Category: Vaccine

HIV-1 is one of the fastest-mutating viruses ever studied. Over a dozen distinct subtypes exist, with countless specific versions of the virus varying from person to person. The extraordinary diversity of HIV-1 and rapid mutation rate makes vaccine development a challenge that researchers have failed to overcome for over three decades. However, a new vaccination strategy for HIV-1 induced a diverse arsenal of protective antibodies in monkeys.

Most vaccines offer protection by inducing antibodies that recognize and bind to a functional region of the pathogen. For example, COVID vaccines result in antibodies that attach to the virus spike protein, which the virus uses to hook to the membrane of host cells. These antibodies effectively neutralize the virus, preventing it from attaching (and subsequently entering and infecting). But what happens when that spike protein changes? Those neutralizing antibodies (nAbs) are less protective and cannot bind as efficiently. In the case of COVIID, researchers are working to develop vaccines that induce antibodies to regions of the spike protein that rarely mutate. HIV-1 also has spike proteins that it uses to attach to host cells, but scientists are taking a different approach.

HIV-1s diversity requires a vaccine capable of inducing not just nAbs in general but a broad arsenal of nAbs that can neutralize the multiple circulating strains. These broadly neutralizing antibodies (bnAbs) emerge in approximately 20-30% of HIV-1-infected people. Thus, the human immune system can produce bnAbs against HIV-1 under the right conditions. But those conditions are tricky.

The HIV-1 spike protein comprises six subunits: three that mediate the spikes attachment to target cells (called gp120) and three that fuse the virus and cell membranes (called gp41). This fusion process requires the spike protein to undergo profound conformational changes; consequently, the spike is an unstable entity. The natural instability of the spike makes it a challenging vaccine choice. However, it is the best candidate scientists have found.

Early HIV-1 vaccine programs focused on immunizing with the spike proteins attachment subunit (that is, gp120). After all, if a virus cant attach, it cant infect. At first, these programs showed great promise. The vaccines protected chimpanzees from HIV-1 infection, and human studies demonstrated that the vaccines were safe and induced robust antibody responses. However, in the real world, the vaccines provided no protection. Outside the laboratory, patients were exposed to strains that evolved under immune pressure, and the vaccinated were just as likely to become infected as the unvaccinated.

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It became clear that vaccines targeting the attachment subunit alone would be ineffective. Researchers hypothesized that an effective vaccine must contain both the attachment and fusion subunits and be capable of undergoing configurational change. So groups raced to create stable forms of the whole spike protein. A group at Cornell University was the first to succeed. They discovered that cleaving a small segment at the end of the spike protein resulted in a highly stable molecule with the regular, propeller shape that is now seen as a defining characteristic of HIV-1 spike proteins.

These researchers didnt pick just any spike protein to model theirs after. Instead, they chose a spike protein from an HIV-1 virus isolated from a 6-week-old Kenyan infant who had become HIV-1 infected at birth. The infant had developed nAb by the time they were 3 years old. Additionally, that particular spike protein had the highly desirable property of binding all known bnAbs. Kevin Saunders and his colleagues at Duke University believed that this made it a perfect candidate for an HIV-1 vaccine.

A new paper in Science Translational Medicine reports that, over the course of about six months, the researchers vaccinated rhesus macaques six times with the stable spike protein. Crucially, they also an added an adjuvant a special immune-stimulating molecule called 3M-052, which also boosts the immune response to the influenza vaccine. The authors found that the monkeys developed bnAbs that could target several sites on the HIV viral envelope. Some vaccinated macaques had a high concentration of these antibodies, whereas others had a low concentration.

To determine if these antibodies protected the macaques from infection, the researchers repeatedly challenged the macaques with intrarectally administered doses of simian-human immunodeficiency virus (SHIV), which is similar to HIV. All nine control macaques that did not receive the vaccine became infected after eight challenges. Thirteen of 15 rhesus macaques were infected after 13 challenges in the low-nAb group, albeit at a slower rate than the control macaques. Only two of seven macaques in the high-nAb group became infected after 13 challenges, demonstrating significant protection compared to the unimmunized control group and the low-nAb group. Notably, the two infected macaques from the high-nAb group had the lowest concentration of HIV-specific antibodies two weeks before the challenge.

The researchers note that the antibodies mimic similar antibodies found in the child from whom the spike proteins were isolated, suggesting that humans also produce these antibodies in response to the stabilized spike protein. In addition, the researchers findings will be assessed in the HIV Vaccine Trials Network (HVTN) 300 trial, providing an opportunity to determine whether this protein can induce bnAb in humans.

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At long last, we might have an HIV vaccine - Big Think

As summer vacations wind down, the days get shorter and children prepare to go to school, preschool and day care, they could encounter an unwelcome classmate: COVID. Yet despite the prospect of another fall surge in cases, a remarkably low percentage of young children have been vaccinated against the disease. The U.S. Centers for Disease Control and Prevention recommends children get vaccinated for COVID. So why have so few parents refrained from getting their child the shot?

The Food and Drug Administration authorized COVID vaccines for children six months through four years oldthe last age group to become eligiblein June. Yet just 3.5 percent of U.S. kids in that group have received at least one dose, according to the CDC. And only about a third of children ages five through 11 have received one or more doses.

In a Kaiser Family Foundation (KFF) survey of parents conducted in July, more than four in 10 of those with children aged six months through four years said they will definitely not get their child vaccinated against COVID. Others said they will only do so if school or childcare requires them to or that they want to wait and see how the vaccine is working. Of parents of children in this age group, nearly two thirds of Republicans and of people who are unvaccinated themselves said they would not vaccinate their child. But even among parents who are vaccinated themselves, more than a quarter said they would not make the same choice for their little ones.

Although children are at a lower risk for severe COVID than adults, the risk is not zero. As of late August, more than 1,400 children in the U.S. had died from COVID, including more than 500 under age five. Studies suggest one in 3,000 to 4,000 kids have been hospitalized with multisystem inflammatory syndrome in children (MIS-C), a condition in which multiple organs can become inflamed. Others have developed long COVID.

Reasons for Not Vaccinating

In the KFF survey, parents gave a wide range of reasons for not vaccinating their young children. Some were concerned that the vaccines are too new and that there has not been enough testing and research. The Pfizer and Moderna vaccines have been tested in thousands of children without causing serious adverse effects. But occasionally very rare complications can show up only after millions of people have been vaccinated. For example, myocarditisan inflammation of the heart muscleonly appeared among some teenagers and young adults after vaccinations became widely available. Most of these cases resolved on their own.

Other parents specified concerns about short-term side effects of the vaccine, which might mean they would have to take time off work to care for their child. In clinical trials, the side effects in children younger than age five were similar to those seen in older children and adults. These included pain and redness at the injection site, headache, fatigue and fever. With the exception of fever, most were milder than those seen in older children.

But a significant proportion of parents of children younger than age five in the KFF surveymore than 10 percentsaid they felt their child did not need the vaccine or that they werent that worried about COVID itself. Many children have gotten COVID already, and most of them have had relatively mild cases and recovered on their own. By the time vaccines became available for the youngest children, they were less effective at preventing infectionso the benefits of vaccination were harder to see. Pretty much everybody knows somebody whos gotten COVID despite being vaccinated, says survey co-author Liz Hamel, vice president and director of public opinion and survey research at KFF. The promise of what the vaccine will do for you is different now.

Hamel and her colleagues asked parents whether getting the vaccine or getting infected would be a bigger risk to their childs health. Parents of kids who had already had COVID were much more likely to say the vaccine would be a bigger risk.

Michelle Fox is the mother of a two-year-old boy in Hochdale, Mass. Her son got COVID in May, just before his age group became eligible for a COVID vaccine, and she and her husband have not gotten him vaccinated yet. I think if he hadnt had COVID, we would have got him vaccinated as soon as we possibly could, she says. But she hasnt been in a great rush, in part because her son already has some immunity to SARS-CoV-2, the virus that causes COVID, and in part because her husband has some reservations. Hes British, and Fox says he is somewhat wary because of the fact that the U.K. has not yet approved the vaccine for use in young children. Were generally people who definitely trust what the doctors say, she says. But Fox had a complicated pregnancy that resulted in her son being born prematurelyso her and her husbands calculus on the risk of rare but serious outcomes has changed somewhat, she says. Nevertheless, she adds, as the weather gets cooler and her son spends more time indoors, where COVID risk is higher, that might play into her decision about whether or not to vaccinate him.

A subset of parents have been extremely eager to get their young children vaccinated against COVID. Allison Moy, a microbiologist and mother in Pittsburgh, Pa., vaccinated her nearly two-year-old son as soon as he was eligible. He has had two out of three doses of the Pfizer vaccine. As a scientist with a background in microbiology, Moy says she felt confident in the science behind the mRNA vaccines and did not have any safety concerns. For her, getting her son vaccinated wasnt just about protecting him but also about protecting those around him. My parents are getting older; my husbands parents are getting older, she says. It was more about doing our part to protect the vulnerable.

The KFF survey also found that vaccination rates among young children were divided along political party lines: parents who identified as Republican were less likely to have vaccinated their child or to have been vaccinated themselves, compared with parents who identified as Democratic. Even among Democrats and vaccinated parents, however, a sizable proportion had not vaccinated their kids.

Racial and ethnic demographics also played a role. More than four in 10 Black parents of children younger than age five cited access barriers such as having to take time off work to care for a child with side effectscompared with fewer than a third of Hispanic parents and fewer than a fifth of white parents. More than four in 10 Hispanic parents of such children said they were concerned about not being able to get their child vaccinated at a place they trust, compared with more than a quarter of Black parents and about a sixth of white parents. And both Hispanic and Black parents were more likely than white parents to say they were worried about having to pay out of pocket for the vaccineswhich are available for free in the U.S. regardless of insurance status. People are not used to getting things for free in health care in this country, Hamel says.

Other research supports the KFF surveys findings. Jessica Calarco, an associate professor of sociology at Indiana University Bloomington, and her colleagues surveyed parents in Indiana about their decisions on vaccination. In data that have not yet been published, they found that, from relatively early on in the pandemic, parents were not all that concerned about their kids getting COVID. Parents told the researchers that messaging in the media suggested that childrenespecially white children without preexisting conditionshad a very low likelihood of getting severely ill or dying, Calarco says.

Parents really latched onto those early messages, in part because it allowed them to feel comfortable sending kids back to in-person schooling and in-person day care, Calarco says. As the pandemic progressed, an increasing percentage of parents told Calarco and her colleagues that they consumed less news about COVID. According to a not-yet-published national survey that was also conducted by Calarco and her colleagues, the more parents who perceive COVID itself as a lower threat to children, [the more] they are significantly less likely to have chosen to vaccinate their children, she says.

In both Calarcos Indiana and national surveys, there was a strong correlation between parents being vaccinated themselves and their kids being vaccinated. But there were a number of parents who had only gotten vaccinated because their workplaces required it. National gender data suggest women are more likely to be vaccinated than men, Calarco says, but her surveys of parents found that stay-at-home mothers with young children had much lower vaccination rates, Calarco says. Parents told Calarco and her colleagues they were more likely to vaccinate their older children, who were going to school and extracurricular activities, than their younger kids, who were staying at home. Many parents also believed that kids were less likely to transmit COVID to others, as early studies showed. But more recent studies suggest that kids canand dospread the disease to others in their household.

Increasing Vaccination through Trusted Sources

The fact that many parents feel less urgency about vaccinating their children may be a product of how the vaccines were tested and rolled out, says Sallie Permar, chair of Pediatrics at Weill Cornell Medicine and pediatrician-in-chief at NewYork-Presbyterian Komansky Childrens Hospital. The youngest kids were the ones who were tested the last for vaccines, Permar says. And I think that the message that parents got through that process is that it wasnt so important.

KFF survey data suggest that pediatricians are the most trusted source of information on the COVID vaccine for children, yet 70 percent of parents of children younger than age five said they hadnt yet talked to their childs health care provider about the COVID vaccine. That could change when they take their kids in for annual checkups.

Permar sees a crucial role for pediatricians in communicating to parents that COVID vaccines are safe and recommended for kids. I do we think that pediatricians do need to lead this messaging to parents, she says, because the data shows that parents really trust that source of information. But staffing shortages and a lack of resources have made it difficult to get the word out. Most healthy children only see their pediatrician once a year. We really have to go beyond the pediatrician being the sole provider and messenger to these parents, Permar says.

Meanwhile the FDA has authorized updated booster shots that target the Omicron subvariants of SARS-CoV-2. But Pfizers booster is only authorized for kids age 12 and older, and Modernas booster is only authorized for those age 18 and older. So the youngest kids will have to wait a bit longer for these updated shots.

Im just worried that we're going down the same pathway of demonstrating to parents that this is a low priority, that children are a low priority, Permar says. I think the FDA and other policy makers should think about What are the requirements for approval of the vaccines in young children? so that all parents and their pediatricians and providers can go in with their eyes open this fall as to what we should be recommending to children.

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Why So Few Young Kids Are Vaccinated against COVIDAnd How to Change That - Scientific American

DUBLIN--(BUSINESS WIRE)--The "UK Travel Vaccine Market Forecast to 2028 - COVID-19 Impact and Country Analysis By Product and Application" report has been added to ResearchAndMarkets.com's offering.

The travel vaccine market is expected to grow from US$ 267.56 million in 2021 to US$ 524.88 million by 2028; it is estimated to grow at a CAGR of 10.1% from 2022 to 2028.

Travel vaccines, also called travel immunizations, are shots travelers get before visiting certain areas of the world that help protect them from developing serious illnesses. Vaccinations work by exposing the body to a weakened/dead germ or part of a germ of the disease.

These vaccines are recommended to protect against diseases endemic to the country of origin or destination. It is intended to protect travelers and prevent disease spread within or between countries. In many cases, countries require proof of vaccination for travelers wishing to enter or exit the country.

Travelling and tourism have become an integral part of the human lifestyle. It has added a change in the ongoing routine of people and offered several opportunities to explore different cultures, traditions, spiritualism, rural and ethnic tourism, and wellness and health holidays worldwide.

Travelling outside the country requires immunization as a safety and precautionary measure to avoid spreading infections. Various countries have policies to protect their citizens from travel-associated infections. For instance, in the UK, National Health Service (NHS) organizes routine immunization or vaccination schedule for its citizens. If a person travels outside the UK, they must get vaccinated to prevent infectious diseases such as hepatitis A, typhoid, and yellow fever.

With ~40 million visitors in 2017, the UK is among the most well-liked foreign travel destinations. Although the UK is renowned for its unpredictable weather, the winters and summers are generally temperate, albeit occasionally damp. The UK recognizes Covaxin as a reliable COVID-19 travel vaccination. This indicates that those immunized with Covaxin, one of the two main COVID-19 vaccines, will not have to separate themselves once they arrive in England. After experiencing a significant annual decline in 2020 due to the COVID-19 pandemic, Statista reports that the number of foreign tourists arriving in Europe increased by ~20% in 2021 compared to 2020.

Based on product, the UK travel vaccines market is segmented into hepatitis A, hepatitis B, meningococcal vaccines, and others. The others segment holds held the largest market share in 2021. However, the meningococcal vaccines segment is expected to register the highest CAGR during the forecast period.

The others segment primarily consists of the human papillomavirus vaccine, Zika virus vaccine, DPT (tetanus/diphtheria/pertussis), yellow fever, typhoid, Japanese encephalitis, measles, mumps and rubella, rabies, polio, influenza, varicella and shingles, cholera, and others.

Based on application, the travel vaccine market is segmented into domestic travel and outbound travel. In 2021, the outbound travel segment is likely to account for the largest share of the market. The market for this segment is expected to grow at the fastest CAGR of 10.4% during 2021-2028.

However, the number of vacations abroad only accounted for 15% of the holiday trips made in 2019. Overall, the number of visits abroad from the UK was approximately 19 million in 2021. Spending on trips abroad by residents of the UK increased by 12% in 2021 over the previous year, after dropping sharply in 2020 due to the pandemic.

Market Dynamics

Market Drivers

Market Restraints

Market Opportunities

Future Trends

Key Topics Covered:

1. Introduction

2. Travel Vaccines Market - Key Takeaways

3. Research Methodology

4. Travel Vaccines Market - Market Landscape

5. UK Travel Vaccine Market - Key Market Dynamics

6. Travel Vaccines Market - UK Analysis

7. UK Travel Vaccine Market Revenue and Forecasts To 2028 - Product

8. UK Travel Vaccine Market Revenue and Forecasts To 2028 - Application

9. Travel Vaccines Market Analysis - By Country

10. Impact Of COVID-19 Pandemic on UK Travel Vaccine Market

11. UK Travel Vaccine Market-Industry Landscape

12. Company Profiles

13. Appendix

Companies Mentioned

For more information about this report visit https://www.researchandmarkets.com/r/6unbvt

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UK Travel Vaccine Market Report 2022: Increasing Travel and Tourism & Growing Incidences of Infectious Diseases Fuel Sector -...

A man in a white shirt on a black background checks the nasal spray.

This is a short series focusing on the challenges of developing effective influenza vaccines. In the first part of this series, I gave a brief overview of the history and nature of influenza viruses, including why they represent a tricky target for vaccine manufacturers. In the previous two articles which can be read here and here I discussed some of the attempts that have been made to overcome these challenges. This article focuses on another such attempt: intranasal vaccination. Finally, the last few installments will offer a detailed analysis of the latest, and most promising, advances in the development of universal vaccines.

Nasal Vaccination: Straight to the Source

Current influenza vaccines are reasonably effective at reducing the risk of severe illness, hospitalization, and death, but they need to be updated on a yearly basis to remain protective. The influenza surface proteins that vaccines use to teach our immune system how to defend itself can mutate rapidly, leading to a mismatch between the vaccine antigens and those actually in circulation. A good season will see around 60% of people protected by the flu vaccines. A poorly matched season can see this number drop as low as 20%.

Even when the vaccines are well matched to the circulating strains, they still need to elicit a high concentration of neutralizing antibodies to be effective. Antibodies bind to the influenza surface protein and prevent viral entry into cells, creating a barrier between virus and host. Unfortunately, these wane very quickly a recent meta-study, performed by scientists at the University of Michigan, Ann Arbor and Northwestern Memorial Hospital, found that the protection offered by the flu shot can be lost completely within a span of 90 days.

Most flu vaccines are administered by intramuscular injection, delivering the antigens deep into the muscle tissue. This raises circulating antibody levels throughout the body; a generalized, systemic response. Over the years there have been a number of suggestions that a vaccine administered intranasally may offer better protection. The flu, being a respiratory virus, is most at home in the nose and the throat. It spreads by aerosol droplets when people talk, sneeze, or cough. Vaccinating through the nose in the form of a spay, rather than injection would more closely mimic influenzas natural route of infection. Ideally, the corresponding antibody response would be localized, offering highly targeted protective immunity at the very source of infection.

Understanding Mucosal Immunity

Why exactly is it thought that nasal administration could improve vaccine efficacy? To understand this, we need to take a closer look at something called mucosal immunity.

Our skin is one of the first lines of defense against injury and infection, acting as a physical barrier that prevents unwanted entry. But some areas of our body need to allow for a degree of exchange between inside and outside. Broadly, these include: the gastrointestinal tract, the urogenital tract, and the respiratory tract. Each of these inhabits a strange in-between space on the one hand they are inside our body, but on the other they are constantly exposed to the outside world, rendering them particularly vulnerable.

To protect against foreign threats, these areas are covered by a lining known as a mucous membrane, or mucosa. As with our outer skin, part of the mucosas protective function lies in acting as a physical barrier. To this effect, the membrane is covered in mucus, which helps trap and slow the advance of microbes a runny nose is our bodys attempt at expelling microbes once theyve been trapped, so too is phlegm.

But aside from this passive form of protection, the mucous membrane is also packed full of pockets of mucosa-associated lymphoid tissue (MALT), which contain all kinds of immune cells (Figure 1). This layer is known as the lamina propria. It includes B and T lymphocytes, roughly three quarters of which reside in our various mucosal regions. B cells produce antibodies, which can bind to viral particles and prevent them from entering our cells, blocking infection. T cells help kill off cells that have already been infected, curbing viral spread. They also recruit additional immune cells to areas of infection, speeding up viral clearance. Along with B and T cells, mucosa-associated lymphoid tissue is also home to natural killer cells and macrophages, which directly engulf and neutralize any pathogens trying to pass through the epithelium. Finally, dendritic cells act as a kind of surveillance system that modulates the specifics of our immune response on a case-by-case basis. Dendritic cells also present naive B and T cells with foreign antigens, prompting them to differentiate and provide the most specific possible immune response against the microbes at hand.

The close proximity of mucosal immune cells to the membrane surface carries with it a distinct advantage: they can jump into action more quickly than they would be able to in non-mucosal regions of the body. They dont need to waste important time traveling to far off sites of infection, since they are already at the main portal of entry.

FIGURE 1. An overview of the various cells and processes involved in mucosal immunity. The mucus ... [+] membrane stretches from the mucus layer to the bottom of the lamina propria.

Crucially, there exists a class of antibodies immunoglobulin A (IgA) that is only produced by B cells in the mucosal membrane. Immunoglobulin A can take on one of two forms: serum IgA, which circulates through the blood as one might expect, and secretory IgA (sIgA), which is made on the underside of the mucosal membrane and is transported across the membrane to the mucosal surface. A key component of this process is the polymeric Ig receptor (pIgR) that binds to the IgA, enabling the antibody to be absorbed by the epithelial cell barrier and ferried through to the surface. As the IgA exits the epithelial cell, the polymeric Ig receptor is cleaved off, preparing the antibody for action (Figure 2).

An additional strength of sIgA is the fact that it is a dimer, meaning it is composed of two identical molecular IgA parts, held together by a small joining-chain (JC). Whereas monomeric antibodies have two binding sites, dimeric sIgA has four. This is suspected to improve its ability to bind to antigens, allowing for quicker viral clearance.

FIGURE 2. Generation and Transportation of Secretory IgA In this example of a mucosal epithelial ... [+] cell lining a body tract, dimeric sIgA binds via its J chain to a polymeric Ig receptor (pIgR) expressed on the cell surface. The polymeric sIgA molecule is endocytosed by pIgR, transported across the cell (transcytosis), and released into the lumen of the tract. During this release, the pIgR is enzymatically cleaved so that the polymeric IgA and a pIgR fragment (secretory component) remain attached and are released together as secretory IgA.

So, unlike most other antibodies, sIgA is stationed on the outside of the body. Here, IgA can bind to microbes including viruses before they even have a chance to enter the body. This prevents the microbes from binding to our cells, and by extension, protects us from infection. Akiko Iwasaki, Sterling Professor of Immunobiology and Molecular, Cellular, and Developmental Biology at Yale University, describes it as putting the guard outside of the door instead of inside the door where antibodies normally work, inside the body.

Problems?

The first nasal flu vaccine, FluMist, was approved by the U.S. Food and Drug Administration (FDA) in 2012. By 2016 it had been pulled off the market, not to reappear until 2018. The reason? Decreased vaccine effectiveness. Combined data from 2013 to 2016 indicates that nasal spray vaccine effectiveness was roughly 26% in children between the ages of 12 and 17. This is compared to 51% effectiveness for inactivated vaccines, administered intramuscularly.

Although these low numbers were brushed off as being a result of poorly matched vaccine virus strains, there may also be other reasons the nasal spray influenza vaccine hasnt quite lived up to expectations.

For one, IgA is typically quite short-lived; it is produced only for a brief period after exposure. Any barrier immunity that the nasal spray vaccine does offer us will likely fade as soon as IgA numbers drop. And durability is already a point of concern with traditional, inactivated flu vaccines, which depend on the longer-lived circulating IgG class of antibodies for protection from infection. So, we cannot expect it to be all that durable.

Another worry is that the nasal spray vaccine may be cleared by our immune system before it has the chance to complete its job. Adults who have previously been exposed to the flu and that means more or less every adult will still have at least partial mucosal immunity against the influenza viruses. The attenuated, or weakened, viruses used in the nasal spray vaccine might simply be getting neutralized before they can infect nasal cells, preventing our B cells from updating sIgA to match the viruses circulating that season.

On a more theoretical note, one might also question the belief that vaccine-induced mucosal immunity can provide lasting protection if natural infection, through the same path of entry, fails to do so. Many people are infected by influenza on a seasonal basis, with waning immunity and viral mutation leading to renewed vulnerability year after year. This happens even though they would have built up some degree of mucosal immunity during prior infection. If prior infection through the nose doesnt protect us from reinfection, why would a nasal vaccine?

This hints at a larger issue: we still know very little about the dynamics of mucosal immunity and about the nuances of nasal vaccination. Speaking at the White House Summit for the Future of Covid-19 Vaccines, Dr. Anthony Fauci stressed that we still lack validated animal models to help us sample and quantify mucosal immune responses. Similarly, we lack clear correlates of protection for intranasal vaccines. Although a simplification, IgG levels following intramuscular injection are associated with improved vaccine effectiveness; we dont yet have enough data to make such inferences in the case of intranasal vaccines. Knowledge about clinical trial designs and endpoints is also lacking, further complicating the development and adoption of nasal vaccines.

There has been tremendous excitement around mucosal vaccines, with many in the field pinning their hopes on long-term protection from infection as well as severe disease. The experience with FluMist serves as a caution that the high hopes for nasal vaccination may not be realized.

We will soon have data from two new efforts. In China, CanSino Biologics has just had their inhaled Covid-19 vaccine authorized for emergency use. And in India, Bharat Biotechs Covid-19 nasal vaccine was authorized for restricted use. Many more are in development. Time will tell if they live up to their promise to prevent infection and reduce transmission.

The next article in this series will look at a shift in strategy: moving away from yearly vaccines that try to closely match predicted wild type viruses, and instead, attempting to create vaccines that neutralize a broad array of influenza viruses even in the face of continued viral mutation. So called universal influenza vaccines.

See the article here:

Getting a Grip on Influenza: The Pursuit of a Universal Vaccine (Part 4) - Forbes

Immunogenicity and safety of an inactivated whole-virus COVID-19 vaccine (VLA2001) compared with the adenoviral vector vaccine ChAdOx1-S in adults in the UK (COV-COMPARE): interim analysis of a randomised, controlled, phase 3, immunobridging trial  The Lancet

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Immunogenicity and safety of an inactivated whole-virus COVID-19 vaccine (VLA2001) compared with the adenoviral vector vaccine ChAdOx1-S in adults in...

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For the past two years, start-of-school rituals and routines have been waylaid by virus surges, public health concerns, quarantines and overall uncertainty.

Will things be different this fall? So far, it looks to be the case.

Schools have been opening up across the country with relatively low fanfare in the first three weeks of August. Our regular review of 100 large and urban districts finds that all those that have started classes are in-person. None have reported closures due to COVID outbreaks. It appears that perhaps students are settling into something like the old sense of normal.

However, this is not a normal year. It follows a school year of multiple unanticipated virus surges, ongoing changes to health and safety policies, and dramatic reports of chronic absenteeism and staffing shortages.

While students and families are eagerly anticipating a simpler start to this year, its not clear that they are receiving adequate information about what to expect should another deadly variant arise.

Our review finds that just 55 have shared updated handbooks or websites that outline health and safety policies for the 2022-23 school year. Of those that have published information, its clear that districts are jettisoning many of the protective measures that they endorsed just months ago.

As of the third week of August, just one district in our review has a mask requirement in place. In Louisville, Kentucky, Jefferson County Schools has kept a mask requirement in place, dependent on the community infection rates. Masking is required for students and staff until the county is no longer in the red (high) level. The district updates its masking status at the end of each week on its website.

In Pennsylvania, Pittsburgh Public Schools has adopted a similar approach, linking its mask policy to community COVID levels. At the time we recorded our data, the districts community infection level was medium, which allowed individuals to remove masks while participating in performances so long as they take weekly COVID tests . The infection rate has since risen to high, meaning that, like Jefferson, Pittsburgh now requires everyone to wear a mask in schools.

All other districts in our review have removed ongoing mask requirements. A small number four do mandate them for specific circumstances.

Related:Analysis: Community Health, Vaccination Policies & Local Preference How 100 Districts Are Reopening After COVID-19 Shutdowns

In Nevadas Clark County School District and the Hawaii Department of Education, staff or students returning to school after a confirmed positive COVID diagnosis must wear a mask. Individuals in Clark County who have been exposed to the virus are required to mask up as well. In Virginia, Richmond Public Schools requires masks but allows parents to opt out on behalf of their children, and South Dakotas Sioux Falls School District will require students showing symptoms of the virus to move to an isolated area of the school building until they can be picked up and taken home. While they wait, anyone who comes in contact with them is expected to wear a mask.

Fewer districts are also requiring vaccinations this school year, with 10 maintaining strict policies for their staff just a third of the number that mandated staff vaccinations just six months ago.

All the districts requiring vaccinations in 2022-23 had a mandate in place the previous school year. Most, like Boston Public Schools and the New York City Department of Education, are continuing their policies from last year. Others, like Marylands Montgomery County Public Schools, have shifted their rules over time.

Montgomery County alternated between requiring vaccines for all staff and allowing regular testing in lieu of vaccination last fall, and landed on a policy that allowed employees to opt out and undergo weekly testing. This fall, it is opening the school year with tighter language that states: MCPS currently requires staff to submit proof of COVID-19 vaccination or documentation of a medical exemption. Employees who request an exemption must undergo regular testing.

Atlanta Public Schools does not require employee vaccinations, but all staff must undergo weekly testing. It is the only district in our review that has adopted this strategy.

Just two districts in our review require COVID vaccinations for students. D.C. Public Schools mandates them for students 12 and older, and New York City requires students to be vaccinated if they participate in high-risk extracurricular activities or sports. Several California districts scaled back student vaccine mandates planned for July 2022 after the state granted an extension until July 2023.

No district has a policy in place requiring testing for all students.

Signs in these first weeks of the academic year look positive that schools are moving toward the most normal start to a year since the virus took the country by surprise in early 2020.

As new data paint an increasingly grim picture about the toll the pandemic, school closures and continuing operational uncertainty in schools took on learning, attendance and staff morale, this is welcome news. CRPE will release a comprehensive State of the Student report in September, compiling more data on student learning and well-being since the pandemics start and highlighting potential solutions for the road ahead.

While masks, testing and vaccines remain important strategies for containing the virus spread, district leaders appear to be giving them less priority than last year. This suggests they recognize that the public has grown more tolerant of COVID and less willing to accept measures designed to stop its spread. In other words, district leaders appear to be calculating that the political and logistical costs of keeping last years safety measures in place do not outweigh the value of a normal year with fewer disruptions.

That does not mean districts can afford simply to return to pre-pandemic ways of doing business. Families, staff, and students need continued clear communication about what to expect as schools return to traditional schedules and expectations, and they deserve to know what to expect if rising viral caseloads or other unanticipated events threaten the stability of yet another school year.

This year presents an opportunity for public school systems to regain families trust. Some districts are taking this to heart, sharing clear and careful plans for the future. Sadly, others have already fallen silent.

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School Mask, Vaccine Mandates Are Mostly Gone. But What if the Virus Comes Back? - The 74

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Microsoft and Unicef drive Covid-19 vaccine roll-out with COVAX platform - Technology Record

In this file photo taken on Feb. 22, 2010, then Prime Minister Yukio Hatoyama looks at a panel presented during questions in the House of Representatives Budget Committee in the Diet. (Mainichi)

In July, former Japanese Prime Minister Yukio Hatoyama posted on Twitter that he had heard from a doctor that the World Health Organization (WHO) had acknowledged the hospitalization rate for people who had been vaccinated was three times higher than those who hadn't been, and the tweet spread. But there is no published WHO data that backs up this claim, and the WHO itself effectively denied it when approached by the Mainichi Shimbun. The information in the post is false.

-- Digital Minister Kono says former PM spreading misinformation

Hatoyama tweeted the information on his official account on July 13. He said he was "astonished" to hear it from Dr. Takuji Shirasawa, head of the Shirasawa Anti-aging Medical Institute. Hatoyama also referred to U.S. pharmaceutical firm Pfizer, which is developing vaccines. His post read as follows:

"I was astonished by what I heard from Dr. Takuji Shirasawa. He said that the WHO had acknowledged that people who have been vaccinated are three times more likely to be hospitalized than those who haven't been. It was also announced that there had been whistleblowing that Pfizer had deleted a large amount of data. I've heard about vaccine interests before, but it's now clear that this is not the kind of thing that can be dismissed as a conspiracy theory."

As of Sept. 2, Hatoyama's post had been retweeted some 27,000 times, and received 52,000 likes. The tweet elicited various replies such as, "Everyone knows this so they're not getting vaccinated," and "Thank you for posting this," as if those users were taking the post seriously. At the same time, others questioned the claim, replying, "Where is the source for this?" and "Are you saying that vaccinated people have been fooled?" Digital Minister Taro Kono, who previously served as the minister in charge of vaccinations, commented that the former prime minister was "spreading misinformation" and asked "What on earth happened?"

-- WHO effectively denies claim

The Mainichi Shimbun searched news releases on the WHO's official site using the terms "covid-19" and "vaccin" (the first letters of the words vaccine, vaccinated and vaccination), and found 95 applicable items (as of Sept. 2), but none of them contained information matching the content in the former prime minister's tweet.

The Mainichi Shimbun additionally asked the WHO by email if the post saying that the "WHO acknowledged that people who have been vaccinated are three times more likely to be hospitalized than those who haven't been" was true or not. The WHO quoted a statement released on June 17 and said that vaccines at present were highly effective against serious ailments and death for all mutations of the coronavirus.

But what about Pfizer, which the former prime minister said had received an internal complaint about the deletion of a large amount of data. Pfizer's Japanese arm merely told the Mainichi Shimbun that it had not confirmed any announcements indicating that people who have been vaccinated are more susceptible to hospitalization, and from current data, it was evident vaccinations were effective in preventing serious illnesses. Regarding the whistleblowing, the company said it was aware of such a claim. Pfizer Japan said it was disclosing the information it could about the vaccine in its press releases.

-- No response from former PM Hatoyama

The Mainichi Shimbun sought a comment from former Prime Minister Hatoyama through the East Asian Community Institute, which he presides over, but it had not received a response by the deadline on Aug. 29. A Shirasawa Anti-aging Medical Institute representative said Dr. Shirasawa had "no comment."

(Japanese original by Moe Yamamoto, Digital News Center)

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Fact check: Post-vaccine hospitalization odds not 3 times higher as ex-Japan PM claimed - The Mainichi - The Mainichi

Sep 5 2022

There has been a noticeable difference between the outbreak of monkeypox in 2022 (MPXV-2022) and previous outbreaks. The previous outbreaks led to a small number of infections and were mostly localized, whereas the current outbreak has led to more than 53,000 confirmed cases in more than 100 countries within a few months of the first report on 7th May 2022. The monkeypox outbreak of 2022 was declared a global health emergency of international concern by the World Health Organization (WHO) on 23rd July 2022. Phylogenetic analyses of genomic sequences obtained from samples that were collected from at least 15 countries reported the West African clade of MPXV (MPXV-WA) to be involved in the 2022 outbreak. However, this is unusual since this clade has a historically low outbreak-causing potential.

Study: Vaccinia-Virus-Based Vaccines Are Expected to Elicit Highly Cross-Reactive Immunity to the 2022 Monkeypox Virus. Image Credit: NIAID

Vaccines based on the vaccinia virus (VACV), which were initially developed against smallpox, can be used to prevent and control monkeypox. Three prominent VACV-based vaccines are available, including first, second, and third-generation vaccines. The use of first-generation vaccines such as Dryvax is not recommended against MPXV due to safety concerns. However, second-generation vaccines such as ACAM2000 are relatively safer compared to first-generation vaccines and can be used against monkeypox in the US.

Currently, one third-generation vaccine, Bavarian Nordics modified vaccinia virus Ankara (MVA-BN), is recommended by the US Centers for Disease Control and Prevention (CDC) as well as WHO, primarily for high-risk groups. MVA-BN is also a VACV-based vaccine but cannot replicate in humans and therefore is safer than the previous generation vaccines. However, the availability of MVA-BN is currently limited.

Although these VACV-based vaccines have been observed to show differences in safety profiles and replication, they have been reported to produce strong T-cell responses and high neutralizing antibody titers. Some previous studies also indicated their cross-reactive and protective immune responses against different MPXV. Although MVA-BN and ACAM2000 have been found to prevent MPXV infections, those studies were conducted using the Congo Basin clade of MPXV (MPXV-CB). There is limited data to support the efficacy and cross-reactivity of these vaccines against the MPXV-WA clade responsible for the current outbreak.

A new study published in the Viruses journal aimed to investigate the cross-reactivity of VACV-based vaccines against the MPXV viruses responsible for the 2022 outbreak.

The study involved downloading complete genome sequences of MPXV-2022, genome reference sequences of MPXV-CB and VACV, and reference sequences for MVA-BN, Dryvax, and ACAM2000 vaccines from several databases for multiple sequence alignment. Assessment of the cross-reactivity of the vaccines was carried out using the VACV reference sequence since it served as a representative of the VACV-based vaccines. In addition, pairwise sequence alignments were carried out to detect genetic similarities.

The data on VACV-derived T cell and B cell epitopes were obtained from the Immune Epitope Database (IEDB). Identification of eight VACV proteins was carried out that served as targets for neutralizing antibodies in humans, while 121 VACV proteins were identified as targets of T cells. Finally, the visualization of VACV protein crystal structures was carried out.

Mapping mutations observed in MPXV-2022 and MPXV-CB on the structure available for VACV (A) H3L [PDB ID: 5EJ0] and (B) D8L [PDB ID: 4E9O] surface proteins. The core structure of each protein is shown in gray, while mutations and their labels are colored according to the scheme in the legend.

The results reported approximately 84% genetic similarity between MPXV-2022 sequences and VACV reference sequences. The sequences were found to contain about 13% insertion/deletion (indel) and 3% single nucleotide polymorphisms (SNPs), which is equal to 27.5 k indels and 6.5 k SNPs. A 94 to 98% genetic similarity was observed for the eight identified immunogenic proteins between VACV as well as the MPXV-CB reference sequence and MPXV-2022 consensus sequence.

The same site of mutations was observed in 4 of the 8 proteins between VACV and the two MPXV sequences. D8L and H3L were found to be the two proteins with the highest number of mutations that were similar to VACV. Moreover, all the common and unique mutations were observed to be exposed and, therefore, can be targeted by neutralizing antibodies.

Furthermore, a high degree of genetic similarity was also observed between T cell epitope associated 121 proteins of VACV with both MPXV-CB and MPXV-2022. 71.6% of VACV-derived T cell epitopes were found to have exact similarities with both MPXV-CB and MPXV-2022. However, genetic variation was observed in over one-quarter of the T cell epitopes between VACV and both MPXV orthologs. Additionally, 89.2% of the T cell epitopes were observed to be identical between MPXV-CB and MPXV-2022.

Therefore, the current study demonstrated a high degree of genetic similarity between the current MPXV-2022 and MPXV-CB. Furthermore, the genetic similarity was also observed between these two MPXV orthologs and the VACV reference sequence. This suggests that the currently available VACV-based vaccines can protect against MPXV-2022. However, further studies are required to determine the efficacy of these vaccines against MPXV-2022.

The current study has certain limitations. First, further experimental studies are required to confirm the genetic conservation of immune factors among viruses related to each other. Second, the study does not include the immunodominance hierarchy of proteins that can detect the impact of protein mutations.

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Impact of vaccinia virus-based vaccines on the 2022 monkeypox virus outbreak - News-Medical.Net

Parents reported 6 percent of young children were unable to do normal activities after second dose

In a CDC survey of over 13,000 children, more than 55 percent of the subjects between the ages of 6 months and two years had a systemic reaction in response to their first dose of the Pfizer-BioNTech or Moderna COVID-19 vaccines, the CDC said on Sept. 1.

A systemic reaction is a response beyond the injection site. The CDC said almost 60 percent had a systemic reaction to the second dose of the Moderna vaccine.

While the most common systemic reactions were fatigue, fever, irritability, and crying, parents of more than 6 percent of the children in the study said their child was unable to perform normal activities after the second dose of either the Pfizer-BioNTech or Moderna vaccine.

The CDC collected the data through a program called V-Safea smartphone-based monitoring system that operates through an app that parents download to their phones.

Between June 18 and Aug. 21, parents of more than 10,000 young children reported reactions to the CDC through V-Safe in the seven days after their child received aCOVID-19 vaccination.

Parents of 8,338 children ages six months to 2 years who received the Moderna vaccine reported information through V-Safe, with 55.7 percent reporting a systemic reaction after the first dose and about 58 percent after the second dose. For the Pfizer vaccine, parents of 4,749 children ages six months to 2 years submitted reports showing that 55.8 percent had a systemic reaction after the first dose and about 47 percent after the second dose of the vaccine.

The most frequently reported reactions for children six months to 2 years were irritability or crying, sleepiness, and fever. The most common reactions for children aged 3-5 years were injection site pain, fatigue, and fever.

The data also showed a more serious reaction category labeled any health impact.

About 10 percent of all children six months to 2 years were reported to have a health impact after getting their first dose of either the Moderna or Pfizer vaccine. For the Moderna vaccine, slightly more children had a health impact after the second dose; for the Pfizer vaccine, it was slightly less.

The information was presented to the CDCs Advisory Committee on Immunization Practices (ACIP) on Sept. 1 as part of an overview of all data related to the safety of COVID-19 vaccines.

In addition to V-Safe, data was presented summarizing reports from the Vaccine Adverse Event Reporting System (VAERS) and the Vaccine Safety Data Link (VSD), which includes data from several large health maintenance organizations in the United States.

All three systems look at the safety of vaccines after theyve already gone to market and have been administered to large numbers of people.

Tom Shimabukuro, the head of the CDCs vaccine safety team, headed the presentation and told committee members that no statistical signals of COVID-19 vaccine reactions were found for young children in the VSD data.

Shimabukuro also said that systemic reactions were commonly reported following vaccines.

However, other medical professionals like Dr. Meryl Nass from Childrens Health Defense have expressed caution over the reported reactions, pointing to the high number ofsystemic reaction reports among very young children.

She told The Epoch Times on Sept. 2 that she was questioning why the government doesnt collect and present more information on these cases.

That stuff is not considered by the CDC to be very important Its assumed that all those side effects go away after a few days and leave the people perfectly well, she said, mentioning the fevers and fatigue. Those reactions may in fact may be harbingers of more serious reactions, but nobody to my knowledge has published anything looking at whether these acute local or systemic reactions are indicators of a later problem.

The FDA approved the emergency-use authorization of COVID-19 vaccines for children aged six months to 5 years on June 17.According to the CDC, about 599,460 children in this age group have received the Pfizer-BioNTech vaccine, and about 440,770 have received the Moderna vaccine.

From June 18 through Aug. 31, approximately 1 million doses of the Moderna and Pfizer vaccines were administered to children in this age group.

In a review of the VAERS data on young children from June 18 to Aug. 31, the CDC had 496 reports of adverse events for children aged six months to 4 years who received the Pfizer vaccine and 521 for children aged six months to 5 years who received the Moderna shot, with an adverse event defined as a possible side effect.

Over 98 percent of reports were for what the CDC considers non-serious events.

There are 220 reports of persons aged six months to 5 years of age being taken to the emergency room following a COVID-19 vaccine. In one case involving a 2-year-old boy in Arizona, the VAERS report says he was given the Pfizer vaccine on July 29 and on July 30 had a life threatening episode.

The report lists his symptoms as clammy skin and vomiting leading (8 minutes) to difficulty breathing. The boy turned blue, was limp and non-responsive, and fully stopped breathing for two minutes, according to the report.

He was revived after chest compressions.

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In CDC Survey of Over 13,000 Children, More Than Half Had 'Systemic Reaction' After COVID-19 Vaccine - The Epoch Times