by Charlotte Kilpatrick | Oct 2, 2024 | Global Health |
In October 2024, CEPI announced the expansion of research into Lassa fever in West Africa in a “pioneering study” to explore the variation in disease symptoms and how this compares to other “worrisome infections” in the region. The project, led by the Nigeria Centre for Disease Control and local study sites, comes under the Enable study, created by CEPI and partners to provide a more accurate picture of the disease burden in West Africa and help inform outbreak preparedness efforts, including Lassa vaccine development. Lassa fever, a known public health burden in the region, infects “hundreds of thousands” every year. However, cases are likely underreported due to detection difficulties.
Lassa fever
Although it was described in the 1950s, the virus causing Lassa fever was only identified in 1969. It is a single-stranded RNA virus in the Arenaviridae family. The disease is a “potentially deadly haemorrhagic illness” with an estimated 1% case fatality rate. Most infections are thought to be “minimally symptomatic or asymptomatic”, which means they avoid detection. People who do experience symptoms can suffer fever, headache, and chills, and could be misdiagnosed with diseases like Ebola, dengue, or malaria.
As a WHO priority disease, Lassa fever is in “urgent need” of research and development. Understanding the disease is critical to vaccine development, which Dr Muhammad Ali Pate, Coordinating Minister of Health and Social Welfare of Nigeria, recognises.
“Lassa fever remains a public health burden in Nigeria and West Africa, but the commitment to research and innovation is yielding promising progress. The new Enable research will deepen our understanding of the virus and enhance the work being undertaken to develop the first-ever Lassa vaccine to safeguard the health of our communities.”
Dr Pate highlighted the Ministry’s commitment to collaboration to “advance these efforts and bring the suffering caused by Lassa fever to an end”.
Enable expanded
Enable was launched in 2019, and in 2021 CEPI announced funding to provide a “more accurate assessment” of the incidence of Lassa fever infections. CEPI offered US$ 10.3 million to partners in Benin, Guinea, Liberia, and Sierra Leone to participate, enrolling up to 23,000 participants to understand the “rate, location, and spread of Lassa virus across the region”. The results are also central to CEPI’s goal of producing a licensed Lassa vaccine.
The new year-long study will invite 5,000 healthy people, including children and infants, to participate at sites in Nigeria (Edo, Ondo, and Ebonyi states), Sierra Leone, and Liberia. It is intended to improve understanding on how commonly the disease occurs, how rates of infection and symptoms vary across locations, ages, sex, and exposure history, and the extent of post-infection symptoms. Scientists will also explore how often people are co-infected with Lassa fever and malaria, as co-infections may complicate the clinical course of each disease.
Vaccine goals
Dr Richard Hatchett, CEO of CEPI, explained that “incomplete detection” of cases affects both the understanding of the true incidence rate and level of response, but could also “threaten the evaluation, rollout, and acceptance of future Lassa vaccines”.
“Insights gained on the diversity of disease symptoms will enhance our understanding of Lassa fever, categorised into mild, moderate, or severe cases. This information will be crucial in guiding where and how future late-stage vaccine trials are conducted and determining priority groups for receiving the Lassa vaccine once it becomes licensed in the coming years.”
A 2024 modelling study found that around 3,300 lives could be saved over 10 years with a Lassa vaccine. It could also avert up to $128 million in societal costs. The most advanced vaccine candidate is developed by IAVI and is currently in Phase II trials in the region. Enable National Project Coordinator in Nigeria, Mrs Elsie Ilori, described the launch of the expanded study as a “key step in our ongoing efforts to understand and combat this dreadful disease”.
“Through deeper investigations into the variations of Lassa fever symptoms and their comparison to other infections within the region, we will obtain valuable insights that can improve diagnosis, boost outbreak preparedness, and inform the future vaccine development.”
Dr Jilde Idris, Director General of Nigeria Centre for Disease Control and co-chair of the Nigeria Lassa Vaccine Task Force agreed that the investigation “represents key progress in our battle against Lassa fever”.
“We are improving our capacity to identify and recognise cases while preparing for future vaccine development by examining the disease’s symptoms and its connection to other infections.”
The work is “vital for forming health practices” and “promoting” public health in the region, and Dr Idris welcomed the support of partners and local communities in “making strides towards lessening the impact of Lassa fever” and preparing for a “future that can block its life-threatening effects”.
For more on IAVI’s vaccine efforts and insights into challenge studies in West Africa, join us at the Congress in Barcelona this month for a session with Dr Marion Gruber. Don’t forget to subscribe to our weekly newsletters here for vaccine updates!
by Charlotte Kilpatrick | Oct 2, 2024 | Therapeutic |
Interim Phase II data from Gritstone bio’s study evaluating GRANITE in September 2024 are described as “encouraging” in a company statement. The study evaluates Gritstone’s individualised neoantigen targeting immunotherapy in frontline microsatellite stable colorectal cancer (MSS-CRC) as maintenance therapy in combination with immune checkpoint inhibitors and fluoropyrimidine/bevacizumab. These data show the vaccine’s potential to extend progression-free and overall survival, but “fell short” of the target that some suggest is needed to “transform its fortunes”.
Encouraging data
104 patients were randomised 1:1 in the study, and the treated analysis shared by Gritstone includes 69 patients. Highlights from the data include:
- An emerging progression-free survival (PFS) benefit to all GRANITE recipients
- 21% relative risk reduction of progression or death with GRANITE compared to standard of care (SOC) control in all treated population
- 33% of GRANITE and 23% of control patients remain on study and free of progression
- Clinical benefit was most notable in patients with low disease burden (defined as patients with circulating tumour DNA (ctDNA) equal to or below the trial population median value at study entry)
- 38% relative risk reduction of progression or death with GRANITE compared to SOC control with low ctDNA subgroup
- Low baseline ctDNA is a likely prognostic and predictive factor
- Immune data were consistent with clinical activity
- Functional neoantigen-specific T cells observed in all 16/16 GRANITE patients tested by ELISPOT
- Association of PFS and peak ex vivo ELISPOT responses was apparent, indicating that ex vivo ELISPOT may be a surrogate for PFS
- GRANITE demonstrated a favourable safety and tolerability profile
- No patients discontinued study treatment due to an adverse event (AE)
- Common AEs were the mild systemic and local effects associated with any potent vaccine
- One treatment-related serious AE (fatigue) occurred in the GRANITE arm but patient continued GRANITE treatment without recurrence upon recovery
Gritstone recognises a need for continued follow-up to “fully assess” the effects of GRANITE and determine whether a plateau of improved PFS, which indicates durable clinical benefit, is achieved. Gritstone bio’s co-founder, President, and CEO Dr Andrew Allen is “excited by the potential” seen in GRANITE to extend both progression-free and overall survival “in a disease where relentless progression is the rule with existing therapies”.
“The field of neoantigen-targeting immunotherapy is evolving rapidly, and the focus is shifting to patients with lower volume disease. Notably, patients with newly diagnosed metastatic disease who have lower ctDNA at study entry and thereby relatively low disease burden, could benefit from this type of immunotherapy.”
More time needed
Dr Allen commented that “typically”, success for immunotherapy “manifests as an elevated plateau in PFS and overall survival Kaplan-Meier curves, and we may be seeing this in our low disease burden population.”
“We need more time to let these data mature.”
The “low and stable” ctDNA measurements in “most” GRANITE patients are “encouraging”, says Dr Allen, as that pattern is “not typically seen in patients about to develop disease progression”. There is also “opportunity for greater effects in tumours more typically amenable to immunotherapy” in the potential benefit observed in MSS-CRC, a “notoriously ‘cold’ tumour”.
“These data support further exploration of GRANITE in frontline MSS-CRC and in other low burden (neo)adjuvant settings. With this new dataset in hand, we continue to actively explore several strategic and funding alternatives to rapidly advance our innovative immunotherapy for the benefit of patients.”
Head above water
The company statement also confirmed that Gritstone has engaged a financial advisor to support its exploration and review of potential “value-maximising strategies”. While Gritstone “does not intend to discuss or disclose further developments”, speculation continues.
Evercore ISI analyst Jonathan Miller is quoted by Fierce Biotech wondering if the company’s cash runway is “functionally no later than” the end of the year. Although “on the face of it” the progress is positive, the data have “limitations”, such as a shift away from patients with more aggressive disease. Miller believes that if Gritstone can keep tracking patients, the extend follow up can continue to look encouraging, but questions the company’s future.
“They don’t have flexibility to run this data out much further, add [patients], or explore [the] adjuvant setting.”
We look forward to welcoming Gritstone’s EVP and Head of R&D, Dr Karin Jooss, to the Congress in Barcelona this month, to share insights in the Cancer and Therapeutic Vaccines track. Get your tickets to join us here, and don’t forget to subscribe to our weekly newsletters for the latest vaccine news.
by Charlotte Kilpatrick | Oct 1, 2024 | Therapeutic |
In an article for npj vaccines in October 2024, researchers present their investigation into the efficacy of a combination of DNA vaccine encoding mouse GPRC5D and PD-1 in preventing and treating multiple myeloma (MM). MM “remains largely incurable”, but the GPRC5D, “highly expressed” in MM, presents a “compelling” immunotherapy candidate. The research suggests that GPRC5D-targeted DNA vaccines are “versatile platforms” for treating and preventing MM.
Managing MM
Multiple myeloma (MM) is the second most prevalent haematological malignancy, characterised by the accumulation of malignant plasma cells in bone marrow. Most MM cases are preceded by monoclonal gammopathy of undetermined significance (MGUS), which can reduce a person’s life expectancy by “more than 4 years”. Around 3.5 million people are affected by MGUS in the United States. Smouldering MM (SMM), distinguished from MGUS for clinical reasons, is an asymptomatic clonal plasma cell disorder between MGUS and MM.
MM treatment has been “transformed with the advent of antibody-based therapies”, with chimeric antigen receptor (CAR) T-cell therapies that target the B-cell maturation antigen (BCMA) showing “considerable promise”. However, the pattern of BCMA expression is heterogeneous, responsible for “varied treatment responses” and the surface expression can “fluctuate” because of gamma secretase-mediated shedding of the extracellular domain. Furthermore, antigen escape has been noted in patients with MM who experienced relapse after BCMA-targeted CAR T-cell therapy.
“Exploring immunotherapies targeting alternative antigens may help counteract antigen escape and provide effective treatment options for patients who relapse after BCMA-targeted CAR T-cell treatment.”
A new vaccine target
C protein-coupled receptors (GPCRs) are the “largest and most diverse” group fo membrane receptors in eukaryotes; humans have almost 1000 different GPCRs. GPCRs are classified into six classes (A-F), among which class C GPCRs initiate metabolic steps to modulate cellular activity.
Orphan GPCR class C group 5 member D (GPRC5D) is expressed in the hair follicle and the bone marrow of patients with MM, as well as in MGUS and SMM. The GPRC5D mRNA is overexpressed between two and four times in MM plasma cells compared to normal plasma cells, and immediate expression is seen in MGUS and SMM.
“GPRC5D is an emerging novel immunotherapeutic and preventive target for MM.”
Although DNA vaccines are a “promising” alternative to mRNA vaccines, with “lower cost and better stability”, they have not yet been widely adopted in clinical practice. DNA cancer vaccine development faces “significant challenges” such as nonspecific formulations, thermal instability, toxicity, and ineffectiveness. However, the authors believe that recent advancements have “greatly enhanced” the clinical efficacy of DNA vaccines in cancer treatment.
The study
In their research, the authors attempted to develop DNA vaccines against MM using plasmids expressing GPRC5D. First, they evaluated a mouse GPRC5D DNA vaccine in the 5TGM1 murine myeloma model, which “closely mimics” human MM. Cancer prevention activity was examined through administration of the DNA vaccine before tumour cell inoculation. The mice that received the mGPRC5D vaccine developed “significantly smaller” tumours than the control mice, and all animals in the mGPRC5D group were alive at day 33.
With ELISA, the authors evaluated the humoral response by measuring the levels of mGPRC5D-specific antibody in the serum collected 5 days after boost. They found a “marked increase” in serum IgG levels in the mGPRC5D group. To explore the possible mechanisms of the antitumour effect of the vaccine, they analysed immune cells in the spleen and tumours through flow cytometry. The percentage of various immune cell populations “significantly increased” in the mGPRC5D-immunised mice.
The research also considered the therapeutic efficacy of the mGPRC5D vaccine in combination with PD1 Ab treatment. After tumour inoculation, mice received two injections of 20µg mGPRC5D vaccine or the control plasmid at 2-week intervals, along with intraperitoneal administration of anti-PD1 antibody. Mice that received either the vaccine or anti-PD1 Ab showed a “moderate inhibitory effect”, but those treated with the combination exhibited “significant inhibition of tumour development”.
When comparing tumour weights in mice, the authors found “significantly” lower weights in the mGPRC5D and PD1 Ab group than in the control group or each monotherapy group. They also assessed the ability of the vaccine to induce TNFα or IFNγ responses in mouse splenocytes with the ELISPOT assay. Splenocytes from mice that received either mGPRC5D or PD1 Ab exhibited a “significant” increase in the number of spots, and a further increase was observed in the group that had the combination. The combination group had higher frequencies of TNFα+CD8+, IFNγ+CD8+, TNFα +CD4+, and IFNγ+CD4+ T cells in the spleen.
In a flow cytometric analysis of immune cell populations in the spleen, the authors found that treatment with mGPRC5D increased the frequency of CD4+ T cells by over 150% and CD8+ T cells by over 30%. PD1 Ab treatment increased the frequency of both cells by more than 100%. The combination had a “more pronounced effect”; CD4+ T cells increased more than 350% and CD8+ T cells increased by more than 130%. Similar observations were made for DCs, Mϕ, and NK cells in the spleen. For tumour-infiltrating lymphocytes (TILs), the combination approach increased the population of CD8+ and CD4+ T cells, DCs, Mϕ, and NK cells more than the monotherapies.
A human vaccine
As the peptide sequences of mGPRC5D and hGPRC5D are only ~81% identical, a human version of the vaccine is needed. The researchers developed a nanoplasmid construct expressing human GPRC5D (Nano-hGPRC5D). Prophylactic studies found that tumour growth was “significantly suppressed” in the mice group that received Nano-hGPRC5D, which also presented a “marked increase” in serum IgG levels. Other findings include a “significant increase” in the levels of cytokines in the Nano-hGPRC5D group, which suggests a “robust activation of inflammatory cytokines” upon vaccination.
In the spleen and tumours of hGPRC5D-immunised mice, percentages of CD3+, CD4+, and CD8+ T cells and DCs were “significantly increased”. Furthermore, higher frequencies of Th1 secretory cytokine-positive CD3+ T cells were observed in this group. A long-acting protective effect against tumours was implied in “significantly higher percentages” of effector and central memory T cells in the splenocytes of the hGPRC5D group. CD8+ T cells stimulated with the hGPRC5D peptide pool exhibited “superior proliferative ability” compared to the control.
Therapeutic combination
To evaluate the therapeutic efficacy of Nano-hGPRC5D in combination with PD1 Ab, the authors used syngeneic murine models. The combination resulted in “significant tumour regression” compared to either treatment alone. Levels of TNFα, IFNγ, IL-6, IL-12p40, and IL-12p70 increased “significantly” in the combination group, and ELISpot analysis revealed more TNFα- or IFNγ-positive cells in the combination group.
In a flow cytometric analysis of immune cell populations in the spleen and tumour, the combination caused an increase in effector CD8+ and CD4+ T cells, DCs, Mϕ, and NK cells, but a decrease in Treg cells. H&E staining of tumour sections revealed necrotic lesions in the hGPRC5D and combination groups, but the lack of gross histological damage in several major organs supports the safety and clinical potential of the vaccine or combination.
Analysis of the immune cells revealed a “marked increase” in CD3+, CD8+, and CD4+ T cells in the splenic marginal zones of the combination group, consistent with flow cytometry data. There was also an increase in B lymphocytes and follicular DCs in this group. For TILs, the combination therapy also increased the number of CD8+ and CD4+ T cells.
Improving outcomes
Despite therapeutic advancements, high-risk patients with MM “continue to have poor outcomes”, and there are limited agents to prevent MM or progression from MGUS and SMM. The results from the study suggest that PD1 blockade “enhances tumour growth inhibition” in mice treated with the DNA vaccine and highlight the potential of the DNA-based GPRC5D vaccine to “overcome self-tolerance and the prospects of advancing” into clinical trials.
For the latest on cancer vaccine development and combination approaches to disease control, join us at the Congress in Barcelona next week. Don’t forget to subscribe to our weekly newsletters for more vaccine updates.
by Charlotte Kilpatrick | Oct 1, 2024 | Global Health |
A study in PLOS Global Public Health in September 2024 compares the WHO and Medicines Patent Pool (MPP) mRNA technology transfer programme with the approach and practices of current biopharmaceutical production. The programme launched in June 2021, with a hub in South Africa, and is intended to increase vaccine manufacturing capacity in low- and middle-income countries (LMICs) in response to the “vaccine apartheid” of the COVID-19 pandemic. The study finds that, despite improvements to the sharing of knowledge, other features are “in line with the status quo”.
Addressing “vaccine apartheid”
During the COVID-19 pandemic “vaccine apartheid” was used to describe the unequal distribution of vaccines against COVID-19. To address this disparity, WHO chose Afrigen Biologics to “change the global landscape of biopharmaceutical production” by developing an mRNA COVID-19 vaccine and distributing the technology to manufacturers in low- and middle-income countries (LMICs).
“Building capacity to make vaccines locally for local populations became imperative.”
WHO identified a model of knowledge-sharing that had been used in efforts to make the global influenza virus sharing network more accessible and useful to people in LMICs. The Medicines Patent Pool (MPP) was assigned the responsibility of managing the mRNA programme’s fundraising and legal needs.
“The programme has the potential to be transformative as a model of vaccine production, encompassing both upstream research and development (R&D), and ‘end-to-end’ vaccine manufacturing.”
However, the initiative faces “several risks”, such as “precarious levels of funding”, the threat of patent litigation by establish manufacturers, and a variety of governance issues as it seeks to develop the capacity for producing high-quality mRNA-based technologies to protect against a range of diseases.
The study
The authors used qualitative research methods to explore the extent to which the WHO/MPP-managed programme differs from current biopharmaceutical production. The “situational analysis” combined data collection and analysis of multiple data sources. In document analysis they analysed “multiple types of documents”, including legal documents, agreements, correspondence, and patent applications.
The approach also involved a purposive sampling strategy, engaging people in leadership positions. Interviews were conducted with executives and officials, scientists, WHO and MPP officials (the “programme’s architects”), representatives from vaccine manufacturers across the world (“programme partners”), and scientists and experts from the global North. The study begins by exploring the programme’s origins, from 2020 to 2021, before comparing its design to four paradigmatic features of global biopharmaceutical production as identified in literature and “numerous scholarly disciplines”:
- Weak conditionalities attached to publicly funded science
- Secret, transactional R&D partnerships
- A high degree of financialization
- Market-based governance
The origin story
The authors describe WHO’s efforts to improve access to COVID-19 interventions as “markedly” different in approaches to mitigating access challenges and the actors involved.
The Access to COVID-19 Tools Accelerator (ACT-A), launched in April 2020, combined public and private actors. The vaccine arm of ACT-A, COVID-19 Vaccines Global Access (COVAX), was intended to procure vaccines for LMICs through the collective purchasing power of high-income countries (HICs). However, this effort was hampered by HICs prioritising domestic populations, “at the expense of equitable global distribution”.
The COVID-19 Technology Access Pool (C-TAP) was established in May 2020, contrasting ACT-A’s charity-based approach with an effort to distribute control of intellectual property (IP), data, and knowledge. This “pooling” of technologies to address population needs in LMICs was “applauded by civil society but fiercely contested by industry, its allies, and the Gates Foundation”.
A third proposal emerged, centred on building capacity “in LMICs for LMICs”, driven by WHO’s lead coordinator for vaccine research, Dr Martin Friede, and Chair of MPP’s Governance Board and former WHO Assistant Director-General, Dr Marie-Paule Kieny. They reflected on the “hub and spoke” model of manufacturing that had been used in the context of influenza vaccines, imagining a “centralised knowledge sharing system with a view to enhancing local vaccine production capacity in LMICs”. There were “crucial questions” about how this model would work in the context of COVID-19.
WHO’s Erika Dueñas Loayza suggested that the initial plan was to embed the COVID-19 hub within C-TAP. In the face of growing industry opposition to C-TAP, the WHO Assistant Director General of Access to Medicines and Health Products at the time, Dr Mariângela Simão, and WHO Chief Scientist at the time, Dr Soumya Swaminathan, elected to move the programme closer to the ACT-A. In this context, WHO issued a call for expressions of interest for technology transfer hubs in April 2021.
Afrigen responded to this call, with Chief Executive Professor Petro Terblanche identifying an opportunity: “we are small, but we know tech transfer”. Professor Terblanche assembled a “consortium” with Biovac and the South Africa Medical Research Council (SAMRC) to apply. This appealed to Dr Friede, who commented that the consortium, and its location, were “attractive”.
Although Afrigen was announced in June 2021, Bio-Manguinhos in Brazil presented a proposal for ‘end-to-end’ mRNA manufacturing capacity transfer. Then head of vaccine innovation, Dr Sotiris Missailidis, reflected that the early impression given was that “the model was going to be a decentralised. Model” with several hubs, each with spokes.
“What I didn’t know was that, at some stage, […] there was a decision taken from WHO or whoever, that as there was increasing political and financial pressure, many people wanted to come in. […] So the decision was taken to have on central hub and everybody else would be spokes.”
The study authors convey a sense of confusion about the hub/spoke situation well into 2022. In 2024, the programme “continues to evolve”, encompassing a “diverse array of actors”. The fourteen LMIC-based “spokes” are now known as “partners” because of “negative connotations”.
Quid pro quo
The “first defining feature” of biopharmaceutical production relates to the “limited quid pro quo” that the public sector expects in return for supplying private actors with financing, R&D, and product leads. Weak conditionalities are often attached to government and philanthropic funding of biopharmaceutical R&D.
“Conventional wisdom is to grant maximum discretion to recipients of public funding, including universities and government laboratories, as well as private actors about how to commercialise biopharmaceuticals.”
From this, the authors infer that the state’s role is to subsidise, not shape, innovation. Funding for the mRNA programmes comes from governmental sources through MPP, which secured commitments from France, the European Commission, Germany, Norway, Belgium, and Canada, as well as the South African government and the African Union. The donors have committed US$117 million to the programme, which is expected to be “self-sustaining” by 2026. These funders have “shaped the programme in multiple ways”.
For example, Germany reserved funding for a staff position at the hub, but the requirement for a French or German national meant that Afrigen was unable to fill the position. Canada, the second largest donor country, stipulated that its funding should be allocated to the Cape Town hub and four countries hosting manufacturers: Senegal, Nigeria, Kenya, and Bangladesh.
“According to one interview participant, while HICs are supportive of transferring technology to LMICs, they would prefer that such transfers do not extend to the more upstream inputs into mRNA vaccine production, including novel LNPs and antigens.”
A “critical question” for the authors is if the funding secured for the programme has been “leveraged into a shared set of commitments geared towards improving equitable access”. Relationships are defined by legal agreements drawn up by MPP, granting LMIC partners a “non-exclusive, royalty-free, non-sublicensable, non-transferable, irrevocable, fully paid-up, royalty-free license” to the technology and rights held by Afrigen and Biovac to “make, or have made, use, offer for sale, sell, have sold, export or import” in their respective territories and other LMICs. LMIC partners must grant MPP a global, non-exclusive, royalty-free license to “practice and have practiced the data and the Inventions for the purposes of fulfilling its mission” that is “non-transferable, but sub-licensable”.
The “pooled, multilateral approach to knowledge production” is “rare” for the sector, which is attributed to the fact that MPP was in a “fundamentally different position”. However, the authors identify several “notable incongruities” in the legal architecture, with a risk of “fragmenting the larger, collective enterprise of improving equitable access”. For example, some partners have still not signed on, and an “unevenness” between LMIC partners and SAMRC-funded laboratories is “embedded in the programme”.
Another feature of the programme’s funding implications is that MPP “stopped short” of requiring products to be priced affordable outside a public health emergency of international concern (PHEIC). As the pathogens targeted by various partners, such as TB and malaria, are not currently designated as PHEICs, the programme does not constrain pricing decisions. Instead, there is an “assumption” that the products brough to market will “of necessity, be affordable”, to ensure LMIC governments pay for them.
On the other hand, SAMRC funded projects must ensure that “resulting products” are “available and accessible at an affordable price”. This enforceability of this expectation is called into question by a lack of experience.
“The programme’s approach reduces the pursuit of equitable access to the task of fostering more localised production. This is a logical step towards addressing local population health needs. But localised access is never guaranteed.”
Licensing limits
Partnerships in the “dominant model” of biopharmaceutical production tend to “secret and transactional in nature”, with agreements shrouded with confidentiality conditions. More open arrangements are therefore “relatively uncommon”. At the time of applying to WHO, the consortium expected to receive technology transfer from an established mRNA manufacturer. However, they “didn’t even want to talk”, so the project became a “green fields vaccine innovation”. As the journey evolved, knowledge gaps emerged and were addressed, often with the “help of outsiders”. This was occasionally “coupled with a commitment to assist Afrigen or another consortium member in gaining internal capacity”.
“Participating in the programme is a business opportunity.”
The programme’s architects are “walking a fine line between trying to seed collaboration” and “trusting all involved to thread the commitments to IP access throughout that evolving web of relationships”.
MPP as a “power broker”
Another feature of the biopharmaceutical sector is the industry’s “highly financialised character”, evident in many firms’ decisions to become publicly traded or on stock exchanges. This has implications for the strategic direction of these firms and product prices. There is “no indication” that the mRNA programme mirrors the financialization of more established biopharmaceutical companies. However, MPP’s role as an intermediary “simultaneously adds value to, and imposes a drain upon”, the programme, which the authors suggest is “not the optimal way to provide technology transfer”.
Some interviewees comment that MPP’s technology remote transfer group seems to be “micromanaging”, striving to “be in charge of everything”. If the programme fails, it would be “because of that kind of dynamic, not because the science doesn’t work”. Additionally, there is concern that MPP’s “presence and philosophy” may not work to the advantage of different participants in the programme, with one interviewee questioning why MPP and the Gates Foundation are not working together.
Market-based governance
The final feature of the “status quo” is that the direction of biopharmaceutical prodcution is “concentrated in the hands of powerful, private actors that are, at bottom, governed by the market”. Afrigen has directed its mRNA product development towards 11 potential diseases, with Professor Terblanche suggesting that priorities have not been shaped by the prospect of financial gains. She looks for the “unmet need”, but acknowledges that she may be “forced to prioritise”.
The lack of pricing commitments in Afrigen’s Grant Agreement with MPP “could be interpreted as an incentive for Afrigen to commercialise its technology” or a suggestion that the architects “did not contemplate” Afrigen generating mRNA products of its own. The potential for Afrigen to “yield to market forces” is recognised by the architects.
“The near inevitability of Afrigen’s exit in the eyes of those who designed the programme speaks to an underlying failure of imagination concerning how the mNRA programme is governed.”
The privatised governance strategy “preserves the programme architects’ control”. Indeed, the governance structure excludes “direct representation from LMIC governments”. These choices “reflect the programme’s alignment with the dominant, market-driven approach” of biopharmaceutical production.
Sticking with the status quo?
The authors find that the programme “does not substantially depart from” at least three of the four identified “status quo” features. They conclude that to “realise technology’s emancipatory potential”, more attention should be directed to “social context and structural challenges”. Their analysis shows that “the needs and perspectives of LMICs are not sufficiently centred in the programme” and that the programme works within the existing biopharmaceutical production system without relinquishing architects’ control.
“There is a significant risk that the programme, which is claimed by WHO and MPP as a collective effort to improve manufacturing capacity in LMICs for LMICs, will not solve the problem of equitable access to biopharmaceutical innovation.”
Do you agree with the concerns raised by the authors in the study? How can they be addressed quickly and effectively in the current context, or would you expect to see lessons learnt in preparation for future efforts? To share your perspectives on initiatives to improve access to essential vaccine technologies, join us at the Congress in Barcelona next month, where we look forward to welcoming Professor Terblanche among experts on the subject. Don’t forget to subscribe to our weekly newsletters for more vaccine news.
by Charlotte Kilpatrick | Sep 30, 2024 | Global Health |
Gavi announced two major funding updates at the United Nations General Assembly High-level week 2024, revealing that it is making progress in its fundraising efforts for the upcoming strategic period. The first of these updates is that the European Commission has pledged funding for the first two years of Gavi 6.0, complementing “strong support” from Team Europe and contributing to Gavi’s goal of helping to protect 500 million more children around the world. Gavi also announced an expanded collaboration with the United States International Development Finance Corporation (DFC), focussed on donor liquidity.
European support
The President of the European Commission, Ursula von der Leyen, addressed a crowd at the Global Citizen Festival on Saturday 28th September, revealing a funding pledge of €260 million for 2026-2027 and promising more to follow. The funds will support Gavi’s 2030 ambition of providing protection to 500 million more children, strengthening immunisation systems, and boosting global health security by “increasing readiness to respond to disease outbreaks”.
Added to the money pledged so far by the United States, France, Spain, and others in June 2024, this pledge takes Gavi’s total for the next strategic period to US$2.7 billion. The target is at least US$9 billion, which would enable Gavi to protect more children against more diseases, faster, and protect the world from outbreaks of disease when they occur. The €260 million pledge is for the first two years of Gavi’s upcoming strategic cycle, which coincide with the last two years of the EU’s 2021-2027 Multiannual Financial Framework (MFF). The European Commission is expected to remain committed to a “high level of ambition in supporting Gavi” as it prepares for the next MFF.
President von der Leyen reflected that “a healthier world is a better world”, with vaccination “one of our best chances for this”.
“Right now, millions of children are still at risk. We must continue to support vaccination around the world to save lives. So today I am proud to pledge 260 million euros for Gavi, the Vaccine Alliance. And more will come.”
DFC collaboration
The DFC and Gavi will expand their partnership with a focus on donor liquidity. This builds on support established during COVID-19, with the US$1 billion Rapid Financing Facility allowing Gavi to access funds quickly in the event of new donor pledges for pandemic response or routine immunisation. The mechanism is also central to Gavi’s Day Zero Financing Facility.
Nisha Biswal, DFC Deputy CEO, recognised that “global health security is economic and national security”. DFC invests in healthcare services, supply chains, and technology to strengthen pandemic preparedness and health system resilience, including over US$3 billion in health-related projects to enable over 50 million patients access healthcare.
“With the new Surge Financing Initiative, the expanded Gavi liquidity facility, and investments in regional manufacturing, we will be able to do far more to expand access to life-saving healthcare products, especially during health emergencies.”
Still on track
Dr Sania Nishtar, CEO of Gavi, expressed gratitude to the European Commission, recognising President von der Leyen’s “leadership in advancing global health outcomes” and DFC.
“Thanks to the European Commission and DFC, we remain on track to meet our target of protecting people, communities, even our entire world through immunisation.”
For more on global health investments at the Congress in Barcelona next month, get your tickets to join us here. Don’t forget to subscribe to our weekly newsletters for the latest vaccine news.
by Charlotte Kilpatrick | Sep 30, 2024 | Global Health |
The University of Connecticut announced in September 2024 that a $3.8 million R01 grant from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), will support efforts to develop universal vaccine candidates for leptospirosis. Assistant Professor Elsio Wunder, from the Department of Pathobiology and Veterinary Science in the College of Agriculture, Health, and Natural Resources (CAHNR), will work with colleagues to tackle the animal-borne disease. Leptospirosis is a “neglected disease” with no worldwide approved vaccine.
Leptospirosis
Leptospirosis is a disease caused by the Leptospira bacteria, found in contaminated water or soil. It affects animals and people, and if left untreated in humans can lead to kidney damage, meningitis, liver failure, breathing difficulty, or death. An estimated 1 million human cases occur globally each year, causing around 60,000 deaths annually. The disease is considered “neglected” because it “typically impacts poorer communities and individuals who lack access to adequate sanitation”. Neglected diseases tend to receive less attention and funding than other diseases. However, researchers like Dr Wunder are hoping to “correct this public health injustice”.
A big investment
Dr Wunder has a background in veterinary and human health and has focused on improving diagnostic and prevention mechanism for leptospirosis. The latest award will support these efforts.
“It’s a big investment from the NIH. I’m very grateful. The fact that you have this major investment in a neglected disease is a really big step.”
The team involves researchers from Yale University, the University of California-Irvine, and Serimmune, bringing “strong and diverse expertise” from various fields. They will spend five years developing vaccine candidates and testing them in animal models, hoping to find a viable candidate that is ready for testing in human clinical trials.
Universal focus
The project focuses specifically on developing a universal leptospirosis vaccine, which could be used in “any epidemiological setting in the world” and protect against disease “no matter which strain is circulating in the area”. To do this, the researchers will need to understand more about leptospirosis causing illness. Dr Wunder’s previous research produced an attenuated leptospirosis vaccine, which produces immune responses for specific strains, rather than multiple variants. However, the work behind this vaccine revealed that the bacteria’s proteins are a key target.
In the new project, Dr Wunder and collaborators will pursue a multi-recombinant protein vaccine. Vaccine development for leptospirosis is “very hard” and bacteria have “so many tools to evade host immune defences”. Therefore, the researchers have tried to use several proteins at once. The goal is to create a vaccine with small and relevant elements of these recombinant proteins and ensure that the vaccine can be produced and distributed cheaply. This would enable the best public health effect for people who suffer the greatest burden of the disease. Alongside the project, Dr Wunder will maintain his research and teaching at CAHNR.
“I teach a class that’s an introduction to pathobiology and a mix of basic and translational research, and how important translational research is to improve life for people – in terms of vaccines, treatments, and diagnostics. But in order to have translational research, you do need basic science. And this grant is very much a mix of both.”
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by Charlotte Kilpatrick | Sep 30, 2024 | Infection |
In September 2024, WHO’s Regional Office for Africa announced that Rwandan health authorities are “intensifying outbreak control efforts” after detecting Marburg virus disease in the country for the first time. 26 cases have been confirmed in seven of the country’s districts, and six deaths have been reported. The health authorities are implementing “comprehensive response measures” and an investigation to determine the origin of the outbreak. WHO states that it is supporting these efforts with expertise and tools.
Cases reported and response triggered
26 cases have been reported; 20 are in isolation and receiving treatment, and six deaths have been recorded. 161 contacts of the reported cases have been identified so far and are being monitored. The Ministry of Health, Rwanda, posted a video on social media with a caption reassuring viewers that “people can continue with their daily activities” and “should not panic” as the “hotspots of the disease” have been identified.
WHO is “mobilising” expertise and outbreak response tools to “reinforce the control measures” that are being rolled out. A consignment of clinical care and infection prevention and control supplies will be delivered from the WHO Emergency Response Hub in Nairobi, Kenya, to Kigali in the next few days. Efforts are also underway to “reinforce collaborative cross-border measures for readiness and response” in countries that neighbour Rwanda.
WHO Regional Director for Africa, Dr Matshidiso Moeti, explained that the critical outbreak response aspects are being put in motion “rapidly” to “halt the spread of this virus swiftly and effectively”.
“With the country’s already robust public health emergency response system, WHO is collaborating closely with the national authorities to provide the needed support to further enhance the ongoing efforts.”
Marburg
Marburg virus disease is a “highly virulent” member of the filoviridae family and causes haemorrhagic fever. It has a fatality ratio of up to 88%, with symptoms progressing rapidly after infection. The virus is transmitted to humans from fruit bats and spread among people through direct contact with the bodily fluids of infected people, surfaces, and materials.
The disease was first recognised after large outbreaks in Germany and Serbia in 1967, associated with laboratory research involving African green monkeys from Uganda. Outbreaks and cases have been reported sporadically since then, and efforts have been made to develop effective medical countermeasures. However, there is no licensed vaccine against Marburg virus disease.
A confluence of infectious disease
The Marburg outbreak will increase pressure on the Rwandan health system, which is already fighting its mpox outbreak, declared on 27th July 2024. In September 2024, Dr Jean Kaseya, Director-General of Africa CDC, reported that Rwanda had begun an mpox vaccine campaign after receipt of 1,000 doses. The campaign targeted districts bordering the Democratic Republic of the Congo, the epicentre of the current PHEIC. How will the health services respond effectively to both infectious disease threats, and will there be similarities or ‘doubling up’ in their strategies?
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by Charlotte Kilpatrick | Sep 30, 2024 | Global Health |
In response to recent data on influenza-associated deaths in the United Kingdom and United States, experts from the UKHSA and the CDC are urging everyone who is eligible for a flu vaccine to get vaccinated. A survey from the National Foundation for Infectious Diseases (NFID) suggests that few adults in the United States intend to get vaccinated against flu, COVID-19, respiratory syncytial virus (RSV) or pneumococcal disease, expressing concerns about side effects and a “general distrust” of vaccines. A decrease in uptake has also been observed in the UK, a source of “real concern” for UKHSA.
NFID’s study
The National Foundation for Infectious Diseases (NFID) commissioned an annual survey of US adults to “better understand current attitudes and behaviours” about infectious diseases like influenza (flu) and COVID-19. The study was conducted in August 2024 and included 1,160 complete responses from adults aged 18 and over. The study found that, although 67% agreed that an annual flu vaccination is the “most effective” way of preventing flu-related hospitalisations and deaths, 45% did not plan to or were unsure if they would get vaccinated this season. Only 38% indicated intention to get a flu vaccine this year.
When asked about attitudes towards each disease, “less than 1 in 5” were concerned about themselves or someone in their family getting infected this season:
- RSV – 16%
- Flu – 17%
- Pneumococcal disease – 17%
- COVID-19 – 20%
The survey explored the “top reasons” for people who will or might get a flu vaccine to get vaccinated against flu, including:
- To protect yourself – 76%
- To protect your family – 65%
- To avoid severe complications, including hospitalisation and death – 51%
- To avoid getting sick and missing work or school – 51%
Nearly half (49%) of participants who are at higher risk for flu-related complications cited their chronic health condition as a reason to get vaccinated against flu. Almost 3 out of 4 (72%) of adults who were diagnosed with flu in the last 2 years were likely to get a flu vaccine.
Mistrust and confusion
The top reasons cited for not getting vaccinated included concerns about side effects and a lack of trust in vaccines. While 75% of respondents trust doctors, nurses, and pharmacists for information about vaccines, only 55% trust the CDC and 51% trust state and local health departments.
“Healthcare professionals remain the most trusted source of information about vaccines and play a critical role in protecting public health by providing clear, consistent, and strong vaccine recommendations.”
Data are concerning
At a press conference in September 2024, CDC Director Dr Mandy Cohen stated that in the previous flu season, “an estimated 25,000 people in the US died from flu or related complications”.
“We can protect ourselves and those we care about by getting updated vaccines to reduce the risk of serious illness from flu and COVID-19 and do more of the things we enjoy.”
CDC data indicate that the 2023-2024 flu season in the US was “moderately severe”, causing around 41 million illnesses, 490,000 hospitalisations, and 25,000 flu-related deaths. 199 children died due to flu-related illness, which matches the previous high from 2019-2020. Also at the press conference, Dr Robert H. Hopkins, Jr., NFID Medical Director, described vaccines as a “shield against illness” and an “important tool in our public health efforts”.
“The low vaccination rates among persons with chronic health conditions are of particular concern because they are more likely to develop serious and even life-threatening complications from respiratory infections.”
Dr Hopkins encouraged “everyone at increased risk” to speak to a healthcare professional about vaccination.
“Vaccines save lives, and we all play an important role in helping protect ourselves, our loved ones, and our communities from preventable infectious diseases.”
Dr Reed V. Tuckson, co-founder of the Black Coalition against COVID and chair of the board of the Coalition for Trust in Health & Science, emphasised the importance of building trust by “enhancing our support for people in using science and evidence to make personally appropriate decisions”.
“The pandemic taught us that it is possible to close some of the gaps in immunisation rates among communities of colour, but we still have a long way to go. In addition to evidence-based messaging, we know that guidance from familiar, trusted healthcare professionals working with minority communities is essential to building vaccine confidence.”
Similar concerns across the pond
UKHSA modelling suggests that in the 2023-2024 season, influenza-attributable mortality was around 2,776 deaths due to influenza, a significant decrease from 15,465 in the previous season. Estimates of influenza vaccine effectiveness (VE) against laboratory confirmed influenza in primary care ranged between 46% and 54%. Effectiveness against hospitalisation ranged from 30% in individuals aged 65 and above to 74% in children between 2 and 17 years. However, uptake was low in people with long-term health conditions (41%), 2- and 3-year-olds (44%), and pregnant women (1 in 3).
“Across eligible groups, influenza vaccine uptake in the UK was generally lower in the 2023 to 2024 season compared to the 2022 to 2023 season.”
The decrease from 2022-2023 to 2023-2024 is broken down into various risk categories:
- Aged 65 years and over: 77.8% compared with 79.9%
- Aged 6 months to under 65 years with one or more long-term health conditions: 41.4% compared with 49.1%
- Pregnant women: 32.1% compared with 35%
There was an increase observed in the 2- and 3-year-olds group, from 43.7% to 44.4%.
Get Winter Strong
A scaled-up Get Winter Strong campaign, the result of a collaboration between UKHSA, the Department for Health and Social Care, and NHS England, is set to launch on 7th October to “help reduce the impact of winter viruses on those most at risk” and ease NHS “winter pressures”. The campaign will urge people who are eligible to get their flu and COVID-19 vaccines when invited, and (for the first time) will encourage pregnant women to get RSV and whooping cough vaccination. The maternal RSV vaccine provides “strong protection” for newborns in their first few months of life, when they are at the greatest risk of severe illness from RSV.
Dr Gayatri Amirthalingam, UKHSA Deputy Director of Immunisation, emphasised that “getting vaccinated ahead of winter is by far your best defence” against the “many dangerous viruses circulating in our communities”.
“If you’re pregnant or have certain long-term health conditions, you are at greater risk of getting seriously ill. Older people and young infants with flu are also much more likely to get hospitalised. So, if you or your child are offered the flu, COVID-19, or RSV vaccines, don’t delay in getting them. Please speak to your nurse or doctor if you have any concerns.”
Maryam Sheiakh from Manchester is quoted by UKHSA reflecting on her experience with her daughter’s flu infection. Saffy, aged 4 at the time of infection, spent a week in hospital and was transferred to a High Dependency Unit. Luckily, Saffy made a full recovery, and Maryam encouraged parents to ensure that their children get vaccinated.
“Just go and get it, don’t take the risk. No parent wants to watch their child suffer like we did with Saffy.”
The Get Winter Strong campaign will last 10 weeks, appearing on television, radio, poster sites, and social media channels. What efforts are your national health agencies making to encourage vaccination ahead of the flu season, or how are they communicating the risks of infection and benefits of vaccination?
To discuss flu vaccine development and strategies with your colleagues at the Congress in Barcelona next month, get your tickets here, and don’t forget to subscribe to our weekly newsletters for the latest vaccine news.
by Charlotte Kilpatrick | Sep 27, 2024 | Global Health |
WHO and TikTok announced a year-long collaboration to provide “reliable, science-based health information” in September 2024. The partnership seeks to address the challenges of misinformation and disinformation on digital channels by “promoting evidence-based content and encouraging positive health dialogues”. TikTok is a social platform where users create and share short-form videos.
The Fides network, a “network of healthcare influencers” who seek to share “good health content” and tackle misinformation, was launched in 2020. It has over 800 creators with a reach of 150 million people on various platforms. Network creators across the globe will be joining TikTok to create and promote evidence-based content. TikTok is also making a $3 million donation to support WHO’s work on “destigmatising mental health conditions and creating an informed, empathetic, and supportive online community”.
Social channels as a source
WHO recognises that social media platforms are important sources of information that can influence health-related behaviours and decisions. It states that one in four young adults seeks news content on social media platforms such as TikTok. However, these digital channels are increasingly allowing the distribution of misinformation and “malinformation”. Thus, the collaboration will “expand efforts” on several health topics, making science-based information “relatable and digestible”, and offering support for influencers through TikTok’s creator training programmes.
WHO’s Chief Scientist Dr Jeremy Farrar hopes that the collaboration will prove to be an “inflection point in how platforms can be more socially responsible”.
“The intersection of health and technology presents an opportunity to reach people of all ages, where they are, when they want to access. By working with TikTok and others, we are helping people access credible information and engage in scientific discourse that collectively helps shape a healthier future for all.”
Dr Alain Labrique, WHO’s Director of Digital Health and Innovation, reflected that “creators who understand their audience’s needs have a unique opportunity to bridge the gap between science and everyday life”.
“This is where WHO can step in to support influencers in delivering evidence-based information, ensuring that health conversations on platforms like TikTok are both impactful and informed.”
TikTok’s Global Head of Trust and Safety, Outreach and Partnerships, Valiant Richey, commented on the importance of TikTok’s commitment to providing “reliable information”.
“We are delighted to be partnering with the World Health Organisation’s Fides network of healthcare content creators to further strengthen this commitment by bringing engaging and authoritative mental well-being content to our community.”
Creators leading the field
Dr Timothy Tiutan has created a community of almost 2 million followers on social media and hopes that the initiative will enable creators to “empower communities to live healthier lives”.
“The network tackles global health challenges in an era where access to health information has dramatically evolved. WHO Fides is a driving force in shaping a healthier, more informed global community for the future.”
Avisha NessAiver specialises in translating research into accessible language and has worked with Fides and the UN as part of “Team Halo”. His content has reached over 100 million views on various platforms.
“The Fides network is the catalyst transforming isolated scientists and health experts into a powerful collective force, armed with shared knowledge and strategies to effectively combat the spread of health misinformation.”
Do you think this initiative will be an effective way of engaging social media users in reliable information? Or will the partnership ruffle feathers online and in the lab?
To discuss the importance of effective communication and translating the latest research into accessible content with your colleagues at the Congress in Barcelona next month, get your tickets here, and don’t forget to subscribe to our weekly newsletters here.
by Charlotte Kilpatrick | Sep 27, 2024 | Global Health |
A study in The Lancet Public Health in September 2024 evaluates the measles dynamics in England between 2010 and 2019 to understand the effects of waning of vaccine-induced immunity. The researchers find that, although the MMR vaccine remains “highly protective” against measles infections for decades, and most transmission is “connected to people who are unvaccinated”, breakthrough infections in vaccinated individuals aged 15 years or older are “increasingly frequent”. However, they emphasise the importance of adequate coverage alongside vaccine effectiveness.
In England, measles “follows typical near-elimination transmission dynamics”, with “sporadic localised outbreaks and high national vaccine coverage”. England reached measles elimination status after “large outbreaks” between 2011 and 2013. From 2017 onwards a resurgence has been observed.
Highly protective vaccines
The authors describe measles vaccines as “highly protective against infection” recognising that they enabled a “great decrease in the global burden of measles” after immunisation programmes began in the 1970s and 1980s. Indeed, some countries became eligible for an elimination status since 2000 after the successful implementation of routine immunisation programmes. However, this is slipping out of reach for many countries in Europe and the Americas, which have reported a resurgence between 2015 and 2020.
“This resurgence was mostly reported in under-immunised communities and linked to past variations in vaccine coverage.”
Further outbreaks have been reported in “highly vaccinated” groups in Portugal and Japan, inviting questions about the waning of measles immunity in adults who had received two doses in childhood. Research suggests a waning of antibodies in young adults who had received two doses of vaccine “more than 20 years earlier”, in contrast to no decrease in previously infected individuals. Analysis of outbreak data suggest a “drop” in vaccine effectiveness in young adults who had received two doses of vaccine. However, effectiveness estimates appear to be “sensitive to assumptions on infection-induced immunity”.
The study
The study addressed the need to understand whether the measles case dynamics of settings with high vaccine coverage result from a waning of vaccine-induced immunity or if changes in the distribution of immunity in the population are driving the distribution of vaccine status among cases. A mathematical transmission model, stratified by age, region, and vaccine status was used to evaluate whether the measles dynamics in England from 2010 to 2019 were “in line with a waning of vaccine-induced immunity”. Three scenarios were modelled:
- Vaccinated individuals might only become infected because of primary vaccine failure
- Vaccinated individuals might become infected because of primary or secondary vaccine failure, with the risk of secondary vaccine failure depending on age
- Vaccinated individuals might become infected because of primary or secondary vaccine failure, with the risk of secondary vaccine failure depending on age and time since measles stopped being endemic
Each scenario was fitted to measles case data reported in England between 2010 and 2019, and the authors compared the resulting performance. Data were collected by UKHSA (formerly Public Health England), and included date of symptom onset, region of residence, age, and vaccine status. The final case dataset included 7,504 cases. The annual proportion of individuals who had been infected with measles and received two doses of the vaccine out of the overall number of individuals with measles was three times higher in 2019 than in 2011. The median age of individuals with measles was 12.5 years.
Results
Scenarios integrating waning of vaccine-induced immunity “better captured measles case dynamics” than the scenario without waning. In the scenario where waning started in 2000, the estimated waning rate was 0.039% per year.
“Although slow, waning was associated with an increased burden over time; setting the waning variable in this scenario to 0 led to a substantial decrease in cases.”
While overall vaccine effectiveness was estimated to stay high over the decades, the estimation suggested that the increasing number of breakthrough infections contributed to the measles burden in England. The additional burden brought by waning is “directly related to the risk of transmission from vaccinated cases”, as individuals infected by people who had been vaccinated would not have otherwise been infected.
“Our results suggest that the waning of vaccine-induced immunity likely explains the observed dynamics and age distribution of vaccinated measles cases in England between 2010 and 2019.”
Low vaccination rates a bigger factor
Dr Alexis Robert, Research Fellow in Infectious Disease Modelling at London School of Hygiene and Tropical Medicine (LSHTM) drew attention to the “biggest factor for measles outbreaks”: low vaccination rates. Dr Robert emphasised that the MMR vaccine is “highly effective” and two doses “will protect you and those around you”.
“This 0.04% waning each year is relatively slow, but because measles is so infectious, over time, this would add up to a ‘gap’ in a population’s defences the virus can exploit, which may increase the duration and size of outbreaks.”
The data patterns in the study emerge “because outbreaks have occurred as a result of declines in vaccine coverage”, said Dr Robert.
“If there were no outbreaks, this small amount of waning would not show up in any data. The key issue here is coverage, not the effectiveness of the vaccine.”
Dr Anne Suffel, co-author from LSHTM, agreed that the study “looks at one small part of the picture” and recognised that the “larger issue” is that “uptake of the MMR vaccine has been decreasing in England since 2015”.
“Understanding the impact of vaccine immunity waning will help anticipate the potential impact of measles in countries where incidence has been low for decades, but vaccine uptake is reducing. The best way to limit the impact of measles and protect everyone from what can be a horrible disease, is to keep vaccine uptake as high as possible.”
Dr Adam Kucharski, Professor of Infectious Disease Epidemiology and co-author from LSHTM, acknowledged the role of “other factors” such as “changes in testing patterns over time”.
“However, the consistency and age distribution of the increase in England – combined with reports of cases in vaccinated individuals in other countries and previous laboratory studies showing a decline in measles antibodies – suggests a biological explanation is involved.”
Join us at the Congress in Barcelona next month to explore the reasons for a resurgence in measles from an uptake perspective, and don’t forget to subscribe to our weekly newsletters for more vaccine news.
by Charlotte Kilpatrick | Sep 26, 2024 | Global Health |
A $4.2 million Programme Project Grant renewal from the National Institutes of Health (NIH) National Institute of Allergy and Infectious Diseases (NIAID) in September 2024 will fund efforts by researchers at Weill Cornell Medicine to develop a cytomegalovirus (CMV) vaccine. The vaccine is intended to prevent the transmission of cytomegalovirus from mother to baby during pregnancy. The grant could be extended for five years and $20.4 million to enable research to accelerate the vaccine’s development.
Protecting the foetus
Cytomegalovirus (CMV) is the most common congenital infection worldwide, but Dr Sallie Permar, chair of the Department of Paediatrics at Weill Cornell Medicine, hopes to find a vaccine that prevents transmission of the virus to the developing foetus. Around 1 in 200 babies is born with CMV, with one-quarter of them experiencing long-lasting effects such as hearing loss, microcephaly, developmental delays, and seizures. Dr Permar compares the effects to those recognised in the Zika epidemic, commenting that CMV “affects ten times as many infants”.
“If we could eliminate this terrible congenital infection, we would give more babies the chance to achieve their full potential in life.”
A model of transmission
More than half of all adults live with CMV, but if it is acquired for the first time during pregnancy, the mother has a 30% to 40% chance of passing the virus to her baby. As it is “challenging” to design a clinical trial large enough to assess the effectiveness of a CMV vaccine to protect the foetus, Dr Permar has created a collaborative network. With researchers at the University of California Davis Primate Centre, Tulane University, and Oregon Health Sciences University (OSHU) and Primate Centre, Dr Permar has developed a non-human primate model of congenital CMV transmission to test vaccines.
“This work requires a cadre of multidisciplinary virologists, immunologists, pathologists, physicians, and veterinary scientists who all care deeply about eliminating this devastating childhood infection through vaccination.”
Tackling “immune-evading tactics”
Dr Permar states that CMV has “multiple strategies” for evading host immunity; the virus conceals itself in a person’s cells and producing factors to catch host antibodies, disable common killer T cells, and cause confusion for the antiviral immune response. With the latest grant renewal, the researchers will explore approaches for “thwarting these viral immune-evading tactics”.
The team will use weakened viruses and some of the virus’ own protein factors as antigens to induce the production of antibodies against “CMV’s evasive manoeuvres”. They hope to have a prototype for a vaccine in five years, at which point they could advise the industry on vaccines that are currently in clinical trials.
For insights into maternal vaccine challenges and strategies at the Congress in Barcelona next month, get your tickets to join us here, and don’t forget to subscribe to our newsletters for regular vaccine news.
by Charlotte Kilpatrick | Sep 26, 2024 | Technology |
UNICEF announced in September 2024 that it is working with Australia and Samoa to improve access to vaccinations in Samoa. To this end, an innovative new vaccine delivery vehicle was delivered, alongside waste management supplies such as bins and masks. These supplies are intended for the benefit of everyone living in Samoa, including healthcare providers in 13 healthcare facilities.
A vehicular ‘boost’
UNICEF describes the arrival of the Pacific nation’s first vaccine delivery vehicle as a “boost” to the health system, with positive implications for cost effectiveness and wastage of resources for healthcare workers. Until this point, a smaller vehicle has been used to transport vaccines from the airport to the National Vaccine Centre, before distribution to health care facilities. This required more trips to ensure the potency and efficiency of the vaccines was maintained.
Although Samoa has been making “steady progress” in reaching eligible children with vaccines in the national immunisation schedule and has received support from UNICEF on cold chain and capacity building, the transportation and distribution of vaccines has been identified as a “gap”. The new vehicle, procured with support from the Australian Government and UNICEF, will enable faster transportation and can protect vaccines in unfavourable weather conditions.
Strengthening the health system
Samoa’s Hon. Minister of Health, Valasi Luapitofanua To’ogamaga Tafito Selesele, expressed gratitude to the Australian Government for “timely support” and UNICEF for “able technical guidance and support”, which will help to strengthen the health system to “get equipped to provide quality services in a cost-effective way”. Australia’s High Commissioner to Samoa, H.E. Will Robinson, stated that the vehicle, although prioritised for vaccines, can be used to “accommodate the pharmaceutical supplies for distribution” to health facilities.
“Australia is proud to be a long-term partner for Samoa in achieving its vision for a healthier community and delivering better health for all.”
UNICEF Pacific’s Chief of Samoa Field Office, Khin Moe Aye, recognised that “most” of the health issues facing children in Samoa and the Pacific are preventable.
“However, preventing them requires an effective primary healthcare system well-supported by sound resources. UNICEF is pleased to partner with the Australian Government and Ministry of Health in Samoa towards the strengthening of healthcare systems. This will enable children and their families to access quality services, while also ensuring that healthcare workers benefit from better resources and services.”
For the latest insights into strengthening healthcare systems and ensuring effective vaccine delivery strategies across the world, join us at the Congress in Barcelona next month. Don’t forget to subscribe to our weekly newsletters for more!
by Charlotte Kilpatrick | Sep 26, 2024 | Global Health |
In September 2024 Africa CDC and IAVI announced the signing of a Memorandum of Understanding (MoU) to enhance the continent’s capacity to fight disease, pandemic readiness, and supply resilience. This will involve expanding capabilities for locally driven research, development, manufacturing, and supply of priority vaccines and antibodies as well as strengthening Africa CDC-led initiatives. The partnership will combine IAVI’s “expertise in vaccine and antibody development and access” and the “extensive network and Africa CDC”.
Initiatives under the MoU
The MoU is intended to tackle pressing public health challenges and promote long-term health security. Some of the key initiatives under the MoU include:
- Supporting the development of vaccines and antibodies for regional health priorities (like Lassa fever and HIV)
- Fostering a sustainable supply and demand ecosystem for priority products in the region (including monoclonal antibodies)
- Strengthening African research and development capacity
- Exploring regional stockpile strategies for licensed and investigational products to ensure rapid responses during health crises
The MoU exemplifies the “action-oriented partnerships” that Africa CDC’s New Public Health Order demands as the organisation drives its vision for “redefining global health architecture” and ensuring that Africa and the world are better prepared for future health threats. IAVI recognises the support of funders and partners, including Wellcome, CEPI, the European and Developing Countries Clinical Trials Partnership (EDCTP), the United States Agency for International Development (USAID) and the United States President’s Emergency Plan for AIDS Relief (PEPFAR) through the Accelerate the Development of Vaccines and New Technologies to Combat the AIDS Epidemic (ADVANCE) programme.
Dr Mark Feinberg, IAVI President and CEO, described the cooperation as a “key step” in IAVI’s mission to “improve global access to biomedical innovations and safeguard public health”.
“It goes beyond R&D; it’s about creating a vibrant health innovation ecosystem that meets current and future needs across Africa.”
We look forward to welcoming senior representatives of IAVI back to the Congress in Barcelona next month to learn more about the various efforts and initiatives they are enabling in pursuit of global health goals. Get your tickets to join us there and don’t forget to subscribe to our weekly newsletters here.
by Charlotte Kilpatrick | Sep 25, 2024 | Global Health |
At the United Nations General Assembly High-Level Week in September 2024, CEPI launched a new Biosecurity Strategy to bolster global health security and emphasise its commitment to addressing emerging epidemic threats. The strategy draws on the latest technologies and encourages international collaboration to mitigate the risks presented by emerging pathogens. This is a “significant step” in the “evolution” of CEPI, positioning it as a “though leader in the rapidly developing fields of biosafety and biosecurity”. Chair of CEPI’s Board, Professor Jane Halton, positioned the 100 Days Mission at the centre of this strategy and highlighted the significance of “security and equity” in this effort.
“To underpin that strategy, and to ensure the world can achieve the 100 Days Mission goal safely and securely, we need a robust, collaborative approach to maximising the benefits of new technologies and reducing their potential threats to human health.”
Remaining vigilant and stepping up
Dr Richard Hatchett, CEO of CEPI, writes in the foreword of the importance of remaining “vigilant” and being able to respond quickly to infectious disease outbreaks in an era of “heightened epidemic and pandemic risk”. He reflects that COVID-19 demonstrated the “devastating global consequences” of a pandemic and, through the “persistent controversy” over the origins of the pandemic, heightened awareness of the risk of accidental release and deliberate misuse of science.
“Most risk created by advances in the biological sciences derives from the fungibility of the tools designed to solve specific problems. The tools that will solve a pressing problem are empowering – but there is no intrinsic limit to their application.”
Dr Hatchett acknowledges the problem of “dual use” in the way that biologists tackle problems. However, he warns against imposing limits on scientists, suggesting that this could present “practical challenges” and “impede our progress towards legitimate and worthy goals”, among which is the 100 Days Mission.
“Global scientific participation is critical to the success of the 100 Days Mission and will enable vaccine research, development, and manufacturing to take place in communities that need it, led by those who will benefit from it, and informed by the priorities of the vulnerable communities that are disproportionately impacted by epidemics and pandemics.”
To address the risk of accidents or misuse, Dr Hatchett highlights the importance of mechanisms to “ensure that the highest, most current standards of biosecurity and biosafety are practiced and maintained”. CEPI’s “highly diverse” research portfolio includes more than 50 countries, each with “highly variable” oversight practices. The need for a biosecurity strategy is directed by a recognition that “as a steward of global funds, no matter where those funds are deployed, we have a critical responsibility to ensure that the research we fund does not lead to the next accident or deliberate incident”.
‘Beyond this threshold obligation, CEPI also has an opportunity to step-up as a thought leader in this emerging area.”
In developing the strategy, CEPI engaged more than 150 entities in the global health and security ecosystems in a consultative process and sought advice from a Biosecurity Strategy Group. Although technological capabilities will evolve and “boundaries blur between disciplines”, the strategy anticipates that “traditional approaches” may prove “inadequate” in the face of emerging threats. Thus, stakeholders must collaborate and develop mechanisms to encourage responsible use, supported by CEPI.
Biosafety and biosecurity
The strategy acknowledges the evolution of the terms biosafety and biosecurity, comparing the WHO (2024) definition of biosecurity with FAO’s (2007) understanding of the term. CEPI’s biosecurity and biosafety priorities must align with its mission to accelerate vaccine development towards the 100 Days Mission. The strategy outlines how an “innovative approach…frontloaded towards preparedness”, can enable the safe and secure delivery of this goal.
Top vulnerabilities
Several biosecurity and biosafety vulnerabilities are identified and considered relevant to the strategy:
- Variable biosafety and biosecurity oversight, risk identification, and management practices among life science funders for research involving high consequence pathogens, including CEPI.
- Substantial variations in biosafety and biosecurity policies, regulations, practices, and competencies where CEPI-funded research takes place, and insufficient health and security collaboration.
- The intersection between biosecurity and equity is insufficiently recognised, which threatens progress towards the 100 Days Mission and future responses to epidemic and pandemic threats.
- Emerging biotechnology and converging technologies present dynamic and evolving biosecurity risks that threaten 100 Days Mission progress.
- The world is insufficiently harnessing technological innovation to reduce safety and security vulnerabilities of the 100 Days Mission.
Focus and priorities
CEPI’s biosecurity focus is to “protect society from epidemic and pandemic threats, with an emphasis on preventing accidental and deliberate misuse of pathogens associated with CEPI-sponsored research”. The strategy therefore addresses global biosecurity vulnerabilities to accelerate current strategic goals with the following priorities:
- Strengthen biosafety and biosecurity risk identification, mitigation, and oversight by CEPI and encourage similar efforts by other life science research funders.
- Enhance global biosafety and biosecurity capabilities of CEPI partners for achieving the 100 Days Mission safely and securely and promote health-security partnerships.
- Drive biosecurity and biosafety in support of equity.
- Monitor and reduce emerging biotechnology and converging technology risks across CEPI’s vaccine research, development, and manufacturing portfolio.
- Accelerate biosafety and biosecurity innovation for vaccine research, development, and manufacturing.
More to come
An implementation plan of activities, goals, and timelines will follow the strategy. It will explore how priorities can be integrated into the wider mission and mandate in three major categories:
- Catalysing strategic partnerships and coalitions
- Advocacy and coordination
- Supporting biosafety and biosecurity capabilities development
Director General of Africa CDC, Dr Jean Kaseya, expressed enthusiasm at the strategy launch and its support of Africa CDC’s efforts.
“With a focus on laboratory systems strengthening, training and infrastructure development, and reducing risks of artificial intelligence and other innovations, the strategy is informed by vulnerabilities across a wide range of resource settings and will help galvanise global progress toward safely and securely achieving the 100 Days Mission.”
Trevor Smith, Deputy Director at Global Affairs Canada and member of the CEPI Biosecurity Strategy Group, welcomed the focus on “effective collaboration between the health and security sectors”.
“The strategy articulates an ambitious vision for reducing vulnerabilities and strengthening global health security.”
For insights from senior representatives of CEPI at the Congress in Barcelona next month, get your tickets to join us here. Don’t forget to subscribe to our weekly newsletters here.
by Charlotte Kilpatrick | Sep 25, 2024 | Therapeutic |
Anixa Biosciences announced a strategic plan for a Phase II study of its breast cancer vaccine in September 2024. The proposed trial follows a Phase I trial at Cleveland Clinic with grant funding from the United States Department of Defence. The trial will evaluate the efficacy of the vaccine administered in combination with chemotherapy and Keytruda in the neoadjuvant setting. This means that it can enrol a broader range of patients across multiple types of breast cancer.
A unique target
Researchers at Cleveland Clinic identified a protein called alpha-lactalbumin, present only in healthy breast tissue engaged in lactating; it becomes “retired” when the person stops nursing their child and does not exist in any other cell in the body. However, it does appear in “many types” of breast cancer, including the “aggressive and deadly” Triple Negative Breast Cancer (TNBC). By developing vaccines that target alpha-lactalbumin, Anixa hopes that the immune system can destroy cancer cells and prevent tumours from forming.
Moving forward
The Phase I clinical trial in the breast cancer vaccine has produced “positive” clinical data, so a cancer vaccine discovery programme has commenced in collaboration with Cleveland Clinic. This will explore additional cancer vaccine opportunities for “intractable” cancers such as high incidence malignancies in lung, colon, and prostate.
The Phase II trial will evaluate the efficacy of a combination of the vaccine, chemotherapy, and Keytruda in a neoadjuvant setting, seeking to reduce tumour burden and prevent recurrence, with “intent to improve survival”. Trial objectives include evaluating the immunological response to the vaccine and comparing clinical efficacy of standard of care therapy alone with the vaccine plus standard of care therapy. It is expected to begin in 2025 and will last between two and three years.
The trial will enable Anixa to engage more patients with various types of breast cancer. This has potential to address the increasing therapeutic market for breast cancer as prevalence and screening increases drive demand for treatment. The development path for breast cancer treatment is expected to be shorter than primary prevention.
Accelerated treatment
Dr Amit Kumar, Chair and CEO of Anixa Biosciences is excited to unveil the plan, “bringing us one step closer to a potentially transformative therapy for breast cancer patients”.
“By targeting treatment rather than prevention, we can reach a broader patient population and potentially expedite the process of regulatory approval and partnerships. This trial marks a key milestone in advancing our mission to fight cancer through innovative therapies.”
As the Phase II trial will focus on the therapeutic market, data will be used for other studies for “both recurrence prevention and primary prevention with partners in the future”.
Join us at the Congress in Barcelona next month for more on cancer treatment strategies and don’t forget to subscribe to our weekly newsletters here.
by Charlotte Kilpatrick | Sep 25, 2024 | Global Health |
A study in Patient Education and Counselling explores the experiences of primary care physicians (PCPs) with vaccine-hesitant patients in the hope that specific challenges can be addressed to support efforts to increase vaccine acceptance. All the PCPs who participated understood the significance of discussing COVID-19 vaccination, but they found strategies targeting people’s thoughts and feelings were “generally ineffective”. They also expressed “frustration” at their interactions with vaccine hesitant patients, which sometimes led them to “truncate their communication with these patients”.
Fostering acceptance and increasing uptake
The authors describe vaccine hesitancy as a “major public health threat” as demonstrated in the COVID-19 pandemic; an estimated 234,000 deaths could have been prevented through vaccination between June 2021 and March 2022 when COVID-19 vaccines were “widely available” in the United States. Despite this availability and evidence of vaccine effectiveness, around 20% of the US population is undervaccinated against COVID-19.
“Strategies to foster vaccine acceptance and increase COVID-19 vaccination are needed.”
Many evidence-based strategies for healthcare organisations to promote vaccine uptake put health care providers (HCPs) at the centre, with doctors “consistently cited” as a trusted source of information. However, the perspectives of primary care providers (PCPs) are a research gap. Thus, the authors identified a need to generate a “more in-depth understanding” of PCPs’ experiences communicating with vaccine hesitant patients. This understanding is a “critical first step to maximising the potential for PCPs to promote COVID-19 vaccination”.
The study
The study was intended to describe PCPs’ experiences and perspectives on COVID-19 vaccine communication with patients, with a focus on COVID-19 vaccine hesitant patients. The researchers conducted focus groups with PCPs from 3 healthcare systems in central Massachusetts. Acknowledging prior research that documents higher rates of COVID-19 vaccine hesitancy among members of racial/ethnic minority groups and those with socioeconomic disadvantage, the authors chose clinics from 3 health systems that serve higher proportions of patients who are a member of a racial/ethnic minority group, primarily speak a language other than English, and/or are insured through MassHealth.
Nine focus groups, conducted for around an hour over Zoom between December 2021 and January 2022, involved 40 PCPs. These included 23 attending physicians, 10 resident physicians, 6 nurse practitioners, and 1 physician assistant. Experiences were characterised by the following themes:
- Importance of and perceived responsibility for discussing COVID-19 vaccination with their patients
- Strategies for promoting COVID-19 vaccination
- Challenges PCPs encountered
- PCPs’ reactions and emotions
- Tailored communication according to degree of hesitancy
- Resources that would be helpful to support these conversations
The findings were integrated with the Increasing Vaccination Model, but the authors added the challenges encountered among “staunchly vaccine hesitant patients” and resultant frustration, truncated communication, and shifting priorities.
Study findings
All participants perceived discussing COVID-19 vaccination with their unvaccinated patients as “extremely important” and described feeling responsible for providing patients with accurate information about vaccination and recommending vaccination to all their unvaccinated patients. However, most PCPs did not feel responsible for whether their patient chooses to get vaccinated.
The focus groups revealed a range of communication strategies for influencing COVID-19 disease risk appraisal and/or increasing confidence in the vaccine. For example, facts and statistics appeared “ineffective”, directing PCPs to other strategies such as emphasising a patient’s risk of disease, sharing stories of other patients who experienced serious illness, and highlighting the risk of Long COVID. Some PCPs acknowledged “explicitly trying to induce fear about COVID-19″.
The main strategy for increasing vaccine confidence across PCPs was sharing information, including referring to studies and/or CDC information, answering questions, acknowledging risks, and addressing myths and misconceptions. Many PCPs presented vaccination as a risk/benefit calculation, emphasising safety by comparing the small number of vaccine-related adverse events with the number of people who had received the vaccine. They also put the risk of vaccine-related adverse events into the context of the larger risk of dying of COVID-19 or risks inherent in everyday activities.
PCPs explored various relationship-based strategies to promote COVID-19 vaccine uptake, including making personalised recommendations for vaccination, leveraging pre-existing relationships, sharing personal decisions to be vaccinated, and building trust. Common approaches to build trust included avoiding making patients feel stigmatised, acknowledging concerns and uncertainty, encouraging repeated discussions, empathising with concerns, and being explicit that PCPs are motivated by the patient’s interests. Although many offered patients a chance to ask questions, only a few reported trying to find common ground and empathise with concerns. However, those who did found it helpful.
“COVID-19 vaccine availability in clinic was consistently cited by PCPs as one of the most influential factors in getting their COVID-19 vaccine hesitant patient vaccinated.”
PCPs observed that vaccine availability overcame practical barriers, and those who worked at clinics without vaccine availability described it as a “major barrier”. Other practical challenges included inadequate time and competing medical priorities, as well as difficulty following ever-changing information on COVID-19 and vaccinations.
Efforts to influence the most “staunchly vaccine hesitant” patients’ thoughts and feelings were “generally ineffective”. Many PCPs reported struggling to overcome strongly held beliefs based in misinformation or conspiracy theories. For some, patients refused them a chance to discuss it, including those who prevented PCPs from leveraging their relationships.
“All PCPs felt frustrated and defeated with not being able to convince some patients to get vaccinated.”
This experience was compounded by the “disheartening” transition between attending to critically ill patients with COVID-19 in the ICU and being unable to get through to patients who have access to a preventative intervention. PCPs also expressed “frustration and anger” with unvaccinated patients who sought treatment for COVID-19 and described “emotional exhaustion” with trying to discuss vaccination with hesitant patients.
“Recognising that most of their strategies were ineffective among the most staunchly hesitant patients, most PCPs tailored their communication according to the degree of COVID-19 vaccine hesitancy.”
Patients were broadly categorised as those who were:
- Very easy to convince or just want PCPs’ confirmation
- Undecided but open to and seeking information
- Staunchly opposed to vaccination
The “staunchly opposed” group demanded the most time and effort, often rejecting data and/or science and having fixed belief systems informed by misinformation, politics, and personal experience. Most PCPs therefore limited the time they committed to discussing COVID-19 vaccination with patients who seemed staunchly opposed. This was also influenced by a desire to maintain relationships and ensure patients continue to seek care for other conditions.
The participating PCPs felt “ill-equipped” to communicate with their most hesitant patients but commented on the value of focus groups for learning from peers and feeling less alone in facing challenges. They expressed interest in easy-to-understand patient-facing educational materials to address common myths, questions, and concerns in multiple languages. They also indicated a desire for accurate, up to date, and easy to find information sources for their own reference. It might also be valuable to develop system-level resources to identify unvaccinated patients, conduct outreach, and offer professional counselling.
Implications and conclusions
“As the spread of medical misinformation and disinformation is expected to persist and potentially increase, our study illustrates the need for innovative and effective strategies for refuting misinformation related to vaccination, and health misinformation more broadly.”
The authors comment that “very few PCPs” in the study described empathising and expressing understanding with their vaccine hesitant patients, but the few who did found it “quite effective”. Expressing empathy and understanding the viewpoint of a staunchly vaccine hesitant patient are “necessary first steps to establishing trust with this population” before refuting misinformation. However, this is “understandably difficult” for healthcare providers.
The paper identifies a need for training in effective approaches for countering misinformation and communication. As a presumptive-style recommendation is the “most well proven provider-based strategy” for encouraging vaccine uptake, PCPs should be trained in making presumptive-style recommendations. However, the effects of this training could be limited if COVID-19 vaccine availability in primary care clinics is “inconsistent”. Efforts should focus on increasing in-clinic availability as an “important first step”.
Associate professor of medicine at UMass Chan Medical School and principal investigator, Dr Kimberly Fisher reflected that the key message from PCPs was “universal frustration” at the number of patients they “couldn’t get through to, despite their pre-existing relationship and feeling like the patients really trusted them”. This challenge continues as advice changes.
“In the early communication, public health officials obviously didn’t know that it would be required every year, and so I think there is a degree of frustration among patients about actually needing to get one every year, like a flu shot.”
Dr Fisher recognised the importance of tempering vaccine advocacy with maintaining a trusting relationship.
“Maybe they won’t get vaccinated. But you could still convince them to get a mammogram or colonoscopy or something else.”
For more on effective vaccine communication and encouraging participation in necessary immunisation strategies, get your tickets to join us at the Congress in Barcelona next month, and don’t forget to subscribe to our weekly newsletters here.
by Charlotte Kilpatrick | Sep 25, 2024 | Technology |
MSD Animal Health announced in September 2024 that it is expanding the newly USDA-approved NOBIVAC NXT vaccine platform to include a best-in-class solution to protect cats against a common feline infectious disease, feline leukaemia virus (FeLV). Describing this technology as a “breakthrough scientific achievement”, MSD Animal Health indicated that the vaccine is expected to be available at veterinary clinics and hospitals in the autumn.
NOBIVAC NXT
The NOBIVAC platform is behind a portfolio of products with an “extensive range of vaccines” to protect companion animals against various diseases. NOBIVAC NXT FeLV is the first and only feline leukaemia virus vaccine built using the RNA-particle technology platform. It is designed to deliver “optimised protection”. It is a nonadjuvanted, low volume 0.5 mL dose vaccine that “harnesses the natural ability of the immune system” to generate a robust response.
NOBIVAC NXT FeLV is labelled effective against persistent viraemia and is indicated for the vaccination of cats aged 8 weeks or older. The American Association of Feline Practitioners (AAFP) recommends administration in two doses, 3 to 4 weeks apart. It follows the AAFP’s recommendations for extended duration protection with a proven 2-year duration of immunity (DOI).
Feline leukaemia virus
Feline leukaemia virus can be spread in a “multitude of ways”, including mutual grooming, fighting behaviour, or shared food. It poses “serious” health risks, but cats often show no symptoms when they are first infected. However, as it persists, the virus can lead to cancer, severe blood disorders, or other infections associated with a compromised immune system. Routine vaccination can help protect from potential illness.
Meg Conlon, DVM, executive director, veterinary professional services, MSD Animal Health, suggested that “nearly 4% of cats” in North America are affected by the disease. This is a “notable percentage when there have been guidelines for prevention in place for decades”.
“That’s why education and awareness of the importance of vaccinating against this disease is so important.”
Ian Tarpey, vice president, research and development, MSD Animal Health, is proud to extend the RNA-particle technology with a vaccine that “protects against one of the most persistent threats to our feline patients”.
“MSD Animal Health and our NOBIVAC brand have a rich history in vaccine innovation, and we’re continuing to prove our dedication to ensuring there are safe and effective treatment options for veterinary professionals with the latest development of NOBIVAC NXT FeLV.”
For the latest on veterinary vaccines at the Congress in Barcelona next month, get your tickets to join us here and don’t forget to subscribe to our weekly newsletters here.
by Charlotte Kilpatrick | Sep 23, 2024 | Technology |
Evaxion Biotech announced the launch of an enhanced version of its clinically validated AI-Immunology platform in September 2024, with an update to the EDEN AI prediction model. Improvements to the model include toxin antigen prediction, which enables the development of improved bacterial vaccines. AI-Immunology allows Evaxion to simulate the immune system and create predictive models to identify and develop personalised and other next-generation immunotherapies. It uses advanced AI and machine learning technologies to design and develop vaccine candidates in response to significant unmet needs.
EDEN upgraded
The AI-Immunology platform can deliver a new target within 24 hours, with “robustly validated” predictive capabilities. The EDEN prediction model is one of five models within the AI-Immunology platform. It rapidly identifies antigens that will trigger a robust protective immune response against “almost any” bacterial infectious disease. The model is fully AI-driven and designed to identify vaccine candidates “faster and at a lower cost than current state-of-the-art methods”. EDEN enables a novel approach to vaccine development that supports efforts against the “rising global issue of antibiotic resistance”.
The latest version 5.0 features several updates:
- Novel bacterial toxin antigen predictor – Evaxion has trained new machine learning models to improve the accuracy and reliability of toxin antigen prediction.
- Expanded training dataset – The process for curating additional training data from published sources has been streamlined with retrieval-augmented generation with large language models, followed by manual domain expert curation.
- Advanced protein feature prediction – The team has developed a new building block for protein feature prediction using protein language models, enhancing the model’s architecture and capability to predict various protein characteristics.
CEO of Evaxion, Christian Kanstrup, described the launch of the model as an “important milestone” that strengthens the AI-Immunology platform.
“As one of the few truly AI-first TechBio companies, our AI-Immunology platform is at the forefront of innovation. We wil continue to invest in its development and refinement to further improve our ability to discover novel targets and develop advanced vaccines.”
We look forward to learning more about the AI-Immunology platform at the Congress in Barcelona next month; get your tickets to join us there and don’t forget to subscribe to our weekly newsletters for more vaccine technology updates.
by Charlotte Kilpatrick | Sep 23, 2024 | Global Health |
In September 2024, WHO described “significant progress” on government-led negotiations on a pandemic agreement after another round of discussions. These discussions took place at the 11th meeting of the Intergovernmental Negotiating Body (INB) between 9th and 20th September in Geneva. Further discussions are scheduled from 4th November.
The pandemic agreement is an effort by WHO Member States to strengthen pandemic prevention, preparedness, and response. The intention to negotiate this agreement was established in December 2021. In June 2024, governments made “concrete commitments” to complete negotiations within a year at the latest.
Collective commitment
WHO Director-General, Dr Tedros Adhanom Ghebreyesus, commented that the “collective commitment” shown in the efforts to reach an agreement is a necessary response to the threat of viruses with pandemic potential.
“The next pandemic will not wait for us, whether from a flu virus like H5N1, another coronavirus, or another family of viruses we don’t yet know about. But all the ingredients are in place to meet the objective of countries to negotiate a generational pandemic agreement. The world needs hope that it is still possible for countries to find common solutions to common problems. You provide that hope.”
Ambassador Anne-Claire Amprou, INB Bureau Co-chair of France, also identified the “visible commitment” shown by governments in the negotiations.
“There was a clear recognition from all countries that we must agree on a way forward to work better, together, to protect their citizens from future pandemics… The constructive contributions by INB relevant stakeholders were incredibly valuable. Together, we must sustain this progress during the coming months to realise our shared goal to forge a pandemic agreement that guides future global responses to pandemics.”
Head of Pandemics at FOUR PAWS, a global animal welfare organisation, Nina Jamal, centred a One Health approach in the “growing urgency” for an effective Pandemic Agreement.
“We thank the Bureau for transparency towards relevant stakeholders, increased openness and constructive proposals by Member States, promoting successful negotiations. We are looking forward to further progress on the substance of the pandemic agreement and improved dialogue among member states to arrive at a meaningful, effective result.”
Michelle Childs, Policy Advocacy Director for the Drugs for Neglected Diseases initiative (DNDi) welcomed the sharing of draft texts and daily briefings.
“These help to improve the ability of stakeholders to follow and input and counter misinformation about what is actually being discussed. We encourage further steps to enhance transparency, including making stakeholder interventions publicly available.”
INB Co-chair from South Africa, Ms Precious Matsoso, suggested that there had been progress on various areas of the draft agreement, from research and development to sharing of benefits such as vaccines. After almost three years, countries are “now focused on the remaining and most critical elements” of the agreement.
“At the heart of the negotiations is recognition that collaboration among countries will ensure the world will not be left vulnerable in the face of future pandemics, while each and every country will maintain their sovereignty and control over national health decision-making.”
For more on efforts to reach an agreement and how the vaccine industry can align itself with this, join us at the Congress in Barcelona next month, and don’t forget to subscribe to our weekly newsletters here.
by Charlotte Kilpatrick | Sep 23, 2024 | Technology |
Vicebio announced $100 million Series B financing and the initiation of a Phase I clinical study of RSV/hMPV bivalent vaccine in September 2024. The financing is led by TCGX with investment from Goldman Sachs Alternatives, Avoro Ventures, and venBio, with participation from UniQuest and founding investor Medicxi. The funding will support and accelerate the development of vaccines based on Molecular Clamp technology, discovered at The University of Queensland.
Molecular Clamp technology
Vicebio’s next-generation vaccines for respiratory viruses are based on the proprietary Molecular Clamp technology from The University of Queensland. This technology “uniquely stabilises” viral glycoproteins in their immunogenic prefusion conformation, which is “crucial for eliciting strong protective immune responses”. The approach enables the production of “highly effective” vaccines that are easy to manufacture and can be available in ready-to-use prefilled syringes.
The technology has applications for a range of viruses, including respiratory syncytial virus (RSV), human metapneumovirus (hMPV), parainfluenza virus, influenza, and coronaviruses. This has been confirmed by “promising” preclinical and clinical studies.
Vicebio has recently initiated a Phase I clinical trial of VXB-241, a bivalent vaccine that targets both RSV and hMPV. These viruses cause a “significant burden of disease” in elderly patients and those with weakened immune systems. There is no commercially available vaccine for RSV and hMPV. The initial clinical readouts of the study are expected mid 2025.
Cutting-edge science
Dr Emmanuel Hanon, Chief Executive Officer of Vicebio, expressed enthusiasm for the latest interest.
“The support from these high-calibre investors underscores the robust data package we have generated for VXB-241, highlighting the significant potential of our proprietary Molecular Clamp technology to develop next-generation vaccines against respiratory viruses.”
Managing Partner at TCGX, Cariad Chester, emphasised TCGX’s dedication to supporting the “translation of cutting-edge science into transformative medicines”.
“We are thrilled to partner with Vicebio. This is a highly experienced team with a breakthrough technology to address a critical public health need. Vicebio has a unique capability to advance vaccine products that simultaneously provide robust immune responses against multiple respiratory pathogens.”
Cariad Chester will be included on the Vicebio Board of Directors and looks forward to working with the team to “bring these important vaccines to the market”. Dr Giovanni Mariggi, Chair of Vicebio and Partner at Medicxi, identified the “significant progress” Vicebio has made in developing the Molecular Clamp platform and advancing VXB-241 with “unmatched vaccine coverage”.
“We are pleased to welcome TCGX, Goldman Sachs, Avoro Ventures, and venBio to the syndicate to support the fight against life-threatening respiratory viral infections.”
For the latest vaccine technology insights at the Congress in Barcelona next month, get your tickets to join us here, and don’t forget to subscribe to our weekly newsletters here.
