The country’s trajectory has been building for years. A fast-growing middle-income population, rising chronic disease burden, and expanding health infrastructure have created both demand and urgency. What is changing now is the environment in which innovation can move, driving faster approvals, a culture of collaboration, digital infrastructure and a government signaling policy readiness to engage global partners in shaping the next era of medicine.

The economic momentum is significant. The Indian health ecosystem has expanded from roughly $372 billion in 2023 to $638 billion in 2025, making it one of the fastest-growing major health markets in the world. The broader industry is expected to exceed $610 billion by 2026, fueled by rising insurance coverage, expanding hospital infrastructure, and growing demand for chronic disease management. Health growth in India continues at approximately 10–12 percent annually, well above the growth rates typical of mature markets, reflecting both rising access and structural transformation.

BIOAsia 2026 reflects this inflection point. The global gathering in Hyderabad, themed “TechBio Unleashed: AI, Automation & the Biology Revolution,” highlights the (bio)convergence of biology, data, and intelligent systems reshaping health worldwide. Organizers emphasize that the meeting aims to drive health transformation and reinforce India’s position as a leading global life sciences force. For multinational innovators, the message is increasingly clear: India is not only where innovation is deployed; it is also where it is developed. It is where innovation is increasingly defined. India has become a go-to market for multinational enterprises.

Policy Signals and Market Scale: From Opportunity to Strategic Partnership

India’s regulatory and policy environment is evolving in ways that matter deeply to multinational innovators. One pivotal shift came with the country’s decision to allow certain medicines approved in specified developed markets to launch without local clinical trials, a move designed to accelerate patient access while aligning more closely with global regulatory science. This policy shift reflected confidence in international data, a commitment to innovation, and recognition that faster access must remain central to national health strategy.

The scale of India’s pharmaceutical and life sciences market reinforces this transformation. The pharmaceutical sector reached approximately $68 billion in 2025 and is projected to grow to more than $170 billion during the next decade, driven by expanding middle-income demand and strong domestic manufacturing. India already supplies roughly one-fifth of the world’s generic medicines. It produces the majority of global vaccines by volume, positioning the country as a central player in global health supply chains.

As Aman Gupta of SPAG/FINN wrote in Medika Life, “India’s health sector is undergoing a profound transformation, bolstered by government-led reforms and a favorable FDI regime. The allowance of 100% foreign direct investment through automatic routes in health and related sectors has already attracted global giants.” His observation reinforces a central reality for multinational innovators: India’s policy environment is increasingly designed not only to welcome global participation, but to encourage long-term strategic partnership in building the future of healthcare.

Investment trends tell the same story. Health and pharmaceutical private equity and venture investments have reached multi-billion-dollar levels annually. At the same time, India’s contract drug development and manufacturing sector is projected to exceed $22 billion within the next decade. These dynamics position India as a growth market and as a strategic partner across the innovation lifecycle from discovery and clinical development to manufacturing and global distribution.

Shakthi Nagappan, CEO of Telangana Life Sciences Foundation, captured this moment clearly, noting that BIOAsia arrives at a time when technology and biology are redefining healthcare and creating “unprecedented opportunities for innovation, investment, and impact.” The language reflects partnership rather than transaction, a signal that India is moving from market opportunity to strategic collaboration.

Digital Infrastructure, BIOAsia and the Multinational Innovation Imperative

India’s digital transformation may be its most potent catalyst for long-term health innovation. Unlike many mature systems, the country is building a national-scale digital health infrastructure designed to connect patients, providers, and health systems across a population of more than 1.4 billion people, with a rising middle class of 400 million.

The Global Digital Health Market is projected to grow from USD 288.55 billion in 2024 to USD 2,688 billion by 2035, expanding at a CAGR of 22.55% during 2025–2035. This surge is driven by the rapid adoption of AI-powered diagnostics, telemedicine, wearable devices, and data analytics solutions that are revolutionizing patient care and operational efficiency worldwide.

Hundreds of millions of citizens are already using digital health services, including telemedicine, electronic prescriptions, and remote care. The Ayushman Bharat Digital Mission is creating an interoperable national health ecosystem, enabling secure health records, improved care coordination, and population-scale data infrastructure that supports research, real-world evidence, and precision health.

For multinational companies, this digital backbone creates a uniquely strategic environment, enabling large-scale clinical research, faster pharmacovigilance, AI-supported health insights, and rapid deployment of innovation across diverse populations. India’s digital infrastructure is not simply modernizing health delivery. It is enabling national-scale transformation.

BIOAsia sits at the center of this conversation and convergence. The gathering reflects India’s ambition to lead at the intersection of biology, artificial intelligence, and scalable innovation. Leaders from industry, government, and science convene not only to discuss growth but to shape the next phase of global life sciences, where biology, data, and digital systems converge to influence global health.

One conference panel, among the many high-powered sessions, brings together global leaders in advanced therapeutics to explore how next-generation modalities are moving from discovery to scalable care. Panelists across biopharma, translational science, and hospital systems are examining progress in cell and gene therapies, mRNA, and radiopharmaceuticals, underscoring that innovation now depends as much on manufacturable scale and delivery as on scientific breakthrough. India’s expanding capabilities in clinical research and bioprocessing strengthen its role as a key partner in advancing next-generation therapies.

For multinational innovators, the implications are clear. Engagement in India now extends beyond commercialization. It calls for collaboration in research, investment in digital and scientific ecosystems, alignment with national health priorities and partnership in strengthening health delivery.

India’s Strategic Role in Global Health Innovation

India’s rise in global health innovation reflects the alignment of policy, market growth, digital infrastructure, and scientific capability forces that together are reshaping where and how healthcare innovation occurs.

For multinational companies, India now represents a full-spectrum innovation environment. It is a place to conduct clinical research across diverse populations, scale manufacturing and supply chains, deploy digital health at a national scale, and co-develop solutions addressing both local and global health challenges. Increasingly, India is not simply a recipient of innovation developed elsewhere. It is becoming a co-creator of next-generation health.

This shift changes the strategic equation. Market entry alone is no longer sufficient. Meaningful engagement requires partnership with policymakers, regulators, scientists, health providers, and digital health ecosystems. Organizations that invest in collaboration, align with national health priorities, and contribute to strengthening healthcare systems are most likely to succeed in India’s evolving landscape.

BIOAsia sets the stage for this transformation. It is more than a conference. It is a convergence of global health ambition, scientific capability, and policy momentum. The conversations taking place in Hyderabad mirror a broader reality: the geography of health innovation is expanding, and India is now central to its future.

For global health innovators, the question is no longer whether India matters. The question is how deeply they choose to engage in shaping what comes next.

The post India: The Growing Focal Point for Health Innovation appeared first on Medika Life.

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.

The post Global childhood vaccination remains resilient, but equity cracks are widening appeared first on Medika Life.

Erica Hayes, 40, has not felt healthy since November 2020 when she first fell ill with covid.

Hayes is too sick to work, so she has spent much of the last four years sitting on her beige couch, often curled up under an electric blanket.

“My blood flow now sucks, so my hands and my feet are freezing. Even if I’m sweating, my toes are cold,” said Hayes, who lives in Western Pennsylvania. She misses feeling well enough to play with her 9-year-old son or attend her 17-year-old son’s baseball games.

Along with claiming the lives of 1.2 million Americans, the covid-19 pandemic has been described as a mass disabling event. Hayes is one of millions of Americans who suffer from long covid. Depending on the patient, the condition can rob someone of energy, scramble the autonomic nervous system, or fog their memory, among many other symptoms.

In addition to the brain fog and chronic fatigue, Hayes’ constellation of symptoms includes frequent hives and migraines. Also, her tongue is constantly swollen and dry.

“I’ve had multiple doctors look at it and tell me they don’t know what’s going on,” Hayes said about her tongue. 

Estimates of prevalence range considerably, depending on how researchers define long covid in a given study, but the Centers for Disease Control and Prevention puts it at 17 million adults.

Despite long covid’s vast reach, the federal government’s investment in researching the disease — to the tune of $1.15 billion as of December — has so far failed to bring any new treatments to market. 

This disappoints and angers the patient community, who say the National Institutes of Health should focus on ways to stop their suffering instead of simply trying to understand why they’re suffering.

“It’s unconscionable that more than four years since this began, we still don’t have one FDA-approved drug,” said Meighan Stone, executive director of the Long COVID Campaign, a patient-led advocacy organization. Stone was among several people with long covid who spoke at a workshop hosted by the NIH in September where patients, clinicians, and researchers discussed their priorities and frustrations around the agency’s approach to long-covid research.

Some doctors and researchers are also critical of the agency’s research initiative, called RECOVER, or Researching COVID to Enhance Recovery. Without clinical trials, physicians specializing in treating long covid must rely on hunches to guide their clinical decisions, said Ziyad Al-Aly, chief of research and development with the VA St Louis Healthcare System.

“What [RECOVER] lacks, really, is clarity of vision and clarity of purpose,” said Al-Aly, saying he agrees that the NIH has had enough time and money to produce more meaningful progress.

Now the NIH is starting to determine how to allocate an additional $662 million of funding for long-covid research, $300 million of which is earmarked for clinical trials. These funds will be allocated over the next four years.

At the end of October, RECOVER issued a request for clinical trial ideas that look at potential therapies, including medications, saying its goal is “to work rapidly, collaboratively, and transparently to advance treatments for Long COVID.”

This turn suggests the NIH has begun to respond to patients. This has stirred cautious optimism among those who say that the agency’s approach to long covid has lacked urgency in the search for effective treatments.

Stone calls this $300 million a down payment. She warns it’s going to take a lot more money to help people like Hayes regain some degree of health.

“There really is a burden to make up this lost time now,” Stone said.

The NIH told KFF Health News and NPR via email that it recognizes the urgency in finding treatments. But to do that, there needs to be an understanding of the biological mechanisms that are making people sick, which is difficult to do with post-infectious conditions.

That’s why it has funded research into how long covid affects lung function, or trying to understand why only some people are afflicted with the condition.

Good Science Takes Time

In December 2020, Congress appropriated $1.15 billion for the NIH to launch RECOVER, raising hopes in the long-covid patient community.

Then-NIH Director Francis Collins explained that RECOVER’s goal was to better understand long covid as a disease and that clinical trials of potential treatments would come later.

According to RECOVER’s website, it has funded eight clinical trials to test the safety and effectiveness of an experimental treatment or intervention. Just one of those trials has published results.

On the other hand, RECOVER has supported more than 200 observational studies, such as research on how long covid affects pulmonary function and on which symptoms are most common. And the initiative has funded more than 40 pathobiology studies, which focus on the basic cellular and molecular mechanisms of long covid.

RECOVER’s website says this research has led to crucial insights on the risk factors for developing long covid and on understanding how the disease interacts with preexisting conditions.

It notes that observational studies are important in helping scientists to design and launch evidence-based clinical trials.

Good science takes time, said Leora Horwitz, the co-principal investigator for the RECOVER-Adult Observational Cohort at New York University. And long covid is an “exceedingly complicated” illness that appears to affect nearly every organ system, she said. 

This makes it more difficult to study than many other diseases. Because long covid harms the body in so many ways, with widely variable symptoms, it’s harder to identify precise targets for treatment.

“I also will remind you that we’re only three, four years into this pandemic for most people,” Horwitz said. “We’ve been spending much more money than this, yearly, for 30, 40 years on other conditions.”

NYU received nearly $470 million of RECOVER funds in 2021, which the institution is using to spearhead the collection of data and biospecimens from up to 40,000 patients. Horwitz said nearly 30,000 are enrolled so far.

This vast repository, Horwitz said, supports ongoing observational research, allowing scientists to understand what is happening biologically to people who don’t recover after an initial infection — and that will help determine which clinical trials for treatments are worth undertaking.

“Simply trying treatments because they are available without any evidence about whether or why they may be effective reduces the likelihood of successful trials and may put patients at risk of harm,” she said.

Delayed Hopes or Incremental Progress?

The NIH told KFF Health News and NPR that patients and caregivers have been central to RECOVER from the beginning, “playing critical roles in designing studies and clinical trials, responding to surveys, serving on governance and publication groups, and guiding the initiative.”

But the consensus from patient advocacy groups is that RECOVER should have done more to prioritize clinical trials from the outset. Patients also say RECOVER leadership ignored their priorities and experiences when determining which studies to fund.

RECOVER has scored some gains, said JD Davids, co-director of Long COVID Justice. This includes findings on differences in long covid between adults and kids.

But Davids said the NIH shouldn’t have named the initiative “RECOVER,” since it wasn’t designed as a streamlined effort to develop treatments.

“The name’s a little cruel and misleading,” he said.

RECOVER’s initial allocation of $1.15 billion probably wasn’t enough to develop a new medication to treat long covid, said Ezekiel J. Emanuel, co-director of the University of Pennsylvania’s Healthcare Transformation Institute.

But, he said,  the results of preliminary clinical trials could have spurred pharmaceutical companies to fund more studies on drug development and test how existing drugs influence a patient’s immune response.

Emanuel is one of the authors of a March 2022 covid roadmap report. He notes that RECOVER’s lack of focus on new treatments was a problem. “Only 15% of the budget is for clinical studies. That is a failure in itself — a failure of having the right priorities,” he told KFF Health News and NPR via email.

And though the NYU biobank has been impactful, Emanuel said there needs to be more focus on how existing drugs influence immune response.

He said some clinical trials that RECOVER has funded are “ridiculous,” because they’ve focused on symptom amelioration, for example to study the benefits of over-the-counter medication to improve sleep. Other studies looked at non-pharmacological interventions, such as exercise and “brain training” to help with cognitive fog.

People with long covid say this type of clinical research contributes to what many describe as the “gaslighting” they experience from doctors, who sometimes blame a patient’s symptoms on anxiety or depression, rather than acknowledging long covid as a real illness with a physiological basis.

“I’m just disgusted,” said long-covid patient Hayes. “You wouldn’t tell somebody with diabetes to breathe through it.”

Chimére L. Sweeney, director and founder of the Black Long Covid Experience, said she’s even taken breaks from seeking treatment after getting fed up with being told that her symptoms were due to her diet or mental health.

“You’re at the whim of somebody who may not even understand the spectrum of long covid,” Sweeney said.

Insurance Battles Over Experimental Treatments

Since there are still no long-covid treatments approved by the Food and Drug Administration, anything a physician prescribes is classified as either experimental — for unproven treatments — or an off-label use of a drug approved for other conditions. This means patients can struggle to get insurance to cover prescriptions.

Michael Brode, medical director for UT Health Austin’s Post-COVID-19 Program — said he writes many appeal letters. And some people pay for their own treatment.

For example, intravenous immunoglobulin therapy, low-dose naltrexone, and hyperbaric oxygen therapy are all promising treatments, he said.

For hyperbaric oxygen, two small, randomized controlled studies show improvements for the chronic fatigue and brain fog that often plague long-covid patients. The theory is that higher oxygen concentration and increased air pressure can help heal tissues that were damaged during a covid infection.

However, the out-of-pocket cost for a series of sessions in a hyperbaric chamber can run as much as $8,000, Brode said.

“Am I going to look a patient in the eye and say, ‘You need to spend that money for an unproven treatment’?” he said. “I don’t want to hype up a treatment that is still experimental. But I also don’t want to hide it.”

There’s a host of pharmaceuticals that have promising off-label uses for long covid, said microbiologist Amy Proal, president and chief scientific officer at the Massachusetts-based PolyBio Research Foundation. For instance, she’s collaborating on a clinical study that repurposes two HIV drugs to treat long covid.

Proal said research on treatments can move forward based on what’s already understood about the disease. For instance, she said that scientists have evidence — partly due to RECOVER research — that some patients continue to harbor small amounts of viral material after a covid infection. She has not received RECOVER funds but is researching antivirals.

But to vet a range of possible treatments for the millions suffering now — and to develop new drugs specifically targeting long covid — clinical trials are needed. And that requires money.

Hayes said she would definitely volunteer for an experimental drug trial. For now, though, “in order to not be absolutely miserable,” she said she focuses on what she can do, like having dinner with her family.

At the same time, Hayes doesn’t want to spend the rest of her life on a beige couch. 

RECOVER’s deadline to submit research proposals for potential long-covid treatments is Feb. 1.

The post Long-Covid Patients Are Frustrated That Federal Research Hasn’t Found New Treatments appeared first on Medika Life.

As parents you’ve been force fed a barrage of carefully scripted “justifications” for these vaccines and in case anyone considered an independent thought, legislation would simply be updated to include new vaccines, essentially removing your choice. In all States in the US a child cannot enter school without having complied with a vaccination schedule. Can you object? Yes, but only in certain states, and usually only on religious grounds. States like California are mandatory, no matter your objection.

The health impacts of the mandated 16 vaccines (spread over 72 doses, before the age of 18) have never enjoyed close scrutiny. What we do know for certain is that older adults (50+) who benefited from far fewer vaccines (3 on average), have far more resilient immune systems when compared to a 20 or 30 year old. Our immune system benefits from each challenge it receives, learning and growing stronger. By preventing many non-fatal infections through an expanded immunization agenda, we actively restrict our immune system from developing properly.

In short, we are producing weaker and less resilient human beings, one’s that are more prone to disease and more likely to develop chronic conditions.

Shockingly, a pre-licensing placebo-controlled safety study is not required in the US for the licensing of a vaccine. Don’t, however, take my word for it. THE HHS confirmed this in response to a written inquiry in 2018, the reply coming from Melinda Wharton, MD, MPH, then Acting Director of the National Vaccine Program Office. The question is shown below;

Please explain how HHS justifies licensing any pediatric vaccine without first
conducting a long-term clinical trial in which the rate of adverse reactions is
compared between the subject group and a control group receiving an inert
placebo?

Inert placebo controls are not required to understand the safety profile of a new vaccine, and are thus not required. In some cases, inclusion of placebo control groups is considered unethical. Even in the absence of a placebo, control groups can be useful in evaluating whether the incidence of a specific observed adverse event exceeds that which would be expected without administration of the new vaccine. Serious adverse events are always carefully evaluated by FDA to determine potential association with vaccination regardless of their rate of incidence in the control group. In cases where an active control is used, the adverse event profile of that control group is usually known and the findings of the study are reviewed in the context of that knowledge.

Decades of indoctrination and conditioning have convinced us that science never lies and that we cannot question anything produced by the scientific community. Science does not lie, not in a pure, unadulterated form. What we are bombarded with on a daily basis is, however, not any form of science any ethical professional would dare to claim. It is business, abetted by regulatory bodies and governments, masquerading behind and appropriating science, which is then twisted to suit the purposes of the companies benefiting from it.

Truth has become an outdated, antiquated word in the modern world of medical science.

You may ask, what this has to do with RFK, Jr., vaccines, and the medical fraternity?

You’ve recently participated in a global medical experiment with completely unknown consequences, at least none that are yet glaringly apparent, aside from a global increase in cancers, heart conditions and a litany of other other medical conditions, many of which can prove fatal. COVID “vaccines” were administered globally to billions of individuals. You may be one.

Almost all of your doctors and medical professionals, with a few exceptions, encouraged you to take these treatments. The billing that they were approved for broad use was misleading and the manner in which approval was obtained left much to be desired. These treatments were experimental, not adequately tested, and couldn’t remotely be called definitively safe. Why would your trusted healthcare providers do this?

Indoctrination is trusting a system of which they are the product. It no longer exists to foster only the best interest of the patients but rather leaves open the possibility of conflict of interest around “patient care or profit.” Most doctors didn’t even think to question the safety of the “miraculous Covid cure.”

A Global Pandemic

At the end of 2019, the world was exposed to a global contagion we were told was deadly, and much like influenza, in some instances it was. The source of the contagion has yet to be established, but facts seem to point at a Chinese research facility, a topic you can read more about here. Covid was to become a household word over the next two years, one that would dictate movement, work, schooling, and every other normal aspect of our lives as countries closed their borders, curfews were installed, and almost every aspect of our day-to-day life was dictated by our elected governments.

Two months after the outbreak, a miraculous breakthrough was announced: a vaccine! Based on a new technology, mRNA, the vaccine promised to reduce transmission and offer protection. We waited with bated breath, and in late November 2020, the vaccine was released for public use. After months of confinement, travel restrictions, working from home, and avoiding elderly members of our families, we sighed a global sigh of relief.

That sigh proved to be a little pre-emptive. Suddenly, taking the vaccine was no longer a matter of choice. It became mandated, and in many countries governments hid behind cloaks of restrictions rather than coming out and publicly mandating the Covid vaccine. Work, school and access to food and housing were subject to individuals being vaccinated. As I sit and type this, I still cannot believe how dystopian it sounds.

Billions had the vaccine administered, many not though choice, but through coercion. No vaccine, no work, no school, no food, and no access to rented property. In countries like Australia people refusing the vaccine, anti-vaxers, as they were quickly labeled, were even put into interment camps.

A Closer Look Behind mRNA and Pfizer and Moderna’s “Vaccines”

Why would people have refused to be injected with the Covid “vaccines” if they promised to protect you and reduce transmission? It turns out not everyone can be classified as a sheep. Questions were asked right from the outset of the announcement of the release of the vaccines.

It takes anywhere between six to 10 years to bring a vaccine to market. The reason for this is that the vaccine requires lengthy trials to prove safety. We know from experience that side effects can take years to manifest. Bringing a product to market in nine months raised huge flags.

We now know that some companies involved in producing what they loosely termed a “vaccine” to take advantage of market protection (in particular, Modena and BioNTech/and Pfizer) obscured data and omitted certain tests in the clinical trials of their Covid treatments. Tests that would have disclosed the reality of their treatments’ ability to integrate with our DNA, use of the SV-40 enhancer (a known link to cancer) in their treatments in levels far exceeding acceptable levels (clear clinical evidence of this vector has been found in the vaccines despite their continued denial) and effecting a bait and switch with the release of their final product, altered from the original provided for testing.

——–

——

Essentially, and we can debate why until time provides answers, these companies, in a global outbreak orchestrated by unknown players and enforced by your governments, forced an essentially untested, new type of gene therapy (not a vaccine) down your global throats, the full consequences of which have yet to become apparent. This quote is from an expert in the field of genomics (Kevin McKernan, who headed up the global genome project) on the mRNA vaccines.

These gene therapies are an attempt to centralize control over this evolutionary process, where they can mandate mRNA injections into billions of people and play SimCity on the evolutionary process and the human trajectory. They are entirely incapable of doing this and it is a disastrous idea. The hubris of authoritarians is an extinction level risk for humankind and needs to be dis-intermediated swiftly.

I have linked to a few articles in the paragraphs abovefor those with an interest in genomics, viruses, and vaccines. Two years ago, this article would have been labelled as anti-vaxer and dismissed. I sincerely hope we’ve moved beyond that point and that science is able to reclaim its integrity. This brings us back to RFK Jr. and America’s co-opted health care system.

The Perfect Pharma Salesman is…

Your doctor, of course. When you present yourself for medical assistance, you are in fact, facing a representative of the pharmaceutical industry. Doctors will argue vehemently against this, but the fact remains, their universities, courses, curricula, and anything relating to their degrees and the educations they receive is regulated by pharma. Doctors are the public face of a multi-billion dollar marketing scheme and pharma are the beneficiaries.

A doctor is indoctrinated from the first day they step into a class.

Little wonder then they would play along with the farce of the Covid “vaccines”, knowing full well mRNA was a new and as yet unproven delivery method (previously restricted to testing on end-of-life patients) for what was an untested and unsafe treatment. Established beliefs and conditioning often fly in the face of logic and common sense. Little wonder they played along. Indoctrination is a powerful tool.

This indoctrination extends to every aspect of modern medicine, including the ridiculous number of times your child (if you’re a US citizen) is vaccinated by the time they reach the age of 18. Don’t believe me? Read this advice from the CDC, and do make a note of how many times Pfizer and Moderna’s names appear (the same companies that just experimented on you). The question this begs, is why would we suddenly be vaccinating our children so heavily, so frequently, and with a such a dizzying array of shots.

H.R.5546 – National Childhood Vaccine Injury Act of 1986

The United States (in a moment of madness or more likely, successful lobbying) indemnified pharma companies to protect them against any possible legal claims arising from the use of a vaccine in children. In effect, this became a “get out of jail free” card that led directly to the frenzied development of “vaccines” for every imaginable disease under the sun. Once again, doctors were at the forefront of selling these treatments to their patients.

If you’ve been indoctrinated into the faith, it is sacrilege to question your god. In modern medicine, it is tantamount to self destruction. This indoctrination is the main obstacle Kennedy faces. Pharma’s influence permeates every level of modern healthcare, from politics to regulatory authorities such as the CDC and NIH and on, down to the doctors and nurses, the real face of modern medicine.

While many label Kennedy as anti-vaccine and a conspiracy theorist, this is simply a ruse to discredit him and evade examining the real and pertinent concerns he raises relating to the state of American healthcare. He has come up with an incredibly simple and elegant solution to the vaccine question.

Burning the “Get Out of Jail Free” Card

Remove the immunity enjoyed by pharma for childhood and other vaccines and sit back and wait to see how many pharma companies have actual faith in the products they are retailing. Expect to see the number of vaccinations your child currently endures reduced dramatically. Why? Simply because these products do carry risks, severe or otherwise, that have been obscured by companies in their haste to get a product to market. Make hay while the sun shines, as the expression goes, only in this instance it was profit rather than sunshine. Profit that was protected by the US government. Until now.

The topic of vaccines is an especially sensitive one, confounded by multiple factors when it should actually be governed by one simple question. Is the vaccine safe for your child? The truth is, we cannot be sure, except in the instance of mRNA based shots now touted for the market. These are fraught with hidden dangers and Kennedy’s removal of the blanket indemnity for these so called “vaccines” which are actually gene therapies, will no doubt result in their removal from the market.

The reason we cannot be sure is that the clinical trial system is as broken as the rest of healthcare, and is subject to the same manipulation and lobbying influences the rest of the healthcare system endures. Manipulation and subversion of data is common practice, the two most glaring public examples being the latest additions to the vaccine stable, namely Pfizer and Moderna’s Covid treatments.

Kennedy simply wants the truth to out. He wants to ensure your children are enjoying the protection they deserve and that the individuals playing medical roulette with their health are held to account. Convincing the devout (your doctors) of his intentions may be an insurmountable obstacle, unless we can bundle the lot on a donkey on the road to Damascus.

***

[Always consult with your physician to determine medical advice and direction. This article does not intend to suggest you should or should not receive vaccines according to a recommended schedule. It does recommend that you study peer-review science and ask informed questions.]

The post Kennedy’s Biggest Challenge Isn’t Vaccines, It’s Medical Indoctrination 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.]

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The FDA has approved an updated covid shot for everyone 6 months old and up, which renews a now-annual quandary for Americans: Get the shot now, with the latest covid outbreak sweeping the country, or hold it in reserve for the winter wave?

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Healthbeat is a newsroom partnership between KFF Health News and Civic News Company that produces reporting on public health and the systems of prevention that communities rely on to stay healthy. 

The new vaccine should provide some protection to everyone. But many healthy people who have already been vaccinated or have immunity because they’ve been exposed to covid enough times may want to wait a few months.

Covid has become commonplace. For some, it’s a minor illness with few symptoms. Others are laid up with fever, cough, and fatigue for days or weeks. A much smaller group — mostly older or chronically ill people — suffer hospitalization or death.

It’s important for those in high-risk groups to get vaccinated, but vaccine protection wanes after a few months. Those who run to get the new vaccine may be more likely to fall ill this winter when the next wave hits, said William Schaffner, an infectious disease professor at Vanderbilt University School of Medicine and a spokesperson for the National Foundation for Infectious Diseases.

On the other hand, by late fall the major variants may have changed, rendering the vaccine less effective, said Peter Marks, the FDA’s top vaccine official, at a briefing Aug. 23. He urged everyone eligible to get immunized, noting that the risk of long covid is greater in the un- and undervaccinated.

Of course, if last year’s covid vaccine rollout is any guide, few Americans will heed his advice, even though this summer’s surge has been unusually intense, with levels of the covid virus in wastewater suggesting infections are as widespread as they were in the winter.

The Centers for Disease Control and Prevention now looks to wastewater as fewer people are reporting test results to health authorities. The wastewater data shows the epidemic is worst in Western and Southern states. In New York, for example, levels are considered “high” — compared with “very high” in Georgia.

Hospitalizations and deaths due to covid have trended up, too. But unlike infections, these rates are nowhere near those seen in winter surges, or in summers past. More than 2,000 people died of covid in July — a high number but a small fraction of the at least 25,700 covid deaths in July 2020.

Partial immunity built up through vaccines and prior infections deserves credit for this relief. A new study suggests that current variants may be less virulent — in the study, one of the recent variants did not kill mice exposed to it, unlike most earlier covid variants.

Public health officials note that even with more cases this summer, people seem to be managing their sickness at home. “We did see a little rise in the number of cases, but it didn’t have a significant impact in terms of hospitalizations and emergency room visits,” said Manisha Juthani, public health commissioner of Connecticut, at a news briefing Aug. 21.

Unlike influenza or traditional cold viruses, covid seems to thrive outside the cold months, when germy schoolkids, dry air, and indoor activities are thought to enable the spread of air- and saliva-borne viruses. No one is exactly sure why.

“Covid is still very transmissible, very new, and people congregate inside in air-conditioned rooms during the summer,” said John Moore, a virologist and professor at Cornell University’s Weill Cornell Medicine.

Or “maybe covid is more tolerant of humidity or other environmental conditions in the summer,” said Caitlin Rivers, an epidemiologist at Johns Hopkins University.

Because viruses evolve as they infect people, the CDC has recommended updated covid vaccines each year. Last fall’s booster was designed to target the omicron variant circulating in 2023. This year, mRNA vaccines made by Moderna and Pfizer and the protein-based vaccine from Novavax — which has yet to be approved by the FDA — target a more recent omicron variant, JN.1.

The FDA determined that the mRNA vaccines strongly protected people from severe disease and death — and would do so even though earlier variants of JN.1 are now being overtaken by others.

Public interest in covid vaccines has waned, with only 1 in 5 adults getting vaccinated since last September, compared with about 80% who got the first dose. New Yorkers have been slightly above the national vaccination rate, while in Georgia only about 17% got the latest shot.

Vaccine uptake is lower in states where the majority voted for Donald Trump in 2020 and among those who have less money and education, less health care access, or less time off from work. These groups are also more likely to be hospitalized or die of the disease, according to a 2023 study in The Lancet.

While the newly formulated vaccines are better targeted at the circulating covid variants, uninsured and underinsured Americans may have to rush if they hope to get one for free. A CDC program that provided boosters to 1.5 million people over the last year ran out of money and is ending Aug. 31.

The agency drummed up $62 million in unspent funds to pay state and local health departments to provide the new shots to those not covered by insurance. But “that may not go very far” if the vaccine costs the agency around $86 a dose, as it did last year, said Kelly Moore, CEO of Immunize.org, which advocates for vaccination.

People who pay out-of-pocket at pharmacies face higher prices: CVS plans to sell the updated vaccine for $201.99, said Amy Thibault, a spokesperson for the company.

“Price can be a barrier, access can be a barrier” to vaccination, said David Scales, an assistant professor of medicine at Weill Cornell Medicine.

Without an access program that provides vaccines to uninsured adults, “we’ll see disparities in health outcomes and disproportionate outbreaks in the working poor, who can ill afford to take off work,” Kelly Moore said.

New York State has about $1 million to fill the gaps when the CDC’s program ends, said Danielle De Souza, a spokesperson for the New York State Department of Health. That will buy around 12,500 doses for uninsured and underinsured adults, she said. There are roughly one million uninsured people in the state.

CDC and FDA experts last year decided to promote annual fall vaccination against covid and influenza along with a one-time respiratory syncytial virus shot for some groups.

It would be impractical for the vaccine-makers to change the covid vaccine’s recipe twice every year, and offering the three vaccines during one or two health care visits appears to be the best way to increase uptake of all of them, said Schaffner, who consults for the CDC’s policy-setting Advisory Committee on Immunization Practices.

At its next meeting, in October, the committee is likely to urge vulnerable people to get a second dose of the same covid vaccine in the spring, for protection against the next summer wave, he said.

If you’re in a vulnerable population and waiting to get vaccinated until closer to the holiday season, Schaffner said, it makes sense to wear a mask and avoid big crowds, and to get a test if you think you have covid. If positive, people in these groups should seek medical attention since the antiviral pill Paxlovid might ameliorate their symptoms and keep them out of the hospital.

As for conscientious others who feel they may be sick and don’t want to spread the covid virus, the best advice is to get a single test and, if positive, try to isolate for a few days and then wear a mask for several days while avoiding crowded rooms. Repeat testing after a positive result is pointless, since viral particles in the nose may remain for days without signifying a risk of infecting others, Schaffner said.

The Health and Human Services Department is making four free covid tests available to anyone who requests them starting in late September through covidtest.gov, said Dawn O’Connell, assistant secretary for preparedness and response, at the Aug. 23 briefing.

The government is focusing its fall vaccine advocacy campaign — which it’s calling “Risk Less. Do More.” — on older people and nursing home residents, said HHS spokesperson Jeff Nesbit.

Not everyone may really need a fall covid booster, but “it’s not wrong to give people options,” John Moore said. “The 20-year-old athlete is less at risk than the 70-year-old overweight dude. It’s as simple as that.”

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KFF Health News correspondent Amy Maxmen contributed to this report. Healthbeat is a nonprofit newsroom covering public health published by Civic News Company and KFF Health News. This article was updated at 2:40 p.m. ET on Sept. 5, 2024, to correct the name of the Department of Health and Human Services’ fall vaccine advocacy campaign.

The post The New Covid Vaccine Is Out. Why You Might Not Want To Rush To Get It appeared first on Medika Life.

Recurrent respiratory papillomatosis (RRP) is just one of those unexpected HPV-driven conditions. RRP is not a sexually transmitted disease and patients are not contagious. An estimated 15,000 to 20,000 people in the United States and more than 125,000 globally have RRP. This burdensome disease takes several forms and impacts people’s upper or lower respiratory tracts or presents as recurrent lesions on the vocal cords or adjacent tissues that require endless corrective surgeries. The treatment often results in permanent damage to a person’s voice.

RRP falls into two demographic subtypes: juvenile-onset (even toddlers) RRP and adult-onset RRP. Each presents unique medical management and lifestyle difficulties, and in addressing these challenges, patient advocacy—raising awareness and building a supportive community—is critically important.

Since it has no Food and Drug Administration (FDA)- approved treatment or cure, patients and scientists devote energy and resources to ensuring people with RRP have access to information. They are in the loop about clinical possibilities for this rare disease. No cure doesn’t mean there is no action!

Beyond the physical challenges of dealing with the disease – and the missed life events and career detours resulting from repeated surgeries, patients also face significant and demoralizing administrative challenges, such as battling payers to cover care using drugs not indicated by the Food and Drug Administration (FDA) for RRP or deemed “not sufficiently proven.”

The lack of treatment does not mean the RRP community is without hope. They are resilient and courageous and are making meaningful connections through the patient advocacy efforts of the Recurrent Respiratory Papillomatosis Foundation. They are reaching and inspiring researchers at the National Institutes of Health to pursue breakthrough research and oversee clinical trials. They also connect with scientists advancing possible therapies at discovery and clinical-stage biopharmaceutical companies like Precigen and encourage them to move forward by enrolling in clinical trials.

Collaboration Accelerates Change

When people unite, their presence creates energy. The Recurrent Respiratory Papillomatosis Foundation, biotech company Precigen, the National Cancer Institute (NCI), and RRP patients and their caregivers met on June 11th at the National Press Club for the Inaugural International Recurrent Respiratory Papillomatosis Awareness Day. This was an inflection point for those who follow the rare disease category.

The gathering wasn’t about hype or baseless optimism; it was a meeting that brought people together, prepared and ready to roll up their sleeves and get to work. It was a day that reaffirmed a commitment to transparency and a truthful assessment of the current situation and path forward.

Virginia Senator Mark Warner, chair of the powerful Senate Intelligence Committee, which oversees cybersecurity efforts that are key to healthcare and innovation data protection, kicked off RRP Awareness Day by expressing his support for people with rare diseases and his desire to help RRP patients find their voice. Senator Warner stated his desire to advance research and innovation and ensure access to care, an expression of determination that reflected his long-standing record on behalf of people seeking treatment options and improved outcomes.   

RRP Foundation President Kim McClellan also spoke as an advocate for the RRP community and as a patient. “We are here to raise awareness about RRP and bring together critical stakeholders in a dialogue on important aspects impacting individuals living with RRP,” she said. “We invite and encourage anyone living with RRP, either as a patient, family member or caregiver, to join us in spreading the word about RRP and participate in clinical trials and advocacy efforts.”

The date of this groundbreaking gathering has special meaning for the RRP community. June 11th (6/11) corresponds to HPV variants 6 and 11 associated with RRP. As the date symbolizes, the gathering united people with the disease, their family members, congressional leaders, and researchers from government agencies and corporate partners in a community united in a common cause.

The opportunity to share and hear multiple perspectives enriched discussions and underscored the importance of taking a comprehensive approach to tackling this condition. Panels of experts and patients sharing personal stories about their journeys gave attendees an unmatched opportunity to delve into the intricacies and impacts of RRP.

Helen Sabzevari, PhD, President and CEO of Precigen, expressed that she and her company were “proud to join forces with the RRP Foundation to establish the first global RRP Awareness Day to bring visibility to the many challenges experienced by RRP patients and to help forge connections among patients, clinicians and government officials.”

A former NCI team leader, Dr. Sabzevari’s commitment to RRP awareness and patient well-being as an animating principle is a model biopharma company C-Suite executives would be wise to emulate. For her and her Precigen colleagues, patients are the focal point of every decision, action, and investment.

RRP Awareness Day was an inspiring platform for discussing struggle, stigma, and science. Lunch was optional, but tissues were required as attendees in the filled-to-capacity room listened to a patient panel on how RRP impacts people and their families. They learned how some individuals living with RRP have needed hundreds of surgeries over the years, beginning when they were toddlers or young children in primary school.

Culture Drives Clinical Performance

Therapeutic innovations are needed to ensure that future generations living with RRP have options reviewed and indicated by the FDA for treating this viral condition.

During the event, a panel of representatives from advocacy and research reflected on how their collaborative approach centering around patients – from the design of clinical trials to allocating resources that have enabled patients to participate in those trials – has been vital in accelerating the R&D process toward identifying and developing viable treatments. The panel included James Gulley, MD., PhD., NIH, Senior Investigator, Center for Immuno-Oncology, Acting Co-Director, National Cancer Institute/Center for Cancer Research; Scott M. Norberg, DO., NIH, Associate Research Physician, Center for Immuno-Oncology; Helen Sabzevari, PhD, CEO, Precigen; and Kim McClellan, President, RRP Foundation.

Dr. Gulley, who is part of the NCI team and has been instrumental in advancing research on RRP and its connection to HPV, emphasized the pressing need for innovative therapies. In his panel comments, Dr. Gulley highlighted the importance of collaborative research efforts to explore potential immunotherapeutic approaches that could offer new hope for patients suffering from this debilitating condition.

No Disagreement – Harmony

Panelists Gulley, Norberg, and Sabzevari applauded the patient community, acknowledging the courage of their readiness to volunteer to participate in clinical trials to speed possible therapeutics forward. It was a reassuring presence and a reminder that public-private collaborations, particularly for rare diseases, do more than spark hope; they spur action. The patient-panel takeaways were: (1) Connect with the RRP Foundation, (2) Support ongoing clinical trial efforts, (3) Prevention through HPV vaccination is key.

While there is still no FDA-approved treatment to manage RRP, this community remains resilient and upbeat, inspiring everyone facing the challenge of rare conditions. The RRP Foundation, Precigen, and NCI are on the same page—science is essential. People living with RRP can remain hopeful that this collaboration will continue until actions result in better options for this patient community.

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