Category: Vaccine

A combined flu and Covid vaccine from Moderna provokes a higher immune response than separate single jabs, according to new data from the firm.

The results raise hopes the new vaccine could be approved by regulators this year, with the possibility of being rolled out on the NHS.

At the moment, Modernas Spikevax vaccine for Covid-19 is used in the NHS booster programmes, alongside Pfizer/BioNTechs Comirnaty.

A newer version of Spikevax has been created and tested by Moderna which includes a dose of flu vaccine.

The combination means people would only need one jab rather than two, as at the moment, to give them full protection against Covid-19 and flu.

This is the first time final phase 3 data for a combined vaccine has been published by any firm.

The findings from Moderna showed that the mRNA-1083 vaccine met its goals and led to higher immune responses against flu and Covid than two other single vaccines currently in use, including the current Spikevax.

Stephane Bancel, chief executive of Moderna, said: Combination vaccines have the potential to reduce the burden of respiratory viruses on health systems and pharmacies, as well as offer people more convenient vaccination options that could improve compliance and provide stronger protection from seasonal illnesses.

Moderna is the only company with a positive phase 3 flu and Covid combination vaccine.

Building on the momentum of positive phase 3 data across our respiratory portfolio, we continue to address significant unmet medical needs and advance public health.

The randomised controlled trial involved two groups of about 4,000 people each, with the first group aged 65 and over testing the new jab compared with a flu vaccine, Fluzone, and the current Spikevax jab. The second group included adults aged 50 to 64.

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Combined flu and Covid vaccine from Moderna shows positive results - Yahoo! Voices

GSKs Arexvy has become the first respiratory syncytial virus (RSV) vaccine to be approved by the US Food and Drug Administration (FDA) for use in adults aged 50 to 59 who are at an increased risk of RSV-caused lower respiratory tract disease (LRTD).

The regulators decision comes just over a year after it approved Arexvy for use in adults aged 60 years and older.

RSV is a common contagious virus affecting the lungs and breathing passages. Although most people can recover within a week or two, 13 million adults aged 50 to 59 years in the US have a medical condition that increases their risk of severe RSV outcomes.

The virus can worsen conditions including chronic obstructive pulmonary disease, asthma and chronic heart failure, and can lead to severe outcomes such as pneumonia, hospitalisation and death.

GSKs Arexvy contains a protein from the surface of the RSV virus and teaches the immune system how to defend itself against disease.

The FDAs latest approval was supported by positive results from a late-stage trial evaluating the immune response and safety of Arexvy in adults aged 50 to 59 years, including those at an increased risk for RSV-LRTD due to underlying medical conditions.

Tony Wood, GSKs chief scientific officer, said the decision reflects the importance of broadening the benefits of RSV immunisation to this patient population.

For those with underlying medical conditions, RSV can have serious consequences, so we are proud to be the first to help protect them from RSV-LRTD, he said.

Beyond the US, Arexvy is approved to prevent RSV-LRTD in adults aged 60 years and older in over 40 countries. GSK has also filed regulatory submissions to extend the use of the vaccine to higher-risk adults aged 50 to 59 in Europe and other markets.

Professor Ann Falsey, University of Rochester School of Medicine, said: When it comes to the risks associated with RSV, age is just a number, an important number, but not the only factor to consider.

Many adults in this age group have underlying health conditions that place them at increased risk for serious illness with RSV infection compared with those without these conditions.

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GSKs RSV vaccine Arexvy approved by FDA for use in adults aged 50 to 59 years - PMLiVE

The FDA expanded the approval of GSK's respiratory syncytial virus (RSV) vaccine (Arexvy) to include adults ages 50 to 59 at risk of RSV-related lower respiratory tract disease (LRTD) due to underlying conditions, the company announced on Friday.

Previously the adjuvanted RSV prefusion F protein-based vaccine had been approved only for adults 60 and older; it is currently recommended for use via shared decision-making by the CDC and Advisory Committee on Immunization Practices.

According to the vaccine maker, an estimated 13 million U.S. adults ages 50 to 59 years have medical conditions -- e.g., asthma, chronic obstructive pulmonary disease, diabetes, heart failure -- putting them at increased risk of RSV-related LRTD and its serious consequences, including pneumonia and death.

"When it comes to the risks associated with RSV, age is just a number, an important number, but not the only factor to consider," Ann Falsey, MD, of University of Rochester School of Medicine in New York, said in a statement from GSK. "Many adults in this age group have underlying health conditions that place them at increased risk for serious illness with RSV infection compared with those without these conditions. Now there is a vaccine approved that can help protect them."

About 42,000 hospitalizations occur each year in the U.S. among adults ages 50 to 64 years old, according to a systematic review and meta-analysis. That compares to approximately 159,000 annual hospitalizations in U.S. adults 65 and older.

The new approval was based on results of a double-blind phase III multinational trial that demonstrated noninferior immune responses with the vaccine for 1,140 participants ages 50 to 59 (half of whom had high-risk conditions for RSV-LRTD) versus older adults. In both of the younger groups, RSV-A and RSV-B neutralization titers were similar 1 month after administration of a single vaccine dose compared to the older group.

Safety and reactogenicity were consistent with the pivotal trial data for adults 60 and over, said GSK, with most adverse events (AEs) being mild to moderate and also transient. In the adults ages 50 to 59, the most commonly reported AEs were pain at the injection site (76%), fatigue (40%), myalgia (36%), headache (32%), arthralgia (23%), erythema (13%), and swelling (10%).

Safety information in the labeling also includes warnings about the potential for severe allergic reaction and syncope after administration, and that immunocompromised people may have a diminished immune response.

Ian Ingram is Managing Editor at MedPage Today and helps cover oncology for the site.

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FDA Expands Use of RSV Vaccine to Include More Adults - Medpage Today

A recent study has sparked another round of headlines claiming that COVID vaccines caused excess deaths. This was accompanied by a predictable outpouring of I-told-you-sos on social media.

Excess deaths are a measure of how many more deaths are being recorded in a country over what would have been expected based on historical trends. In the UK, and in many other countries, death rates have been higher during the years 2020 to 2023 than would have been expected based on historic trends from before the pandemic. But that has been known for some time. A couple of years ago I wrote an article for The Conversation pointing this out and suggesting some reasons. But has anything changed?

The authors of the new study, published in BMJ Public Health, used publicly available data from Our World in Data to determine which countries had statistically significant excess deaths in other words, excess deaths that couldnt be explained by mere random variation.

They studied the years 2020 to 2022 and found that many, but not all, countries did indeed report excess deaths. The authors did not try to explain why these excess deaths occurred, but the suggestion that COVID vaccines could have played a role is clear from their text and indeed widely interpreted as such by certain newspapers.

There is no doubt that a few deaths were associated with the COVID vaccines, but could the vaccination programme explain the large number of excess deaths 3 million in 47 countries that have been reported?

Based on death certificates, during 2020 and 2021 there were more deaths from COVID than estimated excess deaths in the UK. So during the year 2021 when most vaccine doses were administered, there were actually fewer non-COVID deaths than would have been expected. It was only in 2022 that excess deaths exceeded COVID deaths.

If the vaccination campaign was contributing to the excess deaths that we have seen in recent years, then we should expect to see more deaths in people who have been vaccinated than in those who have not. The most reliable analysis in this regard was done by the UKs Office for National Statistics (ONS). In this analysis, the ONS matched death registrations with the vaccine histories of each death recorded. They then calculated age-standardised death rates to account for age differences between those vaccinated and those not.

What the ONS found was that in all months from April 2021 to May 2023, the death rate from all causes was higher in the unvaccinated than in people who had been vaccinated at least once.

That deaths from all causes were lower in the vaccinated than the unvaccinated should come as no surprise given that COVID was a major cause of death in 2021 and 2022. And there is ample evidence of the protective effect of vaccines against severe COVID and death. But what is even more convincing is that, even when known COVID deaths were excluded in the ONS report, the death rate in the unvaccinated was still higher, albeit not by very much in more recent months.

Some COVID deaths would certainly not have been recognised as such. But, on the other hand, people with chronic conditions, such as diabetes, were a high priority for vaccination. And these people would have been at increased risk of death even before the pandemic.

If the vaccine is not the cause of the excess deaths, what was?

The major cause of the excess deaths reported in the first two years of the BMJ Public Health study was deaths from COVID. But by 2022, excess deaths exceeded COVID deaths in many countries.

Possible explanations for these excess deaths include longer-term effects of earlier COVID infections, the return of infections such as influenza that had been suppressed during the COVID control measures, adverse effects of lockdowns on physical and mental health, and delays in the diagnosis of life-threatening infections as health services struggled to cope with the pandemic and its aftermath.

We do need to look very carefully at how the pandemic was managed. There is still considerable debate about the effectiveness of different behavioural control measures, such as self-isolation and lockdowns. Even when such interventions were effective at reducing transmission of COVID, what were the harms and were the gains worth the harms? Nevertheless, we can be confident that the excess deaths seen in recent years were not a consequence of the vaccination campaign.

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COVID vaccines saved millions of lives linking them to excess deaths is a mistake - The Conversation

Vaccine advisers to the Food and Drug Administration (FDA) today recommended switching the SARS-CoV-2 strain from the XBB.1.5 variant to JN.1 for fall vaccine formulations.

The recommendation marks the third remake for the COVID vaccine since 2022. The measure unanimously passed, 16 to 0. FDA officials, concerned about further evolution of JN.1, also asked the group to discuss the possibility of recommending an offshoot of JN.1, such as KP.2, that may more closely match currently circulating strains.

The Vaccines and Related Biological Products Advisory Committee (VRBPAC) was originally slated to meet on May 16 but postponed its discussion until today to allow time to gather more surveillance data and other information so that the group has the most up-to-date information.

JN.1 became the dominant strain in the United States at the end of 2023, but it continues to evolve. Offshoots such as KP.2 and KP.3now overshadowing the parent virushave an immune-evasive spike mutation combination that added more complexity to strain-selection considerations. Scientists have nicknamed the spike mutations FLiRT (FforLat position 456 andRforTat position 346).

The JN.1 FLiRT variants are partly responsible for case rises in some countries, with early US indicators showing aslight uptick from very low illness levels.

In late April, the World Health Organization vaccine advisory group recommended a switch to a monovalent (single-strain) vaccine that contains the JN.1 antigen.

At today's meeting, VRBPAC members heard from experts at the FDA, the Centers for Disease Control and Prevention (CDC), and vaccine manufacturers.

Ahead of the vote, Jerry Weir, PhD, who directs the viral products division in the FDA's vaccines research office, said nonclinical data from three vaccine manufacturers suggest that updated JN.1 lineage formulations prompt stronger neutralizing antibody responses against JN.1-descendant lineage viruses than the current monovalent XBB.1.5 vaccine. He also said serology data from people infected with JN.1 show improved antibody responses against JN.1 lineages, compared with sera from XBB-infected people, though neutralizing antibody responses appear to be reduced by recent mutations in many JN.1 lineage viruses.

After the vote, FDA officials asked advisory group members to weigh in on whether to select a specific JN.1 lineage, such as KP.2

During earlier presentations, a representative from Novavax said the company is already working on a JN.1 vaccine and that a switch to a newer lineage may mean the company won't be able to produce vaccine in time for the US market. Protein-based vaccines have longer manufacturing timelinesabout 6 months, which is similar to flu vaccinesthan mRNA vaccines do.

Most VRBPAC members said they thought JN.1 vaccines would provide good protection, and they didn't want to shut out the Novavax option for people who are unable to receive an mRNA vaccine or would prefer getting a protein-based vaccines.

Several members also said they weren't keen on "chasing variants." Melinda Wharton, MD, MPH, associate director for vaccine policy at the CDC's National Center for Immunization and Respiratory Diseases, said variants emerging when the updated COVID vaccines are released in August and September may not be the same as the ones the committee is discussing today, but will probably be related to JN.1.

Peter Marks, MD, who directs the FDA's Center for Biologics Evaluation and Research, pressed the group on whether it fully considered recommending a strain such as KP.2 that more closely matches circulating viruses. He also raised the possibility of exploring ways to give vaccine manufacturers a little more leeway on strains to include.

Michael Nelson, MD, PhD, professor of medicine and chief of the asthma, allergy, and immunology division at the University of Virginia School of Medicine, said he'd prefer a polyvalent vaccine containing JN.1 and KP.2, but for simplicity and based on reassuring neutralization data, JN.1 seems like a natural and obvious choice.

The group didn't vote whether to recommend a more specific strain, but FDA officials will take their views, alongside the earlier vote, into consideration when making its final recommendation to vaccine.

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FDA panel supports switch to JN.1 for fall COVID vaccines - University of Minnesota Twin Cities

Topline

Cancer vaccines are finally showing promise as Moderna and Merck touted promising data on an experimental skin cancer vaccine and the U.K. announced plans for a landmark scheme to test the technology across the country this week, after decades of research that could bring a new era of personalized medicine.

Moderna is one of the companies researching how mRNA technology can be used to treat cancer.

Merck and Moderna released extremely impressive positive data from a mid-stage trial of the worlds first personalized mRNA cancer vaccine for melanoma, the deadliest form of skin cancer, which when used alongside Mercks blockbuster immunotherapy, Keytruda, halved the risk of patients dying or the cancer returning.

The trial, the longest study into the new technology so far, is one of a growing number of collaborations testing how mRNA vaccines the technology underpinning COVID-19 in shots from Pfizer, BioNTech and Moderna can be turned against different types of cancer.

mRNA, short for messenger ribonucleic acid, is a kind of informational molecule that carries instructions for cells on how to make proteins, including antigens that can stimulate the immune system.

While mRNA shots for viruses like COVID-19 are designed to prevent disease by instructing cells to produce a harmless viral protein that trains the immune system to recognize and defend against the virus in the future, mRNA cancer vaccines are therapeutic and are for people who already have cancer.

Each vaccine is developed using samples of their cancer and personalized to an individual patient using genetic sequencing and artificial intelligence, priming the immune system to recognize unique mutations or features of the cancer cells and attack them if any are remaining or resurface after treatments like surgery, boosting chances of recovery and remaining cancer free in the future.

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While mRNA cancer vaccines are starting to show promise and experts hint a paradigm shift for cancer treatment is on the horizon, it is still early days for the therapy. The treatments have a long way to go until entering mainstream clinical practice. Until approval, the vaccine treatments are considered experimental and will primarily be available as part of clinical trials, for which patients around the world, including the U.S., are already being recruited. In late May, England announced a first-of-its kind scheme aimed at streamlining the often difficult recruitment process for trials. The countrys National Health Service will act as a matchmaker setting up thousands of patients with different clinical trials for specific cancer shots as part of the scheme, which is called the Cancer Vaccine Launch Pad. Victoria Kunene, a clinician leading the trial at Queen Elizabeth Hospital Birmingham, told the BBC she believes the vaccines mark a new era, adding that she hopes they become the standard of care one day.

Merck and Moderna said they started late stage clinical trials for both their melanoma vaccine and a lung cancer vaccine, both of which are actively enrolling participants. The firms have also started mid-to-late stage trials of squamous cell carcinoma, another type of skin cancer, as well as a type of kidney cancer and urothelial carcinoma, which makes up most bladder cancers.

Late last year, Moderna CEO Stphane Bancel told AFP of the melanoma vaccine: We think that in some countries the product could be launched under accelerated approval by 2025, describing the vaccines as immunotherapy 2.0.

The early successes of Modernas cancer vaccine has helped shore up confidence in the company and its future. While Moderna flourished during the pandemic, its coronavirus shots remain its only product on the market. This will soon change following the recent approval of its RSV shot, its second ever, but Moderna has struggled to maintain its profile amid an influx of mRNA competitors and dwindling demand for Covid jabs. Though it maintains a robust pipeline of traditional vaccines in development that use its mRNA technology such as for Lyme disease, flu and norovirus the company has bet big on its personalized cancer treatments and is clear it plans to be at the forefront of this new frontier of medicine.

Read more here:

What's a Cancer Vaccine? What To Know As Trials Show Promise - Forbes

Key Facts

Created in 1999 and formally launched in January 2000, Gavi, the Vaccine Alliance (Gavi) is an independent public-private partnership and multilateral funding mechanism that aims to save lives and protect peoples health by increasing coverage and equitable and sustainable use of vaccines. Gavis main activities include supporting low- and middle-income countries access to new and underused vaccines for vulnerable children through financial support, technical expertise, and market-shaping efforts, such as negotiating with manufacturers, to help lower the cost of procuring vaccines. Gavi operates in five-year funding cycles, with a revised strategy and goals for each cycle. Each five-year strategy is accompanied by a vaccine investment strategy, which determines which vaccines will be made available to countries.

Gavis current five-year strategy, for the 2021-2025 period, which is its fifth strategy, includes four core goals:

1. introduce and scale-up vaccines,

2. strengthen health systems to increase equity in immunization,

3. improve sustainability of immunization programs, and

4. ensure healthy markets for vaccines and related products.

The current strategy emphasizes reducing the number of zero-dose children with the goal of reaching no zero-dose children by 2030; prioritizing programmatic and financial sustainability of country immunization programs; supporting countries that have phased out of Gavi support or have never been eligible for Gavi support; and providing more tailored approaches for Gavi countries to reach under-vaccinated populations, such as those living in remote or conflict settings, by encouraging countries to adopt strategies that reduce potential barriers to vaccination. Gavi is currently in the process of developing its sixth strategy.

In addition to Gavis role in routine childhood immunizations, Gavi was one of the organizations leading COVAX, a multilateral effort that supported the equitable development, procurement, and delivery of COVID-19 vaccines globally that began in 2020 and ended in 2023. Gavis role in COVAX was to facilitate the procurement and delivery of COVID-19 vaccines, with particular emphasis on low- and middle-income countries. Provision of COVID-19 vaccines and funding support to countries has now been integrated into Gavis regular programming.

Gavis Secretariat, with its main headquarters in Geneva and an office in Washington, D.C., carries out the day-to-day operations of the partnership. Gavi does not have program offices or staff based in recipient countries but rather relies on country health ministries and World Health Organization (WHO) regional offices to implement programs. Gavi is led by a Chief Executive Officer (CEO), currently Sania Nishtar.

The 28-member Gavi Board sets Gavis funding policies and strategic direction, and monitors program implementation. It includes 18 representative seats, nine seats for independent individuals, and one ex-officio non-voting seat for Gavis CEO. The 18 representative seats, as specified in Gavis statute, are as follows: donor country governments (5), implementing country governments (5), the WHO, the United Nations Childrens Fund (UNICEF), the World Bank, and the Bill & Melinda Gates Foundation, and one seat each for civil society groups, the vaccine industry in industrialized countries, the vaccine industry in developing countries, and technical health/research institutes. Additionally, several Board committees guide and advise the Board and the CEO on Gavi activities under their purview. The U.S. government is currently represented on Gavis Board as the Board member for the donor country government constituency and is a member of the Audit and Finance Committee, Programme and Policy Committee, and the Market-Sensitive Decisions Committee.

Since its 2000 launch, Gavi has received approximately $30 billion in financing, not including funding for COVAX (see Table 1). Approximately four-fifths (80%) of Gavis funding came from contributions provided by donor governments and private organizations and individuals. The top three government donors were the United Kingdom, the U.S. and Norway, while the largest private donor was the Gates Foundation.

Donors support Gavi through direct contributions as well as funding commitments to innovative financing mechanisms, the proceeds of which help support Gavis overall financing. These innovative financing mechanisms include the International Finance Facility-Immunisation (IFFIm) and the Pneumococcal Conjugate Vaccine (PCV) Advance Market Commitment (AMC). The IFFIm was created in 2006 and uses donor funding commitments to back the issuance of special bonds in capital markets, essentially providing up-front financing to Gavi. The PCV AMC began in 2010, and though it ended in 2020, it supported accelerated access to pneumococcal vaccines through up-front funding commitments from donors and continues to do so through contracts with manufacturers that extend until 2029. The U.S. does not provide support to either of these mechanisms.

In addition to financing Gavis regular activities, donors pledged additional resources to support the Gavi COVAX Advance Market Commitment (COVAX AMC), a financial mechanism within COVAX that supported low- and middle-income countries through procurement and distribution of COVID-19 vaccines; through 2023, Gavi received $12.3 billion from donor governments, private philanthropy, and innovative financing mechanisms for the COVAX AMC for vaccine procurement, delivery, and logistics.

Only low- and middle-income countries with a Gross National Income (GNI) per capita below or equal to $1,730 on average over the last three years are eligible for Gavi support. In 2023, 54 countries were eligible for Gavi support; these included 23 of the 25 U.S. priority countries for maternal and child health assistance.

Recipient countries governments are expected to share responsibility for funding their national immunization efforts through Gavis co-financing requirements (introduced in 2008), determined according to country income level and transition status.As countries develop economically, they are expected to contribute a greater share of the funding required for immunization programs.Countries below the threshold (average of $1,730 GNI per capita over the past three years) and classified as low-income by the World Bank are initial self-financing countries, while countries below the threshold and classified as lower-middle income by the World Bank are in preparatory transition. Initial self-financing countries are responsible for co-financing the equivalent of $0.20 per dose each year. Countries in preparatory transition gradually increase their co-financing contribution each year. When a countrys income rises above the GNI per capita threshold, it moves into an eight-year accelerated transition period of increasing domestic financing share, after which the country is expected to fully fund its own immunization programs. As of 2023, 19 countries have transitioned out of Gavi financial support.

Additionally, as part of its 2021-2025 strategy, the Gavi Board approved limited support for countries that have transitioned out of Gavi eligibility and for middle-income countries (MICs) that have never been eligible for Gavi support. Recognizing that many formerly and never Gavi-eligible countries experience low coverage rates and have yet to make key vaccine introductions, an initial investment of $281 million was approved to provide limited support for 19 former and 26 never Gavi-eligible countries for political advocacy related to immunization, technical assistance, targeted assistance to reach under-vaccinated communities, and financial support for one-off costs and vaccine introductions.

Gavi provides grant financing to country programs in the following five areas:

Country allocations include funding ceilings, representing the maximum available funding each country can apply for during the 2021-2025 period, for all areas of support except vaccines. These ceilings are formulated based on a countrys number of zero-dose children, under-immunized children, birth cohort, and GNI per capita. For vaccines, all countries are required to pay a share of the cost of their Gavi-supported vaccines.

Additionally, Gavi has provided country support through emergency response funding, including: support for Ebola vaccination, allowing for up to $200 million in reprogrammed Gavi support for the COVID-19 response in Gavi-eligible countries, and other support for the COVID-19 response including the creation of COVAX (which helped expand access to COVID-19 vaccines in lower-income countries) and the COVID-19 Vaccine Delivery Partnership (CoVDP, which aimed to improve COVID-19 vaccine coverage in certain COVAX countries, with a particular emphasis on countries that were below 10% coverage in January 2022). In 2022, Gavi supported 40 outbreak response vaccination campaigns.

Since its launch in 2000, Gavi has provided approximately $23 billion to support country immunization programs (not including funding for COVAX). Over the past three years, 2020-2023, more than $7.3 billion has been disbursed, most of which has been for vaccine support (60%), followed by health systems strengthening (13%) (see Table 2).

Gavi reports it has helped to immunize more than 1 billion children in supported countries, including more than 68 million in 2022 alone, and supported 40 different vaccine introductions and preventive campaigns and 40 outbreak response campaigns in 2022. Additionally, Gavi support has helped avert more than 17.3 million deaths and contributed to more than $220 million in economic benefits, since its launch in 2000. Additionally, according to Gavi, its support has led to improved child health and immunization indicators across its supported countries. For example, the average vaccine coverage across multiple key Gavi-supported vaccines including the human papillomavirus (HPV) vaccine, inactivated polio vaccine, and pentavalent vaccine (the vaccine providing protection against diphtheria, tetanus, pertussis, hepatitis B, and Hib), among others was 56% in Gavi-supported countries in 2022, up from 48% in 2019 and higher than the global average of 53%. Lastly, Gavis work has contributed to vaccine market-shaping; for example, Gavi reports that its influence has helped lower the cost of the HPV vaccine from a price per dose of $4.50 in 2015 to $2.90 in 2022.

The U.S. government has supported Gavi since its creation. President Clinton made the initial U.S. pledge to the newly formed partnership in 2000, and the U.S. provided its first contribution in 2001. Currently, the U.S. supports Gavi through financial contributions, participation in Gavis governance, and by providing technical assistance. It also supports other global immunization that complement Gavis activities.

The U.S. has supported Gavi through direct contributions every year since 2001. Over the last 10 years, U.S. contributions grew from $175 million in FY 2014 to $300 million in FY 2024, which is the highest amount appropriated to Gavi thus far (see figure). Additionally, the Presidents Budget Request for FY 2025 signaled support for Gavis upcoming replenishment. Congress provides funding for U.S. contributions to Gavi through the Global Health Programs account at the U.S. Agency for International Development (USAID), specifically within the maternal and child health budget line. See the KFF budget tracker and the KFF fact sheet on the U.S. Global Health Budget: Maternal & Child Health (MCH) for details on historical appropriations for Gavi.

Additionally, in response to the COVID-19 pandemic, the U.S. provided $4 billion in FY 2021 emergency funding to Gavi COVID-19 vaccine procurement and delivery support under COVAX, making the U.S. the largest donor to COVAX (33% of $12.3 billion received overall). In addition to its financial support for COVAX, the U.S. donated the largest number of COVID-19 vaccines to other countries.

A U.S. government representative (from USAID) is currently a Board member of the donor government constituency on the Gavi Board. The U.S. government is also represented on the Gavi Boards Audit and Finance Committee, Programme and Policy Committee, and Market Sensitive Decisions Committee.

The U.S. also provides Gavi with technical support and expertise in the design, implementation, and evaluation of its programs in the field through partnerships with several U.S. agencies. For example, Gavis accelerated vaccine introduction programs have been conducted with technical support from the Centers for Disease Control and Prevention (CDC) and USAID, along with other partners.

Multilateral support of Gavi is one component of a broader set of global immunization activities of the U.S. government. The U.S. also provides bilateral (country-to-country) support for immunization through USAID, CDC, and other agencies, which focuses on strengthening routine immunization systems to deliver vaccines. U.S. multilateral and bilateral vaccine support are intended to be complementary. Indeed, many of the countries in which the U.S. carries out bilateral global immunization activities (provided as part of USAIDs maternal and child health efforts) also receive support from Gavi. See the KFF fact sheets on U.S. global MCH efforts and U.S. global polio efforts.

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The U.S. Government and Gavi, the Vaccine Alliance | KFF - KFF

Cervical cancer is the most common type of female cancer linked to the human papillomavirus or HPV.

Each year, almost 200,000 females are diagnosed with cervical pre-cancer, according to the Centers for Disease Control and Prevention (CDC), and about 11,100 females are diagnosed with HPV-caused cervical cancer. Roughly 4,000 females in the United States die annually from the disease. HPV infections typically resolve within a year or two.

However, some types of HPV can lead to the development of cancer in both males and females, resulting in about 36,000 cases of cancer each year. In fact, almost everyone will get infected at some point in their lifetime by a strain of HPV, according to the CDC.

There is a vaccine for HPV that can prevent over 90% of HPV-related cancers. In 2022, however, just 38.6% of young people in the U.S. had received at least one of the two recommended doses. Despite the risks associated with HPV in either sex, girls are more likely to be vaccinated against it than boys.

Now, new research reveals that HPV vaccinations may reduce the risk of HPV-related cancers by as much as 56% in males and 36% in females.

The findings, which were presented at the annual meeting of the American Society of Clinical Oncology May 31June 4 in Chicago, IL, have not been published in a peer-reviewed scientific journal.

Daniel Ganjian, MD, FAAP, board certified pediatrician at Providence Saint Johns Health Center in Santa Monica, CA, not involved in the research, explained to Medical News Today:

The incidence of HPV-related cancers in men is significant. According to the CDC, about 4 out of every 10 cases of cancer caused by HPV occur among men, with over 15,000 men getting cancers caused by HPV every year in the U.S. The types of HPV that cause cancer can affect both women and men, with HPV-related throat cancers more often affecting men and rapidly increasing in the developed world.

In females, the HPV virus is linked to the development of cervical, vaginal, and vulvar cancers. In males, HPV is associated with cancer of the penis. In both sexes, HPV can lead to throat cancer, as well as anal and anal canal cancer.

The HPV vaccine can prevent more than 90% of vaginal, cervical, and vulvar pre-cancers, involving abnormal cells that indicate a higher risk of cancer later on.

The authors of the new research compared about 1.7 million individuals who had been HPV-vaccinated with another similarly sized and age-matched group who had not been vaccinated.

The researchers found there were 3.4 cases of HPV-related cancer per 100,000 vaccinated males, while there were more than double that amount, 7.5 cases per the same number of unvaccinated males.

For females, the difference was also significant: There were 11.5 cases of HPV-related cancer per 100,000 vaccinated females, and 15.8 cases per 100,000 unvaccinated females.

Rachel Goldberg, LMFT, a therapist in Los Angeles, CA, not involved in the study, has counseled families about HPV vaccines.

For decades, women have been told about the importance of Pap smears to catch any early signs, she told MNT.

Most women know of at least one person [who] had to go through a minor procedure to remove abnormal cells thought to be HPV-related. Its often a woman in her 20s or 30s, Goldberg said.

Goldberg reported a rise in male HPV cancers, particularly among men from 40 to 60 years of age.

The CDC recommends children receive two doses of HPV vaccine starting at ages 11 to 12, although the two inoculations can begin as early as nine years of age.

For children who do not receive their first HPV vaccination before they are 15, three inoculations, not two, are required for optimal protection.

Its important to note that HPV vaccination prevents new HPV infections but does not treat existing HPV infections or diseases. The vaccine works best when given before any exposure to HPV, Ganjian said.

Goldberg noted that some parents may choose to delay vaccinating their children against HPV, perhaps because they are not yet sexually active.

Over time, parents may believe its too late, their child ages out of being under their care, or they assume it wont affect their child because of his [or her] level of responsibility, not understanding how easily HPV spreads, Goldberg explained.

The value of the HPV vaccine for males is known among physicians, but awareness and vaccine uptake among men have been low, Ganjian said.

Other misconceptions may contribute to stigma around HPV for young males, Goldberg noted.

It is still primarily viewed as a protective measure for girls, with some parents holding the belief that vaccinating their sons is only to protect their potential future female partners, Goldberg said.

CDC statistics indicate that demographics may determine whether a child is vaccinated against HPV in the U.S.

For example, vaccination rates increase as children age and are more likely in families with higher socioeconomic status. In addition, children with disabilities are more likely to receive vaccinations than children without disabilities.

In 2022, 41.5% of children vaccinated were from families with private health insurance. Children covered only by Medicaid represented 37% of vaccinations. Those with other government-funded insurance comprised 30.2%, while children with no insurance at all were 20.7% of those vaccinated.

Vaccination is less likely among Hispanic children compared to white children. Additionally, children living outside metropolitan areas are less likely to receive the HPV vaccine.

Studies suggest there are racial and ethnic disparities in HPV vaccine knowledge and trust in receiving cancer information from physicians, Ganjian said.

This could contribute to fewer boys getting the vaccine. Additionally, physician communication practices and the level of trust in cancer information from physicians may influence HPV vaccine awareness, he concluded.

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HPV vaccine reduces head and neck cancer risk in men by more than 50% - Medical News Today

The FDA has approved Moderna's RSV vaccine for older adults.

Courtesy: Moderna

The approval of Moderna's shot is based on a late-stage trial on older adults, who are more vulnerable to severe cases of RSV. The virus kills between 6,000 and 10,000 seniors every year and results in 60,000 to 160,000 hospitalizations, according to data from the Centers for Disease Control and Prevention.

Moderna's shot will be marketed under the brand name mRESVIA. It is the first messenger RNA vaccine to get approved for a disease other than Covid. The company's shot is also the only RSV vaccine to be available in a pre-filled syringe, which is designed to make it easier to administer to patients.

An advisory panel to the CDC will vote in June on recommendations for the use and intended population of Moderna's shot. The company expects an equal recommendation to existing RSV shots from GSK and Pfizer, Moderna executives said during an earnings call on May 1.

A positive recommendation from the CDC would allow Moderna's vaccine to compete against GSK and Pfizer, which launched their respective shots in the U.S. last fall. Pfizer's vaccine has so far lagged behind GSK's, but both shots have so far recorded hundreds of millions in sales.

Moderna's full-year 2024 sales guidance of roughly $4 billion includes revenue from its RSV vaccine.

The approval demonstrates the versatility of Moderna's messenger RNA platform beyond treating Covid. The biotech company is using that technology to tackle a range of different diseases, including RSV, cancer and a highly contagious stomach bug known as norovirus.

"The FDA approval of our second product, mRESVIA, builds on the strength and versatility of our mRNA platform," Moderna CEO Stphane Bancel said in a release. "With mRESVIA, we continue to deliver for patients by addressing global public health threats related to infectious diseases."

The biotech company currently has more than 40 products in development, several of which are in late-stage trials. They include its combination shot targeting Covid and the flu, which could win approval as early as 2025.

Moderna is also developing a stand-alone flu shot, a personalized cancer vaccine with Merck and shots for latent viruses, among other products.

Moderna has said it expects to return to sales growth in 2025 and to break even by 2026, with the launch of new products.

Investors have high hopes for the long-term potential of Moderna's mRNA product pipeline: Shares of the company are up more than 40% this year after falling nearly 45% in 2023.

The FDA was initially slated to make a decision on Moderna's jab on May 12. The agency delayed the approval, citing internal "administrative constraints."

A phase three trial on roughly 37,000 people showed that Moderna's vaccine was 83.7% effective at preventing at least two symptoms of RSV at around three months. New data from that study in February showed the shot's efficacy declined to 63% at 8.6 months.

At the time, those results raised concerns among investors that the shot's efficacy declined faster than that of shots from GSK and Pfizer. Moderna in a statement said comparisons can't be made without head-to-head trials on shots.

The company added that its trial had different study populations, geographic locations and case definitions for RSV, among other differences.

No significant safety concerns were identified in patients who took the shot in the trial. Most side effects were mild to moderate and included injection site pain, fatigue, headache, muscle pain and joint pain.

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FDA approves Moderna's RSV vaccine for seniors, the company's second-ever product - CNBC

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Thursday, May 30, 2024

NIH-funded animal model results will inform vaccine development in humans.

Using a combination of cutting-edge immunologic technologies, researchers have successfully stimulated animals immune systems to induce rare precursor B cells of a class of HIV broadly neutralizing antibodies (bNAbs). The findings, published today in Nature Immunology, are an encouraging, incremental step in developing a preventive HIV vaccine.

HIV is genetically diverse making the virus difficult to target with a vaccine, but bNAbs may overcome that hurdle because they bind to parts of the virus that remain constant even when it mutates. Germline targeting is an immune system-stimulating approach that guides nave (precursor) B cells to develop into mature B cells that can produce bNAbs. A class of bNAbs called 10E8 is a priority for HIV vaccine development because it neutralizes a particularly broad range of HIV variants. The 10E8 bNAb binds to a conserved region of the glycoprotein gp41 on HIVs surface involved in its entry into human immune cells. Designing an immunogena molecule used in a vaccine that elicits a specific immune system responseto stimulate production of 10E8 bNAbs has been challenging because that key region of gp41 is hidden in a recessed crevice on HIVs surface. Prior vaccine immunogens have not generated bNAbs with the physical structure to reach and bind to gp41.

To address this challenge, the researchers engineered immunogens on nanoparticles that mimic the appearance of a specific part of gp41. They vaccinated rhesus macaque monkeys and mice with those immunogens and elicited specific responses from the 10E8 B cell precursors and induced antibodies that showed signs of maturing into bNAbs that could reach the hidden gp41 region. They observed similar responses when they used mRNA-encoded nanoparticles in mice. The researchers also found that the same immunogens produced B cells that could mature to produce an additional type of gp41-directed bNAb called LN01. Finally, their laboratory analysis of human blood samples found that 10E8-class bNAb precursors occurred naturally in people without HIV, and that their immunogens bound to and isolated nave human B cells with 10E8-like features. Together these observations suggest that the promising immunization data from mice and macaques has the potential for translation to humans.

The research was conducted by the Scripps Consortium for HIV/AIDS Vaccine Development, one of two consortia supported by the National Institutes of Healths (NIH) National Institute of Allergy and Infectious Diseases (NIAID). The research also was supported by collaborating partners including the Bill & Melinda Gates Foundation and other NIH Institutes and Offices. According to the authors, these findings support the development of the immunogens as the first part of a multi-step vaccine regimen for humans. Their work further supports research in developing a germline-targeting strategy for priming the immune system to elicit a bNAb called VRC01. This bNAb was discovered by NIAID researchers almost 15 years ago. The goal of this line of research is to develop an HIV vaccine that generates multiple classes of bNAbs to prevent HIV.

Schiffner et al. Vaccination induces broadly neutralizing antibody precursors to HIV gp41. Nature Immunology DOI: 10.1038/s41590-024-01833-w (2024).

Angela Malaspina, program officer in NIAIDs Division of AIDS, is available to discuss this study.

NIAID conducts and supports researchat NIH, throughout the United States, and worldwideto study the causes of infectious and immune-mediated diseases, and to develop better means of preventing, diagnosing and treating these illnesses. News releases, fact sheets and other NIAID-related materials are available on the NIAID website.

About the National Institutes of Health (NIH): NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit http://www.nih.gov.

NIHTurning Discovery Into Health

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Novel vaccine concept generates immune responses that could produce multiple types of HIV broadly neutralizing ... - National Institutes of Health...