Category: Vaccine

Vaccines are crucial in preventing diseases, saving lives, reducing disability and lightening the burden on the nations healthcare system. Therefore, the government has a compelling interest in combating vaccine misinformation to prevent the promulgation of factually incorrect information that causes deaths.

That is the argument presented in anamicus brieffiled with the Supreme Court inMurthy v. Missouriby several prominent medical organizations, including the American Medical Association, American Academy of Pediatrics, American Academy of Family Physicians, American College of Physicians and American Geriatrics Society.

Vaccination is, after all, a pillar of disease prevention, and the CDC estimates that between 2021 and 2030,more than 50 million deaths will have been preventedworldwidethrough immunization.

The brief highlights the commitment to public health of the organizations, whose members are actively involved in the delivery of patient care and the development of disease-prevention strategies. The organizations represent hundreds of thousands of medical professionals who have witnessed the lifesaving effect of vaccination and recognize the destructive potential of misinformation.

The crux of the issue inMurthy v. Missouriis whether the governments challenged conduct transformed private social media companies content-moderation decisions into state action and violated respondents First Amendment rights. The governments stance is that its communication with social media companies was non-coercive and intended to address online misinformation hazards by identifying content violating the companies policies.

The amicus brief focuses narrowly on the effect of misinformation on COVID-19 vaccination, emphasizing how false information that encourages vaccine rejection hampers the vaccines ability to control disease spread and save lives. It posits that combatting vaccine misinformation is a legitimate government effort to prevent factually incorrect statements from jeopardizing lives.

The brief cites studies showing the significant effect of COVID-19 vaccinations on preventing deaths and reducing mortality among hospitalized patients an estimated 235,000 COVID-associated deaths in the United States prevented in vaccinated adults just between Dec. 1, 2020, and Sept. 30, 2021, and reduced mortality by as much as 40 percent among hospitalized patients.

It also underscores the stress that under-vaccination places on medical resources and the worse health outcomes that result from increased strain on hospitals and health professionals. (And, thereby, vaccines reduce government expenditures on preventable diseases.)

The brief also points out that outcomes are worse when healthcare providers time and resources are diverted from clinical care to combating vaccine misinformation.

It also debunks some of the insupportable claims made by anti-vaxxers, such as that COVID vaccines magnetize individuals, implant them with tracking microchips, or make them infertile. It emphasizes that although such claims lack credible evidence, they and other inaccurate assertions have contributed to declining vaccination rates, leading to the resurgence of infectious diseases that were nearing eradication and increased healthcare expenditures.

Measles is a case in point. The most infectious vaccine-preventablediseasecaused by viruses, it illustrates what can happen when the public becomes blas about vaccination. Before vaccines were available, every year in the United States, there were 3 million to 4 million cases of measles,48,000 hospitalizations, and 400 to 500 deaths. Measles was declaredeliminatedin the United States in 2000 after there were no casesfor more than a year due to an aggressive vaccination campaign.However, the CDCissued an emergency warningon January 25, telling the public to remain vigilant after 23 cases were confirmed in eight states between December 1, 2023, and January 23, 2024.

What explains that? About 92 percent of U.S.children have been vaccinated against measles, mumps and rubella (by the MMR vaccine) beforeage 2 below the federal target of 95 percent, which would restore herd immunity.

The physicians organizations amicus brief reinforces the safety of FDA-approved vaccines and their lifesaving role. It argues that misinformation about vaccines reduces immunization uptake, hindering their effectiveness as part of a well-functioning public health system.

The legal timeline of the case involves a District Court ruling in July 2023 that limited the administrations communication with social media companies. The 5th U.S. Circuit Court of Appeals partially upheld this ruling, and in October, the Supreme Court temporarily maintained the modified District Court order until a potential ruling in June.

I join with my physician colleagues in urging the Supreme Court to rule against the spread of toxic misinformation and in favor of promoting public health.

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Does the Government Have a Role in Combating Vaccine Misinformation? Inside Sources - Prescott eNews

(Precision Vaccinations News)

Following detecting a new emergence of variant poliovirus type 2in six wastewater samplesin the Port Sudan locality, Red Sea State, the Republic of Sudan recently announced polio vaccinations will beginin April 2024.

Sudan's Federal Ministry of Health (FMOH) announced on March 11, 2024, that this new detection comes 14 months after Sudan declared an outbreak of variant poliovirus type 2 from an emergence of the virus.

While no vaccination campaign has occurred since April 2023, surveillance for poliovirus in children focused on the most common indicator of a polio infection,acute flaccid paralysis.

While no child has been paralyzed due to the new emergence, detecting poliovirus in wastewater samples puts children across the country at high risk.

"The new detection has only redoubled our commitment to safeguarding our children's future. In collaboration with partners, we are mobilizing an outbreak response campaign to ensure that every child under five years in inaccessible areas receives the polio vaccine, and special plans will follow for hard-to-reach areas," said Dr. Dalya Eltayeb, Director-General of Primary Health Care in Sudan's FMOH, in a media statement.

In October 2022, the FMOH distributed 10.3million doses of oral polio vaccine(OPV) in Sudan.

This year, Sudan is deploying the WHO-authorized type 2 novel oral polio (nOPV2) vaccine, which has been used 1 billion times by over 30 countries.

nOPV2 is reported to be more genetically stable than OPVs, with a lower risk of reversion to neurovirulence and less likely to mutate and cause paralysis.

While the nOPV2 vaccine is not approved in the United States, the government's vaccine committee considered its use under specific conditions during its February 28, 2024 meeting.

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New Polio Vaccine Launches in the Republic of Sudan - Precision Vaccinations

To the editor: Childhood vaccine delay and refusal is a critical threat to the health of our communities. As a pediatrician and vaccine delivery researcher, I have similar experiences with vaccine-hesitant parents to those presented in the article. (More parents are delaying their kids vaccines, and its alarming pediatricians, March 11)

However, before losing hope, it is essential to remember that most parents in the U.S. continue to recognize the value of vaccines and vaccinate their children.

In a recent New England Journal of Medicine piece, I argue along with my co-authors that incorrectly assuming parental vaccine hesitancy is the norm can be harmful. This false narrative can negatively influence vaccine policy, degrade healthcare providers confidence in their ability to influence vaccination behavior, and contribute to parental self-doubt about the value of vaccines.

Efforts to improve parental vaccine confidence should emphasize the overwhelming majority of parents who choose to vaccinate their children according to schedules recommended by the American Academy of Pediatrics and the Centers for Disease Control and Prevention.

David Higgins, M.D., Centennial, Colo.

..

To the editor: I was born in 1946, before most of the vaccines we have today were invented. My sister and I had mumps and measles. She also had polio.

We were very sick with high fevers. Besides my sister, two neighbor kids had polio. I remember my sister screaming from the hot baths every day and my mother taking her to physical therapy. Cab drivers volunteered to take these sick children to their treatment. Ive seen kids crippled by polio.

There was no question when the Salk vaccine came out: My mother got it for us. My four girls and their children all got their shots as soon as possible.

If you do not vaccinate your children, there is an increased likelihood they will become very sick or even die. Your child could also infect others or cause the death of other kids with compromised immunity. Do you really want to be the one who kills these children?

Cheryl Younger, Los Angeles

..

To the editor: It is not complicated. Whenever a parent places a child in preschool, daycare or any environment requiring that child to interact with others, that parent must present a certificate of vaccination.

Parents these days need to work. Children these days need to be vaccinated. Full stop.

Joan Walston, Santa Monica

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Letters to the Editor: Why we need to stop normalizing vaccine hesitancy in parents - Los Angeles Times

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Fine tuning of CpG spatial distribution with DNA origami for improved cancer vaccination - Nature.com

A targeted quality improvement program was associated with increased rates of healthcare providers recommending human papillomavirus (HPV) vaccination initiation to eligible children at a Utah-based family medicine health care system. The methodology may be applicable to other practices that which practice with nurse practitioners (NPs) serving a more involved role in HPV vaccine initiation.

A new poster presented at the National Association of Pediatric Nurse Practitioners (NAPNAP) 2024 National Conference on Pediatric Health Care showed a multifaceted education program targeted for each of healthcare providers and medical assistants resulted in increased rates of HPV vaccination upwards of 60% across 3 pediatric clinics over just 1 year.

A team of investigators from the BYU Family Nurse Practitioner Program, led by Michael S. Robinson, DNP, FNP-C, sought to evaluate the rate of HPV vaccination among pediatric patients aged 9 10 years old following the application of educational interventions across a trio of Salt Lake City-based pediatric clinics. The educational intervention included a pair of 15 20-minute educational presentations, targeted toward healthcare providers and medical assistants, respectively.

The healthcare provider education intervention entailed evidence for delivering the first HPV vaccination to children at age 9 10. It also provided evidence-based responses to common questions raised around HPV vaccination.

The medical assistant education intervention additionally addressed the same evidence, as well as guidance on identifying eligible pediatric patients for vaccination and how to communicate said eligibility to healthcare providers.

The HPV vaccine initiation recommendation was updated to age 9 years old by the American Cancer Society (ACS) in 2020. Whats more, the Healthy People 2030 national strategy has set a goal to increase HPV vaccination rates from 48% to 80%. Despite these initiatives, HPV vaccination has increased by only 10% in the last 3 years.

As Robinson and colleagues noted, an optimal approach to applying better practices may be multifactorial.

Although HPV vaccine is safe and effective, vaccine uptake can improve, they wrote. Nurse Practitioners must identify and implement strategies to improve HPV vaccination.

Investigators assessed the total count of HVP 1 and 2 vaccine doses initiated in children based on age groups of 9 10 years old, 11 12 years old, and 13 years old, in 2022 (pre-education intervention) and 2023 (post-education).

Among children aged 9 10 years old, they observed a 57.3% (n = 140) increase in total HPV 1 vaccine doses provided in 2023 versus 2022. Among children aged 11 12 years old, the increase in HPV 1 vaccine doses was 41.7% (n = 485) and the increase in HPV 2 doses was 54.6% (n = 131) following the educational intervention.

Though the rate of annual HPV 1 vaccine doses in children aged 13 years old actually decreased by 5% in 2023, the team did observe an increase of HPV vaccine regimen conclusion in this age group (n = 105 [18.2%]).

In total, the educational intervention strategy was associated with 811 more HPV vaccine doses administered in 2023 versus 2022 (24.5%). Investigators additionally observed reports of increased confidence among both healthcare providers and medical assistants in initiating the HPV vaccine dose in the ACS-recommended age group following the educational intervention.

Implementing clinic-wide educational interventions to improve HPV vaccination rates among 9-10-year-olds is successful, Robinson and colleagues wrote. To increase HPV vaccination rates among 9-10-year-olds, multiple strategies should be used.

References

Robinson MS, Petersen A, Warhurst JC, Macintosh CI, et al. Increasing HPV Vaccination Rates in Your Clinic. Paper presented at: NAPNAP National Conference on Pediatric Health Care. March 13 - 16, 2024. Denver, CO.

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Educational Intervention Could Prompt More Pediatric HPV Vaccine Initiation - Contemporary Pediatrics

The following essay is reprinted with permission from The Conversation, an online publication covering the latest research.

Why would a mother reject safe, potentially lifesaving vaccines for her child?

Popular writing on vaccine skepticism often denigrates white and middle-class mothers who reject some or all recommended vaccines as hysterical, misinformed, zealous or ignorant. Mainstream media and medical providers increasingly dismiss vaccine refusal as a hallmark of American fringe ideology, far-right radicalization or anti-intellectualism.

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But vaccine skepticism, and the broader medical mistrust and far-reaching anxieties it reflects, is not just a fringe position.

Pediatric vaccination rates had already fallen sharply before the COVID-19 pandemic, ushering in the return of measles, mumps and chickenpox to the U.S. in 2019. Four years after the pandemics onset, a growing number of Americans doubt the safety, efficacy and necessity of routine vaccines. Childhood vaccination rates have declined substantially across the U.S., which public health officials attribute to a spillover effect from pandemic-related vaccine skepticism and blame for the recent measles outbreak. Almost half of American mothers rated the risk of side effects from the MMR vaccine as medium or high in a 2023 survey by Pew Research.

Recommended vaccines go through rigorous testing and evaluation, and the most infamous charges of vaccine-induced injury have been thoroughly debunked. How do so many mothers primary caregivers and health care decision-makers for their families become wary of U.S. health care and one of its most proven preventive technologies?

Im a cultural anthropologist who studies the ways feelings and beliefs circulate in American society. To investigate whats behind mothers vaccine skepticism, I interviewed vaccine-skeptical mothers about their perceptions of existing and novel vaccines. What they told me complicates sweeping and overly simplified portrayals of their misgivings by pointing to the U.S. health care system itself. The medical systems failures and harms against women gave rise to their pervasive vaccine skepticism and generalized medical mistrust.

I conducted this ethnographic research in Oregon from 2020 to 2021 with predominantly white mothers between the ages of 25 and 60. My findings reveal new insights about the origins of vaccine skepticism among this demographic. These women traced their distrust of vaccines, and of U.S. health care more generally, to ongoing and repeated instances of medical harm they experienced from childhood through childbirth.

As young girls in medical offices, they were touched without consent, yelled at, disbelieved or threatened. One mother, Susan, recalled her pediatrician abruptly lying her down and performing a rectal exam without her consent at the age of 12. Another mother, Luna, shared how a pediatrician once threatened to have her institutionalized when she voiced anxiety at a routine physical.

As women giving birth, they often felt managed, pressured or discounted. One mother, Meryl, told me, I felt like I was coerced under distress into Pitocin and induction during labor. Another mother, Hallie, shared, I really battled with my provider throughout the childbirth experience.

Together with the convoluted bureaucracy of for-profit health care, experiences of medical harm contributed to one million little touch points of information, in one mothers phrase, that underscored the untrustworthiness and harmful effects of U.S. health care writ large.

Many mothers I interviewed rejected the premise that public health entities such as the Centers for Disease Control and Prevention and the Food and Drug Administration had their childrens best interests at heart. Instead, they tied childhood vaccination and the more recent development of COVID-19 vaccines to a bloated pharmaceutical industry and for-profit health care model. As one mother explained, The FDA is not looking out for our health. Theyre looking out for their wealth.

After ongoing negative medical encounters, the women I interviewed lost trust not only in providers but the medical system. Frustrating experiences prompted them to do their own research in the name of bodily autonomy. Such research often included books, articles and podcasts deeply critical of vaccines, public health care and drug companies.

These materials, which have proliferated since 2020, cast light on past vaccine trials gone awry, broader histories of medical harm and abuse, the rapid growth of the recommended vaccine schedule in the late 20th century and the massive profits reaped from drug development and for-profit health care. They confirmed and hardened womens suspicions about U.S. health care.

The stories these women told me add nuance to existing academic research into vaccine skepticism. Most studies have considered vaccine skepticism among primarily white and middle-class parents to be an outgrowth of todays neoliberal parenting and intensive mothering. Researchers have theorized vaccine skepticism among white and well-off mothers to be an outcome of consumer health care and its emphasis on individual choice and risk reduction. Other researchers highlight vaccine skepticism as a collective identity that can provide mothers with a sense of belonging.

The perceptions mothers shared are far from isolated or fringe, and they are not unreasonable. Rather, they represent a growing population of Americans who hold the pervasive belief that U.S. health care harms more than it helps.

Data suggests that the number of Americans harmed in the course of treatment remains high, with incidents of medical error in the U.S. outnumbering those in peer countries, despite more money being spent per capita on health care. One 2023 study found that diagnostic error, one kind of medical error, accounted for 371,000 deaths and 424,000 permanent disabilities among Americans every year.

Studies reveal particularly high rates of medical error in the treatment of vulnerable communities, including women, people of color, disabled, poor, LGBTQ+ and gender-nonconforming individuals and the elderly. The number of U.S. women who have died because of pregnancy-related causes has increased substantially in recent years, with maternal death rates doubling between 1999 and 2019.

The prevalence of medical harm points to the relevance of philosopher Ivan Illichs manifesto against the disease of medical progress. In his 1982 book Medical Nemesis, he insisted that rather than being incidental, harm flows inevitably from the structure of institutionalized and for-profit health care itself. Illich wrote, The medical establishment has become a major threat to health, and has created its own epidemic of iatrogenic illness that is, illness caused by a physician or the health care system itself.

Four decades later, medical mistrust among Americans remains alarmingly high. Only 23% of Americans express high confidence in the medical system. The United States ranks 24th out of 29 peer high-income countries for the level of public trust in medical providers.

For people like the mothers I interviewed, who have experienced real or perceived harm at the hands of medical providers; have felt belittled, dismissed or disbelieved in a doctors office; or spent countless hours fighting to pay for, understand or use health benefits, skepticism and distrust are rational responses to lived experience. These attitudes do not emerge solely from ignorance, conspiracy thinking, far-right extremism or hysteria, but rather the historical and ongoing harms endemic to the U.S. health care system itself.

This article was originally published on The Conversation. Read the original article.

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Vaccine-resistant Mothers Blame Bad Experiences in Health Care - Scientific American

(Precision Vaccinations News)

With an estimated 11 to 20 million typhoid fever casesevery year and about 120,000 related deaths, global health leaders are aggressively improving access to new vaccines.

The World Health Organization (WHO) recently confirmed its recommendation to use three vaccines to control endemic and epidemic typhoid fever.

In late February 2024, SK bioscience and the International Vaccine Institute (IVI) announced that the SKYTyphoid typhoid conjugate vaccine had received prequalification (PQ) from the World Health Organization.

WHO PQ certifies a vaccine's safety, efficacy, and GMP by evaluating its manufacturing process, quality, and clinical trial results according to stringent standards.

SKYTyphoidutilizes the 'purified Vi polysaccharide-diphtheria toxoid conjugate' method, which conjugates diphtheria toxin protein (diphtheria toxoid), which acts as a carrier, to polysaccharide of typhoid bacteria, which acts as an antigen.

Adopting conjugation technology, the vaccine is safe for infants and young children aged six months to 2 years. It is expected to provide sufficient immune response and long-term protection with a single dose compared to existing oral live or polysaccharide typhoid vaccines.

SKYTyphoid initiallyobtained a licensure in Korea in 2022.

Dr. Sushant Sahastrabuddhe,Director of IVI's Typhoid program, said in a February 23, 204 press release, "The WHO licensure ofSKYTyphoid... will diversify and expand the supply of TVCs and help improve vaccine access in the endemic countries. With SK's commitment to makingthe vaccine for global public health at a competitive price, SKYTyphoidwill play an important role in typhoid prevention globally."

SK bioscience plans to start supplying the vaccine as soon as possible and expand global supply through public procurement markets including typhoid endemic countries.

Typhoid fever is transmitted by consuming raw or undercooked food or water contaminated with the feces of an infected person.

In 2024, there are significanttyphoid fever outbreaks in sub-Saharan Africa.

In March 2024, local media reported that Taiwan confirmedits first locally acquired typhoid fever case this year. Since 2019, Taiwan has accumulated 49 typhoid cases, 18 of which were domestic cases.

In the United States, about5,700 people gettyphoid fevereach year,and 620 of those people are hospitalized.

There are currently two typhoid fever vaccines available in the United States.

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Enhanced Typhoid Vaccine Receives WHO Qualification Precision Vaccinations News - Precision Vaccinations

(Precision Vaccinations News)

The United States government recentlyissued a strong warning regarding the ongoing measles outbreaks in 46 countries.

And the federal government is supporting Chicago's efforts to curb the spread of the highly infectious measles virus.

To clarify its vaccination recommendations, on March 13, 2024, the U.S. Centers for Disease Control and Prevention (CDC) updated its Level 1 Travel Health Advisory to ensure that all international travelers are fully protected against this vaccine-preventable disease.

Vaccination with a measles-containing vaccine is the best way to make sure that you are protected. Even young infantsshould receive one dose of the MMR vaccine, says the CDC.

If you are unsure if you or your travel companions are fully protected against measles, schedule an appointment to see your clinician or pharmacist at least six weeksbefore traveling so that you have enough time to get vaccinated.

However, some people should not get a measles-containing vaccine or should wait. If you don't think you can safely receive one, talk to your clinician and consider making alternative travel plans.

Individuals must take the necessary steps to safeguard their health and the health of others by following these guidelines, says the CDC.

As of March 16, 2024, measles vaccines are offered at community pharmacies in the U.S.

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When Should Travelers Get Their Measles Protection Precision Vaccinations News - Precision Vaccinations

Vaccines are the most cost-effective strategy to prevent and suppress global infections, such as viral pathogens.

Conventional vaccines are classified under three categories: live, attenuated or non-live. Conventional vaccines have shown utility in irradicating smallpox and slowing the spread of other diseases, such as polio, measles, mumps and rubella over past decades.1 However, producing these attenuated vaccines is complex and time-consuming; creating new vaccines is estimated to take 5-10 years and costs over $500 million, with additional costs associated with manufacturing and equipment.2

Pandemic-era vaccine manufacturing and beyond

The established methods of conventional vaccine production are no longer adequate to identify and produce new vaccines to ensure global protection.

Technology utilizing mRNA promises to change the current paradigm for vaccine development, as the platform allows the production of vaccine candidates in as little as a few weeks by altering just the viral RNA sequence.3,4

While the mRNA vaccine technology allowed the production of a vaccine against SARS-CoV-2 in just one year, global vaccination efforts were severely strained by the capacity to manufacture.

These bottlenecks were caused by a lack of manufacturing facilities, tech-transfer personnel as well as shortages in raw materials.5 It is now apparent that there is a need for more resilience and robustness to allow for rapid, safe and large-scale production of vaccines, especially in developing countries. The COVID-19 mRNA vaccine has sparked a movement to advance mRNA technology into other therapeutic avenues and to develop better manufacturing technology and practices.

Model-based assessment of the mRNA vaccine manufacturing pipeline

As the COVID-19 vaccine was the first authorized vaccine to use mRNA technology and be mass-produced, little data was available regarding the economic production of mRNA-based therapeutics. The vaccine production started at risk, before the completion of clinical trials and before the optimization or scale-up of the product process, which had led to uncertainties in the substrate amount required for dose and the number of doses that would be required.6

Now, data from this experience can be used to model the manufacturing process.

Dr. Zoltn Kis, lecturer and assistant professor of chemical and biological engineering at the University of Sheffield is working to better understand and optimize the mRNA manufacturing landscape. Kis research focuses on experimental and modeling techniques to produce platform processes that enable the rapid development and mass manufacturing of RNA vaccines.

In a recent paper, Kis sought to build a model-based assessment to understand vaccine production better.7 We ran a global sensitivity analysis to evaluate key performance indicators on different vaccine production platforms, namely adenovirus vectors vaccines, mRNA vaccines and saRNA vaccines to assess baseline performance of the production process, Kis says. Certain inputs such as scale, titers, failure rates, dose size, labor rates and failure rates were used. The model sampled 10,000 simulations and plotted these inputs against key performance indicators to understand how each input affects production.

In terms of mRNA production, we found that the process was sensitive to a few process specifics, primarily the substrate dose, batch lead times and the production scale. The main driver is the amount of mRNA per dose as well as production scale and titer, explains Kis. The key takeaways of mRNA manufacturing that should be noted moving forward are:

We believe that producing an mRNA platform technology for vaccine production will help alleviate many issues. This would mean using the same production platform [equipment] and only changing the RNA that is encapsulated for different diseases. Facilitating the move from batch processing to an efficient continuous process would also speed up production, Kis says.

These insights are useful not only for the production of vaccines against emerging SARS-CoV-2 variants, but to also better understand the mRNA production process as technology becomes more efficient.8

Engineering better LNPs for mRNA vaccines

Using vaccines to induce a highly potent immune response, such as the production of neutralizing antibodies, is an urgent need. With mRNA technology, scientists are looking into building a mechanistic insight into the function of LNP-mRNA vaccines and engineering them to be more immunologically potent.

For future vaccine development and manufacturing, we need to look at lowering vaccination dose while maintaining or enhancing vaccination efficacy, says Dr. Yizhou Dong, professor in the Icahn Genomics Institute at the Icahn School of Medicine at Mount Sinai. The Dong lab focuses on designing and developing biotechnology platforms for treating cancers, infectious diseases and genetic disorders.

One approach is to engineer the LNP delivery system to stimulate multiple immune system pathways and increase therapeutic efficacy. A pathway of interest is the STING pathway, known to active type 1 interferon(IFN) secretion. Type 1 IFN response is critical for expanding and activating CD8+ T-cells against viral infections.9

By integrating an agonist for the STING pathway into the LNP of the SARS-CoV-2 vaccine, the Dong lab produced a vaccine that was more immunologically potent than the LNPs used for the current mRNA vaccines. This was achieved by producing a potent STING agonist with unique physiochemical properties on the LNP, which, when endocytosed, activates the STING pathway, causing the production of INF-. When the engineered STING agonist LNP (SAL-12) was compared with the ALC-0315 (the lipid used in the COVID mRNA vaccine) in a mouse study, SAL-12 produced an over 15 times better neutralization titer (NT50), and enhanced protection against SARS-CoV-2.10

This work is a proof of concept for using agonists within LNPS to enhance immune response. Solutions like this one open the avenue for next-generation mRNA vaccines.

How can this technology be used in the future? Well, each disease has its own challenges, and the vaccine will need to be created and studied accordingly. We need to alter the delivery platform or tune the mRNA cargo and final formulation to match the needs of the disease, Dong says.

Although mRNA-based vaccines are being tested for many different indications, augmenting the immune response by targeting pathways that amplify the therapeutic response can lower the required doses and manufacturing costs.11

Emerging platform for viral-like particle vaccines

Virus-like particles (VLPs) are structures that mimic both the organization and conformation of viruses but lack a viral genome, which renders them non-infectious.

VLPs have structural characteristics that enable a stronger immune response than conventional vaccines.12 VLP-based vaccines are already available against Hepatitis B, zika and malaria. 13

The production of VLP vaccines using genetic engineering has been challenging because of low yields, high costs and complex and time-consuming expression and purification processes. Advancements are needed to produce a more simplified workflow for VLP-based vaccines.

In a recent study a team at Qingdao Municipal Hospital in Qingdao, China, developed a novel VLP platform that mimics infection and confers protection to influenza through fluorination-drive self-assembly.14

Fluorination is a chemical process that involves the introduction of fluorine atoms into a chemical structure. Fluorination promotes cytosolic delivery of both small molecules and macromolecules, and promotes self-assembly.15 Taking advantage of this phenomenon allows for the self-assembly of viral antigens for VLP vaccines.

In viral antigen self-assembly, the viral surface antigens are fluorinated by conjugating them with tridecafluoroheptanoic acid. These virus proteins then self-assemble into VLPs through fluorophilic interactions, which mimic a natural virus structure. Different influenza strains were used such as H1N1, H6N2 and H9N2. Besides the production of single VLPs from each influence strain, a mosaic VLP was also produced with surface antigens of all three influenza strains.

Both these mosaic VLPs and individual VLPs from single influence strains provided protection against lethal viral challenges in a mouse model, where mouse body weight change and survival rate were used to test efficacy. Mice were immunized using either the fluorinated VLP influenza vaccine, whole inactivated influenza virus, soluble influenza antigen or with saline. The VLP vaccine demonstrated the most robust protection and survival against other vaccine types and had also showed low viral loads and inflammation in the lungs.

The fluorination process could enhance the breadth of protection offered by vaccines as it enables the targeting of multiple virus strains simultaneously. This could open avenues to produce VLP vaccines against highly mutable viruses. Using this self-assembly approach may also offer a scalable alternative to conventional VLP vaccine production, making it a more attractive option for manufacturing.

Upcoming advancements in vaccine technology and manufacturing

The utility of mRNA and VLPs have shown technology advancements that will alter the vaccine production and manufacturing landscape.

The modularity and quick production of mRNA sequences allow for rapid adaptation to new targets currently being investigated for cancers, viral infections and genetic disorders.16 This technology is still relatively new and suffers from mRNA thermal stability, storage concerns and unwanted immunogenic responses. 17

VLP vaccines are known to produce a strong immune response that closely resemble viral infection. Since VLPs do not contain genetic information, they are neither infectious nor pathogenic. Current research is looking at redefining VLP-based vaccines by altering adjuvants, stabilizers, and delivery vehicles to reduce required dosages and enhance shelf life.

Both mRNA and VLP vaccines represent a significant advancement in vaccine technology and will play a role in protection against infectious diseases. Given the unique advantages of these platforms and ongoing research and development to address drawbacks in their manufacturing, the future of mRNA and VLP-based vaccines holds great promise for production.

About the interviewees:

Zoltn Kis is a senior lecturer and assistant professor of chemical and biological engineering at the University of Sheffield. His research work looks to innovate RNA vaccine and therapeutic production processes. This includes using experimental development, techno-economic modeling and the use of quality by design principles.

Yizhou Dong is a professor at the Icahn Genomics Institute, the Marc and Jennifer Lipschultz Precision Immunology Institute,the Department of Immunology and Immunotherapyand the Department of Oncological Sciences at the Icahn School of Medicine at Mount Sinai. His research focuses on the design and development of nanoparticles delivery systems as well as RNA therapeutics primarily for treating cancers, genetic disorders and infectious diseases.

References (Click to expand)

References:

1. Eddy JJ, Smith HA, Abrams JE. Historical lessons on vaccine hesitancy: Smallpox, polio, and measles, and implications for COVID-19. Perspect Biol Med. 2023;66(1):145-159. doi: 10.1353/pbm.2023.0008

2. Plotkin S, Robinson JM, Cunningham G, Iqbal R, Larsen S. The complexity and cost of vaccine manufacturing An overview. Vaccine. 2017;35(33):4064-4071. doi: 10.1016/j.vaccine.2017.06.003

3. Whitley J, Zwolinski C, Denis C, et al. Development of mRNA manufacturing for vaccines and therapeutics: mRNA platform requirements and development of a scalable production process to support early phase clinical trials. Translational Research. 2022;242:38-55. doi: 10.1016/j.trsl.2021.11.009

4. Youssef M, Hitti C, Puppin Chaves Fulber J, Kamen AA. Enabling mRNA therapeutics: Current landscape and challenges in manufacturing. Biomolecules. 2023;13(10). doi: 10.3390/biom13101497

5. Feddema JJ, Fernald KDS, Schikan HGCP, van de Burgwal LHM. Upscaling vaccine manufacturing capacity - key bottlenecks and lessons learned. Vaccine. 2023;41(30):4359-4368. doi: 10.1016/j.vaccine.2023.05.027

6. Rele S. COVID-19 vaccine development during pandemic: gap analysis, opportunities, and impact on future emerging infectious disease development strategies. Hum Vaccin Immunother. 2021;17(4):1122-1127. doi: 10.1080/21645515.2020.1822136

7. Kis Z, Tak K, Ibrahim D, et al. Pandemic-response adenoviral vector and RNA vaccine manufacturing. NPJ Vaccines. 2022;7(1). doi: 10.1038/s41541-022-00447-3

8. Newall AT, Beutels P, Kis Z, Towse A, Jit M. Placing a value on increased flexible vaccine manufacturing capacity for future pandemics. Vaccine. 2023;41(14):2317-2319. doi: 10.1016/j.vaccine.2023.02.065

9. Ablasser A, Chen ZJ. CGAS in action: Expanding roles in immunity and inflammation. Science (1979). 2019;363(6431). doi: 10.1126/science.aat8657

10. Zhang Y, Yan J, Hou X, et al. STING Agonist-derived LNP-mRNA vaccine enhances protective immunity against SARS-CoV-2. Nano Lett. 2023;23(7):2593-2600. doi: 10.1021/acs.nanolett.2c04883

11. Swetha K, Kotla NG, Tunki L, et al. Recent advances in the lipid nanoparticle-mediated delivery of mRNA vaccines. Vaccines (Basel). 2023;11(3). doi: 10.3390/vaccines11030658

12. Brisse M, Vrba SM, Kirk N, Liang Y, Ly H. Emerging concepts and technologies in vaccine development. Front Immunol. 2020;11. doi: 10.3389/fimmu.2020.583077

13. Tariq H, Batool S, Asif S, Ali M, Abbasi BH. Virus-like particles: Revolutionary platforms for developing vaccines against emerging infectious diseases. Front Microbiol. 2022;12. doi: 10.3389/fmicb.2021.790121

14. Xia Y, Liu K, Wang F, et al. Self-assembled virus-like particle vaccines via fluorophilic interactions enable infection mimicry and immune protection. Adv Healthc Mater. 2023;12(32). doi: 10.1002/adhm.202301647

15. Lv J, Wang H, Rong G, Cheng Y. Fluorination promotes the cytosolic delivery of genes, proteins, and peptides. Acc Chem Res. 2022;55(5):722-733. doi: 10.1021/acs.accounts.1c00766

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Transformative Technologies in Vaccine Manufacturing - Technology Networks

Protected health information and personal details of over a million Irish citizens were accidently exposed by the Irelands Health Service Executive (HSE) during the COVID pandemic, according to an AppOmni security researcher.

This information included individuals vaccine status and type received, which could have been accessed by anyone who registered to the HSE COVID Vaccination Portal before the end of 2021.

The misconfiguration in the portal also made internal HSE documents publicly available, Aaron Costello, Principal SaaS Security Engineer at AppOmni, revealed in a blog dated March 14, 2024.

The exposed health and personal information included:

Costello discovered the issue in December 2021, and HSE confirmed to him it had been fixed on January 17, 2022.

There is no evidence that the information was accessed by any unauthorized individuals with malicious intent.

Costello explained that he has decided to make the issue public to help educate organizations on the risks of handling sensitive data in SaaS applications.

The HSE vaccination portal was created during the COVID-19 crisis to enable Irish citizens to quickly book vaccine appointments, with users signing up through a self-registration form.

The portal was built on top of the Salesforce platform, in what is known as a Digital Community. These communities are configured to grant all registered individuals a specific profile, which gives them permissions to perform actions on the portals user interface, such as register for a vaccination or view their appointment details.

However, the profile permissions were accidently configured by HSE to grant users access to the Health Cloud object that stored information about other registrants including their vaccination status.

Users were also granted excessive privileges that could enable them to access a folder containing internal HSE documents.

Most users would not have realized they had this level of access because the portal is specifically designed to only show the individuals data, Costello noted.

However, a malicious actor could have exploited the misconfiguration to access and exfiltrate the sensitive information about individuals and HSE.

Costello explained this could have been achieved by simply registering to the Vaccination Portal to be automatically assigned the over-privileged Salesforce profile, then viewing all objects that existed within the Salesforce platform through the API, including those in the Health Cloud application.

From there, a malicious actor could iterate over the list of available objects and attempt to access and download the data within them.

This would have allowed the malicious individual to access both internal HSE documentation, and all vaccine administration records for over a million individuals, Costello explained.

The Irish Times quoted a HSE spokesperson who confirmed the misconfiguration had occurred, and said it was remediated the day it was alerted to the issue.

It highlighted the time pressure of the COVID-19 vaccination program as the cause for the accidental exposure, but reiterated that there was no evidence that a malicious actor accessed the data.

Costello set out the best practices for organizations that have publicly facing content on the Salesforce platform to take to avoid the risk of data exposure:

Costello acknowledged that these actions would have been exceptionally difficult for HSE to manually implement amid the rush to manage the rapid vaccination rollout across the country during the pandemic.

Image credit: Lukassec / Shutterstock.com

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HSE Error Exposed Over a Million Irish Citizens' Vaccine Status - Infosecurity Magazine