Category: Vaccine

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New mRNA cancer vaccine from Moderna trialled in British patients – The Independent

February 5, 2024

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A new mRNA cancer vaccine made by pharmaceutical firm Moderna is being trialled in British patients.

The mRNA technology which was adapted to make Covid-19 jabs works by helping the body recognise and fight cancer cells.

Experts believe these vaccines may lead to a new generation of off-the-shelf cancer therapies.

Once in the body, the mRNA (a genetic material) teaches the immune system how cancer cells differ to healthy cells and mobilises it to destroy them.

Current immunotherapies are removing the invisibility cloak that makes cancer hide within the body, but this removal is very non-specific. The appeal of cancer vaccines is that you can make it much more specific - you can basically give the immune system written instructions

Dr David Pinato, Imperial College Healthcare NHS Trust

mRNA cancer vaccines from firms like BioNTech, Merck and Moderna have been undergoing testing in small trials across the globe, with promising results.

In some cases, vaccines are created specifically for the patient in the lab using their own genetic information, while others are more general vaccines targeted at specific types of cancer.

In the latest development, British patients are trialling a vaccine called mRNA-4359 as part of an early-stage clinical trial that will initially look at safety as well as effectiveness.

The vaccine is aimed at people with advanced melanoma, lung cancer and other solid tumour cancers.

An 81-year-old man, who is taking part in the trial arm run by Imperial College London and Imperial College Healthcare NHS Trust, was the first UK person to receive the vaccine at Hammersmith Hospital in late October.

The man, from Surrey, who does not wish to be named, has malignant melanoma skin cancer which is not responding to treatment.

He said: I had a different immunotherapy, I had radiotherapy, the only thing I didnt have was chemotherapy. So, the options were either do nothing and wait, or get involved and do something.

Im extremely grateful to the hospitals and the individuals that are running these trials.

Somehow we have to change the fact that one in every two people get cancer at some point, and we have to make the odds better.

During the trial, the vaccine will be tested alone and in combination with an existing drug pembrolizumab, which is an approved immunotherapy treatment, also known as Keytruda.

Between 40 and 50 patients are being recruited across the globe for the trial, known as Mobilize, including in London, Spain, the US and Australia, although it could be expanded.

Dr Kyle Holen, head of development, therapeutics and oncology at Moderna, told the PA news agency the vaccine may be able to treat a range of cancers.

He said: We currently are studying both melanoma patients and lung cancer patients, but we believe that theres an opportunity for this vaccine in the Mobilize trial to treat many other cancers.

We believe it could be effective in head-neck cancer, we believe it could be effective in bladder cancer, we believe it could be effective in kidney cancer.

So theres a lot of cancers where we think this vaccine can be effective.

But were starting out with the two that we think have the highest probability of being effective and that is melanoma and lung cancer.

We all know how worrying a cancer diagnosis can be for people and their loved ones, but access to these ground-breaking trials alongside other innovations to diagnose and treat cancers earlier provides hope, and we expect to see thousands more patients taking part in trials of this kind over the next few years

Professor Peter Johnson, NHS national clinical director for cancer

Dr David Pinato, consultant medical oncologist at Imperial College Healthcare NHS Trust, and investigator of the UK arm of the trial, told PA that cancer vaccines differ to immunotherapy, which also help the immune system see and attack cancer.

He said: Current immunotherapies are removing the invisibility cloak that makes cancer hide within the body, but this removal is very non-specific.

The appeal of cancer vaccines is that you can make it much more specific you can basically give the immune system written instructions.

Its almost like an identikit of the tumour cells, which is more precise.

He said the advantage of mRNA technology is that it makes your own body produce those instructions.

He added: The fact your body is producing them awakens the immune system, it is even more active.

He said the vaccine being tested in the trial is an off-the-shelf vaccine rather than one that is tailored to each individual patient.

While personalised vaccines can be very effective, they can take weeks to make and rely on a large tumour sample.

There is also not enough data at present to say whether personalised vaccines are in fact better than broader cancer vaccines, he said.

The Moderna vaccine, he added, is looking at specific traits across a number of tumours.

Its basically looking at what is the most frequent hit that you can target in cancer?, he said.

And so that has got incredible advantages in terms of the turnaround time, the fact you can make doses of the vaccines ahead of time even before meeting the patient. That is really the advantage.

Dr Pinato said it is unclear why some patients benefit from immunotherapy and cancer vaccines while others do not.

My educated guess, knowing what I know about cancer immunotherapy, is that the interaction between the tumour and the immune system is very complex, he said.

For example, some types of lung cancer respond much better than others.

It could be that maybe some patients cannot use those vaccines well, so the immune system is still so low it wouldnt benefit, even with precise instructions, he added.

I think, having developed a number of drugs for cancer, there is never really going to be one that does everything.

Professor Peter Johnson, NHS national clinical director for cancer, said the NHS is at the vanguard of trials of cancer vaccines.

He added: We all know how worrying a cancer diagnosis can be for people and their loved ones, but access to these ground-breaking trials alongside other innovations to diagnose and treat cancers earlier provides hope, and we expect to see thousands more patients taking part in trials of this kind over the next few years.

Health and Social Care Secretary Victoria Atkins said: This vaccine has the potential to save even more lives while revolutionising the way in which we treat this terrible disease with therapies that are more effective and less toxic on the system.

Originally posted here:

New mRNA cancer vaccine from Moderna trialled in British patients - The Independent

Malaria vaccine is highly effective in young children, study suggests – The Independent

February 5, 2024

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A malaria vaccine which has been developed with the help of Oxford University scientists is up to 78% effective in the youngest children, new data suggests.

Last year the R21/Matrix-M vaccine was recommended for use by the World Health Organisation (WHO).

New data from a phase 3 trial in African children confirms the jab is effective and safe.

Researchers immunised more than 4,800 young children in a trial in Burkina Faso, Kenya, Mali and Tanzania and found on average 78% efficacy in the five to 17-month age group over the first year.

The Lancet study on R21/Matrix-M phase 3 trials marks a significant advancement in our battle against this global threat

Adar Poonawalla, Serum Institute of India

The experts say that so far no other vaccine has reported more than 55% effectiveness in the same age group.

According to the findings, published in The Lancet, a booster dose at a year maintained good efficacy over the following six to 12 months.

The overall efficacy was between 68% and 75% for children aged five to 36-months-old.

So far, 25 million doses have been manufactured and made ready for roll-out by the Serum Institute of India (SII) in the next three to four months.

Significantly increased immune responses to the vaccine, and slightly higher vaccine efficacy, were observed in five to 17-month-olds compared to 18 to 36-month-olds, supporting planned vaccine deployment initially from five months of age in African children.

Malaria is the largest cause of death in young African children, with 600,000 dying every year.

Two vaccines have recently achieved and completed WHO pre-qualification, and initial deployments are starting early this year.

Professor Adrian Hill, chief investigator of the R21/Matrix-M phase 3 trial, said: The continued high efficacy of this new vaccine in field trials is very encouraging, and consistent with the high efficacy and excellent durability observed in a smaller four-year phase 2b trial.

Audrey Duncanson, innovations transition manager at Wellcome, said: Malaria still remains a huge global health risk for nearly half of the worlds population, with the burden of this disease predominantly in African countries causing approximately 600,000 deaths in children under the age of five years.

The results from this recent phase 3 trial of the malaria vaccine, R21, holds huge potential for a transformative impact on malaria in children.

This is an important step towards getting a highly effective, safe, readily accessible affordable vaccine to protect children from malaria in African countries.

Adar Poonawalla, chief executive of SSI, said: The Lancet study on R21/Matrix-M phase 3 trials marks a significant advancement in our battle against this global threat.

We are dedicated to making this vaccine available, especially in Africa, where malaria poses a substantial threat to millions of lives, bringing us closer to a malaria-free world.

The vaccine is cheap, costing between two US dollars (1.65) and four dollars (3.30) per dose.

At least 28 countries in Africa plan to introduce a WHO-recommended malaria jab as part of their national immunisation programmes.

Matrix-M adjuvant is manufactured by Novavax AB and provided to SII for formulation into the final vaccine drug product.

An adjuvant is an ingredient used in some vaccines to enhance the bodys immune response, which helps them to work better.

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Malaria vaccine is highly effective in young children, study suggests - The Independent

Huge cancer breakthrough as new vaccine could cure illnesses in ‘dawn of a new age’ – Express

February 5, 2024

The Mobilize trial is expected to report its findings next year. (Image: Getty)

An experimental new vaccine from Moderna could help beat cancer, experts have revealed.

The creators of the new jab were one of the companies responsible for Covid vaccines during the pandemic.

In October, an 81-year-old man who has incurable skin cancer was the first person to be jabbed with the potential miracle injection.

He said of the treatment: "Taking part gives a sense of contributing to something which can help a lot of people."

Imperial College NHS Trust's Dr David Pinato and his team are running tests to find out if the jab is safe enough for a three-year worldwide trial.

He said: "Research is in the early stages . . . but it is moving us closer to therapies that are potentially less toxic and more precise."

Dr Pinato is hopeful the treatment will be able to treat skin and lung cancers first, before treating other cancers like bowel and breast.

Professor Peter Johnson, NHS cancer director, said of the new treatment: "Cancer vaccines could be revolutionary.

"We expect to see thousands more patients taking part in trials of this kind over the next few years."

Victoria Atkins, the Health Secretary, added: "This vaccine has the potential to save lives while revolutionising the way we treat this terrible disease with therapies that are more effective and less toxic."

Meanwhile, Modernas Dr Kyle Holen said: "People have been working on cancer vaccines for more than 20 years and the field has finally come to a point where were starting to see a real benefit in patients.

"That was something that we saw with our first vaccine, where we were able to reduce the risk of recurrence by more than half in patients who had high-risk melanoma.

"So were really excited about some of the early results and we hope that this brings in the dawn of a new age of cancer treatments."

The vaccine is part of a trial called Mobilize.

Read more:

Huge cancer breakthrough as new vaccine could cure illnesses in 'dawn of a new age' - Express

Vaccine clinics offering COVID-19, flu shots open to adults on Wednesday – NewsCenterMaine.com WCSH-WLBZ

February 5, 2024

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The clinics will be open in Hallowell and Presque Isle. An insurance card is not needed to receive the vaccines.

Author: newscentermaine.com

Published: 6:32 PM EST February 4, 2024

Updated: 6:32 PM EST February 4, 2024

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Vaccine clinics offering COVID-19, flu shots open to adults on Wednesday - NewsCenterMaine.com WCSH-WLBZ

Immunoinformatics, molecular docking and dynamics simulation approaches unveil a multi epitope-based potent … – Nature.com

February 5, 2024

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Original post:

Immunoinformatics, molecular docking and dynamics simulation approaches unveil a multi epitope-based potent ... - Nature.com

Overview of the 2023-24 COVID-19 Vaccine: Effectiveness, Variants, and Recommendations – Medriva

February 5, 2024

Overview of the 2023-24 COVID-19 Vaccine

In the ongoing battle against COVID-19, the effectiveness of vaccination remains a central focus. A recent study published in the Morbidity and Mortality Weekly Report (MMWR) brings into light insights about the updated 2023-24 COVID-19 vaccine. The study aims at understanding the impact of the updated monovalent XBB.1.5 vaccine against symptomatic COVID-19 infection, including the new JN.1 lineage.

According to the study, the updated vaccine provides approximately 54% protection against symptomatic illness. The estimated vaccine effectiveness (VE) is 57% in the 18-49 age group and 46% among individuals aged 50 and older. The VE was also estimated at 58% and 49% among people tested 7-59 and 60-119 days after receiving the updated vaccine, respectively.

The primary focus of the study was to ascertain the effectiveness of the updated COVID-19 vaccine against symptomatic SARS-CoV-2 infection, including the JN.1 and other circulating lineages. The effectiveness of the vaccine against severe disease and its expected waning over time were also analyzed. The study found that the updated COVID-19 vaccines provide approximately 54% increased protection against symptomatic SARS-CoV-2 infection compared to no receipt of the updated vaccine.

However, its vital to note that the study suggests the VE will likely wane with time since vaccination, especially against less severe outcomes. This finding is consistent with other studies that show vaccine-induced immunity tends to decrease over time, necessitating regular updates to the vaccine and possible booster shots.

The findings of the study have important implications for public health and vaccine strategies. The CDCs Advisory Committee on Immunization Practices recommends that all persons aged 6 months and older should receive the updated COVID-19 vaccine. This recommendation is particularly crucial considering the introduction of new SARS-CoV-2 lineages and the potential for decreased vaccine effectiveness over time.

The MMWR study is one among many public health resources providing crucial information on topics such as asthma, travel-related diagnoses, e-cigarette sales, COVID-19 vaccine effectiveness, HIV behavioral surveillance among transgender women, and CDC guidelines for the prevention and treatment of anthrax. Such reports underline the importance of ongoing research and timely vaccination in managing the COVID-19 pandemic.

The updated 2023-24 COVID-19 vaccine shows promising effectiveness against symptomatic infection, including the JN.1 lineage. However, as with all vaccines, the effectiveness is expected to wane over time, underscoring the importance of staying updated with vaccinations. As research continues to evolve with the pandemic, it is crucial to rely on credible sources for information, like the MMWR, and follow recommended vaccination schedules to safeguard individual and public health.

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Overview of the 2023-24 COVID-19 Vaccine: Effectiveness, Variants, and Recommendations - Medriva

CDC: Notice sent to healthcare workers after mix-up in RSV vaccines for pregnant women, infants – RochesterFirst

February 5, 2024

ROCHESTER, N.Y. (WROC) The Center for Disease Control and Prevention told News 8 Friday they recently sent out a notice to healthcare providers after more than 150 reports of the wrong RSV vaccinations was given to pregnant women and children.

News 8 inquired with the CDC after a caller was wondering why she wasnt able to get the RSV vaccine after getting a prescription from her OB-GYN.

After a response from the CDC said the vaccine is administered from September to January, they also said their vaccine tracker system, Vaccine Adverse Event Reporting System, reported more than 150 children and pregnant women were given the wrong vaccine by doctors offices and pharmacies.

With the RSV vaccine only recently being approved for pregnant women. If they choose to, they are supposed to receive a dose of the maternal RSV vaccine abrysvo.

During weeks 32 through 36 of pregnancy, administered before or during RSV season. Instead, they were receiving the GSK vaccine, Arexvy which is not approved for use during pregnancy.

An OB-GYN with Rochester Regional Health who told News 8 while there were no mix-ups in their healthcare system, she explained the importance of receiving the correct vaccine.

The biggest issue would be that they wouldnt be able to protect their baby, Dr. Fran Haydanek with Rochester Regional Health. Through vaccination of the pregnant patient, we still have ways to protect babies once theyre born. There are medications for babies, and I know a little less about that since thats not my area of expertise. So, there would still possibly be the opportunity to protect babies that way once theyre born, but they just wouldnt be able to pass that immunity on through pregnancy.

The CDC said in their statement to News 8 that while it is rare, vaccine administration errors are known to occur and have the potential to increase after a new vaccine is introduced and reiterated, they have reached out to administrators to educate them.

While rare, vaccine administration errors are known to occur and may increase after a new vaccine or product is introduced. To prevent mix-ups, CDC has reached out to clinicians to educate them about the proper administration of the new RSV vaccines and to alert them that misadministrations, while uncommon, have occurred. Education and additional vigilance will reduce the likelihood of errors.

Original post:

CDC: Notice sent to healthcare workers after mix-up in RSV vaccines for pregnant women, infants - RochesterFirst

Measles: Parents told to rebook missed MMR vaccine appointments – BBC.com

February 5, 2024

4 February 2024

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Vaccine rates in Newcastle, Middlesbrough and Hartlepool are too low, health officials have warned

Health bosses are urging parents to rebook any missed mumps, measles and rubella vaccine (MMR) appointments.

Data showed the North East and north Cumbria had the highest uptake in England, but second doses fell below what is required to avoid outbreaks.

Parts of Newcastle, Middlesbrough and Hartlepool are at risk because numbers are "not high enough".

One health chief said measles is a highly infectious disease but "completely preventable".

Dangers including blindness, deafness and swelling of the brain.

Children require two doses of the MMR vaccine, the first dose given around their first birthday and the second dose given at three years and four months old.

Both doses are needed to ensure full and lasting protection against MMR, according to the NHS.

NHS North of England Care System Support (NECS) data shows in 2022-23, of the 33,937 five- years-olds in the North East and north Cumbria, 96% received their first MMR vaccination however, only 91% received their second.

Dr Neil O'Brien, medical director at the North East and North Cumbria Integrated Care Board, said: "Spending just 15 minutes or more in direct contact with someone infected is enough to catch measles, making it one of the most infectious diseases in the world."

Dr O'Brien added: "Whilst overall MMR rates in our region are good, there are still some localised places where it is not high enough to prevent a rapid spread of measles; including areas of Newcastle, Middlesbrough and Hartlepool."

Cumbria's director of public health Colin Cox said: "Measles can be a very serious illness but getting vaccinated is safe, free of charge and offers the best possible protection."

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Measles: Parents told to rebook missed MMR vaccine appointments - BBC.com

Has a decade of maternal pertussis vaccination reduced its effectiveness? – News-Medical.Net

February 5, 2024

In a recent modeling and meta-analysis study published in the journal Nature Communications, researchers evaluated if maternal immunization against pertussis, a highly contagious bacterial respiratory infection, experienced reduced efficacy (blunting) due to prolonged use. They reviewed four studies with up to six years of follow-up and designed a novel mathematical model to evaluate immunizations short- and long-term effects on disease transmission dynamics. While incapable of ruling out minor reductions in vaccine effectiveness (VE), their findings highlight that maternal immunizations are (and will continue to be) essential in preventing pertussis transmission and, more importantly, saving the lives of unvaccinated newborns.

Study: Maternal pertussis immunization and the blunting of routine vaccine effectiveness: a meta-analysis and modeling study. Image Credit:Kateryna Kon/ Shutterstock

Pertussis, colloquially called whooping cough, is a highly contagious respiratory illness caused by the bacteria Bordetella pertussis. Its symptoms included chronic or severe cough, general fatigue and fever, nausea, and difficulty breathing. It is characterized by its severe hacking cough from which the name whooping is obtained. Pertussis infections are most severe in children, especially newborns, and were a significant cause of childhood mortality before the 1940s.

Thankfully, pertussis is easily preventable via vaccines. Global large-scale immunization efforts in the 1940s reduced transmission rates by 90% in most countries. Unfortunately, for reasons hitherto unknown, pertussis has been staging a comeback over the past two decades. This has prompted a resurgence into pertussis-centric research aimed at evaluating the mechanisms underpinning rising transmission rates.

Infants, especially newborns, are the cohort most vulnerable to the disease, given their suboptimal immune development and lack of immunization. To counter this, numerous nations (since 2012) and the World Health Organization (since 2015) have recommended and initiated maternal immunization programs. Vaccinating women during the gestation period has been clinically revealed to transfer its protective effects to their unborn infants, resulting in an estimated 70% reduction in newborn mortality.

However, the downstream consequences of maternal immunization, when infants receive their routine pertussis vaccines, are poorly understood. Specifically, there has been long-standing concern regarding potential immunological blunting, i.e., the interference of maternally transferred antibodies with the infant immune response.

Understanding if current vaccination protocols are resulting in immunization blunting, and if so, to what extent, will allow for the revision of present immunization policies and may require an overhaul of the vaccines used or the process itself.

In the present study, researchers conducted a meta-analysis to investigate if prolonged (2012 to 2023) maternal immunization has reduced vaccine effectiveness (VE). The study followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines.

Data collection was initiated by collating relevant publications from three online databases (PubMed, Web of Science, and Scopus) from database initiation till August 25, 2023. This search revealed 374 articles across databases, 146 of which were duplicate records. Of the 228 remaining publications, abstract screening revealed 69 potential articles, which full-text screening further narrowed down to the final sample set four.

To be included in our review, studies had to provide an estimate of the relative risk (RR) of pertussis in infants having received at least one dose of their primary immunization from vaccinated vs. unvaccinated mothers. We selected only those studies that used laboratory-confirmed diagnosis of pertussis.

Each of the four included studies reported at least five pertussis relative risk estimates in comparing vaccinated and unvaccinated mothers. Study analyses were carried out using two steps Firstly, to account for different metrics used in the included studies, standard relative risks were calculated and applied to each included metric. Secondly, the meta-analyses were carried out. The meta-regression used herein was corrected to account for population as a random intercept.

Finally, researchers devised a novel mathematical model based on the Susceptible-Exposed-Infected-Recovery (SEIR) model, explicitly testing for VE accounting for immunization blunting. The model had two outcome measures 1. failure in take (if the primary vaccine failed), and 2. failure in duration (loss or reduction of vaccine protection). The model works in a hierarchical compartmentalization framework comprising three levels, each with their own paths.

Level 1: These three possible paths or compartments start from their mothers immunization status during pregnancy, followed by an infant immunization schedule that resembles that of the empirical studies. Level 2: newborns can be born in three possible compartments: from vaccinated mothers whose immunization succeeded, mothers whose immunization failed (i.e., who received the vaccine but whose infant remained unprotected), or unvaccinated mothers. Level 3: Each of the three compartments is followed by a compartment for successful primary infant immunization and a compartment for failed primary infant immunization, thereby becoming susceptible, or no immunization thereby also becoming susceptible.

Exploring the historical landscape of VE in infant pertussis via the novel model revealed that infant (maternal) immunization substantially decreased disease incidence. However, consistent with global reports, this was followed by a gradual rebound in pertussis persistence. This is consistent with the previously described end-of-honeymoon effect and is expected in most diseases managed using imperfect yet highly efficient vaccines. These results validate model reliability.

Analyzing the sample dataset using this model revealed that the first vaccine dose in infants following maternal immunization is highly effective against pertussis contraction, but the second and third doses are much more uncertain, consistent with previous uncertainty regarding blunting effects. The model demonstrated the presence of a decade-long lag phase following the introduction of maternal immunization, during which time blunting effects are liable to be underestimated in trial studies.

Encouragingly, quantifying the blunting effects suggests that they are minor and pale compared to the infant mortality-saving that maternal immunization provides. These findings support the public health decisions of many countries (55 as of 2021) to continue maternal immunization efforts and recommend that other nations follow suit.

The present study conducted a meta-regression analysis of four epidemiological publications to investigate the potential blunting effect of decade-long maternal immunization efforts. They further devised and implemented a mathematical model to interpret pertussis relative risk while explicitly accounting for vaccine efficacy blunting.

Their findings reveal the presence of a transient decade-long lag phase following maternal immunization, characterized by the masking and underestimation of blunting effects, thereby explaining previous inconsistencies in the literature. More importantly, the study highlights that while moderate levels of VE loss via blunting do exist, they are far outweighed by the infant mortality savings that maternal vaccination provides.

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Has a decade of maternal pertussis vaccination reduced its effectiveness? - News-Medical.Net

New phase 3 trial data confirm the uniquely high efficacy and good safety profile of the R21/Matrix-M malaria vaccine in … – University of Oxford

February 5, 2024

Phase 3 Trial data results of The R21/Matrix-M vaccine developed by Oxford University and Serum Institute of India Pvt Ltd, leveraging Novavaxs Matrix-M adjuvant has confirmed high efficacy and supported regulatory approvals and licensure in several African countries. The R21/Matrix-M vaccine was designed in 2011 as a potential improvement on the RTS, S/AS01 malaria vaccine designed in the 1980s. A phase II trial in Burkina Faso, reporting in 2021, was the first to show that R21/Matrix-M could reach the WHO-specified target of 75% efficacy in African children. Recent WHO endorsement will lead to the initial rollout of R21/Matrix-M in the coming months. The new results are published inThe Lancettoday.

The trial investigators immunised over 4800 young children in a trial in Burkina Faso, Kenya, Mali and Tanzania and found on average 78% vaccine efficacy over the first year of follow-up across all sites in the 5-17-month-old age group, the age range group which is studied for most malaria vaccines. Efficacy over this period was broadly similar across sites and in different transmission settings. Safety data from the trial have been reassuring with no serious adverse events linked to immunisation. No other vaccine has reported over 55% efficacy in the same age group. A booster dose at a year maintained good efficacy over the following 6-12 months. The vaccine also reduced infection rates in children measured at 12 and 18 months after vaccination suggesting a potentially beneficial effect in reducing malaria transmission.

R21/Matrix-M vaccine was well tolerated, with injection site pain and fever as the most frequent adverse events. Number of adverse events of special interest and serious adverse events did not significantly differ between the vaccine groups. There were no treatment-related deaths.

Malaria is the largest cause of death in young African children with over 600,000 deaths globally each year. Two vaccines have recently achieved and completed World Health Organization (WHO) prequalification and initial deployments are starting early this year.

Professor Adrian Hill, chief investigator of the R21/Matrix-M phase 3 trial saidThe continued high efficacy of this new vaccine in field trials is very encouraging, and consistent with the high efficacy and excellent durability observed in a smaller four-year phase IIb trial. These data support an important role for the unique high-density nanoparticle display of the conserved repeat region of the malaria parasite circumsporozoite protein, a feature in the design of the R21 vaccine, in providing such high vaccine efficacy and, thereby, an important new tool for malaria control.

Significantly increased immune responses to the R21/Matrix-M vaccine and slightly higher vaccine efficacy were observed in 5-17-month-olds compared to 18-36-month-olds malaria vaccines, supporting planned vaccine deployment initially from 5 months of age in young African children.

The vaccine is licensed to the Serum Institute of India (SII), the worlds largest vaccine manufacturer and a long-term partner of the University of Oxford. This is critical because vaccinating those at high risk of malaria will be important in stemming the spread of the disease, as well as protecting the vaccinated. Matrix-M adjuvant is manufactured by Novavax AB and provided to Serum Institute of India for formulation into the final vaccine drug product.

Adar Poonawalla, CEO, Serum Institute of India, said,"The Lancet study on R21/Matrix-M Phase 3 trials mark a significant advancement in our battle against this global threat. Our collaboration with the University of Oxford has been instrumental in developing the R21/Matrix-M malaria vaccine. We are dedicated to making this vaccine available, especially in Africa, where malaria poses a substantial threat to millions of lives, bringing us closer to a malaria-free world."

Professor Alassane Dicko, Principal Investigator in Mali of the R21/Matrix-M vaccine saidIt has been very exciting to generate high efficacy data with the new R21/Matrix-M vaccine so quickly. I predict that this vaccine should be very impactful in preventing malaria deaths in African children.

John C Jacobs, CEO of Novavax commentedApproximately 1,300 children die from malaria every day, a staggering statistic for a preventable disease. The R21/Matrix-M Phase 3 efficacy data published in The Lancet reinforce the potential of R21/Matrix-M vaccine to protect children against this disease. We are proud of the role of Novavax's patented saponin-based Matrix-M adjuvant, which has been demonstrated to enhance the immune response, in the outcome of this clinical trial and are eager to see the realized impact of the vaccine when it is rolled out globally.

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New phase 3 trial data confirm the uniquely high efficacy and good safety profile of the R21/Matrix-M malaria vaccine in ... - University of Oxford

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