Category: Flu Vaccine

ByVinod RMT Balasubramaniam,

Monash Universityin Kuala Lumpur

Clinical trials of a universal influenza mRNA vaccine have begun in the US.

The US National Institute of Allergy and Infectious Diseases has started enrolling volunteers at Duke University in North Carolina to test itsexperimental mRNA-LNP vaccineagainst seasonal influenza, one of several universal influenza vaccine candidates now in the pipeline.Another clinical trialhas begun at the US National Institutes of Healths Clinical Centre in Maryland.

Influenza kills up to 650,000 people around the world each year.

Ninety-nine percent of deaths in childrenunder five years of age in developing countries are due to influenza-related infections, according to the World Health Organization.

The current crop of influenza vaccines haslimitationsin effectively combating thebillion casesof seasonal influenza each year as they provide immunity against only one specific existing strain or mutation. The propensity of flu viruses to mutate into new strains means vaccines must be continuously monitored and reformulated each year.

But a universal influenza vaccine, using mRNA technology which was used with success during the COVID pandemic has the potential to provide broader and longer-lasting immunity against diverse influenza strains.

The technology allows for rapid development and deployment and offers versatility in targeting multiple regions of the influenza virus.

New or mutated influenza variants are always a threat, particularly those originating from animal sources. Pandemics such as theSpanish fluof 1918, which killed 50 million people, and recent outbreaks of theavian influenza(bird flu) viruses underscore the persistent threat posed by influenza.

It also underscores the urgent need for auniversal influenza vaccinecapable of safeguarding against all subtypes of the virus.

In recent years, lipid nanoparticle (LNP)-encapsulated nucleoside-modified mRNA (mRNA-LNP) vaccines have emerged as a potent tool in combating influenza and other infectious diseases.

These vaccines use mRNA created in a laboratory to teach our cells how to make a protein or even just a piece of a protein that triggers an immune response inside our bodies.

The limited efficacy of current vaccines can be attributed to their focus on only generating strain-specific antibodies against the influenza virus hemagglutinin (HA). This is a protein within the virus which causes infection.

To broaden protective immunity, novel vaccine strategies aim to elicit responses against more proteins (fragments of a virus). One promising avenue involves triggering T-cell responses. T-cells are a type of white blood cell and are part of the bodys immune system.

T-cell-mediated immunity not only eliminates infected cells but also correlates with improved outcomes in individuals affected by influenza.Animal studieshave demonstrated the protective role of T-cells against various influenza virus strains.

These vaccines, exemplified by the successful development and global deployment of mRNA-LNP-basedCOVID-19 vaccines, elicit robust T-cell and antibody responses. These vaccines also offer the advantage of rapid production and adaptation to target emerging viral variants.

While several mRNA-LNP influenza vaccines arein development, most prioritise stimulating antibody responses and under-exploit the potential of T-cell immunity.

As shown by COVID-19, mRNA vaccines have demonstrated safety and efficacy in clinical trials forvarious infectious diseases. This instils confidence in the feasibility of developing a universal influenza mRNA vaccine that is safe and effective.

Ongoing advances in mRNA technology, such as improveddelivery systems and stabilisationmethods, further enhance the prospects of creating a universal influenza vaccine that ticks all the boxes.

The mRNA vaccine technology offers several advantages, including rapid development, scalability, and precise design. Two categories of mRNA vaccines exist,conventional and self-amplifyingand both are being explored for their potential to confer broad protection against influenza viruses.

Despite their promise, challenges remain in effectivelydelivering mRNA moleculesinto a vaccine due to their inherent instability. Overcoming these challenges is essential for the successful development of universal mRNA vaccines for influenza.

Dr Vinod Balasubramaniamis Associate Professor (Molecular Virology) at the Jeffrey Cheah School of Medicine and Health Sciences, Monash University Malaysia.

Originally published underCreative Commonsby360info.

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A revolutionary new vaccine in the battle against influenza - Cosmos

FORT WORTH, Texas, May 20, 2024 (GLOBE NEWSWIRE) -- TFF Pharmaceuticals, Inc (Nasdaq: TFFP) (the Company or TFF Pharmaceuticals), a clinical-stage biopharmaceutical company focused on developing and commercializing innovative drug products based on its patented Thin Film Freezing (TFF) technology platform, today announced that, in collaboration with Cleveland Clinic, the Company is advancing multiple multivalent universal influenza vaccines to protect against seasonal and pandemic viruses into preclinical testing. The decision to advance the vaccine candidates into preclinical testing was based upon the successful completion of formulation testing with stability data on the combination of hemagglutinin (HA) antigens with four different adjuvants. Based on these data, three HA antigen/adjuvant candidate vaccines have been selected for testing in a pre-clinical model at Cleveland Clinic Florida.

Funded through the National Institute of Allergy and Infectious Diseases (NIAID), the purpose of the research collaboration between TFF Pharmaceuticals and Cleveland Clinic is to develop a first-in-class, stable, universal, easy-to-transport and easy-to-stockpile vaccine that would overcome the vaccine failures that result from mishandling, mismatches between predicted and actual seasonal flu strains, and evolutionary changes in influenza viruses across the season. Successful completion of the work funded by the Direct to Phase II SBIR grant will fulfill the IND-enabling requirements to potentially advance to human clinical testing.

A recent survey1 of infectious disease specialists presented at this years ESCMID Global Congress indicates that influenza could represent the next pandemic threat to the global population, said Dr. Harlan Weisman, Chief Executive Officer of TFF Pharmaceuticals. Working in collaboration with Dr. Ted M. Ross and his colleagues, our goal is to develop a shelf-stable mucosal vaccine with unique characteristics for inhalational delivery and would circumvent the need for cold chain storage which could significantly improve the availability and distribution of potentially life-saving medicine. We look forward to advancing these vaccine candidates into preclinical studies formulated with our Thin Film Freezing technology.

Over the last year, we have generated an impressive body of positive in vitro and in vivo data from these experimental influenza vaccines, enabling us to further advance these promising candidates into additional in vivo preclinical efficacy studies, said Ted M. Ross, Global Director of Vaccine Development at Cleveland Clinic and PI of the Center for Influenza Vaccine Research for High-Risk Populations (CIVR-HRP). Our team at Cleveland Clinic looks forward to advancing this important research, which brings us one step closer toward developing a universal influenza vaccine with the potential to protect patients worldwide.

In June 2023, the Company was awarded a Direct to Phase II Small Business Innovation Research (SBIR) grant of $2.97 million to continue development of a novel, pan-flu multivariant mucosal vaccine using the Companys Thin Film Freezing technology. The purpose of the SBIR is to provide funding to support preclinical and IND enabling studies to advance the development of a shelf-stable dry powder formulation of a novel universal influenza virus vaccine, developed in the laboratory of Dr. Ross, that is more than 75% effective against symptomatic influenza virus infection and protects against groups I and II influenza A viruses, the form of virus that has historically given rise to all known influenza pandemics and that contributes to seasonal flu each year.

Influenza is a contagious viral infection that attacks the respiratory system, infecting the nose, throat and sometimes the lungs. According to the U.S. Centers for Disease Control and Prevention (CDC), influenza has resulted in tens of thousands of deaths annually in the US since 2010 and hundreds of thousands of deaths globally. There is a significant need to improve flu prevention and management programs, and major efforts are under way to develop better and more broadly protective influenza vaccines.

ABOUT TFF PHARMACEUTICALS THIN FILM FREEZING (TFF) TECHNOLOGY TFF Pharmaceuticals proprietary Thin Film Freezing (TFF) technology allows for the transformation of both existing compounds and new chemical entities into dry powder formulations exhibiting unique characteristics and benefits. The TFF process is a particle engineering process designed to generate dry powder particles with advantageous properties for inhalation, as well as parenteral, nasal, oral, topical and ocular routes of administration. The process can be used to engineer powders for direct delivery to the site of need, circumventing challenges of systemic administration and leading to improved bioavailability, faster onset of action, and improved safety and efficacy. The ability to deliver therapies directly to the target organ, such as the lung, allows TFF powders to be administered at lower doses compared to oral drugs, reducing unwanted toxicities and side effects. Laboratory data suggests the aerodynamic properties of the powders created by TFF can deliver as much as 75% of the dose to the deep lung. TFF does not introduce heat, shear stress, or other forces that can damage more complex therapeutic components, such as fragile biologics, and instead enables the reformulation of these materials into easily stored and temperature-stable dry powders, making therapeutics and vaccines more accessible for distribution worldwide. The advantages of TFF can be used to enhance traditional delivery or combined to enable next-generation pharmaceutical products.

ABOUT TFF PHARMACEUTICALS

TFF Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company engaging patented rapid freezing technology to develop and transform medicines into potent dry powder formulations for better efficacy, safety, and stability. The companys versatile TFF technology platform has broad applicability to convert most any drug, including vaccines, small and large molecules, and biologics, into an elegant dry powder highly advantageous for inhalation, or for topical delivery to the eyes, nose and the skin.

SAFE HARBOR

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements in this press release include, but are not limited to, statements by the Company relating to the expectation that the preclinical testing of the Companys multiple multivalent universal influenza vaccine candidates will favorably consistent with formulation testing conducted to date, the expectation that the Company will be able to move its vaccine candidates into the Phase II clinical trial and the benefits of the Companys TFF platform. Forward-looking statements involve known and unknown risks, uncertainties and other factors that could cause actual results to differ materially, including (i) the risk the preclinical testing of the Companys influenza vaccine candidates will not be favorably consistent with the formulation testing to date, (ii) the risk that the Company may not be able to advance its influenza vaccine candidates to Phase II clinical trials, (iii) success in early phases of pre-clinical and clinicals trials do not ensure later clinical trials will be successful; (iv) no drug product incorporating the TFF platform has received FDA pre-market approval or otherwise been incorporated into a commercial drug product, (v) the Company has no current agreements or understandings with any large pharmaceutical companies for the development of a drug product incorporating the TFF Platform, and (vii) those other risks disclosed in the section Risk Factors included in the Companys Quarterly Report on Form 10-Q filed with theSEConMay 14, 2024. The Company cautions readers not to place undue reliance on any forward-looking statements. The Company does not undertake and specifically disclaims any obligation to update or revise such statements to reflect new circumstances or unanticipated events as they occur, except as required by law.

Investor Relations Contact: Corey Davis, Ph.D. LifeSci Advisors (212) 915-2577 cdavis@lifesciadvisors.com

1 Source: https://medicalxpress.com/news/2024-04-experts-influenza-pathogen-pandemic-potential.html

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TFF Pharmaceuticals and Cleveland Clinic to Advance Multivalent Universal Influenza Vaccine Candidates into ... - GlobeNewswire

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Response to updated vaccine is shaped by earlier vaccines yet generates broadly neutralizing antibodies

Health-care workers received the first doses of the COVID-19 vaccine in December 2020. A study by researchers at Washington University School of Medicine in St. Louis has found that repeat vaccination with updated versions of the COVID-19 vaccine promotes the development of antibodies that neutralize a wide range of variants of the virus that causes COVID-19, as well as related coronaviruses.

The COVID-19 pandemic is over, but the virus that caused it is still here, sending thousands of people to the hospital each week and spinning off new variants with depressing regularity. The viruss exceptional ability to change and evade immune defenses has led the World Health Organization (WHO) to recommend annual updates to COVID-19 vaccines.

But some scientists worry that the remarkable success of the first COVID-19 vaccines may work against updated versions, undermining the utility of an annual vaccination program. A similar problem plagues the annual flu vaccine campaign; immunity elicited by one years flu shots can interfere with immune responses in subsequent years, reducing the vaccines effectiveness.

A new study by researchers at Washington University School of Medicine in St. Louis helps to address this question. Unlike immunity to influenza virus, prior immunity to SARS-CoV-2, the virus that causes COVID-19, doesnt inhibit later vaccine responses. Rather, it promotes the development of broadly inhibitory antibodies, the researchers report.

The study, available online in Nature, shows that people who were repeatedly vaccinated for COVID-19 initially receiving shots aimed at the original variant, followed by boosters and updated vaccines targeting variants generated antibodies capable of neutralizing a wide range of SARS-CoV-2 variants and even some distantly related coronaviruses. The findings suggest that periodic re-vaccination for COVID-19, far from hindering the bodys ability to recognize and respond to new variants, may instead cause people to gradually build up a stock of broadly neutralizing antibodies that protect them from emerging SARS-CoV-2 variants and some other coronavirus species as well, even ones that have not yet emerged to infect humans.

The first vaccine an individual receives induces a strong primary immune response that shapes responses to subsequent infection and vaccination, an effect known as imprinting, said senior author Michael S. Diamond, MD, PhD, the Herbert S. Gasser Professor of Medicine. In principle, imprinting can be positive, negative or neutral. In this case, we see strong imprinting that is positive, because its coupled to the development of cross-reactive neutralizing antibodies with remarkable breadth of activity.

Imprinting is the natural result of how immunological memory works. A first vaccination triggers the development of memory immune cells. When people receive a second vaccination quite similar to the first, it reactivates memory cells elicited by the first vaccine. These memory cells dominate and shape the immune response to the subsequent vaccine.

In the case of the flu vaccine, imprinting has negative effects. Antibody-producing memory cells crowd out new antibody-producing cells, and people develop relatively few neutralizing antibodies against the strains in the newer vaccine. But in other cases, imprinting can be positive, by promoting the development of cross-reactive antibodies that neutralize strains in both the initial and subsequent vaccines.

To understand how imprinting influences the immune response to repeat COVID-19 vaccination, Diamond and colleagues including first author Chieh-Yu Liang, a graduate student, studied the antibodies from mice or people who had received a sequence of COVID-19 vaccines and boosters targeting first the original and then omicron variants. Some of the human participants also had been naturally infected with the virus that causes COVID-19.

The first question was the strength of the imprinting effect. The researchers measured how many of the participants neutralizing antibodies were specific for the original variant, the omicron variant or both. They found that very few people had developed any antibodies unique to omicron, a pattern indicative of strong imprinting by the initial vaccination. But they also found few antibodies unique to the original variant. The vast majority of neutralizing antibodies cross-reacted with both.

The next question was how far the cross-reactive effect extended. Cross-reactive antibodies, by definition, recognize a feature shared by two or more variants. Some features are shared only by similar variants, others by all SARS-CoV-2 variants or even all coronaviruses. To assess the breadth of the neutralizing antibodies, the researchers tested them against a panel of coronaviruses, including SARS-CoV-2 viruses from two omicron lineages; a coronavirus from pangolins; the SARS-1 virus that caused the 2002-03 SARS epidemic; and the Middle Eastern Respiratory Syndrome (MERS) virus. The antibodies neutralized all the viruses except MERS virus, which comes from a different branch of the coronavirus family tree than the others.

Further experiments revealed that this remarkable breadth was due to the combination of original and variant vaccines. People who received only the vaccines targeting the original SARS-CoV-2 variant developed some cross-reactive antibodies that neutralized the pangolin coronavirus and SARS-1 virus, but the levels were low. After boosting with an omicron vaccine, though, the cross-reactive neutralizing antibodies against the two coronavirus species increased.

Taken together, the findings suggest that regular re-vaccination with updated COVID-19 vaccines against variants might give people the tools to fight off not only the SARS-CoV-2 variants represented in the vaccines, but also other SARS-CoV-2 variants and related coronaviruses, possibly including ones that have not yet emerged.

At the start of the COVID-19 pandemic, the world population was immunologically nave, which is part of the reason the virus was able to spread so fast and do so much damage, said Diamond, also a professor of molecular microbiology and of pathology & immunology. We do not know for certain whether getting an updated COVID-19 vaccine every year would protect people against emerging coronaviruses, but its plausible. These data suggest that if these cross-reactive antibodies do not rapidly wane we would need to follow their levels over time to know for certain they may confer some or even substantial protection against a pandemic caused by a related coronavirus.

Liang CY, Raju S, Liu Z, Li Y, Arunkumar GA, Case JB, Scheaffer SM, Zost SJ, Acreman CM, Gagne M, Andrew SF, Carvalho dos Anjos DC, Foulds KE, McLellan JS, Crowe JE, Douek DC, Whelan SPJ, Elbashir SM, Edwards DK, Diamond MS. Imprinting of serum neutralizing antibodies by Wuhan-1 mRNA vaccines. Nature. May 15, 2024. DOI: 10.1038/s41586-024-07539-1

This study was supported by the National Institutes of Health (NIH), grant number R01 AI157155; the National Institute for Allergy and Infectious Diseases (NIAID)s Centers of Excellence for Influenza Research and Response, contract numbers 75N93021C00014 and 75N93019C00051; NIAIDs Vaccine Research Center; and a sponsored research agreement with Moderna. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health (NIH).

About Washington University School of Medicine

WashU Medicine is a global leader in academic medicine, including biomedical research, patient care and educational programs with 2,900 faculty. Its National Institutes of Health (NIH) research funding portfolio is the second largest among U.S. medical schools and has grown 56% in the last seven years. Together with institutional investment, WashU Medicine commits well over $1 billion annually to basic and clinical research innovation and training. Its faculty practice is consistently within the top five in the country, with more than 1,900 faculty physicians practicing at 130 locations and who are also the medical staffs of Barnes-Jewish and St. Louis Childrens hospitals of BJC HealthCare. WashU Medicine has a storied history in MD/PhD training, recently dedicated $100 million to scholarships and curriculum renewal for its medical students, and is home to top-notch training programs in every medical subspecialty as well as physical therapy, occupational therapy, and audiology and communications sciences.

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Repeat COVID-19 vaccinations elicit antibodies that neutralize variants, other viruses Washington University School ... - Washington University...

Wyoming has the fifth-lowest percentage of residents vaccinated for influenza at 43%, according to recent data from the U.S. Centers for Disease Control and Prevention (CDC).

The Wyoming Department of Health wishes that figure was higher, though its typical for Wyoming to be among the lowest states for flu vaccination, the departments spokeswoman said Thursday in response to a Cowboy State Daily inquiry.

Unfortunately, Wyoming typically does not have high rates for influenza vaccines, Kim Deti, Wyoming Department of Health (WDH) spokeswoman told Cowboy State Daily in a Thursday email. Our rates for most other vaccinations such as for polio and the measles are much higher.

Deti said vaccines help prevent many serious illnesses, and WDH will keep encouraging Wyoming residents to follow its vaccine recommendations. She said influenza vaccines have increased in availability in recent years.

Deti noted that the data is based on two nationally conducted surveys, and said the states low population and a possible low number of participants could have affected the data.

Nope, Never

Wyoming anti-vaccine-mandate lawmaker Sen. Anthony Bouchard, R-Cheyenne, told Cowboy State Daily hes not surprised Wyomings flu vaccination rates are so low. He said it amounts to Wyomingites mistrust toward the shots.

He also pointed to Wyomingites growing suspicion in the wake of the COVID-19 vaccine rollout, an oft-politicized event accompanied by federal and tribal government vaccine mandates and ultimatums.

Wyomings flu vaccine uptake exceeded half the population (51.45%) just as COVID-19 was starting, in the 2019-2020 flu season.

But amid the 2021 COVID-19 vaccine rollout, the states figures dipped back down to 43.9%, then plunged to 40% in the 2021-2022 flu season.

Bouchard said he has never taken the flu vaccine: Nope, never.

He also pointed to the shots occasional side effects.

For Example...

Wyoming people reported 13 medical incidents stemming from seasonal flu vaccines administered in the state in 2023 and 2024, to the CDCs voluntary reporting database the Vaccine Adverse Event Reporting System.

For example:

One patient had a sore arm months after vaccination, at the injection site, according to VAERS data. A mother reportedly submitted data about her childs full body shaking and leg twitch for four days following the childs Feb. 19, 2024 flu vaccination. The child was seen in the emergency room on Feb. 26, the database says.

Another mother reported a childs arm was swollen and too painful to move, but five-to-six days later, the arm was back to normal.

One patient was diagnosed with palsy after vaccination in December, 2023.

Another simply called to report that he tested positive for flu on Nov. 1, 2023.

One patient whose arm became infected after vaccination was adamant that her medical provider understand the vaccine was the culprit.

I informed her that this is a risk of a vaccination because bacteria can get under the skin whenever we break it, the medical staffer wrote in the VAERS report. I told patient I would report this event and she agreed that was alright.

One patient who had been on birth control, stomach acid and allergy medications when vaccinated became unable to form (a) sentence and developed slurred speech and nausea, reportedly. The report doesnt say how or if those symptoms resolved.

None of these events is listed as resulting in death, serious bodily injury or permanent disability.

Idaho Lowest

Wyomings flu vaccination rates among adults in the 2022-23 season were even lower than its all-age average, at 38.2%.

Idaho is the only state lower for adult flu vaccinations, at 34%. Idaho also had the lowest rate for kids flu vaccinations at 39.95%.

Next came Mississippi, in which kids received flu vaccinations at a 40.5% rate; then Nevada (41.6% kids flu vaccination rate) and Oklahoma (42.75%).

Wyoming was the fifth-lowest in the kids category, at 42.95%.

Massachusetts Highest

Massachusetts had the highest all-age vaccination rate at 68.85% - with 62.4% of adults vaccinated for flu and 75.3% of kids.

Next came Rhode Island, as 68.35% (60.7% for kids and 76% for adults) and Washington, D.C., at 68.3% (59.9% for adults and 76.7% for kids).

Same For COVID Shots

Wyoming shows even more hesitancy toward COVID-19 vaccines, ranking lowest in percentage of people who have had at least one COVID-19 vaccination dose, according to aUSAFacts.org vaccination tracker.

That figure is 59.8%, for Wyoming, as of April 26, 2024, the tracker says, adding that 81% of the U.S. population has received at least one dose.

Vermont, D.C., Massachusetts, Rhode Island and Connecticut all have greater than a 95% partial-complete-or-boosted vaccination rate, the tracker reports.

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Wyoming 5th Lowest In The Country For Flu Vax Rates - Cowboy State Daily

Is it possible to develop an effective, long lasting flu vaccine? andreswd/Getty Images This article originally appeared on Medical News Today

Influenza viruses cause billions of flu infections and thousands of deaths across the globe each year.

Developing an effective, long-term flu vaccine is challenging because of viral mutations. Researchers are interested in what strategies they can use to get around this problem.

Results from a recent study suggest that targeting multiple areas of the virus proteins may be the key to creating a flu vaccine that offers long-term immunity, specifically focusing on an area that experiences less mutation.

Developing a long lasting flu vaccine could be highly beneficial for the health of society, and research is getting closer to this goal.

Astudypublished inScience Translational Medicinefound that developing a vaccine that additionally targets an area of the hemagglutinin (HA) glycoprotein that experiences less mutation may be how we reach long-term flu vaccination options.

Researchers tested their vaccine in mice and ferrets and found it offered better protection than conventional vaccination. While more research is required, this successful test directs how to proceed with creating a long-term flu vaccine.

The flu is a common infection, affectingbillions of peopleeach year. The World Health Organization also estimates that the flu is responsible for 3-5 million cases of severe illness and 290,000 to 650,000 respiratory deaths yearly. Certain people are more at risk for severe illness or complications from the flu, including children under five and older adults.

Influenza viruses cause the flu, and these viruses change. Currently, the strategy for protection from the flu is the use of annual flu vaccines. Expertscreate these vaccinesbased on what influenza viruses they believe will be most common during flu season.

Changes in influenza virusesin influenza viruses are part of the challenge of creating a long-term vaccine. These changes often occur in the viruss surface proteins, like hemagglutinin (HA).

Non-study authorYoshua Quinones, MD, board certified internist with Medical Offices of Manhattan, noted the following to Medical News Today:

The difficulties with flu vaccines include needing to update them every year because the flu virus changes, certain parts of the virus making the vaccine less effective, and not being able to protect against all types of the flu virus. Its also hard to make sure everyone can get the vaccine. But getting the flu shot can help reduce how many people get sick, help protect those who cant get the shot, and maybe one day there will be a vaccine that works for all types of the flu. Making the immune system respond better to the flu shot could also help protect against more types of the flu.

The researchers of the current study note that annual flu vaccines help create antibodies that target specific areas of HA globular head. However, this region often experiences frequent mutation.

Thus, if they could figure out a way to target an area of the HA that doesnt change as much, the stalk, they may be able to create a vaccine that could protect against many flu strains. However, while this has been tried in the past, it has not been effective in also eliciting an effective response in the head region.

Thus, researchers wanted to create a vaccine that could produce head and stalk-directed antibodies to offer long-term immunity against multiple flu strains. Ultimately, they made an HA antigenic mixturebased vaccine. This vaccine contained a mixture of HA proteins with a conserved stalk region and various mutations at a key site in the head.

Researchers in this study tested the vaccines effectiveness on mice and ferrets. They compared the response to conventional vaccine approaches.

They found that their vaccine elicited a better antibody response than the control vaccine option. The vaccine even offered protection when mice were exposed to lethal viral doses.It also offered protection against multiple H1 viral strains.

However, this newly developed vaccine appears most effective after receiving an initial prime dose and a booster rather than just a single dose.

Non-study authorLinda Yancey, MD, Infectious Disease Specialist, Memorial Hermann Health System in Houston, commented with her thoughts on the study to MNT:

This is a nice step in the direction of a universal flu vaccine. Producing one has been the goal of researchers for years. It has proven to be a complex and difficult task, so it is nice to see solid progress being made towards it. At this time scientists are still working on developing the building blocks of a vaccine. We probably wont see any changes in clinical practice based on this for a few years. But every step in the right direction brings that universal vaccine a little closer.

This study has limitations, mainly because animal testing differs from testing something in people. These animals had also not experienced any previous flu vaccine or flu exposure, which could have affected the observed results. Researchers note that most people have some pre-existing immunity to influenza, which could minimize or influence the response to this type of vaccine. The study also only looked at one H1 HA, so its unclear how the approach would impact other HAs. In addition, not all animal experiments were conducted in a blinded manner.

Researchers also acknowledge that further study is required to understand more of the underlying mechanisms and confirm why they observed the response they did. They acknowledge that the protection from infection may not always be correlated with decreasing classical antigenic site-directed responses.

Even if this potential vaccine is developed, experts, government agencies, and health professionals will need to address distribution and acceptance. Non-study authorDavid Cutler, MD, board certified family medicine physician at Providence Saint Johns Health Center in Santa Monica, CA, noted the following:

While safety and effectiveness are the major concerns, vaccine uptake is also an important issue to consider. Presently, only about 50% of adults receive a flu vaccine. Any improvement in effectiveness could be offset be reluctance to receive a new vaccine. It is the role of our public health agencies to convince people that the benefits of approved vaccines greatly exceed their risks. So, while scientists may develop new, improved vaccines the benefit to society may not be realized if the vaccines do not get administered.

However, the research sets up the potential development of a long-term flu vaccine. This could make it easier to maximize the vaccines impact and ultimately minimize the detrimental health effects of the flu.

Quinones was hopeful about the results and noted the following:

The new flu vaccine might work better than the old ones. If it works in people like it did in animals, it could mean fewer people getting sick from the flu each year. It might also lead to a vaccine that works for all types of the flu, which would be a big deal for keeping people healthy.

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Is a flu vaccine with long-term effectiveness on the horizon? - AOL

There are H5 vaccines out there, and there are some stockpiled in some high-income countries, said Dr Nicole Lurie, executive director for preparedness and response at the Coalition for Epidemic Preparedness Innovations (Cepi).

[But] a lot of things have been frozen for a pretty long time now and are quite old. I think we all hope that they will be fine, but we dont necessarily know.

Even the optimists point out that even if the stockpiled vaccines do work, existing supplies would barely be enough to cover healthcare workers.

Dr Richard Webby, director of the World Health Organization (WHO) Collaborating Centre for Studies on the Ecology of Influenza in the US, said we were better prepared for H5N1 than other viruses but said it would take a while to gear up.

Are we going to have enough vaccine to meet demands in the first few weeks of such an outbreak? The answer to that is clearly no, he said.

There is also the important question of whether the vaccines we have today are a good match for the new strains of H5N1 circulating.

The limited data available is not convincing. Only two of the four vaccines currently stockpiled are thought to be a good match for the current H5N1 stain, and even they may not work especially well.

Former FDA official Dr Luciana Borio told the World Vaccine Congress in Washington last month that the efficacy is potentially as low as 45 per cent, based on studies looking at antibody responses.

A similar problem happened when H1N1 swine flu broke out in 2008/9. Although vaccine stockpiles covered the strain circulating, a study later found it protected young people but had no discernible impact on older adults.

In other words: theres no guarantee a shot would live up to expectations or arrive in time.

With swine flu, the vaccine rollout began in earnest only after the most significant wave of infections had peaked. Thankfully, the virus turned out to be very mild.

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There might be stockpiles, but making a bird flu vaccine won't be quick or easy - The Telegraph

New South Wales health authorities are urging people to protect themselves against influenza, with the latest data indicating an early flu season is imminent.

Respiratory surveillance reports published by NSW Health indicate approximately 5,160 people across the state were diagnosed with influenza in April, an increase of more than 20 per cent from the same time last year.

Nearly 200 people have presented to hospital emergency departments with influenza-like illnesses every week in that time.

The Australian Influenza Surveillance Report shows influenza cases typically rise in May, leading to a peak circulation of the disease in July and August.

This year, NSW is experiencing a flu season more akin to what it experienced in 2019, when cases rose in April and peaked in June and July.

However, Associate Professor of Health at the University of NSW Holly Seale said an early flu season itself was not a cause for deep concern.

"It has peaks and troughs that have changed over the years," she said.

"Prior to the COVID-19 pandemic, it was more common to have late seasons in which peak influenza activity was occurring in September and October as the weather was getting warmer.

"This year, we're seeing a repeat in trends from what the northern hemisphere has encountered in terms of having an earlier flu season."

While changes to the timing of flu season are not uncommon, the early start to the season in 2024 has seen politicians and health professionals encourage people to take earlier action than usual to protect themselves.

NSW Minister for Health Ryan Park has been advising the community to get vaccinated as soon as possible, emphasising that the flu was far more serious than the common cold that people often mistake it for.

"This is not an ordinary cold and flu," he said.

"We know that it can lead to hospitalisations and serious impacts on people's health, and unfortunately, this year, we're already seeing significant increases in cases compared to the same time last year."

The government's respiratory surveillance reports show 1,458 children under the age of 10 were diagnosed with influenza in April, making up 28 per cent of all diagnoses.

Chair of the Immunisation Coalition Rod Pearce told ABC Radio National that children under the age of five were especially susceptible to influenza, having not been exposed to the disease throughout the COVID-19 pandemic.

"A three- or four-year-old child hasn't seen influenza through natural protection," Dr Pearce said.

"They're being hit with a disease the body's not yet seen."

According to the Australian Immunisation Register, only one in 14 children under the age of five are currently vaccinated against influenza in NSW, despite vaccines being available for all children over six months old.

Dr Seale said the most effective way someone can protect themselves against infection is by getting a vaccination, but misconceptions about influenza and the effectiveness of the vaccine are complicating this process for many.

Vaccinations help the body develop immunity to influenza using deactivated or weakened versions of the virus.

Antigens in the vaccine stimulate the immune system to recognise the virus and develop antibodies that fight infection.

This process takes approximately two weeks to take effect, during which Dr Seale said the vaccinated person is still susceptible to contracting influenza.

"You may end up getting the flu in that period when you're still waiting for your vaccine to kick in," Dr Seale said.

"That's when you hear people say the flu vaccine didn't work for them or that they had the worst case of flu the year that they got vaccinated."

Because of this, she says there is no ideal time to wait for vaccination, and that members of the community are best protected by vaccinating themselves as early as they are able.

Beliefs about the severity of influenza and alternative forms of treatment also complicate the matter.

Dr Seale said a high number of people are attempting to obtain antibiotics as treatment, despite evidence that they don't remedy symptoms of influenza.

The frustration of having to get vaccinated annually also disincentives people from protecting themselves against infection, she said.

The Australian Immunisation Register indicates that, as of April 28, only one in 10 people had been vaccinated against influenza.

The beginning of the influenza season this year coincides with a breakthrough discovery that could change the need for an annual vaccination against influenza.

Currently, as new strains of influenza develop every year, new vaccines must be rolled out to match the risk posed by the virus, making an annual flu jab necessary.

Different vaccines are available for people of different ages and with different health conditions.

Two weeks ago,scientists from the Peter Doherty Institute for Infection and Immunity in Melbourne discovered nine viral fragments of influenza that have been present in all historical strains of the virus.

These nine fragments are key to activating killer T-cells, a type of cytotoxic T cell in the body that is crucial to fighting influenza.

It is their hope that this discovery can be used to develop a universal influenza vaccine.

Posted10h ago10 hours agoSun 12 May 2024 at 7:47pm, updated8h ago8 hours agoSun 12 May 2024 at 9:39pm

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NSW's flu season is on track to arrive early. But who's at risk, and should we be concerned? - ABC News

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Posted: May 11, 2024

This story is part of CBC Health's Second Opinion, a weeklyanalysis of health and medical science news emailed to subscribers on Saturday mornings. If you haven't subscribed yet, you can do that by clicking here .

While there's no sign a dangerous form of bird flu has gained the ability to transmit between humans, the steady spread of the virus to new species of mammals most recently, dairy cattle throughout the U.S. suggests H5N1 is closer to us than ever before.

Officials are quick to note that without a few key evolutionary leaps, this pathogen won't spark a human health crisis. Dr. Michael Ryan, executive director of the World Health Organization's (WHO) health emergencies program, said as much during remarks on Wednesday.

"Nobody is suggesting that H5N1 is the new, next pandemic. I don't believe anybody can predict that," he said.

"But it's certainly concerning when a virus like this begins to infect multiple mammalian species, which means the virus that is adapting to [animals] that are more like us than birds, and therefore there's a higher level of alert."

Given the risks, WHO officials say that behind-the-scenes processes are in place, including agreements with drugmakers, to produce "billions" of H5N1 vaccine doses within the first year of a pandemic,should this virus gain the ability to spread between humans.

Other scientists warn that's easier said than done, given the complexities involved in manufacturing and distributing a new set of vaccines.

"Even though we have a massive global infrastructure capable of producing flu vaccines we will never be ready for a pandemic," McMaster University immunologist and vaccine researcher Matthew Miller said.

The spread of H5N1 throughout cattle herds across at least nine U.S. states is the latest curve ball froma virus that's proven adept at latching onto new hosts, raising questions over whether the world is prepared for more surprises.

U.S. farm workers in multiple states may now be in regular contact with infected cattle, as officials are monitoring at least 260 people for symptoms amid growing concerns that limited testing could be masking the true scale of the outbreak, both in cows and in humans. ( On Friday,the U.S. federal government did announce major funding to expand testing efforts, which includes paying up to $75 to farm workers who take part in studies.)

Early research, which hasn't yet been peer reviewed, also suggests the cells in cows' mammary glands can be infected by both avian and human influenza viruses. Scientists warn that scenario may provide a viral mixing vessel, fuelling the development of adaptations that hike the risk to human hosts.

None of these signals are a smoking gun that H5N1 will evolve to sustain transmission in a human population. Yet the possibility is always present, even if the virus's next moves remain somewhat unpredictable.

In response to questions from CBC News, WHO officials stressed that there are two H5N1 vaccine candidates already available that could be used in a pandemic scenario, along with options targeting other forms of avian influenza.

There's no need to begin manufacturing these shots now, the WHO's Ryan said. Scaling up to produce pandemic vaccines would also mean a trade-off where manufacturers are forced to hit pause on annual shots for other strains.

"You can't just press the button and begin producing pandemic [H5N1] vaccines," Ryan said. "You have to stop producing your seasonal vaccine, and all of you out there know how life-saving that vaccine is... so this requires very careful consideration."

Some countries have H5N1 vaccines already on hand, including the U.S., which has two types of shots that are well matched with the currently circulating strain in dairy cattle. Both candidate vaccines are available to manufacturers, according to the U.S. Centers for Disease Control and Prevention (CDC).

The CDC is also testing human blood samples from people previously vaccinated with H5N1-based vaccines to see how it reacts to virus samples taken from the recent human case in Texas. So far, their research suggests vaccination "will offer good cross-protection against cattle outbreak viruses."

Here in Canada where no cases have been reported yet in dairy cattle federal officials say they're not acquiring a fixed stockpile of shots, since any changes in the virus that would allow it to transmit between humans could "fundamentally influence the antigen required for a human vaccine."

Currently, there are two H5N1 vaccines authorized in Canada, based on strains from previous outbreaks. The Public Health Agency of Canada (PHAC) also has agreementswith several vaccine manufacturers, both domestic and international, the agency noted in a statement.

A GlaskoSmithKline facility in Quebec, for instance, produces seasonal flu shots each year, and one of its subsidiaries also developed one of the country's two authorized H5N1 shots. That vaccine is approved for use in children six months of age and older, and nospecial safety concerns were identified in clinical studies, according to Health Canada's regulatory decision on its use.

"Under these contracts, the vaccine production process would be triggered by a WHO pandemic influenza declaration or a decision by the Government of Canada that influenza vaccine manufacturers switch from seasonal to pandemic influenza vaccine production," PHAC's statement continued.

While those preparations paint a rosy picture of countries' ability to rapidly respond, Miller, from McMaster, stressesthat the process from testing to manufacturing to shipping is complex and lengthy, even in a best-case scenario.

He pointed to the COVID-19 pandemic, during which drugmakers raced to develop brand-new vaccines for a never-before-seen threat. The pace of those trials was astounding; shots began rolling out in some countries as early as December2020.

Yet, a year later, infections and deaths soared to new heights thanks to the highly contagious Omicron variant, even as vaccination campaigns kept rolling out through the population.

It wasn't because the shots weren't effective, Miller added, "but because the virus evolves, and that causes problems."

The explosive spread of H5N1 among dairy cattle in mere months also points to how fast this kind of situation can change. Miller agreesthat while it's a simple switch to start producing pandemic-based vaccines, manufacturing and distributing eight billion global doses can't possibly happen overnight.

And the challenges don't stop there. Jillian Kohler, a professor at the University of Toronto whose research focuses on global access to essential medicines, says nationalism and rampant misinformation would surely complicate vaccination efforts in the event of another pandemic.

"There are a lot of variables that could easily derail getting vaccines out. And it's not just getting vaccines out, it's getting people to accept the vaccines."

Vaccine equity, she says, also remains a major issue. During the COVID pandemic, wealthier countries Canada included had an oversupply of vaccines, while others went without. And in 2022, when mpox spread worldwide for the first time, vaccines rolled out in many higher-income countries, yet the hardest-hit regions of Africa didn't have any shots.

Without learning lessons from those prior crises, Kohler warned much of the world could be sidelined during vaccination campaigns if H5N1 ever makes its human-to-human leap.

She also questioned the role of private industry in preventing pandemics, including decisions over which shots and customers to prioritize at any given time.

"Why are we relying on drugmakers to make the policy decisions that should be in the hands of government?" Kohler asked.

"To put trust in the industry to make sure we get the vaccines out in a timely fashion is repeating a mistake that we had before."

Lauren Pelley Senior Health & Medical Reporter

Lauren Pelley covers health and medical science for CBC News, including the global spread of infectious diseases, Canadian health policy, pandemic preparedness, and the crucial intersection between human health and climate change. Two-time RNAO Media Award winner for in-depth health reporting in 2020 and 2022. Contact her at: lauren.pelley@cbc.ca

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Bird flu vaccine candidates already exist. But if H5N1 sparks a pandemic, making enough doses won't be easy - CBC.ca

Key Takeaways

In the current bird flu outbreak, the virus has been detected in dairy cattle herds across nine states and infected at least one person. CDC health officials say two existing H5N1 candidate vaccine viruses are available for manufacturers if the bird flu virus spreads more easily to humans.

The CDC has developed a candidate vaccine virus nearly identical to the protein in the current strain. If needed, this could be used to produce a vaccine for humans. According to a preliminary analysis, the vaccine is expected to offer good protection against the current H5N1 strain.

Both vaccine candidates are in the governments stockpile in limited quantities, and hundreds of thousands of prefilled syringes and vials are ready to ship.

Theres no word yet from health officials on the potential risks and side effects of the bird flu vaccine.

As of now, theres no evidence that bird flu is spreading between people. But if we started seeing transmission to humans, a vaccine could help, said William Schaffner, MD,an infectious disease specialist and professor at the Vanderbilt University School of Medicine.

Having a vaccine ready to go ensures that public health officials are prepared just in case its needed, Schaffner added.

A blueprint is on the shelf, ready to put into the manufacturers hands for them to start making doses if necessaryall that preliminary work has been done, saidJohn Sellick, DO, an infectious disease expert and professor of medicine at the University at Buffalo SUNY.

Sellick added that a vaccine isnt usually produced before theres a major health issue, but its part of pandemic preparedness and thinking ahead.

If the virus develops the capacity to spread readily from person to person, the general consensus is that were in for another pandemic, Sellick said. Vaccination is the foundation of the response, putting it into as many arms as possible to prevent hospitalizations and deaths.

The biggest concern about bird flu now is in dairy farm workers, who are at the highest risk of exposure. But you could also make the argument that people who work on poultry farms could potentially get into trouble as well, he said.

Sellick added that people who work in the manufacturing of dairy and poultry products may need a vaccine, too.

However, a lot of unknowns remain with the development of bird flu and a vaccine. This is like COVID all over again, Sellick said. The virus will tell us whats happening.

Sellick noted that bird flu hasnt been able to spread readily in humans. Theres nothing we can do except to continue to do surveillance and be ready, just in case, he said.

Theres no bird flu vaccine right now. However, two candidate vaccine viruses are readily available to be made into vaccines if the virus spreads more easily to and between people.

By Korin Miller Miller is a health and lifestyle journalist with a master's degree in online journalism. Her work appears in The Washington Post, Prevention, SELF, Women's Health, and more.

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Is There a Vaccine for Bird Flu? - Verywell Health

French pharmaceutical giant Sanofi and struggling US rival Novavax announced Friday an alliance to sell a Covid vaccine and develop another that combines with a flu shot.

Under a licensing deal worth up to $1.2 billion, the companies will co-commercialise Novavax's Covid-19 vaccine worldwide, except in some countries including India, Japan and South Korea, where the US firm already has partnership agreements.

Novavax will receive an upfront payment of $500 million and up to $700 million if it reachers certain milestones while Sanofi will take a five percent stake in the US company.

Sanofi will book sales of Novavax's protein-based Covid-19 vaccine from 2025.

The French group will be able to develop a combination flu-Covid vaccine using its own flu shots with the US company's Covid jab.

The announcement comes as pharmaceutical companies have reported drops in sales for Covid vaccines.

Novavax, which is highly dependent on its Covid vaccine, raised doubts last year about its ability to continue its business.

The Maryland-based firm was an early frontrunner in the global vaccine race, but fell behind after being hit by manufacturing and regulatory delays.

For Sanofi, the deal is a chance to develop a combination flu-Covid jab.

"With flu and Covid-19 hospital admission rates now closely mirroring each other, we have an opportunity to develop non-mRNA flu-Covid-19 combination vaccines offering patients both enhanced convenience and protection against two serious respiratory viruses," said Jean-Francois Toussaint, Sanofi's global head of vaccine research and development.

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French, US drug firms team up for Covid-flu shot - The Bryan Times