Category: Vaccine

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Current COVID boosters offer good protection against severe outcomes but less so against JN.1 – University of Minnesota Twin Cities

June 2, 2024

The current COVID-19 boosters targeting the Omicron XBB.1.5 subvariant are still offering solid protection against infection, hospitalizations, and death, but are somewhat limited in efficacy against illnesses caused by the JN.1 subvariant, now the dominant strain in the United States, according to a research letter yesterday in the New England Journal of Medicine.

Protection against infection 4 weeks after vaccination was 52%, and against COVID-related hospital illness it was 67%, but during the JN.1-dominant period it dropped to 44% and 60%, respectively.

The authors said the findings underscore the need for new boosters. Next week, the US Food and Drug Administration's VRBPAC (Vaccines and Related Biological Products Advisory Committee) will meet to select COVID and influenza strains to include in updated vaccines.

The elected strain will likely be the JN.1 subvariant.

"The relatively low effectiveness of the XBB.1.5 vaccines against the JN.1 subvariant, together with the waning effectiveness over time, underscores the need for new vaccines targeting the JN.1 strain," said first study author Dan-Yu Lin, PhD, in a press release from the University of North Carolina Gillings School of Public Health.

Lin and colleagues assessed the efficacy of the Moderna, Pfizer, and Novavax boosters from September 11, 2023, to February 21, 2024, in a cohort of approximately 1.8 million people captured in the Nebraska Electronic Disease Surveillance System and the Nebraska State Immunization Information System (NESIIS).

In total, 218,250 people in the cohort (11.9%) received XBB.1.5 vaccines, of whom 133,403 (61.1%) received the PfizerBioNTech vaccine and 84,307 (38.6%) received the Moderna vaccine, the authors said.

The researchers recorded a total of 21,988 SARS-CoV-2 infections, 1,364 COVID-19related hospitalizations, and 237 COVID-19related deaths in the cohort.

Efficacy peaked at 4 weeks

For all three booster vaccines targeting XBB.1.5, efficacy peaked at 1 month, with significant waning at 10 to 20 weeks.

At 4 weeks after vaccination, the XBB.1.5 vaccines were 52.2% effective at preventing infection (95% confidence interval [CI], 44.6% to 58.7%). Efficacy against infection dropped at 10 weeks to 2.6% (95% CI, 28.1% to 36.8%), and at 20 weeks to 20.4% (95% CI, 6.2% to 32.5%).

The boosters were 66.8% effective at preventing hospitalization at 4 weeks (95% CI, 51.7% to 77.1%), and decreased to 57.1% (95% CI, 40.4% to 69.2%) after 10 weeks.

"The effectiveness against death was higher than that against other end points; however, there remains substantial uncertainty owing to the small number of deaths," the authors said.

To assess how the booster performed against JN.1, the authors analyzed data comparing people who received the XBB.1.5 vaccines on or before October 25, 2023when JN.1. was first detected in Nebraskaand those who received them after October 25, 2023.

During that period, boosters provided 44.3% protection against infection at 4 weeks (95% CI, 33.5% to 53.4%) and 60.1% protection against hospitalization (95% CI, 30.9% to 77.0), which likewise waned over time.

"The vaccine effectiveness was lower in the second cohort than in the first cohort, which indicates that the XBB.1.5 vaccines were less protective against JN.1 than against XBB sublineages," the authors wrote.

It would be worthwhile to deploy new vaccines this fall that target the JN.1. strain.

"It would be worthwhile to deploy new vaccines this fall that target the JN.1. strain," Lin said in the release.

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Current COVID boosters offer good protection against severe outcomes but less so against JN.1 - University of Minnesota Twin Cities

South Sudan receives its first batch of a new vaccine for malaria from the WHO – PIX11 New York News

June 2, 2024

DENG MACHOL, Associated Press

1 day ago

JUBA, South Sudan (AP) South Sudan got its first batch of a new malaria vaccine on Friday from the U.N. health agency, an important step in efforts to battle a disease that is the biggest killer of children in this African country.

The more than 645,000 doses of the R21 malaria vaccine received will be distributed across 28 counties with the highest malaria burden.

In 2022, South Sudan had an estimated 2.8 million cases and 6,680 deaths from malaria. It has one of the regions highest rates of malaria incidence, with an estimated 7,630 cases and 18 people dying of the disease every day, according to the World Health Organization.

South Sudans health minister, Yolanda Awel Deng, said the new vaccine, alongside other preventive measures such as insecticide-treated bed nets and timely access to medical care, will be instrumental in a push to eliminate malaria.

Others also welcomed the development.

UNICEF South Sudan Representative Hamida Lasseko said that the governments proactive engagement and health systems preparedness are pivotal in facilitating the successful rollout of the immunization program.

Dr Humphrey Karamagi, WHOs representative for South Sudan, said the integration of the vaccine into routine immunization will enhance our ability to deliver comprehensive malaria prevention to those most at risk.

The R21 vaccine was the second malaria vaccine recommended by WHO in 2023, after the RTS,S/AS01 vaccine, which received a WHO recommendation in 2021.

The R21 vaccine has been hailed as a cheaper and a more readily available option. Research suggests it is more than 75% effective and that protection is maintained for at least another year with a booster.

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South Sudan receives its first batch of a new vaccine for malaria from the WHO - PIX11 New York News

Scientists are testing mRNA vaccines to protect cows and people against bird flu – San Francisco Chronicle

June 2, 2024

FILE - Cows stand in the milking parlor of a dairy farm in New Vienna, Iowa, on Monday, July 24, 2023. The bird flu outbreak in U.S. dairy cows is prompting development of new, next-generation mRNA vaccines akin to COVID-19 shots that are being tested in both animals and people. In June 2024, the U.S. Agriculture Department is to begin testing a vaccine developed by University of Pennsylvania researchers by giving it to calves.Charlie Neibergall/AP

The bird flu outbreak in U.S. dairy cows is prompting development of new, next-generation mRNA vaccines akin to COVID-19 shots that are being tested in both animals and people.

Next month, the U.S. Agriculture Department is to begin testing a vaccine developed by University of Pennsylvania researchers by giving it to calves. The idea: If vaccinating cows protects dairy workers, that could mean fewer chances for the virus to jump into people and mutate in ways that could spur human-to-human spread.

Meanwhile. the U.S. Department of Health and Human Services has been talking to manufacturers about possible mRNA flu vaccines for people that, if needed, could supplement millions of bird flu vaccine doses already in government hands.

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If there's a pandemic, there's going to be a huge demand for vaccine, said Richard Webby, a flu researcher at St. Jude Childrens Research Hospital in Memphis. The more different (vaccine manufacturing) platforms that can respond to that, the better."

The bird flu virus has been spreading among more animal species in scores of countries since 2020. It was detected in U.S. dairy herds in March, although investigators think it may have been in cows since December. This week, the USDA announced it had been found in alpacas for the first time.

At least three people all workers at farms with infected cows have been diagnosed with bird flu, although the illnesses were considered mild.

But earlier versions of the same H5N1 flu virus have been highly lethal to humans in other parts of the world. Officials are taking steps to be prepared if the virus mutates in a way to make it more deadly or enables it to spread more easily from person to person.

Traditionally, most flu vaccines are made via an egg-based manufacturing process that's been used for more than 70 years. It involves injecting a candidate virus into fertilized chicken eggs, which are incubated for several days to allow the viruses to grow. Fluid is harvested from the eggs and is used as the basis for vaccines, with killed or weakened virus priming the body's immune system.

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Rather than eggs also vulnerable to bird flu-caused supply constraints some flu vaccine is made in giant vats of cells.

Officials say they already have two candidate vaccines for people that appear to be well-matched to the bird flu virus in U.S. dairy herds. The Centers for Disease Control and Prevention used the circulating bird flu virus as the seed strain for them.

The government has hundreds of thousands of vaccine doses in pre-filled syringes and vials that likely could go out in a matter of weeks, if needed, federal health officials say.

They also say they have bulk antigen that could generate nearly 10 million more doses that could be filled, finished and distributed in a matter of a few months. CSL Seqirus, which manufactures cell-based flu vaccine, this week announced that the government hired it to fill and finish about 4.8 million of those doses. The work could be done by late summer, U.S. health officials said this week.

But the production lines for flu vaccines are already working on this fall's seasonal shots work that would have to be interrupted to produce millions more doses of bird flu vaccine. So the government has been pursuing another, quicker approach: the mRNA technology used to produce the primary vaccines deployed against COVID-19.

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These messenger RNA vaccines are made using a small section of genetic material from the virus. The genetic blueprint is designed to teach the body how to make a protein used to build immunity.

The pharmaceutical company Moderna already has a bird flu mRNA vaccine in very early-stage human testing. In a statement, Moderna confirmed that we are in discussions with the U.S. government on advancing our pandemic flu candidate."

Similar work has been going on at Pfizer. Company researchers in December gave human volunteers an mRNA vaccine against a bird flu strain that's similar to but not exactly the same as the one in cows. Since then, researchers have performed a lab experiment exposing blood samples from those volunteers to the strain seen in dairy farms, and saw a notable increases in antibody responses," Pfizer said in a statement.

As for the vaccine for cows, Penn immunologist Scott Hensley worked with mRNA pioneer and Nobel laureate Drew Weissman to produce the experimental doses. Hensley said that vaccine is similar to the Moderna one for people.

In first-step testing, mice and ferrets produced high levels of bird flu virus-fighting antibodies after vaccination.

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In another experiment, researchers vaccinated one group of ferrets and deliberately infected them, and then compared what happened to ferrets that hadn't been vaccinated. All the vaccinated animals survived and the unvaccinated did not, Hensley said.

The vaccine was really successful, said Webby, whose lab did that work last year in collaboration with Hensley.

The cow study will be akin to the first-step testing initially done in smaller animals. The plan is for initially about 10 calves to be vaccinated, half with one dose and half with another. Then their blood will be drawn and examined to look for how much bird flu-fighting antibodies were produced.

The USDA study first will have to determine the right dose for such a large animal, Hensley said, before testing if it protects them like it did smaller animals.

What scares me the most is the amount of interaction between cattle and humans, Hensley said.

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Were not talking about an animal that lives on a mountain top," he said. "If this was a bobcat outbreak Id feel bad for the bobcats, but thats not a big human risk.

If a vaccine reduces the amount of virus in the cow, then ultimately we reduce the chance that a mutant virus that spreads in humans is going to emerge, he said.

The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institutes Science and Educational Media Group. The AP is solely responsible for all content.

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Scientists are testing mRNA vaccines to protect cows and people against bird flu - San Francisco Chronicle

The bird flu vaccine is made with eggs. That has scientists worried. – CBS News

June 2, 2024

Even a peep of news about a new flu pandemic is enough to set scientists clucking about eggs.

They worried about them in 2005, and in 2009, and they're worrying now. That's because millions of fertilized hen eggs are still the main ingredient in making vaccines that, hopefully, will protect people against the outbreak of a new flu strain.

"It's almost comical to be using a 1940s technology for a 21st-century pandemic," said Rick Bright, who led the Health and Human Services Department's Biomedical Advanced Research and Development Authority during the Trump administration.

It's not so funny, he said, when the currently stockpiled formulation against the H5N1 bird flu virus requires two shots and a whopping 90 micrograms of antigen, yet provides just middling immunity. "For the U.S. alone, it would take hens laying 900,000 eggs every single day for nine months," Bright said.

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And that's only if the chickens don't get infected.

The spread of an avian flu virus has decimated flocks of birds (and killed barn cats and other mammals). Cattle in at least nine states and at least two people in the U.S. have been infected, enough to bring public health attention once again to the potential for a global pandemic.

So far, the only confirmed human cases of infection were dairy workers in Texas and Michigan, both of whom suffered pink eye and quickly recovered. Yet the virus's spread into multiple species over a vast geographic area raises the threat that further mutations could create a virus that spreads from human to human through airborne transmission, causing respiratory infections.

If they do, prevention starts with the egg.

To make raw material for an influenza vaccine, virus is grown in millions of fertilized eggs. Sometimes it doesn't grow well, or it mutates to a degree that the vaccine product stimulates antibodies that don't neutralize the virus or the wild virus mutates to an extent that the vaccine doesn't work against it. And there's always the frightening prospect that wild birds could carry the virus into the henhouses needed in vaccine production.

"Once those roosters and hens go down, you have no vaccine," Bright said.

Since 2009, when an H1N1 swine flu pandemic swept around the world before vaccine production could get off the ground, researchers and governments have been looking for alternatives. Billions of dollars have been invested into vaccines produced in mammalian and insect cell lines that don't pose the same risks as egg-based shots.

"Everyone knows the cell-based vaccines are better, more immunogenic, and offer better production," said Amesh Adalja, an infectious disease specialist at Johns Hopkins University's Center for Health Security. "But they are handicapped because of the clout of egg-based manufacturing."

The companies that make the cell-based influenza vaccines, CSL Seqirus and Sanofi, also have billions invested in egg-based production lines that they aren't eager to replace. And it's hard to blame them, said Nicole Lurie, HHS' assistant secretary for preparedness and response under President Barack Obama who is now an executive director of CEPI, the global epidemic-fighting nonprofit.

"Most vaccine companies that responded to an epidemic Ebola, Zika, COVID ended up losing a lot of money on it," Lurie said.

Exceptions were the mRNA vaccines created for COVID, although even Pfizer and Moderna have had to destroy hundreds of millions of doses of unwanted vaccine as public interest waned.

Pfizer and Moderna are testing seasonal influenza vaccines made with mRNA, and the government is soliciting bids for mRNA pandemic flu vaccines, said David Boucher, director of infectious disease preparedness at HHS' Administration for Strategic Preparedness and Response.

Bright, whose agency invested a billion dollars in a cell-based flu vaccine factory in Holly Springs, North Carolina, said there's "no way in hell we can fight an H5N1 pandemic with an egg-based vaccine." But for now, there's little choice.

BARDA has stockpiled hundreds of thousands of doses of an H5N1-strain vaccine that stimulates the creation of antibodies that appear to neutralize the virus now circulating. It could produce millions more doses of the vaccine within weeks and up to 100 million doses in five months, Boucher told KFF Health News.

But the vaccines currently in the national stockpile are not a perfect match for the strain in question. Even with two shots containing six times as much vaccine substance as typical flu shots, the stockpiled vaccines were only partly effective against strains of the virus that circulated when those vaccines were made, Adalja said.

However, BARDA is currently supporting two clinical trials with a candidate vaccine virus that "is a good match for what we've found in cows," Boucher said.

Flu vaccine makers are just starting to prepare this fall's shots but, eventually, the federal government could request production be switched to a pandemic-targeted strain.

"We don't have the capacity to do both," Adalja said.

For now, ASPR has a stockpile of bulk pandemic vaccine and has identified manufacturing sites where 4.8 million doses could be bottled and finished without stopping production of seasonal flu vaccine, ASPR chief Dawn O'Connell said on May 22. U.S. officials began trying to diversify away from egg-based vaccines in 2005, when avian flu first gripped the world, and with added vigor after the 2009 fiasco. But "with the resources we have available, we get the best bang for our buck and best value to U.S. taxpayers when we leverage the seasonal infrastructure, and that's still mostly egg-based," Boucher said.

Flu vaccine companies "have a system that works well right now to accomplish their objectives in manufacturing the seasonal vaccine," he said. And without a financial incentive, "we are going to be here with eggs for a while, I think."

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

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The bird flu vaccine is made with eggs. That has scientists worried. - CBS News

New polio vaccines are key to preventing outbreaks and achieving eradication – Our World in Data

June 2, 2024

Weve come a long way in the fight against polio the infectious disease that used to paralyze hundreds of thousands of people each year. Most of them were children. Eradication is possible, but the last stretch has proven difficult.

Two of the three serotypes (distinct types within a species of virus) of wild poliovirus have already been eradicated.

However, two big challenges remain in crossing the finish line. One is eliminating the last serotype of wild poliovirus. Another is containing vaccine-derived polioviruses, which arose from oral polio vaccines in rare circumstances and spread in some regions where protection against the disease declined.

The world can overcome these hurdles. We can use new vaccines to contain them and improve testing, outbreak responses, and sanitation.

The chart below shows the dramatic decline in polio cases.

This was possible due to effective vaccination efforts with two types of vaccine: inactivated polio vaccines (IPV), developed by Jonas Salk in 1955, and oral polio vaccines (OPV), developed by Albert Sabin in 1961.

Improvements in providing clean water and sanitation have also helped to reduce the spread of poliovirus through contaminated water and food and the risks of other infections, which prevent children from developing immunity against polio.1

In the early 1980s, there were around 400,000 estimated cases annually. In the last few years, there have been around 4,000. Thatsa hundred-fold decline. Millions of children have been spared lifelong paralysis.

Wild poliovirus has three serotypes.The three serotypes are distinct types of poliovirus with protein structures that differ sufficiently that protection from one doesnt protect from the other.

The world has eradicated wild poliovirus serotypes 2 and 3.2

The world is, therefore, very close to eradicating all serotypes of wild poliovirus globally.

As shown in the map below, only two countries Afghanistan and Pakistan are still endemic for wild poliovirus serotype 1 (WPV1).

But as the chart shows, the number of cases is now very low. In 2023,only six cases of wild polio were reported in Afghanistan and another six in Pakistan.

By testing widely to identify potential cases, working with local communities in hard-to-reach areas and at borders, and improving vaccination rates and sanitation, this goal is within reach.4

Although the absolute number of cases is much lower than in the past, most cases recently have come from vaccine-derived polioviruses (VDPVs), as shown in the chart below.5

Vaccine-derived polioviruses can arise from the weakened virus in the oral polio vaccine if it has mutated significantly over time in vaccinated people and reverted to the original strain of polio.

Oral polio vaccines are used in poorer countries because they are much easier to administer (as oral drops) and cheaper to manufacture than inactivated polio vaccines, which are given by injection.6

People with immune deficiencies are at higher risk of the vaccine reverting because they can sustain longer infections, giving the virus more time to evolve.7

It can then spread and cause new outbreaks if immunity has fallen in communities. So, somewhat counterintuitively, communities with lower vaccination coverage are more vulnerable to vaccine-derived polio.8

So far, most cases of vaccine-derived poliovirus have come from vaccine-derived polioviruses of serotype 2 known as VDPV2 which can mutate faster than other serotypes, making it more likely to revert than other serotypes.9

In addition, there were interruptions in vaccination against polio serotype 2 in 2016, when vaccination against that particular serotype was switched from the oral to the inactivated polio vaccine. It was harder to provide inactivated polio vaccines at scale in poorer regions and reach every child, leading to a rise in cases.10

Since 2021, new oral polio vaccines against serotype 2 have been used to prevent further outbreaks of VDPV2.

These are much more genetically stable than the previous oral polio vaccine and much less likely to mutate or potentially revert to the original strain.11

They have already been rolled out widely and helped effectively control outbreaks of VDPV2.12

New oral polio vaccines against serotypes 1 and 3 are still in development.13

In addition, new types of inactivated polio vaccines are also being developed. For example, some candidate vaccines can be administered through skin patches instead of injections. These could be cheaper, easier to provide, and unable to revert to the original strain.14

These new technologies will be crucial in preventing further outbreaks as we approach the ultimate goal of polio eradication.

To achieve polio eradication, its crucial to contain every last case quickly to prevent the spread of polio and protect children from this debilitating disease.

We can use new vaccines, increase polio testing, and improve access to clean water and sanitation.

Together, we can successfully close the chapter on polio, which would be a major victory for humanity.

Edouard Mathieu, Max Roser, and Hannah Ritchie provided helpful feedback on this article.

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The growing promise of cancer vaccines – Cosmos

May 27, 2024

Dr Bidyut Sarkar

A cure for cancer which issecond only to cardiovascular diseasesin its contribution to the global burden of disease has long been a dream.

While no magic bullet is yet in sight, three vaccines for particular skin and lung cancer types have advanced to the last stage of clinical trials in recent months.

If successful, these vaccines should be available to patients in the next three to 11 years. Unlike vaccines which prevent diseases, these aim to cure them or prevent relapses.

Cancer in every person is different because the cells in every cancerous tumour have different sets of genetic mutations. Recognising this, two of the vaccines are personalised and tailor-made for each patient. Oncologists working with pharmaceutical companies have developed these individualised neoantigen therapies.

A vaccine typically works by training the immune cells of our body to recognise antigens proteins from pathogens, such as viruses against future attacks by the pathogen.

In cancer, however, there is no external pathogen. The cells of a cancerous tumour undergo continuous mutations, some of which help them to grow much faster than normal cells while some others help them evade the bodys natural immune system. The mutated proteins in cancerous cells are called neoantigens.

In individualised neoantigen therapy, the gene sequence of the tumour and normal blood cells are compared to identify neoantigens from each patient, and then a subset of neoantigens are chosen that are most likely to induce an immune response. The vaccine for an individual patient targets this chosen subset of neoantigens.

These vaccines, jointly developed by pharma giants Moderna and Merck, have been shown in trials conducted so far to be significantly more effective in combination with immunotherapy than immunotherapy alone in preventing both the relapse of melanoma a type of skin cancer and non-small cell lung cancer after the tumours had been surgically removed.

Following these promising results in phase II clinical trials, the vaccines are now being tested on a larger group of patients in phase III trials. The studies are expected to be complete by 2030 formelanomaand 2035 forlung cancer.

The Moderna-Merck cancer vaccine may not be the first to reach the market. The French company OSE Immunotherapeuticspublished positive resultslast September from phase III clinical trials of a vaccine using a different approach for advanced non-small cell lung cancer. Its vaccine, Tedopi, is scheduled to startconfirmatory trials which are the last step before regulatory approval later this year and may be available by 2027.

Vaccines for pancreatic cancer being developed by BioNTech and Genentech, and for colon cancer by Gritstone, are also showing promising results in the early phases of clinical trials. Like the vaccines being developed by Moderna and Merck, these too are individualised neoantigen therapies based on messenger RNA (mRNA).

There is another kind of RNA therapy also under development that uses small interfering RNA (siRNA) and microRNA (miRNA). Since 2018, six siRNA-based therapies have been approved by the US Food and Drug Administration for the treatment of neural, skin, heart and renal diseases. Several more siRNA drugs are at various clinical trial stages for different types of cancer and a diverse range of other diseases.

Within cells, there are two kinds of nucleic acid molecules that contain coded information vital to life: DNA and RNA. While DNA contains genetic information, mRNA one among the different types of RNA carries the codes for the proteins. In addition, there are also non-coding RNA, some of which are functionally important. siRNA and miRNA are examples of such non-coding RNA.

The RNA vaccine for an individualised neoantigen therapy is a cocktail of mRNA carrying the codes for neoantigens the mutated fingerprint proteins in cancerous cells. For theModerna-Merck study, scientists identified 34 neoantigens per patient. They delivered the corresponding mRNA vaccine cocktail packed in lipid nanoparticles, just like the mRNA vaccines for COVID-19 developed by Moderna and Pfizer-BioNTech.

When the vaccine is delivered after removing the tumour, it trains the immune system to recognise neoantigens and fight back against the cancer returning. Usually, the bodys natural immune system corrects mutations and prevents us from having cancers. However, in some cases this natural immune response is insufficient, leading to tumour growth. In individualised neoantigen therapy, these mutations in the tumour cells are used for vaccine development and for training the immune system to fight back against relapse after removal of the tumour.

Recent advances in artificial intelligence are helping identify potential neoantigens and manage personalised therapies. Firstly, gene sequencing of tumours and normal blood cells of a patient and their comparison produces a huge amount of data. AI is used to find the genetic mutations of the patients cancer in such big data. Moreover, individualised therapy requires timely production and delivery of vaccines that are different for each patient. AI is also useful in the management of such data.

The individualised nature of the treatment is probably why it has beenmore effective in trialsthan previous, unsuccessful RNA vaccine candidates. However, this personalisation is also likely to raise challenges for the timely and cost-effective delivery of treatment to populations around the world.

The siRNA and miRNA treatments work in a way opposite to mRNA. While each mRNA in a vaccine carries the code for producing a protein from a pathogen (antigen) or tumour (neoantigen) to train our immune systems against future attacks by the pathogen or tumour, siRNA directly targets the mRNA of the antigen or neoantigen and terminates the production of the protein it codes. Thus, the effect of a siRNA is more direct and immediate (like a drug), rather than a protection against future attacks (like a vaccine).

Discovered at the turn of this millennium, siRNA-based therapeutics attracted immediate attention, but their initial success was limited due to their inherent low stability, difficulties in delivering them to desired locations, and rapid clearance from the bloodstream. However, in recent years, siRNA therapies have been boosted through chemical modifications that have increased their stability and ability to be delivered to specific locations such as tumours, and improved delivery systems such as lipid nanoparticle encasings.

These improvements led to recent successes in FDA approvals of siRNA-based therapies and furtherpromising reports of advancesin the treatment of diseases including a type of liver cancer.

Research scientistDr Bidyut Sarkaris the DBT-Wellcome Trust India Alliance Intermediate Fellow in the Department of Chemistry at Shiv Nadar Institute of Eminence, Delhi NCR, India.

Originally published underCreative Commonsby360info.

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The growing promise of cancer vaccines - Cosmos

4 ways vaccine skeptics mislead you on measles and more – CBS News

May 27, 2024

Measles is on the rise in the United States. So far this year, the number of cases is about 17 times what it was, on average, during the same period in each of the four years before, according to the Centers for Disease Control and Prevention. Half of the people infected mainly children have been hospitalized.

It's going to get worse, largely because a growing number of parents are deciding not to get their children vaccinated against measles as well as diseases like polio and pertussis. Unvaccinated people, or those whose immunization status is unknown, account for 80% of the measles cases this year. Many parents have been influenced by a flood of misinformation spouted by politicians, podcast hosts, and influential figures on television and social media. These personalities repeat decades-old notions that erode confidence in the established science backing routine childhood vaccines. KFF Health News examined the rhetoric and explains why it's misguided

A common distortion is that vaccines aren't necessary because the diseases they prevent are not very dangerous, or too rare to be of concern. Cynics accuse public health officials and the media of fear-mongering about measles even as 19 states report cases.

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For example, an article posted on the website of the National Vaccine Information Center a regular source of vaccine misinformation argued that a resurgence in concern about the disease "is 'sky is falling' hype." It went on to call measles, mumps, chicken pox and influenza "politically incorrect to get."

Measles kills roughly 2 of every 1,000 children infected, according to the CDC. If that seems like a bearable risk, it's worth pointing out that a far larger portion of children with measles will require hospitalization for pneumonia and other serious complications. For every 10 measles cases, one child with the disease develops an ear infection that can lead to permanent hearing loss. Another strange effect is that the measles virus can destroy a person's existing immunity, meaning they'll have a harder time recovering from influenza and other common ailments.

Measles vaccines have averted the deaths of about 94 million people, mainly children, over the past 50 years, according to an April analysis led by the World Health Organization. Together with immunizations against polio and other diseases, vaccines have saved an estimated 154 million lives globally.

Some skeptics argue that vaccine-preventable diseases are no longer a threat because they've become relatively rare in the U.S. (True due to vaccination.) This reasoning led Florida's surgeon general, Joseph Ladapo, to tell parents that they could send their unvaccinated children to school amid a measles outbreak in February. "You look at the headlines and you'd think the sky was falling," Ladapo said on a News Nation newscast. "There's a lot of immunity."

As this lax attitude persuades parents to decline vaccination, the protective group immunity will drop, and outbreaks will grow larger and faster. A rapid measles outbreak hit an undervaccinated population in Samoa in 2019, killing 83 people within four months. A chronic lack of measles vaccination in the Democratic Republic of the Congo led to more than 5,600 people dying from the disease in massive outbreaks last year.

Since the earliest days of vaccines, a contingent of the public has considered them bad because they're unnatural, as compared with nature's bounty of infections and plagues. "Bad" has been redefined over the decades. In the 1800s, vaccine skeptics claimed that smallpox vaccines caused people to sprout horns and behave like beasts. More recently, they blame vaccines for ailments ranging from attention-deficit/hyperactivity disorder to autism to immune system disruption. Studies don't back the assertions. However, skeptics argue that their claims remain valid because vaccines haven't been adequately tested.

In fact, vaccines are among the most studied medical interventions. Over the past century, massive studies and clinical trials have tested vaccines during their development and after their widespread use. More than 12,000 people took part in clinical trials of the most recent vaccine approved to prevent measles, mumps and rubella. Such large numbers allow researchers to detect rare risks, which are a major concern because vaccines are given to millions of healthy people.

To assess long-term risks, researchers sift through reams of data for signals of harm. For example, a Danish group analyzed a database of more than 657,000 children and found that those who had been vaccinated against measles as babies were no more likely to later be diagnosed with autism than those who were not vaccinated. In another study, researchers analyzed records from 805,000 children born from 1990 through 2001 and found no evidence to back a concern that multiple vaccinations might impair children's immune systems.

Nonetheless, people who push vaccine misinformation, like candidate Robert F. Kennedy Jr., dismiss massive, scientifically vetted studies. For example, Kennedy argues that clinical trials of new vaccines are unreliable because vaccinated kids aren't compared with a placebo group that gets saline solution or another substance with no effect. Instead, many modern trials compare updated vaccines with older ones. That's because it's unethical to endanger children by giving them a sham vaccine when the protective effect of immunization is known. In a 1950s clinical trial of polio vaccines, 16 children in the placebo group died of polio and 34 were paralyzed, said Paul Offit, director of the Vaccine Education Center at Children's Hospital of Philadelphia and author of a book on the first polio vaccine.

Several bestselling vaccine books on Amazon promote the risky idea that parents should skip or delay their children's vaccines. "All vaccines on the CDC's schedule may not be right for all children at all times," writes Paul Thomas in his bestselling book "The Vaccine-Friendly Plan." He backs up this conviction by saying that children who have followed "my protocol are among the healthiest in the world."

Since the book was published, Thomas' medical license was temporarily suspended in Oregon and Washington. The Oregon Medical Board documented how Thomas persuaded parents to skip vaccines recommended by the CDC, and reported that he "reduced to tears" a mother who disagreed. Several children in his care came down with pertussis and rotavirus, diseases easily prevented by vaccines, wrote the board. Thomas recommended fish oil supplements and homeopathy to an unvaccinated child with a deep scalp laceration, rather than an emergency tetanus vaccine. The boy developed severe tetanus, landing in the hospital for nearly two months, where he required intubation, a tracheotomy and a feeding tube to survive.

The vaccination schedule recommended by the CDC has been tailored to protect children at their most vulnerable points in life and minimize side effects. The combination measles, mumps, and rubella vaccine isn't given for the first year of a baby's life because antibodies temporarily passed on from their mother can interfere with the immune response. And because some babies don't generate a strong response to that first dose, the CDC recommends a second one around the time a child enters kindergarten because measles and other viruses spread rapidly in group settings.

Delaying MMR doses much longer may be unwise because data suggests that children vaccinated at 10 or older have a higher chance of adverse reactions, such as a seizure or fatigue.

Around a dozen other vaccines have discrete timelines, with overlapping windows for the best response. Studies have shown that MMR vaccines may be given safely and effectively in combination with other vaccines.

Kennedy compares the Florida surgeon general to Galileo in the introduction to Ladapo's new book on transcending fear in public health. Just as the Roman Catholic inquisition punished the renowned astronomer for promoting theories about the universe, Kennedy suggests that scientific institutions oppress dissenting voices on vaccines for nefarious reasons.

"The persecution of scientists and doctors who dare to challenge contemporary orthodoxies is not a new phenomenon," Kennedy writes. His running mate, lawyer Nicole Shanahan, has campaigned on the idea that conversations about vaccine harms are censored and the CDC and other federal agencies hide data due to corporate influence.

Claims like "they don't want you to know" aren't new among the anti-vaccine set, even though the movement has long had an outsize voice. The most listened-to podcast in the U.S., "The Joe Rogan Experience," regularly features guests who cast doubt on scientific consensus. Last year on the show, Kennedy repeated the debunked claim that vaccines cause autism.

Far from ignoring that concern, epidemiologists have taken it seriously. They have conducted more than a dozen studies searching for a link between vaccines and autism, and repeatedly found none. "We have conclusively disproven the theory that vaccines are connected to autism," said Gideon Meyerowitz-Katz, an epidemiologist at the University of Wollongong in Australia. "So, the public health establishment tends to shut those conversations down quickly."

Federal agencies are transparent about seizures, arm pain and other reactions that vaccines can cause. And the government has a program to compensate individuals whose injuries are scientifically determined to result from them. Around 1 to 3.5 out of every million doses of the measles, mumps and rubella vaccine can cause a life-threatening allergic reaction; a person's lifetime risk of death by lightning is estimated to be as much as four times as high.

"The most convincing thing I can say is that my daughter has all her vaccines and that every pediatrician and public health person I know has vaccinated their kids," Meyerowitz-Katz said. "No one would do that if they thought there were serious risks."

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

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4 ways vaccine skeptics mislead you on measles and more - CBS News

Experimental Gene Editing Reduces 90% of Herpes Infections Precision Vaccinations News – Precision Vaccinations

May 27, 2024

Austin (Precision Vaccinations News)

The global gene editing marketis forecast to reach around $29billion by 2032, with the goal of targeting underserved diseases, such asherpes simplexvirus (HSV).

Researchers recently announced thatthey found an experimental gene therapy for genital and oral HSVthat removed 90% or more of the infection.

They developed a potentially curative approach against HSV infection based on gene editing using HSV-specific meganucleases delivered by adeno-associated virus (AAV) vectors.

Additionally, researchers at Fred Hutch Cancer Center located in Seattle, WA,stated that this pre-clinical therapy suppressed the amount of virus thatcan be released from an infected individual, which suggests that the therapy would also reduce the spread of the herpes virus.

Published in the journal Nature Communications on May 13, 2024, thisexperimental therapy involves injecting a mixture of gene-editing molecules into the blood to locate the herpes virus in the body.

The mixture includes laboratory-modified viruses called a vector commonly used in gene therapies plus enzymes that work like molecular scissors.

Once the vector reaches the clusters of nerves where the herpes virus hangs out, the molecular scissors snip away at its genes to damage them or remove the virus entirely.

"Herpes is very sneaky. It hides out among nerve cells and then reawakens and causes painful skin blisters," saidKeith Jerome, MD, PhD, professor in the Vaccine and Infectious Disease Division at Fred Hutch, in a press release.

"Our aim is to cure people of this infection so that they don't have to live with the worry of outbreaks or transmitting it to another person."

The study's abstractsays the gene editing performed with two anti-HSV-1 meganucleases delivered by a combination of AAV9, AAV-Dj/8, and AAV-Rh10 can eliminate 90% or more of latent HSV DNA in mouse models of orofacial infection, and up to 97% of latent HSV DNA in mouse models of genital infection.

Using a pharmacological approach to reactivate latent HSV-1, we demonstrate that ganglionic viral load reduction leads to a significant decrease in viral shedding in treated female mice.

While therapy is well tolerated, in some instances, we observe hepatotoxicity at high doses and subtle histological evidence of neuronal injury without observable neurological signs or deficits.

Simplifying the regimen through a single serotype (AAV9) delivering single meganuclease targeting a duplicated region of the HSV genome, dose reduction, and use of a neuron-specific promoter each results in improved tolerability while retaining efficacy.

These Fed Hutch researchers concluded these results reinforce the curative potential of gene editing for HSV disease.

Herpes simplex virus1 and 2 are among the most common viral infections in the U.S., with up to 80% of people between the ages of 14 and 49 infected with HSV-1 and more than 10% infected with HSV-2, says the U.S. NIH.

To advance research to understand and address HSV infection, the NIH has established the Strategic Plan for Herpes Simplex Virus Research. This plan aligns with ongoing national efforts, including the Sexually Transmitted Infections National Strategic Plan, and provides the framework for HSV research.

To date, no HSV vaccines have been approved by the U.S. FDA.

While herpes clinical trials advances have resulted in several therapeutics, the effectiveness of these treatments in reducing HSV symptoms and viral transmission varies widely.

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Experimental Gene Editing Reduces 90% of Herpes Infections Precision Vaccinations News - Precision Vaccinations

HPV Vaccines Prevent Cancer in Men as Well as Women – TIME

May 27, 2024

New research suggests the HPV vaccine is preventing cancer in men, as well as in women, but fewer boys than girls are getting the shots in the United States.

The HPV vaccine was developed to prevent cervical cancer in women and experts give it credit, along with screening, forlowering cervical cancer rates.Evidence that the shots are preventing HPV-related cancers in men has been slower to emerge, but the new research suggests vaccinated men have fewer cancers of themouth and throatcompared to those who didn't get the shots. These cancers are more than twice as common in men than in women.

For the study, researchers compared 3.4 million people of similar ages half vaccinated versus half unvaccinated in a large health care dataset.

As expected, vaccinated women had a lower risk of developing cervical cancer within at least five years of getting the shots. For men, there were benefits too. Vaccinated men had a lower risk of developing any HPV-related cancer, such as cancers of the anus, penis and mouth and throat.

These cancers take years to develop so the numbers were low: There were 57 HPV-related cancers among the unvaccinated men mostly head and neck cancers compared to 26 among the men who had the HPV vaccine.

We think the maximum benefit from the vaccine will actually happen in the next two or three decades," said study co-author Dr. Joseph Curry, a head and neck surgeon at the Sidney Kimmel Cancer Center in Philadelphia. What were showing here is an early wave of effect.

Results of the study and a second were released Thursday by the American Society of Clinical Oncology and will be discussed next month at its annual meeting in Chicago. The second study shows vaccination rates rising but males lag behind females in getting the HPV shots.

HPV, or human papillomavirus, is very common and is spread through sex. Most HPV infections cause no symptoms and clear up without treatment. Others develop into cancer, about 37,000 cases a year, according to the Centers for Disease Control and Prevention.

In the U.S., the HPV vaccine has been recommended since 2006 for girls at age 11 or 12, and since 2011 for boys the same age. Catch-up shots are recommended for anyone through age 26 who hasnt been vaccinated.

In the second study, researchers looked at self- and parent-reported HPV vaccination rates in preteens and young adults in a large government survey. From 2011 to 2020, vaccination rates rose from 38% to 49% among females, and among males from 8% to 36%.

HPV vaccine uptake among young males increased by more than fourfold over the last decade, though vaccination rates among young males still fall behind females, said study co-author Dr. Danh Nguyen at the University of Texas Southwestern Medical Center in Dallas.

Parents of boys, as well as girls, should know that HPV vaccines lower cancer risk, said Jasmin Tiro of the University of Chicago Medicine Comprehensive Cancer Center who was not involved in the research. And young men who haven't been vaccinated can still get the shots.

It's really important that teenagers get exposed to the vaccine before theyre exposed to the virus, she said.

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The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institutes Science and Educational Media Group. The AP is solely responsible for all content.

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HPV Vaccines Prevent Cancer in Men as Well as Women - TIME

R21 Malaria Vaccine is a Milestone for Child Survival – Precision Vaccinations

May 27, 2024

(Precision Vaccinations News)

The World Health Organization (WHO) today announced that UNICEF successfully delivered over 43,000 doses of the R21/Matrix-Mmalaria vaccine to Bangui, Central African Republic.

As of May 24, 2024, 122,000additional R21 doses are scheduled for delivery, funded by Gavi, the Vaccine Alliance.

TheCentral African Republic, with a population of over 5 million, is the first country to receive the R21vaccine for routine childhood immunization. This marks another step forward in preventing the disease and saving children's lives.

The WHO says that along with the earlier WHO recommendation of the RTS,S vaccine, there is now sufficient vaccine supply to scale up malaria vaccination in Africa.

Chad, Cote d'Ivoire, Democratic Republic of Congo, Mozambique, Nigeria, South Sudan, and Uganda are preparing to receive R21 shipments.

Director of UNICEF Supply Division Leila Pakkala commented in a press release,"Previous concerns about supply meeting demand are firmly behind us. Our priority is for the vaccines to reach every child at risk."

The Central African Republic has one of the highest rates of malaria incidence globally. In 2022, an estimated 1,733,000 malariacases were reported in the country, averaging about 4747 cases a day.

The disease also claimedaround 5180 lives over the year, or 14 deaths each day.

Dr. Sania Nishtar, CEO of Gavi, the Vaccine Alliance, stated,"That is what matters most that countries, where our vaccines can be most impactful, can access them, saving thousands of lives each year and offering relief to families, communities, and entire health systems."

On October 2, 2023, the WHOrecommendedR21 vaccination to prevent malaria in children. R21is a protein-basedvaccinedeveloped by the University of Oxford, using Novavax AB'sMatrix-M adjuvant technology.

"The R21/Matrix-M vaccine is a vital new tool to help stop the devastating health and economic impact of malaria on nearly half of the world's population, including the tragic loss of 1,300 children every single day," said John C. Jacobs, President and Chief Executive Officer, Novavax,on May 20, 2024.

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R21 Malaria Vaccine is a Milestone for Child Survival - Precision Vaccinations

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