new vaccine research

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• NEWS FEATURE
• 18 May 2023

The next next-gen vaccines

• Mark Zipkin 0

Mark Zipkin is a freelance writer covering the pharmaceutical and biotech industries.

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By all accounts, the pandemic response was remarkable. Hundreds of vaccine candidates based on a wide range of traditional and novel technologies were investigated at exceptional speed, and one of the novel technologies—mRNA vaccines—became established as a key tool to combat COVID-19.

But the approved mRNA vaccines are not without limitations. Last year, the vaccine development foundation Coalition for Epidemic Preparedness Innovations (CEPI) launched a call for proposals seeking innovative RNA platforms that could offer improvements over existing mRNA vaccine technology.

“What we’re looking for are high-impact innovations that potentially could be used for next-generation RNA platforms—things that would maybe improve on some of the characteristics of the current RNA vaccines, which obviously made huge strides,” said In-Kyu Yoon, CEPI’s director and global head of programs and innovative technology. Yoon pointed to a range of characteristics with room for improvement, such as the balance between immunogenicity and reactogenicity, the thermostability profile, and cost.

Then, in April 2023, the Biden administration announced Project Next Gen, the $5 billion successor to Operation Warp Speed, charged with coaxing development of COVID-19 vaccines that would improve on today’s approved vaccine in three areas: durability, effectiveness against new variants, and ability to block transmission. It’s a clear sign that public health bodies recognize that available vaccines are not optimal, said Ji Li, who is co-founder, president and CEO of vaccine developer Uvax Bio.

A month later, the United States Food and Drug Administration (FDA) approved GSK’s Arexvy, the first respiratory syncytial virus (RSV) vaccine. The RSV vaccine relies on advances in structural biology, and adjuvants that took more than three decades to develop, said Philippe Denoël, head of external research and development GSK Vaccines. The various technologies deployed for recently approved vaccines highlight the value of pursuing novel approaches.

mRNA technologies

The relative success of mRNA-based vaccines has energized groups seeking to improve on the technology.

One commonly overlooked distinction between mRNA and more traditional technologies is that mRNA itself is not actually a vaccine—it effectively turns human cells into vaccine factories by inducing them to produce viral antigens. That means it has to be delivered into cells, which to date has been through lipid nanoparticles (LNPs), artificial shells that house the fragile mRNA molecules and transport them across cell membranes.

LNPs, however, are imperfect taxis. For one, they are suspected to play a role in vaccine reactogenicity, resulting in inflammatory responses that lead to both local side effects like pain or swelling, and systemic side effects including fever.

As such, several groups are developing alternative vehicles that can carry mRNA without the side effects. In January 2023, CEPI announced the first grant from its calls for proposals, choosing Tiba Biotech’s polymer nanoparticle technology. Beyond reduced reactogenicity, Yoon cited several potential advantages of polymer nanoparticles over LNPs, including increased RNA payload capacity and even thermostability—“ultra-cold storage is a feature of the currently licensed mRNA vaccines.” The $2 million CEPI grant will support preclinical research for Tiba’s polymer nanotechnology.

Meanwhile, Moderna announced a partnership in April 2023 with IBM that aims to utilize artificial intelligence and quantum computing to optimize LNPs for both safety and performance.

Denoël also noted that there are opportunities to improve activity once mRNA has reached a cell, using bioinformatics tools. “There are new technologies that allow us to really optimize your mRNA sequence—for higher expression levels, and to lower any undesired natural response of the host cell, such as interferon responses,” he said. In addition, synthetic biology companies are developing DNA templates that could make the production of mRNA even faster in response to emerging pathogens.

Another approach to improving intracellular activity is self-amplifying RNA, where a vaccine encodes not only a viral antigen but also the RNA itself. The result is more antigens produced over a longer period, with less vaccine required. A self-replicating mRNA vaccine for COVID-19 from Gennova Biopharmaceuticals has been approved under emergency use authorization in India. And Yoon notes there are groups developing circular RNA, with similarly long-lasting transcription within the cell.

Learning from nature

Beyond mRNA, several novel technologies are seeking to expand what’s worked for approved vaccines, often harnessing naturally occurring elements to trigger immune responses.

One new approach that does both is a self-assembling protein nanoparticle platform developed by researchers at the Scripps Research Institute. In April 2023, researchers led by senior author Jiang Zhu, associate professor in the Department of Integrative Structural and Computational Biology at Scripps, published positive preclinical data in Nature Communications ( Nat. Comms. 14 , 1985; 2023) for a human immunodeficiency virus (HIV) vaccine candidate based on the platform.

Zhu—who spun out the technology to form Uvax Bio—was inspired by the virus-like particle (VLP) vaccine that produced a highly successful human papillomavirus (HPV) vaccine. “Our intention is to mimic the most successful vaccine on the market,” said Zhu. He added that protein-based vaccines are known for producing a more robust neutralizing antibody response than nucleic acid-based vaccines. The goal, he said, is “one shot, protection for life.”

HPV vaccines resemble hollowed-out papillomaviruses, sharing a self-assembling protein-based outer capsid but having no genetic information inside. And they are highly immunogenic; 98% of recipients develop antibody responses. But the approach has not been broadly repeatable because, unlike papillomaviruses, many pathogenic viruses are protected by an outer lipid envelope.

Zhu developed protein nanoparticles that resembled the HPV shell and that could display multiple copies of HIV’s envelope glycoprotein, inducing a strong immune response in preclinical testing. Because optimized antigens can easily be swapped into the VLP, Uvax Bio has an early pipeline including the HIV program and 11 other enveloped viruses, as well as one for tuberculosis. With backing from the US National Institutes of Health, Uvax is on track to launch its first clinical trial with its HIV vaccine candidate next year.

There’s a clear logic to mimicking pathogens in order to trigger immunogenicity. Another such approach is generalized modules for membrane antigens (GMMA), which are modified versions of vesicles naturally produced from the outer membranes of Gram-negative bacteria. “Those vesicles contain surface antigens in a native context,” said Denoël. “And they are presented this way to the immune system, like bacteria would present those surface antigens to the immune system.”

As with VLPs, the vesicles contain no genetic material. They are produced by bacteria engineered to express a high proportion of multiple selected antigens. “It’s really a key technology for bacterial vaccines development,” said Denoël.

GSK has three ongoing clinical GMMA programs for vaccines against Shigella, Salmonella and Neisseria gonorrhoeae . Denoël said the simplicity of development and relatively low manufacturing costs leave room to grow additional programs for bacterial pathogens with global health implications.

GSK is one of several companies exploring bacterial outer membrane vesicles or other vesicles, such as human cell-based exosomes, as vaccines. Last year, CEPI funded a program to advance the development of vaccines that provide broad protection against SARS-CoV-2 and other coronaviruses using Codiak BioSciences’ exosome platform, although the company has since declared bankruptcy. And in April 2023, Capricor Therapeutics published preclinical data in Microbiology Spectrum showing promise for its exosome-based approach to a COVID-19 vaccine.

One advantage shared across the variety of novel platform technologies is the ability to display multiple antigens. It reflects a recognition that the focus on just a single antigen—like the spike glycoprotein for COVID-19 vaccines—does not make for an ideal vaccine.

Scratching the surface

A surprising limitation of the traditional vaccine paradigm is the injection, which bypasses several immune functions that could be harnessed to improve efficacy.

In this regard, some groups have explored delivery options to mucosa in the respiratory tract or gut, which are promising approaches given that these are common ports of entry for pathogens. “We believe that it’s essential to induce mucosal protective immune response locally, really at the site of the infection or the site of colonization,” said Denoël. He added that the industry is beginning to recognize which molecules are likely to induce the right mucosal immune response.

“We are interested in the mucosal approach, especially in terms of its potential for transmission blocking,” said Yoon, who added that CEPI’s portfolio includes intranasal and orally dissolved vaccine candidates. But these platforms face additional regulatory hurdles: “The usual immune marker correlates that might be relevant for systemically administered vaccines may be less relevant when it comes to the markers for mucosal immunity,” he added.

In December 2022, a nasal vaccine against SARS-CoV-2 from Bharat Biotech International received emergency use authorization in India for people aged over 18.

Another often overlooked part of the immune system is the skin, said David Hoey, CEO of vaccine patch-developer Vaxxas. “If they knew at the start of vaccines that most of the immune cells [can be found] in the skin, they would never have wanted to inject.”

Vaxxas has developed a needle-free, high-density microarray patch (HD-MAP) platform. The patch is applied to the skin for about ten seconds, delivering vaccine beneath the surface via thousands of coated microprojections. The goal is to reach dendritic cells, which Hoey expects to route the vaccine more directly to the lymphatic system, than intramuscular injections.

One potential advantage is that a lower quantity of vaccine is required—efficiency that could be crucial in a pandemic response. To that end, CEPI announced a $4.3 million partnership with Vaxxas this year, which will determine the potential for delivering heat-stable, dried-formulation mRNA vaccines through the HD-MAP. But unlike mucosa-based approaches, Vaxxas’ platform is agnostic to the vaccine type. “If you think of it conceptually as an insulin syringe, it doesn’t care what the antigen is,” said Hoey. The patch technology has been demonstrated safe in three phase 1 clinical trials, with two more ongoing.

Recent developments in vaccine technology look promising and continue to advance, though it is yet to be seen which novel approach makes its impact globally, as others have before.

doi: https://doi.org/10.1038/d43747-023-00035-x

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Vaccine Research & Development

How can covid-19 vaccine development be done quickly and safely, typical vaccine development timeline.

• Each clinical trial phase follows completion of the prior phase
• Can take a long time to accumulate cases to assess vaccine efficacy outside pandemic
• Manufacturing capacity is scaled-up after phase III trial and regulatory approval

Accelerated timeline in a pandemic

• Some clinical trial phases are combined
• Cases accumulate rapidly to assess vaccine efficacy because of the pandemic
• Manufacturing capacity is scaled up during the clinical trials but at financial risk

Typical Timeline

A typical vaccine development timeline takes 5 to 10 years, and sometimes longer, to assess whether the vaccine is safe and efficacious in clinical trials, complete the regulatory approval processes, and manufacture sufficient quantity of vaccine doses for widespread distribution.

to the Accelerated Timeline

Preclinical Trials

Preclinical testing of vaccine candidates typically starts in animal models, first in small mammals such as mice or rats and then non-human primates such as monkeys. Preclinical studies are important for eliminating potential vaccines that are either toxic or do not induce protective immune responses. But many vaccines that appear to be safe and induce protective immune responses in animals fail in human studies. Only vaccine candidates that are very promising in preclinical testing move forward into phase I clinical trials.

Phase I Clinical Trials to Assess Safety, Dosing, and Immune Responses

Phase I clinical trials are the first step in assessing vaccines in people. Typically involving one to several dozen healthy volunteers, phase I trials assess short-term safety (e.g., soreness at the site of injection, fever, muscle aches) and immune responses, often with different vaccine dosages. Only if a vaccine candidate is shown to be safe in phase I trials will it move to larger phase II trials.

Phase 1 trials can be completed in two to three months, allowing for two doses of a vaccine three to four weeks apart

Phase II Clinical Trials to Assess Safety and Immune Responses

Phase II clinical trials continue to assess safety and immune responses but in a larger number and more diverse group of volunteers, typically one to several hundred people. Phase II trials may include target populations of a specific age or sex, or those with underlying medical conditions. Vaccines for children start with adult volunteers and move to progressively younger groups of children. Different types of immune responses are often measured, including antibodies and cell-mediated immunity, but phase II trials do not assess how well a vaccine actually works. Only in phase III trials is vaccine efficacy assessed.

Phase 2 trials can be completed in three to four months, allowing for longer follow-up to better assess safety and immunogenicity. This timeline is shortened when phase 1 and phase 2 trials are combined.

Phase III Clinical Trials to Assess Safety and Efficacy

Phase III clinical trials are critical to understanding whether vaccines are safe and effective. Phase III trials often include tens of thousands of volunteers. Participants are chosen at random to receive the vaccine or a placebo. In Phase III, participants and most of the study investigators do not know who has received the vaccine and who received the placebo. Participants are then followed to see how many in each group get the disease. Assessing short- and long-term safety is also a major goal of phase 3 trials.

Phase 3 trials may take six to nine months to allow early assessment of safety and efficacy, particularly if conducted in areas with a high risk of infection, but with follow-up continuing for two years or more to assess long-term safety and efficacy.

Regulatory Approval Process

Each country has a regulatory approval process for vaccines. In the United States, the Food and Drug Administration (FDA) is responsible for regulating vaccines. In situations when there is good scientific reason to believe that a vaccine is safe and is likely to prevent disease, the FDA may authorize its use through an Emergency Use Authorization (EAU) even if definitive proof of the efficacy of the vaccine is not known, especially for diseases that cause high mortality.

Scaling Up Vaccine Manufacturing

Scaling up vaccine manufacturing is typically done near the end of the regulatory process because of the huge financial investment needed. In the United States, the FDA will inspect the manufacturing facilities. The cost of developing a new vaccine can be several billion U.S. dollars prior to the scale up of manufacturing facilities.

Post-Licensure Vaccine Safety Monitoring

After a vaccine is approved and in widespread use, it is critically important to continue to monitor vaccine safety. Some very rare side effects may only be detectable when large numbers of people have been vaccinated. Safety concerns that are discovered at this late stage could lead a licensed vaccine to be withdrawn from use, although this is very rare.

New vaccine effective against coronaviruses that haven't even emerged yet

Researchers have developed a new vaccine technology that has been shown in mice to provide protection against a broad range of coronaviruses with potential for future disease outbreaks -- including ones we don't even know about.

This is a new approach to vaccine development called 'proactive vaccinology', where scientists build a vaccine before the disease-causing pathogen even emerges.

The new vaccine works by training the body's immune system to recognise specific regions of eight different coronaviruses, including SARS-CoV-1, SARS-CoV-2, and several that are currently circulating in bats and have potential to jump to humans and cause a pandemic.

Key to its effectiveness is that the specific virus regions the vaccine targets also appear in many related coronaviruses. By training the immune system to attack these regions, it gives protection against other coronaviruses not represented in the vaccine -- including ones that haven't even been identified yet.

For example, the new vaccine does not include the SARS-CoV-1 coronavirus, which caused the 2003 SARS outbreak, yet it still induces an immune response to that virus.

"Our focus is to create a vaccine that will protect us against the next coronavirus pandemic, and have it ready before the pandemic has even started," said Rory Hills, a graduate researcher in the University of Cambridge's Department of Pharmacology and first author of the report.

He added: "We've created a vaccine that provides protection against a broad range of different coronaviruses -- including ones we don't even know about yet."

The results are published today in the journal Nature Nanotechnology .

"We don't have to wait for new coronaviruses to emerge. We know enough about coronaviruses, and different immune responses to them, that we can get going with building protective vaccines against unknown coronaviruses now," said Professor Mark Howarth in the University of Cambridge's Department of Pharmacology, senior author of the report.

He added: "Scientists did a great job in quickly producing an extremely effective COVID vaccine during the last pandemic, but the world still had a massive crisis with a huge number of deaths. We need to work out how we can do even better than that in the future, and a powerful component of that is starting to build the vaccines in advance."

The new 'Quartet Nanocage' vaccine is based on a structure called a nanoparticle -- a ball of proteins held together by incredibly strong interactions. Chains of different viral antigens are attached to this nanoparticle using a novel 'protein superglue'. Multiple antigens are included in these chains, which trains the immune system to target specific regions shared across a broad range of coronaviruses.

This study demonstrated that the new vaccine raises a broad immune response, even in mice that were pre-immunised with SARS-CoV-2.

The new vaccine is much simpler in design than other broadly protective vaccines currently in development, which the researchers say should accelerate its route into clinical trials.

The underlying technology they have developed also has potential for use in vaccine development to protect against many other health challenges.

The work involved a collaboration between scientists at the University of Cambridge, the University of Oxford, and Caltech. It improves on previous work, by the Oxford and Caltech groups,to develop a novel all-in-one vaccine against coronavirus threats. The vaccine developed by Oxford and Caltech should enter Phase 1 clinical trials in early 2025, but its complex nature makes it challenging to manufacture which could limit large-scale production.

Conventional vaccines include a single antigen to train the immune system to target a single specific virus. This may not protect against a diverse range of existing coronaviruses, or against pathogens that are newly emerging.

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Story Source:

Materials provided by University of Cambridge . The original text of this story is licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License . Note: Content may be edited for style and length.

Journal Reference :

• Rory A. Hills, Tiong Kit Tan, Alexander A. Cohen, Jennifer R. Keeffe, Anthony H. Keeble, Priyanthi N. P. Gnanapragasam, Kaya N. Storm, Annie V. Rorick, Anthony P. West, Michelle L. Hill, Sai Liu, Javier Gilbert-Jaramillo, Madeeha Afzal, Amy Napier, Gabrielle Admans, William S. James, Pamela J. Bjorkman, Alain R. Townsend, Mark R. Howarth. Proactive vaccination using multiviral Quartet Nanocages to elicit broad anti-coronavirus responses . Nature Nanotechnology , 2024; DOI: 10.1038/s41565-024-01655-9

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Game Changers: 5 Global Vaccine Innovations on the Horizon

The world fell behind on immunizations during COVID. Now it’s time to play catch-up and, with some new breakthroughs, really move the needle on preventing disease and deaths.

Lindsay Smith Rogers

“The Big Catch-Up,” the theme of this year’s World Immunization Week (April 24-30), is both a reference to the state of global immunizations following the acute phase of the COVID-19 pandemic and a call to action.

The annual observance “comes at a critical time” said William J. Moss, MD, MPH , moderator of a recent panel on potentially game-changing vaccine developments in honor of WIW. Because of COVID-19, “[immunization] levels decreased in more than 100 countries with millions of children missing out on lifesaving protection … It’s critical that we restore immunization services.” 

The pandemic also made possible the potential for real innovation in terms of the technology, evaluation, and speed with which vaccines come to the market, Moss pointed out. 

It’s a good time to take stock. In the webinar, five public health experts presented exciting advances in the world of vaccines—some of which could help facilitate “The Big Catch-Up,” and perhaps even leapfrog the field beyond the previous status quo. These include microarray patches and new advances in much-needed vaccines for malaria, RSV, tuberculosis, and Shigella . There’s also interplay between these advances: As we learned with COVID, breakthroughs in vaccines for one disease can lend knowledge and problem solving to others. 

INNOVATION 1: Microarray Patches Could Deliver Vaccines Virtually Anywhere

Microarray patches have “the potential to revolutionize accessibility,” said Birgitte Giersing, PhD, who leads the Vaccine Prioritisation and Platform work within the WHO’s Immunization Department. 

In LMICs, which are disproportionately affected by many vaccine-preventable diseases, both cost and logistics present considerable challenges to immunization programs. More than half of the price tag required to vaccinate a child is “generated in the last mile,” Giersing said. That’s due to the costs of shipping and storing vaccines at cold temperatures upon arrival, then the mixing and administration by a registered health professional in a clinical setting. Then there are the logistics of actually getting shots into arms, which can be challenging in remote locations where health care might not be accessible. 

Microarray patches, or MAPs, are coin-sized patches covered either with tiny needles coated in dry vaccine that painlessly penetrate the skin or a formula that dissolves when the patch is pressed onto the skin for 2-5 minutes. These patches don’t require cold temperatures, weigh significantly less than vials requiring needles and syringes, don’t require any mixing, and can be given by untrained community health workers in almost any conditions. Plus, there’s a needle-free advantage of painless delivery, upping the odds that people will get all of the vaccinations they need. 

Importantly: although MAP vaccines would be more expensive to purchase up front than needle-and-syringe vaccines, said Giersing, the overall price tag would be lowered by eliminating many of the costlier factors of that “last mile.” 

There are currently two MAP’s in the market pipeline: one for measles and one for rubella. Two important next steps, Giersing said, are to evaluate where and in what circumstances MAPs would most likely be used—i.e., for routine, seasonal, or other kinds of immunizations and in what countries or settings—and then leverage those use cases to spur commercial partnerships between vaccine manufacturers and MAP developers. 

Ultimately, “the public health and socioeconomic impacts of vaccinating groups you couldn’t previously reach” can’t be ignored, said Giersing, and there’s high interest in many lower- and middle-income countries. Ethiopia, for example, is looking for “a full switch from needle-and-syringe for routine immunizations,” and it’s likely other countries may follow suit.

INNOVATION 2: Two Shelf-Stable Malaria Vaccines

Researchers have been trying to develop a malaria vaccine for over 100 years, but “it’s been pretty tough,” said Sir Adrian Hill, director of the Jenner Institute at Oxford University. “You need exceptionally high titers of antibodies to protect against any stage of the parasite’s life cycle,” which is hard to achieve. 

Two vaccines are now showing promise, however: RTS,S and R21/Matrix-M, both of which target a specific protein on the malaria parasite. Although both require four doses to achieve the immune response needed to fight off an infection, the vaccines showed efficacy of 67-75% in adults and up to 80% in children aged 5 to 17 months. Both have met safety standards and vaccinated people maintained good antibody levels for more than two years after the primary series. 

Even better: RTS,S and R21/MM don’t require sub-zero storage temperatures. R21/MM, in particular, has a long shelf life, comes in a single vial that doesn’t need to be mixed, and can withstand temperatures up to 104°F for two weeks, making it extremely portable in countries where malaria is endemic. 

Ghana and Nigeria have both approved the vaccine for use in children aged 5 months to 3 years, and in 2021 the WHO recommended RTS,S to all children under two in sub-Saharan Africa .

INNOVATION 3: RSV Vaccines Could Put a Major Dent in Global Hospitalizations

“2023 is the year of RSV,” Ruth Karron, MD , professor in International Health said, in terms of licensure and, hopefully, deployment of new products. 

As we saw this past winter, RSV poses a significant threat to very young children and elderly adults in every country in the world, but the majority of hospitalizations and deaths occur in LMICs where care options may be limited at best and first come, first served at worst. 

There are currently three strategies to mitigate RSV:

• Passive immunization, which involves vaccinating pregnant women so they can pass on antibodies to the fetus. 
• “Immunization” of infants with a single dose of monoclonal antibodies.
• Live attenuated or mRNA vaccines for infants, toddlers, and older adults.

There are advancements across all three. 

The maternal RSVpreF vaccine from Pfizer, which was given to pregnant women at 24-36 weeks’ gestation during Phase III clinical trials, saw 70-80% protection against severe disease for infants up to 6 months after birth. 

Two monoclonals, nirsevimab and clesrovimab, in late-stage development show “high efficacy against all endpoints,” Karron said, which includes lower-respiratory tract infections, hospitalizations, and deaths. Both have been submitted to the FDA, and it’s anticipated that the new products will be on the market by the end of 2023.

Several vaccine candidates for the young and elderly passed Phase 3 clinical trials, and two have applied for licensure from the FDA which has already given favorable reviews. 

But there are challenges with uptake to consider: Maternal vaccination rates in the U.S. for flu and TDAP are already abysmal, so it’s unclear what the demand would be for an RSV vaccine. Deployment strategies could get more bang for the buck by targeting countries where there are often severe shortages of hospital beds for children during RSV/respiratory virus seasons.  

INNOVATION FOUR: A Slow Process for a New TB Vaccine Creates Opportunities to Build Demand Ahead of Time

The WHO’s End TB Strategy calls for reducing new cases by 80% and deaths by 90% before 2030 , said Rupali Limaye, PhD, MPH , an associate scientist in International Health with joint appointments in Health, Behavior and Society and Epidemiology . If there’s not enough investment in new treatments and vaccines to meet these targets, she said, we could see 43 million people develop TB and 6.6 million die by then, totaling $1 trillion in economic costs. 

There’s currently one TB vaccine on the market—bacile Calmette-Guerin, or BCG—a live, attenuated (weakened) vaccine with so-so efficacy (18% against infection, and a 75% reduction in deaths but only through age 15) and limited use, as it’s not safe for those with HIV—a key population of people at risk of TB.

A lackluster vaccine won’t move the needle towards ending TB but there are significant challenges inherent to cooking up a new TB vaccine. One is that there’s limited knowledge about the human protective immune response to TB. Another is a lack of animal models that can accurately predict how humans may respond, which significantly hampers a critical step in vaccine development. Other challenges include a lack of clear correlates that relate to protection (for example, the presence of a specific titer in the blood that can indicate higher immunity levels), the need for large and expensive trials to do all of this work, and a disproportionate lack of funding priority from international groups despite TB’s incredible burden. 

A TB vaccine pipeline with several candidates in Phase III clinical trials does exist. That process is slow and it’s unlikely we’ll see a new TB vaccine brought to market this year, Limaye said, but this offers another opportunity to start building demand.

“Vaccines do not save lives, vaccinations do,” Limaye said, and now is an opportune time to restore trust in vaccines and apply lessons learned from the COVID-19 vaccine rollouts during the pandemic. While waiting for a TB vaccine to come to market, there’s time to collect and evaluate data around misinformation, mistrust in science, and look at what makes for successful vaccine campaigns. 

“Behavioral and social data collection is important to help prepare countries so once a vaccine is available people are interested in/able to access it.”

INNOVATION FIVE: Considering Dual Markets for Shigella Vaccines

Shigella is the second leading cause of diarrheal deaths worldwide and the most common bacterial cause of moderate-to-severe diarrhea in children under 5, said Kawsar Talaat, MD , an associate professor in International Health and co-director of clinical research at the Johns Hopkins Institute for Vaccine Safety . In addition to huge numbers of infections in children in LMICs, Shigella infects travelers and is “a significant antimicrobial threat” all over the world, making it an excellent candidate for vaccine development.

It’s been nearly 100 years since the first attempts at Shigella vaccines. A few things have stood in the way: first, the fact that Shigella vaccines must be “quadvalent,” or containing four different serotypes in order to protect against the majority of strains. Second, oral vaccines showed less efficacy in LMICs so needle-and-syringe vaccines would most likely be needed. Finally, many attempts have resulted in vaccines that cause too many side effects or aren’t effective, so there’s little incentive for manufacturers to invest time or money in creating a low-cost vaccine.

But there are some potential solutions, Talaat said. First, presenting a “dual market” for the vaccines to include children in LMICs and travelers from higher-income countries to those same LMICs. Travelers could pay more for the vaccine which might offset costs for children. Another idea is to create a combination vaccine that protects against other diarrheal diseases that could work for both populations in a dual-market solution.

With these in mind, Talaat said, there are some promising candidates in clinical trials and she hopes there will be something brought to market in the next five to 10 years.

Bottom Line: Vaccine Innovations Save Lives

New methods of delivery, shelf-stable formulas, consideration of benefits of a vaccine campaign beyond preventing disease in an individual, creating robust communications to build vaccine demand, and tapping into new and innovative markets can all build global momentum towards better immunization coverage.

“We’re looking towards the future where we can protect millions of more lives from malaria, TB, RSV, and Shigella,” Moss concluded.

Lindsay Smith Rogers, MA, is the producer of the Public Health On Call podcast , an editor for Expert Insights , and the director of content strategy for the Johns Hopkins Bloomberg School of Public Health. 

• World Immunization Week: Preventing a Global Measles Outbreak
• How Human Challenge Trials Accelerate Vaccine Development
• The Deciding Decade for Infectious Disease

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Researchers Discuss New Vaccine That Could Prevent Future Pandemics

On Monday, two key researchers on the vaccine development project spoke with reporters

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A new vaccine under development at Duke University has the potential to protect against a broad variety of coronavirus infections that move from animals to humans, now and in the future.

The new vaccine – called a pan-coronavirus vaccine - has been 100 percent effective in non-human tests including testing on primates. Success in primates is very relevant to humans.

On Monday, two key researchers on the vaccine development project spoke with reporters about their findings thus far and their hopes that this vaccine could eventually give a dramatic boost to the current vaccines combatting COVID-19.

Watch the briefing on YouTube .

Here are excerpts:

Kevin Saunders, director of research, Duke Human Vaccine Institute

ON HOW THE NEW DUKE VACCINE WORKS

“What this vaccine does, it takes a small part of the virus, the part of the virus that attaches to the cells, and it presents multiple copies of that to the immune system. That allows the immune system to focus a response against that part of the virus, preventing the virus from being able to attach to cells, and hopefully preventing subsequent infection.”

“What we found in this study is that we got antibodies -- this is the part of the immune system that can attach to viruses and prevent infection -- we got that part of the immune system stimulated such that it was able to bind to not only SARS-CoV-2, but also to coronaviruses that circulate in animals.”

Dr. Bart Haynes, director, Duke Human Vaccine Institute

“We’ve worked for the past almost 20 years now … to develop an HIV vaccine. ... When the epidemic broke in early 2020 in the United States, we asked, ‘What could we do that would help Operation Warp Speed and the already five or six vaccine developers that the government was funding?”

“We knew the SARS-CoV-2 virus was an RNA virus – that means the kind of genetic material it uses – and has the same kind of genetic material the HIV virus uses. The HIV virus is one of the most rapidly evolving life forms that we know, because RNA viruses tend to make mistakes as they replicate. And we knew the SARS-CoV-2 virus would also develop mutants that would escape our immune system as our immune system made antibodies against it.”

“We decided to (shift) all these years of work from HIV to the coronavirus vaccine work and work on vaccines that would be useful as boosters in case we need it to make the immune response stronger. We are now discussing these kinds of possibilities for boosting the existing vaccines.”

“And secondly, for dealing with … variants of the SARS-CoV-2 that would evolve.”

“And then third, now is the time to plan for the next coronavirus pandemic or outbreak. We’ve had two major outbreaks before COVID-19, one in 2003, the SARS outbreak, and one in 2011, the MERS outbreak. Both coronaviruses. And certainly we expect others. So now is the time to provide the vaccine that will prepare for those.”

ON MOVING TO HUMAN TRIALS

“We’re concerned that the antibody response is not going to be long-lived enough so that we’ll never have to be boosted again. We’re expecting that in one year or two years, there’s a good chance the population of the United States will have to be boosted again. We’re working to get this particular vaccine candidate made … so it can be put into humans in what’s called a phase 1 safety trial and get it through that trial as quickly as possible.”

ON A VACCINE MAKING MULTIPLE COPIES OF CELLS

“Our immune cells are actually engineered to be able to see multiple copies. So they respond well to things like viruses because the viruses have multiple copies of the thing they’re looking for.”

“It’s very similar to Velcro. If you think of one hook and loop, that’s a pretty weak interaction. But if you can put one hook and loop together multiple times with multiple copies, that becomes a really strong interaction. By doing that with our nanoparticle platform, and interacting with the immune cell, we believe we can get a better activation of the immune system and hopefully generate a better response.”

ON THE EXCITEMENT OF VACCINE DISCOVERY

“The spotlight is on vaccine development right now. People who were not necessarily focused on what we did before this pandemic are really paying attention to it. It’s a great time to talk about science and careers in science. There’s just been an eye opening to the field in general.”

“From a scientific standpoint, we’ve seen a lot of achievements and a lot of milestones reached that we probably would have never thought were possible. To move a vaccine so quickly through phase 1 and phase 2 and phase 3 testing and make it into emergency use over the short period of time it took … was unprecedented. To be able to make that many doses that quickly is also unprecedented. There’s been some advances in technology and some advances in how the clinical trials were conducted that really changed the way the vaccine development field has moved.”

“This has been an incredibly exciting time. This is what we do.”

“Our job is to prepare for pandemics. We’re already preparing for what might be the next pandemic. One of the ones we’re very concerned about is the bird flu, or avian flu … which has the capability but hasn’t completely jumped to humans.”

“Whether it’s another coronavirus … or with influenza or yet another type of outbreak, that’s what the vaccine institute is here for. It’s a very exciting time.”

ON GOVERNMENT FUNDING AND INTEREST

“The NIH is very concerned about this issue and preparing for the next pandemic. We’ve had two pandemics before, SARS and MERS, over the last 20 years. And vaccines were made but those epidemics died out before they got to the pandemic stage, and interest in moving those vaccines stopped. I think we’ve all learned now with this particular pandemic that now is the time to prepare for the next time so we can have vaccines on the shelf or vaccines that can be developed very rapidly and deployed very rapidly.”

ON WHETHER PANDEMICS ARE GETTING WORSE

“I don’t have any evidence the next coronavirus pandemic will be the same or worse than SARS-CoV-2. I think hopefully we will have monitoring in place to quarantine and hopefully control outbreaks a little bit better so they don’t become pandemics. Given our current experience, hopefully there will be some measures put in place.”

“I’m hopeful we’ll have measures that would be able to prevent another pandemic while the vaccines … are being made. But I don’t have any evidence the virus is becoming easier to spread, or more transmissible, or more virulent.”

ON A BEST-CASE TIMELINE FOR THE NEW VACCINE

“We’re working hard to get the material made. The limiting factor is getting the material made in what’s called ‘good manufacturing practice conditions’ to make it safe for putting it into humans. The bottom line is we’re trying to get this made as soon as possible so it can have some sort of positive impact in the current epidemic/pandemic while we’re waiting on figuring out if we’ll be able to use it as a booster, and if a booster is going to be needed.”

The experts:

Dr. Bart Haynes Dr. Bart Haynes  is a professor of medicine and immunology at the Duke School of Medicine and director of the Duke Human Vaccine Institute. His research focuses on immunology, retrovirology and HIV vaccine development.

Kevin Saunders Kevin Saunders is an associate professor of surgery at the Duke University School of Medicine. He is also director of research at the Duke Human Vaccine Institute, where he oversees the design of proteins used in vaccines.

Duke experts on a variety of topics can be found here.

Follow Duke News on Twitter: @DukeNews

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Beyond the pandemic: The next chapter of innovation in vaccines

Vaccines are vital to global health, saving millions of lives each year. The COVID-19 pandemic underscored their importance, with more than 20 million lives saved in the first year of vaccine deployment alone. This achievement was fueled by an unprecedented acceleration in innovation, with multiple COVID-19 vaccine candidates developed and launched within roughly one year, a process that has historically taken a decade on average.

About the authors

This article is a collaborative effort by Adam Sabow , Jennifer Heller , Michael Conway , and  Rosa Poetes , with Elizabeth Rowland and Jen DeBerardinis, representing views from McKinsey’s Life Sciences Practice.

This level of activity was dramatically different from what we saw in our 2019 analysis , which revealed signs that the vaccine innovation engine had begun to sputter. While the two decades preceding the pandemic saw strong growth in the vaccine industry—with pipelines doubling and annual growth rates of 12 to 15 percent—we identified four indicators of stagnation in 2019: slowing revenue growth (only 5 percent across the industry over the previous five years), a flattening development pipeline, higher attrition rates for vaccines compared with other biologics, and limited progress targeting disease areas of high unmet need, particularly those endemic to low- and middle-income countries (LMICs).

At that time, we highlighted opportunities to reinvigorate vaccine innovation across six major vaccine archetypes (Exhibit 1) by addressing commercial and technical obstacles and advocated for a comprehensive and shared approach among the relevant stakeholders, including manufacturers, governments, academia, research centers, and the private sector. Some of these strategies proved instrumental to the rapid development of the COVID-19 vaccines.

Now, roughly three years after the surge of innovation spurred by the pandemic, the vaccine industry faces another critical juncture. Despite accelerated vaccine innovation for certain diseases, progress remains uneven, and significant unmet needs persist. This article explores how the pandemic transformed the business case for vaccines. It proposes five actions the vaccine ecosystem can take to harness the pandemic-driven momentum to accelerate vaccine innovation more broadly and to tackle global health challenges more effectively.

Progress (and unmet needs) across the postpandemic vaccine landscape

The rapid development of COVID-19 vaccines was propelled by multiple factors, including enhanced funding, operational efficiency, technological advancements, and regulatory flexibility. The COVID-19 innovation model has spurred advancements in other areas, particularly in respiratory diseases, which saw ten launches in the United States alone from 2020 to 2023 (up from three between 2016 and 2019). 1 Vaccines licensed for use in the United States, US Food and Drug Administration, updated on December 1, 2023. In the past several years, multiple vaccines targeting diseases that primarily affect LMICs, such as dengue and chikungunya, have also been approved by the US Food and Drug Administration (FDA). The vaccine development pipeline has also seen a rise in Phase III candidates (Exhibit 2), which include two meningitis vaccines, a possible human cytomegalovirus (CMV) vaccine, and a promising vaccine against invasive pneumococcal disease in adults.

The overall vaccine development timeline is also compressing (Exhibit 3). Although not as rapid as the unprecedented COVID-19 timeline, which was roughly one year, respiratory syncytial virus (RSV) vaccines have been developed within a three- to five-year time frame (the start of clinical development through regulatory approval), 2 Based on data from ClinicalTrials.gov, National Library of Medicine, accessed in April 2024. a pace significantly quicker than historical norms. Other vaccine types that are also moving relatively quickly through the clinical phases include Moderna’s messenger ribonucleic acid (mRNA) combination vaccine candidate for RSV and seasonal influenza, which is on a three- to four-year projected development timeline. 3 Based on data from ClinicalTrials.gov, National Library of Medicine, accessed in April 2024.

Despite these advances, progress has been uneven across different vaccine archetypes (Exhibit 4). 4 The archetypes have been slightly modified from the 2019 article to reflect market evolution. Multiple vaccines were launched in recent years that target residual unmet needs (archetype two) such as malaria, pneumonia, and meningitis, with additional late-stage candidates in the pipeline. However, few vaccine candidates for neglected diseases (archetype five) have progressed to late-stage clinical development. Vaccines for this disease archetype face high levels of commercial uncertainty as well as technical complexity, including difficulty in generating protective immunity.

Vaccines targeting persisting global threats (archetype three), including HIV and the Epstein–Barr virus, face technical challenges in identifying appropriate antigens and generating sufficient immune responses, especially for pathogens with complex life cycles. And although concerns about hospital-acquired antibiotic-resistant infections have piqued interest in nosocomial-associated threats (archetype six), efforts to develop vaccines for them have returned mixed results.

Some projects, such as an E. coli vaccine candidate, 5 “Press release: Sanofi announces agreement for potential first-in-class vaccine against extraintestinal pathogenic E. coli,” Sanofi, October 3, 2023. have moved into Phase III trials; others, including several C. difficile vaccine attempts, 6 Nick Paul Taylor, “Pfizer fails phase 3 C. diff vaccine test but still spies possible path forward,” Fierce Biotech, March 1, 2022. have not been successful. These initiatives also face commercial and logistical challenges, including uncertainties about how to identify the target demographic for vaccination and the optimal timing for vaccine administration.

Addressing disparities and accelerating vaccine development for these unmet needs remain crucial in the ongoing fight against infectious diseases. Overcoming technical challenges and streamlining the development process will be essential to closing the gaps in the vaccine development pipeline and ensuring worldwide equitable access to lifesaving vaccines.

How COVID-19 vaccine development changed the business case

The response to the COVID-19 pandemic strengthened the vaccine business case and led to a remarkable 30 percent increase in vaccine candidates over the past five years.

The development of vaccines targeting infectious diseases has historically been hindered by an unfavorable business case characterized by high capital costs, long regulatory timelines, increased opportunity costs, technical complexity, and commercial uncertainty. However, the response to the COVID-19 pandemic strengthened the vaccine business case and led to a remarkable 30 percent increase in vaccine candidates over the past five years (Exhibit 5). These changes to the business cases—which demonstrated what is possible when the right stakeholders work together to accelerate innovation—included the following:

• Clarity of commercial demand. Advanced purchase commitments by organizations—including the US Biomedical Advanced Research and Development Authority and the US Department of Defense, which collectively purchased $29 billion worth of COVID-19 vaccines between 2020 and 2022, and the public–private partnership (PPP) Gavi, which committed to raising $3.8 billion for the purchase of COVID-19 vaccines for 92 LMICs 7 “New partnership to help meet country demand for COVID-19 vaccines,” MedAccess, April 7, 2022. —provided demand clarity and reduced commercial uncertainty for COVID-19 vaccines.

Economic R&D and manufacturing incentives. Unprecedented levels of funding were also appropriated for vaccine R&D, including more than $2 billion each from the US federal government and the global PPP Coalition for Epidemic Preparedness Innovations (CEPI). Canada, Germany, and other public- and private-sector stakeholders worldwide also directly invested in expanding manufacturing capacity to reduce the financial risk of scaling up vaccine production. 8 “COVID-19 vaccine R&D investments,” Knowledge Portal on Innovation and Access to Medicines, European Commission, June 6, 2021.

Despite a substantial increase in public funding, it is important to note that private funding for infectious disease vaccine R&D still lags behind funding in other areas, with only 3.4 percent of the total venture capital raised for biopharmaceutical companies during the past ten years going to companies with infectious-disease-vaccine programs, compared with 38 percent for oncology programs. 9 David Thomas and Chad Wessel, The state of innovation in vaccines and prophylactic antibodies for infectious diseases , BIO, December 2023.

• Collaboration, data sharing, and early consultation on innovation design. The collaborative operating model between innovators and regulators included more frequent interactions, clarity on target product profiles and trial design, and a commitment to rapid-review timelines, all while prioritizing patient safety. This new operating model significantly reduced clinical trial risk and uncertainty for innovators, leading to faster development and authorization of COVID-19 vaccines.

Although the speed, magnitude, and cohesiveness of these responses are far more sustainable during a pandemic than in a “steady state” (noncrisis-related) vaccine development environment, they have given the industry a model for accelerating innovation.

Five actions for accelerating vaccine innovation beyond a crisis

The vaccine ecosystem now faces another inflection point: Will it revert to a state that is more susceptible to a challenging business case, or will it draw lessons from the pandemic and sustain or even accelerate the vaccine innovation momentum it ignited? The five actions detailed below (and outlined in Exhibit 6) aim to enhance the vaccine development landscape by addressing key drivers such as investment requirements, regulatory hurdles, and market uncertainties.

1. Expanding R&D and manufacturing partnerships: New collaboration models

The COVID-19 pandemic showed how alliances among companies, not for profits, academia, and governments can accelerate R&D and manufacturing. Several of the most quickly approved COVID-19 vaccines represented R&D partnerships among research institutes, academia, and industry, including the National Institutes of Health/Moderna and the University of Oxford/AstraZeneca collaborations.

In addition, broader collaborations such as the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) partnership brought together US federal agencies, innovators, academia, and others to develop a research strategy to accelerate the development of COVID-19 vaccines and therapeutics and coordinate clinical trials. Vaccine manufacturing partnerships and networks also grew significantly during the pandemic—more than 70 percent of the 374 manufacturing and supply chain announcements involved a collaboration among multiple stakeholders. 10 “First-of-its-kind event brings together 10 companies that partnered to deliver vaccines and treatments in response to COVID-19,” IFPMA, June 9, 2023.

There are signs that these types of partnerships will continue to grow in the coming years, particularly partnerships focused on rapid production of vaccines for future pandemics, such as the one CEPI is building in the Global South. 11 “CEPI invites vaccine developers and manufacturers to join global outbreak response network,” CEPI, April 6, 2022. Maintaining these partnerships beyond the pandemic context could lower capital costs and speed up production. However, new collaboration models are required to ensure rapid technology transfer with minimal risk and resource demands.

2. Enhancing commercial viability through global funding: New sources for vaccine development

The scale of COVID-19 funding is unrealistic for steady-state vaccine development and potentially even unnecessary for more commercially attractive “blockbuster” vaccines. However, targeted funding commitments can reduce investment risks and promote ongoing innovation, particularly for vaccine candidates aimed at diseases prevalent in LMICs. The ones set up by the Biomedical Advanced Research and Development Authority (BARDA) and Gavi could inspire the design of future funding mechanisms.

Even without the scale of COVID-19 investment, global funders and international institutions can boost the commercial appeal of vaccine development if they offer clear innovation funding incentives. For example, Gavi’s recently established African Vaccine Manufacturing Accelerator has committed to making $1 billion available to manufacturers at critical moments in the development process to offset their start-up costs and create demand certainty for vaccines that may be needed to prevent future pandemics.

3. Boosting vaccination rates: New ecosystem partnerships to create commercial demand

The pandemic demonstrated the potential for high vaccination rates among the adult population. Sustaining such levels will require coordinated efforts across the healthcare ecosystem to improve vaccine access, engage populations that are more vulnerable to certain diseases, and innovate delivery methods.

COVID-19 vaccination rates among adults who received first doses were historically high during the pandemic; conversely, the vaccination rates for subsequent booster doses have been in line with and, in some cases, lower than the rates for other adult vaccines. As of March 2024, fewer than 25 percent of eligible adults in the United States had received an updated 2023–24 COVID-19 vaccine since September 2023. 12 COVIDVaxView: Weekly COVID-19 vaccination dashboard, US Centers for Disease Control and Prevention, 2024. Despite the US Centers for Disease Control and Prevention’s recommended immunization schedule for adults, 13 “Recommended adult immunization schedule, United States, 2024,” Annals of Internal Medicine , January 2024, Volume 177, Number 2. adult immunization rates are consistently lower than those of children and vary significantly by geography and demography. 14 Routine vaccinations: Adult rates vary by vaccine type and other factors , US Government Accountability Office, October 17, 2022. Each year for the past decade, only 30 to 50 percent of mid-adults (18 to 64 years old) have gotten a seasonal influenza vaccine. 15 Flu vaccination coverage, United States, 2022-23 influenza season , US Centers for Disease Control and Prevention, October 10, 2023.

To help ensure the public health benefits and stabilize the commercial demand, the public sector, vaccine manufacturers, retail pharmacies, and other stakeholders could take the following coordinated and complementary actions:

• Gather better insights related to vaccination rates and drivers, with an aspiration to build COVID-19-level granular data on vaccination rates and demographics, as well as investments to regain vaccine confidence and build momentum.
• Use digital and nondigital tools to disseminate and clarify the immunization schedule for individuals, recognizing barriers to reach certain populations.
• Invest in novel strategies to identify target populations that are more vulnerable to certain diseases and engage them where they are, including employing trusted messengers.
• Maintain access to vaccines through new channels that were activated during the COVID-19 pandemic (for example, pharmacies and mobile clinics) to support more convenient delivery of new vaccines.
• Utilize innovator and funder investments in new delivery technologies that have the potential to increase people’s willingness to get vaccinated. For example, vaccine microarray patches (VMAPs) and vaccine pills, which can potentially increase vaccine adoption, will need to overcome significant hurdles to widespread availability, including production at commercial scale.

4. Investing in flexible manufacturing capabilities: New funding and incentives to derisk vaccine production

The COVID-19 pandemic highlighted the importance of fungible capacity to reduce bottlenecks to widespread vaccine availability. Transitioning toward flexible, multiproduct manufacturing can help ensure readiness for future pandemics and streamline production processes.

The historical model, in which most large vaccine manufacturing facilities specialize in a single product, may no longer be fully fit for purpose, particularly given the need to prepare for future pandemics. One example of fungible manufacturing is at-scale systems that either allow the production of multiple vaccine types on the same platform or can produce the same vaccine on various platforms. Such flexible technology platforms will be critical to avoid building excess capacity. They will also likely be most crucial in the shorter term, particularly in the context of pandemic preparedness.

However, the expense of flexible capacity will require new incentives and significant investment on behalf of funders and manufacturers. We are seeing some promising signs of innovation. For example, Sanofi’s Evolutive Vaccine Facilities platform is designed around a central unit housing several fully digital production modules, making it possible to produce three to four vaccines simultaneously. 16 “Sanofi invests to make France its world class center of excellence in vaccine research and production,” Sanofi press release, June 16, 2020. This modularity can make it possible to prioritize the production of a specific vaccine more quickly.

5. Advancing global regulatory alignment and regulator–innovator collaboration: Lessons from the COVID-19 pandemic

The COVID-19 pandemic highlighted the benefits of cooperation, communication, and collaboration between innovators and regulators, which could be integrated into regular practice for other diseases. For example, at a 2023 US Senate hearing, the FDA commissioner discussed a program from the Center for Biologics Evaluation and Research (CBER) devoted to emerging pathogens. The program would, among other things, expedite reviews, provide guidance to developers, leverage real-world data for product assessment, and support advanced manufacturing. 17 “Preparing for the next public health emergency: Reauthorizing the pandemic and all-hazards preparedness act: Testimony of Robert M. Califf,” US Committee on Health, Education, Labor and Pensions, May 4, 2023.

Initiatives launched before the pandemic can offer inspiration for the design of new vaccine-focused mechanisms. For example, the European Union’s PRIME initiative, launched in 2016, offers enhanced support for the development of therapies addressing unmet needs, including early contact with the European Medicines Agency and expedited scientific advice during development. The FDA’s Oncology Center of Excellence Real-Time Oncology Review (RTOR) program, launched in 2018, enables faster reviews by allowing submission of top-line efficacy and safety results for drug candidates likely to demonstrate substantial improvements or candidates with straightforward study designs. This allows for earlier identification of issues that may arise during development and helps regulators and innovators align on trial design.

Global regulatory cooperation can also accelerate vaccine innovation and streamline administrative processes. During the pandemic, forums such as the International Coalition of Medicines Regulatory Authorities formed COVID-19 working groups that rapidly accelerated vaccine development by establishing governing protocols, agreeing on approaches to adapt vaccines to address variants, and improving regulatory agility. Also, the WHO-backed African Vaccine Regulatory Forum introduced an emergency joint review process that led to an accelerated review turnaround. Working groups for other diseases could promote consistent standards and requirements, encouraging innovation and bolstering clinical trial efficiencies. Expanding regulatory measures such as accepting electronic files and conducting virtual inspections could also promote vaccine innovation.

In the meantime, innovators can consider assessing and improving the level of their “ submission excellence ,” or their ability to quickly prepare high-quality regulatory submissions, which can help boost the odds of first-cycle approval.

The COVID-19 pandemic ignited a revolution in vaccine development. Unprecedented speed and scale brought lifesaving vaccines to the world in record time. However, without concerted effort, the urgency that fueled innovation during the crisis could easily dissipate. The five actions outlined in this article provide a road map for sustaining the innovation surge and accelerating the development of lifesaving vaccines for the world’s most pressing health challenges. With collective action and unwavering commitment, stakeholders in the vaccine ecosystem can harness the lessons of the pandemic to spur transformative change and help secure a healthier future for all.

Adam Sabow is a senior partner in McKinsey’s Chicago office; Jennifer Heller is a partner in the Bay Area office; Michael Conway is a senior partner in the Philadelphia office, where Elizabeth Rowland is an associate partner; Rosa Poetes is a partner in the Zurich office; and Jen DeBerardinis is a consultant in the Boston office.

The authors wish to thank Jenna Benefield, Delaney Burns, Ying Chen, Mitch Cuddihy, and Jeff Morell for their contributions to this article.

This article was edited by Jermey Matthews, an editor in the Boston office.

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July 25, 2023

Research in Context: Progress toward universal vaccines

Preparing for the next pandemic before it starts.

This article, about the concept of universal vaccines, inaugurates a new periodic feature of NIH Research Matters called Research in Context . These in-depth articles will focus on cutting-edge NIH biomedical research topics, describing the current state of research in a field and where it may be heading.

In March 2020, the world changed in the blink of an eye as countries around the world locked down to slow the spread of COVID-19. This often deadly disease, caused by a previously unknown coronavirus called SARS-CoV-2, seeded outbreaks across the globe in record time. By the end of 2022, it had killed more than 6 million people worldwide.

But COVID-19 was far from humanity’s first pandemic. As recently as 15 years ago, an outbreak of pandemic flu sickened 60 million people globally. In 2003, a new disease called severe acute respiratory syndrome, or SARS, sickened more than 8,000 people worldwide. It was caused by a virus called SARS-associated coronavirus (SARS-CoV). No one can predict when the next pandemic will happen—only that one eventually will.

These recent pandemics have brought into stark relief the need to be prepared for the next emerging disease, whenever it arrives. To this end, NIH-funded research teams have been working to develop universal vaccines against diseases with pandemic potential. Unlike current vaccines, which confer immunity to one or several strains of a disease, universal vaccines are designed to teach the immune system to defend against all versions of a pathogen—even versions that don’t exist yet. They do this by targeting an element of the pathogen that remains the same across all strains and types.

Such targets are usually those that are least accessible to the immune system. This has posed a significant challenge to vaccine researchers. But with recent progress in vaccine technology, researchers believe that universal vaccines are closer to reality than ever before.

Moving beyond educated guesses

For some viruses, the only constant is change. Locked in a continuous battle with the human immune system, many common viruses change, or mutate, rapidly. This means that even if you’ve been infected with a previous version of a virus, your immune system may not recognize an altered version the next time around.

A well-known example of the arms race between viruses and humans is the influenza virus, commonly known as the flu. More than 20 types of the virus—each of which, in turn, contains many different strains—circulate among people and animals, changing almost constantly.

The flu vaccine you get every year targets four strains that the scientific community predicts are most likely to predominate that season. “We have a well-established system to collect [information] on which strains are circulating all over the world,” says NIH vaccine researcher Dr. Karin Bok. “But it takes at least six months from the decision of which [strains] to include to the vaccine being available to the public.” And which flu strains circulate during that time can change unpredictably.

As a result, seasonal flu vaccines vary in their effectiveness. Their ability to prevent severe disease ranges from as high as 60% to as low as 10%.

All widely used flu vaccines to date teach the immune system to recognize a protein called hemagglutinin, which is found on the surface of the influenza virus. The virus uses hemagglutinin to enter human cells.

In a recent NIH-funded study, researchers designed a flu vaccine to provide broad protection against different influenza viruses. To create the vaccine, the researchers fused hemagglutinin to building blocks that assemble into nanometer-sized particles, or nanoparticles. The nanoparticles included hemagglutinin from four different flu strains. The researchers reasoned that this would encourage the immune system to respond to parts of the protein that were more similar, or conserved, between influenza strains.

“What these nanoparticles do is repetitively display the antigen—the protein from the virus—that you’re trying to mount an immune response to,” explains Dr. Neil King of UW Medicine, who helped lead the study along with researchers from NIH’s Vaccine Research Center (VRC). “And repetition…tells the immune system that this is something dangerous.” This approach can create a strong immune memory of the conserved part of these viral proteins.

In studies in mice, ferrets, and monkeys, the nanoparticle vaccines induced antibody responses against the included strains that were as good as or better than those elicited by a commercial vaccine. Notably, the nanoparticle vaccines also provided near-complete protection against several related flu strains that were not included in the nanoparticles. In contrast, the commercial vaccine did not protect against those other strains.

“These nanoparticle vaccines may be what we call a “supra-seasonal vaccine”—a vaccine that protects for more than one year,” King says.

The vaccine, called FluMos-v1, is now in phase 1 clinical trials .

VRC researchers have also been working on another vaccine that may provoke an even broader immune response to influenza. The team based their approach on the structure of hemagglutinin, which consists of a stem and a head. Flu vaccines to date have targeted the head of the protein, which is most accessible to immune cells. But this is also the part of the protein that mutates fastest.

The new VRC vaccine, which has completed an early-phase human trial, uses a nanoparticle to display the hemagglutinin stem without the head. The hemagglutinin stem tends to remain relatively unchanged, even as the head rapidly changes. The trial found that immunization with this vaccine was safe and elicited immune responses to a range of hemagglutinins that lasted more than a year after vaccination.

Showing the immune system the stem has an added advantage, Bok explains: it’s not something the immune system is used to seeing. This novelty provokes a stronger immune response. That, plus the conserved nature of the stem, “may make it so you would be able to mount an immune response to any hemagglutinin you’re exposed to [after vaccination],” Bok says.

A pressing need for universal protection

The nanoparticle technologies pioneered to develop universal flu vaccines are now being tested to create vaccines that could protect against multiple current and future coronaviruses, including SARS-CoV-2.

“SARS-CoV-2 has proven itself capable of making new variants that are prolonging the global COVID-19 pandemic,” says Dr. Pamela Bjorkman, who leads an NIH-funded research team at the California Institute of Technology. And SARS-CoV-2 wasn’t the first virus of its kind—a type called a betacoronavirus—to jump from animals to people. SARS-CoV came before, and so did MERS-CoV, which causes the deadly Middle East Respiratory Syndrome (MERS).

“The fact that three betacoronaviruses—SARS-CoV, MERS-CoV, and SARS-CoV-2—have spilled over into humans from animal hosts in the last 20 years illustrates the need for making broadly protective vaccines,” she says.

In a recent study, Bjorkman and her team combined pieces of the spike proteins from eight different coronaviruses into a new nanoparticle vaccine. The portion of the spike protein they used is called the receptor binding domain, or RBD. Coronaviruses use the RBD to enter human cells.

Each nanoparticle included 60 RBDs, so that any two adjacent ones were rarely from the same coronavirus. As with flu vaccines, this arrangement encourages antibody-producing immune cells to target areas that are similar across the proteins.

The team tested the new vaccine in mice engineered to be vulnerable to SARS-CoV-2. Following vaccination, the mice produced antibodies that recognized a range of different coronaviruses. And as expected, the antibodies recognized parts of the spike protein that remained similar between coronaviruses.

Promising results were also seen when the vaccine was tested in monkeys. The animals were protected not only against a SARS-CoV-2 variant that wasn’t included in the vaccine but also against SARS-CoV.

“We can’t predict which virus or viruses among the vast numbers in animals will evolve in the future to infect humans to cause another epidemic or pandemic,” Bjorkman explains. “What we’re trying to do is make an all-in-one vaccine protective against SARS-like coronaviruses. This sort of vaccine would also protect against current and future SARS-CoV-2 variants without the need for updating.”

The arrival of mRNA vaccines

Another tool being tested to create more broadly effective vaccines is mRNA technology. This technology enabled COVID-19 vaccines to be developed and brought to the clinic within less than a year after the genome of SARS-CoV-2 was sequenced.

Traditionally, vaccines used weakened or killed versions of an actual pathogen, Bok explains. As technology improved, more refined vaccines were made that included only the pathogen proteins that interact with human cells. mRNA vaccines are very similar, Bok says.

“You’re still getting the same protein,” she explains. “It’s just the delivery mechanism that’s different. Instead of giving you the protein, it’s giving [your body] the source code—the software—so you can make [that protein] yourself.”

This approach allows the immune system to be exposed to substantially greater quantities of a protein than with a traditional vaccine. That, in turn, can produce a stronger immune response. Another advantage of mRNA vaccines is that they can be much cheaper to produce and easier to modify quickly. These vaccines are now being tested to prevent a variety of illnesses beyond SARS-CoV-2, including influenza.

An NIH-funded research team led by Dr. Scott Hensley from the University of Pennsylvania designed a vaccine that includes mRNAs for hemagglutinin from all 20 influenza types known to infect people. It hadn’t been possible to include so much variation with traditional vaccine production methods. But the researchers thought it might work with mRNA technology.

In animal tests, mice that received the experimental mRNA vaccine produced antibodies against both similar and unique regions of all 20 different types of hemagglutinin. Levels of these antibodies remained unchanged for months after vaccination. This robust antibody production occurred whether or not the mice had previously been exposed to one of the flu strains.

Further experiments showed that vaccination protected both mice and ferrets from a dangerous flu strain similar to one of those in the vaccine.

“For a conventional vaccine, immunizing against all these types would be a major challenge, but with mRNA technology it’s relatively easy,” Hensley says. “The idea here is to have a vaccine that will give people a baseline level of immune memory to diverse flu strains, so that there will be far less disease and death when the next flu pandemic occurs.”

“When we think about pandemic preparedness,” Bok says, “what we’re most worried about is the first few months, before vaccines can be prepared. Universal vaccines, along with antivirals and other treatments, could provide [vital] protection against severe disease from the next pandemic.”

—by Sharon Reynolds 

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References:  Quadrivalent influenza nanoparticle vaccines induce broad protection.  Boyoglu-Barnum S, Ellis D, Gillespie RA, Hutchinson GB, Park YJ, Moin SM, Acton OJ, Ravichandran R, Murphy M, Pettie D, Matheson N, Carter L, Creanga A, Watson MJ, Kephart S, Ataca S, Vaile JR, Ueda G, Crank MC, Stewart L, Lee KK, Guttman M, Baker D, Mascola JR, Veesler D, Graham BS, King NP, Kanekiyo M.  Nature . 2021 Apr;592(7855):623-628. doi: 10.1038/s41586-021-03365-x. Epub 2021 Mar 24. PMID: 33762730. A multivalent nucleoside-modified mRNA vaccine against all known influenza virus subtypes.  Arevalo CP, Bolton MJ, Le Sage V, Ye N, Furey C, Muramatsu H, Alameh MG, Pardi N, Drapeau EM, Parkhouse K, Garretson T, Morris JS, Moncla LH, Tam YK, Fan SHY, Lakdawala SS, Weissman D, Hensley SE.  Science . 2022 Nov 25;378(6622):899-904. doi: 10.1126/science.abm0271. Epub 2022 Nov 24. PMID: 36423275. Mosaic RBD nanoparticles protect against challenge by diverse sarbecoviruses in animal models.  Cohen AA, van Doremalen N, Greaney AJ, Andersen H, Sharma A, Starr TN, Keeffe JR, Fan C, Schulz JE, Gnanapragasam PNP, Kakutani LM, West AP Jr, Saturday G, Lee YE, Gao H, Jette CA, Lewis MG, Tan TK, Townsend AR, Bloom JD, Munster VJ, Bjorkman PJ.  Science . 2022 Aug 5;377(6606):eabq0839. doi: 10.1126/science.abq0839. Epub 2022 Aug 5. PMID: 35857620. An influenza hemagglutinin stem nanoparticle vaccine induces cross-group 1 neutralizing antibodies in healthy adults. Widge AT, Hofstetter AR, Houser KV, Awan SF, Chen GL, Burgos Florez MC, Berkowitz NM, Mendoza F, Hendel CS, Holman LA, Gordon IJ, Apte P, Liang CJ, Gaudinski MR, Coates EE, Strom L, Wycuff D, Vazquez S, Stein JA, Gall JG, Adams WC, Carlton K, Gillespie RA, Creanga A, Crank MC, Andrews SF, Castro M, Serebryannyy LA, Narpala SR, Hatcher C, Lin BC, O'Connell S, Freyn AW, Rosado VC, Nachbagauer R, Palese P, Kanekiyo M, McDermott AB, Koup RA, Dropulic LK, Graham BS, Mascola JR, Ledgerwood JE; VRC 321 study team. Sci Transl Med . 2023 Apr 19;15(692):eade4790. doi: 10.1126/scitranslmed.ade4790. Epub 2023 Apr 19. PMID: 37075129. An influenza H1 hemagglutinin stem-only immunogen elicits a broadly cross-reactive B cell response in humans. Andrews SF, Cominsky LY, Shimberg GD, Gillespie RA, Gorman J, Raab JE, Brand J, Creanga A, Gajjala SR, Narpala S, Cheung CSF, Harris DR, Zhou T, Gordon I, Holman L, Mendoza F, Houser KV, Chen GL, Mascola JR, Graham BS, Kwong PD, Widge A, Dropulic LK, Ledgerwood JE, Kanekiyo M, McDermott AB. Sci Transl Med . 2023 Apr 19;15(692):eade4976. doi: 10.1126/scitranslmed.ade4976. Epub 2023 Apr 19. PMID: 37075126.

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Emily Mullin

There’s New Hope for an HIV Vaccine

Since it was first identified in 1983, HIV has infected more than 85 million people and caused some 40 million deaths worldwide.

While medication known as pre-exposure prophylaxis , or PrEP, can significantly reduce the risk of getting HIV, it has to be taken every day to be effective. A vaccine to provide lasting protection has eluded researchers for decades. Now, there may finally be a viable strategy for making one.

An experimental vaccine developed at Duke University triggered an elusive type of broadly neutralizing antibody in a small group of people enrolled in a 2019 clinical trial. The findings were published today in the scientific journal Cell .

“This is one of the most pivotal studies in the HIV vaccine field to date,” says Glenda Gray, an HIV expert and the president and CEO of the South African Medical Research Council, who was not involved in the study.

A few years ago, a team from Scripps Research and the International AIDS Vaccine Initiative (IAVI) showed that it was possible to stimulate the precursor cells needed to make these rare antibodies in people. The Duke study goes a step further to generate these antibodies, albeit at low levels.

“This is a scientific feat and gives the field great hope that one can construct an HIV vaccine regimen that directs the immune response along a path that is required for protection,” Gray says.

Vaccines work by training the immune system to recognize a virus or other pathogen. They introduce something that looks like the virus—a piece of it, for example, or a weakened version of it—and by doing so, spur the body’s B cells into producing protective antibodies against it. Those antibodies stick around so that when a person later encounters the real virus, the immune system remembers and is poised to attack.

While researchers were able to produce Covid-19 vaccines in a matter of months, creating a vaccine against HIV has proven much more challenging. The problem is the unique nature of the virus. HIV mutates rapidly, meaning it can quickly outmaneuver immune defenses. It also integrates into the human genome within a few days of exposure, hiding out from the immune system.

“Parts of the virus look like our own cells, and we don’t like to make antibodies against our own selves,” says Barton Haynes, director of the Duke Human Vaccine Institute and one of the authors on the paper.

The particular antibodies that researchers are interested in are known as broadly neutralizing antibodies, which can recognize and block different versions of the virus. Because of HIV’s shape-shifting nature, there are two main types of HIV and each has several strains. An effective vaccine will need to target many of them.

Some HIV-infected individuals generate broadly neutralizing antibodies, although it often takes years of living with HIV to do so, Haynes says. Even then, people don’t make enough of them to fight off the virus. These special antibodies are made by unusual B cells that are loaded with mutations they’ve acquired over time in reaction to the virus changing inside the body. “These are weird antibodies,” Haynes says. “The body doesn’t make them easily.”

Brian Barrett

Brendan I. Koerner

Steven Levy

Scott Gilbertson

Haynes and his colleagues aimed to speed up that process in healthy, HIV-negative people. Their vaccine uses synthetic molecules that mimic a part of HIV’s outer coat, or envelope, called the membrane proximal external region. This area remains stable even as the virus mutates. Antibodies against this region can block many circulating strains of HIV.

The trial enrolled 20 healthy participants who were HIV-negative. Of those, 15 people received two of four planned doses of the investigational vaccine, and five received three doses. The trial was halted when one participant experienced an allergic reaction that was not life-threatening. The team found that the reaction was likely due to an additive in the vaccine, which they plan to remove in future testing.

Still, they found that two doses of the vaccine were enough to induce low levels of broadly neutralizing antibodies within a few weeks. Notably, B cells seemed to remain in a state of development to allow them to continue acquiring mutations, so they could evolve along with the virus. Researchers tested the antibodies on HIV samples in the lab and found that they were able to neutralize between 15 and 35 percent of them.

Jeffrey Laurence, a scientific consultant at the Foundation for AIDS Research (amfAR) and a professor of medicine at Weill Cornell Medical College, says the findings represent a step forward, but that challenges remain. “It outlines a path for vaccine development, but there’s a lot of work that needs to be done,” he says.

For one, he says, a vaccine would need to generate antibody levels that are significantly higher and able to neutralize with greater efficacy. He also says a one-dose vaccine would be ideal. “If you’re ever going to have a vaccine that’s helpful to the world, you’re going to need one dose,” he says.

Targeting more regions of the virus envelope could produce a more robust response. Haynes says the next step is designing a vaccine with at least three components, all aimed at distinct regions of the virus. The goal is to guide the B cells to become much stronger neutralizers, Haynes says. “We’re going to move forward and build on what we have learned.”

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U.S. Tightens Rules on Risky Virus Research

A long-awaited new policy broadens the type of regulated viruses, bacteria, fungi and toxins, including those that could threaten crops and livestock.

• Share full article

By Carl Zimmer and Benjamin Mueller

The White House has unveiled tighter rules for research on potentially dangerous microbes and toxins, in an effort to stave off laboratory accidents that could unleash a pandemic.

The new policy, published Monday evening, arrives after years of deliberations by an expert panel and a charged public debate over whether Covid arose from an animal market or a laboratory in China.

A number of researchers worried that the government had been too lax about lab safety in the past, with some even calling for the creation of an independent agency to make decisions about risky experiments that could allow viruses, bacteria or fungi to spread quickly between people or become more deadly. But others warned against creating restrictive rules that would stifle valuable research without making people safer.

The debate grew sharper during the pandemic, as politicians raised questions about the origin of Covid. Those who suggested it came from a lab raised concerns about studies that tweaked pathogens to make them more dangerous — sometimes known as “gain of function” research.

The new policy, which applies to research funded by the federal government, strengthens the government’s oversight by replacing a short list of dangerous pathogens with broad categories into which more pathogens might fall. The policy pays attention not only to human pathogens, but also those that could threaten crops and livestock. And it provides more details about the kinds of experiments that would draw the attention of government regulators.

The rules will take effect in a year, giving government agencies and departments time to update their guidance to meet the new requirements.

“It’s a big and important step forward,” said Dr. Tom Inglesby, the director of the Johns Hopkins Center for Health Security and a longtime proponent of stricter safety regulations. “I think this policy is what any reasonable member of the public would expect is in place in terms of oversight of the world’s most transmissible and lethal organisms.”

Still, the policy does not embrace the most aggressive proposals made by lab safety proponents, such as creating an independent regulatory agency. It also makes exemptions for certain types of research, including disease surveillance and vaccine development. And some parts of the policy are recommendations rather than government-enforced requirements.

“It’s a moderate shift in policy, with a number of more significant signals about how the White House expects the issue to be treated moving forward,” said Nicholas Evans, an ethicist at University of Massachusetts Lowell.

Experts have been waiting for the policy for more than a year. Still, some said they were surprised that it came out at such a politically fraught moment . “I wasn’t expecting anything, especially in an election year,” Dr. Evans said. “I’m pleasantly surprised.”

Under the new policy, scientists who want to carry out experiments will need to run their proposals past their universities or research institutions, which will to determine if the work poses a risk. Potentially dangerous proposals will then be reviewed by government agencies. The most scrutiny will go to experiments that could result in the most dangerous outcomes, such as those tweaking pathogens that could start a pandemic.

In a guidance document , the White House provided examples of research that would be expected to come under such scrutiny. In one case, they envisioned scientists trying to understand the evolutionary steps a pathogen needed to transmit more easily between humans. The researchers might try to produce a transmissible strain to study, for example, by repeatedly infecting human cells in petri dishes, allowing the pathogens to evolve more efficient ways to enter the cells.

Scientists who do not follow the new policy could become ineligible for federal funding for their work. Their entire institution may have its support for life science research cut off as well.

One of the weaknesses of existing policies is that they only apply to funding given out by the federal government. But for years , the National Institutes of Health and other government agencies have struggled with stagnant funding, leading some researchers to turn instead to private sources. In recent years, for example, crypto titans have poured money into pandemic prevention research.

The new policy does not give the government direct regulation of privately funded research. But it does say that research institutions that receive any federal money for life-science research should apply a similar oversight to scientists doing research with support from outside the government.

“This effectively limits them, as the N.I.H. does a lot of work everywhere in the world,” Dr. Evans said.

The new policy takes into account the advances in biotechnology that could lead to new risks. When pathogens become extinct, for example, they can be resurrected by recreating their genomes. Research on extinct pathogens will draw the highest levels of scrutiny.

Dr. Evans also noted that the new rules emphasize the risk that lab research can have on plants and animals. In the 20th century, the United States and Russia both carried out extensive research on crop-destroying pathogens such as wheat-killing fungi as part of their biological weapons programs. “It’s significant as a signal the White House is sending,” Dr. Evans said.

Marc Lipsitch, an epidemiologist at Harvard and a longtime critic of the government’s policy, gave the new one a grade of A minus. “I think it’s a lot clearer and more specific in many ways than the old guidance,” he said. But he was disappointed that the government will not provide detailed information to the public about the risky research it evaluates. “The transparency is far from transparent,” he said.

Scientists who have warned of the dangers of impeding useful virus research were also largely optimistic about the new rules.

Gigi Gronvall, a biosafety specialist at the Johns Hopkins Bloomberg School of Public Health, said the policy’s success would depend on how federal health officials interpreted it, but applauded the way it recognized the value of research needed during a crisis, such as the current bird flu outbreak .

“I was cautiously optimistic in reading through it,” she said of the policy. “It seems like the orientation is for it to be thoughtfully implemented so it doesn’t have a chilling effect on needed research.”

Anice Lowen, an influenza virologist at Emory University, said the expanded scope of the new policy was “reasonable.” She said, for instance, that the decision not to create an entirely new review body helped to alleviate concerns about how unwieldy the process might become.

Still, she said, ambiguities in the instructions for assessing risks in certain experiments made it difficult to know how different university and health officials would police them.

“I think there will be more reviews carried out, and more research will be slowed down because of it,” she said.

Carl Zimmer covers news about science for The Times and writes the Origins column . More about Carl Zimmer

Benjamin Mueller reports on health and medicine. He was previously a U.K. correspondent in London and a police reporter in New York. More about Benjamin Mueller

Health funders unite to support climate and disease research, plus other top health stories

Global attention to health has faltered since COVID-19, according to experts. Image:  Reuters/Nadja Wohlleben

.chakra .wef-1c7l3mo{-webkit-transition:all 0.15s ease-out;transition:all 0.15s ease-out;cursor:pointer;-webkit-text-decoration:none;text-decoration:none;outline:none;color:inherit;}.chakra .wef-1c7l3mo:hover,.chakra .wef-1c7l3mo[data-hover]{-webkit-text-decoration:underline;text-decoration:underline;}.chakra .wef-1c7l3mo:focus,.chakra .wef-1c7l3mo[data-focus]{box-shadow:0 0 0 3px rgba(168,203,251,0.5);} Shyam Bishen

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Stay up to date:, global health.

• This global round-up brings you health stories from the past fortnight.
• Top health news: Health heavyweights form new partnership; WHO report highlights key health advances; UK doctors trial first "personalized" skin cancer vaccine.

1. Health funders unite to support climate and disease research

Three of the globe’s biggest health organizations have joined forces to address the impacts of climate change, malnutrition and infectious diseases, and antimicrobial resistance.

The $300 million partnership between the Novo Nordisk Foundation, Wellcome and the Bill & Melinda Gates Foundation aims to find affordable solutions for people in low- and middle-income countries.

A key aim of the project is stated as bridging often isolated areas of research – such as obesity being a risk factor for the severity of some infectious diseases or the link between extreme weather, food insecurity and disease.

The partners emphasized the importance of the initiative following the waning global attention to health after COVID-19, and called for private, philanthropic and public partners to join them.

2. WHO report highlights ‘notable health achievements’

World health is advancing in several key areas, according to a new data from the World Health Organization (WHO).

The WHO’s latest results report – which it describes as its most comprehensive to date ­– shows progress towards targets in areas including healthier populations, universal health coverage, and protection from health emergencies.

It also lists successes including the world’s first malaria vaccine, the elimination of at least one neglected tropical disease in 14 countries and the decline of tobacco use in 150 countries.

However, the report warns that the world is still far from reaching health targets outlined in the United Nations’ Sustainable Development Goals. “With concrete and concerted action to accelerate progress, we could still achieve a substantial subset of them,” WHO Director-General Dr Tedros Adhanom Ghebreyesus said.

3. News in brief: Health stories from around the world

UK doctors are trialling the world’s first personalized skin cancer vaccine . The mRNA vaccine – which uses the same technology as some COVID-19 shots – is designed to suit the individual patient and help their immune system recognize and eliminate cells with melanoma.

Women may live longer than men, but they experience more years in poor health, according to new research. The study, published in The Lancet , found that women had a higher burden of “morbidity-driven conditions”, including low back pain, depressive illness and headache disorders.

A new first-of-its-kind study has found that while a person’s genetics can mean a 21% greater risk of early death, a healthy lifestyle could offset this by more than 60% and add another five years to a person’s life.

A new study suggests that olive oil could lower the risk of dying from dementia . The research, by Harvard scientists and published in the journal JAMA Network Open, linked around half a tablespoon of olive oil eaten daily to a 28% lower risk of dementia-related death.

An experimental gene therapy has restored some vision in patients with inherited blindness . The trial used CRISPR gene editing and doctors said the results provided “proof of concept” that these technologies could be used to treat inherited retinal disorders.

The Global Health and Strategic Outlook 2023 highlighted that there will be an estimated shortage of 10 million healthcare workers worldwide by 2030.

The World Economic Forum’s Centre for Health and Healthcare works with governments and businesses to build more resilient, efficient and equitable healthcare systems that embrace new technologies.

Learn more about our impact:

• Global vaccine delivery: Our contribution to COVAX resulted in the delivery of over 1 billion COVID-19 vaccines and our efforts in launching Gavi, the Vaccine Alliance, has helped save more than 13 million lives over the past 20 years .
• Davos Alzheimer's Collaborative: Through this collaborative initiative, we are working to accelerate progress in the discovery, testing and delivery of interventions for Alzheimer's – building a cohort of 1 million people living with the disease who provide real-world data to researchers worldwide.
• Mental health policy: In partnership with Deloitte, we developed a comprehensive toolkit to assist lawmakers in crafting effective policies related to technology for mental health .
• Global Coalition for Value in Healthcare: We are fostering a sustainable and equitable healthcare industry by launching innovative healthcare hubs to address ineffective spending on global health . In the Netherlands, for example, it has provided care for more than 3,000 patients with type 1 diabetes and enrolled 69 healthcare providers who supported 50,000 mothers in Sub-Saharan Africa.
• UHC2030 Private Sector Constituency : This collaboration with 30 diverse stakeholders plays a crucial role in advocating for universal health coverage and emphasizing the private sector's potential to contribute to achieving this ambitious goal.

Want to know more about our centre’s impact or get involved? Contact us .

4. More on health from our blog

In India, mental health has often been overshadowed by other pressing healthcare concerns. But, as this article examines, philanthropy is empowering the country’s mental health sector to help address the crisis.

Vaccine programmes save millions of lives each year and have been key to helping the world deal with viruses including smallpox and COVID-19. This piece looks at 50 years of immunization progress .

People across the globe are living longer, which is placing increased demand on healthcare systems. Community-based long-term care could form part of the solution.

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World Economic Forum articles may be republished in accordance with the Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International Public License, and in accordance with our Terms of Use.

The views expressed in this article are those of the author alone and not the World Economic Forum.

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HPV vaccine slashes cervical cancer rates across society

16 May 2024

The NHS HPV vaccination programme is preventing the highest number of cervical cancer cases in the most deprived groups, according to our latest study of data from England .

The findings, which reflect the fact that more deprived groups have higher rates of cervical cancer, show that the HPV vaccine is reaching people from all backgrounds.

In 2021, the same research team, led by Professor Peter Sasieni, found that offering the HPV vaccine to girls aged between 12 and 13 prevents almost 9 in 10 cervical cancers . Still, some scientists had been concerned that differing levels of vaccine uptake could be increasing cervical cancer inequalities.

There’s more work to do to address those inequalities, but it’s now clear the HPV vaccine is a big part of the solution. Sasieni’s team at Queen Mary University of London estimates that it has prevented more than three times as many cases in the most deprived group in England (around 190) than in the least (around 60).

Our research highlights the power of HPV vaccination to benefit people across all social groups. Historically, cervical cancer has had greater health inequalities than almost any other cancer and there was concern that HPV vaccination may not reach those at the greatest risk. Instead, this study captures the huge success of the school-based vaccination programme in helping to close these gaps and reach people from even the most deprived communities. In the UK, the elimination of cervical cancer as a public health problem in our lifetime is possible with continued action to improve access to vaccination and screening for all.

More work to do to prevent cervical cancer

Around 3,300 people are diagnosed with cervical cancer in the UK every year.* Research has shown that the HPV vaccine, combined with cervical screening, can bring that number right down.   

However, the percentages of eligible people receiving an HPV vaccine and attending screening have both fallen in the wake of the COVID pandemic.   

And, although this research shows that the HPV vaccine is preventing cervical cancer in all socioeconomic groups, rates are still higher in people from deprived backgrounds.  

That’s why we’re calling on the government to do more to ensure that as many young people as possible get the HPV vaccination. We’re also pushing for better reporting on uptake by deprivation and ethnicity, along with more research, to help us understand how to reach those most at risk.  

Our scientists helped to prove the link between HPV and cervical cancer 25 years ago . That discovery made it clear that we could use HPV vaccines to prevent cervical cancer. It also helped improve cervical cancer screening.

Thanks to these scientific developments, cervical cancer rates in the UK have fallen by almost a third since the early 1990s.**

Who is eligible for the HPV vaccine?

After decades of research, the HPV vaccination programme was first introduced for girls aged 12-13 in England in 2008. Since September 2019, the vaccine has also been available to boys of the same age. Anyone who missed their vaccine can request it through the NHS up to the age of 25.   

The vaccine is also available to men who have sex with men and some transgender people up to the age of 45 through sexual health and HIV clinics.  

We encourage people to take up the HPV vaccine if they are eligible. If you are concerned that you or your child has missed out on the HPV vaccine, you can contact your child’s school nurse, school immunisation service or GP surgery to find out more.

Gem’s story

36-year-old Gem Sofianos, from London, found out that she had cervical cancer after a screening appointment in 2015.

The HPV vaccination programme launched after Gem had left school. Now she’s a strong advocate that eligible people should take up the offer of the vaccine, as well as cervical screening.

Gem said: “If I had been offered the vaccine when I was younger, I wouldn’t have hesitated to take it up. My younger sister was given the HPV vaccine in the first rollout at school. It gives me comfort knowing that she and others are protected against HPV, and therefore less likely to develop cervical cancer.”

Gem was 28 when she was diagnosed. “I was young and healthy and hadn’t experienced any symptoms, so to be told I had cervical cancer took me completely by surprise. It was a lot to take in.”

Because Gem’s cancer was caught early, she had surgery a month later and the treatment was successful. Gem is now free from cancer, but she still attends regular screening.

“I still suffer from the aftermath of my diagnosis,” she said, “and I hope one day we live in a world where cervical cancer is eliminated. With advances in research and more people getting the HPV vaccine, this could be a reality.”

* Based on the average annual number of new cases of cervical cancer (ICD10 C53) diagnosed in the United Kingdom in the years 2017-2019.

* Based on the percentage change in incidence rates from 14 cases per 100,000 women in the UK between 1991-1993 to 10 cases per 100,000 women between 2017-2019.

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