly 650,000 deaths occur each year due to infection. As seasonal flu vaccination campaigns “represent a major investment for countries and governments”, the authors identified a need to assess the effectiveness of the vaccine.  

There are two main types of study used to assess the SIV performance: RCTs and observational studies. The paper suggests that among these, the most common are cohort studies and the case-control study, or TND. RCTs are “always conducted” for marketing authorisation of the vaccine, with vaccine performance determined by VER, equal to:  


Here, PR is the “relative risk”. However, these trials are “expensive and time-consuming”, and are therefore not a “parsimonious method” for monitoring the efficacy of an SIV. To assess the annual effectiveness of different vaccines, TND is used when laboratory confirmation is required; the sample comprises individuals with influenza-like illness (ILI), who seek professional consultations. They are tested for the disease, with positive cases being recognised as cases and negative cases identified as controls. The effectiveness of the vaccine is measured by comparing the odds of infection between vaccinated and unvaccinated individuals. The vaccine effect is measured by effectiveness (VE), which is equal to: 


Here, OR is the odds ratio. However, several factors can affect the VE or introduce bias in the estimates. A given example is that VE can be “seriously affected” by a mismatch of virus strains in the vaccine to those in circulation each season. Another example is previous vaccination or natural infection. Thus, RCTs and TNDs are used in “different contexts”.  

The study 

The paper describes a “systematic review and meta-analysis of RCTs and TNDs conducted to assess the VER and VE of SIVs in humans aged 15 to 64 years”. This builds on previous “scarce” information regarding VE.  

“The main objective of this work is to measure the effect of a vaccine assessed in RCTs and TNDs using a common measure: VE.”  

The focus on 15–64-year-olds is explained as they are a lower-risk group for severe illness. Elderly people are excluded because of their potential for comorbidities, and RCTs in the elderly population have another vaccine as a comparator. As vaccination is recommended a placebo is not used.  

What does the study conclude? 

In the review it becomes evident that the “most important factor” is the match between a vaccine and circulating strains. A comparison of trivalent inactivated (TIV) and tetravalent inactivated (QIV) found higher effectiveness values for TIV vaccines, a “surprising” result for the team.  

“Our understanding is that a match between the strains included in the vaccine and those that are predominantly circulating is the most influential factor.” 

Therefore, having a high number of strains included in a vaccine is not relevant if they don’t match the strains in circulation. The authors emphasise that future efforts should “focus on improving the match” between vaccine strains and strains in circulation.  

For more on prevention of respiratory diseases like influenza, join us at the World Vaccine Congress in Barcelona in October. Or, subscribe for weekly vaccine updates!

Gavi leadership: Berkley passes the baton to Marlow

Gavi leadership: Berkley passes the baton to Marlow

A week ago, on 2nd August 2023, Dr Seth Berkley’s tenure as CEO of Gavi came to an end after 12 years. The following day the position of Interim CEO was assumed by David Marlow, a “transformational global life sciences and social responsibility executive” who has worked with Gavi for just over a year. He takes this post in Dr Muhammad Ali Pate’s stead, after the Nigerian health leader declined the role to “prioritise serving his country”. So, as Gavi enters a period of transition, what is on the cards for the Alliance? 

Dr Berkley’s departure 

Reflecting on his 12 years as CEO of Gavi on LinkedIn, Dr Seth Berkley commented that he leaves with “deep pride” and “gratitude” for the “incredible people” he has met. He also celebrated some of Gavi’s most notable achievements since its establishment at the turn of the century. Among these achievements, Dr Berkley recognised a “dramatic 70% reduction in vaccine-preventable child deaths”.  

Another remarkable success is the recent surpassing of 1 billion children immunised through Gavi’s “direct engagement”. This protection of “an entire generation” is particularly notable as a piece of good news amidst concerns about global immunisation rates. However, as Dr Berkley emphasises, Gavi’s successes “are not just statistics”. 

“They are lives saved, futures secured, and opportunities created for the next generation.” 

In a recent interview with STAT, Dr Berkley reflected that he has “watched the organisation from the beginning”, growing from a “small secretariat” to make an “extraordinary” difference. In the interview he offered a greater insight into his pride in what has been done; he refers to the work done around Ebola.  

Through Gavi’s involvement in an advance purchase commitment and ensuring that there would be sufficient doses in between proof of efficacy and licensure, they were able to trigger the incentive that was lacking: “it was a disease of poor countries, and the outbreaks were little”. Thanks to Gavi’s encouragement, we currently have a licensed stockpile of vaccines, which can limit the “scary, terrible disease”.  

Room for improvement 

Despite Gavi’s clear successes, Dr Berkley does acknowledge that “we got it wrong” in some cases. In the STAT interview he identifies Ebola Sudan and Marburg as examples of this, as “the candidate vaccines weren’t in vials ready to go” when the need arose. Dr Berkley suggests that the timeline of vaccine investigation to deployment will require a “lot of work”.  

Other areas for improvement include routine vaccination for HPV, for which Dr Berkley believes pilot programmes could have been terminated sooner to give way to vaccination.  

“This is our most impactful vaccine. There are more women who die of cervical cancer than who die in childbirth today, so we need to get that vaccine out.”  

Another example is the malaria vaccine, as Dr Berkley considers “moving it quicker would have saved lives”. Finally, in COVID-19, he bravely admits “I made a mistake – and I will live with that”. To the outsider, the “enormous” pressure Dr Berkley experienced would surely be enough to encourage errors. It appears that Dr Berkley’s mistake was optimism: 

“We felt, OK, we don’t need to worry at the beginning about delivery, because others will flood countries with money to deal with that. That turned out not to be true.”  

This oversight is something that Dr Berkley raised again in an interview with TIME. Among the lessons he thinks we should learn from COVID-19, he states that “we did not prioritise having delivery systems for the vaccines”, which “led to delays”.  

“Had we started with enough financing for delivering the vaccines alongside purchasing them, that would have been a really good thing.” 
A long road ahead 

Without speculating too much about what David Marlow’s inbox contains, we wonder what big challenges he faces in his new role. From Dr Berkley’s interview with STAT, there are a “few things” to consider. The first is the “tough economic time” that will make raising resources “difficult”. However, he insists that we must be prepared to address multiple challenges at once.  

“The world tends to think about things seriatim…That is important. I’m not balancing the importance of different things. But we need to think about this and this and this.”  

As evidence of this, Dr Berkley refers to an “era of poly-epidemics”, thanks to “land use and population growth and climate change”. These will encourage “more and more outbreaks” that will require “resilient systems”. Within this demand, the need to develop technology for “preventative mechanisms” must include the consideration of accessibility.  

Marlow takes the reins 

In a blog post for Gavi dated 8th August 2023, David Marlow expresses his excitement and humility as he begins the interim assignment as CEO. He mentions that he is “optimistic” about what the Alliance can achieve in “the coming months”, signalling his intention to get off to an ambitious start. Acknowledging the history of “tirelessly” working to reach vulnerable populations and a “historic pandemic response”, Marlow is conscious that there are “many more children and communities left behind”.  

“During my tenure, I will focus on supporting the organisation in maintaining a laser-sharp focus on executing its current mission, setting an ambitious strategy for the 2026-2030 period defined and approved by the Gavi Board, and ensuring Gavi is properly resourced to accomplish our work in the coming years.” 

So, what expertise is he bringing to this “laser-sharp focus”? For “more than 30 years” he has served multiple organisations is various capacities, from audit and legal and compliance, to risk management and international operations. Before joining Gavi he was Chief Operations Officer of the Mastercard Foundation, during which he led the redesign and implementation of a new operating model. He also held “various senior executive global roles” at Bristol-Myers Squibb.  

At Gavi, Marlow has “spearheaded” Gavi’s Operational Excellence (OE) work, which he describes as “efforts to simplify day-to-day Alliance processes to help carry out our mission more effectively and efficiently”. In the first few days of this new interim role, Marlow emphasises that the “leadership team remains deeply and firmly committed” to the Gavi mission. He also highlights that the “strength” of the Alliance depends on “core partners”: governments, private sector and philanthropic partners, civil society, vaccine manufacturers, academia, and other health actors.  

“My personal commitment is always to listen and be open to constructive feedback from our partners, contributors, and supporters, ultimately acting in the best interest of the Alliance and our vital collective work.

What do you expect to see from Marlow in the coming months, and what advice might you offer to Gavi’s leadership at this time? We look forwarding to hearing more from Gavi at the World Vaccine Congress in Barcelona this October; get your tickets here today! For more on international vaccine programmes and policies, don’t forget to subscribe here.