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.
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.
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.
FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC) met on June 5, 2024, to discuss and make recommendations on the selection of the 2024-2025 Formula for COVID-19 vaccines for use in the United States beginning in the fall of 2024.
The committee unanimously voted to recommend a monovalent JN.1-lineage vaccine composition. Following the vote, the committee discussed considerations for the selection of a specific JN.1 lineage SARS-CoV-2 strain (e.g., JN.1 or KP.2) and expressed a strong preference for JN.1.
During this meeting, the advisory committee was informed of the manufacturing timelines, and they reviewed the available data. These data included information on the circulation of SARS-CoV-2 virus variants, current vaccine effectiveness, human immunogenicity data of current vaccines against recently circulating virus variants, the antigenic characterization of circulating virus variants, animal immunogenicity data on new candidate vaccines expressing or containing updated spike components, and preliminary human immunogenicity data on JN.1 candidate vaccines.
Based on the totality of the evidence, FDA has advised the manufacturers of the licensed and authorized COVID-19 vaccines that the COVID-19 vaccines for use in the United States beginning in fall 2024 should be monovalent JN.1 vaccines to more closely match currently circulating SARS-CoV-2 viruses.
FDA will continue to monitor the safety and effectiveness of the COVID-19 vaccines and the evolution of the SARS-CoV-2 virus.
Modernas combo flu and COVID-19 vaccine zipped through a late-stage trial this winter, and the results are showing a higher immune response than licensed comparatorsincluding the famed biotechs own Spikevax.
MRNA-1083 is made up of Modernas flu shot mRNA-1010 and the next-generation COVID-19 vaccine mRNA-1283. Both components have individually shown efficacy in late-stage trials.
But together, Moderna hopes to create a product that can reduce the burden on patients and caregivers each season.
One of the things that we learned from the COVID experience is that there is a certain, let's say, fatigue to COVID-19 vaccine, and the difference between the vaccine coverage rates of influenza and COVID is quite substantial, Francesca Ceddia, M.D., Modernas chief medical affairs officer, said in an interview.
Moderna is hoping to offer a one-and-done shot that provides protection for both flu and COVID.
That is really a big advantage for not only pharmacists, but for health systems. And, of course, there is also a reduced burden in terms of cost for the hospitals, because if you're able to uplift vaccination rates because of the improved compliance, you are likely to prevent more hospitalization and other severe consequences due to COVID and influenza, Ceddia said.
These combo shots have become a central pillar of Modernas next act, as has the recently approved respiratory syncytial virus shot, which will be marketed as mRESVIA.
In the ongoing phase 3 trial, mRNA-1083 was tested in two groups of 4,000 adults each. One group featured adults 65 years or older and compared Modernas offering with co-administered Fluzone HD (Sanofi) and Spikevax. The second group had adults aged 50 to 64 years and compared mRNA-1083 to co-administered Fluarix (GSK) and Spikevax.
Across both groups, Modernas combo demonstrated noninferiority to the comparators and elicited statistically significantly higher immune responses against three influenza virus strainsH1N1, H3N2 and B/Victoriaand against SARS-CoV-2, Moderna said.
Ceddia said the COVID-19 portion of the combo showed higher responses because its an updated vaccine compared to Spikevax.
The fascinating thing is that we have developed a shorter version of the sequence of the mRNA which is currently available in the licensed vaccine, she said. The idea was to have a more stable version that could provide also better storage conditions.
That would mean mRNA-1083 could be made available at more locations without the complicated storage requirements that proved tricky in the early days of the pandemic. The combo can be stored in a refrigerator, Ceddia explained. The COVID-19 portion of the vaccine also has a lower dose than the approved shot.
Moderna also measured immunogenicity against the B/Yamagata flu strain, meeting noninferiority there as well. However, the World Health Organization has recommended that this strain not be included in vaccines for the 2024/25 flu season as it has disappeared from circulation.
Safety and tolerability for mRNA-1083 was acceptable, according to Moderna, with the majority of adverse reactions listed as grade 1 and 2 and consistent with the licensed products.
The combo vaccine advanced into phase 3 in fall 2023 after phase 1/2 data similarly showed thatmRNA-1083 matchedor beat two already approved shots for flu and the companys own Spikevax COVID shot in terms of developing antibody titers. Vaccine trials based on seasonal flu are quick to enroll, Ceddia said.
MRNA-1083 could soon become Modernas third marketed product, although Ceddia was mum on exactly what the next steps are beyond bringing the data to the FDA.
The approval of mRESVIA means Moderna is hard at work rolling out a shot. Ceddia sees that, plus Spikevax and eventually mRNA-1083, as a highly complementary portfolio for the marketing team to advance. It also marks Modernas move beyond being a one-trick COVID-19 company.
The beauty about the fact that they are all respiratory vaccines is that there is potential for a synergistic approach, she said. You're targeting the same stakeholders, you are targeting the same population. I see more potential for synergies than complexity.
Vaccines and immunisation
Clinical trials show two-in-one jab may bring about higher immune responses than separate inoculations
Mon 10 Jun 2024 10.14 EDT
A combined flu and coronavirus vaccine brings about a higher immune response to both diseases than when the vaccines are administered separately, a clinical trial has shown.
Moderna, the biotech firm behind the Spikevax vaccine used in NHS booster programmes, is trialling a two-in-one jab that can also protect from the flu. Initial results have shown it may be better at protecting against them than what is now being used.
The results showed that the antibody response in the participants brought about higher immune responses against flu and Covid-19 than when the vaccines were administered separately.
The company said they hoped the vaccine would be made widely available as early as next year.
The results came from a randomised controlled phase 3 trial of 8,000 people split into two groups.
The first group were aged 65 and over, and were testing the new jab in comparison with the flu vaccine and the Spikevax jab, while the second group were adults aged 50 to 64.
Stphane Bancel, the 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.
He added: 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.
Earlier this year, Boots said the retailer would offer the Pfizer-BioNTech vaccine to healthy customers in England aged 12 and over from next week, at a cost of 98.95 a jab.
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As much as wed like to think that COVID-19 is behind us, the virus isnt going anywhere. Health officials continue to recommend that people get vaccinated for both COVID-19 and influenza every year for the foreseeable future, and high hospitalization rates for COVID-19 in the past winter were a reminder that SARS-CoV-2 can still cause serious disease.
Soon, that may be possible with one shot instead of two. On June 10, Moderna reported that its combination COVID-19/influenza shot generated even better immune responses against SARS-CoV-2 and influenza than those elicited by existing, separate vaccines.
Both of the shots used in the study are experimental. The COVID-19 portion relies on a slightly different form of SARS-CoV-2s spike protein than the existing vaccine. Instead of encoding for the entire spike protein, the combination vaccine includes two key parts of it in a way that streamlines the shot to require a lower dosewhich is useful for a combination vaccine, and also potentially extends its shelf life. The influenza component of the vaccine uses the same mRNA technology behind the existing COVID-19 vaccine but targets influenza proteins in the three strains that circulated during the past season: H1N1 and H3N2 from the influenza A group, and an influenza B strain.
Read More: An mRNA Melanoma Vaccine Shows Promise
In a study of more than 8,000 adults ages 50 and older, about half received the combination vaccine. The other halfthe control groupreceived two separate shots: Moderna's latest COVID-19 vaccine, which targets the XBB.1.5 variant, and a flu shot (either Fluarix, if people were 50 to 64 years old, or Fluzone HD for those 65 and older).
In the younger group, the combo vaccine generated about 20% to 40% higher levels of antibodies to the influenza strains, and 30% higher levels to XBB.1.5, compared to the control group. Among older people, antibodies were 6% to 15% higher against the flu strains and 64% higher against XBB.1.5 compared to older people in the control group.
The real advantage of a single shot is that people only need to get one needle," says Dr. Jacqueline Miller, senior vice president and head of development in infectious diseases at Moderna. There's a public-health advantage, too, she says, since U.S. vaccination rates for both diseases are relatively low. "When we are able to give the two vaccines as one, it could increase vaccine compliance rates, especially for those at highest risk."
Read More: How to Navigate the New World of At-Home Testing
Moderna is continuing to study the COVID-19 vaccine and the flu shot used in the combo as separate shots as well. That data will also help the U.S. Food and Drug Administration (FDA) when it reviews the companys request for approval of the combination shot, which could come by the end of the year. The specific strains targeted in the shot will depend on which forms of the viruses are circulating at the time. (The company also filed a request to the FDA on June 7 to update its COVID-19 vaccine to target the JN.1 variant.)
The combination vaccine will likely not arrive in time for the flu and COVID-19 season this fall. But in coming years, a two-in-one vaccine could help to increase vaccination rates, which in turn could contribute to lower hospitalization rates for both diseases.
Moderna has filed an application with the US Food and Drug Administration (FDA) to review its updated Spikevax formula, designed to combat the SARS-CoV-2 variant JN.1, for the 2024 to 2025 season.
The move follows guidance from the FDA recommending an update to Covid-19 vaccines to include the monovalent JN.1 composition.
The recommendation was unanimously supported by the Vaccines and Related Biological Products Advisory Committee during a meeting held on 5 June 2024.
It aligns with theguidance from the World Health Organization Technical Advisory Group on Covid-19 Vaccine Composition and the European Medicines Agencys Emergency Task Force on the use of Covid-19 vaccines targeting the JN.1 variant.
The most common local adverse event linked to the updated Covid-19 vaccine of Moderna was pain at the injection site.
Systemic adverse events reported include headache, fatigue, myalgia and chills.
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These findings are critical as Moderna aims to secure global regulatory approval and supply the vaccine in time for the next vaccination season.
While the updated Spikevax vaccine for the 2024 to 2025 season is under review, the current 2023 to 2024 formula has been authorised for emergency use in individuals aged six months to 11 years.
The Spikevax vaccine is indicated for active immunisation against Covid-19 in individuals aged 12 years and above.
Moderna CEO Stphane Bancel stated: For four years, Moderna has consistently delivered vaccines that offer protection against Covid-19, and work is well underway to provide a vaccine targeting JN.1.
Staying up to date with your Covid-19 vaccine remains one of the best ways to protect yourself during the upcoming respiratory illness season.
The latest submission comes on the heels of Modernas recent success in securing FDA approval for its mRNA-based respiratory syncytial virus (RSV) vaccine, mRESVIA, for adults aged 60 and above.
Give your business an edge with our leading industry insights.
The experimental combo shot could also assist Moderna offset declining demand for COVID-19 vaccines caption Image: Dado Ruvic (Reuters )
Moderna said on Monday that its experimental combination vaccines against COVID-19 and the flu produced a higher immune response than existing, standalone vaccines in a late-stage trial.
GameStop stock falls yet again
The combo shot could become the companys third product on the market, after the U.S. Food and Drug Administration (FDA) in May approved Modernas mRNA-based respiratory syncytial virus (RSV) vaccine for people 60 and older.
It could also help Moderna offset declining demand for COVID-19 vaccines.
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, said Moderna CEO Stphane Bancel in a statement. Moderna is the only company with a positive Phase 3 flu and COVID combination vaccine.
Modernas experimental mRNA-1083 is made of up the companys flu vaccine candidate and its next-gen COVID-19 shot, Spikevax.
The combo vaccine is being tested in an ongoing phase 3 trial involving 8,000 people 50 and older.
In half the group, the shot was compared with patients receiving Modernas Spikevax and GSKs flu shot Fluarix. In the other half, the shot was compared with patients receiving Spikevax and Sanofis Fluzone HD, a high-dose flu shot for older people.
In both groups, mRNA-1083 produced a statistically significantly higher immune responses against three strains of the flu (H1N1, H3N2, and B/Victoria) and COVID-19. The shot was also found to be safe, with most common side effects being injection site pain, fatigue, myalgia and headaches.
Pfizer and Novovax are also developing their own combo vaccines.
Additionally, Moderna is testing a combo shot that would protect from COVID, RSV and the flu.
We have to talk about the word spikeopathy, not to be confused with psychopathy.
Our office recently celebrated its 25thanniversary25 years of, among other things, separating sense from nonsense on scientific matters. I would argue that our work is harder now than it has ever been: as the dance of science becomes ever more convoluted, pseudoscience follows in its footsteps, imitating its complexity and looking more and more convincing.
When a panic-inducing claim is made about a serious topic, like the COVID-19 vaccines, some will be reassured when an expert they trust simply tells them not to worry. Others, however, find the evidence for the claim so detailed and academic-looking that, even if they do not understand it, they require a deeper debunk. As Brandolinis law states, the amount of energy (and the number of words, I would add) required to refute nonsense is an order of magnitude bigger than was needed to produce it. Defecating on a pasture is easy; shoveling it out of there is a slog.
You may have heard from unscrupulous sources that our blood supply is now contaminated by the blood of the vaccinated, that the spike protein encoded by the COVID-19 vaccines is dangerous on its own and could now make the unvaccinated ill through transfusions. A prominent anti-vaxxer, the American Del Bigtree, even flew to Mexico to get a transfusion ofunvaccinated bloodfollowing a substantial blood loss from hemorrhoids.
As we slide down this rabbit hole, you will see why scientists have had to write multiple 10,000-word refutations on this subject. Those of us trying to fairly explain our understanding of the science of vaccines are at a major disadvantage: we cant simply make stuff up.
I am indebted to the work of medical doctors and scientists likeDavid Gorski,Ed NirenbergandDan Wilson, who regularly tackle bad COVID studies and perform their extensive pre-mortem autopsies. Its messy work. I will try to clean it up and summarize.
The tainted blood supply claim recently resurfaced thanks toa Japanese pre-print, meaning a scientific manuscript that has yet to be reviewed by other scientists. It paints a horrifying picture of studies apparently showing that the spike proteinitself, divorced from the coronavirus, stays in the body and takes on weird shapes that are infectious much like the prions of mad cow disease. The alleged disease caused by the spike protein has been called spikeopathy. And now the blood of vaccinated people has infected blood banks. The twist is that these fears arent voiced by an inmate in a madhouse; they come with citations to actual scientific papers, making them appear credible.
Lets look at the claim that the spike protein from the vaccine stays in the body for weeks, if not months. You will remember that the COVID vaccines contain molecular instructions, in the form of messenger RNA (mRNA) for the Pfizer and Moderna vaccines, for our bodies to make the coronavirus spike protein, which adorns the virus like a crown and helps it bind to the cells lining our airway. These instructions are read by some of our cells, the spike protein is made, and our immune system learns to recognize it in case it encounters it in the wild.
Anti-vaxxers claim this process, which was only supposed to last a few days, goes on for much longer in the body. We were lied to, they say. Onestudy, coming out of Harvard and the Universit de Montral, reported seeing the spike proteinin the bloodof 11 people who had been vaccinated, and the spike protein was not even supposed to end up in the blood but to stay inside of immune cells. How much of this spike protein was detected? A fewtrillionths of a gramper millilitre of blood, almost nothing, because the authors used a highly sensitive method and they managed to detect a signal at the edge of the assays limit. It is likely that some of the immune cells now displaying the spike proteina desirable thing for vaccines to workwerekilled by other cells or simply died, and these bits and parts of dead cells were picked up by this incredibly sensitive test. This is similar to apaperfrom Italy and the United Kingdom in whichfragmentsof the spike protein were found in the blood of vaccinated people up to 187 days post-vaccination. We have become the victims of our laboratory-enhanced eyes: we can now detect parts per quadrillion of chemicals, traces of traces. Its not far from spotting a single grain of rice on a beach and thinking the sand is getting contaminated.
When its not the spike protein itself that is seen, its the mRNA coding for it. ADanish studyshowed that this mRNA molecule could be found in the blood up to a month after receiving either the Pfizer or Moderna vaccine. But what the researchers found weeks after vaccination were, again,smallfragmentsof the mRNA, which cannot result in the production of the spike protein, like how a few lines from a recipe book arent enough to produce a cake. None of these findings are alarming once we contextualize them.
But can the spike protein make us sick divorced from the rest of the coronavirus?
The RNA instructions we get from the vaccines to make the spike protein are different from the ones found in the coronavirus. The RNA molecule is a string of bases, so-called letters, like beads on a string, and some of these bases have been modified for the vaccine through a process known as methylpseudouridylation. Without it, the RNA in the vaccines would have been recognized as foreign by our body and immediately destroyed, causing a bad immune reaction in the process. The vaccines would have failed. Scientists, knowing this, made these alterations so the RNA would be treated the same as human-made RNAs and would remain in cells long enough to be translated into the spike protein.
But panic erupted in anti-vaccine circles when it was discovered that this alteration meant the spike protein may not always be produced correctly. Rather, it was shown that the protein-producing apparatus wouldslipon this altered RNA molecule and read it differently. This is known as a frameshift. RNA is read three bases at a time and each triplet corresponds to a specific building block in the nascent protein. Imagine the phrase BAD JAB, where each triplet forms a word. If you slip and miss the initial B, you end up with ADJ AB, which is meaningless. Methylpseudouridylated RNA can slip in this way and produce nonsensical proteins. Could these nonsensical proteins, let loose in our cells, harm us?
We actually know, from using an artificial construct based on the vaccine mRNA, that these nonsensical proteins are much fewer in numbers compared to the actual spike protein (see the starred bands in figure 1E ofthis paper), and we also know from looking at the proteins made when we expose the Pfizer vaccine to the molecules in our cells that translate it into a protein thatonly the expected spike protein is easily detected. Anomalous versions of it, if they are there, are often too rare to be seen. Our bodies have already evolved to deal with the occasional wrong protein, so this is unlikely to be an issue.
Anti-vaxxers will tell you that frameshifting mutations can causesome diseases(many of which canalsobe caused by other types of mutations, by the way). But there is a vital difference here. In the case of the disease, the DNA itself has the frameshift mutation. The correct protein cannot be made from that bit of DNA. In the case of the COVID vaccines, frameshiftcanhappen occasionally, but it is not baked into the molecule and the correct spike protein is almost always produced in the end.
All of these individual claims are now routinely packaged into narrative reviews, often written by anti-vaccine celebrities like computer scientist Stephanie Seneff and ivermectin guru Peter McCullough, that scare the reader with speculative and decontextualized findings like these and that benefit from getting published in academic journals. These papers sneakily take findings in the coronavirus itself and the disease that it causes and speculate that it must also apply to the vaccine, as if our understanding of the damage the influenzaviruscan do was relevant to the safety of the fluvaccine. One suchinfamous reviewcontains 29 instances of the word potential or potentially and another 29 occurrences of could outside of its bibliography. With this much imaginary obsession over the spike protein, its no longer speculation; its spikulation.
One of these bits of spikulation is that the spike protein itself behaves like a prion. You may remember the scare over mad cow disease. Prion-based diseases are peculiar: they are caused by misshapen proteins whose altered shape is infectious. They corrupt our own version of the same protein and can cause nasty, degenerative conditions like Creutzfeldt-Jakob disease. But calling the spike protein a prion is a stretch: its because looking at the proteins sequence, scientists foundregions that are commonly found in prions. This is not evenin vitrowork; this isin silicostuff, done on the computer. This is then combined with areportthat 26 people were diagnosed with a prion disease within weeks of receiving a COVID vaccine. These oddities get repackaged in review articles to sound the alarm about mass harm.
So how do these fantastical, pseudoscientific review articles even get published in the first place? When the one with 29 uses of the word potential was published in the journalFood and Chemical Toxicology(the one which, appropriately enough, had publishedthe infamous Seralini studywrongfully linking GMOs and the commercial pesticide Roundup to cancer in rats, before retracting it), an emeritus professor in oncology wrote to the editor-in-chief, calling the paper amilitant, agitational tract.The editor did not take the paper down; in fact, you canstill read ittwo years after its publication. Through either naivet or kinship, some journal editors actually let anti-vaccine crusaders publish their sloppy work. Much of it gets published in journals that look predatory, with a quick turnaround time and little scrutiny. Then there is the impressive-soundingInternational Journal of Vaccine Theory, Practice, and Research, which appears to be a journal recently set up specifically to launder COVID-19 anti-vaccine speculation. Its editor-in-chief hasa doctorate in general linguistics, and associate editors include noted anti-vaxxers like Seneff and Brian Hooker.
The Japanese preprint about the tainted blood supply is similarly speculative and alarmist. It calls for the suspension of the vaccination campaign against COVID, using the same repackaged half-truths and fictions that so many other anti-vaccine review articles spew. One of its authors, Masanori Fukushima, hasalready publishedwith Seneff and McCullough.
But if the mRNA vaccines were so dangerous, inoculating us with a prion protein comparable to what we see in mad cow disease, we would know by now. The intense scrutiny these vaccines are under resulted in the detection of a one-in-a-million blood clot risk with the Johnson&Johnson vaccine six weeks after it started to be widely distributed. Anti-vaxxers will thenturn to the VAERS websiteand other databases dedicated to the reporting of illness following vaccination as proof of harm, but they refuse to understand how these databases work to protect the public. Just because I get a headache the day after receiving a vaccine does not mean the vaccine gave me the headache. We have to look at how common headaches are in general and see if there has been an increase. The same goes for prion diseases.
The COVID vaccines, administeredover 13 billion times, are really, really safe. Amassive reviewlooking at 41 randomized controlled trials of 12 different COVID-19 vaccines on a total of nearly half a million participants concluded that there was probably little to no difference between most vaccines and placebos when it came to serious side effects. Yes, rare serious side effects do happen, and scientists are trying to figure out why, with their early clues misused by anti-vaccine activists to paint these vaccines as genocidal. But if the spike protein encoded by these vaccines was so deadly, you would not survive receiving 217 of these injections. Yet a German man did. Why? Thearticlereporting on this oddity mentions private reasons, but his immune system was fine and he did not die.
I wouldnt worry if he offered to donate some of his blood.
Take-home message: - The claim that the spike protein or its messenger RNA can be detected for weeks or months after vaccination is based on studies where fragments were barely detectable, often trillionths of a gram, which is in keeping with our understanding of biology - The fears around the wrong protein being made because the vaccine RNA has been modified is not backed up by the evidence, which shows that those wrong proteins are few and far in between and are likely destroyed by the cell like most malformed proteins we naturally produce - The idea that the spike protein would behave like a prion and cause disease is not based on laboratory studies in cells and animals, but rather on computer analyses of its sequence - Over 13 billion doses of the COVID-19 vaccines have been administered, with robust data showing they are overwhelmingly safe
@CrackedScience
