Category: Vaccine

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BNT162b2 Vaccine Shows High Efficacy in Youth During COVID Delta and Omicron – HealthDay

January 9, 2024

MONDAY, Jan. 8, 2024 (HealthDay News) -- In children and adolescents, BNT162b2 was effective for COVID-19-related outcomes during the delta and omicron periods, according to a study published online Jan. 9 in the Annals of Internal Medicine.

Qiong Wu, Ph.D., from the University of Pennsylvania Perelman School of Medicine in Philadelphia, and colleagues examined the effectiveness of BNT162b2 with different strains of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in previously uninfected children. Effectiveness was examined among 77,392 adolescents (45,007 vaccinated) during the delta phase and 111,539 children (50,398 vaccinated) and 56,080 adolescents (21,180 vaccinated) during the omicron phase.

The researchers found that the estimated effectiveness of the BNT162b2 vaccine was 98.4 percent against documented infection among adolescents during the delta period, with no significant waning observed after receipt of the first dose. No significant difference was seen in cardiac complications between vaccinated and unvaccinated groups. The effectiveness against documented infection during the omicron period was estimated to be 74.3 percent among children, with higher effectiveness observed against moderate or severe COVID-19 (75.5 percent) and intensive care unit admission with COVID-19 (84.9 percent). Among adolescents, the corresponding effectiveness was 85.5, 84.8, and 91.5 percent. There was a decline noted in the effectiveness of the BNT162b2 vaccine against the omicron variant four months after the first dose, which then stabilized. During the omicron period, the risk for cardiac complications was lower in the vaccinated group.

"Our assessment of vaccine effectiveness across diverse outcomes underscores the vaccine's pivotal role in reducing SARS-CoV-2 transmission, minimizing COVID-19-related sick leaves, and alleviating economic burdens during the pandemic," the authors write.

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BNT162b2 Vaccine Shows High Efficacy in Youth During COVID Delta and Omicron - HealthDay

Building Vaccine Confidence: Strategies for dispelling myths and misinformation – Open Access Government

January 9, 2024

Vaccines are a critical public health measure to mitigate the threat and severity of diseases. While we know how beneficial vaccines can be in protecting the public, many barriers and complex factors can prevent or make people hesitant about getting vaccinated. The COVID-19 pandemic highlighted the impact of vaccine hesitancy and misinformation as many sought information to address their concerns following rapid vaccine development.

According to a recent study conducted by the Vaccine Confidence Project at the London School of Hygiene & Tropical Medicine (LSHTM) and the Africa Centres for Disease Control and Prevention, in the past two years, Africa has seen the most significant sustained drop in routine childhood immunizations in three decades. Approximately six million children have missed getting vaccinated for preventable diseases like tetanus, polio, diphtheria, and measles. This worrying trend threatens to reverse decades of progress made against these diseases, leading to rising outbreaks in the region.

According to the CDC, vaccine confidence is the belief that vaccines work, are safe and are part of a trustworthy medical system, but what factors, vaccine- specific or otherwise, can influence peoples decision-making? To discuss this, we spoke to Heidi J Larson and her team at the Vaccine Confidence Project, an initiative set up to understand and map vaccine confidence globally.

The Vaccine Confidence ProjectTM (VCP) was launched in 2010 at the London School of Hygiene & Tropical Medicine to establish systematic approaches to monitoring public confidence in vaccines around the world using population-based surveys, ongoing news and social media surveillance, as well as in-depth interviews and focus groups. This multifaceted approach helps us map vaccine sentiment and detect early warning signals of declining trust, while also exploring digital interventions through implementation science and experimental designs.

Since 2019, we have opened a European office at the University of Antwerp in Belgium and an Asia Pacific office at Hong Kong University, which leads on digital and AI innovation. The VCP developed the Vaccine Confidence IndexTM (VCI) to measure individual vaccine confidence in nationally representative surveys worldwide.

The VCI data informs national and subnational estimates of vaccine confidence that can be tracked over time and used to identify subpopulations with faltering confidence to inform policy and communication strategies. The VCP has published global studies comparing data from more than 140 countries from 2015 to the present, and these analyses have identified critical trends in confidence. (1,2)

Over the past decade, we have learned that declines in vaccine confidence often flag broader trust issues such as loss of trust in the health services or the government. Sometimes, prior negative experiences with the health system or feelings of being disrespected, marginalized, or stigmatized can inhibit people from returning to a health clinic. Historic bad experiences can also linger in the minds of individuals or communities and undermine their trust more broadly, which can be detected in declining trust in vaccines.

Once trends or signals of drops in confidence are identified, we then do deeper dives in trying to understand what is driving the change, initially contacting collaborators in the country or setting for their local insights and then working together to understand where the source of distrust is emanating from.

Sometimes, underlying online misinformation is less visible in the day-to-day running of the immunization programme and is coming from outside the health sphere. Another challenge is that some narratives are not explicitly misinformation but instead play on uncertainty and amplify the scale of real, albeit very small, risks sometimes dramatically to fuel fear. Attempting to directly rebut misinformation can serve to amplify it. As a result, public attention can shift from medical or government advice towards alternative explanations, which may be dangerous and can have negative health consequences, impacting how people process and act upon information.

One of the various strategies that is being used to mitigate the spread and negative impacts of misinformation is to surround the negative or inaccurate narrative with a better, more accurate and relatable story through other online groups or media in other words, creating a media ecosystem that slows as well as undermines the plausibility of the emerging misinformation.

To better understand the dynamic nature of misinformation and consider ways to address it, the VCP at the LSHTM leads a research consortium called IRIS committed to understanding infodemics, fostering healthy information ecosystems and developing a suite of solutions, insights, best practices, international standards, models, and training to counter online misinformation around vaccines. The other members include the University of Cambridge, Sapienza University of Rome, Ca Foscari University of Venice, City University of London, the Alan Turing Institute, and the Harvard T. H. Chan School of Public Health.

Existing research gives us an outline of some of the key factors influencing vaccine hesitancy, but we know that a one-size-fits-all strategy will not work, and public health approaches of the past cannot be relied on given the highly volatile current communication landscape and emboldened voices and demands from publics.

To successfully roll out vaccines during any pandemic, one needs to know who to target, with what messages, when and where. Most importantly, we need to have a deep understanding of what is driving public dissent, reluctance, or inability to vaccinate and how barriers (including susceptibility to misinformation) differ within and between countries.

Because the mpox outbreak appears to have disproportionately affected the LGBTQ+ community, mpox stigma started to emerge in the context of judgement around sexual orientation. This stigmatization further inhibited mpox vaccine-seeking behaviour. For issues such as these, vaccine programmes can help alleviate stigma, firstly by implementing a zero-tolerance policy around any stigma or discrimination expressed by healthcare professionals.

It is important to promote accurate data showing that mpox is not exclusive to the LGBTQ+ community, but can affect anyone. Finally, collaborating with LGBTQ+ communities will be key in the design of vaccination services to ensure they are accessible and reduce the risk of stigma.

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Building Vaccine Confidence: Strategies for dispelling myths and misinformation - Open Access Government

How Penn Medicine is changing the world with mRNA | Penn Today – Penn Today

January 9, 2024

Vaccines for COVID-19 were the first time that mRNA technology was used to address a worldwide health challenge. The Penn Medicine scientists behind that technology were awarded the 2023 Nobel Prize in Physiology or Medicine. Next come all the rest of the potential new treatments made possible by their discoveries.

Starting in the late 1990s, working together at Penn Medicine, Katalin Karik and Drew Weissman discovered how to safely use messenger RNA (mRNA) as a whole new type of vaccine or therapy for diseases. When the COVID-19 pandemic hit in 2020, these discoveries made Pfizer/BioNTech and Modernas new vaccines possiblesaving millions of lives.

But curbing the pandemic was only the beginning of the potential for this Nobel Prize-winning technology.

These biomedical innovations from Penn Medicine in using mRNA represent a multiuse tool, not just a treatment for a single disease. The technologys potential is virtually unlimited; if researchers know the sequence of a particular protein they want to create or replace, it should be possible to target a specific disease. Through the Penn Institute for RNA Innovation led by Weissman, who is the Roberts Family Professor of Vaccine Research in Penns Perelman School of Medicine, researchers are working to ensure this limitless potential meets the worlds most challenging and important needs.

Just consider some of the many projects Weissmans lab is partnering in: Were working on malaria with people across the U.S. and in Africa, Weissman says. Were working on leptospirosis with people in Southeast Asia. Were working on vaccines for peanut allergies. Were working on vaccines for autoimmunity. And all of this is through collaboration.

Clinical trials are underway for the new malaria vaccine, as well as for a Penn-developed mRNA vaccine for genital herpes and one that aims to protect against all varieties of coronaviruses. Trials should begin soon for vaccines for norovirus and the bacterium C. difficile.

The Weissman lab is working to deploy mRNA technology as an accessible gene therapy for sickle cell anemia, a devastating and painful genetic disease that affects about 20 million people around the world. About 300,000 babies are born each year with the condition, mainly in sub-Saharan Africa. Weissmans team has developed technology to efficiently deliver modified mRNA to bone marrow stem cells, instructing red blood cells to produce normal hemoglobin instead of the malformed sickle version that causes the illness.

Conventional gene therapies are complex and expensive treatments, but the mRNA gene therapy could be a simple, one-time intravenous injection to cure the disease. Such a treatment would have applications to many other congenital gene defects in blood and stem cells.

In another new program, Penn Medicine researchers have found a way to target the muscle cells of the heart. This gene therapy method developed by Weissmans team, together with Vlad Muzykantov, the Founders Professor in Nanoparticle Research, could potentially repair the heart or increase blood flow to the heart, noninvasively, after a heart attack or to correct a genetic deficiency in the heart. That is important because heart disease is the number one killer in the U.S. and in the world, Weissman says. Drugs for heart disease arent specific for the heart. And when youre trying to treat a myocardial infarction or cardiomyopathy or other genetic deficiencies in the heart, its very difficult, because you cant deliver to the heart.

Weissmans team also is partnering on programs for neurodevelopmental diseases and for neurodegenerative diseases, to replace genes or deliver therapeutic proteins that will treat and potentially cure these diseases.

The potential is unbelievable, Weissman says. We havent thought of everything that can be done.

Crucially, mRNA technology is simple enough that it should be possible to make these future treatments for sickle cell and other diseases available around the world, at low cost, even in places with few resources. And this is a priority for Weissman and for Penn. Its just an IV injection, Weissman explains. You can do that anywhere. You dont need fancy equipment, a fancy medical center. You give somebody an IV injection, and youre done.

To date, Weissman has partnered in building 18 mRNA-capable Good Manufacturing Practice (GMP) sites across the world, a type of specialized production facility that can make drugs and vaccines for human use. All of these sites are beginning with manufacturing vaccines in low- and middle-income countries, Weissman says, but all are interested in developing therapeutics and gene therapies. I think, in the next few years, were going to see more and more of these GMP sites and research infrastructure sites across the world developing new and novel treatments.

Collaboration is key for the global reach of Penn Medicines mRNA research, something at the heart of new lab space that is home to Weissmans team, allowing them to partner with colleagues across teams.

It would be impossible for the members of my lab to have to learn and set up new model systems for every disease we wanted to follow, Weissman says. We find the best people in the world and ask them, Do you want to collaborate on making this vaccine or therapeutic? And to me, thats the most important thing that makes research work, and that allows research to move forward.

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How Penn Medicine is changing the world with mRNA | Penn Today - Penn Today

Transgene and NEC Extend their Collaboration to Continue Joint Clinical Development of Neoantigen Cancer Vaccine … – NEC

January 9, 2024

About myvac myvac is a viral vector (MVA Modified Vaccinia Ankara) based, individualized immunotherapy platform that has been developed by Transgene to target solid tumors. myvac-derived products are designed to stimulate the patients immune system to recognize and destroy tumors using their own cancer specific genetic mutations. Transgene has set up an innovative network that combines bioengineering, digital transformation, established vectorization know-how and unique manufacturing capabilities. Transgene has been awarded "Investment for the Future" funding from Bpifrance for the development of its platform myvac. TG4050 is the first myvac-derived product being evaluated in clinical trials. Click here to watch a short video on myvac.

About TG4050 TG4050 is an individualized immunotherapy being developed for solid tumors that is based on Transgenes myvac technology and powered by NECs longstanding artificial intelligence (AI) and machine learning (ML) expertise. This virus-based therapeutic vaccine encodes neoantigens (patient-specific mutations) identified and selected by NECs Neoantigen Prediction System. The prediction system is based on more than two decades of expertise in AI and has been trained on proprietary data allowing it to accurately prioritize and select the most immunogenic sequences. TG4050 is designed to stimulate the immune system of patients in order to induce a T-cell response that is able to recognize and destroy tumor cells based on their own neoantigens. This individualized immunotherapy is developed and produced for each patient.

About the clinical trial TG4050 is being evaluated in a Phase I clinical trial for patients with HPV-negative head and neck cancers (NCT04183166). An individualized treatment is created for each patient after they complete surgery and while they receive adjuvant therapy. Half of the participants received their vaccine immediately after completing adjuvant treatment. The other half were given TG4050 as an additional treatment at the time of recurrence of the disease as an additional treatment to standard of care (SoC). This randomized study is evaluating the treatment benefits of TG4050 in patients who are at risk of relapse. Thirty-two patients have been included in this trial under way in France, the UK, and the USA. The principal investigator of the trial is Prof. Christian Ottensmeier, MD, PhD, Consultant Medical Oncologist at the Clatterbridge Cancer Centre and Professor of Immuno-Oncology at the University of Liverpool. In France, the clinical trial is conducted at Institut Curie by Prof. Christophe Le Tourneau, MD, PhD, Head of the Department of Drug Development and Innovation (D3i), and at the IUCT-Oncopole, Toulouse by Prof. Jean-Pierre Delord, MD, PhD. In the USA, the trial is being led by Yujie Zhao, MD, PhD, at the Mayo Clinic. Endpoints of the trial include safety, feasibility, and biological activity of the therapeutic vaccine. Initial immunological and clinical data presented at AACR 2023 and ASCO 2023 are very encouraging.

About Transgene Transgene (Euronext: TNG) is a biotechnology company focused on designing and developing targeted immunotherapies for the treatment of cancer. Transgenes programs utilize viral vector technology with the goal of indirectly or directly killing cancer cells. The Companys clinical-stage programs consist of a portfolio of therapeutic vaccines and oncolytic viruses: TG4050, the first individualized therapeutic vaccine based on the myvac platform, TG4001 for the treatment of HPV-positive cancers, as well as BT-001 and TG6050, two oncolytic viruses based on the Invir.IO viral backbone. With Transgenes myvac platform, therapeutic vaccination enters the field of precision medicine with a novel immunotherapy that is fully tailored to each individual. The myvac approach allows the generation of a virus-based immunotherapy that encodes patient-specific mutations identified and selected by Artificial Intelligence capabilities provided by its partner NEC. With its proprietary platform Invir.IO, Transgene is building on its viral vector engineering expertise to design a new generation of multifunctional oncolytic viruses. Additional information about Transgene is available at: http://www.transgene.fr Follow us on social media: X (formerly Twitter): @TransgeneSA LinkedIn: @Transgene

About NECs Neoantigen Prediction System NECs neoantigen prediction system utilizes its proprietary AI, such as graph-based relational learning, trained on multiple sources of biological data to discover candidate neoantigen targets. These targets are carefully analyzed using proprietary machine learning algorithms that include in-house HLA binding and antigen presentation AI tools to evaluate the likelihood of eliciting a robust and clinically relevant T-cell response. With NEC OncoImmunity now on board, NEC continues to strengthen its top-class neoantigen prediction pipelines with the aim of maximizing the therapeutic benefits of personalized cancer immunotherapy for patients worldwide. For more information, visit NEC at http://www.nec.com. For additional information, please also visit NEC OncoImmunity at https://www.oncoimmunity.com/

About NEC Corporation NEC Corporation has established itself as a leader in the integration of IT and network technologies while promoting the brand statement of "Orchestrating a brighter world." NEC enables businesses and communities to adapt to rapid changes taking place in both society and the market as it provides for the social values of safety, security, fairness and efficiency to promote a more sustainable world where everyone has the chance to reach their full potential. For more information, visit NEC at https://www.nec.com and NECs AI Drug Development Business at https://www.nec.com/en/global/solutions/ai-drug/

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Transgene and NEC Extend their Collaboration to Continue Joint Clinical Development of Neoantigen Cancer Vaccine ... - NEC

RSV Vaccines Would Greatly Reduce Illness if Implemented Like Flu Shots – Yale University

January 9, 2024

Respiratory syncytial virus (RSV) vaccines recently approved for people 60 and older would dramatically reduce the diseases significant burden of illness and death in the United States if they were widely adopted like annual influenza vaccines, a new study has found.

A high level of RSV vaccination would not only potentially reduce millions of dollars in annual outpatient and hospitalization costs, it would also produce an economy of scale with individual shots being delivered at a relatively modest cost of between $117 and $245 per dose, the study said.

The vaccines are currently covered by most private insurers without a patient copay because they are recommended by the Centers for Disease Control and Preventions Advisory Committee on Immunization Practices. Some Medicare beneficiaries can also obtain the shots at no cost, but only if they are enrolled in Part D of the program, which deals with drug benefits.

RSV causes substantial morbidity and mortality among the elderly in the U.S. and globally, but this is the first time that RSV vaccines have been available, said senior author Alison Galvani, PhD, the Burnett and Stender Families Professor of Epidemiology (Microbial Diseases) at the Yale School of Public Health. We wanted to understand the potential impact of RSV vaccination in terms of averting illness, medical costs, hospitalizations, and deaths.

RSV is a common respiratory virus that causes mild cold-like symptoms in most people, who usually recover in one or two weeks. But older adults and infants are more likely to develop serious RSV, which can be life-threatening. The current study looked only at the potential impact and cost of RSV vaccines for older adults.

We hope that our results will inform decision-makers about the health and economic benefits of vaccination.

Two RSV vaccines, Arexy and Abrysvo, were approved by the U.S. Food and Drug Administration earlier this year. RSV disease causes an estimated 60,000 to 160,000 hospitalizations and 6,000 to 10,000 deaths annually in adults 65 and older, according to the Centers for Disease Control and Prevention (CDC). As of Dec. 1, just 14.8% of people 60 or older in the U.S. said they had obtained an RSV vaccine, CDC records show.

In conducting their study, the researchers created a model for RSV outcomes based on characteristics of the U.S. population 60 or older. Measured outcomes included the annual incidence of cases per 100,000 people requiring outpatient, inpatient, and intensive care, and the death rate for hospitalized patients. The researchers then calculated the medical care costs for these outcomes and lost productivity.

The researchers analyzed how these outcomes would be reduced if 66% of adults 60 and older received an RSV vaccine. That is the typical influenza vaccination coverage for adults 65 years or older in the U.S.

It would be great if we could achieve even higher levels, said Galvani, who also serves as the director of Yales Center for Infectious Disease Modeling and Analysis. But if we can achieve that for flu, it makes sense that would be feasible for RSV vaccination as well.

For comparison, the researchers also analyzed the impact of 100% RSV vaccination coverage. In each scenario, they factored in the efficacy of the vaccine at preventing the need for medical care and death. They looked at the impact of these levels of RSV vaccination over one year and then over two years.

They found that 66% vaccination coverage in the first year reduced outpatient care by as much as 53.6%, hospitalizations by up to 60.5%, and RSV-related deaths by as much as 60.4%.

Increasing vaccination coverage to 100% reduced outpatient care by up to 81.2%, hospitalizations by as much as 91.7%, and deaths by up to 91.3%.

Based on these numbers, the maximum cost-effective price per dose for one season at 66% coverage was $118 to $127. The difference was small $1 to $3 for 100% coverage.

With the annual costs savings achieved from vaccination, a program where 66% of adults 60 and older are vaccinated for RSV would costs the U.S. health care system $6.4 to $7.1 billion for one season, and at 100% $9.7 to $10.7 billion at 100% vaccination, the researchers found.

The vaccines are intended to protect people over two RSV seasons, as clinical trials for the vaccine showed efficacy for that time. But the researchers felt that until real-world efficacy data are available, a one-season analysis was more appropriate.

Within the next year or two years, as these vaccines are rolled out, we will get a lot of data on effectiveness and better analysis, said Seyed Moghadas, PhD, the papers first author and professor of applied mathematics and computational epidemiology at York University. This new data will help us better inform vaccination strategies for improved impact against RSV disease.

If real-world data show strong efficacy over two seasons, Arexvy could be cost effective up to $235 per dose and Abrysvo up to $245 per dose, the researchers found.

These are important issues to understand, Galvani said. Some private insurers have not decided if they will cover the vaccines, and whether Medicare does depends on the plan, she said. People 60 to 64 are not eligible for Medicare and may not have health coverage, she added.

Accessibility and cost are definitely concerns in the American health care system, she said. We hope that our results will inform decision-makers about the health and economic benefits of vaccination, as our results demonstrate the importance of making these vaccines accessible to everyone over 60 years to realize their full benefit.

The research was published Nov. 30 in Clinical Infectious Diseases.

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RSV Vaccines Would Greatly Reduce Illness if Implemented Like Flu Shots - Yale University

‘Vaccine victims’ left with life-changing injuries from Covid jab claim they have been censored – GB News

January 9, 2024

People impacted by the Oxford-AstraZeneca Covid vaccine claim they have been censored on social media about discussing symptoms.

Victims who have suffered life-changing injuries from the jab say they have been given "warnings" online while trying to talk about their experiences.

It comes after a test case was brought to the High Court against the pharmaceutical company by a father-of-two who suffered a significant permanent brain injury which resulted in a blood clot after receiving the jab in 2021.

A similar case has also been launched by the widower of a woman who died after having the jab.

People impacted by the Oxford-AstraZeneca Covid vaccine claim they have been censored on social media about discussing symptoms

While some individuals experienced severe side effects from the vaccine, research estimates that across the UK for every 10 million people who were vaccinated with AstraZeneca, there are just 66 extra cases of blood clots in the veins and seven extra cases of a rare type of blood clot in the brain.

Many people - who have not taken legal action - now say they are being forced to "self censor" and speak in code, or face their support group being closed down.

Charlet Crichton launched UK CV Family, a private Facebook group for those injured or bereaved from Covid vaccines, in 2021.

The 42 year-old suffered an adverse reaction from the AstraZeneca jab and has since lost her sports therapy business and spends weeks at a time in bed.

"I set up the group because I was finding people online in the UK like me. And we felt we didnt have anyone to talk to about it apart from each other," she told the Telegraph.

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The group says it is "not anti-vax" and requests that members "refrain from posting anything that suggests otherwise."

Crichton added: "We very quickly learned that we had to self censor, otherwise wed be shut down."

She was blocked from commenting for a period of time "to prevent misuse" and alleges that social media platforms "shadow banned" members - a process which sees the algorithm hide some posts from others on the app.

She added: "Its very, very difficult because we want to talk about what were going through. We need to talk about what were going through."

Many people - who have not taken legal action - now say they are being forced to "self censor" and speak in code, or face their support group being closed down

Similarly, it has bene reported that YouTube tried to censor videos of testimony given by lawyers to the Covid Inquiry about vaccines.

Stephen Bowie, a member of the Scottish Vaccine Injury Group (SVIG) tried to upload a video of a statement given in a hearing by Anna Morris KC, a lawyer representing those who have suffered injuries or bereavements from jabs, to his YouTube channel.

The social media platform flagged the clip as a violation of its "medical misinformation policy."

Bowie, who suffered a spinal stroke and blood clots after having the AstraZeneca vaccine, was told by YouTube: "We reviewed your content carefully, and have confirmed that it violates our medical misinformation policy."

AstraZeneca said that patient safety was its "highest priority", that its vaccine - Vaxzevria - had "continuously been shown to have an acceptable safety profile", and that regulators around the world "consistently state that the benefits of vaccination outweigh the risks of extremely rare potential side effects."

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'Vaccine victims' left with life-changing injuries from Covid jab claim they have been censored - GB News

Vaccine from UCSD researchers targets acne inflammation – CBS News 8

January 9, 2024

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Dr. George Liu expects the vaccine could be available to the public within the next five to 10 years.

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Published: 6:11 PM PST January 8, 2024

Updated: 6:11 PM PST January 8, 2024

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Vaccine from UCSD researchers targets acne inflammation - CBS News 8

Drug discovery and development: what’s new in the world of vaccines? – BioTechniques

January 9, 2024

Following their conception in 1796 by Edward Jenner, vaccines have been an important part of healthcare, protecting humans and animals from harmful viruses. Immunization took center stage at the advent of the COVID-19 pandemic as researchers, such as Katalin Karik and Drew Weissman, and pharmaceutical companies raced to get their mRNA vaccines into circulation to lessen the severity of the virus.

But how has inoculation developed since to fight viruses such as HIV and influenza? Below are five key developments that have been published recently, which highlight how vaccines are being optimized to target both the common cold virus as well as conditions like high cholesterol. Plus, how does the actual design of the vaccine factor into its effectiveness?

The search for an HIV vaccine has been going on since 1984 when scientists discovered that HIV caused AIDS. A recent study has made researchers at the National Institute of Allergy and Infectious Diseases (part of the NIH; MD, USA) hypothesized that an effective HIV vaccine may rely on promoting a stronger and longer-lasting immune response from CD8+ T cells. By comparing immune activity in previous HIV vaccine candidates and those who naturally keep HIV from replicating, the team demonstrated that those who received the vaccine previously showed reduced CD8+ T cell activity compared to the natural response of individuals with non-replicating HIV [1].

Read the paper

Two-pronged strategy boosts mRNA COVID-19 vaccines

Researchers have modified COVID-19 vaccines to produce a stronger immune response in mice.

Researchers at the University of Pittsburgh School of Medicine (PA, USA) have identified a group of previously unidentified antibodies with neutralizing effects against multiple strains of the flu virus. This discovery has led to the development of a new influenza vaccine that has the potential to protect individuals against a range of strains simultaneously [2].

Read the paper

The future of lipid nanoparticles and mRNA cancer vaccines

mRNA vaccines would not have been possible without breakthroughs in lipid nanoparticles, both of which researchers are now developing for cancer therapeutics.

A vaccine that blocks a protein PCSK9 involved in negatively regulating cholesterol metabolism has shown promise in lowering cholesterol levels in non-human primates. Researchers at The University of New Mexico School of Medicine (NM, USA) developed a twice-monthly vaccine comprised of non-infectious viral particles with PCSK9 fragments stuck to the surface. This prompts the immune system to build a strong barrier against PCSK9, therefore reducing the proteins pro-cholesterol characteristics [3].

Read the paper

Experimental vaccine packs a punch against broad range of antimicrobial-resistant strains

A vaccine shows promising preclinical results in supercharging immune responses to a range of drug-resistant superbugs.

During the COVID-19 pandemic, mRNA vaccines made waves in the drug discovery and development sphere. The next step is to optimize their effectiveness so they can be utilized across more pressing disease areas. A multi-institutional group of researchers developed a method for investigating how mRNA nanoparticles in nanomedicines vary in size a factor that can affect drug efficacy. In addition to the methods ability to separate nanoparticles by their size, it also allows researchers to investigate their structure thanks to X-ray scattering [4].

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The microparticles behind self-boosting vaccines

A smart vaccine may be on the horizon as researchers develop microparticles that can release their contents at different time points, potentially streamlining the vaccination process.

Bioinformaticians at Heinrich Heine University Dsseldorf (Germany) have illuminated the benefits of combining epitopes, protein fragments of pathogens, in developing novel vaccines. The team developed a method, termed HOGVAX, for identifying which epitope combinations can guarantee safe immunization and maximize population coverage [5].

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Drug discovery and development: what's new in the world of vaccines? - BioTechniques

Declining Vaccine Rates May Cause Thousands of Deaths, Put US ‘At Risk’: FDA Chief – The Messenger

January 9, 2024

Americas health leaders worry that declining vaccination rates can lead to the return of deadly diseases and thousands of avoidable deaths.

Robert Califf, M.D., commissioner of the Food and Drug Administration (FDA) and Peter Marks, M.D., who oversees vaccine regulation at the agency, wrote in JAMA last week that they were concerned about falling vaccination rates.

The situation has now deteriorated to the point that population immunity against some vaccine-preventable infectious diseases is at risk, they wrote. Thousands of excess deaths are likely to occur this season due to illnesses amenable to prevention or reduction in severity of illness with vaccines.

They point to measles as the prime example of a once-handled virus making a sudden return. In the U.S., cases of the highly contagious virus have sporadically emerged around the country in the years since the COVID-19 pandemic. Just last week, Philadelphia officials warned that at least four people were infected in a measles cluster linked to the citys iconic Childrens Hospital of Philadelphia (CHOP).

Regrettably, pediatric vaccine hesitancy now has been responsible for several measles outbreaks in the U.S., Dr. Califf and Dr. Marks continue.

Its not just the U.S., however. The World Health Organization reported a 40% jump in measles deaths globally in 2022, and a 30% increase in European cases.

The pandemic led to a wave of vaccine hesitancy, with many casting doubts on the new class of shots meant to fight the pandemic an in-turn to vaccines as a whole. Many U.S. states also loosened vaccine exemptions for children, allowing more children to attend school without receiving shots to prevent measles and other infections.

Some states, such as Mississippi, have recorded drastic falls in vaccine uptake since the loosening of these mandates.

The pair of FDA officials point to parents with at least a college degree who preferred social media narratives over evidence-based vaccine information delivered by clinicians as being at fault for falling vaccination rates.

To fix the growing problem, the FDA leaders want investment into plain language campaigns that inform the public of why vaccines are so important. They specifically point to the devastating diseases polio and smallpox both of which are no longer major health threats because of vaccination as success stories that should be highlighted.

Such information is now needed because vaccines have been so successful in achieving their intended effects that many people no longer see the disturbing morbidity and mortality from infections amenable to vaccines, Dr. Marks and Dr. Califf added.

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Declining Vaccine Rates May Cause Thousands of Deaths, Put US 'At Risk': FDA Chief - The Messenger

Big changes will streamline CPT coding for immunization – American Medical Association

January 9, 2024

Significant changes in the Current Procedural Terminology(CPT) code setfor immunizations reflect the changing nature of how COVID-19 is being addressed as actions transition from a public health emergency response to combatting emerging variants much like the flu.

One significant change involves the consolidationof more than 50 previous codes tostreamline reporting of immunizations for COVID-19. A new vaccine-administration code,90480, was approved for reporting the administration of any COVID-19 vaccine for any patient. This replaces all previously approved, product-specific vaccine-administration codes.

From a public health perspective, there was great initial value in tracking each individual vaccine during the public health emergency, With the end of the public health emergency, there is no longer a need for the coding granularity of individual administration codes for every vaccine product.

Additionally, the Vaccines and Related Biological Products Advisory Committee (VRBPAC), an advisory group of the FDA, recommended that the COVID-19 vaccine for the 20232024 vaccination season be a monovalent vaccine that contains the XBB.1.5 strain, and noted that a number of COVID-19 vaccine products will no longer be recommended for use. The streamlined structure brings greater alignment between CPT and the current COVID-19 vaccine reporting environment.

The new coding system will allow for new vaccines for new variants whenever they come up without having to do a new code, said Samuel Le Church, MD, MPH, a member of the CPT Editorial Panel and vice-chair of its Immunization Coding Caucus.

Dr. Church, president of the Georgia Academy of Family Physicians, spoke at the annual AMA CPT and RBRVS Annual Symposium, held virtually this year.

The CPT Editorial Panel approved five new COVID-19 vaccine product codes and one administration code in August 2023. These new COVID-19 codes replaced all previously approved specific COVID-19 product and administration codes, except for vaccine product code 91304 for the Novavax vaccine.

Specific information to assist with proper code selection of the more than 50 COVID-related vaccine product and administration codes were contained in Appendix Q of the CPT code set. With the removal of those COVID-19 codes, Appendix Q was also deleted in November.

Some vaccine and immune globulin products are assigned a code in anticipation of eventual approval by the Food and Drug Administration. These codes are marked with a lightning bolt symbol in the Category I Immunization code descriptors (PDF).

The new codes added for 2024 include three Pfizer-product codes and reflect vaccine concentrations developed for different age groups:

There are also two new Moderna-product codes:

My hope is that all these changes will dramatically simplify your coding experience when dealing with the COVID-vaccine products, Dr. Church said.

Learn more with the AMA about the most current COVID-19 CPT vaccine and immunization codes.

Typically, vaccine codes are electronically published July 1 and January 1, though some may require expedited release due to public health concerns as was the case with the vaccines for COVID-19 and respiratory syncytial virus (RSV).

After the final approval is done, then that lightning bolt will be taken away, Dr. Church said.

Reflecting all these developments, the CPT vaccine early release schedule will now be known as the immunization early release schedule and will include vaccines/toxoids, immune globulins and serum or recombinant products.

There are a lot of changes that are happening in the world of immunization, so it was a bit restrictive to have it be a vaccine early release policy, so we expanded that, Dr. Church explained.

Weve got a lot going on in the RSV world, he added.

This includes two new seasonal RSV monoclonal antibody immunization pediatric codes for children less than 24 months of age with dosage based on the childs weight, as well as two new administration codes for these products that are differentiated by the inclusion of counseling:

Additionally, three vaccine codes were created and associated with use in the adult population:

These codes were developed to provide better tracking to support data-driven planning and allocation, and to track patient outcomes.

Also new are:

The CPT 2024 Professional Edition and CPT Changes 2024: An Insiders View are available from theAMA Storefronton Amazon.

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Big changes will streamline CPT coding for immunization - American Medical Association

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