I believe in making it very difficult for people to refuse vaccines. There’s enough of the libertarian about me that I wouldn’t actually strap them down and inject them, but I’m fine with school districts making parents write out their conscientious objections to children being immunised or with sports clubs requiring adult proof of immunisation before people can join. What I or you think is, though, beside the point. Much of the US is walking away from cajoling and compulsion and there’s great pressure in Europe for similar change. We can either go on moaning about how we wish the world hadn’t changed or we can respond effectively.

Before the current US Administration began rewriting vaccine recommendations, one in six US parents wasn’t following them. We used to joke that vaccine-preventable diseases in the West had become diseases of children of the over-educated middle classes who shopped at Whole Foods and did naked yoga classes; vaccine refusers now are still more likely to be white, but they skew to being conservative, very religious, and young. Recommendations actually reduced uptake in this group because most have a deep distrust of the Federal Government and its agencies.

Formal vaccine refusals in Poland more than doubled from 2017 to 2022 and reached over 87,000 in 2023, a 1685% increase since 2003; measles cases surged 10x in early 2024 due to falling rates. Ireland, where I live, has the third-lowest childhood vaccine coverage rate in the OECD.

There are bright spots too, Italy for example, and the battle is far from lost. But the mistrust now endemic to the United States is coming to Europe.

High-handed US and European experts

You can understand confusion, if not mistrust. About half of parents in the USA did not vaccinate their children for flu in the past year, compared with 41 percent who said they had done so, a Washington Post / Kaiser Family Fund poll found. Coverage started declining after 2019. In 2016, the US CDC said that the nasal flu vaccine used in children provided “no measurable benefit” (injectable vaccines for adults were, as usual, highly effective). In the same year, Public Health England said that the same vaccine (produced by a British company in a British factory) was 58 percent effective. Canada followed the UK, saying that its population was very different to the USA! It’s very unlikely that both the Americans and the Canadians were right — despite those obvious population differences…. Few journalists covered the story — I suspect because no-one wanted to be accused of promoting vaccine scepticism. The vaccine is now recommended again in the USA.

Few American paediatricians and even fewer nurses would have been able to explain this to parents because no-one ever bothered to give the professionals an explanation. What do we think doctors told parents who asked why a vaccination was recommended then was not and then was again? British parents who did a web search (this was pre-Chat GPT, remember) might have asked why their children were getting an apparently ineffective vaccine and would have met equally bemused stares from their health providers. Did anyone brief social media influencers or health journalists? Of course not, who do they think they are? What impudence…

I know some of those involved and I’m sure that there was no subterfuge and nothing sinister going on; the answer is likely to be dull and involve methodology and surveillance systems.

This is the way we all used to approach treatment discussions 40 years ago — the doctor told you what to do, you thanked him (it was nearly always a him) and you did it. Questions were a sign of disrespect, of even psychological illness. I was recently treated by a Russian dentist, now practising in Ireland, who was shocked and outraged when I questioned his recommendation to use antibiotics prophylactically; if he had been Irish, he would have been completely used to it.

Nonsensical recommendations in developing countries

Vaccine hesitancy looks a bit different in France. Those least likely to have their children vaccinated tend to be more educated, high users of the internet for information and to have lower trust in health authorities. Those who refuse vaccines for themselves tend to be at the lower end of the social hierarchy with less education and fewer financial resources. Many are ​immigrants and descendants of immigrants, and residents of French overseas departments. Both are probably likely to know about the vaccines which Western experts recommend for children in the developing world, including in Francophone countries.

I remember doing a policy interview with the health minister of a large Indian state. I was trying to find out what he might pay for an effective TB vaccine. “But”, he said, “we already have a TB vaccine. Why do I need a new one?” His top civil servant was sitting behind him and frantically gesticulating to me to try to stop me explaining that the BCG vaccine, given to almost every Indian newborn, may do nothing to prevent TB infections and, at best, may make the disease less severe in some of the children who contract it. It is, though, very good at causing severe side effects. No developed economy uses it; almost every poor one does.

I’m ashamed to say that I did not explain BCG as clearly as I should have to the minister. He was the norm, not the exception, in that series of policymaker interviews: few of those making decisions about TB vaccine policy had ever been given a thorough, honest briefing about the limitations of the vaccines their expert advisers recommended. None of the parents, of course, were ever told about any of these reservations.

There might also be a case for the current practice of giving many children in Africa and Asia a vaccine that sometimes causes polio, instead of preventing it, although I doubt it. The risks of a child contracting polio from the live-attenuated oral vaccine are probably underestimated when they’re presented to politicians and policy influencers. Hardly any parents who bring their children forward for these vaccines are told about the risk or the rationale for continuing to use them, rather than the perfectly safe inactivated vaccine used throughout the rich world.

Is it any wonder that those with insight into the developing world are sceptical? The real wonder is that vaccine confidence is still so high in Africa and Asia. That probably comes from everyday encounters with the tragic consequences of infection by vaccine-preventable illnesses, an experience blessedly denied to most Americans and Europeans.

What we need to do now

The road ahead has been cleared for us. Thirty years ago, I went out with a trainee doctor at the Royal College of Surgeons in Ireland. He was upset one evening because he had been berated by his tutor for telling an older patient that she had cancer — it had been agreed with the family that she would be told that she had a “growth” to avoid upsetting her. At least she found out: King George VI of the United Kingdom sent his daughter, Princess Elizabeth, on a world tour in 1952 because neither he nor she had been told that he had lung cancer and that it was terminal. He never saw her again. These stories shock us now because honesty, realism and communication are taken for granted in what we tell patients who are ill. These principles need to be the new basis for what we tell people who are healthy and want to stay that way.

First we need a change in attitude. Whether to be immunised or not is a decision that people will take — actually, a series of decisions. We don’t need to think about whether we like the concept or not, it is the way things increasingly are. We have to get ordinary people used to making good decisions, just as they do about other life issues such as house buying or insurance or continuing education. Ordinary people are not property experts or risk analysts or trained evaluators of course offerings, but they mostly make reasonable choices. They can do the same thing with vaccines.

Then, we need to communicate much more. Vaccine producers are free to talk to the public about recommended vaccines in many countries; where they are not, they need to be allowed to. Then they need to accept their responsibility to speak often, clearly and loudly. They are the experts on the vaccines they produce and they must tell potential recipients or the parents of recipients about the benefits and disadvantages. Of course, they need to do it in an honest and balanced way. They will be more successful if they communicate in partnership with professional organisations, charities and respected consumer groups. They can be transparent: they have a commercial interest in getting people to accept vaccines but a legal responsibility to set out all the factors in deciding whether to or not. It’s like banks selling mortgages and car dealerships selling warranties.

Researchers and healthcare providers need training in communication and answering questions. They need to be much better at helping policy makers to make decisions about vaccines. Today, too few vaccines are reimbursed and many are offered only to some of those who would benefit from them. In many countries, it is still too hard to get vaccinated and even where rules have changed, practices have not — look at Poland, for example. Politicians and public officials can unleash vaccines so that they can do even more to boost productivity, growth and wealth in society.

Those same scientific and medical experts need to be much better at talking to people who are making decisions about immunisation. Research tells us clearly what helps the right decision, but too few professionals follow the evidence. The most powerful prompt to action is a trusted health professional saying, “I would like you to do this”. Setting a good example works wonders too, but too few health professionals have had all of the vaccines recommended for them.Communication can change all of this.

The vast majority of social media influencers want to give good advice and powerful motivation but no-one talks to them — after all, we want people to follow the guidelines, not think, don’t we? For example, have you seen Dr Mike Varshavski take on 20 vaccine sceptics at once? Thirty million people probably have over various platforms and he’s brilliant. Industry and professionals need to work with influencers who specialise in women’s issues, childhood, workplace effectiveness and, of course, health. Look at this from Dr Ahmed Ezzat — his videos on RSV reduced calls to the emergency services by 25% — and just think what he can do for vaccines.

Journalists are discouraged from writing pieces about vaccine decisions — “just tell people to follow expert recommendations”. Many, consequently, avoid writing about vaccines. We need to treat these journalists as powerful allies in helping lay people to make important decisions with lifelong implications for their risk of developing chronic illnesses. It’s the way that property developers treat journalists who write about houses,

Honestly, I still think it would be simpler and still ethically correct to just nudge almost everyone into getting immunised but that is not an option in many places now and, given the global market in ideas, won’t be one anywhere soon.

Parents get things right

Asia should encourage us. Many parents save and spend to get their children the best vaccines. The state often provides old tech or nothing, so middle-class parents take their children to private clinics for the best protection and pay full price for it. Of course, it’s not fair to poorer children and it is crazy public policy given that population sizes will plunge across Asia over the next 30 years so every child, whether middle class or not, is a precious national resource. Still, it shows that individual families can and do make better decisions than health policy makers when the routes of communication are open and used well.

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Department of Health and Human Services Secretary Robert F. Kennedy Jr. has floated a seismic idea: adding autism to the list of conditions covered by the Vaccine Injury Compensation Program. The program, known as VICP, provides a system for families to file claims against vaccine providers in cases in which they experience severe side effects. Kennedy has also suggested broadening the definitions of two serious brain conditions — encephalopathy and encephalitis — so that autism cases could qualify.

Either move, experts warn, would unleash a flood of claims, threatening the program’s financial stability and handing vaccine opponents a powerful new talking point.

Legally, HHS “is required to undergo notice and comment rulemaking to revise the table,” said Richard Hughes, a law firm partner who teaches at George Washington University. The “table” is a list of specific injuries that the U.S. government accepts as presumed to be caused by a vaccine if those injuries occur within a certain time window. If someone can show they meet the criteria, they have a simpler path to securing compensation without having to prove fault. Autism is not in the table because a link between vaccines and autism has been thoroughly debunked.

If autism is added, Hughes explained, the VICP could face “an exorbitant number of claims that would threaten the viability of the program.”

Asked about its possible plans, an HHS spokesperson told CBS News the agency does not comment on future or potential policy decisions.

Carole Johnson, former administrator of the Health Resources and Services Administration, which oversees VICP, cautioned that the system is already overburdened: “The backlog is not just a function of management, it’s built into the statute itself. That’s important context for any conversation about adding new categories of claims.”

Dorit Reiss, a law professor at the University of California College of the Law-San Francisco, said that any such change would be exploited: “This can, and likely will, be used to cast doubt on vaccines.”

Compensation Without Causation

The Vaccine Injury Compensation Program was born of crisis. In 1982, “Vaccine Roulette,” a television documentary, aired nationwide, alleging routine childhood shots were causing seizures, brain damage, and even sudden infant death. The program alarmed parents and triggered a surge of lawsuits against vaccine makers.

“That led to a flood of litigation against vaccine makers,” recalled Paul Offit, a pediatric infectious disease specialist and vaccine inventor at the University of Pennsylvania. “I mean, to the point that it drove them out of the business. … By the mid-1980s, there were $3.2 billion worth of lawsuits against these companies.”

Were it not for the VICP, Offit said, “We wouldn’t have vaccines for American children. The companies — it wasn’t worth it for them.”

The National Childhood Vaccine Injury Act of 1986 created a no-fault system. Families who believed a vaccine caused harm could file a claim; if the injury appeared on the table within a set time frame, compensation was automatic. If not, claimants could present medical evidence. The system had two purposes: provide compensation and protect the vaccine supply.

From the beginning, the table was understood not as a scientific document but as a legal tool.

“It’s a legal document and things can be included for policy reasons even if the causation evidence is weak,” Reiss said. She explained, “The program is designed to be generous, to compensate in cases of doubt.”

But, she said, “autism is not in that category. The science is clear. Adding it would be pure politics.”

This tension — between law, science, and public perception — has defined the program for nearly four decades.

What Expansion Would Mean in Practice

Since 1988, federal data shows more than 25,000 petitions to the VICP have been adjudicated; of those, 12,019 were granted compensation and 13,007 were dismissed. About 60% of compensated cases involved negotiated settlements in which HHS drew no conclusion about the cause. Over the same period, billions of vaccine doses were safely administered to millions of Americans.

Adding autism to the VICP table would change that picture overnight.

Federal estimates suggest up to 48,000 children could qualify immediately under a “profound autism” standard, with potential payouts averaging $2 million per case, at an initial cost of nearly $100 billion, followed by annual totals of about $30 billion a year — dwarfing the current $4 billion trust, a new analysis finds.

“Any case where the symptoms appeared in the past eight years and the parents blame vaccines,” Reiss said. “I don’t know how many that would be. The fund has a surplus of over $4 billion. One seriously disabled child’s care can cost millions, so a significant number, say 100,000 compensations, might exhaust it.”

Furthermore, with only eight special masters handling cases, the system would also be paralyzed by backlogs.

The stakes are not just fiscal. If the fund collapses under the weight of autism claims, vaccine makers may question whether producing vaccines for the U.S. market is worth the risk. That would mirror the crisis of the 1980s, which led to the establishment of the VICP.

Autism and the Courts

In the late 1990s and early 2000s, Andrew Wakefield’s now-retracted paper alleging a link between the MMR vaccine and autism fueled a surge of VICP claims. By 2002, the VICP was swamped with petitions alleging vaccines had caused autism. The court consolidated thousands of cases into the Omnibus Autism Proceedings, selecting a handful of test cases to decide them all.

After years of hearings and expert testimony, the conclusion was unequivocal: vaccines do not cause autism. In 2010, the court ruled against petitioners on every theory of causation. The U.S. Court of Federal Claims affirmed, and the Court of Appeals upheld, the decision.

“That precedent is binding,” said Richard Hughes, a vaccine law expert at George Washington University and former VICP legal counsel. “Autism was litigated thoroughly and rejected. That still carries weight in the court today.”

The Ghost of Hannah Poling

Yet, the vaccine-autism debate has never quite faded. In 2008, the government conceded a case involving Hannah Poling, a girl with a rare mitochondrial disorder who developed autism-like symptoms after vaccination. Officials stressed the concession was specific to her condition, not evidence of a general link. But headlines told another story: “Family to Receive $1.5 Million in First-Ever Vaccine Autism Court Award.”

The Poling case fueled years of confusion.

Autism Science Today

The science is clearer than ever. Autism begins early in pregnancy, not in toddlerhood when most vaccines are given.

“Vaccinations … happened around the time families were recognizing symptoms of autism in their children,” said Catherine Lord, a UCLA clinical psychologist and specialist in autism diagnosis. “However, we now know that autism begins much earlier, likely as the fetus develops during pregnancy, so it cannot be an explanation.”

Peter Hotez, a pediatric infectious disease specialist and vaccine scientist at the Baylor College of Medicine who is also the father of a young adult with autism, underscores that point: “The drivers of autism are genetics and, in rare cases, environmental exposures during pregnancy, not vaccines. We’ve been over this ground for decades, and the evidence is overwhelming.”

Sarah Despres, former legal counsel to the secretary of Health and Human Services in the Biden administration and now a consultant to nonprofit organizations on immunization policy, adds that the compensation program itself is often misunderstood.

“The table was originally written as a political document,” she said. “The purpose of the program was to be swift, generous, and fair. … There would be cases that may not be caused by the vaccine but would be compensated if you went through this table injury scheme, where you don’t have to prove causation.”

What’s at risk: Harm from the Diseases Themselves

The stakes are not abstract. Measles, one of the most contagious pathogens on Earth, spreads so efficiently that one infected child can transmit it to 90% of susceptible contacts. Before vaccinations began in the 1960s, measles sickened hundreds of thousands annually in the U.S., killing hundreds and causing thousands of cases of encephalitis and lifelong disability. Complications included pneumonia, brain swelling, and, in rare cases, a fatal degenerative brain disorder called subacute sclerosing panencephalitis, or SSPE, that can strike years later. This year, a school-age child in Los Angeles County died of SSPE after contracting measles in infancy, before being eligible for vaccination.

Mumps was once a near-universal childhood illness. Though often dismissed as mild, it can cause sterility in men, meningitis, and permanent hearing loss. Outbreaks on college campuses, as recently as the 2000s, showed how quickly it can return when vaccination rates slip.

Rubella, also known as German measles, is mild in most children, but can be devastating during pregnancy. Congenital Rubella Syndrome, or CRS, caused waves of tragedy before the development of the vaccine: Thousands of babies each year were born blind, deaf, with heart defects, or with intellectual disabilities. In medical texts, autism itself is listed as one of CRS’ sequelae, or possible consequences — proof that rubella infection, not vaccination, can contribute to developmental disorders.

Measles, mumps, and rubella “are not trivial,” said Walt Orenstein, former head of the Centers for Disease Control and Prevention’s immunization program. “Fever, high fever, is common … and they have frequent complications.”

And yet, as these diseases fade from living memory, a counternarrative has gained traction. On Sept. 29, the nonprofit Physicians for Informed Consent, a group that disputes the scientific consensus on vaccines, announced it had mailed its “Silver Booklet” on vaccine safety to every member of Congress, as well as to President Donald Trump and Vice President JD Vance. The book claims that “vaccines are not proven to be safer than the diseases they intend to prevent,” and calls on federal leaders to punish states that restrict vaccine exemptions. (The booklet isn’t free. The group sells copies for $25 on Amazon.)

Scientists say this framing misrepresents the basic math of risk. “Measles is one of the most important infectious diseases in human history,” notes “Plotkin’s Vaccines,” the field’s authoritative textbook. “The widespread use of measles vaccines in the late 20th and early 21st centuries led to a further marked reduction in measles deaths. Measles vaccination averted an estimated 31.7 million deaths from 2000 to 2020.”

Kennedy’s possible move to expand the Vaccine Injury Compensation Program hinges on casting doubt — on suggesting that science is unsettled, that vaccines may be riskier than diseases.

“One tactic used to argue that vaccines cause autism is the use of compensation decisions from the National Vaccine Injury Compensation Program to claim such a link,” said Reiss of UC Law-San Francisco. “Even the cases that most closely address the question of vaccines and autism do not show the link that opponents claim exists, and many of the cases used are misrepresented and misused.”

Offit underscores the danger on the perception side. “When people see the Vaccine Injury Compensation program, they assume that any money that is given is because there was a vaccine injury,” he said.

Kathryn Edwards, an expert in pediatric infectious diseases and vaccine safety at Vanderbilt University, said, “Expanding compensation for issues that are not clearly related to vaccines … suggests that these conditions are related to vaccines when they are not.” She compared it to the removal of thimerosal, a preservative dropped from most childhood vaccines to ease public fears, despite no evidence of harm. “Now, we are still suffering from that action.”

Public health experts stress that such narratives invert reality. The very diseases being downplayed once killed or disabled tens of thousands of American children each year. As pediatrician, psychiatrist, and medical historian Howard Markel put it: “Back a hundred years ago, everybody lost a kid or knew a kid who died of one of these diseases. … We never conquer germs, we wrestle them to a draw. That’s the best we do. And so this is a real … handicap to the other side, the microbes who live to infect.”

Families and the Future

The hardest voices to reckon with are those of families. Parents of autistic children often feel abandoned — unsupported by disability programs, exhausted by care needs, searching for answers. Kennedy’s appeal to them is emotional, not scientific.

Reiss noted that families deserve far more support but argues that it shouldn’t come through VICP.

“The program is to award compensation to those injured by vaccines,” she said. “We should have more direct support — disability funding, disability aid. Kennedy has been taking HHS in the opposite direction, cutting services where we need more.”

Despres made the same point: “The goal of the program really was if there’s a close call, we’re going to err on the side of compensation. … And it’s really important that everyone understands that compensation does not mean that the vaccine actually caused the injury. … And I think we have seen statistics around the compensation program misused by those who would want to sow distrust in vaccines, to say vaccines are unsafe, when in fact … that’s not what this is.”

UCLA’s Lord urged a shift in focus. “For the last 50 years, science has focused on the biological causes of autism, which has led to great progress, especially in genetics,” she said. Of Secretary Kennedy, she said, “He could help more by acknowledging the value of science, but also the need to better attend to the actual lives of autistic people and their families.”

What Comes Next?

If Kennedy decides to move forward with such a plan, HHS would need to draft a rule, open it to public comment, and then defend the change in court. The pushback will be fierce: from scientists, from public health leaders, and from families who fear being misled yet again.

The debate over adding autism to the Vaccine Injury Table is not just a policy debate. The program was built on the principle of compensation without causation, a fragile balance designed to sustain both trust and supply. Adding autism could collapse that distinction entirely.

[KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF — the independent source for health policy research, polling, and journalism.]

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Conflicts compound these inequities. Fragile and conflict-afflicted countries account for just a quarter of the world’s infants, yet they harbour half of all zero-dose children, whose numbers have increased from 3.6 million in 2019 to 5.4 million in 2024. In Sudan, vaccination coverage collapsed — from 85% pre-war to as low as 8% in conflict zones — while Yemen’s zero-dose figures climbed significantly, driven by instability, health service disruptions, and misinformation.

Conversely, Gavi-supported, low-income countries saw marked improvements, reducing un- and under-vaccinated cohorts by around 650,000 in 2024. Yet even high- and upper-middle-income economies are experiencing slippage, with measles coverage hovering at 84% (first dose) and 76% (second), below the 95% threshold needed for herd immunity. Consequently, measles outbreaks surged, with 60 countries reporting significant incidents in 2024, doubling since 2022.

Country case snapshots powerfully illustrate these trends. In Bosnia and Herzegovina, measles vaccination rates are at just 55%, compared to Croatia’s 90%, contributing to over 7,000 cases and two adolescent deaths, prompting WHO and UNICEF to urge intensified immunisation campaigns. In Pakistan, polio resurgence has occurred amid militant threats and disrupted campaigns, with over one million children missing doses in 2024. The government’s response includes large-scale vaccination drives and policy enforcement, such as arrest warrants, signalling both the challenge and political recognition of routine immunisation’s fragility. Meanwhile, Bangladesh has steadily expanded its vaccine schedule — adding Hib, rubella, PCV, IPV and MR2 — achieving DTP3 coverage around 93% and fully vaccinated rates near 84% by 2019.

These illustrations reveal both progress and vulnerability. Countries with strong political will, robust systems, and community trust — like Bangladesh — are managing gains. Others, like Pakistan and Bosnia, highlight how instability, mistrust, and misinformation can swiftly unravel public health gains.

The 2024 immunisation data reiterates an urgent message. Global coverage has stabilised and broadened, but millions of children remain vulnerable in conflict zones and complacent high-income settings. Measles outbreaks, polio flare-ups, diphtheria spikes, and new threats like RSV underscore that the progress we’ve made is neither permanent nor evenly shared. Unless we decisively fill funding gaps, fortify health delivery in emergencies, ensure vaccine equity, and strengthen trust, these vulnerabilities will deepen — and outbreaks will follow.

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Conflicts compound these inequities. Fragile and conflict-afflicted countries account for just a quarter of the world’s infants, yet they harbour half of all zero-dose children, whose numbers have increased from 3.6 million in 2019 to 5.4 million in 2024. In Sudan, vaccination coverage collapsed — from 85% pre-war to as low as 8% in conflict zones — while Yemen’s zero-dose figures climbed significantly, driven by instability, health service disruptions, and misinformation.

Conversely, Gavi-supported, low-income countries saw marked improvements, reducing un- and under-vaccinated cohorts by around 650,000 in 2024. Yet even high- and upper-middle-income economies are experiencing slippage, with measles coverage hovering at 84% (first dose) and 76% (second), below the 95% threshold needed for herd immunity. Consequently, measles outbreaks surged, with 60 countries reporting significant incidents in 2024, doubling since 2022.

Country case snapshots powerfully illustrate these trends. In Bosnia and Herzegovina, measles vaccination rates are at just 55%, compared to Croatia’s 90%, contributing to over 7,000 cases and two adolescent deaths, prompting WHO and UNICEF to urge intensified immunisation campaigns. In Pakistan, polio resurgence has occurred amid militant threats and disrupted campaigns, with over one million children missing doses in 2024. The government’s response includes large-scale vaccination drives and policy enforcement, such as arrest warrants, signalling both the challenge and political recognition of routine immunisation’s fragility. Meanwhile, Bangladesh has steadily expanded its vaccine schedule — adding Hib, rubella, PCV, IPV and MR2 — achieving DTP3 coverage around 93% and fully vaccinated rates near 84% by 2019.

These illustrations reveal both progress and vulnerability. Countries with strong political will, robust systems, and community trust — like Bangladesh — are managing gains. Others, like Pakistan and Bosnia, highlight how instability, mistrust, and misinformation can swiftly unravel public health gains.

The 2024 immunisation data reiterates an urgent message. Global coverage has stabilised and broadened, but millions of children remain vulnerable in conflict zones and complacent high-income settings. Measles outbreaks, polio flare-ups, diphtheria spikes, and new threats like RSV underscore that the progress we’ve made is neither permanent nor evenly shared. Unless we decisively fill funding gaps, fortify health delivery in emergencies, ensure vaccine equity, and strengthen trust, these vulnerabilities will deepen — and outbreaks will follow.

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Yet today, we find ourselves dismantling these hard-won achievements. Extraordinary cuts to disease prevention, research, and surveillance programs signal a large-scale reversal of a successful strategy of containment and elimination. Such an irresponsible pivot risks opening the door for vaccine-preventable diseases, drug-resistant infections and new pandemics to reemerge with devastating force. If we continue down this path, the consequences will be felt not just in developing nations, but across the industrialized world, where health systems already are under strain.

It could take years to regain the high ground we currently hold against infectious diseases; many countries may never get there again. While pursuing modernization and efficiencies in the global health system is vital, randomly eliminating or suppressing funding and institutions we rely on to develop the pipeline of new vaccines, therapeutics, and practices to fight tomorrow’s pathogens only weakens us further. Our most dangerous disease threats constantly evolve, probe our weaknesses, and exploit natural opportunities to strike.

The attack on America’s preeminent medical research institutions and the innovations they fuel severely undermines our ability to counter disease while degrading the very talent we need to protect us: the next generation of scientists and medical researchers.

Many prominent health leaders are sounding the alarm, but until a coalition of the informed begins to take shape, we may as well be screaming into the wind. Unless a concerted effort is made to change course, the infrastructure, jobs, institutional knowledge, and recruitment of future health experts that constitute one of humanity’s greatest achievements may be dismantled. Surely by now we have learned that research and disease prevention is dramatically less costly than deploying the vast resources necessary to respond to a new outbreak.

Here’s one path forward: U.S. health communicators, advocates, and leaders should coordinate framing the issues to state and congressional lawmakers who stand to lose the most from the current health funding policy direction. Many of the places contributing the most to America’s competitive advantage in biomedical research are in conservative districts that receive funding from the NIH and other public sources.

Similarly, emerging diseases often pose the highest threat to people battling chronic diseases or living in areas underserved by health services, which means all of us are affected, regardless of economic status or ideological belief. People at every level of the health system—from practitioners to patients, researchers to drugmakers—should be energized to speak with one voice and let policymakers know that retreat in the face of defeatable disease threats is the wrong direction for the U.S.

Disease is humanity’s greatest enemy, and it constantly hovers at our doorstep. Do we pretend not to hear it knocking, or do we recognize its dangers and act?

That’s exactly the moment we are facing now. Our situation is complicated by the fact that our most important defenses – biomedical research and disease prevention infrastructure – are being demolished before our eyes. It will take real courage to act, but we must marshal our resources, defying the ambivalence and dismissiveness that make us more vulnerable to looming infectious disease threats. This is no time to retreat.

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Perhaps the biggest wild card is Donald J. Trump’s return to the White House and the nomination of several candidates who have suggested that they will reinvent Health and Human Services, the Food and Drug Administration, Centers for Disease Control, and the Centers for Medicare and Medicaid Services—key agencies that set the agenda for public health and innovation.

The second unknown is the thin line separating misinformation from disinformation.  Historically, we looked to public health scientists to guide us.  Now, we are uncertain who to trust regarding health information.  Advice:  Do not rely on “X” as a fact-checking source – it’s merely noise.  But can you trust significant news sources, C-Suite execs, or elected officials?  It’s hard to say.  There is a vast divide between an honest mistake and willful deception. When it comes to health, do your homework – always!

A third factor must be included in the many 2024 health rankings and “Top 10” analyses that will appear in the days ahead. Our planet’s and people’s health are deeply intertwined. Rising temperatures, air pollution, and extreme weather events are not just environmental concerns but public health emergencies. These factors disproportionately impact vulnerable populations, exacerbating chronic conditions like asthma, cardiovascular disease, and mental health disorders. Addressing these challenges requires health professionals to embrace a broader perspective, recognizing that the fight for cleaner air, sustainable food systems, and resilient communities is inseparable from the mission to improve individual health outcomes.

Here are 10 health-sector developments—not ranked—to watch in the coming year, determined by media coverage, reader interest, and personal interest. These “10” could be Top Hundreds or Thousands. Happily, there were many advancements in 2024 to applaud. Yet, the pain points, too, are many. There are many publication lists to check – reviewing many is worthwhile. What is most important is to reflect on the needs of people and planet and commit to make a difference. The planet doesn’t need people. People need the planet. Equally so, people need each other.

This list’s topics were selected using data from global news outlets, academic publications, press releases, analytics platforms like Google Trends, and social media engagement metrics. While the list reflects the broad measure of public interest, it provides an overview of some of the positive and most worrisome health shifts and signals of what lies ahead.

1. AI-Powered Diagnostics Revolutionize Early Detection

Augmented implementation (AKA artificial intelligence) will redefine diagnostics in the years ahead. AI is poised to redefine diagnostics, with breakthroughs in the early detection of diseases like pancreatic cancer offering unprecedented accuracy and saving lives. Recent breakthroughs set the stage for broader adoption of AI in detecting other cancers and chronic diseases in 2025 and beyond, enticing the biopharma sector to interest in clinical trials to develop treatments for these deadly cancers.  This is a prime example of where AI can become a tipping point for earlier interventions and better patient outcomes globally.

2. India Leadership in Affordable Vaccine Development

India is quietly solidifying a reputation as the “pharmacy of the world” through several initiatives, such as launching a low-cost universal flu vaccine. Developed through a groundbreaking public-private partnership, this vaccine leverages advanced mRNA technology to provide broad-spectrum protection against multiple flu strains. By prioritizing affordability and accessibility, the initiative aims to protect millions of people in low- and middle-income countries, showcasing a scalable model for addressing global health inequities.

India has all the pieces to become a more significant player in the life science innovation puzzle – talent, scientific rigor, and an open-minded government willing to align its drug regulatory system with the world’s gold standard – the Food and Drug Administration.

India’s new rare disease center in New Delhi addresses critical global health gaps, setting a precedent for similar initiatives worldwide. Keep an eye on future developments from India to the world and investments from US-based life science companies in India’s strong talent base.

3. Breakthroughs in Alzheimer’s Disease Treatment

A novel gene-editing therapy targeting the APOE4 gene variant in the United States shows promise in addressing Alzheimer’s progression, and three new drugs were approved in the United Kingdom that may slow down memory decline in early Alzheimer’s disease. This continuing commitment by life science companies to invest in Alzheimer’s treatments after waves of disappointments could mark a turning point in one of the most vexing and worrisome neurodegenerative diseases.

Additionally, long-standing preventive disease pioneer Dean Ornish, MD, Founder and President of the Preventative Medicine Research Institute, has shown a possible pathway to reversing Alzheimer’s symptoms without medication. Ornish’s research on lifestyle interventions—emphasizing diet, exercise, and stress management—gained significant attention in 2024 and highlights the role of holistic approaches in improving cognitive health. His pathway does not dismiss using prescription medicine. Leading medical minds and consumers’ minds should take lifestyle medicine seriously.  It’s not the first time that Dr. Ornish has been proven right.

4. United Kingdom Moves Toward Digital Health Leadership

The United Kingdom launched a nationwide digital health initiative integrating wearable technology with its revered National Health Service (NHS). By enabling people to track chronic conditions like diabetes and hypertension in real-time, the initiative enhances patient engagement and accelerates preventive care delivery. Early results indicate improved patient outcomes and reduced hospital admissions. Looking ahead, 2025 could see the expansion of this initiative to include predictive analytics, further enhancing preventative care and patient empowerment.

UK Finance Minister/Chancellor Rachel Reeves announced in 2024 that the government is increasing the national health budget by US$29.33bn, a significant increase in NHS resourcing. Increased investment in infrastructure, technology and patient care position the United Kingdom as a launching point for new biomedical research and innovation waves.

5. Cancer Vaccines Gain Momentum

Personalized cancer vaccines emerged as a game-changing innovation in oncology. These vaccines train the immune system to target and destroy cancer cells based on the unique genetic mutations in an individual’s tumor, offering a highly tailored approach to treatment. A U.S.-based biotech company reported successful Phase 3 trial results for a melanoma vaccine, demonstrating significant reductions in recurrence rates.  

One promising example is the Moderna and Merck mRNA-based vaccine program for adjuvant treatment of high-risk melanoma. In Phase IIb results, the therapy showed a 44 percent lower risk of cancer recurrence or death compared to Merck blockbuster cancer drug Keytruda alone. Ongoing trials are exploring its efficacy in combating other cancers, such as lung and breast cancer. These are rigorous clinical programs with all the scientific peer-review requirements of a new medication.

6. America Begins to Take Serious Note of Obesity

The United States has finally begun to address obesity as a serious health concern. New policies and initiatives have been implemented to combat this epidemic, including improved access to nutrition education, increased funding for obesity research, and the development of innovative treatment options. Food and Drug Administration approval of new weight-loss GLP-1 drugs has sparked hope for more effective interventions. Additionally, public health campaigns have raised awareness about the long-term health risks associated with obesity, leading to a shift in societal attitudes and increased support for those struggling with weight management.

While weight-loss drugs offer promise, addressing obesity as a multifaceted health issue—spanning diabetes, heart disease, and more—remains critical. However, medications alone are not the miracle solution to the world’s weight problem. Will 2025 become the year of recognizing obesity as an umbrella disease?

7. Israeli Innovation –  Resilience Under Pressure

Sudden attacks from all directions would consume any nation’s emotional and physical energies. If so, the past 16 months should absolutely distract Israel – a country the size of New Jersey – and its nine million Jewish, Muslim, and Druze citizens – from anything other than self-defense.  Despite incredible challenges, Israel continues to innovate, with its 1,600 life science companies driving advancements in digital health, diagnostics, and bio-convergence. Israeli startups raised $2.43 billion in the third quarter of 2024 across 99 rounds, representing a 32 percent increase compared to the same period in 2023 (pre-October 2023)

The number of groundbreaking Israeli-developed medical devices, biologics, and information technologies incorporated into US-headquartered life science companies’ pipelines and product portfolios secures this nation’s position as a global innovator hub. Its role model hospital, Sheba Medical Center, ranks among the world’s top health systems and seamlessly integrates the country’s cutting-edge technologies in intensive care, telemedicine, early diagnostics, smart surgical equipment, and digital imaging throughout its system.

Israel is taking another leap in health innovation through its investment in bio-convergence. It is poised to play a significant role in the next technological wave of the 21st century. 

8. US Advances in Regenerative Medicine

Regenerative medicine focuses on repairing or replacing damaged tissues and organs, tapping into the body’s natural healing processes. Innovations like stem cell regeneration, cell therapy, diabetes and regenerative knee treatments offer alternatives to invasive surgeries and improve outcomes for chronic conditions.

Regulatory frameworks are crucial to this progress, providing clear guidelines and streamlined approval processes to ensure safety while fostering innovation. As regenerative medicine reshapes health delivery, it stands out as a transformative force in addressing some of the most pressing medical challenges. It is science fiction in many ways—maintain an open mind.

9. Global Antimicrobial Resistance Collaboration

The WHO’s global antimicrobial resistance network is a critical step in combating superbugs. It enables real-time data sharing to identify resistance patterns and drive new antibiotic development. It is a big deal. In a world where pathogens know no borders, collective action through such a network is essential to safeguarding the efficacy of treatments and protecting lives worldwide. The urgency has willing partners ready to engage.

This collaborative surveillance network is a big step forward in the response to a silent pandemic threatening global health. Coordinated action across nations equips health systems with real-time tools to identify and respond to resistance patterns. The rise of drug-resistant infections undermines decades of medical progress, turning treatable conditions into life-threatening challenges. A unified surveillance network enhances early detection and targeted interventions and drives the development of new antibiotics and stewardship programs.  Watch what happens in the coming year – our well-being is at stake.

10. A New White House Administration – Anxiety Versus Reality

As the second Trump administration prepares to take up residence in the White House, health ecosystem stakeholders are abuzz about potential policy shifts. Drawing from past actions and election campaign rhetoric, it’s anticipated that this administration – based on executive nominees such as Robert F. Kennedy, Jr., might implement changes through executive authority, bypassing congressional approval.  Food regulation policy is almost a given.  What about access to (some) vaccines? How about the review and regulations of medicines?  Verbal controversy leaves many wondering what will happen next.

The incoming administration’s health policy agenda remains uncertain, with potential changes to the ACA, Medicaid, and reproductive health policies sparking debate. Additionally, there may be moves to restrict access to abortion and contraception, reshape Medicaid through waivers and work requirements, and revise policies affecting LGBTQ+ health and immigration-related health needs.  The possibilities that can generate anxiety are numerous.  Wait and watch!

The Year Ahead and Beyond

These 10 health developments reflect the intersection of innovation, policy, and global collaboration. As we navigate 2025, the focus on improving lives and addressing disparities remains our collective responsibility – to rally to ideas and innovations that can improve people’s and our planet’s well-being.

From AI-supported diagnosis to vaccine breakthroughs in India and digital health leadership in the UK, the global health community demonstrates endless ingenuity. The developments of 2024 offer a roadmap for the future, proving that innovation is a team sport and together can overcome even the most formidable health challenges.

But innovation is like a Jenga structure—pull out the wrong piece at the wrong time, and health innovation can crumble or come to a screeching halt. It rests on three pillars: 1. People, 2. Policy, and 3. Investment. If policies do not support continued biomedical advances, equity and big business will likely search for other sectors that offer promise with a clear vision of a return on investment.

Let’s watch and advocate for a world where health in developed and emerging nations remains a top priority.

The post 2024 Health Trends: Progress, Challenges, and Opportunities appeared first on Medika Life.

Introduction

Infant vaccination has been a cornerstone of global health, demonstrating over more than 100 years the health and socio-economic benefits of the reduced burden of infectious diseases. Yet, despite being the most cost-effective intervention after hygiene improvements, vaccination has repeatedly faced multiple challenges in its implementation. From the difficulty of ensuring sustainable and equitable access to vaccines, to the programmatic complexity of an increasing number of vaccine-preventable diseases and socio-cultural challenges to vaccine uptake, various factors continue to jeopardize the optimal benefits of vaccination.

Pertussis, also known as whooping cough, used to be one of the primary causes of childhood disease and death worldwide until the 1980s. Vaccination has since successfully reduced the overall burden and mortality from pertussis¹, yet it remains among the ten major causes of mortality in children < 5 years-old². Modelled estimates suggested as many as 116,510 deaths globally in 2019³. In fact, as early as twenty years after generalized vaccination, epidemiologic trends, first in the USA^4, then in France⁵ and in other European countries, showed that the disease was still not sufficiently controlled.

There are numerous factors that contribute to the issue: 1) the waning of the protection elicited by infection or vaccination, 2) the absence or low uptake of regular vaccine booster doses beyond early childhood, 3) demographic dynamics such as the aging of previously unvaccinated cohorts exposed to the intense pre-vaccination force of infection, along with 4) high transmissibility of the pathogen. These factors coalesce to rebuild the pool of susceptible individuals after initial vaccine introduction.

Individuals not only become ill with pertussis but also intensify the circulation of the pathogen across age groups, inducing a shift of the burden towards unvaccinated individuals. The latter may be too young to be vaccinated or be under-vaccinated because they do not have access to, are not eligible to, or chose not to receive vaccination, including boosters.

Pertussis is highly transmissible and natural infection or vaccination does not produce life-long immunity. As a result, its control at the population level requires a high rate of vaccine-induced protection across age groups. Modelling of the pertussis epidemiology in Massachusetts, USA, has shown that suboptimal vaccination across age groups has resulted in the resurgence observed across the 2010-2020 period⁶.

Data from outbreaks across the 2010s have shown that large-scale outbreaks are still an ongoing issue. California for example had its worst outbreak in 60 years in 2010⁷. While the disease had nearly disappeared during the COVID-19 pandemic, likely owing to non-pharmaceutical interventions and possibly under-detection, since 2022, sizeable outbreaks have re-started to occur on all continents. The patterns observed in these outbreaks reflect the same trends as observed in the 2010s.

On one hand, in high-income countries and some middle-income countries, vaccine coverage rates are close to, or above 90% with the primary series in infancy. This has shifted the burden of pertussis to infants too young to be vaccinated (especially those whose mothers have not received a booster vaccine during pregnancy), and older children, adolescents and adults in the absence of booster vaccinations.

Outbreaks in the UK⁸, Denmark⁹, Spain¹⁰, or Russia¹¹ in 2023-2024 followed this pattern. On the other hand, many low- and middle-income countries have struggled with maintaining or achieving the necessary high vaccine coverage rates (VCR). Most do not offer comprehensive booster vaccination yet, and often have limited surveillance capacity. As a result, these countries typically have a heterogeneous and incomplete understanding of the burden of pertussis and its distribution.

As observed in the 2022-2024 outbreaks in South Africa^12,13,14, Indonesia¹⁵ and the Philippines¹⁶, where suboptimal infant VCRs persist, the disease and its associated mortality likely continue to affect infants of various ages, including of the age to be vaccinated, along with older age groups.

Contrary to pertussis, a respiratory bacterial disease for which neither infection nor vaccines induce long-term protection, polio is a rare yet devastating neurological complication of a just as highly infectious enterovirus, which induces strong and long-lasting immunity as an infection and as a vaccine. Vaccination has reduced polio cases by over 99% since its introduction. More than 40 cases of wild-type polio have been reported in 2024¹⁷. We may be closer to eradication, but reductions in VCR have placed this goal in jeopardy.

The continued use of oral polio vaccine (OPV) in settings struggling to achieve and maintain high VCRs and the challenges encountered in the discontinuation of OPV2 vaccines have resulted in persistent circulation of vaccine-derived polioviruses (cVDPV¹⁸) which are the cause of more than 90% of cases of paralytic polio today.

Yet, even following eradication, inactivated polio vaccine (IPV) will continue to be a necessary component of routine immunization (RI) due to the potential for resurgence that may arise from issues such as reservoirs of wild-type or vaccine-derived virus and disease slipping by surveillance programs, or from contamination from stockpiles of the virus.

 Vaccine coverage rates are in jeopardy

The high infectiousness of B. pertussis and poliomyelitis virus requires VCRs exceeding 90% for all doses and – in the case of pertussis – regular immune boosting to ensure durable protection to control the diseases and avoid large outbreaks^19,20,21,22  as highlighted by global vaccine targets.

The rapid resurgence of pertussis incidence in the UK following infant VCR decrease in the wake of the whole-cell pertussis vaccine safety scare in the 1970s²³, or the re-appearance of cases among young children in Australia after the country removed the toddler booster dose of pertussis vaccine in 2003 should serve as historical demonstrations that compliance and timeliness for all doses of the recommended pertussis vaccination schedule are essential to pertussis control^24,25.

Unfortunately, not only are we not reaching these targets globally, but VCRs have been decreasing in countries across the globe and the COVID-19 pandemic made matters worse²⁶. There had been progress in the WHO SEARO region with a significant improvement in VCR from 2010 to 2019, but the COVID-19 pandemic pushed it back to 82%, comparable to the level observed in 2010. This has since risen to 91% in 2022, returning to pre-COVID-19 levels²⁷. But post-COVID19, most RI systems have still not recovered.

There had been a notable decline in VCR in the Americas in recent years, with DTP-3 vaccination, used as a benchmark for VCR, reported to have dropped from a high point of 96% in 2015 to 77% by 2022, by which time it had started to recover from a low of 68% in 2021²⁷. Even in HICs such as France, there were delays in RI due to the pandemic²⁸. UNICEF estimates that 67 million children missed out entirely or partially on RI between 2019 and 2021; 48 million of them missed out entirely²⁹. Global and national figures of vaccine coverage reported by UNICEF, WHO or national institutions often are not a complete representation of the heterogeneous, subnational situations.

Numerous countries of all socio-economic development strata face situations where, even if country-level infant VCRs are high, communities with low VCRs, often for a variety of reasons, pose a challenge to disease control creating fertile ground for outbreaks. This had already been observed in the 2010s, with a number of outbreaks in North America. Communities with high vaccine exemption rates were found to exacerbate circulation of the pathogen and concentrated initial outbreaks eventually spilled into the broader community^30,31,32,33.

Recent post-COVID-19 epidemiology of pertussis is demonstrating this once more, with instances in Israel and Thailand, where outbreaks in 2023 were initially concentrated among poorly vaccinated religious communities ^34,35.  

While the COVID-19 pandemic has wreaked havoc in healthcare systems, including vaccination programs, the difficulty many countries face in reaching and sustaining high VCRs has been a long-standing issue that has had an increasing impact in recent years. Suboptimal VCRs can have multiple causes, and the 5 As principle³⁶ (Access, Affordability, Awareness, Activation, Acceptance) provides an excellent framework for evaluating them. Access, or lack of it, refers to various parameters of healthcare and vaccination services which may impact the capability of individuals to receive vaccination such as distance and location, hours of opening, staffing and vaccine stock availability.

Affordability denotes the ability of individuals to afford vaccination, both in terms of financial and non-financial costs, for example, in terms of time away from work to receive the vaccine. While these first two parameters may vary from country to country, diphtheria, tetanus, pertussis and polio vaccinations have long been established as the cornerstone of vaccination programs in all countries. The framework’s concept of awareness encompasses the extent and limitations in the knowledge of disease risk and of the vaccination schedule, which can affect the willingness and motivation to vaccinate, leading to complacency.

Activation is related to awareness as it refers to the motivation of parents and healthcare providers, through reminders or nudges towards ensuring complete and timely vaccination of the infants. In this regard, the role of healthcare providers in activating parents towards vaccinating their children is essential. Issues such as healthcare providers opposing mandatory vaccination (as demonstrated in a study from Switzerland³⁷) have further cemented some individuals against vaccination, impacting VCR.

Finally, acceptance has likely become one of the core factors affecting vaccine uptake, notably in the wake of the COVID-19 pandemic. Vaccine hesitancy is associated with a lack of trust in vaccine safety and science, and skepticism about vaccine efficacy^38,39. It was increasingly affecting VCRs before the COVID-19 pandemic, but the large-scale vaccination campaigns against COVID-19 further fueled vaccine hesitancy⁴⁰.

How hexavalent vaccines have become the standard of care

The value of combination vaccines has been long recognized and explains why pertussis vaccines have been combined with other antigens in a single injection practically since their development. With combined pediatric vaccines, children benefit from fewer injections, resulting in less discomfort, fewer potential episodes of adverse effects, and improved adherence to vaccination schedules⁴¹. For parents, acceptability has been shown to be higher when appointments are reduced through fewer injections⁴².

Studies in the Gambia and South Africa documented concerns among parents about a child receiving more than two injections in a single visit^43,44. The fewer injections afforded by combination vaccines also mitigate productivity loss due to medical appointments for parents. From the perspective of healthcare providers, fewer injections reduce the time imposed on medical staff for the administration – a critical advantage in low-resource settings – while reducing administrative burden and potential for errors and injuries.

For the overall health system, not only do combination vaccines ease the logistical management of vaccines (e.g. cold chain management, procurement and distribution administration), and open up the RI programs for new vaccines, but they have also been shown to improve VCRs for all covered diseases^41,45,46, reducing the potential for outbreak occurrence, and in turn, potentially easing the burden on the healthcare system.

Until the early years of the 21^st century and up to recent years in many countries, pentavalent vaccines were established as the standard of care⁴⁷. However, different pentavalent vaccines contained different antigens. Pentavalent vaccines developed with whole-cell pertussis vaccine (wP) lacked IPV, an essential element of polio eradication, while pentavalent vaccines produced with acellular pertussis vaccine (aP) lacked Hep B. This divergence meant that gaps and inequities remained globally in the immunization of infants.

Technological advances, first attained with aP vaccines and more recently with wP vaccines, led to the formulation of hexavalent vaccines providing immunization against diphtheria, tetanus, pertussis, hepatitis B, Hib disease and polio with inactivated vaccine in a single injection. This breakthrough holds the promise of providing all infants worldwide with early protection against six diseases, cementing polio eradication efforts into infant RI⁴⁸.

The introduction of hexavalent in South Africa reduced the number of injections per visit, potentially saving three visits and three Hep B injections while implementing five new vaccines (four IPV + one Hib) into existing RI schedules. This has saved an average of 8 USD per child and 3 USD of additional savings in HCP labor costs and parents’ time. Consequently, combination vaccines help save around 10 USD per child in South Africa⁴⁹.

Characteristics of aP vs wP hexavalent

Manufacturing and composition

While hexavalent vaccines are increasingly viewed as the gold standard of care for infant vaccination, the fundamental difference in pertussis antigen composition between aP and wP-based hexavalent formulations has important implications.

Whole-cell pertussis vaccines are suspensions of the entire Bordetella pertussis organism that has been inactivated. This bacterium is fastidious to grow, and the complexity of its more than 3000 antigens makes it impossible to precisely characterize the composition of the vaccine and its reproducibility⁵⁰. As a result, different wP vaccines and different batches of the same wP vaccine may contain variable amounts of protective antigens and reactogenic components⁵¹.

The use of an optic measure of bacterial density in wP vaccine formulation and of imprecise and poorly controlled potency assays for measurement of potency⁵² reflects and reinforces this lack of control over the vaccine composition and precludes prediction of its efficacy from potency measures⁵³.

In contrast, aP vaccines are formulated using purified antigens, including at least the pertussis toxin, and one or more adhesins for most aP vaccines. Each antigen is purified and detoxified individually, ensuring the removal of most reactogenic components of the bacterium. The formulation relies on precise quantification of each antigen, resulting in the inclusion of defined amounts of each antigen in the final vaccine⁵¹. As a result, the composition of aP vaccines, confirmed through antigen-specific precise evaluation of potency, has proven reliable and reproducible since their development in the 1990s.

Efficacy/effectiveness

This fundamental difference in control over the consistency in antigenic composition of pertussis vaccines has direct implications for their immunogenicity and protective effect. Historical wP vaccines were tested for efficacy in the clinical trials of aP vaccines in the 1990s. These wP vaccines, which are no longer produced, were found to range in efficacy from 36% to 98% for different wP vaccines, as well as for the same wP vaccine in different trials⁵⁴.

The current wP vaccines have never been tested for their efficacy against pertussis disease in a randomized clinical trial, and the single available study of effectiveness recently conducted in the Central Africa Republic would appear to put their protective effectiveness and duration in doubt⁵⁵. Furthermore, the inherent difficulty in producing wP vaccines of consistent composition resulting from the difficulty in standardizing the culture of B. pertussis is compounded by the use of inadequate clinical immunogenicity assays in the few clinical trials conducted with the current wP vaccines. These assays are generally semi-quantitative and designed to diagnose pertussis. They are rarely validated for precisely quantifying the immune response to a pertussis vaccine⁵⁶.

For this combination of reasons, wP vaccines have previously been shown to give variable results between different manufacturers, but also for the same manufacturer with different assays^57,58,59. This makes it difficult to reliably evaluate the strength and consistency of the immune response elicited by wP vaccines, let alone comparing immune responses between vaccines.

In contrast, the aP vaccines used in the formulation of currently licensed hexavalent vaccines, regardless of the number of pertussis antigens, demonstrated consistent levels of efficacy in the 1990s clinical trials, and recent real-world evidence has confirmed their continued, consistent effectiveness^60,61,62,63. Extensive clinical development plans have yielded a large body of evidence on their immunogenicity. Clinical trials conducted in diverse settings using many of the existing infant vaccination schedules have confirmed through validated immunological assays that currently licensed aP hexavalent vaccines induce robust and consistent immune responses^64,65,66.

The immunity induced by pertussis vaccines, wP or aP, as by disease, is not life-long and has been shown to wane over time as illustrated by peaking disease incidence in age groups several years away from their last dose of vaccine⁶⁷. There has been controversy over a potential different duration of protection elicited by aP and wP vaccines^68,69,70.  Yet, while several studies have tried to measure the duration of protection afforded by currently used aP vaccines, only very little data exist on the effectiveness, let alone its duration, of currently used wP vaccines^55,71,72,73. 

Newer studies have clearly demonstrated that neither aP nor wP provides long-lived protection and that a robust booster schedule is required to ensure prolonged protection and disease control^55,74,75,76.

Safety profile

The development of aP vaccines was triggered by concerns not only about the reliability and efficacy of wP vaccines but also their reactogenicity. The higher reactogenicity of wP vaccines compared to aP vaccines has long been demonstrated^77,78, including the impact it can have on vaccine acceptance and completion of vaccine schedules.

In a Cochrane meta-analysis of historical clinical trials, wP recipients had a 77% higher risk of failing to complete their schedule due to adverse events compared with aP recipients⁷⁸. The study also found that aP recipients did not have any statistically significant increase in risk of failing to complete their vaccination schedule compared to the placebo control group, indicating a high degree of acceptability.

In more recent evidence, the frequency of adverse events reported in a phase 3 clinical trial following vaccination with one of the current hexavalent wP vaccines was largely higher than with an aP hexavalent vaccine in the same population using the same schedule^57,79. In fact, real-world evidence analyzed at the time the Chilean national immunization program transitioned from wP to aP vaccines showed a 67% reduction in the reporting of adverse events⁸⁰.

This higher reactogenicity of wP vaccines was found to affect acceptance and completion of the infant schedule of vaccination in a recent example of high media coverage of a series of severe adverse event-related hospitalizations and one death following wP vaccination in Vietnam resulting in a significant drop in VCR⁸¹.

Hesitation regarding adverse events was also observed in Brazil, where a study in São Paulo state showed a 20% decrease in schedule completeness and timeliness in children of parents who reported a previous adverse event following vaccination compared with parents who did not report an adverse event⁸².

Finally, the difficulty in ensuring consistent composition of wP vaccines, including in reactogenic components also poses a challenge to the sustainability of VCRs. In two examples in Chile and in El Salvador^83,84, a change in the supplier of the wP pentavalent vaccine used in the national immunization programs of these countries resulted in a near doubling of the frequencies of adverse events, including serious adverse events such as febrile seizures and hypotonic-hyporesponsive episodes.

Such unexpected, dramatic increases in the frequency of adverse events can further erode parental confidence in the safety of the vaccines and their willingness to see their child fully vaccinated. 

Inequities resulting from the different profiles of aP and wP vaccines

In countries where wP vaccines remain the only publicly funded pertussis vaccines, the higher reactogenicity of wP vaccines poses the risk of lower acceptance and VCR among the poorer segments of the population, leaving infants unprotected against pertussis as well as the other diseases included in the combination vaccines such as diphtheria, as well as polio in hexavalent combinations.

Pentavalent acellular pertussis vaccine introduction in Costa Rica was followed by a marked increase in VCR, this was most prominent among the lowest wealth quintiles. In 2011 the overall coverage among the lowest wealth quintile was 79.2% for the third dose of pneumococcal conjugate. By 2018 this had risen to 94.4%⁸⁵.

Inequities also arise from the burden of reactogenicity. In countries where aP vaccines are only available to those who can afford to pay for them, the poorer families also have to bear the economic burden of higher frequency and severity of adverse events resulting from publicly funded wP vaccines.

The potentially variable safety and efficacy profile of wP vaccines may also expose infants of lower-income families to inequitable exposure to health burdens due to the increased risk of adverse events and potentially increased risk of disease compared to those who can afford more consistent aP vaccines.

The higher nominal cost of purchase of aP vaccines compared to wP vaccines is often an important limitation to ensuring publicly funded, equitable access to aP vaccines, especially in developing and emerging economies. However, the cost of vaccination programs reaches well beyond the procurement cost of vaccines; it encompasses not only the vaccine purchase but also the costs of its logistical management as well as the cost of managing adverse events following immunization, the cost of VCR catch-up campaigns and the cost of illness resulting from under-vaccination.

Considering the economics of the broader public health budget, the adoption of aP hexavalent vaccines in national immunization programs (NIPs) represents a much smaller premium compared to the purchase price of the vaccines⁸⁶.

 Conclusion

The scientific and technological advances in vaccine production of the last two decades have yielded options for routine immunization that can help achieve the WHO’s Immunization Agenda 2023 to “leave no one behind” and to help ensure infants worldwide receive adequate and complete protection against up to 6 diseases in a single injection.

A purposeful decision needs to be made, however, when deciding to opt for a pentavalent or a hexavalent, and for the type of hexavalent vaccine sourced for a national immunization program. In making this decision, policymakers should consider the following factors.

Acceptability of hexavalent vaccines

Multiple injections have been shown⁴³ to be less acceptable to parents, and hexavalent vaccines can reduce this concern. This has been demonstrated across numerous economic settings, including the examples illustrated above in the United States, South Africa, and Gambia.

Evidence has demonstrated time and time again and in every setting that elevated reactogenicity can hinder the achievement and maintenance of the required high VCRs. Besides the higher healthcare costs associated with adverse event management, these lower VCRs may induce increases in the incidence of the disease and increased costs for public health authorities both for disease management and vaccination catch-up.

While these considerations are likely applicable in all settings, the heterogeneous robustness of surveillance settings may mean that local, sentinel surveillance studies with trained pediatricians in selected healthcare facilities may be required to establish convincing evidence.

Conserving vaccine system resources

Hexavalent vaccination presents the opportunity to reduce the number of necessary vaccination doses while optimizing efficiency (resource needs over results achieved). Though up-front costs may be higher, hexavalent acellular vaccination may be more cost-effective in the long run through their contribution to help raise and sustain VCRs.

Costs must be determined on a country-specific basis, and include additional costs incurred through adverse reactions and remediation of suboptimal VCRs (disease costs, catch-up costs).

Reducing the number of zero-dose and under-immunized children, aiming toward the global vaccine agenda

Zero-dose children have increased in number since the start of the pandemic, increasing the risk of disease and creating reservoirs of transmission, typically among geographically isolated and/or economically vulnerable communities. Hexavalent vaccination, as with all the component parts of the vaccine, will reduce long-term disability and impairment. This must be factored into costs.

Hexavalent can help VCR for the six antigens in the same way that pentavalent improved VCR for Hib/Hep B and DTP3⁴⁵. There is a need for high VCR to reduce the risk of polio recurrence. Following the withdrawal of OPV, coverage with IPV will be essential to prevent resurgence. The inclusion of IPV as part of hexavalent vaccination ensures its use in routine immunization and is aligned with the WHO’s recommendations⁸⁷.

Sustainability stemming from reliability

Higher predictability of safety and efficacy of aP vaccines is key in ensuring high National Immunization Programme VCR, and reliability of disease control at the population level. Acellular pertussis vaccines have been used for over 25 years and have a well-established safety, efficacy and effectiveness profile. This is sharply contrasted by the very limited to complete lack of available data for currently used wP vaccines.

Strong pharmacovigilance and surveillance of the disease in countries still using wP vaccines would help in the reassessment of the type of vaccine used in their national immunization programs. These data will increase awareness of the disease for public health authorities and establish the need for robust programs with reliable vaccines.

[This consensus paper is based on the discussions of a global expert panel (consisting of the paper’s authors) focusing on paediatric immunisation, supported by Sanofi.]

References

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As the world gradually recovers from the shockwaves of the COVID-19 pandemic, the spectre of another potential public health crisis looms ominously on the horizon. A recent report in The Lancet on the risks of avian influenza H5N1 at mass gatherings is a critical reminder that our vigilance against infectious diseases must remain steadfast, especially as we approach a summer filled with major religious, cultural, and sporting events.

Mass gatherings have always been fertile ground for spreading infectious diseases, serving as hubs for international transmission. From the annual Hajj pilgrimage to the bustling celebrations of Kumbh Mela, these events draw millions of people from around the globe, creating perfect storm conditions for pathogen spread. The resurgence of avian influenza, particularly the H5N1 strain, poses a renewed threat that demands immediate and focused attention.

The Silent Spread of H5N1

H5N1, also known as Highly Pathogenic Avian Influenza, has been on the radar of global health authorities since its emergence in 2004. Despite not currently transmitting easily from person to person, recent reports of mild or asymptomatic human cases in the USA, China, Vietnam, and Europe are alarming. The first human case in the USA was reported in 2022 in Colorado, linked to direct poultry exposure. Similarly, England has documented 298 cases since October 2021. This underscores the virus’s persistence and the potential for rapid, widespread outbreaks if left unchecked.

Lessons from History: Preparedness Pays Off

Historical precedents demonstrate the critical importance of proactive public health measures. The past decade has seen mass gatherings successfully navigate Zika, Ebola, and COVID-19 threats through meticulous planning and surveillance. For instance, the 2015 Africa Cup of Nations in Equatorial Guinea proceeded safely amidst the Ebola outbreak, thanks to stringent health protocols and international cooperation.

The ongoing efforts to prevent outbreaks at events like the Tokyo 2020 Olympics and various religious gatherings highlight the effectiveness of preparedness. Yet, these successes should not breed complacency. The ever-evolving nature of viral pathogens necessitates continuous vigilance and adaptation of our health strategies.

The One Health Approach: A Unified Front Against Zoonotic Diseases

The interconnectedness of human, animal, and environmental health underscores the need for a comprehensive One Health approach. Mass gatherings often involve the consumption of animal products and, in some cases, live animal sacrifice. This creates multiple avenues for zoonotic transmission, particularly with avian influenza viruses.

Countries hosting mass gatherings must implement rigorous screening and testing protocols for poultry and other animals to mitigate these risks. This includes mandatory surveillance of imported animals and those used in religious rituals. Wastewater surveillance can also provide early detection of viral presence, allowing for swift intervention.

Bridging Knowledge Gaps: Research and Surveillance

Mass gatherings present unique opportunities for real-time research and data collection. Understanding the transmission dynamics of H5N1 and other zoonotic pathogens is crucial for developing targeted interventions. Enhanced surveillance, using advanced diagnostic platforms, can identify and monitor emerging threats, filling critical knowledge gaps.

The Path Forward: International Cooperation and Vaccine Development

Ultimately, the global community must unite in the face of these emerging threats. Developing and distributing effective vaccines for H5N1 and its variants will be pivotal in safeguarding public health. Collaborative efforts involving organisations like the WHO, FAO, and OIE are essential for a coordinated response.

A Two-Year Effort to produce a global pandemic treaty misses its deadline. On Friday, May 24, Tedros Adhanom Ghebreyesus, the director general of the World Health Organization, announced that the negotiators from the group’s 194 member nations couldn’t reach a consensus in time for the World Health Assembly, which started this week.

The goal had been to draft a document that could be adopted at the meeting and then sent to countries for ratification. However, the sticking points—including the willingness of richer countries to share vaccines and treatments with less well-off countries in the Global South—could not be resolved in time.

What Next?

Scientists predict the next pandemic could occur soon, perhaps in two years or twenty. Still, the message is clear: proactive surveillance and preparedness are not optional. They are imperative. By learning from past experiences and embracing a unified approach, we can protect millions of lives and ensure that mass gatherings are celebrated safely worldwide.

Christopher Nial is a senior partner at FINN Partners. He specialises in global public health and the intersection between climate change and public health. With over 30 years of experience, he is passionate about leveraging public health strategies to save lives.

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It was a move that supercharged my mission to make a difference in the world. It sparked a passion for providing people with a better shot at prosperity by improving access to health services, often by working in some of the world’s most challenging places.

My public health journey has had a lot of high points and reached another milestone this week with the launch of the FINN Partners Global Health Impact Group dedicated to harnessing the potential for health to catalyze economic growth in emerging markets and underserved communities around the world.

Looking back, I could not have wished for a better time to shift to public health. I started my career working in the consumer goods sector in Southeast Asia when countries there were the hottest economies around. This background and my corporate experience in the U.S. prepared me to blend traditional marketing and communications practices with the real-world challenges that confronted me in DR Congo and many other African and Asian countries where I would later work.

In the years since I moved to Kinshasa, a historic shift in the balance of power has gained momentum as traditionally poor and middle-income countries – nations whose citizens make roughly between $1,100 and $13,000 per year – gain prominence on the global economic stage.

“The rise of the rest,” as author and CNN Commentator Fareed once called this phenomenon, captures the growth of the group of low- and middle-income countries that now contribute almost 34 trillion dollars to the global economy, nearly one-third of total worldwide output, according to the World Bank.  To highlight the tremendous pace that developing countries have set over the past two decades, consider:  Real Gross Domestic Product (GDP), as reported by the International Monetary Fund, increased at an average rate of 4 percent among developing economies, compared with an average just under 2 percent growth for advanced countries.

While the astounding population growth of young African consumers has not yet translated to an economic boom, as global health communication advocate Mark Chataway notes, I remain optimistic that the dynamic growth we need to drive the global economy will come from the future markets of Africa and Asia.

The emergence of lower-income consumers as a major market force in these two regions offers tremendous opportunities for companies that can re-tool their marketing mix from a model that has traditionally targeted the most affluent one billion people on the planet to one that efficiently reaches the following several billion people.

While this idea isn’t new, it warrants renewed interest and investment in a post-pandemic, highly fractured world flirting with a rejection of globalism in favor of economically ruinous national isolationism.

Here’s why U.S. companies need to deepen their engagement with emerging markets: As incomes continue to rise in more than 100 countries throughout Africa, Asia and Latin America, so too will the demand for better healthcare, convenience products, electronics, and household staples, to name a few categories. 

How can organizations most effectively and sustainably succeed in this environment? In evaluating strategies for entry and sustainable management in many emerging markets, companies should consider establishing alliances with an unlikely resource: leading Non-Governmental Organizations (NGOs) operating locally. 

Building public-private partnerships between corporate and non-profit organizations can benefit both groups working in nascent and emerging markets. NGOs can often provide sharp insight into consumer habits and preferences, access to government influencers, and opportunities to build significant goodwill, brand recognition, and loyalty among local communities through the effective sponsorship of corporate social responsibility projects.

A strategic alliance between non-profits and companies also offers a less threatening means for global firms to operate in a new country than through the development of a venture with a local company in the same industry, a potential competitor that could receive protection from a host government down the road.

International and locally based NGOs have operated in developing countries for decades and have learned through tough lessons what works and what will often lead to failure.  Working with lean budgets and staff, many of these organizations have succeeded in grassroots outreach, communications, mobilization, and behavior change within population segments, often well outside of conventional marketing channels.  Those segments define the middle and bottom-of-the-pyramid consumers now sought after by multinational firms trying to build their brands and sustain competitive advantage in emerging markets.

At the same time, many non-profit organizations now view partnerships with the private sector as essential to their long-term ability to fulfill their mission of serving local populations.  Highly effective corporate responsibility programs have become mainstream in emerging markets as companies work with NGOs to contribute goodwill to needy populations while also meeting operational interests, such as improving employee and community health or safeguarding valuable natural resources that drive local economies.

The power of partnerships can offer three areas of strategic advantage to firms entering developing markets, particularly in Africa and South Asia:

• 360^o Market Data: Rather than relying solely on outside research firms, companies can work with NGO partners to round out their understanding of the consumer landscape in a new country, mainly when vital economic and cultural elements are in play. By operating in poorer communities and managing customer research and outreach operations over several years, NGOs often have a ready-built network of communities for private companies to engage as part of their market shaping.  These communities may deliver a more representative study sample, and the methodology for any consumer research efforts will be more informed through the input that NGOs and local community representatives can offer. At the same time, NGOs need more sophisticated marketing and outreach tools, particularly in segmenting populations, to deliver more relevant messaging.  These are areas of technical expertise that private sector partners can share.

• Access to Government Decision Makers: The emergence of mainstream consumerism in developing countries alters how some governments can support private sector development and direct foreign investment. Local and international NGOs have valuable insights regarding which government contacts are most appropriate to engage and how best to work with them. Money may talk in emerging markets, but transparent relationships with key government decision-makers are paramount for long-term operational success and competitive advantage. NGOs are an integral resource for helping companies to forge these government relationships. Correspondingly, the changing world of international aid requires NGOs to develop multilateral funding streams. Public-private partnerships offer a means for NGOs to build greater credibility and differentiation by demonstrating that they have the project scope and capacity to appeal to a broad base of donors.

• Brand Equity Development: Corporate responsibility programs offer a platform for companies to create brand awareness and loyalty in new markets while building goodwill in under-resourced populations. A partnership with an NGO operating in a developing country provides the opportunity to identify projects that meet a community’s social needs and the sponsoring company’s interests. NGOs undertaking projects may also gain positive recognition through such partnerships, particularly in countries where the reputations of development organizations have suffered from aid fatigue.

The risks are significant for firms venturing into low- and middle-income markets.  Market data, local relationships, and flexible operating models are indispensable resources, as are the right alliances.  Before relying on traditional approaches for assessing new market opportunities, consider how successful engagement and communication with NGO partners may offer the insights and understanding required for companies to reach efficiently and sustainably some of the most promising but untapped segments of the world’s population.

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Advocacy for Africa’s potential as a global vaccine production hub has gained significant momentum. The Africa Centres for Disease Control and Prevention (Africa CDC), through its Partnership for African Vaccine Manufacturing (PAVM), aspires to achieve 60% self-sufficiency in local vaccine use by 2040. This ambitious yet attainable goal underscores the vital steps necessary for realisation.

BioNTech aims to start mRNA vaccine output in Rwanda

Simultaneously, the African Vaccine Manufacturing Initiative (AVMI), a network of manufacturers, has broadened its role, engaging more deeply with multilateral partners and championing the industry’s interests. For example, BioNTech aims to start mRNA vaccine output in Rwanda in 2025. Additionally, the recent surge in bilateral technology transfer agreements and infrastructural investments with local African producers marks a notable shift in the landscape.

The International Monetary Fund (IMF) is playing a role in supporting vaccine manufacturing in Africa by providing financial assistance to governments and businesses involved in the effort. For example, the IMF provided $100 million to Ghana to support the establishment of a vaccine manufacturing facility in the country. The IMF has already worked with African governments to develop harmonised standards and regulations for vaccine manufacturing and provides technical assistance to African governments and businesses on vaccine manufacturing.

Moderna, BioNTech, and the Serum Institute of India (SII) plan to establish vaccine manufacturing facilities in various African countries in 2024. These facilities will initially produce COVID-19 vaccines, but they also have the potential to produce other essential vaccines, such as the measles, mumps, and rubella (MMR) vaccine and the polio vaccine specifically for African populations.

Sustaining Growth

However, sustaining this growth trajectory beyond 2023 necessitates immediate action in three critical areas.

First, ensuring predictable vaccine demand and procurement from African governments is essential. This certainty enables manufacturers to plan effectively and achieve economies of scale. A continental pooled purchasing agreement could guarantee the requisite offtake, providing much-needed stability.

Secondly, a significant increase in financing is crucial. This funding could come from donors, lenders, and public budgets, which are essential to spur ongoing projects and innovation. Initiatives proposed by entities like the Gavi, the Vaccine Alliance and the African Union are critical starting points that must be actualised. The plans from the combined efforts of SII, Moderna and BioNTech must be maintained and not left to be a ‘health-washing’ exercise.

Lastly, a streamlined and efficient regulatory framework is vital for expediting vaccine development and approval processes. Strengthening national regulatory agencies and fostering an integrated system are underway, with the imminent launch of the African Medicines Agency poised to enhance coordination across the continent.

Thus, 2024 emerges as a pivotal year, a unique opportunity for tangible progress if all parties commit to a shared vision of long-term, sustainable success. The groundwork laid by pioneers has brought the dream of African vaccine independence closer to reality. The key to unlocking this potential lies in decisive actions and implementing mechanisms ready for utilisation by Africa’s emerging vaccine enterprises.

The Stakes are High

The stakes are high, with continental health security and economic growth hanging in the balance. The COVID-19 pandemic exposed the risks of dependency on external supply chains. At the same time, a burgeoning pool of local talent in pharmaceutical sciences and biotechnology is eager to address regional health challenges. Decisions made in the next year will determine the pace at which these health and economic benefits can be integrated into the broader economy.

As we face a steady rise in infectious diseases, Africa stands at a crossroads in 2024. It has the opportunity to establish a world-class, integrated vaccine industry that serves its needs and those of the global community. This pivotal moment calls for bold leadership and unwavering commitment. We are at the threshold of a unique opportunity and must mobilise our collective resolve to leverage it effectively. The dawn of Africa’s era of health autonomy and leadership is within grasp, contingent on the essential roles played by key actors.

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