As the countdown to the World Vaccine Congress in Washington continues with only days to go, we are excited to share another pre-event interview. This conversation with Dr Fadil Bidmos was conducted over email and gives us an insight into what he will be exploring during his session in the AMR workshop on the 3rd of April. We are so grateful to Dr Bidmos for his time and the detail he offered in his answers. We hope you enjoy the interview!
Introducing Dr Bidmos
Dr Bidmos is an Advanced Research Fellow at Imperial College London, directing “innovative research” that is focused on the development of a vaccine that targets “both main causes of bacterial meningitis”: Neisseria meningitidis and Streptococcus pneumoniae. Dr Bidmos explained that bacterial meningitis “mostly affects children under the age of 5 and the immunocompromised”.
The “rapid pace of progression of disease” and “non-specificity of early symptoms” ultimately leads to death, which is why there is a significant need for preventative measures as an alternative to post-infection therapy. This research is funded by Dr Bidmos’ MRC Career Development Award and uses “advanced pre-clinical strategies” with the goal of designing “cost-effective” vaccine candidate antigens. The intention is then to extend these strategies to other bacterial diseases.
Alongside his research responsibilities, Dr Bidmos teaches and supervises the laboratory projects of university students, as well as executing administrative tasks within the College.
“I contribute to the wider community by reviewing and editing journal manuscripts in the area of bacterial infectious diseases, and review of grant applications for both national and international agencies.”
Reverse Vaccinology 2.0
Dr Bidmos will present a session on “Reverse Vaccinology 2.0” at the Congress next week. We asked about a general perspective but also how this can be considered in the context of AMR prevention. He suggests that it is an “update on the previous Reverse Vaccinology strategy”.
“One can see it in the same light as the software updates required for computerised devices.”
A key difference is that “candidates recommended by RV studies are not necessarily known to be immunogenic in humans”. However, “because of the nature of RV2.0”, we can make a “solid assumption” about the immunogenicity status of RV2.0 antigens.
“In the context of AMR, RV2.0 is a powerful tool that can unravel vaccine antigens at a rapid pace, but more importantly, the RV2.0 strategy can also yield an alternative agent – therapeutic antibodies – which can be used for treatment of cases of significant multidrug resistance.”
Why is RV so useful for public health threats?
A quick google search reveals that many consider RV to be an improvement or advancement on ‘traditional’ vaccinology. We therefore asked Dr Bidmos about the advantages it brings to the public health sphere.
“One of its main advantages is pace of antigen discovery. Given the appropriate facilities and robust study design, candidate vaccine antigens for a pathogen can be discovered in about 2 months.”
Another advantage is the “quality of antigens”. In Dr Bidmos’ experience, it reveals “rare but highly immunogenic antigens which would be missed by traditional approaches because of our limited knowledge and adherence to paradigms that correspond to theoretical assumptions”
“Here lies another strength of RV2.0 – its non-bias for ‘antigens’ as defined by our limited understanding.”
At the cloning stage, the maximum number of antibody-producing cells will be sorted. As Dr Bidmos suggests, “the bigger the lab/human resources, the better”, for this stage.
“Because the cognate antigen antigens of antibodies produced by each cell is unknown, there is a much greater likelihood that novel antigens, including those that would have never been considered by traditional hypothesis-based/RV approaches, will be discovered.”
On that note, Dr Bidmos acknowledges that “even classical RV” is “susceptible to missing rare antigens” because it relies on “our assumptions of an antigen’s characteristics”.
Technological advances and areas for improvement
Over the past few years, the speed of technological change has been noticeable even to the untrained observer, so we asked Dr Bidmos about areas that have been important for RV and areas for more attention. Although not so recent, he recalls “advancements in fluorescence-activated cell sorting equipment” and “the availability of whole genome sequence data” as “critical” to “high-throughput strategies” like RV2.0.
“Further advancements in automated solutions will greatly enhance its capacity – while powerful, RV2.0 can be labour-intensive, especially when its full benefits are desired.”
These solutions will be particularly important for “basic lab tasks”. Dr Bidmos considers things like “agarose gel electrophoresis of 1000s of samples and cloning”. On a “less technical but more crucial level”, Dr Bidmos states that identifying correlates of protection for individual pathogens requires “significant effort”. Without these correlates, the “determination of what constitutes functional immunogenicity will remain unknown”.
“If we can’t delineate cloned antibodies based on functional ability, how will we select which cognate antigens to take forward?”
AMR and access
Access should always be central to vaccine development, but for AMR it is particularly relevant. Thus, we should be ensuring that vaccines used in AMR prevention efforts should be accessible to all. We asked Dr Bidmos about challenges that are associated with establishing cost-effective processes to produce accessible products.
Dr Bidmos began by suggesting that some aspects of this herculean task “go beyond science”. However, he tactfully opted to “stick with science-y bit”. Perhaps if you meet him at the Congress, you can dig deeper into these other factors with him!
The cost of vaccine research and development, especially with “advanced technologies”, is “not cheap”. Referring to a study from 2018, Dr Bidmos tells us that the cost of progressing just one vaccine from “pre-clinical through to Phase IIa trial completion” was between $319 and $469 million, accounting for “risk of failure”.
“Perhaps, further funding support, if available, from intergovernmental networks could help support industry in offsetting some costs in the vaccine development process, thus limiting the burden on industry and their need to recoup expenses by setting high prices for vaccines that make it to market.”
“Cross-talk between regulatory bodies for knowledge sharing may help eliminate bottlenecks in licensure (following due processes, of course) for diseases with little to no vaccine licensure track record.”
For example, Dr Bidmos identifies a “wealth of experience” in the meningococcal vaccine regulatory field that could be “somewhat useful to other disease regulatory bodies”.
“Finally, scientists like myself who are at the heart of the development process can continue to apply new knowledge (some of which is obtained from ‘blue skies’ research, an area suffering from limited funding) to the development of processes that can help industry overcome manufacturing bottlenecks.”
Looking forward to next week!
With the Congress just days away we were eager to hear what Dr Bidmos is excited about. For him, the call of “new technologies” is strong; he’s looking forward to meeting them and exploring how their products and services can take his research to the “next level”.
“I am also excitedly looking forward to gaining a deeper understanding of what goes on at the other side of the lab door, i.e., when we finish our bit, and the product goes to industry, what processes are involved in transforming our research into the final product.”
We hope that you found Dr Bidmos’ insights useful and are encouraged to attend his workshop for more information. Thank you to Dr Bidmos for his time and participation in our exclusive interview series! For more like this, keep an eye on your inbox over the next few weeks!
A study in Microbiology Spectrum in March 2023 demonstrated the benefits of an oral vaccine for COVID-19 that could “dramatically improve immunisation rates”. The universal vaccine is based on the nucleocapsid protein, which evolves at a slower rate than the spike protein. It exploits a weakened bacterium to produce the nucleocapsid protein and membrane protein in infected cells. Tested in hamsters, the vaccine displayed safety and potency.
Continuing the fight against SARS-CoV-2
The authors note that the COVID-19 pandemic, caused by SARS-CoV-2, has (at time of writing), caused over 585 million cases and over 6.4 million deaths worldwide. In a worldwide vaccination campaign that varies “widely”, approximately 60% of the global population has been vaccinated. However, vaccination rates are much lower that this in many places.
Although the available vaccines have been “highly successful” in reducing the effects of infection, variants are “continuously emerging” to render them “less and less effective”. Most are centred on responses to the Spike (S) protein. The paper identifies one approach to this problem as “redesigning and testing new vaccines” in response to circulating variants. This means essentially opting into a game of catch up against a virus, and current vaccines quickly become “obsolete”, says Dr Marcus Horwitz of UCLA. The researchers suggest that in order to tackle the pandemic “most effectively”, we really need “universal vaccines”.
“The optimal COVID-19 vaccines would be safe, potent, and affordable, as well as universal.”
The candidate in question
The researchers believes that their vaccine, which comprises a replicating bacterial vector expressing the SARS-CoV-2 membrane (M) and nucleocapsid (N) proteins, fulfils these criteria. They break down each criterion as follows.
Safety – the vaccine vector is a further attenuated version of a tularemia vaccine, which has been administered to “millions” of people.
Potency – two immunisations of the MN vaccine have been demonstrated to protect golden Syrian hamsters after “high-dose SARS-CoV-2 respiratory challenge”.
Affordability – the vaccine can be grown to “hundreds of millions of doses overnight” in a “simple broth culture”. Furthermore, after lyophilisation, it can be stored and transported at “refrigerator temperature”.
Universality – the MN vaccine is centred on inducing immunoprotective humoral and T cell responses to “highly conserved SARS-CoV-2 proteins”.
Another feature of the vaccine is capability for oral administration, which would address “two major factors hampering more all-inclusive vaccination”. The first is a lack of equipment and “trained personnel” to deliver injectable vaccines. The second is a “contributing, albeit difficult to quantitate” factor to vaccine hesitancy: feat of needles. This would be “rendered moot” by oral delivery.
The study advances previous research to demonstrate the efficacy of this vaccine when administered orally, as opposed to intradermally or intranasally. The results suggest that it prevented against “severe weight loss” and protection was “at least as strong” as with other methods of administration. It also “significantly protected against lung pathology” and “significantly reduced the viral load in the oropharynx and lungs”.
The authors believe that their “highly demanding animal model” is a positive indication of the potential presented by their vaccine.
“This conveniently administered, easily manufactured, inexpensive, and readily stored and transported vaccine could play a major role in ending the COVID-19 pandemic by protecting immunised individuals from serious disease from current and future strains of SARS-CoV-2.”
Dr Horwitz hopes that the vaccine will progress to manufacturing for oral administration through an acid-resistant enteric capsule. This would allow it to be safely released in the small intestine, and it could then be tested in humans.
“We also plan to expand the vaccine to protect against infections caused by other types of potentially pandemic coronaviruses such as the virus that causes Middle Eastern Respiratory Syndrome.”
This could be a helpful tool in our continued fight against the constantly evolving virus. Do you think an oral vaccine is the solution? Will it help us overcome elements of vaccine hesitancy?
For more on COVID-19 vaccine strategies at the World Vaccine Congress in Washington next month, get your tickets here.
In March 2023 the board of directors at CSPC Pharmaceutical Group Limited announced that the company’s COVID-19 mRNA vaccine has been included for emergency use in China for the prevention of COVID-19. This is the “first independently developed mRNA vaccine product in China” granted for emergency use, as reported by CSPC.
The vaccine, SYS6006, is an mRNA vaccine that covers the Omicron subvariant BA.5’s core mutation at the spike mutation positions. It was granted emergency clinical trial approval in April 2022, and has completed trials with over 5,500 participants to demonstrate safety, immunogenicity, and efficacy.
The statement from CSPC reports that SYS6006 “consistently induces specific T-cell immunity” against strains of SARS-CoV-2, with immunity sustained at “high levels for an extended period”.
“The Product adopts advanced technology with independent intellectual property rights, with the advantages of achieving higher production capacity, better process reproducibility, large-scale production, and scale-up more easily.”
Jumping into action
This inclusion comes at a time of regrowth for China following its stringent COVID-19 policy, the “zero COVID” approach. The New York Times suggests that it may be used to support efforts to “jump-start an economy that had been hurt” by among the “harshest COVID-19 restrictions in the world”. It also describes this vaccine as a “source of national pride” for the Communist Party leadership.
Although it is not clear when the vaccine will become available to the public, this announcement marks a step forward in enabling China to move forward from a complicated COVID-19 approach, particularly considering the leadership’s reluctance to accept externally developed mRNA vaccines.
If the quality of this vaccine can be proven to the people of China, perhaps greater headway can be made into establishing a more equal and effective vaccination trend across the population. Despite lack of clarity in reporting, we have learnt in the past of public reluctance due to confusion and mistrust.
We will hear much more about mRNA vaccine development efforts and applications at the World Vaccine Congress in Washington next month. If you would like to join us, get your tickets here.
In March 2023, Vaxxinity announced that the first subjects of a Phase I trial had been dosed. The trial of VXX-401 will evaluate the safety, tolerability, and immunogenicity of the investigational vaccine designed to lower low-density lipoprotein (LDL) cholesterol. This is a known contributing factor of heart disease, which remains the “leading cause of death globally”.
LDL and heart disease
Vaxxinity states that heart disease claims “over 18 million lives per year”. LDL cholesterol, also known as ‘bad’ cholesterol, is a leading factor in heart disease incidence. Although there are approved treatments to lower LDL, it continues to contribute to deaths.
The investigational vaccine by Vaxxinity is designed to lower LDL levels by targeting proprotein convertase subtilisin/kexin type 9 serine protease (PCSK9). Designed using Vaxxinity’s proprietary synthetic peptide vaccine platform, it is being developed for the treatment of hypercholesterolemia. The platform is designed to “harness the immune system to convert the body into its own natural ‘drug factory’, stimulating the production of antibodies”.
The vaccine is being tested in a multi-centre Phase I dose-escalation trial that aims to enrol 48 subjects between the ages of 18 and 75 years with LDL cholesterol between 2.59 and 4.89 mmol/L.
CEO of Vaxxinity, Mei Mei Hu, described this progress as an “exciting milestone” in the pursuit to “vaccinate the world against heart disease”. This goal includes an intention to keep the vaccine “convenient and accessible” in order to address an “unmet need”.
“With an LDL-lowering vaccine we can potentially offer an option that’s cost-effective, safe, convenient, long-acting, and deployable.”
Hu believes that the solution to the “problem of heart disease” will be a “scalable, accessible technology” that reaches the “hundreds of millions, if not billions of people at risk”. Professor Stephen Nicholls of Monash University and Victorian Heart Hospital in Australia is “excited” to get the “first-in-human trial” underway.
Professor Nicholls suggests that the “concept of a vaccine for cholesterol” could be a “game-changer in cardiovascular health”.
“Targeting PCSK9 with a monoclonal antibody is a proven and effective approach for lowering cholesterol and reducing the risk of heart attack and stroke. Despite the availability of statins and the approval of PCSK9-targeting medicines, there is still a need for new therapies.”
Data from non-human primate studies demonstrate that VXX-401 was “well tolerated” and “provided durable and significant LDL reduction of 30% to 50% change from baseline”. They also prove strong immunogenicity and suggest that VXX-401 “may safely overcome immune tolerance”.
We look forward to hearing more from Vaxxinity’s Mei Mei Hu at the World Vaccine Congress in Washington next month! Join us by getting tickets here.
SpyBiotech, a biotechnology company spin out from the University of Oxford, announced in March 2023 that it had received a grant of $4,094,561 from the Bill & Melinda Gates Foundation to “further develop” its novel SpyVector platform. This platform technology targets infectious diseases, cancer, and chronic diseases. The project will “harness” SpyBiotech’s “plug and display” technology to create a broadly cross-protective coronavirus vaccine.
SpyBiotech describes SpyVector as a platform based on recombinant adenovirus that enables “easy and efficient covalent decoration of the surface of the adenovirus” with pathogen antigens. Furthermore, a recent publication demonstrated that it genetically encodes the antigen.
“The platform increases the quantity of antibodies induced by decorating the adenovirus with the antigen while maintaining the T cell response to the encoded antigen.”
SpyBiotech continues to develop this platform with Principal Scientist Dr Matthew Dicks and team. Dr Sumi Biswas, President and CEO of SpyBiotech, hopes the grant will “showcase” its potential for vaccines “against a wide range of pathogens and therapeutic applications”.
The platform is based on science developed at Oxford, using a proprietary protein “superglue technology”. This “minimises delivery risk and enhances immunogenicity and efficacy”. SpyBiotech suggests that the technology is “potentially one of the safesy and most effective way to create vaccines: cost-effective and highly scalable”.
It therefore has potential for infectious disease use in “challenging environments”, but also potential applications in non-infectious disease settings such as cancer.
In March 2023 GSK announced positive headline results from a Phase III trial evaluating its MenABCWY combination vaccine candidate. Assessing safety, tolerability, and immunogenicity, the trial started in August 2020. All primary endpoints were met, and the vaccine candidate was “well tolerated” and displayed a safety profile consistent with Bexsero and Menveo.
MenABCWY in trial
MenABCWY combines the antigenic components of GSK’s previously licensed meningococcal vaccines, Bexsero (MenB) and Menveo (MenACWY). Targeting all five Neisseria meningitides serogroups (A, B, C, W, and Y), MenABCWY met non-inferiority endpoints in terms of immune response.
The candidate vaccine was administered as two doses given 6 months apart in healthy individuals between the ages of 10 and 25. The trial was randomised, controlled, observer-blind, and multi-country. It is part of a “comprehensive programme to generate clinical evidence on the benefits of meningococcal immunisation”. Around 3,650 participants were enrolled globally.
GSK describes Invasive meningococcal disease (IMD) as an “uncommon but serious illness”. It can cause “life-threatening complications or even death” as a major cause of meningitis and septicaemia.
“Among those contracting meningococcal diseases, one in ten will die, sometimes in as little as 24 hours, despite treatment. One-in-five survivors suffers long-term consequences, such as brain damage, amputations, hearing loss, and nervous system problems.”
The previously mentioned serogroups A, B, C, W, and Y account for “nearly all IMD cases in most of the world”, yet no licensed combination vaccine offers protection in a single vaccine. GSK refers to two separate vaccines, requiring four injections, that are available in the US. However, “low awareness of the disease” has led to “sub-optimal immunisation coverage rates”.
An encouraging step
Dr Tony Wood, Chief Scientific Officer at GSK, described the “statistically significant Phase III data” as a “very encouraging step”. Dr Wood suggests that use of the candidate could “drive significant public health impact”.
“In addition, our 5-in-1 meningococcal vaccine candidate builds on our global leadership in meningococcal vaccines and commitment to innovation.”
GSK will continue to collaborate with regulators to review the full data set and intends to present a publication and further information at future scientific meetings. For more discussion on the importance of combination vaccines at the World Vaccine Congress in Washington next month, get your tickets here.
With just weeks to go until the World Vaccine Congress in Washington, we are delighted to continue sharing interviews. In this post, we spoke to Dr Ike James, Head of Technology Transfer at the Medicines Patent Pool. Dr James will participate in the conversation around global manufacturing capacity.
In this interview, we got an insight into Dr James’ work with MPP and his session at the Congress. This was a written interview. We are so grateful for Dr James’ time and the answers he provided, and we hope that you enjoy reading them!
Can you tell us more about MPP and your work there?
Dr James works at the Medicines Patent Pool, the UN-backed public health organisation working to increase access to and facilitate the development of medicines for LMICs. He describes the lack of “proper access to essential medicines and healthcare” which leads to the neglect of “fundamental healthcare needs”. He identifies “millions of people” who face “catastrophic health expenditures”.
“The COVID-19 pandemic has exacerbated such inequities.”
So, what is MPP hoping to do about this? Dr James states that it exists to “help people in LMICs live longer and healthier lives”.
“We do this by driving down the costs of vital medicines and technology through licensing and technology transfer, and working closely with others in public health to ensure better access to the products and technologies that people in LMICs need.”
The role that Dr James holds in MPP is lead on the technology transfer component of their mandate. His “initial focus” has primarily been the mRNA technology transfer programme they are “co-leading with WHO”. However, his team will also be “working with partners” to “support technology transfer for other health technologies. These include “complex formulations and biotherapeutics”.
Challenges we face in pursuing accessible vaccines
Recently, many of us became aware of accessibility concerns involved in developing and delivering vaccines. Indeed, Dr James says that these concerns were “highlighted” by the COVID-19 pandemic, which emphasised the need for “local sustainable manufacturing of vaccines and other essential medical products”.
“The pandemic has revealed the weaknesses in the existing pull and push mechanisms for vaccine research, development, and manufacturing.”
Moving forward from the COVID-19 pandemic, Dr James identifies some areas for consideration.
Investment in R&D for neglected diseases: the pharmaceutical industry has historically focused on developing drugs for markets that are profitable, leading to a lack of investment for neglected diseases. This has resulted in a shortage of vaccines for diseases that affect the world’s poorest populations.
Establishing local production capability: we are reliant on a few manufacturers for vaccines and other essential medical products. This leads to supply chain disruptions and shortages during global health emergencies.
Access to technology and information: developing countries often lack access to the technology and information needed to develop and manufacture vaccines locally. This results in a dependence on imports, which can lead to supply chain disruptions and high costs.
What changes are coming, and which do we need to drive?
We hear a lot from our speakers about changes that were accelerated during the COVID-19 pandemic. However, there are also areas where further change is needed. We asked Dr James about these areas, and he highlighted some key focus points for us.
Surveillance and monitoring of emerging and re-emerging diseases are essential for protecting public health: by identifying outbreaks early, preventing disease transmission, and improving treatment outcomes, surveillance systems can help to reduce the impact of these diseases on individuals and communities.
Speed of vaccine development: this is often limited by the time required for clinical trials and regulatory approval. This can take several years, which may not be fast enough in the case of rapidly spreading diseases.
Manufacturing capacity: the scale-up of vaccine production to meet global demand can be a major challenge, particularly for new and complex vaccines. The COVID-19 pandemic has highlighted the need for increased global vaccine production capacity.
Equitable access: ensuring equitable access to vaccines, especially for populations in LMICs, remains a challenge. This is often due to the high cost of vaccines and limited resources for vaccine delivery in these regions.
Levelling the playing field
Dr James’ panel explores gaps between “multinational manufacturers” and LMIC vaccine production capacity. We asked for insight into how Dr James believes we can close this gap. He therefore suggested several steps that might get us closer to “local sustainable manufacturing”.
Increase investment in R&D for neglected diseases: we need greater investment in R&D for neglected diseases so that vaccines and other medical products can be developed and manufactured locally.
Promote technology transfer and sharing: developed countries can help by transferring technology and information to developing countries, enabling them to manufacture vaccines locally.
Strengthen local pharmaceutical industries: developing countries need to strengthen their local pharmaceutical industries through investment in infrastructure and training. This helps to create sustainable manufacturing capabilities and reduce dependence on imports.
Foster regional and international collaboration: this ensures that everyone has access to the vaccines and other medical products they need. This includes sharing information, technology, and resources to achieve common goals, as well as encourage investment and build resilience through demand signals and procurement models that prioritise locally produced vaccines.
Why the Congress?
We ask our speakers why they are coming to the Congress, and what they most look forward to. For Dr James, the answer is simple.
“COVID-19 has certainly left a legacy; I would be eager to hear of new ideas and progresses towards being better prepared next time.”
We hope you enjoyed this interview with Dr James, and we look forward to hearing more at the Congress in April. To join us, get your tickets here. Thank you to Dr James for the time and thought he gave us!
Tuberculosis is one of the leading infectious causes of morbidity and mortality across the world. In 2020 it killed 1.5 million people and caused 10 million new infections. It also has a disproportionate case burden of two-thirds in 8 countries. Although there is a vaccine, the Bacillus Calmette-Guérin (BCG), it has limited efficacy in adults. NIH reports that BCG is “only partly effective”.
Thus, there is a great medical need for an update to our tuberculosis strategy, and although adjuvanted subunit vaccines have “shown promise” in testing, they require refrigeration. This is “costly” and “difficult in low-resource areas”. Therefore, research into a more thermostable vaccine is required, and a team from the US took on the challenge with results published in Nature Communications in March 2023.
The TB burden
Tuberculosis (TB) is caused by infection with Mycobacterium tuberculosis bacteria. Although it primarily affects the lungs, it is also known to affect other areas such as the kidney, spine, or brain. When untreated or inadequately treated it is deadly. However, it is both curable and preventable, according to WHO.
WHO reports that, although TB occurs in “every part of the world”, greatest number of new cases was observed in the WHO South-East Asian Region in 2021. The second most affected region was the WHO African Region, followed by the WHO Western Pacific.
Context of the study
The authors of the study identify “progress” in the “rational selection of antigens made more immunogenic by the combination with vaccine adjuvants”. However, they state that there are “no thermostable adjuvanted subunit TB vaccine candidates” in development.
“Considering the enormous worldwide burden of TB, particularly in Southeast Asia and Sub-Saharan Africa, a thermostable vaccine could provide substantial advantages for global vaccine distribution.”
Establishing a need is one thing, and although “various technologies” can be used to increase a vaccine’s thermostability, there is “substantial complexity” to adapting these technologies for vaccines containing adjuvants.
A major step forward
The Phase I study was a randomised, double-blind clinical trial, designed to “evaluate the safety, tolerability, and immunogenicity” of a single-vial lyophilised ID93 + GLA-SE vaccine candidate in comparison with a previously developed two-vial presentation in healthy adult subjects. The results demonstrate a “similar safety profile” alongside a “comparable or improved immunogenicity profile”.
“The present report represents a major step forward for the field of thermostable lyophilised adjuvant-containing vaccine candidates.”
The authors recognise that some formulations with “thermostable properties” have progressed through testing and licensure, with “significant beneficial impact”. However, the stability of these vaccines outside refrigerated temperatures is “limited to days or a few weeks”. By contrast, the thermostable single-vial presentation of ID93 + GLA-SE is “stable for 3 months at 37°C.
As is always the case in vaccine development, cost is an “important consideration”. The researchers estimate that the excipient cost of the thermostable presentation would be “approximately $0.15 more per dose than the non-thermostable composition at commercial scale”. Additional costs are associated with the “multi-day lyophilisation processing time”.
However, the authors suggest that these costs will be mitigated by “anticipated cost savings and reduced wastage” from the “less stringent storage requirements of the thermostable formulation”.
Study author Dr Corey Casper, President and CEO of the Access to Advanced Health Institute, says that “equitable access to vaccines has been significantly impeded” by refrigeration requirements.
“As observed with COVID-19, no one is safe until everyone is safe.”
We will hear more from speakers such as Dr Mark Feinberg and Dr Jerome Kim in a World Vaccine Congress panel on “silent, forgotten, and underfunded” diseases that persistently cause tragic deaths before, during, and after the COVID-19 pandemic. To join us, get your tickets here.
With less than a month to go before we congregate for the World Vaccine Congress in Washington in April, we are pleased to share the organisations and individuals who have progressed to the final shortlist for the VIE Awards.
After successful rounds of submissions and voting we now present the shortlist. The names below have been contacted to fill in a submission form for review by the Scientific Advisory Board, which contributes to the final decision. This will be announced on the evening of the 4th April at the Awards Dinner.
Good luck to all shortlisted; we look forward to celebrating your achievements at the Congress and Dinner.
Best Clinical Trial Company
Benchmark Research Cedar Health Research CTI Clinical Research Centre Flourish Research PanAmerican Clinical Research Rochester Clinical Research Velocity/Meridian Clinical Research
Best Clinical Trial Network
Accelerated Enrollment Solutions (AES) Accellacare Alliance for Multispecialty Research (AMR) CenExel DM Clinical Research Pratia Tekton Research
Best Central/Speciality Laboratory
Charles River Labs ICON Labs Labcorp Drug Development Nexelis, a Q² Solutions Company PPD Clinical Research business of Thermo Fisher Scientific Viroclinics-DDL, a Cerba Research Company
Best Contract Research Organsation
FHI Clinical ICON IQVIA Nexelis, a Q² Solutions Company Parexel PPD Clinical Research business of Thermo Fisher Scientific Syneos Health
Best production/process development
3M Bharat Biotech Luminex MilliporeSigma Moderna VGXI
Best new vaccine technology/platform
BioNTech – mRNA platform GSK’s RSV vaccine candidate Janssen’s RSV vaccine candidate Moderna – RNA NOVAVAX – RECOMBINANT PROTEIN-BASED VACCINE WITH MATRIX-M™ ADJUVANT Pfizer’s RSV vaccine candidate Vaxcyte, Inc. –XpressCF™ cell-free protein synthesis platform
AstraZeneca GlaxoSmithKline Janssen Merck Moderna Pfizer Sanofi Pasteur
Best logistics, technology, and cold chain delivery
DHL Marken Sanaria Siemens UPS Viroclinics-DDL, a Cerba Research Company World Courier
Best academic/research team
Center for Vaccine Development and Global Health, University of Maryland on Malaria – Dr Miriam K. Laufer City of Hope – COVID-19, Dr Don Diamond Institute for RNA Innovation, University of Pennsylvania – Dr Drew Weissman & Dr Katie Kariko La Jolla Institute’s work on COVID-19 T-cell responses – Dr Alessandro Sette & Dr Shane Crotty Precision Vaccines Program, Division of Infectious Diseases, Boston Children’s Hospital, Professor, Harvard Medical School – Dr Ofer Levy Stanford University, Dr Bali Pulendran’s lab for pioneering systems biological approaches to assess mechanisms and correlates of vaccine responses Texas Children’s Hospital Center for Vaccine Development – Dr Peter Hotez & Dr Maria Elena Bottazzi UW Medicine’s research in preventative breast cancer vaccine – Dr Nora Disis
Writing for Nature in March 2023, Carrie Arnold explores the possibilities presented by cell-free processes. Arnold identifies a “growing number of biomanufacturing firms” that are “embracing” a cell-free biosynthesis strategy.
Without relying on yeast or bacteria for biomolecules, researchers have been able to remove the “components of a cell that make it ‘alive’”, including DNA and endoplasmic reticulum. By freeze-drying “what remains”, scientists are able to rehydrate this material and programme the “molecular machinery” with nucleic acids. The result? An “infinite array of proteins on demand”.
Baking a biological cake or exploiting a car engine
Professor Tobias Erb of the Max Planck Institute for Terrestrial Microbiology in Germany suggests to Arnold that the process is like using a cake mix to which the baker simply adds water. This allows biology to “become more chemically diverse” whilst allowing “chemistry to become more complex”, he says.
For Professor Michael Jewett of Northwestern University in the US, it is similar to opening up a car bonnet to extract the engine and repurpose it to power a drill. Professor Jewett has demonstrated that ribosomes in cell-free systems can be “used to build biopolymers with new chemical backbones, as well as proteins”.
From research to manufacturing
Arnold states that cell-free systems have been used for biochemical reactions “for decades”, but largely in research settings.
“Now, thanks to advances in both reliability and scale, cell-free synthesis is emerging as a major tool for everything from diagnostic-sensor development to vaccine biomanufacturing.”
Despite these advances, there are “hurdles” to overcome, such as the complication of “key protein modifications”. This will be a matter of engineering, says Professor Matthew DeLisa of Cornell University.
“Cell-free systems turn protein synthesis into more of a chemistry problem than a biology problem.”
However, biomanufacturing has been “slow to adopt the technology”, Arnold suggests, partly due to “inertia”. Professor James Swartz of Stanford University thinks it has “taken a long time for people to wrap their heads around the idea”.
“We don’t need a living organism to do complex metabolism, to make complex molecular rearrangements, even to make complex proteins”.
Arnold also believes that the transition has been slow due to the low cost and ease of growing large quantities of bacteria and yeast in comparison with running biochemical reactions. These “require expensive reagents” and “energy sources” as well as other materials. Furthermore, cells “can generate higher yields of the desired product”.
However, we are now seeing the fruits of “years of molecular tinkering” to improve cell-free systems.
Professor Jewett identifies key element to the attraction of cell-free processes. As we know, refrigeration and complex cold chain requirements for vaccine products put pressure on both development and distribution. For cell-free preparations, however, researchers can store products for longer periods and rehydrate on demand.
“It’s kind of like freeze-dried ice cream – something you can transport wherever you go.”
The pressure that storage and distribution place on vaccine deployment was highlighted during the COVID-19 pandemic, says Dr Jessica Stark of Stanford.
“We need better ways to make and distribute medicines very quickly in order to address emerging pathogens.”
What will we do with cell-free systems?
Arnold identifies an “expanded repertoire of applications” for these cell-free processes. So, too, does the US Army, which has awarded $13 million to a new Cell-Free Biomanufacturing Institute at Northwestern University.
However, cell-free systems “remain enormously complex” and we don’t have a “good enough handle” on the process and the potential for scaling up.
“But as cell-free systems take their place in the biomanufacturing toolset, they are providing researchers with a new and increasingly attractive option: just add water.”
For more on innovation in the vaccine development space, join us at the World Vaccine Congress in Washington this April.
As we continue our countdown to the World Vaccine Congress in Washington this April we are delighted to share more conversations with some of our fascinating speakers across a range of subjects. In this interview we were pleased to speak to Dr Yongjun Sui of NIH. She will be featured in the Vaccine Technology workshop, on Monday 3rd April, in which breakthrough vaccine technologies will be explored.
This was a written interview, conducted over email, in which she shares some insight into her work and what she will discuss at the Congress. We hope you enjoy it!
Can you tell us a bit about your current role?
Dr Sui is currently an associate scientist at Vaccine Branch, National Cancer Institute, National Institute of Health.
“I have been working on the development of mucosal HIV and SARS-CoV-2 vaccines using non-human primate and rodent models.”
With interests in “identifying innate and adaptive immune correlates of protection against HIV and SARS-CoV-2 infections”, as well as “exploring trained innate immunity mediated by myeloid cells”, Dr Sui is fully immersed in the world of immunity!
What will your session at the Congress explore?
We know from the agenda that Dr Sui will be discussing “repurposing mucosal combination adjuvant technology from HIV to SARS-CoV-2 vaccines”, so we asked for a bit of an insight into what this will involve. Dr Sui states that “adjuvant combinations” have been used in “mucosal HIV vaccine development” for “more than ten years”.
“When the COVID-19 pandemic struck in March 2020, we repurposed the adjuvant combination for the development of a SARS-CoV-2 mucosal vaccine”.
Dr Sui suggests that she will be sharing data generated in “non-human primate and rodent” at the Congress, as well as exploring “the induction of mucosal immunity, and their contribution in controlling viral replication and COVID-19 diseases”.
What do adjuvants mean to you?
We hear a lot about how important adjuvants are in vaccine development, including recent research into reducing dependency on natural resources. We asked Dr Sui how she views adjuvants and how important they are for her work. She states that they provide “two types of help for the vaccine”.
“1) Enhance the immune response to a given vaccine.
2) Modulate the types of immune responses to mediate different levels of protection.”
For mucosal vaccines in particular, adjuvants have “additional roles to facilitate the delivery of antigens through mucosal layers”. Furthermore, they protect the antigen from “degradation at the harsh mucosal microenvironments”.
What technological developments has COVID-19 brought?
Although the pandemic has put pressure on several different research areas, there have also been some technological developments that might be useful when applied to these areas. So, we asked Dr Sui how she views the state of play, and what she hopes to see in the future.
As she has been working on HIV vaccine development, she has witnessed “tremendous efforts invested”. Unfortunately, these efforts yield “only limited success”.
“I think new technology is the key for breakthrough.”
Dr Sui hopes that the technologies that “advanced during the COVID-19 pandemic” will apply to the “problems” or “bottlenecks” that we encounter in other diseases, including HIV vaccine development.
Although we have taken huge steps forward, we also encountered a lot of scepticism and mistrust of these new technologies. Dr Sui hopes that “we have more experience” dealing with both emerging diseases and the growing threat of anti-science information or confusion.
“I think we should be prepared for both.”
What brings you to the Congress?
As always, we love to hear about the attraction of our event when we chat to our amazing speakers. Dr Sui is “excited to have the experience of in-person interaction and discussion with [her] peers”.
“I would like to share and to know the academic achievements, challenges, and future directions on vaccine development.”
We hope that Dr Sui can experience this at the Congress in a few weeks, and we hope that those of you who will join us are able to attend her session. Thank you to Dr Sui for her time and insight in answering our questions; we look forward to learning more soon!
Just one day after Pfizer announced that the Vaccines and Related Biological Products Advisory Committee (VRBPAC) had voted on its RSV vaccine candidate, GSK announced the results of the Committee’s vote on its candidate. This follows “exceptional” results of a trial in October.
GSK’s joins Pfizer
With this approval, GSK’s direct competition with Pfizer increases, with the odds leaning in GSK’s favour in terms of the vote. The Committee voted 12-0 on effectiveness and 10-2 on safety. Dr Phil Dormitzer, Global Head of Vaccines R&D at GSK, described the vote as an “important step closer to delivering one of the world’s first vaccines for RSV”.
“We’re delighted that the Advisory Committee recognised the strength of our vaccine’s data and its potential to make a positive public health impact with a unanimous vote on the effectiveness of the vaccine.”
Dr Dormitzer stated that RSV imposes a “major health burden on healthcare systems”.
Just as with Pfizer’s results, the final decision on approval will be made by the FDA following these recommendations by the VRBPAC. This decision is expected in May 2023. However, decisions are also expected from regulatory agencies across the world, including the European Medicines Agency, and Japan’s Ministry of Health, Labour, and Welfare. Further submissions will continue throughout the year.
In February 2023, a few days after the FDA requested further studies into the link between GBS and its RSV vaccine candidate, Pfizer announced that the FDA had voted that available data supports the “safety and effectiveness” of the vaccine. The Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted 7 to 4 on safety and 7 to 4 on effectiveness.
What does the vote mean?
Although the VRBPAC provides recommendations to the FDA, Pfizer emphasises that they “are not binding” and the FDA is still considering the approval of RSVpreF with a decision expected in May 2023.
The vote was based on available evidence from Pfizer, including data from the RENOIR study last year. However, some of the members of the committee expressed concerns about the safety of the candidate, particularly in light of the perceived connection between the vaccine and GBS. Dr Hana El Sahly, Committee Chair, described the risk as “concerning”, voting in favour of the vaccine based on efficacy but against its safety profile.
A step forward for Pfizer with GSK following
Dr Annaliesa Anderson, Senior Vice President and Chief Scientific Officer, Vaccine Research and Development at Pfizer, described the “significant need” to protect older adults from “serious illness, hospitalisation, or even death” from RSV.
“We are encouraged by the outcome of today’s VRBPAC meeting as it is a testament to the strength of our science and dedication to bringing this important vaccine candidate to the market.”
Dr Anderson looks forward to “working with the FDA” to complete the application.
Closely following Pfizer in the ‘race’ to secure approval for its RSV vaccine is GSK. The Committee meets again today, on the 1st March, to evaluate its candidate following “positive” results last year.
For more updates on RSV vaccine developments and the timeline to success, join us for discussions with representatives of these key participants in the efforts to achieve it at the World Vaccine Congress in Washington this April.
Following the FDA’s acceptance for review of a Biologics License Application for Pfizer’s respiratory syncytial virus (RSV) vaccine candidate, the agency has asked for further studies into the connection between the vaccine and cases of Guillain-Barré syndrome (GBS). Documents released in February 2023 indicate that if the vaccine is approved, “post-marketing surveillance” will be warranted.
GBS and the vaccine
Guillain-Barré syndrome (GBS) sometimes occurs when the immune system affects the peripheral nervous system, often after an infection. It is most commonly observed in the hands or feet, before spreading to other parts of the body, with symptoms such as numbness, muscle weakness, or pain.
The FDA reports than one case of GBS was identified 7 days after vaccination, with a case of Miller Fisher syndrome, “considered a variant of GBS”, identified 8 days after vaccination. Thus, a total of 2 cases among 19,942 vaccinated participants were recorded. The FDA puts this into the context of a background rate of 1.5-3 cases per 100,000 people each year among US adults. Consequently, it is requesting that GBS and other “immune-mediated demyelinating conditions” are included in the Pharmacovigilance Plan (PVP).
Furthermore, the FDA requests that Pfizer proposes a post-marketing safety study to assess the risk of GBS and other conditions among vaccine recipients post-licensure. Pfizer stated that it will do this.
The race continues
Despite this hurdle, Pfizer continues to keep pace in the race for an RSV vaccine with competitors such as GSK and Moderna also developing candidates. CNN reports that GSK also reported a ‘potential case” of GBS among vaccine recipients but found “insufficient evidence” for confirmation of a diagnosis.
Data for both GSK and Pfizer candidates is under consideration by the CDC, with “post licensure surveillance” being described as “critical” by the Advisory Committee on Immunisation Practices.
For more updates on RSV from key players in the vaccine industry, join us at the World Vaccine Congress in Washington this April.
In February 2023 LinKinVax announced positive interim results from the ANRS VRI06 Phase I trial, evaluating a preventative HIV vaccine. This was conducted by sponsor INSERM-ANRS and the Vaccine Research Insititute. LinKinVax reports that the candidate is “safe” and “induces an early, significant, and sustained immune response”.
The vaccine candidate is developed by the Vaccine Research Institute (VRI) with LinKinVax technology, the first vaccine based on this technology, targeting an immune response binding HIV envelope protein to monoclonal antibodies specifically targeting CD40 receptors on dendritic cells. The Env protein is injected and “delivered directly” to the dendritic cells. The vaccine is combined with the Hiltonol adjuvant, “designed to enhance its potential action”.
Professor Yves Lévy, Executive Director of the VRI and CMSO of LinKinVax, explained that the candidate has done well so far, with the “immune response profile” it generated being “associated with a reduced risk of HIV infection in the RV144 trial”.
“However, at this early stage of vaccine development, it is important to remember that volunteers should continue to protect themselves from any risk of HIV infection, as the efficacy of the vaccine will only be evaluated in the Phase II/III studies.”
The ANRS VRI06 clinical study was conducted in France and Switzerland and included 72 healthy volunteers. Safety and immunogenicity were assessed at Weeks 6, 26, and 48, with results suggesting that it is “safe and well tolerated”.
Dr André-Jacques Auberton-Hervé, Co-founder and CEO of LinKinVax is “pleased” with the “promising immunogenicity results, which demonstrate the robustness of our DC Targeting vaccine platform and confirm its safety”.
“This important milestone paves the way for the upcoming Phase II/III clinical studies that we will conduct once the final Phase I results have been obtained. These studies will aim to demonstrate the efficacy of the vaccine, the ‘Everest of vaccine strategies’, which has been the elusive goal of HIV research for the past 40 years.”
The complex process of vaccinating pigs is time consuming and requires direct interaction between humans and animals, or so we thought. A study in Nature Scientific Reports in February 2023 details a successful study investigating the possibility of presenting pigs with a device that they use to apply a vaccine to themselves. Conducted by US researchers, the study indicates that understanding and appealing to pigs’ tendencies to root around in their surroundings offers a more efficient and effective vaccination strategy.
Time for a change
The authors note that in the US, pig producers are “experiencing a shortage in labour”. Thus, agriculture sectors “have and will need to continue increasing mechanisation” and pursuing “technological advances to reduce labour requirements”.
“Pig producers are now seeking smart farming, digital farming, and precision farming solutions.”
The current approach to vaccine administration requires “significant time” and “direct interactions” that “interrupt normal behaviour” and “can be a stressful time for the animal and workers”. Clearly, there is an unmet technological need.
Enter environmental enrichment (EE)
Environmental enrichment describes the stimulation of a captive animal’s brain with the effect of improving the animal’s quality of life. For many countries, EE is a requirement for commercial pigs, and is “encouraged” elsewhere. The authors suggest that current EE devices “often do not accommodate the behavioural need for pigs to root and push/dig”.
“Most awake and active behaviours of pigs involve rooting and other oral/facial/nasal behaviours (ONF).”
In the article, they explore prototype EE devices based on the rooting motion, resulting in a rewarding “spray in their ONF regions”. Using this method to encourage self-administration of an oral vaccine, the researchers were looking for pig interactions and antibody responses. Pigs were “encouraged to interact with the sprayer” through the inclusion of a maternal pheromone and the “novelty of the sprayer”.
Oral vaccination approaches
The traditional approaches to oral vaccine administration include water system methods, which sometimes means the whole population accessing the system must be vaccinated. Furthermore, oral vaccines for swine are “avirulent live cultures” that are only viable for a few hours. Thus, pigs can easily be excluded from vaccination during the short window of opportunity.
The hypothesis for the study was that accommodating “natural pig behaviours using a form of operant conditioning” would enable pigs to self-vaccinate. This would save labour and possibly improve vaccine delivery efficacy. They used the target species (domestic pigs) as found on farms, with “facilities and procedures” modelled after “common practices on farms”.
The results demonstrated a “significant elevation in IgG and IgA response in all pigs”, as is “consistent with a vaccine-type antibody response”. Indeed, pigs that self-administered that vaccine had “equal or higher IgA in their oral fluids” than the hand-drenched pigs 21 days after vaccination. This is believed to be because self-administration delivers “equal or more antigen to more mucous membranes”.
Although the approach relied on pig behaviour, the antibodies and behaviour data confirm that all pigs were vaccinated. No risk of over vaccination is perceived, as is the case when administering vaccines through watering devices. However, future systems “may use tracking systems to only turn on the sprayer if a given pig has not been vaccinated”.
Benefits of the device
The device used was “mechanical and had no electronic or plumbing parts” and could be used to administer other animal health products beyond vaccines. For the “newer smart-barn systems”, it could be modified to contain electronic valves so that different liquids or powders could be used.
It is not clear if this technology will work for killed vaccines, intranasal vaccines, or those usually given as intramuscular injection. However, the potential to apply this device to feral swine would allow vaccination, medication, sterilisation, or surveillance of a population.
The University of Queensland, Australia, announced in February 2023 that a university-led research effort had secured almost $8 million in philanthropic funding. The researchers are trying to develop an mRNA vaccine against Group A Streptococcus (Strep A), with the possibility of reducing the more than 500,000 deaths each year.
The team comprises researchers from the University of Queensland (UQ), the University of Melbourne, the Murdoch Children’s Research Insititute, Emory University, CONACYT, and Moderna, with support from the Leducq Foundation.
Promising research and innovation
Professor Mark Walker from UQ’s Institute for Molecular Bioscience is encouraged by promising efficacy data from preclinical studies. In collaboration with Moderna, and with support from the Leducq Foundation, he hopes to “build on research already underway”. Although there is no vaccine for prevention of Strep A, it is a “major driver of antibiotic use in children”, the university reports.
“Repeated infections can lead to rheumatic heart disease, the most significant cause of childhood death due to heart failure.”
Dr David Milan is Leducq’s Chief Scientific Officer. Dr Milan is “excited about the potential” of a vaccine to “significantly reduce not only strep throat infections but subsequent rheumatic heart disease”. This is a “major source of mortality” particularly in LMICs.
UQ and Moderna
Vice-Chancellor of the university, Professor Deborah Terry, is extremely grateful for the recognition and support from the Foundation.
“It is a great example of how industry, academia, and philanthropic organisations can work together to tackle some oof the world’s significant global public health challenges.”
Moderna’s Dr Obadiah Plante is “excited to develop” an mRNA vaccine for Strep A, and looks forward to continuing the partnership to “accelerate this research”.
“This brings together Moderna’s research team and leaders in the Strep A field across research, immunology, and clinical practice to address a common goal.”
For more on childhood vaccinations and mRNA vaccine technology, join us at the World Vaccine Congress in Washington this April.
An article in npj vaccine in February 2023 explores the role of squalene in vaccine development and how a synthetic alternative, squalane, opens new doors. The authors, from the US, suggest that although squalene is a useful addition to vaccine composition, the natural, highly concentrated source is under pressure. It is traditionally isolated from shark liver oil, yet overfishing and a reduction in shark populations highlight the need to seek an alternative.
What is squalene?
Squalene is a triterpene belonging to the “large natural product family of terpenoids”. There are over 55,000 known members of this sprawling family. Many of these are found in low concentrations in plants, but squalene is “unusual in that it occurs at high concentrations in shark liver oil”.
What does it do?
Shark-derived squalene has been used as a vaccine adjuvant in “hundreds of millions of influenza vaccine doses” and has a demonstrated “excellent safety profile” and “dose-sparing capability”. More recently, several COVID-19 vaccine candidates are including shark squalene-based formulations. These candidates are expected to contribute to the “global pandemic response” with improved stability profiles compared to mRNA vaccines.
Shark squalene is also being used in candidates for tuberculosis, malaria, schistosomiasis, and leishmaniasis.
“Indeed, next to aluminium salts, shark squalene-based emulsions are the most widely employed vaccine adjuvant formulation in licensed inactivated or protein-based vaccines.”
However, the “mechanisms of action” of shark squalene emulsion adjuvants are “not completely understood”.
“For instance, it has been shown that shark squalene-based emulsions increase vaccine antigen uptake, enhance recruitment and activation of various immune cells at the injection site and the draining lymph node, and cause production of danger-associated molecular patterns that result in proinflammatory signalling cascades; however, it is not clear how the structural properties of squalene relate to these mechanisms.”
Unfortunately, the study identifies a decline in oceanic sharks and rays, “by 71% since 1970”, attributed to overfishing. This has, understandably, led to calls for “prohibitions and precautionary catch limits” to prevent population collapse. Thus, a replacement with “equivalent or better” adjuvant properties is desired.
The authors suggest that a union between synthetic biology and metabolic engineering has resulted in “industrial-scale production of volumes of natural products” that were previously “subject to supply constraints” or unavailable in the “quantities and purities required for commercial usage”.
For squalene, a “sustainable, renewable” solution appears to be squalane, derived from “β-farnesene by semi-synthesis”. The researchers “leveraged the ready availability of fermentation-derived, isomerically pure β-farnesene to investigate the structure-activity relationship (SAR) of squalene analogues as vaccine adjuvant components”.
Squalane vs squalene
The compounds were investigated in blood assays to compare immune responses. Dr Christopher Fox led the study and told Chemistry World that he observed “enhanced adjuvant activity” in “four or five of the molecules”. They found that chain length and saturation was key. Although the results of the study were promising, this requires further study before “next generation vaccines” can be developed.
“Additional preclinical work in different animal models is needed to establish protective efficacy and safety.”
As we get closer to the World Vaccine Congress in Washington our introductions to the start-up zone continue! This time we are pleased to present the final round of start-ups that have signed up so far: the Vs of the start-up zone.
If your application is successful, you will receive the following benefits:
1m wall space in the Start-up Zone
2 passes to the conference and exhibition
Branding and marketing materials
Access to our networking portal
Further details can be found on the Congress website; don’t delay as spaces are limited!
Who is already in the zone?
VacTrack’s mission is to improve population health through digital health innovation. They aim to improve vaccination access, adherence and advance data driven research into vaccine-preventable diseases. The archaic reliance on paper-based vaccination logs is a global issue and requires a digital solution.
VacTrack have created an end-to-end vaccination solution for patients and clinicians, with an integrated booking and management platform alongside personalised recommendations for childhood immunisations as well as travel. VacTrack will help improve uptake and adherence of vaccinations in a world where hesitancy and access are key obstacles. VacTrack boasts an elegant solution to these problems by eliminating these aforementioned barriers, transforming adherence rates, and seamlessly providing a centralised, user-friendly solution.
VaxSyna, Inc. is a pre-clinical vaccine R&D company developing an antibody-based vaccine platform. Their vaccine platform can be utilised to create both prophylactic and therapeutic vaccines and is
up to 50% cheaper to manufacture compared to other vaccines,
stable at room temperature in preliminary studies,
generates a protective immune response in 1-2 doses without the use of expensive adjuvants
effective in multiple pre-clinical trials against various diseases.
VaxSyna’s two primary vaccine candidates are against Human Papillomavirus (HPV) and Herpes Simplex Virus (HSV).
Verndari is a preclinical start-up based in Northern California, focused on advancing a painless skin vaccination platform, VaxiPatch™, designed from the ground up for low-cost, high-speed automated manufacturing.
They harness the power of intradermal delivery to achieve dramatic dose-sparing and achieve superior immune responses with a platform which is exquisitely thermostable and amenable to self-administration. Their approach has been demonstrated in two proof-of-concept studies published in Vaccine, the most recent of which appeared in the January 2023 issue.
Their photochemically-etched stainless steel arrays leverage key advantages of solid-coated and dissolvable microneedle platforms, allowing precision dosing with no appreciable skin reactogenicity. They successfully executed a $1MM cost-sharing contract from BARDA DRIVe to develop their technology and are currently targeting a Series A raise to achieve clinical validation in a first-in-man Phase I trial.
ViQi is modernising image processing technology and expediting science discovery through the creation of AI-based assay development systems. Their technology not only generates better results and reduces employee oversight during testing, but their cloud-based platform allows them to scale quickly and interact with over 150 types of large-scale image formats.
The ViQi leadership team is composed of life science and business leaders with backgrounds in computer-vision, database, large-scale informatics, AI/ML, and image-processing, but their real strength is how they work collaboratively and welcome diverse backgrounds and thoughts. This working environment ensures that they solve real pain points, modernising and transforming the image analysis industry.
Virongy Biosciences is an early-stage, virus-technology development company. Virongy was founded by Dr. Yuntao Wu, an internationally recognized virologist, and together with its CEO, Dr. Brian Hetrick, the company has built a team with over 60 years of virology experience.
Virongy’s mission is to accelerate discovery through innovative virological solutions with elegantly simple workflows. Their flagship technology, the hybrid alpha-pseudovirus, is a versatile nanoparticle platform for both vaccine and diagnostic use against high-risk viral pathogens.
Virongy is bringing a core set of unique technologies to the gene therapy and vaccine industries. They are driven to foster and recruit talent in their region, and they are honoured to be recognized by the Virginia Jobs Investment Program (VJIP) for a continued push to build a strong biotech industry in the DMV area.
In February 2023 Pfizer and Valneva announced that Pfizer, study sponsor of the VALOR Phase III clinical study, has decided to “discontinue a significant percentage of participants in the US” who had been enrolled already.
This discontinuation represents “approximately half of the total recruited participants” and is due to “violations of Good Clinical Practice (GCP) at “certain clinical trial sites”. The statement from Pfizer and Valneva emphasises that these were run by a “third-party clinical trial site operator”. Furthermore, the discontinuation was not caused by safety concerns associated with the vaccine candidate.
GCP and violations
GCP is internationally recognised as a set of requirements to uphold ethical and scientific quality in clinical trials. Valneva states that they put “participants’ interests first and ensure high scientific integrity”.
Pfizer learnt of “potential violations” and responded with a “thorough review” of both operations and data collections, following “standard operating safeguards” to determine the “correct course of action”.
Consequences for the trial
The joint statement suggests that the wider trial is ongoing with other sites that are not managed by the third party responsible for these violations and continues to enrol new participants. Participants are being notified, and Pfizer has also notified the appropriate regulatory agencies and the independent Institutional Review Board for the study.
“Integrity of data collected in clinical trials is critical to provide evidence and confidence in a potential vaccine or medicine’s safety and efficacy.”
Pfizer and Valneva are “committed to collecting robust data” in order to achieve regulatory submission of VLA15, the candidate in investigation. As we have previously explored, strong immunogenicity data were reported from Phase II studies.
We will hear more from representatives of Pfizer and Valneva at the Congress in Washington this April, as well as specific sessions on improving clinical trial procedures and outcomes.