Among the core vaccines no longer recommended for all children are those that protect against rotavirus, RSV, influenza, meningococcal disease, hepatitis A, and hepatitis B. 

HHS Secretary Robert F Kennedy Jr makes good on promise to reduce the number of recommended vaccines.

US health officials announced Monday an overhauled version of the vaccines recommended to infants and adolescents, shrinking the number of diseases for which vaccines should be administered from 17 to 11. 

The decision follows a December 5, 2025 directive from President Donald Trump to the US Centers for Disease Control and Prevention (CDC) to review the US childhood vaccine schedule in comparison to those of wealthy, peer-nations, citing Denmark, Germany and Japan in particular.

The revisions now mean that the US will go from being one of the developed nations with the highest number of diseases covered – to one of the lowest – according to HHS’s own analysis.

In fact, only Denmark recommends fewer jabs – for just 10 diseases in total. Greece and Ireland recommend immunization for 16 diseases and five countries recommend immunization against 15 diseases, including Australia, Canada, Denmark, Ireland, Spain and the United Kingdom.  Japan recommends childhood immunization against 14 different diseases.

New jan 2026 CDC vaccine guidance country comparison
A table from HHS’s assessment of the US vaccine schedule in comparison to other wealthy nations. The table shows the number of doses for each type of vaccine recommended. The “# Mandated” row uses the example of New York state. The “18-19” number in the bottom right reflects the number of shots a child could receive if they take a yearly COVID-19 and flu shot. Some vaccines are duplicated, such as the measles, mumps, rubella combined vaccine (MMR). “A” reflects the new CDC guidance that these shots be only for high-rish patients or at the bequest of caregivers. The US has no childhood federal vaccine mandate – these vary by state.

Among the core vaccines CDC will no longer recommend for all children are those that protect against rotavirus, influenza, meningococcal disease, hepatitis A, and hepatitis B (HBV). 

The CDC also dropped a relatively new recommendation for newborns to be vaccinated against  Respiratory Syncytial Virus (RSV) – if their mothers had not been previously vaccinated.  

RSV is the single largest cause of childhood hospitalizations in the US today, burdening the healthcare system with 80,000 hospitalizations a year. 

And the new CDC policy reduces the number of recommended doses against HPV – a key cause of cervical cancer – from two to one. This is contrary to the two-dose advice of most other developed nations and the World Health Organization. WHO’s cervical cancer elimination strategy calls for a dramatic reduction in cases by 2030, largely through mass immunization programs. 

Another key point of concern for US public health experts is the removal of any broad recommendation for vaccination against hepatitis B – a leading cause of liver disease and a vaccine that almost every other developed country includes for newborns or infants. Instead, the updated recommendation urges caregivers to consult with their physicians if their child falls into a “high risk” category. 

Already in December 2025, the CDC in recommended to delay  administration of the hepatitis B (HBV) vaccine for infants by six months. 

The Department of Health and Human Services Secretary Robert F Kennedy Jr’s longtime skepticism about the HBV vaccine played a central part of his Senate confirmation hearing where Senator Bill Cassidy (R-LA), a medical doctor and liver specialist, credited the vaccine with saving some 90,000 children’s lives in the US since 1991. 

Despite the reassurances that Kennedy provided at that time to the Senate Confirmation Committee to follow well-established evidence on immunization’s benefits, the HHS Secretary, who built his career around vaccine hesitancy, has now made good on his previous record as a vaccine skeptic.    

Changes announced Monday following a brief review

cdc acting director jim o'neill vaccines
U.S. Department of Health and Human Services (HHS) Secretary Robert F. Kennedy, Jr. conducts the swearing-in ceremony of Jim O’Neill as the Department’s Deputy Secretary Monday, June 9, 2025 at the Hubert H. Humphrey Building in Washington, D.C. (Source: HHS by Amy Rossetti)

The changes were announced abruptly Monday by acting Centers for Disease Control and Prevention Director Jim O’Neill.  He directed the public health agency to move forward immediately on the new CDC recommendations. 

The Trump Administration’s health leadership has argued that the change will increase transparency and rebuild trust in health institutions. 

“After an exhaustive review of the evidence, we are aligning the U.S. childhood vaccine schedule with international consensus while strengthening transparency and informed consent. This decision protects children, respects families, and rebuilds trust in public health,” Kennedy said in the statement. 

But the overhaul also is an unprecedented departure from the evidence-based process the US previously used to decide its vaccine schedule.

Normally an independent federal advisory panel of experts would review studies and data for each vaccine before publishing recommendations. 

In this instance, CDC director O’Neill issued the changes in a memorandum responding to a request by Trump for such a review only a month ago – and with the underlying analysis based on a comparison of schedules in other nations.  

The comparisons between the seemingly high number of actual shots, or  jabs, US children previously received as compared to those of other nations is also somewhat misleading – insofar as annual flu and COVID-19 vaccines up until the age of 18 are included in the US count of previous recommendations – totaling about 35 or 36 more shots across 18 years. 

But in November, the CDC last year already stated that COVID vaccination for children, while recommended, should be a matter of “individual decision-making.”  And WHO’s own recommendations for COVID-19 vaccination of children were already reversed  post-pandemic, advising only one dose for never-vaccinated children with co-morbidities. 

In 2010, the CDC did adopt a universal recommendation for annual childhood sesasonal flu vaccination. That went further than the current WHO recommendation which recommends prioritizing seasonal flu vaccine for “health workers, individuals with comorbidities and underlying conditions, older adults and pregnant women,” adding only that “Depending on national disease goals, capacity and resources, epidemiology, national policies and priorities, and disease burden, countries may consider additional (sub)populations for vaccination, such as children.”

Concerns that hospitalizations, deaths may increase

“Fewer vaccinations (specifically for rotavirus, COVID-19, influenza, RSV, meningococcal disease, hepatitis A and hepatitis B) will result in an increase in disease, disability, and death, wrote epidemiologist and infectious disease specialist Jessica Malaty Rivera in a post. 

“Please ignore this unscientific nonsense and follow the @ameracadpeds schedule alongside your pediatrician.” 

Prior to the vaccines and therapeutics that prevent RSV, for instance, the virus accounted for over one in four hospitalizations among young children in the US. 

Other physicians and health experts criticized the shift for causing confusion and for ignoring decades of vaccine studies demonstrating safety and efficacy. 

“Know this: Even as our government shifts its recommendation language, I would never forgo the RSV, hepatitis A & B, or meningitis vaccines for my own kids,” said Dr Scott Hadland, a pediatrician and chief of adolescent medicine at Harvard.

“This is health policy malpractice at the highest level and must be reversed before children and families suffer,” said Dr George C Benjamin, executive director of the American Public Health Association.

Attempt to bring US “in-line” with other wealthy countries

The 33-page CDC policy document argues that in light of falling vaccination rates across the US and the lack of trust in public health institutions, the US should therefore cut back on the number of recommended vaccines.

“Bringing the U.S. pediatric immunization schedule in line with the consensus of peer nations while keeping non-consensus vaccines available for high-risk groups and populations and/orthrough shared clinical decision-making is a balanced approach to reform and restore trust in public health,” the document says.

Traditionally, the US has recommended slightly more vaccines, on average, than “peer” nations. However, the US also continues to face surges of measles, hepatitis A, RSV, and other infectious diseases. 

The other problem with policy decisions based on comparisons with other high income countries experts say, is that the US has a far larger, and more sickly, population that often lacks access to primary healthcare. 

“Many high-income countries have universal coverage and paid family leave that make it easier to get care and stay safe when kids get sick,” said Dr Uché Blackstock, a physician and health equity advocate in a social media post. 

“You cannot copy the [vaccine] list without copying the supports,” Blackstock said. 

Denmark and Japan’s healthier population, more robust healthcare systems, surveillance, testing, and social support mean there is less of a reliance on vaccines. 

“We have fragmented insurance, we’ve got millions uninsured, we don’t have a national health registry and we’ve got enormous gaps in the continuity of care,” said Dr. Jake Scott, an infectious disease specialist at Stanford University School of Medicine. “And we use broader vaccine recommendations because our system can’t reliably identify and follow up with every person at risk.”

Assessment downplays risk of rotavirus, meningococcal disease, HPV

Rotavirus vaccines
A screen capture of the CDC website with the burden of rotavirus on the US

Of the vaccines being cut from the list, RSV and rotavirus pose a significant burden to the healthcare system. Prior to the RSV maternal vaccine and monoclonal antibodies, up to 80,000 children were hospitalized with the virus. Nearly all children were infected with rotavirus prior to the vaccine. It caused 20-60 deaths each year, according to the CDC.

“Reasonable people can reach different conclusions about recommending the rotavirus vaccine for all children,” says the assessment. 

The assessment also argued that low rates of meningococcal disease warranted an end of recommendations. “Considering the low incidence of meningococcal disease in the U.S., the meningococcal vaccine should not be part of the consensus recommended vaccine schedule.” These low rates are due in large part to vaccinations.

Still covered by health insurers? 

The vaccines dropped from the CDC’s recommendations should still be covered by health insurance systems  – the new CDC policy also states. 

But it is unclear whether health insurers in the US’s fragmented public health system will in fact guarantee continued access for all of those who would like to get a shot – once the actual CDC recommendation has been removed. 

The authors of the new CDC policy are Dr Tracy Beth Høeg, a Danish-American physician and Food and Drug Administration director of the Center for Drug Research and Evaluation, and Martin Kulldorff.  

They are self-described in the assessment as “one of the most pro-vaccine scientists in the country” – however, they garnered significant attention during the COVID pandemic for their anti-COVID-19 vaccine stances. 

Kulldorff’s bio continues in the assessment: “In early 2021, he was one of the first public health scientists to publicly oppose Covid vaccine mandates and it is hard to imagine a policy doing more harm to the trust in vaccines and public health.”

Image Credits: European Union, Quinn Dombrowski, HHS , Amy Rossetti, CDC.

EPA atrazine corn fields
Over 70 million tons of atrazine is applied to US soil each year. The chemical is now deemed a ‘probable’ carcinogen to humans.

The US Environmental Protection Agency has dismissed a recent finding that atrazine, the second most widely-used herbicide in the United States, is “probably carcinogenic to humans” by the World Health Organization’s cancer review agency. 

Atrazine is used extensively in the US on crops like corn, sorghum, and sugarcane. However, over 60 countries have banned the chemical due to its endocrine-disrupting properties and tendency to contaminate groundwater. 

In a new classification, published in the January, 2026 issue of The Lancet Oncology, the International Agency for Research on Cancer (IARC) ranked atrazine as probably carcinogenic to humans based on what it described as “limited evidence” for cancer in humans and “sufficient evidence for cancer in experimental animals.”

The agency’s findings are independent assessments that guide national regulatory authorities worldwide in the promulgation of rules around chemicals used in agriculture, food systems and occupational settings.  

The IARC assessment was the first in nearly three decades. In 1998 the organization said the compound was not classifiable as to its carcinogenicity to humans. 

Since the IARC findings were initially released in late November, the US Environmental Protection Agency (EPA), as well as chemical producers in China and elsewhere, have pushed back against the new classification. Both used almost identical terms in describing the determination as “flawed” and “inconsistent with scientific consensus.”

Hormone disruptor, cancer risk of atrazine  

Farm workers atrazine EPA
Atrazine has been linked to non-Hodgkin’s lymphoma

Atrazine’s cancer links include evidence of oxidative stress, hormone disruption, immune suppression, and actual tumor growth, IARC found in its abbreviated evaluation of atrazine and two other compounds.

In particular, IARC pointed to animal studies that showed tumor growth in the mammary glands and uterus of female rats, reduced estrogen and testosterone in both male and female rats, and induced cell death and division. The most recent study IARC cites, from 2024, also concluded that male rats also experience oxidative stress and severe hormone disruption.

In humans, only a handful of studies have been published so far. However, IARC noted that two case-control studies that reported “strong positive associations between exposure to atrazine…and translocation-positive NHL [non-Hodgkin’s Lymphoma]” among exposed farm workers. Links to other human cancers did not show “consistent positive findings.” 

Beyond its cancer inks, atrazine exposure is also associated with birth defects, reproductive harm, and hormone disruption, in papers not cited by IARC – an agency that focuses almost exclusively on cancer risks. 

US regulators and manufacturers push back  

EPA
The US EPA said IARC’s findings used a “deeply flawed approach to its cancer assessments”

In a 21 November statement, Syngenta, the agrochemical company that produces most of the US’s atrazine, said:  “[c]urrent scientific evidence clearly demonstrate[s] that atrazine is safe when applied in accordance with registered label instructions.” Syngenta is owned by the Chinese state-operated company Sinochem.

Speaking to Health Policy Watch just a few days after the Syngenta statement, EPA used identical terms, arguing that IARC’s findings “stir up fear” by also including “very hot beverages, red meat, working the night shift and hairdressing in the same classification.” 

“This announcement on atrazine is just another example of the World Health Organization International Agency for Research on Cancer (IARC) using a deeply flawed approach to its cancer assessments on multiple levels,” the EPA added. 

The EPA spokesperson complained, in particular, that the two-page article published so far is just a brief summary of the full review, which is only due to be published later this year, according to IARC.

“[F]or IARC to roll out these “findings” and unnecessarily stir up fear when IARC has said it will not be publishing any of its detailed science until late 2026 or 2027 is irresponsible and lacks transparency. Currently, there is no opportunity for anyone to meaningfully review how IARC has reached its conclusions,” said the EPA’s press office. 

“In contrast, atrazine has been extensively studied by EPA across multiple administrations, including having five meetings of independent Scientific Advisory Panels peer review the cancer potential of atrazine between 2009-2011,” EPA said. 

“As a reminder, IARC also has a long history of being severely misguided in its findings,” the EPA spokesperson said, citing past IARC findings on red meat and night shift work, among other factors, as possible or probable causes of cancer. 

In 2015 IARC concluded that red meat was a possible cause of cancer and processed meat is a probable cause. Those findings have since been echoed by the American Institute for Cancer Research, which in 2021 concluded “there is strong evidence that eating high amounts of red meat increases the risk of colorectal cancer.” 

The US Department of Agriculture’s most recent dietary guidelines also suggest reducing red meat consumption. The US CDC concluded in a 2021 report that there is “high confidence” that persistent night shift work that results in circadian disruption can cause human cancer.

Environmental groups welcome IARC re-evaluation 

EPA USGS atrazine map usage
Latest estimates of atrazine use from the US Geological Survey, 2019

Separate EPA reviews in 2003 and 2018 concluded that available evidence does not support a relationship between atrazine exposure and human cancers. IARC cites one new animal study from 2024, while re-evaluating older data in a new light.

For pesticide experts like Dr Jennifer Sass, a senior scientist at the Natural Resources Defense Council (NRDC), IARC’s re-evaluation was welcome – correcting industry bias in previous evaluations. . 

“With atrazine, there’s hormone disruption, there’s oxidative stress, there is indication of tumors in human and animal studies,” said Sass. “IARC gathered a solid expert array of people from different disciplines, including industry people. They didn’t second-guess or overinterpret the data. 

“The EPA needs to take another look at their assessment to account for the carcinogenicity,” said Sass. 

Canada, Australia and Brazil also use atrazine extensively

Atrazine, also known under brand names such as Aatrex®, Aatram®, Atratol®, and Gesaprim®  is the second most widely-used pesticide in the US after glyphosate – also known as Roundup®. Glyphosate also was designated as a probable carcinogen in humans by IARC in 2015, in a ruling that continues to trigger controversy between the US and trading partners that have banned the chemical.  

Across the US’s corn belt, up to 60 million pounds of atrazine is applied to treat US crops each year. 

Atrazine also is flushed from soil into streams or groundwater aquifers where it can contaminate drinking water supplies, according to the US Centers for Disease Control and Prevention. 

A 2017 analysis of EPA tap water data found that nearly 30 million Americans across 28 states have tap water that contains atrazine. Drinking water in these areas had atrazine levels three to seven times higher than the federal limit of three parts per billion during spikes due to run-off in spring and summer, according to another major research and advocacy non-profit, Environmental Working Group. 

“Because the EPA has been sweeping the evidence on cancer under the rug for the time it has been on the market for 50 years, they’re not monitoring for atrazine in the water. The drinking water standard should be zero, because it’s a carcinogen,” said Sass. 

But the US is not alone in its reliance on the chemical, which is typically applied to unplanted fields so as to kill any other weeds or plants before crops are planted. 

Canada, Australia, Brazil and China also use atrazine to increase crop yields. 

In the decades prior to IARC’s classification, 60 countries banned the use of atrazine. These include 27 European Union countries, most Middle Eastern countries, and even many African countries. However, in many lower-and-middle income countries where atrazine is banned, the chemical is often smuggled in illegally. 

The European Union banned atrazine in 2004 and most EU countries have since banned glyphosate as well. Mexico, which exports tens of billions of dollars of agricultural products to the US, had attempted to ban glyphosate.  But in 2024 it postponed the ban indefinitely  following pressure from industry and the US, citing the lack of an effective alternative.

As international assessments increasingly flag risks associated with such chemicals, the US remains an outlier among high-income countries in continued widespread use. 

“We were all told for a long time that weed killers aren’t harmful to people because their mechanism of toxicity targets photosynthesis. We all believed them,” said Sass.

“Because of that, we didn’t have proper food monitoring. We didn’t have proper drinking water monitoring. The people exposed to atrazine occupationally, whether by mixing it, loading it, applying it, manufacturing it, need to take the proper precautions because of how toxic it is.

EPA stance contrasts sharply with MAHA rhetoric about healthier foods 

EPA’s pro-pesticide stance under the new US administration of President Donald Trump contrasts sharply with the healthy foods rhetoric of the “Make America Healthy Again” (MAHA) movement, critics also said.   

“Despite the rhetoric of MAHA, there will be no robust review of the dangers of pesticides by the Trump Administration,” said Sylvia Wu, of the Washington DC-based Center for Food Safety.  “Instead, a toxic poison like atrazine will continue to contaminate our lands and waters, making our children sick for decades to come,” said Wu.

Wu was responding, in particular, to another recent US Fish and Wildlife’s (FWS) statement that atrazine does not pose an extinction risk to any US endangered species. 

The Center for Food Safety sued the EPA in 2020 when the agency moved to reapprove atrazine, along with a host of other pesticides and herbicides, as part of a routine evaluation. 

“The public trust has been steamrolled by agrochemical interests,” said Sass of the Natural Resources Defence Council. “The EPA has fast-tracked the approval of their poisons, which is not only a violation of the public’s trust, but also of the mission of the EPA.”

“Using modern farming methods, we do not need weed killers like atrazine. We simply don’t have to kill every weed to grow our crops. It. We don’t have to be so scorched earth in our farm practices,” Sass argued. 

“I look forward to the day that the US catches up to other countries in keeping American families safe from chemicals.”

Image Credits: Akshat Jhingran , Waldemar Brandt , AP/Sierra Club, USGS.

Air pollution
Delhi air pollution during peak days in mid-November 2025 – an annual public health crisis that remains unresolved.

The latest ten-year data shows almost no change. Can the momentum of outrage finally push officials to take high-impact measures to lower pollution this year?

It’s Delhi 2026.

Since 2016, there’s been near-zero improvement in the city’s air pollution during the annual peak pollution period of October to December, a new analysis by the Center for Research on Energy and Clean Air (CREA) reveals. This period also usually sees peak coverage and public outrage about the crisis.

In 2025, average levels for those peak months even inched up a notch over the year before to 177 micrograms/cubic meter (µg/m³) of PM2.5 – despite a slight decline in the annual average levels in 2025 as compared to 2024 (96 µg/m³ in 2025 versus 105 in 2024).

This means average levels in the peak pollution months were over 35 times the WHO’s annual average guideline of 5 µg/m³ and 11 times the peak 24 guideline limit of 15 µg/m³. And that’s if questions over the robustness of the latest government monitoring data are ignored for the moment.

For nine of these last 10 years, opposition-led the Aam Aadmi Party was in power in Delhi, while Narendra Modi’s BJP party has been in power at the national level during the entire time.

Delhi air pollution graph
Near-zero improvement in Delhi’s peak pollution months since 2016.

In 2025, Delhi also elected a BJP-led state government, which means the BJP is now in power at the national, state and municipality level – a ‘triple engine sarkar’, as the Hindustan Times framed it, referring to the Hindi term for “government.” Indeed, the BJP not only controls Delhi, but also the governments of two key bordering states, Haryana and Uttar Pradesh – which generate smoke from crop waste burning that contributes to the capital’s autumn smog crisis.

That’s also why the new Delhi government, led by Chief Minister Ms Rekha Gupta, was expected to be uniquely placed to reduce pollution when she assumed office. Yet, as the peak season began, there was little indication of a significant shift in strategy.

Unprecedented outrage against air pollution

Public outrage against air pollution in Delhi and northern India has escalated to a level not seen in many years. It’s been characterised by a mix of anger and cutting humour – reels, memes and so on – against the government and the crisis.

There were other aspects. Multiple protests, including the one on 9th November where police detained several demonstrators, including parents, among others, demanding clean air for their children.

Multiple groups have been created on various social media and messaging apps.

Some TV anchors and journalists, seen to be close to the ruling establishment since 2014, took many by surprise by pivoting and questioning official inaction and apathy.

 

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India’s air pollution is “a metaphor for the challenges facing the nation more broadly.… if India cannot solve a problem that manifestly and acutely affects its elite, the prospects for solving the larger challenges confronting the country remain slim,” observed Arvind Subramanian and Devesh Kapur, in their book, A Sixth of Humanity, published last October.

India’s environment minister Bhupender Yadav held a series of meetings on Delhi’s pollution, including one where he directed officials to “ensure visible improvement” in the air quality across Delhi and its neighbourhood “within one week.” That was mid-December. By the end of the month, there was no improvement. In fact, this December saw the worst pollution since 2018.

Delhi’s environment minister and chief minister held several meetings, extensively posted policy action and photo ops on social media.

There have been some positive steps, like distributing electric heaters to gatekeepers at various residential areas, curbs on categories of polluting vehicles, and stricter enforcement of OCEMS, online continuous emissions monitoring systems, at thousands of factories.

Gaps in pollution control

Along with the global “embarrassment” mentioned in A Sixth of Humanity, critical technical gaps remain.

Firstly, misplaced focus on PM10:

The government’s focus remains on spraying water to control dust because it continues to prioritise controlling PM10 particulate matter pollutants rather than the finer PM2.5 ones. PM2.5 is dangerous because it is small enough to enter the bloodstream and, so, is more lethal, whereas the body’s defenses can often stop the larger PM10 particles.

In theory, watering down dust may help, but in practice, there hasn’t been much improvement. As this clip shows there’s simply too much pollution. And this water mist barely tackles PM2.5.

Secondly, lack of political will:

At a national level, there’s a lack of political will to stop the practice of farmers burning the residue of the paddy harvest in the three states north of Delhi and upwind of the city – Punjab, Haryana and Uttar Pradesh. This contributes almost 10% of the pollution in October and November in Delhi and the neighbourhood, according to a government (IITM) study, but on certain days and hours, it can be much higher.

Thirdly, pseudo-science over evidence:

There has been a reluctance among decision-makers to fully embrace scientifically evidence-based action. So a lot of time, taxpayers’ money, and effort over the years have gone into what may be described as pseudo-science, like smog towers, or action taken against scientific advice, like cloud-seeding trials.

Fourthly, flawed monitoring of vehicular pollution:

The Delhi government has, in a well-intentioned move, made pollution-under-control (PUC) certificates mandatory for all vehicles. However, the old PUC regime is flawed, and it needs to be replaced as it doesn’t check for key pollutants like PM2.5 and nitrogen oxides, which are major contributors to Delhi’s pollution.

But to give credit where credit is due: a new panel has been formed by the national government with external experts on curbing vehicular pollution, which contributes more than a third of the capital’s air pollution levels.

Many vehicles in Delhi are highly polluting, contributing more than a third to ambient air pollution levels.

Battle against air pollution, 2026

There have been political missteps, too.

One example: In early July, after public protests pressured the Delhi government to quickly roll back stricter enforcement of limits on old, polluting vehicles, the same government also successfully petitioned the Supreme Court to reverse a previous ban on firecrackers during the annual Diwali festival of lights, arguing that certain brands of so-called “green firecrackers” would not pollute. They were wrong. And the ensuing smoke was a factor in 2025’s post-Diwali pollution being the worst in years; and the chief minister repeatedly came in for criticism for comments she made on pollution.

In 2026, can the public’s pressure, and even the government’s momentum, for clean air action be sustained or will it, as in the past, fizzle out when Delhi’s peak pollution season tapers off?

Republished, with slight adaptation, from the original ‘What Am I Breathing’ Substack by Chetan Bhattacharji, a senior correspondent for Health Policy Watch from Delhi. 

 

Image Credits: Chetan Bhattacharji, Centre for Research on Energy and Clean Air.

Hans Henri Kluge, the WHO/Europe Regional Director, emphasised that vaccines save lives in the midst of a new flu strain surging early.

Sudden fever, a severe cough and acute respiratory distress are the familiar onset symptoms of seasonal flu, which has affected WHO’s European Region with unusual intensity and speed this year. As the Northern Hemisphere enters winter, health systems are struggling to manage an epidemic driven by an aggressive, genetically mutated influenza strain A(H3N2) subclade K.

But a new report by the European Centre for Disease Prevention and Control (ECDC), published on Friday, concluded that current seasonal influenza vaccines remain effective against this new strain of the virus. Health experts urge vulnerable groups to get vaccinated.

The current influenza outbreak is dominated almost entirely by the A(H3N2) subclade K, which now accounts for up to 90 per cent of all confirmed cases in the region, according to data from WHO’s European Regional Office (EURO). Subclade K marks a “notable evolution in influenza A(H3N2) viruses,” having undergone genetic drift and displaying several amino acid changes in the hemagglutinin protein (the “key” the virus uses to unlock and enter human cells). Due to these slight changes, antibodies acquired from previous infections or older vaccines may not recognise the virus as effectively.

“Flu comes around every winter, but this year is a little different,” stated Hans Kluge, WHO Regional Director for Europe, in a press release on Wednesday. Although there is no evidence that it causes more severe disease, Kluge explained that the small genetic variation in the virus places “enormous pressure on our health systems because people don’t have built-up immunity against it.”

Flu season gains early momentum

Map of the Influenza cases in the WHO/Europe region.
A(H3N2) subclade K is fuelling a flu surge across the WHO/Europe region, with protection stalling as most countries fail to meet critical vaccination targets.

With the new strain spreading quickly, the current influenza season began approximately four weeks earlier than in previous years. High or very high activity is now being reported in at least 27 of the 38 countries being monitored by the WHO European Region. These countries range from EU Member States such as Ireland and Slovenia to Kyrgyzstan and Montenegro.

“This is expected to cause a significant burden in terms of morbidity and mortality, as observed in past years, and target groups should be vaccinated rapidly,” said Bruno Ciancio, an ECDC senior expert, in response to a query from Health Policy Watch.

WHO data shows that the strain has been detected in more than 34 countries globally over the last six months. While it is most prevalent in the European and Western Pacific regions, its expansion has also been confirmed in the WHO South-East Asia region. Since October, A(H3N2) subclade K sequences have been reported in Nepal, India and Thailand, as well as in the WHO African and Eastern Mediterranean Regions.

Vaccines remain primary shield against severe illness

Vaccinations remain the key protection against the new strain.
Vaccinations remain effective and a key protection against the new strain, experts emphasize, based on preliminary findings.

With cases expected to continue rising, likely peaking in late December or early January, protecting the most vulnerable is paramount. Public health authorities are emphasising urgently that vaccination is the most important protective measure for vulnerable groups, including adults aged 65 and over, pregnant women, people with chronic conditions and healthcare workers.

Although recent reports suggest that subclade K shows “reduced reactivity” to current vaccines, it remains effective in preventing severe health outcomes, the ECDC concluded. “The current influenza vaccine is not perfectly matched to circulating strains, including H3N2. However, the primary aim of vaccination is to prevent severe disease, and effectiveness against severe outcomes is expected to be preserved,” explained ECDC expert Ciancio.

According to the preliminary data published by the ECDC for this flu season, vaccine effectiveness in preventing influenza cases that require medical attention at the primary care level ranges from 52% in children (ages 0–17) and 57% in adults (ages 18–64). For the critical group of individuals aged 65 and older, it was not possible to estimate vaccine effectiveness separately, due to the low number of influenza cases so far considered in the study. ECDC experts emphasized, moreover, that the findings rely on small sample sizes from nine participating countries and have low statistical precision (e.g. wide confidence intervals). Efficacy could fluctuate as the season progresses.

According to a ECDC analysis released only this week, vaccines significantly cut hospital admission rates in the last 2024-25 flu season. The modeling study found that seasonal vaccines were 70-75% effective at preventing hospital admissions among children aged 2-17 years and 30-40% effective in adults. Using computer simulations, the analysis estimated that vaccination programmes prevented 26-41% of flu-related hospitalisations among adults aged 65 and over across European Union (EU) countries between August 2024 and June 2025.

Low vaccination rates remain public health concern

To protect the vulnerable and to reduce transmission, a multilayered approach following the WHO playbook is essential.

Within the EU, only Denmark, Portugal, and Ireland met the 75 percent target for older adults during the reporting period. The ECDC projects that a 75% vaccination rate can prevent up to three-quarters of flu-related hospitalisations, significantly reducing the strain on public health systems.

Influenza vaccination rates for high-risk groups in other EU countries remained below WHO targets in the past seasons, as ECDC data from the most recent available season (2021-2022) shows. The overall median influenza vaccine coverage for adults aged 65 years and older was only 43 percent.

The scale of the challenge is huge. Recent interim data from Germany’s Robert Koch Institute (RKI) for the 2024-25 season found that flu vaccination coverage among German adults aged 60+ declined from 39.7-34.5% since 2020-21, the first year of the COVID pandemic, reaching its lowest level in over 17 years. And at the same time, a severe flu season can strain hospital staff and capacity in already overburdened health systems.

Combating the flu requires a multi-layered approach, experts underline. Slowing transmission requires proactive public health and social measures alongside vaccination, says WHO. These steps, proven effective during the COVID-19 pandemic, include staying home if unwell, wearing a mask in public if symptomatic, maintaining regular hand hygiene, and improving indoor ventilation.

European health systems have “decades of experience managing influenza,” said Kluge, striking a note of optimism alongside the WHO warning. “We have safe vaccines that are updated annually, and we have a clear playbook of protective measures that work.”

Image Credits: European Union, WHO/Europe , World Health Organization, European Union.

 

Cervical Cancer
Though largely preventable, cervical cancer continues to kill thousands of Indian women each year.

MUMBAI, India – Cervical cancer kills more than 75,000 women in India each year, according to figures recently disclosed in Parliament – yet it is one of the most preventable cancers.

In India, low human papillomavirus (HPV) vaccination coverage, limited access to routine screening and deep-rooted social behaviours – such as early marriage and low condom use – drive late diagnosis and high mortality.

Globally, cervical cancer is the fourth most common cancer among women, with an estimated 660,000 new cases and 350,000 reported deaths in 2022, accoridng to WHO.

Public health experts say these factors increase exposure to HPV, the underlying cause of nearly all cervical cancer cases, while allowing the disease to progress silently for years before detection.

For Neha, a 29-year-old hotel worker in the city of 12.5 million, India’s largest, the statistics reflect a deeply personal loss.

My two cousins died from cervical cancer,” she told Health Policy Watch. “What frightens me most is how silent it is. People seem completely normal for years, and then you discover they have had cancer for a long time  only when they are close to dying.

Early marriage and rising HPV exposure

india
A wedding procession in India, where early marriage remains common.

Doctors say nearly all cervical cancer cases are caused by persistent infection with high-risk types of HPV, one of the most common sexually transmitted infections worldwide.

Mumbai physician, Dr Sonali Roy told Health Policy Watch that HPV exposure in India is closely tied to early marriage, low awareness and limited access to vaccination and screening, particularly in rural areas.

“In some villages, girls are married as young as 14 or 15,” Roy said. These marriages often do not last, and women may remarry multiple times. Each marriage increases exposure to HPV, especially when condoms are rarely used and sexual health awareness is very low.

Early marriage often leads to early sexual debut, repeated pregnancies and limited agency over reproductive health decisions, experts say  all of which raise the risk of persistent HPV infection. The biological vulnerability of the cervix during adolescence further increases susceptibility to the virus.

Unlike many high-income countries, India has yet to roll out a nationwide HPV vaccination programme, despite repeated recommendations from public health experts and the World Health Organization (WHO). While some states have launched pilot projects, coverage remains patchy and largely urban, leaving millions of girls unprotected before sexual debut.

Routine cervical cancer screening also remains uneven across Indian states, with weak outreach in rural areas and among informal urban settlements, where health services are often overstretched.

Evidence from research

HPW vaccine introduction; India and South-East Asia lag behind most other regions of the world in routine HPV vaccination.

Research supports the link between early sexual debut, multiple partners and higher HPV infection risk. A 2019 study reviewing medical records of 349 women who tested positive for high-risk HPV found that women who began sexual activity at a younger age or had multiple sexual partners faced a significantly higher risk of infection with HPV types 16 and 18, the two strains responsible for the majority of cervical cancer cases globally.

The study found that about one in five women was infected with HPV 16, while nearly 9% were infected with HPV 18 – the types of HPV most likely to cause cervical cancer. Women who reported their first sexual intercourse at age 19 or younger were significantly more likely to be infected with HPV 16 than those who became sexually active later.

The risk rose sharply with multiple partners. Women who reported more than three lifetime sexual partners were four times more likely to be infected with HPV 18 than women who had fewer partners.

Public health researchers caution that these findings reflect structural conditions rather than individual behaviour. “In many cases, women do not have the power to negotiate when to marry, when to have sex or whether protection is used,  ” said a health researcher.

Men refuse to use protection

Condoms
With fewer than one in 10 Indian men using condoms, women bear the health consequences of preventable HPV infections.

Even when women understand the risks, many say they have little control over prevention. A 27-year-old woman from the East Mumbai suburb of Kurla, who spoke on condition of anonymity, told Health Policy Watch that her partner refuses to use condoms.“He says it affects his pride,” said Priya (not her real name). This is common, even in cities like Mumbai, India’s modern financial center.

She said stigma is far stronger in rural areas, where access to contraception is limited and social scrutiny is intense. Many women end up with these infections simply because men refuse to use protection.

Her account echoes broader national trends. A 2021 report found that fewer than one in 10  men in India use condoms, making male sterilisation and barrier contraception among the least-used family planning methods in the country.

Female sterilisation remains the dominant form of contraception, often placing the burden of reproductive health entirely on women. By comparison, a 2025 Zipdo educational report estimated that around 45% of sexually active people worldwide used a condom during their last sexual encounter.

Priya recalled a close friend who had part of her cervix surgically removed after an early cancer diagnosis. Doctors later told her that consistent condom use would likely have prevented the HPV infection that led to the disease.

Screening gaps

Cancer
Nearly 90% of cervical cancer deaths occur in low- and middle-income countries, where routine screening programmes remain limited.

Nearly 90% of cervical cancer deaths occur in low- and middle-income countries, where routine screening programmes remain limited. In India, the absence of a structured nationwide screening system has meant that many women are diagnosed only at advanced stages of the disease when treatment is more expensive and survival rates drop sharply.

Under India’s National Programme for Prevention and Control of Non-Communicable Diseases and Ayushman Bharat, its health insurance for vulnerable families, women aged 30 to 65 are supposed to be screened for cervical cancer at primary health centres using visual inspection with acetic acid, a low-cost test known as VIA.

Coverage, however, remains extremely low. Only about 2% of eligible women are currently being screened, with wide variations across states based on education levels and rural–urban divides.

Health workers cite multiple barriers, including staff shortages, limited training, lack of privacy at health centres and social stigma around gynaecological examinations. For many women, domestic responsibilities and daily wage work also make preventive care a low priority.

Cancer means financial ruin

Health
Doctors perform a surgical procedure on a woman patient.

For some women, barriers go beyond awareness and access. A woman living on the rural outskirts of Mumbai, nearly 87 kilometres from the city centre, told Health Policy Watch that fear of financial ruin often outweighs concern about infection itself.

“May God save us from expensive diseases. Unfortunately, cancer is one,” said Afshana, not her real name. “Even though we have a five lakh cover [around $5,500 annually] under Ayushman Bharat [insurance plan], we often end up going to private hospitals because services are lacking.”

Her experience reflects broader systemic gaps. A 2024 NITI Aayog review of Health and Wellness Centres linked to Ayushman Bharat, India’s flagship government insurance scheme, found significant shortfalls in cancer screening delivery.

While most centres had initiated screening for noncommunicable diseases, fewer than 10% had completed a full annual round. Cervical cancer screening was “yet to be operationalised,” according to the report, while oral cancer screening was carried out only selectively.

The review also found that many auxiliary nurse-midwives, staff nurses and medical officers had not received adequate training to conduct screenings or manage referrals. Although most centres met basic infrastructure standards and provided essential medicines free of charge, service delivery continued to lag behind national goals for early detection and prevention.

A preventable tragedy

Cervical cancer is widely regarded as one of the most preventable forms of cancer. HPV vaccination, regular screening and timely treatment of precancerous lesions have dramatically reduced incidence and mortality in countries that have invested in these measures.

Public health experts warn that without urgent action, India risks continuing to lose tens of thousands of women each year to a disease that can largely be stopped.

“Cervical cancer is not just a medical issue,” Roy said. “It is a reflection of gender inequality, weak health systems and the failure to prioritise women’s health.”For women like Neha, the cost of that failure is already painfully clear. 

“If they had found it earlier, my cousins might still be alive,” she said. “No one should die from something that can be prevented.”

Image Credits: Saiyan Mondal/Pexels, Gurpreet Singh/ Unsplash, Han J et al, eClinicalMedicine, Vol. 84June 2025, Deon Black/ Unsplash, Bermix Studio/Unsplash, Richard Catabay/Unsplash.

Gonorrhoea bacteria

A new treatment has been approved for gonorrhoea, a sexually transmitted infection (STI) that is increasingly developing resistance to all current antibiotics. 

The US Food and Drug Administration (FDA) approved the use of zoliflodacin to treat uncomplicated gonorrhoea on Friday, following the publication in The Lancet of the results of a phase 3 trial of the new drug, which found that one dose of it was as effective as the current standard treatment.

Uncomplicated urogenital gonorrhea refers to a localised infection of the urethra or cervix that has not spread to other areas of the body.

Each year, over 82 million people are infected with Neisseria gonorrhoeae, but this bacterium has developed resistance to almost all antibiotics, with only one last remaining recommended antibiotic treatment, ceftriaxone. 

But there has been a six-fold increase in resistant infections to ceftriaxone in some countries – particularly Cambodia and Viet Nam – and gonorrhoea was in danger of becoming one of the first diseases to become untreatable due to antimicrobial resistance. 

“This is the first new treatment solely for gonorrhoea in decades and the first to be developed using a novel not-for-profit approach to antibiotic research and development (R&D) aimed at tackling the rise and spread of antimicrobial resistance (AMR),” according to the Global Antibiotic Research & Development Partnership (GARDP).

GARP sponsored the trial of zoliflodacin, which involved 930 participants in five countries – Belgium, the Netherlands, South Africa, Thailand, and the US. 

“This approval marks a huge turning point in the treatment of multidrug-resistant gonorrhoea, which until now has been outpacing antibiotic development,” said GARP executive director Dr Manica Balasegaram. 

“Zoliflodacin shows that a different public-private partnership approach to antibiotic development is possible — one that prioritizes global health needs, strengthens access where the burden is highest, and protects the effectiveness of new drugs for the long-term.” 

Game-changer

“As clinicians, we see the devastating impact drug-resistant gonorrhoea can have on people’s lives in Thailand,” said Dr Rossaphorn Kittiyaowamarn, principal investigator for the trial site in Thailand. 

“Having a single-dose, oral treatment like this will be a game changer for gonorrhoea control. This is essential to reduce the burden of disease for individuals and to prevent the spread of highly drug-resistant gonorrhoea globally.”  

Sinead Delany-Moretlwe, principal investigator for the trial in South Africa, said that gonorrhoea can have a “devastating impact on women in particular”, which, if untreated, “can lead to infertility, life-threatening ectopic pregnancies and chronic pelvic pain”. 

“Babies born to mothers with untreated gonorrhoea may be born prematurely and can develop serious eye infections that can lead to blindness. With the number of gonorrhoea cases on the rise, there is great value in carrying out trials to bring about effective new treatment options,” she added.

Zoliflodacin belongs to a new class of antibiotics, called spiropyrimidinetriones, which has a unique mechanism of action in the way that it inhibits a crucial bacterial enzyme called type II topoisomerase, which is essential for bacterial function and reproduction. 

It is being developed exclusively for the treatment of gonorrhoea, with the hope that this will minimise the likelihood of excessive use, which could contribute to the development of resistance.  

GARDP has the right to register and sell zoliflodacin in more than three-quarters of the world’s countries, including all low-income countries, most middle-income countries, and several high-income countries. 

Entasis Therapeutics,, the original license holder and an affiliate of Innoviva Specialty Therapeutics, retains the commercial rights for zoliflodacin in the major markets in North America, EU, and Asia-Pacific. 

Innoviva Specialty Therapeutics will continue to collaborate with GARDP to advance regulatory filings with the European Medicines Agency.

GARDP is also taking steps to obtain market authorisation in Thailand and South Africa as both countries played a key role in the phase 3 trial. 

Zoliflodacin was submitted for priority review in Thailand last month, and a submission in South Africa is planned for early 2026.  

GARDP’s work on zoliflodacin was funded by the governments of Germany, UK, Japan, the Netherlands, Switzerland, Luxembourg, the Canton of Geneva, the South African Medical Research Council (SAMRC), and the Leo Model Foundation.

The Indian government monitors the burning of crop stubble by farmers in Punjab using satellites that capture a snapshot of the farms only at 1:30pm daily, but farmers are evading detection by burning at different times, as these satellite images show (above).

The Indian government claims that farm fires in Punjab, which contribute significantly to air pollution, were reduced by 90% during the autumn season of harvest and crop-waste disposal – historically a factor in sending heavy clouds of air pollution drifting around northern India in late October and November.

But in this Earth Chakra podcast, Health Policy Watch senior correspondent Chetan Bhattacharji debunks that claim. Bhattacharji interviewed Dr Hiren Jethva, an scientist specializing in remote sensing of aerosols at Morgan State University and NASA Goddard Space Flight Centre. Jethva exposes how Punjab farmers are, in fact, evading satellite monitoring.

According to Jethva, the true number of stubble burning incidents in Punjab could be 10 to 11 times higher than the official government count of about 5,000 for the harvest and crop-burning season, which ended in late-November. In the podcast, he teases apart the data to explain the reasons why the numbers are so misleading. ⬇️

Significantly, the Indian government’s space agency, Indian Space Research Organisation (ISRO), has, in a recent paper, reached a similar finding to Jethva’s, effectively endorsing what he has been saying for the past two years.

Growing public anger over pollution levels

The government claims of progress have appeared all the more specious as Delhi’s skyline once again become buried in a smoky haze over the past week, with fine particulate pollution levels (PM2.5) 35-40 times above WHO safe limits. On Sunday, 14 December, Delhi’s Air Quality Index, which reflects a combined score of the most dangerous pollutants, hit a season’s high of 461.

The crisis came against a backdrop of social media outrage and building public pressure – including protests that spilt over Monday to a football stadium event hosting the legendary Argentinian player Lionel Messi. The debate over the data comes as the effects of the burning fires on pollution levels appear undeniable. 

On Monday, Messi found himself in the middle of an unprecedented protest against Delhi’s air pollution while on a four-city tour to India. As the city’s Chief Minister, Rekha Gupta walked towards the footballer in the middle of a stadium full of ticket-paying visitors, the slogan “AQI, AQI,” decrying her handling of the air pollution crisis reverberated throughout the crowd. Videos quickly went viral.  The event was held amidst a thick haze – a palpable sign of the toxic air quality. 

On Tuesday, Delhi’s Environment Minister, Manjinder Singh Sirsa, apologised to the people of Delhi. He also announced fresh curbs on vehicle emissions, including an order that fuel not be sold to the drivers of vehicles lacking a a valid Pollution Under Control (PUC) certificate. That, despite the fact that the PUC testing system is outdated and does not screen for key pollutants like particulate matter (PM) and nitrogen oxides (NOx). 

While in November, the drift of smoke neighbouring agricultural states like Punjab and Haryana, which are burning crop waste, is a major factor in Delhi’s pollution, by December, conditions change. This month, weather conditions, including lower temperatures and low winds, are among the culprits. This traps more pollution at ground level. Simultaneously, there is a big increase in fires for household heating. Vehicular emissions are estimated to contribute some 27-51% of ambient air pollution levels in winter-time. 

Schools in hybrid mode

Along with the fuel sales restrictions, schools have been shifted to a hybrid mode. However, a government clampdown on coal and wood-fired tandoors also triggered protests and digs at the government. 

In another unprecedented move, the Singapore High Commission (embassy) in Delhi tweeted a note asking its citizens to heed the health, work and travel advisory of Indian pollution control officials. The UK and Canada reportedly put out advisories as well.

Gupta, a member of the governing BJP part of Nahrenda Modi, has been under attack for a series of decisions and comments by her administration, which took over the reins of Delhi government in February for the first time in 27 years, following elections. Those decisions range from allowing firecrackers in the recent Diwali festival, a move that ushered in the worst post-Diwali air pollution in five years, to defending videos which showed water being sprayed on and around the government’s air quality monitors.  She also has been quoted recently saying ‘AQI is like temperature.’

While Sirsa was quick to blame Delhi’s previous AAP and Congress governments of the last two and a half decades for the air pollution crisis, those opposition parties have called for the Chief Minister’s resignation. 

On Tuesday, India’s Environment Minister, Bhupender Yadav, also held a meeting on Delhi’s air pollution crisis. However, the capital’s daily PM2.5 levels have remained over 120 micrograms per cubic metre (μg/m3)  for weeks on end, with some neighbourhoods recording far higher levels. In contrast, the WHO 24-hour air quality guideline for PM2.5 is 15 μg/m3 with a recommendation of no more than 3-4 excedences per year. 

Children from El Fasher refugee families at village school in Tawila, North Darfur. The desert town’s population has swelled to 650,000 due to the war.

The World Food Programme (WFP) is warning of a rapidly deteriorating humanitarian emergency in Sudan on Friday, with conditions in the besieged city of El Fasher in Sudan’s Darfour region described as “beyond horrific.” 

Speaking at a briefing to UN reporters in Geneva, Ross Smith, WFP’s Director of Emergency Preparedness, said “anywhere between 70 and 100,000 people” are believed to be trapped inside the city,  amid “network blackouts” and “mass killings.”

The Rapid Support Forces (RSF), overran the city, the strategic capital of North Darfur, in October 2024 and in the months since, there has been little or no access to outside groups. 

Satellite images and survivor accounts, however, portray “the city as a crime scene with the mass killings, with burned bodies, with abandoned markets,” and WFP has “no partners left on the ground,” Smith added, saying that he had “no verified reports… that any of the community kitchens are operating.”

World Food Programme’s Ross Smith, speaking at a UN press briefing Friday in Geneva.

Attempting to flee is also extremely dangerous. “The city and its surrounding roads are littered with mines [and] unexploded ordnance,” he said. Those who escape face “robbery, looting and gender-based violence,” and must often pay “extraordinary amounts for transport.” Many arrive in surrounding areas “under the open sky without medicine and shelter.”

Smith said WFP continues to call for “unimpeded access into El Fasher,” noting that the agency now has “agreement in principle with the Rapid Support Forces that control the area for a set of minimum conditions to enter the city.” 

But after more than a year and a half under siege, he said, “the essentials for survival have been completely obliterated.” WFP has food and trucks ready to move “once that safe passage is secured.”

A massive displacement crisis in Tawila

Red dotted line denotes the Tawila district, now a camp for 650,000 refugees from North Darfur’s strategic capital of El Fasher, beseiged by the RSF for over a year.

Sudan is the world’s largest displacement crisis with more than 12 million people uprooted inside and outside the country.

In the Darfur region, one of the worst affected, Smith highlighted the extreme strain on Tawila, once a small desert town which has now swelled into a massive IDP holding more than 650,000 people. Families fleeing famine, atrocities, and recent fighting in El Fasher and Zamzam camp are now living in “very negative structures, grass, straw structures, etc.” He warned that “cholera and disease outbreak is widespread,” and that while WFP can deliver food to Tawila, “there’s very limited health care, sanitation, clean water and other… support.”

Across Sudan, WFP is reaching “over 4 million people per month,” and “half a million people in and around Tawila” were assisted in November. But escalating violence against aid workers—including an incident in which “one of our trucks was hit… and [a] driver is seriously injured”—continues to disrupt operations.

Smith warned that shifting battle lines are putting new communities at “grave risk,” including in nearby Kordofan, where the UN Refugee Agency, UNHCR reported on further deterioration over  the past two weeks. After a week of heavy fighting, the RSF reportedly seized control of a Sudanese Armed Forces base in Babanusa, West Kordofan.

In South Kordofan, “civilians remain trapped in besieged cities such as Kadugli and Dilling, and as women, children, and the elderly find ways to escape, men and youth are often left behind due to specific high risks they face along flight routes such as detention by armed groups for perceived affiliation with parties to the conflict,” UNHCR said.

Preventing the devastation seen in El Fasher from being repeated “must be a top priority for all of us,” said Smith.  

He added that WFP faces imminent funding shortfalls, Smith also said: “Pipeline breaks are right in front of us,” and assistance will require “almost $ 700 million” over the next six months.

Gaza: Winter storm deepens suffering 

As thousands of displaced Gazans’ tents were flooded by Storm Byron, mounds of debris and waste were the only stormwalls.

Meanwhile, in Gaza, humanitarian and health conditions remain dire – with a massive storm Byron leaving thousands of tents flooded, increasing disease risks and leaving families homeless once again. 

Speaking to reporters from Gaza, WHO representative Rick Peeperkorn to the Occupied Palestinian Territory (OPT), described the widespread infrastructure destruction he had witnessed and the growing public-health crisis aggravated by Storm Byron, the massive winter storm that swept through the region this week. 

“The storm environment struck Gaza with force,” Peeperkorn said. “The deplorable conditions, especially shelter conditions, are deepening the suffering of already displaced families. 

He described how high ocean waves had hit particularly hard at the thousands of families sheltering in “low lying and debris-studded coastal areas with no drainage or protective barriers, simply the heaps of garbage everywhere along the roads. 

“And we’ve seen, of course, winter conditions, combined with poor water and sanitation causing a surge in acute respiratory infections, including influenza –  as well as hepatitis, diarrhoeal diseases, etc,” Peeperkorn said.

Hospitals only partly functional 

WHO’s early warning system has recorded 1.47 million acute respiratory infections and over 670,000 acute diarrheal cases since being established in January 2024. But that’s only partial data insofar as diagnosis and testing are severely constrained by a shortage of clinics, laboratories and diagnostic equipment, Peeperkorn added. 

Only about half of Gaza’s 36 hospitals are functioning, along with 46 primary health care centers, while another 84 clinics out of a total of 195 are partly functional. 

Rik Peeperkorn, WHO Representative to the Occupied Palestinian Territory (OPT) speaking with reporters Friday from Gaza.

North Gaza remains the most severely underserved, with tens of thousands of displaced people and almost no functioning medical facilities within the “Yellow Line” that demarcates Israeli-controlled areas from areas controlled by Palestinians – where the militant Hamas group has largely reasserted itself. 

Among the roughly 650 essential medicines on WHO’s list, “50% of them are zero, or close to zero, stock.” Peeperkorn said the Shifa Hospital director “was almost crying,” as major hospitals operate “without CT, without MRI, without proper X-ray, without proper ultrasound equipment.”

Despite immense shortages, he observed creative reconstruction efforts, where clinic and hospital reconstruction teams are managing to rebuild using repurposed materials salvaged from destroyed buildings.

Critical need for medical evacuations

Peeperkorn called on Israel again to reopen the traditional medical evacuation route from Gaza to West Bank and East Jerusalem Palestinian hospitals, saying: “There’s no reason why this… cannot be reopened.” WHO is prepared to facilitate daily evacuations once access resumes, he said.  

While WHO and partners have managed to evacuate some 10,645 people since the war began in October 2023 to third countries in Europe, the Middle East or elsewhere, there are still some 18,500 patients awaiting medical evacuation, including 4096 children. And over 1000 patients have died while waiting. 

Call for sustained ceasefire and rehabilitation 

Peeperkorn meanwhile warned that makeshift shelters, widespread debris, and deteriorating sanitation pose long-term threats,  especially for children and the elderly. 

“There’s an enormous amount of garbage and debris everywhere, it’s an environmental health disaster,” he said. 

And while formal reconstruction processes remain on hold, pending further negotiations between Israel and Hamas, mediated by the US and Arab brokers, the situation on the ground is not static, Peeperkorn warned. 

“The 2.2 million people of Gaza cannot wait before we renegotiate again, those materials need to get in now.”

Image Credits: UNICEF/Mohammed Jamal, Google Maps , IOM .

From left to right: the two negotiators for the European Parliament Tiemo Wölken (Socialists and Democrats, DE) and Dolors Montserrat (European People’s Party, ES) with the chair of the EP Committee on Public Health Adam Jarubas (European People’s Party, PL) at the presentation of the new EU pharma package on Thursday.

Following eleven hours of intense negotiations overnight, the European Union (EU) clinched a landmark agreement on the most significant pharma reform of its medicines market in over 20 years on Thursday.  Reached in the final moments of the Danish EU Presidency’s mandate, the deal aims to strike a critical balance stimulating pharma innovation, particularly for critical new antibiotics and rare disease drugs, but also speeding the development of generics to ensure more affordable treatment in all 27 member states.

“The deal demonstrates the EU’s commitment to innovation and ensuring that patients in Europe have access to the medicines they need,” remarked Sophie Løhde, Denmark’s Minister for the Interior and Health, a member of the EU Council, the governing body driven by ministers from all EU countries. She led the negotiations between the Council and the Members of the EU Parliament (MEPs) that clinched the deal.

The EMA welcomed the pharma reform package in a statement published shortly after the deal was announced, with Emer Cooke, EMA’s Executive Director, hailing it as a “historic milestone for European medicines regulation and for patients across the EU.” However, leading industry representatives warned that the compromise does not go far enough to ensure Europe’s global competitiveness and attract investment.

Pharma reform aims to reward innovation and access

The EU pharma reform offers companies longer data protection periods for certain medicines categories based on public health goals.
The EU pharma reform offers companies longer data protection periods for certain medicines categories based on public health goals.

At the heart of the pharma reform lies a revised regulatory regime that reduces the previous 10-year data protection and market exclusivity period to a baseline protection of nine years that aims to incentivise drug development and accessibility through a performance-based model – including eight years of data protection and one added year of exclusive market access.

In the first eight years after a medicine receives marketing authorisation, the pharma innovator’s preclinical and clinical test results from the regulatory dossier remain confidential and inaccessible to use by companies developing generic or biosimilar versions of most patented drugs.  After one additional year, generic or biosimilar producers could then put competing drugs on the market, effectively reducing a key aspect of patent protections by a year.

The pharma reform deal strikes a balance between the interests of drug developers and market access for cheaper generic products, Spanish MEP Dolors Montserrat from the European People’s Party (EPP) stated. She was one of the European Parliament’s two leading negotiators.

The European Commission had initially proposed a much shorter Regulatory Data Protection (RDP) period of six years as a baseline. The European Federation of Pharmaceutical Industries and Associations (EFPIA) strongly advocated for a longer baseline period. They claimed that shorter protection periods would deter investment in research and development.

Exceptions for drugs addressing unmet needs and rare diseases

But the EU deal also introduces exceptions allowing the total combined Intellectual Property (IP) protection period to be extended in the case of rare diseases or other unmet needs.

Products that address rare diseases for which there is currently no treatment available, and which are defined as ‘breakthrough orphan medicinal products’, may benefit from up to 11 years of market exclusivity, with a maximum of 13 years.

The IP protection period could also be extended from nine to eleven years, if any of the following public health criteria are met:

  • If the medicine is continuously supplied in sufficient quantity in all Member States;
  • If products address unmet medical needs, such as a disease for which there is not yet a cure;
  • A new therapeutic indication for the existing drug provides significant clinical benefits
  • A company conducts comparative clinical trials in several EU Member states (rewarding comprehensive data generation), as well as applying for authorisation outside the EU within 90 days (to incentivise global competitiveness).

Crucially, the new package also shortens the timeframe in which the European Medicines Agency (EMA) would be expected to review and approve new drugs from the previous standard of 210 days to 180 days – a measure welcomed as “encouraging steps” by industry.

The ‘Bolar Exemption’: prepping generics for Day One launch

Dolors Montserrat (EPP, ES) explains the deal reached between the EU Parliament, Council, and Commission on Thursday at a press conference.

In another move to lower costs, the EU agreed to speed up the market entry of more affordable generic and biosimilar medicines immediately following the expiration of the original protections under a strengthened version of the so-called “Bolar Exemption”. This exemption will now allow generic and biosimilar manufacturers to access data from a patented product to conduct their own clinical trials, even during the eight-year Regulatory Data Protection (RDP) period.

“The day after a patent expires on a medicine, generics will be available,” explained MEP negotiator Montserrat. She described it as a clear win for the generic industry.

The various exceptions illustrate how negotiators had to strike a balance between pharma incentives to invest in new medicines development, including for rare diseases, and ensuring that a broad range of other drugs remained accessible and affordable across the continent.

To promote affordability further, the EU pharma reform intends to implement various measures. For example, it will require manufacturers to publicly disclose all “direct financial support” received from public authorities or funded bodies for R&D. This is expected to help Member States in their price negotiations.

‘Netflix’ model to incentivise development of new antibiotics

The pharmaceutical package aims to boost competitiveness and investment in drug development, especially to stimulate R&D on antibiotics.

Another key element of the deal is tackling antimicrobial resistance (AMR), which, according to the European Medicines Agency (EMA), is responsible for over 35,000 deaths in Europe each year – and over 1 million deaths globally.

To address the conundrum that new, and more effective antibiotics must be used sparingly as a last resort, thereby reducing the sales volume needed to recoup research and development (R&D) costs, a new financial incentive is introduced.

This comes in the form of transferable vouchers for another year’s worth of data exclusivity.  A company that develops a priority antimicrobial can use the voucher to protect another drug from competitors for a longer period – or sell to another company.

However, this also comes with a “blockbuster” restriction. This stipulates that the data exclusivity vouchers cannot be used for products with annual gross sales exceeding 490 million Euro in the preceding four years.

A “Netflix model” procurement mechanism also enables Member States to purchase antimicrobials via multi-year subscription contracts. MEP Tiemo Wölken from the Socialists and Democrats (S&D) hailed its inclusion as a breakthrough that would decouple antibiotic developers’ revenue stream from actual sales volumes. That will provide pharma developers with a stable income stream to recoup R&D costs while enabling to only use the new drugs when absolutely necessary, thereby reducing the spread of more drug resistance.

New measures to fight antimicrobial resistance

According to the European Federation of Pharmaceutical Industries and Associations, the package lacks keys elements to bolster competitiveness.

These incentives are complemented in the pharma reform by strict requirements, including mandatory medical prescriptions for all antibiotics sold across the EU, with only a few exceptions, as stated by EPP politician Dolors Montserrat.

The new rules also require manufacturers to submit an “antimicrobial stewardship plan” and include an evaluation of the risk of AMR selection across the entire “manufacturing supply chain inside and outside the Union” as part of a compulsory environmental risk assessment (ERA, which tracks risks like AMR selection throughout the manufacturing supply chain).

The issue is particularly critical in countries outside the EU, specifically Lower- and Middle-Income Countries (LMICs). Global surveillance data from the WHO indicates that resistance to life-saving antibiotics is extremely high and increasing, particularly in settings with limited resources. Globally, more than 1.1 Million people die due to AMR, according to WHO numbers.

By mandating environmental risk assessments covering AMR throughout the manufacturing supply chain, both within and outside the EU, the bloc is also leveraging its substantial market influence to impose stronger global standards. This also applies to the sale of antimicrobials for use for farming animals, in meat production and aquaculture – three of the main drivers of AMR.

This push for environmental standards is expected to provide positive effects globally, Dorothea Baltruks, Director at the Berlin-based Centre for Planetary Health Policy (CPHP), explained in a statement to Health Policy Watch. “When a large market such as Europe sets binding environmental compatibility standards for medicines, this can provide significant impetus for the global market, which also benefits people in LMICs,” Baltruks emphasised.

Industry: package lacks steps to bolster competitiveness

European Parliament negotiator Tiemo Wölken emphasises the balance between industry and public health interests contained in the pharmaceutical package.

“It is crucial that Europe has a regulatory system in place that can keep up with all these challenges,” concluded Wölken. “We cannot forget that we are faced with international challenges.” According to him, the package is key to assure competitiveness and innovation.

This perspective, however, is precisely where EFPIA views the reform package as insufficient. In a statement released shortly after the agreement, the industry association charged that the current baseline protection is not long enough to attract and retain global investment into European R&D. EFPIA also called the stronger language on the Bolar exemption an “unnecessary move” that would further erode competitiveness.

Nathalie Moll, Director General of the EFPIA said: “Our region has lost a quarter of its global share of investment to other parts of the world in two decades, while our share of clinical trials has halved. If this is the legislative framework that is expected to attract the medicines innovation of the next 20 years to Europe, the outcome is underwhelming,” she criticised.

Despite the objections, the agreement on the pharma reform now heads to the European Parliament and the Council for formal endorsement, which is expected in the coming weeks.

Image Credits: European Union, EU Parliament, Felix Sassmannshausen, European Union, EU Parliament.

Kenya’s President William Ruto applauds Kenyan Cabinet Secretary Musalia Mudavadi and US Secretary of State Marco Rubio after the signing of the health Memorandum of Understanding (MOU) between the two countries.

Kenya’s High Court suspended the implementation of the country’s Memorandum of Understanding with the United States on Thursday after two separate court challenges by the Consumer Federation of Kenya (COFEK) and local Senator Okiya Omtatah.

COFEK argues that the agreement contravenes Kenya’s Data Protection Act, Digital Health Act, Health Act, and new data regulations that protect citizens’ health data.

Meanwhile, Omtatah petitioned the court to halt the agreement on the grounds that it undermines the principles of public participation, parliamentary oversight and binds Kenya to terms that could strain the country’s budget.

The five-year agreement signed in Washington last week commits the US to providing up to $1.6 billion between 2026 and 2030, mainly for HIV/AIDS, tuberculosis (TB) and malaria prevention; maternal and child health, and outbreak surveillance and response.

Kenya has committed to increasing domestic health spending by $850 million over the five years, with incremental annual increases from $77,5 million (10 billion Kenyan shillings) in 2026 to $387,7 million in 2030.

Extract from the US-Kenya MOU detailing each country’s financial obligations.

But the additional expenditure will cover priority issues for the US, such as employing additional epidemiologists and lab technicians to monitor outbreaks.

The court has given COFEK until 17 December to lodge court papers, and the government has until 16 January to file its response. The case will return to court on 12 February.

Speaking after the judgement, Omtatah told the Kenya Broadcasting Corporation that there had been no involvement of the Senate in developing the agreement, which has “major” implications for the country’s finances as it commits the country to spending billions of extra Kenyan shillings.

“Who has appropriated that money? Where is the government going to get that money? Thousands of employees are going to be recruited to work under this arrangement, and then [in 2030], when the arrangement expires, they are supposed to transfer to the government,” Omtatah said.

An earlier draft of the agreement gave the US unfettered access to Kenya’s health data but, following an outcry from local organisations about the violation of patient confidentiality, the signed agreement has been amended to commit to data sharing in terms of Kenyan law:

The US-Kenya MOU tightens up confidentiality but gives the US a loophole in the event of a data breach.

The US-Kenya Data Sharing Agreement, which is an appendix to the main MOU, sets out the terms of access in more detail.

The court has instructed COFEK to serve all involved officials with the petition and court orders by December 17. The government has until January 16 to file its response. The case will return to court on February 12.

Civil society appeal to African leaders

Earlier this week, almost 50 civil society organisations published a letter calling on African heads of state and government to demand “equity and sovereignty” in their new bilateral health agreements with the United States.

Last week, the US signed bilateral agreements with Kenya, Rwanda, Liberia, Uganda and Lesotho as part of the revival of US health aid, including the US President’s Emergency Plan for AIDS Relief (PEPFAR), which was stopped abruptly when Donald Trump became US president in January, severely straining several African countries’ health systems.

In exchange, African countries have to commit to signing “specimen sharing agreements” to provide the US with “physical specimens and related data, including genetic sequence data, of detected pathogens with epidemic potential for either country within five days of detection”. 

Initially, the specimen-sharing was for 25 years, but in the agreements seen by Health Policy Watch, this has been trimmed down to between seven and 10 years. 

US, which pulled out of the World Health Organization (WHO) in January, appears to be trying to undermine the global talks on pathogen access and benefit-sharing (PABS) currently underway at the WHO.

The PABS system, the last outstanding issue in the Pandemic Agreement, will govern both how information about dangerous pathogens should be shared (the access part) and how countries that share this information should be rewarded (the benefits).

Countries that have signed MOUs have three months to present “implementation plans” to the US, and thus have the opportunity to negotiate better terms. However, civil society is completely shut out of these agreements, with the exception of “faith-based organisations” in Uganda that provide health services.

‘One-sided terms’

The letter urges African governments to “advance counterproposals grounded in national law, regional strategies, and public accountability, rather than accept one-sided terms”. 

“These agreements risk entrenching unequal power dynamics and compromising sovereignty,” said Aggrey Aluso, Executive Director of the Resilience Action Network Africa (RANA). 

“Africa has committed to building its own health sovereignty; no government should accept terms that hand long-term control of our data and pathogens to a foreign government – and its contractors – without clear, enforceable obligations that protect our people, uphold our laws, and strengthen public institutions,” Aluso added.

For example, Uganda’s MOU with the US demonstrates a lack of regard for the country’s sovereignty by declaring that the MOU’s implementation plan will be “an annex to Uganda’s national health budget and guide parliamentary appropriation”:

Uganda’s MOU with the US will become an annex to its health budget.

As with the Kenya-US MOU, the US commits $1,7 billion over five years while Uganda commits to increasing its domestic share of the items covered by $500 million over the same period.

Summary of Uganda and US financial obligations.

Meanwhile, Liberia will need to fund an additional 1,851 health workers, including 342 laboratory workers who may not normally have been a priority for the country, according to its MOU with the US.

By 2030, Liberia will shoulder almost its entire expenditure for commodities, including malaria and HIV diagnostics and countermeasures, at an annual cost of $10 million by 2030.

US-Liberia obligations for commodity payments.

‘Trade power and dignity’

“These deals ask countries to trade their power and a little of their dignity for less support than Trump took away early this year,” said Peter Maybarduk, director of Public Citizen’s Access to Medicines Program. 

“African nations have stood together to negotiate better access to medical tools ever since COVID’s deadly vaccine inequity. Trump would undermine even that principled stand. Each time we think we’ve seen the bottom, the Trump administration finds a way to dig a deeper, darker role for the United States in global health.”

Meanwhile, World Health Organization (WHO) Director General Dr Tedros Adhanom Ghebreyesus told a media briefing in Geneva on Thursday that the bilateral MOUs are agreements between two sovereign nations with their own national interests.

He added that the MOUs did not threaten the global pathogen-sharing agreement currently being negotiated at the WHO, as they would cover 50 countries maximum (according to the US) in comparison to the 194 WHO member stats.

“How many countries, maximum target, do they have? They say 50 countries. This cannot replace an agreement of an international nature. That means 194 countries. So the multilateral system, the common platform, fills almost every space. 

“We say solidarity is our best immunity, and this means all 194 countries should come to the table, if possible. Otherwise, the majority, probably 90% should achieve [a pathogen sharing arrangement] in order to make sure that the antigen come from all corners of the world. Because we never know where the next outbreak will come from.”