US announces further Global Health Security Partnerships

US announces further Global Health Security Partnerships

In November 2022 the White House issued a statement indicating the intention of the Biden-Harris Administration to continue to “prioritise global health security” as part of wider efforts in “national biodefence”. Highlighting ongoing outbreaks alongside the continued threat of COVID-19, the statement emphasised the importance of preparedness for infectious diseases and how “global health systems remain ill-equipped to identify and contain these threats”. With “new actions” the Administration hopes to accelerate the “National Biodefence Strategy and Implementation Plan for Countering Biological Threats, Enhancing Pandemic Preparedness, and Achieving Global Health Security (Strategy)”.  

Constant and consistent threats 

The statement began with the acknowledgement that the world is continuing to fight COVID-19. This comes just weeks after Biden’s statement that the pandemic was “over”, perhaps inadvertent, which caused ripples in the pharmaceutical industry. It continued by referring to the suffering caused by Mpox, recently renamed, and the Ebola outbreak in Uganda. These are “two of the most recent examples of how the risks and impact of emerging infectious diseases are increasing daily”.  

A roadmap  

The Administration describes a “bold and ambitious roadmap” that will “protect American lives and livelihoods” and offer protection against infectious disease threats, “whether naturally occurring, accidental, or deliberate”. This qualification is perhaps a recognition of the heated debate over the origins of COVID-19.  

Capacity-building partnerships 

Through secure partnerships, the statement highlights the importance of stopping disease threats “at their source”. As we saw recently in the mpox outbreak, this is something we continue to fail to do, prioritising apparent national interests over obvious international health.  

“The United States is committed to directly supporting at least 50 countries, by 2050, to strengthen and achieve regional, national, and local capacity in five critical areas to prevent, detect, and respond to infectious disease threats.” 

How will this happen? The White House sets out several specific goals as follows: 

  • Expand and strengthen bilateral partnerships with at least 25 countries to develop measurable capacity to prevent, detect, and rapidly respond to epidemic and pandemic threats. 
  • Build and expand regional partnerships in Africa, Asia, and Latin America on infectious disease surveillance and early warning systems, biosafety and biosecurity, strengthening emergency operations centres, training and supporting health workers, investing in community and national leadership for global health security, and legal preparedness. These partnerships also include the multisectoral African Partner Outbreak Response Alliance (APORA) and joint efforts between the US Indo-Pacific Command and Australian Defence Force.  
  • Leverage bilateral US global health security programmes alongside investments from the newly established Pandemic Fund at the World Bank to achieve additional measurable results at the national, regional, and global level, and spur new resource mobilisation for pandemic preparedness and response. 
  • Support implementation of the third edition of the WHO’s Joint External Evaluation (JEE). The CDC will provide technical experts to support 10 countries’ JEEs, assisting in gap assessments and developing recommendations to address them.
Global example and encouragement 

The statement suggests that global health security “cannot be achieved alone”. Thus, in addition to “expanding bilateral partnerships”, the US will “utilise its unparalleled catalytic leadership to unlock more commitments” to “bolster support”. The following actions are set out in the statement: 

  • Strengthen and support the extension of the multilateral GHSA beyond 2023, as a forum for working across countries, regions, sectors (including non-governmental) to provide technical assistance and share best practices and measure and hold global partners accountable for progress.  This week, the United States joined other multi-sectoral delegations in committing to and calling for new actions during the 7th GHSA Ministerial in Seoul, Republic of Korea. 
  • Strengthen the new Pandemic Fund at the World Bank as a founding Board Member to deliver early impact for those countries and regions most in need, including supporting them to strengthen and achieve measurable capacity in critical areas. 
  • Accelerate G7 commitments made by the United States and its close allies in 2021 and 2022, including meeting milestones of the G7 Pact for Pandemic Readiness towards assisting at least 100 countries, and collaborating with Japan’s G7 Presidency to expand health security investments, bolster medical countermeasure development and delivery, and grow pandemic preparedness and response financing.  This G7 commitment matches the United States’ own 50 country target commitment and aligns with the target of the GHSA 2024 initiative. 
  • Support the planned Global Health Security Coordinating Office being established by Republic of Korea and expected to launch in 2023, including strengthening coordination and collaboration with the U.S. Centers for Disease Control & Prevention’s new East Asia regional office. 
Regional safety 

As well as global concerns, the White House will continue to promote national pandemic preparedness within the country and its region, working with “partners in the Western Hemisphere”. Working regionally, in North and South America, the Administration will: 

  • Commit, working with the WHO and the Pan American Health Organisation (PAHO), to initiate and conduct a renewed external evaluation of U.S. health security and pandemic preparedness capacity by the end of 2024, in line with strong U.S. commitment to the International Health Regulations and using the new Joint External Evaluation (JEE) 3.0 Tool. 
  • As tasked in NSM-15, revise the U.S. Global Health Security Strategy to incorporate lessons from the COVID-19 pandemic and further outline the Administration’s international strategy and support for achieving a stronger, more secure global health security architecture with equity at the centre. 
  • Work collaboratively with Canada and Mexico under the North American Leaders’ Summit (NALS) to revise the North American Plan for Animal and Pandemic Influenza (NAPAPI) based on lesson learned from COVID-19. The three countries plan on developing and launching a new NAPAPI at the 11th NALS as a key cross-sectoral, flexible, and scalable trilateral framework for strengthening regional preparedness and response to a broader range of health security threats that includes influenza and beyond. 
  • Strengthen regional engagement, including establishing a new U.S. Centers for Disease Control & Prevention regional office in Panama City, Panama, serving Central America and the Caribbean.  
  • Establish and support, in collaboration with PAHO and the InterAmerican Development Bank, the Economic and Health Dialogue of the Americas (EHA), which aims to convene Ministries of Health, Finance, Economy, and Foreign Affairs of countries in the Western Hemisphere to jointly address the economic repercussions of COVID-19 and strengthen regional pandemic preparedness. 
Results delivered 

“Investing billions of dollars today in global health security can save trillions of dollars and millions of lives.” 

The Biden-Harris Administration thus “urges” Congress to “fully meet this unique moment in history”. With the opportunity to provide the additional resources to “sustain and accelerate progress” for the partnerships, the Administration hopes that Congress will respond favourably. To demonstrate the effect of such investments, the Administration also released its annual report to detail “key outcomes”.

“In publishing these significant and measurable results, the United States continues to model transparency and accountability for its health security investments with global partners and calls on countries and non-governmental organisations to do the same.”

“The results are clear:  Investing in preparedness and prevention saves lives and yields tangible results, including helping to rapidly address outbreaks of Ebola, yellow fever, Lassa fever, polio, influenza, and many others.” 

To access the full report, click here.  

For more from the White House at the World Vaccine Congress in Washington 2023, click here to get your tickets.  

 

WHO approval for Republic of Korea regulator

WHO approval for Republic of Korea regulator

The WHO announced in November that the Ministry of Food and Drug Safety (MFDS), Republic of Korea, achieved maturity level 4 (ML4) in its ranking of regulatory authorities for medical products. This is the highest level. Out of 33 countries assessed, only the Republic of Korea was listed as securing this level of regulatory recognition.  

Important milestone 

WHO described the occasion as an “important milestone” for both the Republic of Korea and the world. It signifies that the MFDS is “operating at an advanced level of performance with continuous improvement”. Dr Zsuzsanna Jakab, WHO Deputy Director-General and Office-in Charge of the Western Pacific Regional Office, received the “great news”, remarking that the Republic of Korea is the “first country in the world to be assessed by WHO and recognised as having achieved the highest level for both vaccines and medicines regulation”.  

Dr Oh Yu-Kyoung, Minister, MFDS, stated that it was a “great honour” to receive confirmation of the WHO’s recognition.  

“The Ministry of Food and Drug Safety will continue to strengthen close collaborations with the WHO in sharing its experience of establishing advanced level of regulatory system and supplying safe and high-quality medicines and vaccines.”  

The rest of the world  

WHO suggests that “only about 30%” of the regulatory authorities across the globe have the “capacity to ensure” that health products are “produced to required standards, work as intended, and do not harm patients”.  

The benchmarking efforts shine a spotlight on advanced regulatory authorities to set an example for others that “lack the resources to perform all necessary regulatory functions”. Based on the “Global Benchmarking Tool” the assessment revealed that 11 other countries have attained ML3, and Singapore has attained ML4 in medicines regulation. 

“Countries with ML3 and ML4 are eligible to become a WHO listed authority (WLA), following a further performance evaluation.” 

The WLA is a scheme for “designating regulatory authorities” as reference points for others to support them in decision-making.  

We will hear more on the various regulatory processes involved in vaccine development and distribution at the World Vaccine Congress in Washington next year. To join us, get your tickets now.  

UK applies Vaccine Taskforce model to health problems

UK applies Vaccine Taskforce model to health problems

The UK government announced in November 2022 that it would be introducing a “Vaccine Taskforce style approach” to some of the biggest health challenges facing the UK. Pledging over £113 million towards research, the government has identified 4 healthcare “missions”: cancer, obesity, mental health, and addiction. The hope is that this will “unlock the next generation of medicines and diagnostics to save lives, transform patient care, and ensure UK patients are the first to benefit”.  

Following vaccine success 

The announcement on 28th November identified the “Vaccine Taskforce model” as the driver behind one of the “most successful vaccine roll outs in the world”. Through this approach the government aims to “harness world-leading research expertise, remove unnecessary bureaucracy, strengthen partnerships, and support the new healthcare challenges”.  

Furthermore, it is hoped that addressing these challenges will “save the NHS and the economy billions of pounds”. The government estimation is that obesity costs the NHS £6.1 billion a year and “poor mental health” costs the economy £118 billion a year. The decision builds on the earlier Life Sciences Vision.  

Life Sciences Vision 

Launched in July 2021 under the supervision of former Prime Minister, Boris Johnson, the Life Sciences Vision was “co-developed with business and experts” to promote “scientific excellence” alongside the “dynamism of industry”. It addressed 7 key “missions”: 

  • Accelerating the pace of studies into novel dementia treatment 
  • Enabling early diagnosis and treatments, including immune therapies such as cancer vaccines 
  • Sustaining the UK’s position in vaccine discovery, development, and manufacturing 
  • Treatment and prevention of cardiovascular diseases and major risk factors, including obesity 
  • Reducing mortality and morbidity from respiratory disease in the UK and globally 
  • Addressing the underlying biology of ageing 
  • Increasing the understanding of mental health conditions, including work to redefine diseases and develop tools to address them 

The model allegedly attracted £1 billion investment to the UK. This further funding is expected to gain additional investment from leading global companies.  

Funding to top priorities 

The top health priorities were identified by the NHS and will receive the following funding allocations: 

  • Cancer – £22.5 million towards immune-based cancer therapies, including cancer vaccines, as well as technologies that enable earlier and more effective diagnosis. 
  • Mental health – £40.2 million towards research to develop and introduce digital technologies, including technology to allow patients to self-monitor at home and report to doctors when in need of help. 
  • Obesity – £20 million to trial medicine delivery and technologies for patients living with obesity, particularly in deprived communities.  
  • Addiction – £30.5 million towards the acceleration of new technologies to prevent deaths from overdoses 
How will it work? 

As with the Vaccines Taskforce, the 4 missions will be chaired by an independent “expert in that field”. They will be able to supervise the accelerated “development and introduction of the latest treatments and technology into the NHS” as well as greater collaboration. The chairs will be appointed by an “expert panel dedicated to each mission”. This panel will include Kate Bingham who “headed up” the Vaccine Taskforce.  

The government emphasised its commitment to ensuring patients benefit from the latest treatments. It coincides with Innovate UK’s launch of a new £30 million fund to “advance life-changing cancer therapeutics”. This is “directly supports” the government’s cancer mission, by “combining expertise in immuno-oncology and the vaccine capabilities developed throughout the pandemic”.  

Senior figures meet 

The statement from the government indicated that on 28th November the current Prime Minister Rishi Sunak, alongside the Health and Social Care and Business Secretaries will meet with “key industry figures”. Their discussions will cover how to “deliver life-changing innovations to patients, boot NHS efficiency, and ensure the UK remains a global life sciences superpower”.  

Rishi Sunak stated that the NHS faces “real pressures”. He hopes that “outcomes for patients” will improve. Furthermore, he expects to “save the NHS millions of pounds”.  

“It is hugely welcome too that the highly successful Vaccine Taskforce, which procured millions of life-saving vaccines in record time during the pandemic, will now become a blueprint for how we harness the best talent and expertise from around the world and drive investment in research and development.” 

Steve Barclay, Health and Social Care Secretary identified the “billions of pounds each year” that are spent of treating conditions such as cancer and obesity. By “leading the way” in research he hopes to “ensure a better quality of life for patients”.  

“By harnessing the same spirit of innovation that delivered the vaccine rollout and working hand in hand with the NHS, industry, and healthcare experts we’re building a stronger, healthier NHS with record numbers of staff and record funding”.  

For more on governmental roles in vaccine delivery and how the vaccine community can work with policy makers in the future, come to the World Vaccine Congress in Washington next year.  

WHO declares measles a dangerous “growing threat”

WHO declares measles a dangerous “growing threat”

The WHO announced in November 2022 that almost 40 million children were “dangerously susceptible” to the “growing threat” of measles following a decline in vaccination coverage. This decline is recorded from the beginning of the COVID-19 pandemic and is observed across a range of routine childhood vaccinations.  

A worrying decline 

The statement from WHO, published on 23rd November 2022, suggested that WHO and CDC data identified 25 million children who had missed their first dose and a further 14.7 million children who missed their second dose.  

“This decline is a significant setback in global progress towards achieving and maintaining measles elimination and leaves millions of children susceptible to infection.”  

In 2021 we experienced an estimated 9 million cases, with an unfortunate 128,000 deaths. 22 countries had “large and disruptive outbreaks”. This is attributed to “declines in vaccine coverage”, poor surveillance, and COVID-19 related disruptions.  

A grave situation 

Measles is “one of the most contagious human viruses but is almost entirely preventable through vaccination”. Herd immunity can be obtained with coverage of 95% and higher. Sadly, we are “well under” this, with only 81% of children receiving the first dose of a measles-containing vaccine, and only 71% of children a second.  

“These are the lowest global coverage rates by the first dose of measles vaccination since 2008, although coverage varies by country”.  

Dr Tedros Adhanom Ghebreyesus, Director-General of WHO, identified the “paradox of the pandemic” as the contrast between the “record time” of the “largest vaccination campaign in history” and the disruption of routine immunisations. 

“Getting immunisation programmes back on track is absolutely critical. Behind every statistic in this report is a child at risk of a preventable disease.”  

Calls to action 

No WHO region has achieved and sustained elimination of the virus. Furthermore, 10 countries that had previously eliminated measles have experienced outbreaks since 2016. This is concerning to CDC Director Dr Rochelle P. Walensky, who suggests that “public health officials can use outbreak response to identify communities at risk”. In doing so, she hopes that they will be able to “deliver locally tailored solutions to ensure vaccinations are available to all.”  

CDC and WHO now “urge coordinated and collaborative action”, as is their wont. In addition, several WHO partners have come forward to comment on the situation. Gail McGovern, President and CEO of the American Red Cross emphasised the importance of “averting needless deaths”. 

“It is imperative we work together to close existing immunity gaps and ensure that no one suffers from vaccine preventable diseases.” 

Gavi’s CEO, Dr Seth Berkley describes the decline in measles coverage as “alarming”. Gavi’s support for lower-income countries will continue to “get routine immunisation programmes back on track”. Furthermore, it is “pushing” with “targeted efforts” to reach zero dose children. Elizabeth Cousens, President and CEO of the United Nations Foundations agrees that “plummeting measles vaccination rates should set off every alarm”.  

“There is no time to waste.” 

The alarm motif continues in a comment from UNICEF’s Chief of Immunisation Ephrem Tekle Lemango. His team have been “sounding the alarm” for 3 years and he demands “decisive action”. So, how can a world battling vaccine reluctance and emerging from COVID-19 spring back into defensive mode against a vaccine preventable virus? Will “coordinated and collaborative action” engage communities in hard-to-reach areas, and will vaccines reach every child? 

For more on measles vaccination programmes at the World Vaccine Congress in Washington next year, get tickets at this link.  

Vaccines: the missing piece in the dementia puzzle?

Vaccines: the missing piece in the dementia puzzle?

Dementia is described by the NHS as a syndrome associated with an “ongoing decline of brain functioning”. This may manifest in an impaired ability to remember, think, or make decisions, suggests the CDC. The most common type of dementia is Alzheimer’s disease, and although dementia generally affects older patients, it is not considered a “part of normal ageing”. The WHO states that around 55 million people worldwide who experience dementia, with 10 million cases added each year. For these patients and their families, the experience of dementia can be deeply upsetting, confusing, and frightening. So, how do we deal with it now? 

Current efforts and immune potential 

FDA-approved drugs comprise 2 categories of Alzheimer’s treatment. The first option is to change disease progression, and the second is to temporarily mitigate some symptoms. However, we do not have a cure for Alzheimer’s disease or most cases of dementia.  

Therefore, researchers are exploring the possibility of protection from dementia through vaccination. We are familiar with the traditional approach of vaccines, which encourage or train the immune system to respond to specific infections. Might this be applicable to dementia? Dr David A. Merrill, of Providence St John’s Health Centre in Santa Monica, told MedicalNewsToday that a growing “appreciation” of the immune system’s role indicates it might be “relevant” to “potentially recovering from or even preventing a disease”.  

For example, research presented at the Alzheimer’s Association International Conference in 2020 suggested that flu and pneumonia vaccinations were associated with a reduced risk of developing Alzheimer’s. Dr Merrill suggests that “treatments can and should involve helping or addressing immune system function with ageing”.  

How would a vaccine work? 

Dr Heather Snyder of the Alzheimer’s Association described an exciting time for research, with numerous therapies in development. However, she is also interested in “active immunisation, such as vaccines”.  

“They are, in some cases, leveraging the biology of decades of vaccine-related development more broadly in medical care.” 

Some of the molecules in the body that are associated with dementia would be targeted by a dementia vaccine. These include: 

  • Beta-amyloid proteins – abnormal levels of these form plaques that disrupt cell function 
  • Tau – proteins that stabilise the structure of neurons in the brain, often abnormally folded in Alzheimer’s patients’ brains 
  • Alpha-synuclein – a protein in neurons that is associated with Parkinson’s disease and Lewy body dementia in abnormal levels 
  • Who is exploring vaccines? 

MedicalNewsToday suggests that several vaccines are in various stages of clinical trials. These include a nasal vaccine in the US, and a Swiss-based candidate. Vaxxinity also announced in 2022 that it had received fast-track designation for an immunotherapeutic vaccine for Alzheimer’s disease.  

Dr Michael G Agadjanyan at The Insititute for Molecular Medicine in the US is developing a vaccine for Alzheimer’s that can “delay/halt the onset”. The goal, he suggests, is to develop an “immunogenic vaccine that can induce a sufficient level of antibodies in the periphery of all vaccinated cognitively unimpaired elderly with immunosenescence”.  

Although several options are being explored, Dr Merrill believes it will take a “number of years” for candidates to get through the process and “regulatory hurdles”. Furthermore, Dr Snyder thinks that “more research in large, diverse human populations” is needed before any chance of “comment on the potential usefulness of a vaccine”.  

Is this likely? 

There is also the concern that people might be hesitant towards vaccines for dementia, particularly depending on the length of the vaccination process. If there is a clear indication that it “truly protects” the patient, Dr Merrill hopes people would “line up”. However, things at the moment are “uncertain”.  

As well as public reluctance, there is debate among the scientific community as to whether a vaccine would be successful. Dr Karl Herrup of the University of Pittsburgh School of Medicine believes that attempting to harness the immune system against the predicted root causes of the disease, “rests on shaky grounds”. Specifically discussing therapies, he describes the “bitter disappointment” of results that are “not surprising”.  

“I would rather be wrong and have a useful Alzheimer’s disease therapy than be right and have to have millions of people continue to suffer”.  

He suggests that the only significant question is if the treatment can “meaningfully alter the disease course”.  

To hear more about vaccine therapies and protection at the World Vaccine and Immunotherapy Congress get your tickets now. Or, join us next year in Washington for the World Vaccine Congress 2023.
 

WHO on vaccine safety: it’s a “shared responsibility”

WHO on vaccine safety: it’s a “shared responsibility”

In November 2022 the WHO, with “financial support” from USAID, finalised a project on vaccine safety monitoring in Kyrgyzstan. Described as providing support to its government in response to the COVID-19 pandemic, it focused on “adapting and implementing regulatory pathways and procedures” for public health emergencies. It further “strengthened the pharmacovigilance, monitoring, and surveillance of adverse effects following immunisation (AEFI)”.  

High standards for all 

Promoting the notion of “shared responsibility” the WHO statement indicates that vaccine safety monitoring in Kyrgyzstan is covered by several stakeholders, including the National Immunisation Programme and the National Regulatory Authority for Medicines. Among the achievements of the project was the “establishment of client follow-up and self-reporting systems on AEFI”.  

Recording and monitoring AEFI against COVID-19 has taken place since March 2021, with the development of an electronic database. This was integrated with the national system for registering vaccinated persons. Consequently, more than 2109 AEFI could be registered in the system by September 2022. Validated AEFI were shared with the WHO database, VigiBase. 

VigiBase is a “unique” global database of potential side effects for medicinal products. It contains over 30 million reports of suspected adverse effects and is continuously updated. Its purpose is to ensure that medicine-related safety problems are quickly identified.  

National training 

In Kyrgyzstan more than 800 health care workers were trained in the “surveillance and reporting” of AEFI against COVID-19 and pharmacovigilance. Furthermore, over 100 experts from the Department of Medicine and Medical Devices were trained in “vaccines and medicines regulation”.  

“Training was provided by recognised experts, including from the Eurasian Economic Union, and capacity-building training on causality assessment of adverse effects following immunisation and adverse drug reactions was also conducted.” 

Internal strength: legislation, policy, and coordination 

During the project, revisions were made to the regulatory framework for reporting, surveillance, and monitoring of AEFI. Results of the procurement and supply chain management system assessment and the evaluation of state drug policy for 2016-2020 were “communicated”

“These are building on the foundation for the future development of the strategy document on medicines, vaccines, and medical devices regulation, including in emergencies.”  

WHO states that one of the “main objectives” was to “build institutional capacity in vaccine development management, and regulatory mechanisms”. Furthermore, preparation for coordination within “future activities” was developed.  

The announcement comes just days after the WHO’s publication of the Global Vaccine Market Report 2022 in which national regulatory and development efforts were promoted. If you would like to hear more about legislation and regulatory importance then get your tickets to the World Vaccine Congress in Washington 2022.  

WHO publishes Global Vaccine Market Report 2022

WHO publishes Global Vaccine Market Report 2022

In November 2022 the WHO shared its Global Market Vaccine Report for the year 2022. It is the “first report to capture the implications of COVID-19″ on vaccine markets. It also highlights the “dynamics” that are at play that prevent or hinder the “development, supply, and access” of vital vaccines. In this post we unpack the report and examine some of the calls to action for the future.  

Director-General’s foreword 

The report begins with a foreword by Dr Tedros Adhanom Ghebreyesus. He describes immunisation as one of the “most iconic global health success stories”. However, this is denied to millions of people across the world as access continues to be a major barrier. For example, 20 million infants miss out on key vaccinations each year. Although COVID-19 “reminded the world of the immeasurable power of vaccines as key public goods” it also served as a reminder of “inequities in access” that are the “rule rather than the exception globally”.  

Dr Tedros identifies the HPV vaccine as an example of this, introduced in “only 41% of lower-income countries”. In 83% of high-income countries, it is “saving lives”. Clearly the implication is not that we need to strip it back from these high-income countries but accelerate and improve efforts to raise the percentage across the world.  

“We will not recover from the historic backsliding in essential immunisation if we continue to allow market dynamics alone to shape global vaccine priorities. Nor will we achieve equitable access to vaccines globally unless we have more transparency and active government oversight.” 

Dr Tedros calls for a “more favourable intellectual property landscape” and “proactive technology transfers” as well as increased “building and retention of technical, manufacturing, and regulatory capacity in every region”. We have seen great strides in this direction in recent months in Africa, but the importance of maintaining momentum on this front is evident.  

WHO is calling on governments, industry, international institutions and partners to act now to improve sustainable and equitable access to vaccines. I trust this report will also be used to inform ongoing negotiations on a new international accord on pandemic prevention, preparedness and response, which will allow us to respond to and end future pandemics rapidly.” 

Ups, downs, and pandemics 

The report continues with a summary of “important progress” and “significant challenges”. For example, there were “many new vaccines developed” such as meningococcal meningitis A, and malaria, which “translate into millions of lives saved”. However, not every dangerous disease is associated with markets of commercial value. They therefore remain “neglected”.  

Although there is an “expanding manufacturing base”, with over 90 manufacturers supplying vaccines to Member States in 2021, supply continues to be “highly dependent on fewer than 10 manufacturers”. Additionally, for specific vaccines, a couple of vaccine suppliers dominate the scene. Despite “positive” trends, the “African and Eastern Mediterranean Regions” experience “market health issues and regional supply insecurity”.  

More effort (and investment) is also needed to facilitate broader vaccination programmes and “counter the growing threat of vaccine hesitancy”. What we can learn from COVID-19 is that “some of these challenges can be overcome”. For example, the rapid development of vaccines with “innovative technology platforms” came as a result of “unprecedented public investment” as well as “investment in clinical development and manufacturing capacity, and the streamlining of regulatory processes”. 

“This incredible achievement in the face of a public health emergency of international concern made stark the long-standing need to reconsider the value of vaccines as a fundamental and cost-effective public good rather than a commodity.” 

However, alongside recognised successes during the pandemic, there have been “highly problematic” access issues due to “dynamics repeatedly experienced in other vaccine markets”. Take the “lack of transparency along the value chain of vaccine manufacturing and distribution, and the lack of government oversight” for example, which made it difficult for governments to implement vaccination programmes nationally and internationally.  

Early suggestions 

“We need to enhance government oversight of vaccine production and distribution and strike a much better balance between serving national interests and global public health objectives.” 

How can we do this? The report indicates that the “only means” to this is “high-level diplomacy” and “pre-defined and binding rules”.  Taking on board the lessons we were taught by the pandemic, we have an “opportunity” to “establish a new paradigm for vaccine development and access”.  

As part of this, the following government commitments are recommended:  
  1. Establish early, evidence-informed strategic goals and leadership that serve the collective global health interest and to shoulder risks and invest aggressively in order to address the needs of today and prepare for future emergencies.  
  2. Strengthen market preparedness by investing in new vaccine technologies, regional research and development and manufacturing hubs, and by enabling regulatory harmonisation.
  3. Ensure transparency and oversight along the vaccine value chain towards enhanced health impact, as well as define principles and operational mechanisms for collaboration across countries in times of scarcity, including for intellectual property and the circulation of inputs and goods. 
Industry is called upon with the following commitments: 
  1. Ensure that activities are aligned with WHO’s guidance: research and development efforts focused on the WHO list of priority pathogens and target product profiles, more clinical trials performed in low-income countries, and targeted to inform global policy needs and expedited data submissions for regulatory approvals and prequalification. 
  2. Establish provisions for technology transfer and ensure transparency along the vaccine value chain.  
  3. Commit to specific measures allowing for equity-driven allocation of products. 
Finally, international organisations and partners are asked to commit to: 
  1. Prioritise the achievement of global public health priorities as per the Immunisation Agenda 2030 as an umbrella for individual organisational strategies, priorities and interests. 
  2. Support country-driven initiatives and projects consistently with organisations’ missions and avoid the creation of duplicate efforts. 
  3. Continue to call for technology transfer and for the application of resolutions on market transparency for health products.  

 

Vaccine portfolio and regulation 

The key takeaway from this section is that “significant progress has been achieved in the development of new vaccines”, but that “diseases associated with markets with less commercial value remain neglected”. Diseases that “primarily affect lower-income countries” have been addressed. 

Secondly, COVID-19 proved that with “large public investments, joint planning of clinical development, regulation and manufacturing capacity, and leveraging innovative platforms”. The report suggests that “political pressure” contributed to the amazing work in developing COVID-19 vaccines at breakneck speed. However, before the emergence of COVID-19, work on viral-vectored platforms could be “quickly leveraged”. This innovative work is “set to increase in the coming years”. 

Regulation remains a challenge, despite “years of harmonisation efforts”.   

“Vaccines are medical products that are routinely administered to healthy people, and, as a result, real or perceived quality issues can compromise trust in immunisation, rapidly erasing progress”.  

Thus, “quality assurance” is critical to vaccine development. During the pandemic, we made progress in regulatory “strengthening and harmonisation”. However, the “divergence in vaccine registration requirements” across the world has been highlighted. Filling gaps is particularly “cumbersome for manufacturers in developing countries”, which creates further access issues. In markets with “less commercial value” delays are caused by “suboptimal investment and few pipeline products”. Diseases prioritised by the WHO R&D Blueprint, are “still missing a vaccine”. For the Africa, Eastern Mediterranean, and South-East Asian regions, there is tension between “demographics” and “market value”. 

Manufacturing base 

Although manufacturers continue to emerge and grow across the world, the supply base remains “highly concentrated”. The report cites “country data”, which indicate that 10 manufacturers provide 70% of non-COVID-19 vaccine doses and 85% of the global value. Some “clear causes” are identified: vaccine development has “high costs of entry” and yields “lower profits relative to the entry costs” in comparison with other pharmaceutical products”.  

What does this mean for market health? For “high impact” vaccines, each market is “highly dependent on one or two manufacturers”. Furthermore, for 6 vaccines that may be needed in emergencies, the health market is “concerning”. On top of this, manufacturing bases are located mostly in the “European Union, Indonesia, Japan, and the United States of America”.  

Demand puts further pressure on vaccine supply, and this has had consequences throughout vaccine history. Examples include shortages of the HPV vaccines and inactivated polio vaccines. Although “technology transfer” and manufacturing changes can tackle these issues, they are “costly and take time”. To counteract this, “large public contracts” and “guarantee of purchase” have made a “significant difference”. The vaccine market, the report suggests, is “highly complex” and therefore “less attractive”.  

  • The market requires “advanced know-how” 
  • It is protected by intellectual property rights. 
  • Expansion of capacity “implies non-linear production costs”. 
  • Demand is “very uncertain”.  
Allocation of scarce supply 

This section suggests that in order to promote “equitable and efficient distribution of vaccines” within and across borders we need a “much higher level of transparency, public oversight over production and distribution, commitment from manufacturers, and high-level diplomacy”. 

Another lesson that COVID-19 taught us is that “governments could have played a more active role” in overseeing vaccine supply”. Without this oversight, leaders found themselves in difficult positions regarding “informed, rapid, and strategic decisions”.  

“Inequitable distribution, although not unique to COVID-19 vaccines, was a moral and global security failure with health and economic consequences.” 

With “substantial progress” towards vaccine equity through initiatives such as the PAHO Revolving Fund, UNICEF, and Gavi, there are still constraints. This is particularly important in paediatric vaccines. COVAX reminded us that “financing and procurement mechanisms” cannot achieve equitable vaccine distribution alone. Despite efforts to “coordinate global demand and supply”, most volumes have “sat outside” the Facility.  

“We need to strike a much better balance between serving national interests, global public health objectives and commercial interests.” 

Country demand for vaccines 

Central to guiding investments is “predictable country demand”. Thus, in “tackling affordability, planning and procurement issues, and by boosting political will and fortifying health systems” we might be able to enhance its predictability. The causes for unpredictable vaccine demand across countries supposedly range from “insufficient political will to inadequate infrastructure and market segmentation due to different products”.  

Attempts to address demand issues are both global and regional. For example, “pooled procurement attaints lower prices for 14 of the 18 vaccines most widely used in middle-income countries” compared to self-procurement. 

Conclusions and calls to action 

As explored above in the early suggestions section, the report contains a call for stakeholders to “assume their shared but differentiated responsibilities”. With suggestions for government, industry, and international organisations, the hope is that this paradigm will serve “both equity and national interests” through a “more coordinated and more equitable global response”. 

For full access to the report click here, and make sure you get your tickets to join us at the World Vaccine Congress in Washington 2023 to hear more about vaccine equity and market dynamics.  

WHPA and WHO sign memorandum of understanding

WHPA and WHO sign memorandum of understanding

On 8th November 2022 the WHO and the 5 members of the World Health Professions Alliance (WHPA) signed a memorandum of understanding to “enhance” their collaboration on “protecting and investing in the health workforce”.  

WHPA 

The WHPA includes the FDI World Dental Federation (FDI), the International Pharmaceutical Federation (FIP), International Council of Nurses (ICN), World Physiotherapy, and the World Medical Association (WMA). Collectively, they represent over 41 million health professionals. Furthermore, they bring “essential knowledge and experience” from “key health professions” in more than 130 countries. Dr Tedros Adhanom Ghebreyesus, Director-General of the WHO, hopes the memorandum of understanding will “support health care professional associations and governments”.  

“There is no health without health workers.” 

He hopes that the memorandum will ensure the protection of and investment in the “multi-disciplinary teams of health workers” required to “deliver essential health services and prevent and respond to emergencies”.  

Historic collaboration  

The memorandum of understanding was described by the WHO as reflecting the “importance of investing in the health workforce through a multi-stakeholder integrated approach”.  

“It provides a framework for joint action” 

Specific intentions include collaboration on “priority health workforce issues” as well as “universal health coverage, noncommunicable diseases, and ageing populations”. Both the WHPA and WHO have continued to pursue “common goals” throughout the pandemic, including vaccination of health workers and stronger health systems. Enzo Bondioni is Chair of the WHPA and Executive Director of FDI. He hopes that we will learn from the COVID-19 pandemic that “today’s public health problems cannot be solved by one country or one organisation or one profession by itself”.  

“Through collaboration between stakeholders we can tackle interlinked global health challenges by taking joint action to protect and strengthen the health workforce and make progress towards universal health coverage.”  

Some of the key issues facing the WHPA and WHO include health worker safety in dangerous or hard-to-reach locations and effective education and support for health workers across the globe. As we continue to emerge from the sustained effects of the COVID-19 pandemic, health workers remain on the ‘front line’ of the fight.  

For more on public health approaches with a specific focus on pandemic preparedness and vaccination strategies, join us at the World Vaccine and Immunotherapy Congress in San Diego 2022 or the World Vaccine Congress in Washington 2023.  

Exclusive interview with Dr Carl Dieffenbach

Exclusive interview with Dr Carl Dieffenbach

As we continue sharing interviews that took place during the World Vaccine Congress in Europe 2022 we are also gearing up for our next event, the World Vaccine and Immunotherapy Congress in San Diego in November 2022. In doing so we are delighted to share some exclusive pre-Congress interviews with the community. The first of these is a call with the Director of the AIDS Division at NIAID in the US. Dr Carl Dieffenbach is a highly regarded researcher and team leader who will speaking about pandemic preparedness and bringing HIV/AIDS to an end. We were delighted to claim some of his time for a quick conversation about these concerns.

What does your role involve?

As head of the HIV/AIDS portfolio Dr Dieffenbach has a lot on his plate across a range of areas. Pandemic preparedness is a huge aspect of his work, and he is really keen to emphasise this at the congress. He believes this involves 3 critical components: “vaccines, therapeutics, as well as diagnostics”. However, there is also a “really important bridge between vaccines and therapeutics, and that is the development of neutralising monoclonal antibodies.” In terms of how this fits into Dr Dieffenbach’s role, he is encouraging an “integrated” approach at NIH. Without giving too much away, he indicated that this was coming together in a “pretty good plan”!

 

 

From COVID-19 to future pandemics

As with all of our interviewees, Dr Dieffenbach has a useful insight into how we move forward from COVID-19, particularly with regard to a future threat. We asked about gaps in our preparedness for COVID-19, and how we can address them in time for the next threat. For Dr Dieffenbach, preparedness is about “having programmes to a specific stage where you can respond quickly”. For example, with vaccines, we have to have “good platforms” ready for action. In terms of appropriate drugs, we “should” be able to prepare “family specific inhibitors” that then need only a bit of “tweaking” to be effective.

The example Dr Dieffenbach highlights from COVID-19 is Pfizer’s journey to Paxlovid. They had a SARS-1 drug and “went back into medicinal chemistry” to get the active component. This was done effectively, but thanks to a “lot of work in that medicinal space”. Contrasting COVID-19 with Zika virus, we were only so quick in our response to the former because we had a “tremendous amount of experience with coronaviruses”.

 

 

The “forgotten” epidemic

Dr Dieffenbach’s role will bring a valuable insight to the Congress this month. We asked about progress in the HIV/AIDS fight and where we need greater efforts. One thing that Dr Dieffenbach made clear is that he and his team did not drop the ball during COVID-19.

“When people talk about the forgotten epidemic, I the only people that have forgotten about it is the press.”

When a new pandemic arrived, researchers were faced with a “fork in the road”. Their decision was to take both paths. Thus, work on HIV continued at speed whilst “infrastructure” was also shifted to support the development of COVID-19 vaccines and therapeutics. This was “incredibly successful”, resulting in the trial of CAB-LA, a potential “game-changer”. Contrasting regular pills with less frequent injections, Dr Dieffenbach thinks that progress was made during the pandemic. However, on the “implementation side” and the “healthcare delivery side”, things have “slipped”.

At the Congress, the “Holy Grail” of HIV research will come up, two key issues that Dr Dieffenbach and his colleagues are trying to tackle. The first is the search for a “safe, effective, and durable vaccine”. The second is a cure that can be developed and implemented in such a way that “people don’t have to take medicine everyday”.

 

Outside threats

Our penultimate question was about health threats that we are currently facing, and will continue to face for the future. For Dr Dieffenbach, these are the nebulous threats of “complacency”, “disinformation“, and the knowing dissemination of “falsehoods”. In COVID-19 we saw this twofold, with anti-vaccine movements but also drug disinformation around hydroxychloroquine and ivermectin.

“We’re so fact-based and rule-bound about how we respond that if somebody says something outlandish, it’s like, how do you respond to that?”

Dr Dieffenbach looks back to 1918 and the Spanish Flu. There was a “tremendous amount of that kind of behaviour as well”, suggesting that it is “innate”. However, without the inflammatory effects of social media, it could have less of an immediate and impenetrable hold.

 

 

This year’s Congress

Our interview concluded with a reflection on the Congress and why it is important. For Dr Dieffenbach, it is “really important to help us understand where we are” on a range of diseases. It is also about “innovation”, and communication between industry, academia, and innovators.

 

It was a privilege to speak to Dr Dieffenbach during his busy working day, and we are so excited to hear more from him later this month. If you would like to join us at the Congress, get your tickets here! We will also be focusing on HIV/AIDS at the World Vaccine Congress in Washington next year so do get tickets for that!

Study shows vaccine confidence sinking after COVID-19

Study shows vaccine confidence sinking after COVID-19

A study by researchers at the University of Portsmouth in Vaccine at the end of October explored the effects of the COVID-19 pandemic on vaccine confidence. As we have previously explored, vaccine fatigue, vaccine hesitancy, and anti-vaccine disinformation have contributed to lower rates of vaccinations in certain populations. This recent study compares two cross-national surveys with “similar modalities” in 2019 and 2022 to explore changes in vaccine confidence and the links to “specific demographics”.  

How did we get here? 

Although “vaccination is widely considered to be one of the safest and most effective primary health care measures” it is a hugely contentious subject. In the face of historic successes, such as reductions in typhus, cholera, and plague, and more recent effects such as a “substantial drop in cervical cancer incidence”, large groups remain unsure of or opposed to vaccines.  

“Despite overwhelming evidence supporting its importance as a key primary prevention measure, immunisation has been the object of controversy and vocal opposition ever since its inception.”  

The authors consider “Wakefield’s infamous article” in 1998 and the “subsequent MMR controversy” but acknowledge that vaccine hesitancy and refusal have their origins in the “early days of variolation, even before the administration of the first vaccine”.  

SAGE 

The Strategic Advisory Group of Experts (SAGE) was established in 1999 by the WHO to “provide guidance” on its work. It is the “principal advisory group to WHO for vaccines and immunisation”. In 2011 it proposed the 3Cs Model as determinants of vaccine hesitancy: Confidence, Complacency, and Convenience. As we explore in our post in the 5C model, it has since been expanded by other sources, to include Calculation and Collective responsibility. SAGE frameworks contribute to global national health approaches and vaccination campaigns, most recently to “model hesitancy and refusal of COVID-19 vaccines”.  

COVID-19 

The authors of the paper reflect that at the time they were writing, “11.9 billion doses” of a COVID-19 had been administered. This corresponds to “61.2% of the global population being” what is contentiously referred to as “fully vaccinated”. However, they do acknowledge “wide variation in vaccination rates” between countries.  

“While the rapid development and administration of COVID-19 vaccines are widely considered an extraordinary public health accomplishment, they also spurred considerable controversy and opposition.”  

The authors suggest that “confidence” factors seem to be “preponderant”. Misinformation about the safety of these vaccines was particularly problematic. Although there were demonstrated benefits to mass vaccination programmes, The Lancet published an article in 2021 stating that “willingness to vaccinate against COVID-19 has declined” between the “early months of the pandemic” and the end of 2020. Thus, this study aims to ascertain whether public vaccine confidence has fallen “below pre-pandemic levels despite the successful implementation and outcomes” of COVID-19 vaccinations.  

The study 

Two anonymous online surveys were carried out to “investigate the public perspectives on the practice of vaccination and the factors that might underpin hesitancy and refusal”. The first took place between November and December 2019, just as early cases of the virus were identified in China. The second was distributed in January and February 2022. The questionnaires were “adapted from the WHO SAGE Vaccine Hesitancy Scale”. Most importantly for this study, 10 questions were the same across the surveys.  

Overall, 1009 participants were recorded, with demographic “deviations”. However, “both cohorts showed a majority of female, white, young adults”. Within each cohort the study suggests “internal trends were relatively consistent”. Despite these, “irrespective of the participants’ gender, age, graduate status, ethnicity, and religious belief” there was a “decline in vaccine confidence scores following the COVID-19 pandemic”.  

“Only approximately 1 in 5 participants of the 2022 cohort self-assessed their vaccine confidence as having increased since the pandemic”.  

The implications  

Although the study is limited, with the lead author Dr Alessandro Siani suggesting to SkyNews it should be “interpreted with a grain of salt”, it does corroborate “other observations suggesting that vaccine confidence may be yet another victim of the COVID-19 pandemic”. Another limitation is the “use of a non-probability sampling strategy”, which means the cohorts were not necessarily “representative of the wider population”. With this in mind, “further investigations are required” to confirm the extent to which this observed reduction in confidence is “representative” of other populations.  

The authors conclude that across all demographic groups there was a reduction in confidence but state a “statistically significant association” between “Asian ethnic backgrounds and low vaccine confidence” among other trends. Overall, the general decrease in vaccine confidence implies a decrease in uptake for routine immunisations, childhood immunisations, and protection against future threats.  

For more on vaccine views at the World Vaccine Congress in Washington 2023 get your tickets now.  

 

Calls for ASEAN AVRF to move forward from COVID-19

Calls for ASEAN AVRF to move forward from COVID-19

In November 2022 a commentary in The Lancet Global Health reflected that COVID-19 vaccination programmes have been “relatively successful” across the Association of Southeast Asian Nations (ASEAN), which now includes 10 member states. According to the authors, these programmes were effective in “blunting the worst of the pandemic and increasing overall public understanding of and support for vaccination programmes”. However, they identify more to be done. 

Inspiration from PAHO’s Revolving Fund 

The Pan American Health Organisation (PAHO) has a Revolving Fund, which the authors believe to be a “useful reference” for the formation of an ASEAN Vaccines Revolving Fund (AVRF). With the intention of promoting “long-term vaccine procurement” it would start with COVID-19 vaccines and move outwards to “other vaccine-preventable diseases”.  

PAHO’s Revolving Fund was founded in 1977 and “pools the resources” of 41 PAHO states. Each year it is estimated to purchase $1.1 billion worth of 47 vaccines and 29 vaccine-related supplies for 15 million people. Furthermore, it is credited with doubling PAHO vaccination rates. The article reports that it was the 1st of 6 WHO regions to be “certified polio free in 1994”. Later, measles and rubella were “eliminated”.  

The AVRF 

The suggested objectives for the AVRF are threefold: 

  1. Coordinate pooled procurement of vaccines in southeast Asian countries 
  2. Support country-level delivery 
  3. Build capacity for national level public procurement of other goods and services 

“A successful AVRF can increase vaccine supplies, reduce the price for new vaccines, accelerate access to new vaccines, and increase vaccination rates and health equity.” 

There are four “structural challenges” identified as barriers to vaccine procurement in southeast Asia. The recommended AVRF would “resolve” these as follows: 

  1. Providing a “strong negotiating position with vaccine manufacturers” by representing 650 million people across the region. 
  2. Modernising procurement through “innovative tools such as value-based purchasing, health technology assessments, demand forecasting, and new types of reimbursement contracts with manufacturers in the short term, while building country-level capacity and harmonising regional standards in the long term”.  
  3. Strengthening local vaccine production and creating incentives for local manufacturers to “expand” production.  
  4. Supporting member countries to “amortise capital spending on expensive infrastructure such as cold chains and data systems”.  

The benefits are also “strategic”, the authors indicate. With greater purchasing power will come greater access to cheaper and more reliable vaccines. Additionally, “consistent access” to vaccines will reduce the “administrative and financial burdens of disease” throughout the region. Finally, they hope that an AVRF would “institutionalise modern practices and reduce corruption risks”.  

Getting there 

The authors recognise that an AVRF will be a “multiyear journey”. The first step would be a coalition, “anchored” by the ASEAN Secretariat or other organisation, such as the IVI in South Korea or the National Vaccines Institute in Thailand. Then it would need to partner with a “geopolitically important country”. The hope is that 3 to 5 founding ASEAN countries would offer “crucial mass” across “population, diplomatic, financial, and technical terms”, with other countries following the example.  

The article concludes that an AVRF would help assure “stable, predictable, cost-effective, and early access to new vaccines”. Following the lead of PAHO, and using “political will and skill”, an AVRF can be launched.  

“Vaccines have been called public health’s best buys, and an AVRF can make these best buys even better”.  

For more on international vaccine partnerships at the World Vaccine Congress in Washington 2023, get your tickets here.  

Exclusive interview with Dr Jerome Kim

Exclusive interview with Dr Jerome Kim

In the aftermath of the World Vaccine Congress in Europe 2022 we are delighted to present the second in our series of live on-site interviews. We were lucky to catch Dr Jerome Kim of the International Vaccine Institute (IVI) for a quick chat on the morning of Day 2. Dr Kim is another big name in the vaccine community, and his reputation was confirmed by shrewd and sensitive responses to our questions. It is a pleasure to share these with the community.

Meeting Dr Kim

Just like Dr Sadoff, Dr Kim is a man who needs very little introduction. However, he patiently detailed the work of the IVI, of which he is the Director-General. Founded in 1997,  it is “devoted” to the “discovery, development, and delivery” of “safe, effective, and affordable vaccines”. Dr Kim believes it also functions as a “little biotech company”, with two of its own approved vaccines. IVI takes an end-to-end approach, starting with development, securing funding, and generating relevant data.

In particular, IVI is interested in vaccines against cholera, typhoid, and other poverty-associated infectious diseases. Most recently, during the COVID-19 pandemic, IVI worked with “over 2 dozen companies” to support everything from pre-clinical studies to global clinical trials. Although it didn’t produce its own vaccine, it supported “whatever company needed help”.

 

COVID-19

As many of us are interested in understanding what effect COVID-19 had on international vaccine programmes, we asked the eternal “what lessons” question. Specifically, we wanted to know what it has taught us about development and distribution of vaccines. Interestingly, Dr Kim reflected that all but 2 projects IVI was working on continued at full speed during the pandemic. This, he believes, is a “tribute” to the fact that it is a “development organisation” that collaborates so closely with other institutions. IVI’s mission, he emphasised, is the “development of vaccines, technology transfer, capacity building”.

What have we taken from the pandemic, then? For Dr Kim, the “value of vaccines” was re-emphasised. Further emphasis was placed on the “value of innovation, the importance of funding”, and the “importance of coordination” between vaccine developers and implementers. It is not enough to simply have a vaccine, without allowing the vaccine to have the “impact that we wanted it to have”. Finally, with global implementation, Dr Kim insists that we have more work to do, particularly in lower-income countries.

 

A more effective future

As an expert in the whole journey of vaccines, from idea to inoculation, Dr Kim understands a thing or two about collaboration with policy makers and leaders. Therefore, we asked him about what work needs to be done. His answer focused on the “importance of innovation” and the fact that COVID-19 did have the positive effect of showing us just how quickly we can work.

However, “access and equity” failures get in the way of vaccines having their desired effects. He explores the example of rotavirus – for which a vaccine has been developed and approved. “60% of the world’s children” have not benefitted from this vaccine. He hopes that companies will “think earlier” about how they can use their technologies to improve roll out across the globe.

“Like everything in vaccines, we have to plan for them before we need them.”

 

What does the Congress offer?

Our interview concluded with our question about the benefits of gathering industry experts under one roof. Dr Kim suggests that at the moment it is a “great time for vaccines”. Thus, the Congress presents an opportunity to capitalise on a “success story” whilst identifying things that “we could do better”. His focus remains on the future, for the coming COVID-19 variants, but also other vaccines.

 

It was an honour to speak to Dr Kim, and we are grateful that he made time for us during a very busy few days!

If you are interested in joining us for the World Vaccine Congress in Washington, 2023, then get your tickets now.

Thinking bee: oral vaccination against AFB in honeybees

Thinking bee: oral vaccination against AFB in honeybees

According to a paper in Frontiers in Veterinary Science in October 2022, an oral vaccination study in honeybees “constitutes a turning point” in insect disease management. The collaboration between European and American researchers investigated the safety and efficacy of a vaccination against American Foulbrood infection in honeybees. They report the “first-ever successful randomised placebo-controlled double-blinded trial using a classical vaccination approach to protect honeybees against a disease”.  

AFB 

American Foulbrood is a fatal bacterial disease that the study describes as “highly contagious”. It is caused by the spore forming Paenibacillus larvae and can infect bee larvae in the first 3 days of life. The Scottish government describes the spores as “resistant to extremes of temperature, chemical attack, and other adverse conditions”. Spores are transported by worker bees into a hive.  

“Because of its virulent nature and detrimental effects on honeybee colonies, AFB is classified as a notifiable disease worldwide”. 

The only effective means of treating the disease targets the vegetative state. Therefore, by the time a hive presents a clinical manifestation eradication is essential. Furthermore, the “growing concern” of AMR and antibiotic contamination means the use of antibiotics is “under growing scrutiny”. In the EU there is a zero-tolerance policy for antibiotic use in honeybee management. Unfortunately, this means the solution is burning the hive, equipment, and colony. 

The bee all and end all 

The study describes beekeeping as pivotal in the food supply chain, particularly as climate change and growing populations weaken food security. “Managed” bees, kept at “high densities”, are essential in functioning ecosystems and productive livestock.  

“While honeybees are the most economically valuable pollinators, they are threatened by a variety of pathogens. Yet, safe and effective prophylactic solutions for disease prevention are lacking.” 

Insects do not produce antibodies, but they can “prime” their offspring against “persisting pathogens”. They transfer pathogen knowledge in a mysterious “phenomenon” known as transgenerational immune priming (TGIP).  Research on honeybees has revealed that this knowledge can be inherited with the “help” of the protein Vitellogenin, carrying immune elicitors. However, this is not the only way that insects prepare their offspring to face diseases. Transferal of “other signals, such as mRNA and proteins as well as epigenetic factors” has been suggested. The more that is understood about these processes, the more we can develop effective preventative strategies for disease management.  

The trial  

Previous research has proven that larvae can be protected from infections when the queens were injected with a “heat-killed P. larvae bacteria of the same strain”. However, with “limitations” and health implications for the queens, it is not the ideal method. As oral infection is the “natural way of infection” for many bacterial pathogens, other researchers have used similar methods in the past. 

“Oral administration of an inactivated AFB bacterin to the queen bees is safe and induces protection in the next generation larvae.” 

Two trials were carried out in different locations. The first was in Austria, using Apis mellifera carnica, and the second in Spain, using Apis mellifera iberiensis. Only hives that had enough larvae (30 in each) were enrolled. The queens, from local queen breeders, were “probably related but not sister queens”.  

The researchers derived bacterin preparation from a strain that was isolated in 2018. It was a “proprietary aqueous suspension of inactivated P. larvae vegetative stage bacilli” and passed purity testing. It was then blended with “queen feed”, comprising 48 ml corn syrup per 500g powdered sugar, at a ratio of 1ml per 100g. The queens were vaccinated for 8 days and then released into hives. 

Making a buzz

The results suggest an increase in disease resistance of up to 50% in the laboratory. Data indicate that the “innate immune response in insects” is enough to “decrease spore count” to “significant effect”. The authors call for further trials, but might this be a step towards more effective and efficient disease management? A future with “enhance[d] colony health” and safer pollinators would have myriad benefits.  

To hear data from exciting new trials and learn more about vaccination come to the World Vaccine Congress in Washington 2023.

Ukraine receives 700,000 Td doses from UNICEF

Ukraine receives 700,000 Td doses from UNICEF

The UN Office for the Coordination of Humanitarian Affairs (OCHA) reported in October 2022 that UNICEF had delivered 700,000 doses of a tetanus-diphtheria (Td) vaccine to Ukraine. This delivery was provided as humanitarian aid during the continued conflict initiated by Russia. The OCHA indicated that the vaccine was procured with “financial support from the Italian government”.  

Survive and thrive 

For UNICEF, ensuring children “thrive and remain in good health” is essential at all times. Thus, it is committed to enabling children in Ukraine, “irrespective of background or circumstance” to access education. In order to facilitate this education and continuation of childhood, UNICEF considers vaccination an important step in promoting health and happy children.  

Tetanus and diphtheria 

Tetanus can infect anyone through cuts or wounds. It causes problems for the nervous system and can even trigger seizures. The OCHA suggests that mortality can “be as high as 70%”. It is prevented by vaccination. Diphtheria is a contagious bacterial infection, and can be fatal to 1 in 5 patients, particularly children.  

The Ukrainian national immunisation schedule vaccinates children against tetanus and diphtheria at 2, 4, 6, and 18 months, before revaccination at 6 and 16 years. Furthermore, adults are encouraged to get revaccinated every 10 years. These vaccinations are free.  

Humanitarian aid 

In September UNICEF delivered 70,000 doses for children from 6 years of age, also provided as aid. Ukraine is receiving vaccines against polio, diphtheria and tetanus, measles, rubella, mumps, and rabies. These are supplied with the support of the US Agency for International Development (USAID) and the Japanese and Italian governments.  

In August UNICEF began delivering refrigerator vans for vaccine transport. 14 of a total of 30 were given to the Regional Centres for Disease Control and Prevention of the Ukrainian Ministry of Health. 

“UNICEF, together with partners, continues to support Ukraine in responding to the emergency humanitarian situation created by the war, including by providing medicines and medical equipment”.   

For more on supporting and sustaining routine immunisation rates come to the World Vaccine Congress in Washington 2023.  

Senegal launches programme for measles and rubella vaccine

Senegal launches programme for measles and rubella vaccine

The Institut Pasteur de Dakar (IPD) in Senegal announced in October 2022 that it was creating a new vaccine programme in collaboration with Univercells and Batavia Biosciences. The programme is funded by a grant from the Bill and Melinda Gates Foundation. The development of a measles and rubella vaccine in Africa would speed up and improve affordable access to these critical vaccines across the continent. 

Move to MADIBA 

It is becoming increasingly clear after recent outbreaks that vaccine equity is a problem pertinent to Africa. As a continent it produces only 0.1% of the global supply yet need there is often great. For example, calls to stop monkeypox “at its source” went unheard as other countries held monopolies on potential vaccines. Furthermore, during COVID-19 Africa had the slowest rate of vaccination against the disease. Unfortunately, this might have been prevented by a reduction in vaccine nationalism.  

However, things began to look up in 2022. The IPD and the European Investment Bank (EIB) announced an agreement to develop a manufacturing facility in Senegal. The Manufacturing in Africa for Disease Immunisation and Building Autonomy project (MADIBA) intended to localise vaccine production.  A manufacturing facility was assembled in Sweden and then disassembled and shipped to Senegal in under 8 months. With hopes of starting production at the end of 2022, this could be a game-changer for the African vaccine scene.  

Teamwork and funding 

The project has been supported by a grant from the Bill and Melinda Gates Foundation and will use technology from Batavia Biosciences and Univercells. Batavia’s HIP-Vax production process for GMP measles and rubella material as well as Univercells NevoLine Upstream platform will “accelerate manufacturing and affordable access” according to Univercells.  Dr Amadou Alpha Sall is the CEO of IPD. He believes this project will take the “region” a “step closer to a diversified manufacturing landscape for epidemic preparedness”.  

“This will help countries in the region build autonomy and reach every child with lifesaving vaccines.” 

The COO of Batavia Biosciences, Dr Christopher Yallop, is “privileged” to work with IDP. He hopes that the HIP-Vax technology will increase “affordability and availability”. Finally, the co-founder of Univercells, Jose Castillo, echoed this, describing how “honoured” Univercells is to collaborate with these partners. He commented on the “exciting” prospect of using the NevoLine Upstream platform to “accelerate the manufacture of vaccines in Africa”.

We will hear from a number of speakers with a focus on developing vaccines in Africa and global health from an African perspective at the World Vaccine Congress in Washington 2023. To join us and learn more, click here.

Gavi CEO calls for vaccine market “interventions”

Gavi CEO calls for vaccine market “interventions”

Dr Seth Berkley, CEO of Gavi, the global alliance pursuing vaccine equity, wrote in the Financial Times in October 2022 of the need for improved access to vaccines. Dr Berkley has been CEO since 2011, during which time he has drawn on his epidemiology experience to “lead Gavi in its mission to improve access”. Despite the remarkable achievements of the organisation, he believes the vaccine community as a whole has a long way to go, particularly considering the increasing risk of future pandemics.  

A “taste” of the future 

Dr Berkley warns that despite the continued distribution of boosters and updated doses, “this pandemic is far from over”. When we do finally lift our heads above the parapet, he is concerned that there will be future threats to face.  

“Driven by climate change, migration, and other global trends, infectious disease is a growing threat to our lives and economies. Vaccines are our strongest defence by far.” 

Despite the recognisable benefits of rapid vaccine development, it is no use creating these powerful tools if they can’t be used globally. Dr Berkley identifies “geopolitical and economic factors” as determinants of vaccine equity.  

“One of the largest barriers to global, equitable access to vaccines – and arguably one of the biggest chinks in our pandemic-preparedness armour – is market failure.”  

Market failure 

Dr Berkley refers to the 2009 swine flu crisis, during which “a few wealthy governments rapidly bought up almost the entire global supply” of shots. Thus, during COVID-19, Covax was created. A “mechanism” for access, it was intended to “ensure ability to pay did not determine whether people received the protection they needed”. Although we can celebrate the successes of Covax, it “hasn’t been an easy journey”.  

“The scale of vaccine hoarding, export restrictions, and the complete lack of transparency among manufacturers seriously hindered the global supply of vaccines”  

Market failure is “not unique to pandemics”, Dr Berkley suggests. To deal with it, Gavi creates a “pool” of demand, which gives “certainty” to incentivise manufacturers. Furthermore, it encourages new vaccine developers to enter the market, which “stimulated innovation and competition”. As a result, more than 16 million deaths have been prevented. However, “more interventions” are needed in the future.  

“Covid has triggered a renaissance in vaccine development”. 

Regional supply 

Although the future of vaccines is busy, regional supply is another market failure that concerns Dr Berkley. He suggests that only 0.1% of the global supply of vaccines comes from Africa, despite a great need. Consequently, African nations struggle to compete for necessary vaccines, as we saw with the Covid jabs, which “cost lives”.  Going forward, there are more than 30 vaccine initiatives in Africa, one of which we explored here. Gavi is also contributing, trying to balance sustainable market entries with competitive development.  

“The increasing risk posed by infectious diseases means equitable access to vaccines must become a priority.” 

For Dr Berkley, this can’t be delayed. We must learn from our experience with COVID-19, in which millions died from a “vaccine-preventable disease”.  

“When science delivers, markets must too”. 

We will hear from several Gavi speakers at the World Vaccine Congress in Washington next year. If you would like to join us, get your tickets now.  

African swine fever: the deadly pig pandemic

African swine fever: the deadly pig pandemic

First detected in East Africa in the early 1900s, African swine fever (ASF) has a high mortality rate in domestic pigs. The World Organisation for Animal Health (WOAH) describes it as a “highly contagious viral disease” that is “not a danger to human health”. Despite this, it has “devastating effects on pig populations and the farming economy”. The WOAH also indicates that the virus is “highly resistant in the environment” and survives in “various pork products”. Thus, human behaviours, when not managed, enable the spread of the disease across borders.  

A publication in the Veterinary Journal in 2018 described the “challenge” of controlling the disease. The authors identified the lack of a vaccine as central to this. The only available control measures are “strict quarantine and biosecurity, animal movement restrictions, and slaughtering affected/exposed animals”.

The current crisis 

The Guardian reports that the current outbreak is “believed to threaten around three-quarters of the world’s herds”. It is linked to an appearance of the virus in 2007, in Georgia, which spread “beyond the Caucasus” thanks to its ability to survive “up to 1,000 days in frozen meat”.  

In 2018 the virus was detected in China, which is “home to around half of the world’s pigs”. In 2020, it was confirmed in Germany, which is “home to one of the EU’s largest swine herds”. This sustained wave of infection is “the biggest animal disease outbreak we’ve ever had on the plant”, according to Professor Dirk Pfeiffer of City University of Hong Kong.  

Vaccine hopes 

WOAH suggests that pork meat is a primary source of animal protein, “accounting for more than 35% of the global meat intake”. Furthermore, it affects wild boars as well as domestic pigs, so presents a “concern for biodiversity and the balance of ecosystems”. Therefore, the pressure is on to develop a vaccine. Current attempts include an EU-funded project: VACDIVA. This was launched in 2019 with the goal of providing 3 safe and effective pilot vaccines. With their sights set on a roll out in late 2024, the researchers must answer questions about the international efficacy of a vaccine developed in Spain, and the frequency of administration.  

They are not the only scientists with ASF ambitions. Harbin Veterinary Research Institute in China claims to have made progress towards a live attenuated vaccine. The Pirbright Institute in the UK has a team dedicated to “refining” a vaccine. Dr Linda Dixon leads ASF research and is often asked why it is taking so long to produce a successful candidate. 

“People are quite nervous about it because the thing with a live attenuated vaccine – which all of these are – is basically you’re releasing a live virus into the field. And there’s not enough of a history to know exactly what’s going to happen.”  

A messy past 

The Guardian reports that “the risks” of vaccination were “laid bare” earlier in 2022 when Vietnam announced it would administer a vaccine to 600,000 animals across 20 provinces. Unfortunately, within three months the programme was stopped after around 750 pigs were reported to have died. The company that produced the vaccine has suggested that the deaths occurred in provinces where farms had ignored specific instructions. However, the complexity of the virus and the importance of a successful vaccine has been brought home to researchers across the world.  

As with other diseases, ASF provides a reminder of global inequalities. The paper in Veterinary Journal recalls the effect of culling campaigns and pig movement on “global trade and people’s livelihoods”.  

“The impact is often greatest for resource poor livestock farmers in developing countries, who rely on pigs as an additional source of income and a relatively cheap source of protein.”

For more on the importance of One Health approaches in tackling animal and human diseases click here.

To hear more on progress towards successful vaccine candidates at the World Vaccine Congress in Washington 2023, get your tickets here.
 

Cholera vaccine supply issues disrupt double-dose regime

Cholera vaccine supply issues disrupt double-dose regime

The WHO announced in October 2022 that the International Coordinating Group (ICG) on Vaccine Provision will have to “suspend” its standard two-dose cholera vaccine programme in favour of a single-dose approach. This is attributed to a “strained global supply” of cholera vaccines.  

ICG 

The ICG was established in 1997 after outbreaks of meningitis in Africa. It is described as a “mechanism to manage and coordinate” emergency vaccine supplies and antibiotics during major outbreaks. In collaboration with vaccine producers, it maintains a global stock of vaccines for cholera, meningitis, and yellow fever.  

The ICG unites partners to “improve cooperation and coordination of epidemic preparedness and response”. It also forecasts vaccine stocks, negotiates prices, and evaluates disease interventions and protocols.  

The cholera vaccine stockpile was created in 2013. Since then, 120 million doses of the oral cholera vaccine have been shipped to 23 countries. Of these doses, 73 million have been approved for emergency response.  

Cholera outbreaks 

The WHO reports that, since January 2022, 29 countries have detected cholera cases. Among them, Haiti, Malawi, and Syria are “facing large outbreaks”. This global phenomenon is described as an “unprecedented rise”, particularly when compared to the preceding 5 years. During that time, the average number of countries reporting outbreaks was fewer than 20.  

“The global trend is moving towards more numerous, more widespread, and more severe outbreaks, due to floods, droughts, conflict, population movements, and other factors that limit access to clean water and raise the risk of cholera outbreaks.”  

This further emphasises the link between climate health and human health, with experts warning that the consequences of climate change include more frequent and more severe disease outbreaks. 

One or two doses? 

The move to a one-dose strategy has been an effective outbreak response, although “evidence on the exact duration of protection is limited”. Furthermore, the WHO suggests that “protection appears to be much lower in children”.  

With a two-dose approach in which the second is administered within 6 months of the first, immunity is believed to last for 3 years. This is obviously a preferable solution but resorting to a single dose will allow greater distribution of the vaccine.  

Limited supply 

The WHO statement in October indicated that “of the total 36 million doses forecast to be produced in 2022, 24 million have already been shipped”. These doses are split between preventative (17%) and reactive (83%) campaigns. Furthermore, 8 million doses were approved by the ICG for 4 countries’ emergency vaccination programmes.  

“As vaccine manufacturers are producing at their maximum current capacity, there is no short-term solution to increase production.”  

We will hear more from WHO representatives on infectious diseases and priorities as we emerge from the pandemic at the World Vaccine Congress in Washington 2023. To join us, get your tickets here.  

WHO launches One Health Joint Plan of Action

WHO launches One Health Joint Plan of Action

In October 2022 the WHO, as part of a wider Quadripartite, launched a One Health Joint Plan of Action. The Quadripartite includes the Food and Agriculture Organisation of the UN (FAO), the United Nations Environment Programme (UNEP), the WHO, and the World Organisation for Animal Health (WOAH). The plan aims to “create a framework to integrate systems and capacity” in order to “prevent, predict, detect, and respond to health threats”. The initiative hopes to improve human health but also animal, plant, and environmental health. Sustainability will also be at the forefront of its mission.  

OHJPA 

The One Health Joint Plan of Action (OHJPA) was developed through a “participatory process” and offers activities to “strengthen collaboration, communication, capacity building, and coordination” across all sectors. It is a 5-year plan addressing 6 key areas:  

  • One Health capacities for health systems, 
  • Emerging and re-emerging zoonotic epidemics, 
  • Endemic zoonotic, neglected tropical, and vector-borne diseases, 
  • Food safety risks, 
  • Antimicrobial resistance, 
  • The environment 

It is “informed by evidence, best practices, and existing guidance”. Covering actions to advance One Health at all levels, the document includes the development of an “upcoming implementation guidance”. Operational objectives include: 

  • Providing a framework for collective and coordinated action to mainstream the One Health approach at all levels, 
  • Providing upstream policy, legislative advice, and technical assistance to help national targets and priorities, 
  • Promoting multinational, multi-sector, multidisciplinary collaboration, learning and exchange of knowledge, solutions, and technologies.  

“It also fosters the values of cooperation and shared responsibility, multisectoral action and partnership, gender equity, and inclusiveness.” 

The importance of One Health 

The WHO describes One Health as the “main approach” to addressing “complex health challenges” that we are facing. These include ecosystem degradation and antimicrobial resistance. WOAH Director General Dr Monique Eloit believes that it is a “lens” that brings together “all relevant sectors”. This is “critical” in the fight against global health threats.  

“Animal health is our health”. 

The Director-General of FAO, Qu Dongyu, echoed the importance of starting with the environment.  

“We need all sectors working closely together to identify and implement adaptation and mitigation measures”.  

For UNEP Executive Director Inger Andersen, a “clean and healthy environment” is the “foundation of all life on Earth”. She referred to the “current pandemic” as demonstrating that the “degradation of nature” increases health risks “across the board”. However, this can’t be tackled by one sector alone. She hopes the Joint Plan of Action will “drive down health risks through an integrated approach to human, animal, and environment health”.  

WHO Director-General Dr Tedros Adhanom Ghebreyesus reflected that a One Health approach will be “central” to strengthening our defences against disease.  

“That’s why One Health is one of the guiding principles of the new international agreement for pandemic prevention, preparedness, and response, which our Member States are now negotiating.” 

To hear more about One Health approaches in vaccine development at the World Vaccine Congress in Washington 2023 get your tickets here.  

 

Menstruation after COVID-19 vaccination: tracking changes

Menstruation after COVID-19 vaccination: tracking changes

Research published in BMJ Medicine in August 2022 reflected a collaboration between US and UK partners to investigate the effects of COVID-19 vaccination on the menstrual cycle. The study describes how a “range of menstrual cycle changes” had been reported but that clinical trials did not include outcomes related to these.  Led by Professor Alison Edelman of Oregon Health and Science University the study found minimal changes but points to the need for further research. 

The study 

The reported changes to the menstrual cycle following COVID-19 vaccination included longer or shorter cycles, missed cycles, spotting, or a change to the flow. However, the lack of clinical trial data means that until further research took place the only evidence was based on self-report.  

“The absence of prospectively collected menstrual cycle data that include an unvaccinated comparison group limits our ability both to address public concerns about the relation between COVID-19 vaccination and menstrual cycles and to counsel individuals who menstruate about what to expect with vaccination.” 

The study rightly acknowledges that small changes are important to the patient, can “cause alarm”, and, when associated with the vaccine, can “contribute to vaccine hesitancy”. Furthermore, the authors suggest that the lack of evidence about the links between vaccination and menstrual health, “coupled with the long-standing sex specific research inequities” might be interpreted by the public as a “dismissal from the scientific and medical community”. Following global vaccine rollouts, the authors were able to analyse a previous US study and an international sample.  

Methods and results 

The study was a “retrospective cohort analysis of prospectively collected menstrual cycle data” from across a year using a digital fertility awareness application. To participate individuals had to “consent to use of their deidentified data” and report their COVID-19 vaccination status. They then had to record at least 1 cycle after 1st October 2020. Participants ranged from 18-45 years old and contributed a minimum of 4 consecutive cycles. Specific requirements varied for those who received a vaccination and those who didn’t.  

Of 41504 users, 19622 met the inclusion criteria. The final sample included 14936 vaccinated individuals and 4686 unvaccinated individuals. The publication details how the “vaccinated cohort had a less than one day unadjusted mean increase in the length of their menstrual cycle during the first vaccine dose cycle”. By contrast, the unvaccinated cohort had “no significant change in the notional vaccine designated cycle”. After adjustment the difference in change in cycle length by vaccination status was 0.71 days. This suggests that “vaccination is associated with a less than one day adjusted increase in cycle length”. The publication can be accessed online to examine further results in more detail.  

What’s next? 

The results of this study are described as “reassuring” and useful in informing vaccination risk assessments for patients. Despite the observed changes, they are “small compared with normal variation”. However, the authors recommend future research into other changes to the cycle.  

Hopefully these results will be a step towards further investigations into menstrual health but also provide the assurance that many need to take the vaccine. As reported by The Economist in October 2022, these results suggest that there is “probably nothing to worry about”. However, it is important to be sensitive to the fact that the most minute change to a menstrual pattern can be alarming, and without clinical trial data misinformation quickly spreads.  

“False speculation and fake news found fertile ground in an often sensitive and emotive issue”. 

We can only hope that with continued exploration into the effects that vaccination has on menstrual health, this misinformation will be tempered with data. As The Economist identifies, misinformation often comes from misinterpretation. 

“The easiest way to promote a conspiracy theory is to take a grain of truth and blow it out of sensible proportion.” 

For more information on testing and developing COVID-19 vaccines at the World Vaccine Congress in Europe, get your tickets here.