Category: Vaccine

Oregons governor and the director of the Oregon Health Authority are immune from lawsuit or liability stemming from the priorities they set that established who received COVID-19 vaccines first in state prison, a panel of the 9th U.S. Circuit Court of Appeals ruled Thursday.

The three-judge panels ruling reverses a lower courts refusal to grant the governors and health-authority directors motion to dismiss a class-action suit by current and former inmates.

At the start of the COVID-19 pandemic, then-Gov. Kate Brown and Oregon Health Authority Director Patrick Allen set priority tiers to guide the rollout of the states supply of vaccine, which became available in February 2021. They put state prison inmates at a lower priority than correctional officers.

The appellate panel found that the administration of the vaccination included its prioritization when supply was limited, and that the federal Public Readiness and Emergency Preparedness Act (PREP), passed in 2005, extended immunity to people who make policy-level decisions on who was eligible to receive the vaccine first.

Attorneys for the prisoners, who argued that the federal law did not extend immunity to policy-level decisions on the prioritization of the vaccines, contended that the governor and the health authority were deliberately indifferent to state prisoners serious medical needs and physical safety, in violation of their civil rights.

The class-action suit included inmates who were diagnosed with COVID-19 while in state custody and the estates of inmates who died from the virus or COVID-19 contributed to their deaths.

U.S. Magistrate Judge Stacie F. Beckerman ruled in 2022 that the wrongful-death class in Oregon was likely to exceed 40 people, while the class of prisoners who were infected with COVID-19 while in state prison was more than 3,600 people.

Several of the PREP Acts provisions expressly show Congresss intent to extend immunity to persons who make policy-level decisions regarding administration or use of covered countermeasures and do not directly administer countermeasures to particular individuals, Circuit Judge Jennifer Sung wrote for the panel.

Circuit Judges Johnnie B. Rawlinson and Carlos T. Bea joined in Sungs ruling.

The Oregon Health Authority had recommended a phased allocation of the vaccines. Healthcare workers, residents in long-term care facilities and corrections officers were eligible for vaccination in what was called Phase1A. Then, teachers, childcare workers and persons age 65 or older were eligible in Phase 1B.

Neither phase covered adults in custody, but those who met the above eligibility criteria were prioritized for vaccination on the same terms as the general population, according to the courts ruling. For example, all inmates who were 65 or older were eligible for vaccination in Phase 1B.

Lawyers who filed the suit argued that the states decision to issue vaccines to corrections officers before most state prisoners violated the Eighth Amendments prohibition against cruel and unusual punishment.

-- Maxine Bernstein

Email mbernstein@oregonian.com; 503-221-8212

Follow on Twitter @maxoregonian

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Oregons governor immune from liability stemming from COVID-19 vaccine prioritization decisions, appellate co - OregonLive

CLAIM

Polio vaccine doesnt work; India had no cases of non-polio paralysis until polio vaccine was introduced; polio was renamed to hide its existence

DETAILS

Flawed reasoning: Acute flaccid paralysis (AFP) surveillance is the gold standard for detecting polio. Part of surveillance is to investigate whether AFP cases are caused by polio through laboratory testing. Non-polio acute flaccid paralysis is, by definition, established to not have been caused by polio and therefore cannot simply be another name for polio. Factually inaccurate: The reel inaccurately suggested that there was a sudden jump in cases of non-polio AFP only after India was declared polio-free in 2014. In fact, epidemiological data showed a steady rise in cases of non-polio AFP that began in 2004. Cases peaked in 2012 and have since declined.

KEY TAKE AWAY

Polio is a disease caused by the poliovirus that is spread through the oral-fecal route. It affects the nerves and can lead to life-threatening and disabling disease in a certain proportion of infected people. The polio vaccine, coupled with improvements in sanitation and polio surveillance programs, have been critical to eradicating polio around the world. Nationwide surveillance of acute flaccid paralysis (AFP), which is the main way in which polio manifests itself, is considered the gold standard for polio detection.

The reel was posted by the Instagram account you.dont.know.jac and received more than 15,000 views by the time of writing. The account, which has more than 83,000 followers, is run by an individual named Jaclyn Simone, who also claims vaccines cause encephalitis and autism (they dont) and promotes an oil that allegedly detoxes and treats autism (theres no evidence this works).

The claim that the polio vaccine doesnt work and that polio has simply been renamed to hide its existence is an old one, as numerous articles, like this one by pediatrician Vincent Iannelli and another by virologist Ian Mackay, demonstrate. This claim is commonly used to downplay the public health achievements made possible by the polio vaccine. Readers may also recognize this tactic repurposed in the false but viral claim that the flu had simply been relabeled as COVID-19 to manufacture the semblance of a pandemic.

We explain below why the claims in the Instagram reel are inaccurate and arent substantiated by evidence.

Before the polio vaccine was introduced in India in 1978, the country saw an estimated 200,000 cases of polio annually. Indias polio eradication campaign, named the Pulse Polio Programme, was officially inaugurated in 1995. This vaccination campaign aimed to vaccinate all children under the age of five using the oral polio vaccine. At the time the campaign started, India saw around 50,000 polio cases every year.

In addition to the vaccination campaign, India conducted a polio surveillance program. This involved environmental surveillance of wastewater for poliovirus as well as the detection of cases of acute flaccid paralysis (AFP), the latter beginning in 1997. AFP is the main way in which polio manifests itself and is commonly seen in children under the age of 15. It is a neurological condition that results in weakness of limbs and often muscles involved in respiration and swallowing.

Polio doesnt always cause paralysisin fact, about 70% of infected children show no symptoms. However, infected people can shed virus from their nose, throat, and gut for days to weeks. This means that the virus can spread quickly in a population, especially one with low polio vaccine coverage.

Therefore, nationwide AFP surveillance is important for detecting polio cases early to curb its spread. Such surveillance is considered to be the gold standard for polio surveillance programs.

This involves finding cases of AFP and testing stool samples for the poliovirus. This testing is important because viruses other than polio can also cause AFP. In fact, the U.S. saw concerning outbreaks of AFP in November 2018, which were linked to enterovirus D68, a relative of the poliovirus.

AFP cases in which polio isnt detected arent considered polio and are instead classified as non-polio AFP (NPAFP). The Global Polio Eradication Initiative states that countries should detect at least one annual case of NPAFP per 100,000 people aged less than 15 years to ensure that the surveillance program is sufficiently sensitive. This is because 1 in 100,000 is the known background rate of NPAFP.

The last case of polio in India was reported in 2011. After decades of concerted efforts at polio eradication, India was declared polio-free in 2014, after reporting zero cases of polio for three consecutive years.

The reels claim that India didnt have any cases of NPAFP before the polio vaccination program started in 1995 is highly misleading, given that India didnt have an AFP surveillance program at that time. The surveillance program only began in 1997, as explained earlier. Therefore, the country wouldnt have had data on NPAFP to begin with.

Furthermore, NPAFP cases are, by definition, cases that arent caused by polio. AFP cases are investigated in order to rule out polio as a cause. Part of this investigation is testing patient samples for poliovirus. If poliovirus isnt detected, then the case isnt considered to be caused by polio.

While India continued to see tens of thousands of AFP cases after it was declared polio-free, none of these cases tested positive for polio, per the WHOs Country Office for India:

A total of 59,436 AFP cases were investigated in India in 2012, another 53,421 in 2013 and 53,383 in 2014. Not a single AFP case has tested positive for polio in 2012, 2013 and 2014. All AFP cases during the last 3 years have been due to non-polio causes.

Therefore, the reels claim that polio cases have simply been relabeled as NPAFP is inaccurate and demonstrates a lack of understanding of how NPAFP cases are identified.

Nor is polio being renamed as acute flaccid myelitis or Guillain-Barr syndrome. Cases of suspected acute flaccid myelitis undergo laboratory testing in order to determine the cause of the disease. This includes testing patient samples to identify viruses. If polio is detected, the case is considered polio, not acute flaccid myelitis.

Guillain-Barr syndrome is another neurological condition that produces weakness and sometimes paralysis, but isnt associated with poliovirus. Instead, it is associated with infection by the bacterium Campylobacter jejuni, the flu virus, cytomegalovirus, and Epstein-Barr virus.

The epidemiological data from India does show that NPAFP cases were particularly high after India was declared to be polio-free in 2014 (Figure 1).

Figure 1 The rate of NPAFP in India per 100,000 children between 2001 and 2021. Source: Our World in Data. Data retrieved on 30 January 2024.

But as the graph above also shows, the rise in NPAFP had already begun sometime in 2005, nearly a decade before India was declared polio-free, and continued to rise after 2005. And while it did peak in 2012, it has since fallen.

Both observations speak against the claim that NPAFP is simply a new label for polio after the disease was declared eradicated. If the claim were true, then we would have expected the number of NPAFP cases to continue to climb after 2014, but cases have fallen instead.

It is worth noting that it was also between 2004 and 2005 that India stepped up its efforts to detect polio cases[1]. To that end, the definition of AFP was broadened to include even transient weakness and facial paralysis. Moreover, to further enhance the sensitivity of the program, the number of AFP case-reporting sites in the country rose from 21,403 in 2004 to 36,629 in 2012 to include health facilities serving migrant and high-risk populations.

This combination of changes to the AFP surveillance program likely contributed, at least in part, to the rise in the number of NPAFP cases detected.

Virologist Ian Mackay, who works at the Infectious Diseases Laboratory, Pathology Queensland, highlighted how polio hasnt been detected in India, despite the tens of thousands of AFP cases every year, underscoring the specificity of the polio vaccines effect:

Ironically the fact that India still has tens of thousands of NPAFP cases each year and not a single polio case among them highlights that the polio vaccine is what made the real difference. Vaccines work. And polio is almost eradicated because of their effectiveness.

The reels claim that the polio vaccine doesnt work hinges on cherry-picking epidemiological data and a conspiracy theory that polio has simply been renamed acute flaccid myelitis and Guillain-Barr syndrome to hide its existence. However, this is inconsistent with what we know of polio surveillance programs. A critical part of such programs is laboratory testing to identify the cause of AFP cases. NPAFP cases are, by definition, cases in which polio wasnt detected and therefore arent considered polio cases. Acute flaccid myelitis is also, by definition, not caused by polio, and therefore arent polio cases. And Guillain-Barr syndrome isnt associated with poliovirus.

The reel also claimed that there was a sudden rise in these cases only after India was declared polio-free, but this is also inaccurate. While NPAFP cases were quite high in 2014, which is when India achieved its polio-free status, NPAFP cases had already begun to rise between 2004 and 2005, which also coincides with increased efforts to detect polio cases in India. Part of this included using a broader definition of AFP to include even transient cases, which likely contributed to the rise, since such cases wouldnt have been included in the past based on the earlier, narrower definition.

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Epidemiological data refutes the claim that polio is renamed to hide the disease and the polio vaccine doesnt work - Health Feedback

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Phase III trial results of the R21/Matrix-M vaccine developed by Oxford University and Serum Institute of India Pvt Ltd, leveraging Novavax's Matrix-M adjuvant, has confirmed high efficacy and supported regulatory approvals and licensure in several African countries.

The R21/Matrix-M vaccine was designed in 2011 as a potential improvement on the RTS, S/AS01 malaria vaccine designed in the 1980s. A Phase II trial in Burkina Faso, reporting in 2021, was the first to show that R21/Matrix-M could reach the WHO-specified target of 75% efficacy in African children.

Recent WHO endorsement will lead to the initial rollout of R21/Matrix-M in the coming months. The new results are published in The Lancet.

The trial investigators immunized over 4,800 young children in a trial in Burkina Faso, Kenya, Mali and Tanzania and found on average 78% vaccine efficacy over the first year of follow-up across all sites in the 517 month age group, the age range group which is studied for most malaria vaccines.

Efficacy over this period was broadly similar across sites and in different transmission settings. Safety data from the trial have been reassuring with no serious adverse events linked to immunization. No other vaccine has reported over 55% efficacy in the same age group.

A booster dose at a year maintained good efficacy over the following 612 months. The vaccine also reduced infection rates in children measured at 12 and 18 months after vaccination suggesting a potentially beneficial effect in reducing malaria transmission.

R21/Matrix-M vaccine was well tolerated, with injection site pain and fever as the most frequent adverse events. Number of adverse events of special interest and serious adverse events did not significantly differ between the vaccine groups. There were no treatment-related deaths.

Malaria is the largest cause of death in young African children with over 600,000 deaths globally each year. Two vaccines have recently achieved and completed World Health Organization (WHO) prequalification and initial deployments are starting early this year.

Professor Adrian Hill, chief investigator of the R21/Matrix-M Phase III trial said "The continued high efficacy of this new vaccine in field trials is very encouraging, and consistent with the high efficacy and excellent durability observed in a smaller four-year Phase IIb trial. These data support an important role for the unique high-density nanoparticle display of the conserved repeat region of the malaria parasite circumsporozoite protein, a feature in the design of the R21 vaccine, in providing such high vaccine efficacy and, thereby, an important new tool for malaria control."

Significantly increased immune responses to the R21/Matrix-M vaccine and slightly higher vaccine efficacy were observed in 5- to 17-month-olds compared to 18- to 36-month-olds malaria vaccines, supporting planned vaccine deployment initially from 5 months of age in young African children.

The vaccine is licensed to the Serum Institute of India (SII), the world's largest vaccine manufacturer and a long-term partner of the University of Oxford. This is critical because vaccinating those at high risk of malaria will be important in stemming the spread of the disease, as well as protecting the vaccinated. Matrix-M adjuvant is manufactured by Novavax AB and provided to Serum Institute of India for formulation into the final vaccine drug product.

Adar Poonawalla, CEO, Serum Institute of India, said, "The Lancet study on R21/Matrix-M Phase III trials mark a significant advancement in our battle against this global threat. Our collaboration with the University of Oxford has been instrumental in developing the R21/Matrix-M malaria vaccine. We are dedicated to making this vaccine available, especially in Africa, where malaria poses a substantial threat to millions of lives, bringing us closer to a malaria-free world."

Professor Alassane Dicko, Principal Investigator in Mali of the R21/Matrix-M vaccine said "It has been very exciting to generate high efficacy data with the new R21/Matrix-M vaccine so quickly. I predict that this vaccine should be very impactful in preventing malaria deaths in African children."

John C Jacobs, CEO of Novavax commented "Approximately 1,300 children die from malaria every day, a staggering statistic for a preventable disease. The R21/Matrix-M Phase III efficacy data published in The Lancet reinforce the potential of R21/Matrix-M vaccine to protect children against this disease."

"We are proud of the role of Novavax's patented saponin-based Matrix-M adjuvant, which has been demonstrated to enhance the immune response, in the outcome of this clinical trial and are eager to see the realized impact of the vaccine when it is rolled out globally."

More information: Mehreen S Datoo et al, Safety and efficacy of malaria vaccine candidate R21/Matrix-M in African children: a multicentre, double-blind, randomised, phase 3 trial, The Lancet (2024). DOI: 10.1016/S0140-6736(23)02511-4

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High efficacy and good safety profile for the R21/Matrix-M malaria vaccine in African children - Medical Xpress

As she watched her teenage son being wheeled into an ambulance, before being blue-lighted to hospital, Rebecca Evans felt a terrifying sense of helplessness. And she felt a stomach-churning guilt too. For the reason her precious boy was in this life-threatening state related directly to a decision she herself had made.

When Rebecca was invited to give Louis the Measles, Mumps and Rubella (MMR) vaccine at the age of one, she thought she was doing the right thing by declining it. At that point the jab was tainted by claims, later wholly disproved, linking it to the developmental disability autism.

Yet it was a decision with almost catastrophic results, causing Louis to catch measles 16 years later and suffer such severe respiratory problems he had to be resuscitated by paramedics. He would spend a week in isolation in hospital with a serious infection and dangerously high temperature, and for years afterwards, would resent his mother for not giving him the shot.

It was a terrible time, says Rebecca, 55, as she describes that panicked dash to the hospital. I feared I might lose him. Its the worst imaginable thought for any mother and I had to force myself to stop it and focus on supporting my son, who was also terrified. I feel quite emotional recalling it now.

I remember a consultant at the hospital asking why I hadnt had him vaccinated and when I told him about my fears that Louis might develop autism, he looked up at the ceiling, in despair, and said: I must have heard this a hundred times. It was, of course, too late by then. I apologised for not realising how serious measles could be, and for putting other, more vulnerable, people at risk by not having him inoculated.

In the most serious cases, measles can cause complications including meningitis, seizures and even blindness and encephalitis swelling of the brain

Louis is now 26 and Rebecca has decided to speak out because the UK is in the grip of a measles emergency, with outbreaks in London, Birmingham and Yorkshire leading the UK Health Security Agency (UKHSA), which replaced Public Health England during the pandemic, to declare a national incident.

Since October 2023, there have been 347 laboratory confirmed measles cases reported in England, with 127 of these recorded in January.

Public health officials fear that we have now lost herd immunity to the disease with only

85 per cent of children in the UK vaccinated against it compared to the 95 per cent needed and that urgent action is required to prevent the worlds most contagious virus spreading like proverbial wildfire.

The outbreak appears to be the result of a perfect storm: a fall in the number of children given jabs during the pandemic and those unvaccinated children now mixing with young adults whose parents opted not to let them have it during the late 1990s and early noughties, at the height of the MMR scare.

The outbreak is especially dispiriting, given that, in 2017, the World Health Organization declared the disease had been eliminated for the first time in the UK, since no indigenous cases of measles had been recorded for three years.

Foolish though Rebecca admits she was to leave her son unprotected from the threat of measles not to mention rubella, which carries similar risks, and mumps, which can cause infertility in men she was far from the only middle-class mum to opt out of giving her child the triple jab during those years.

The controversy began in February 1998 with the publication of a paper in the highly respected medical journal The Lancet by Andrew Wakefield, at the time a gastroenterologist at the Royal Free Hospital in North London, claiming a link between the MMR vaccine, gut problems in children and autism.

In 2010, the Lancet retracted Wakefields paper which featured case studies of just 12 children, so fell way short of being based on any kind of robust clinical trials on the grounds that elements appeared to be false. He was then struck off the medical register.

However, to the frustration of medics, the seeds of fear had been sown and many children went unvaccinated, unless their parents paid for the jabs to be given separately, which was the only other option.

While most are now well aware that the suggested link with autism was entirely bogus, Helen Bedford, a professor of childrens health at the UCL Great Ormond Street Institute of Child Health, has said those not vaccinated due to the scare together with children who missed out on jabs during the pandemic may be helping the virus to spread.

Over the years, the number of unvaccinated people has accumulated in the population, enabling measles to take hold and spread quickly within communities, warns Professor Bedford.

For Rebecca, the choice seemed stark. A single mum, whose ex supported Louis financially, including paying for him to attend a prestigious private school in West London, she had read Wakefields paper when the letter arrived in 1998 asking her to take her one-year-old to his GP for an MMR shot.

Autism is, of course, on a spectrum but it can be serious, so I declined the invitation, recalls Rebecca. My GP kept asking if I was sure. She didnt tell me I was a bad mother for refusing, but she did say: I really hope you dont live to regret this decision. Which, of course, I did.

Rebecca has always taken an alternative approach to healthcare, but she was not anti-vaccines. Conscious that babies are vulnerable to disease, she ensured her son had all other infant vaccines, including diphtheria, tetanus, whooping cough and hepatitis B (and they both had all the Covid jabs offered to them in recent years).

Yet, when it came to MMR, she felt a sense of deep unease. At the back of her mind Rebecca felt her son had been a little slower to talk than his peers something her GP put down to him being bilingual and it was this, in part, which made her decide any risk associated with the MMR vaccine was not worth taking.

She was unaware her son could have been given the inoculations individually had she paid to have it done privately a route some middle-class parents took at the time.

But, in any case, she believed the diseases MMR protects against were not too serious and was largely unconcerned about his risk of contracting them. This, it turned out, was a big mistake.

It was just before the October half-term in 2014 that sixth-former Louis, then 17, woke one morning complaining of a sore throat and very achy joints, which made it difficult for him to move. His torso was covered in red spots.

Concerned, but never imagining it was measles, Rebecca took him to see their GP, who diagnosed some sort of viral infection, and prescribed paracetamol and rest.

It is perhaps not surprising that this GP did not recognise measles given its rarity back then, it was simply not on the radar for most.

When, the following day, there were more spots and Louis was worryingly lethargic, with a temperature so high you could have fried an egg on his forehead, Rebecca took him back to the surgery.

This time I saw a different GP, who called in a colleague, and together they stood looking at my son, checking his temperature, recalls Rebecca. Then one said: This is quite an advanced case of measles and extremely serious. We must call an ambulance.

I felt sick with worry and shock I had no idea measles could be so debilitating. The doctors asked if my son had come into contact with any elderly people, or pregnant women, over the past three days because, if so, they would need to be informed as measles could be very dangerous for them.

Hed gone on the bus, to and from his sixth-form college, which is probably where hed picked it up, as we knew of no one else with measles, so had come into contact with lots of people we didnt know.

I was so freaked out thinking my son could have infected someone at high risk I said: I feel terrible. What can I do?.

Their response was that theyd be keeping him in the surgery until the ambulance arrived, to avoid any further risk of infection.

Rebeccas dogs were in her car, so she had to drop them home, leaving Louis to make the journey to Londons St Thomas hospital alone with the paramedics.

Terrifyingly, en route, he developed such severe breathing problems he went into respiratory arrest and the ambulance crew had to pull over to resuscitate him.

When an already anxious Rebecca arrived at St Thomas, she was horrified to learn that her son was so unwell he was being treated in the accident and emergency departments resuscitation area and she was not able to see him.

It was horrendous. I remember a doctor looking me in the eye and saying: This is extremely serious, recalls Rebecca, shaken by the memory.

And, of course, each time I told a different medic that he had not had the MMR I tormented myself with the thought that it was all my fault and could have been prevented. Mercifully, my son pulled round and, the following day, they were able to move him on to a side ward, where I could visit.

Alarming though it undoubtedly was, Louiss condition could, in fact, have been much worse. As many as one in 20 children with measles gets pneumonia, the most common cause of death from the disease in the young.

In the most serious cases, the measles virus can cause other complications too, including meningitis and seizures and, although rare, even blindness and encephalitis swelling of the brain which can lead to permanent brain damage. It is also highly risky for pregnant women, potentially leading to miscarriage, stillbirth and premature births.

Louis spent a week in a sealed room being given a cocktail of medicines. Rebecca doesnt recall what they were it was all a bit of a blur, she says but believes they included paracetamol to control his temperature, antibiotics, for the ear and chest infections which can be a complication of measles, and steroids to ease his respiratory issues.

Since October 2023, there have been 347 laboratory confirmed measles cases reported in England, with 127 of these recorded in January

So infectious is the disease that anyone who entered his quarantined space, including Rebecca, had to remove their clothes and replace them with protective plastic suits, hats, socks and gloves, which then had to be thrown away before leaving.

Luckily, Louis, who was discharged after eight days, has suffered no long-term physical effects. However, as a teenage boy, he was embarrassed about having such a highly infections virus, which meant he didnt broadcast news of his hospital stay once back at college, following the half-term break.

Their GP had informed the college there had been a case of measles, without giving Louiss name, so that anyone he may have come into contact with could be vigilant about checking for symptoms and seeing a doctor, if necessary.

One can only imagine how mortifying it must have been for Louis, seeing posters on the college walls, warning of the risk of infection and knowing he was the source.

Indeed, a few years later, in his early 20s, Louis made his feelings about his mothers rejection of the MMR, and the frightening consequences of that decision for him, very clear.

I hadnt realised how much he resented it, says Rebecca. But we were talking about something, I dont recall what, and he got angry and said: Your beliefs almost killed me. I spent a week in hospital and could have died.

It hurt hearing that. I told him I hoped that one day he would be a parent and understand that we only do what we think is best for our children.

If another mum had told me: I almost lost my son to measles. Be careful, of course I may have done things differently. But, at the time, I believed I was doing what was right.

Rebecca says she fell for Wakefields claims hook, line and sinker. She is not proud to admit that she even persuaded a friend with a child the same age as Louis to decline the MMR.

How, I wonder, does she feel about Andrew Wakefield now?

Of course, we now know that his report was complete nonsense, she says. Maybe he was negligent, or stubborn, but was he malicious? Im not sure. He may have thought that he was on to something but, unfortunately for parents like me, who paid a price, he was completely wrong.

If she could turn back the clock, Rebecca would certainly take her GPs advice and let her son have the jab, sparing him the trauma of measles.

Im hearing news reports about more people becoming infected every day and find it quite traumatic as they bring memories of that terrible time flooding back, says Rebecca.

In talking about my experience with my son, I hope I can persuade other parents to get their children vaccinated, whatever age they are now, because its never too late.

Please learn from our awful experience, she begs, before this measles outbreak becomes an epidemic.

Names have been changed.

Continue reading here:

Guilt of mum whose son nearly died of measles after she refused MMR - Daily Mail

Kate O'Brien, Director of the Department of Immunization, Vaccines and Biologicals at WHO

As the world welcomes a new year, the global health landscape is brimming with both opportunities and challenges. Let's take a closer look at the ongoing efforts and significant developments shaping the narrative of the first months of 2024.

Last week, the WHO Executive Board (EB) concluded its review of the Immunization Agenda 2030 (IA2030) 2nd progress report summarizing where things stand on the IA2030 goals, high-level priorities, and the implementation status of the IA2030 at country, regional, and global levels. The EB expressed strong appreciation for the DGs report to the Member States and re-emphasized many points raised in the report while recognizing the role played by WHO, UNICEF, Gavi Alliance and other partners. The EB emphasized the need for continued cooperation, essential to achieve the goals of the IA2030, across all key partners and stakeholders, and through national effortsandinvestment. Member States are calling for enhanced political will to increase investment in immunization.

We also achieved a significant milestone for child health as the scale up of malaria vaccines start across Africa, first in Cameroon on 22 January, and soon in many more countries. The first malaria vaccine, RTS,S, has been evaluated in large pilot implementations in Ghana, Kenya and Malawi that reached more than 2 million children and the impact of vaccination was remarkable: a 13% drop in mortality among children age-eligible to receive the vaccine, and a substantial reduction in child hospitalizations for severe malaria. There is high demand for malaria vaccine, and with the recent WHO policy recommendation and prequalification of a second malaria vaccine, R21, we now have two safe and effective malaria vaccines to drive down child illness and death from malaria. Tens of thousands of lives could be saved every year through the implementation of malaria vaccines, adding to the existing prevention tools.

The past year has seen the continued re-emergence of vaccine-preventable diseases such as cholera and measles in areas where they had previously been well controlled, while the total number of outbreaks of vaccine-preventable diseases also continued on an upward trend. The underlying, and often interrelated, drivers of this trend include insufficient vaccination coverage, health system fragility, conflict and insecurity, as well as climate factors, population growth, urbanization and displacement.

Nearly a year after the World Health Organization (WHO) classified the global resurgence of cholera as a grade 3 emergency, operations to control the disease continue. Since January 2023, 30 countries have officially reported cases of cholera. The overall global risk is very high, and up to 1 billion people are at risk of being affected by cholera. Given vaccine supply constraints and the increase in outbreaks and cases, the risk is getting more significant. WHO is conducting a comprehensive review of its response globally. The aim is to identify key lessons and make evidence-based adjustments for more effective coordination in the months ahead.

Dengue has been now classified as a Grade 3 emergency by WHO, as it demands the highest level of response from WHO and touches almost all the regions. About 4 billion people are at risk of becoming infected with the dengue virus worldwide, with over five million cases and 5000 deaths of dengue reported across 80 countries in 2023. The distribution of mosquitoes has changed in the last few years due to several factors and in 2023, El Nino phenomena and climate change have resulted in a rise in dengue, along with other arboviruses such as Zika, chikungunya and yellow fever.

Of particular concern is the elevated risk of vaccine-preventable disease outbreaks in areas marred by conflict or fragility, especially in the African and Eastern Mediterranean regions. Such settings often experience compromised healthcare and water and sanitation infrastructure, limited access to immunization services, and population displacements, amplifying the vulnerability to these diseases. To mitigate these risks, WHO is intensifying efforts to strengthen surveillance, laboratory capacity, clinical management and vector control in conflict and fragile settings, ensuring equitable access to vaccines when possible, and fostering community engagement. WHO is leading the Global Arbovirus Initiative - an integrated strategic plan to tackle emerging and re-emerging arboviruses with epidemic and pandemic potential focusing on monitoring risk, pandemic prevention, preparedness, detection, and response, and building a coalition of partners.

In a significant stride toward eradicating poliomyelitis, WHO has officially prequalified the novel oral polio vaccine type 2 (nOPV2) in December 2023, the first vaccine ever to be prequalified after previously being used under a WHO Emergency Use Listing (EUL) recommendation. This innovative vaccine is a critical tool to combat outbreaks of variant poliovirus type 2 (circulating vaccine-derived poliovirus type 2), affecting numerous countries primarily in the African and Eastern Mediterranean Regions.

The WHO's prequalification follows thorough reviews of safety, effectiveness, genetic stability, and quality assurance checks of manufacturing sites, marking the end of the vaccines EUL use phase. The transition to prequalification aims to streamline access to nOPV2, making it more readily available for countries grappling with outbreaks of variant poliovirus type 2.

While the availability of this vaccine is a crucial step, the success of polio eradication efforts also hinges on strengthening routine immunization services and surveillance. Efforts to ensure communities have access to routine immunizations and the establishment and maintenance of robust surveillance systems are essential components of a comprehensive strategy to detect and respond promptly to outbreaks.

This year marks an important public health anniversary. It is exactly 50 years ago, in 1974, that WHO established the Expanded Programme on Immunization(EPI). This milestone offers an opportunity to celebrate the program's success in preventing diseases, improving child and maternal health, and advancing healthcare equity. It is also an important moment to look ahead at the next decade with promises new and improved vaccines, technologies, and opportunities. The commitment of various stakeholders, including national governments, global and regional agencies, civil society, vaccine manufacturers, and many more, will be crucial for sustainability and delivering vaccines throughout the lifespan.

As the world progresses towards universal health coverage, the call for stronger, more equitable health systems resonates. Accessible and high-quality healthcare for all remains a shared goal, underscoring the collective efforts needed to create a healthier and more prosperous world.

Thank you for all you do, each day, to help get us there.

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Message by the Director of the Department of Immunization, Vaccines and Biologicals at WHO - January 2024 - World Health Organization

The latest versions of COVID-19 vaccines were 54 per cent effective at preventing symptomatic infection in adults, according to the first U.S. study to assess how well the shots work.

The shots became available last year and were designed to better protect against more recent coronavirus variants.

In Thursdays study, the Centers for Disease Control and Prevention looked at 9,000 people who got tested for COVID-19 at CVS and Walgreens pharmacies, checking who tested positive and whether they had gotten a new shot or not.

The 54 per cent finding is similar to whats been reported in other countries, and its also about what was reported for an earlier vaccine version, said the Ruth Link-Gelles of the CDC, the studys lead author.

Studies coming out later this year will assess how effective the shot was at preventing symptoms severe enough to send patients to a doctors office or hospital, she said.

The CDC recommends the new shots for everyone six months and older, but most Americans havent had them. The latest CDC data suggests only about 22 per cent of U.S. adults have had the shots, and only 11 per cent of children. The slow uptake meant it took longer for researchers to gather enough data to assess how well the shots work, Ms. Link-Gelles said.

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Newest COVID vaccines are 54 per cent effective in preventing symptoms, U.S. CDC finds - The Globe and Mail

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First boosters, second boosters, monovalent, bivalent. Just like the SARS-CoV-2 virus strain, the vaccines to combat the virus are always changingand perhaps confusing.

With the goal of better understanding the variety of vaccines and the methods used globally to study vaccines' effectiveness, a group of University of Michigan researchers, led by Sabir Meah and Bhramar Mukherjee, evaluated some 80 studies and 150 million observations from patient datasets across the world to understand the various designs and methods that were used to study the effectiveness of COVID-19 vaccine doses following the primary series vaccination. Their study has been published in Science Advances.

They then applied all the methods used in those studies to patient data from Michigan Medicine.

Meah is a School of Public Health alumnus with a master's degree in biostatistics and currently a biostatistician in urology at Michigan Medicine. Mukherjee is the John D. Kalbfleish Distinguished University Professor of Biostatistics, the Sioban Harlow Collegiate Professor of Public Health, and assistant vice president for research in the Office of the Vice President for Research.

"What we have been able to create is a repository of methods that can be applied for future annual vaccines," Mukherjee said. "It is important to have robust and reproducible results and reliable estimates of vaccine effectiveness to solidify public trust and fight misinformation."

Meah explains further:

In our study, we evaluated three different vaccination regimens: 1) the monovalent booster targeting the original strain, 2) the second monovalent booster also with the original formulation, and 3) the new bivalent vaccine updated in fall 2022 to target newer omicron variants. We saw that all sequential doses provided a substantial benefit in terms of preventing hospitalization and death, and the estimates from the fall 2022 omicron specific vaccine dose were stronger from worldwide studies we looked at.

These findings support the practice of periodically updating the COVID-19 vaccines for currently circulating variants. Fortunately, it appears that in the U.S. and many other countries, such as those in the European Union, we will be getting updated COVID-19 vaccines on an annual frequency. The fall 2022 vaccine has already been succeeded by a new updated vaccine in fall 2023, which you can still get now in early 2024, if you haven't already, targeting the even newer XBB1.5 omicron variant.

We expect that our conclusions on the utility of updating vaccines should generalize to any updated COVID-19 vaccine, not just the fall 2022 bivalent vaccine, but additional monitoring and study of the real-world effectiveness of an annual vaccine is still necessary, and we hope that the findings of our research can aid these studies. What we have been able to do is to establish an analytic pipeline where researchers can study the vaccine effectiveness of future annual vaccine formulations.

Biostatistics and epidemiology provide a toolbox for the complex process of evaluating vaccine effectiveness in scientific observational studies. However, there are quite a number of different approachesboth in study design and methods that researchers have employed in vaccine effectiveness studies conducted all over the world, which is what motivated us to conduct our review of their methodology and results and subsequent case study of these methods using Michigan Medicine data.

Quite fortunately, a key finding of our study was that vaccine effectiveness estimates remain relatively stable and do not depend heavily on choice of methods for the outcomes of hospitalization and mortality. We did not observe this advantageous property for infection outcomes, but hospitalization and death are arguably much more important points of study as we advance further into the endemic stage of the pandemic.

COVID-19 vaccines examined in our study, including the fall 2022 bivalent vaccine, provided strong protection against hospitalization and death. We expect this pattern to continue with additional annual vaccines approved by the FDA, but continued study of future vaccines is warranted, and our findings provide some important points of consideration for these future studies.

More information: Sabir Meah et al, Design and analysis heterogeneity in observational studies of COVID-19 booster effectiveness: A review and case study, Science Advances (2023). DOI: 10.1126/sciadv.adj3747

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Vaccine effectiveness: Which COVID-19 shots are most protective against severe disease? - Medical Xpress

Oregon inmates cant proceed with a lawsuit claiming the state governments plan to ration Covid-19 vaccines during the pandemic harmed them, a federal appeals court said.

The Public Readiness and Emergency Preparedness Act barred the inmates lawsuit against Oregon governor Kate Brown (D) and state officials who put them on the lowest tier when prioritizing access to the vaccine in early 2021, the US Court of Appeals for the Ninth Circuit said Thursday. The PREP Act provided immunity to the officials from being sued and held liable for the administration or use of a covered countermeasure to stave off a ...

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Oregon Officials Fend Off Suit Over Covid Vaccine Priority Tiers - Bloomberg Law

We all know someone touched by cancer. Around 2.7 million people in the European Union are diagnosed with cancer every year, and this number is predicted to grow in the future. About 40% of cancer cases in the EU are preventable. Safe and effective vaccines exist and could save a lot of lives.

The Commission has therefore put forward new recommendations to support Member States in their efforts to prevent cancer through vaccination, as part of Europe's Beating Cancer Plan. It recommends significantly increasing the uptake of two key vaccinations that can prevent two viral infections which can lead to cancer:

Coverage of these vaccinations should also be monitored more closely.

The new measures include:

HPV vaccination coverage is well below 50% in many Member States. There is also a significant lack of data on HBV vaccination rates. Europe's Beating Cancer Plans target is to vaccinate 90% of girls and a significant number of boys against HPV by 2030. The Commission has dedicated the largest budget ever to beating cancer, including 4 billion from the EU4Health programme and other instruments.

For more information

A cancer plan for Europe

Factsheet on preventing cancer through vaccination

Factsheet how Europe's Beating Cancer Plan is making a difference

Video we all know someone touched by cancer

Press release: Commission recommends new measures on vaccine-preventable cancers under Europe's Beating Cancer Plan

Questions and Answers on vaccine-preventable cancers

Data on cancer prevalence

Human papilloma virus (HPV)

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New measures to prevent cancer through vaccination - European Union

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Repurposing of Zika virus live-attenuated vaccine (ZIKV-LAV) strains as oncolytic viruses targeting human glioblastoma ... - Journal of Translational...