Malaria vaccine development since 5 Mayr 2021

Africans Welcome New Malaria Vaccine. But Is It a ‘Game Changer'? [The New York Times, 7 Oct 2021]

By Abdi Latif Dahir

The arsenal of weapons to use against malaria, which kills hundreds of thousands of people annually, just grew bigger.

NAIROBI, Kenya — When babies are born in western Kenya, where malaria is rife, many mothers are sent home from the hospital with one all-important baby gift: a bed net treated with insecticide.

“Malaria is our number one health problem,” said Mathews Ajwala, a community health worker who gives out the nets to ward off malarial mosquitoes that can cause severe illness and death. More than 400,000 people died of malaria worldwide in 2019, and two-thirds of those were children in Africa under age 5.

So when the World Health Organization on Wednesday announced that it had approved the world’s first malaria vaccine, African parents, government officials and health workers like Mr. Ajwala celebrated the moment as a milestone in the fight against a scourge that has plagued humans for millennia.

“This vaccine will be a big game-changer,” Mr. Ajwala said in a telephone interview.

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A ‘Historic Day’: W.H.O. Approves First Malaria Vaccine
Dr. Tedros Adhanom Ghebreyesus, the World Health Organization’s director general, said the long-awaited vaccine was a breakthrough for science and could save tens of thousands of young lives each year.

As some of you may know, I started my career as a malaria researcher, and I longed for the day that we would have an effective vaccine against this ancient and terrible disease. And today is that day — an historic day. Today, W.H.O. is recommending the broad use of the world’s first malaria vaccine. This recommendation is based on results from an ongoing pilot program in Ghana, Kenya and Malawi that has reached more than 800,000 children since 2019. This long-awaited malaria vaccine is a breakthrough for science, child health and malaria control. Using this vaccine, in addition to existing tools to prevent malaria, could save tens of thousands of young lives each year.


The vaccine, the first developed for any parasitic disease, was widely discussed on social media and on radio and television stations on Thursday. Many across the continent took pride in the fact that African scientists, research institutions and citizens helped provide and interpret the data that eventually led to the approval of the vaccine. The W.H.O. endorsement was based on the results of more than 2.3 million doses administered since 2019 to about 800,000 children in Kenya, Malawi and Ghana.

But Africans were also coming to grips with the fact that the vaccine alone will not solve the malaria problem.

In clinical trials, the vaccine, made by the British pharmaceutical company GlaxoSmithKline, was effective at reducing severe malaria by only 30 percent in the first year after it was administered, according to the W.H.O. — though some experts put the figure at closer to 50 percent.

To be effective, four doses of the vaccine must be administered starting at the age of 5 months — which could pose logistical problems since delivering vaccines on the continent is already a challenge.

“The vaccine saves lives but it will not be a silver bullet,” said Dr. Githinji Gitahi, the chief executive officer for Amref Health Africa, a nongovernmental organization.

The vaccine, called Mosquirix, targets the deadliest malaria parasite and the most common in Africa — Plasmodium falciparum. While the vaccines are a “huge addition to the fight” against malaria, said Dr. Gitahi, health officials will still have to deploy “a Swiss cheese strategy,” which includes insecticide-treated bed nets and indoor spraying.

Faith Walucho is the mother of an 11-month-old who was recently diagnosed with malaria. The 29-year-old trader of used clothing in the city of Kisumu in western Kenya said she received the news about the vaccines “with a lot of happiness.” In Kenya, an estimated 10,700 deaths from malaria are recorded annually, and Kisumu, on the shores of Lake Victoria, is one of the high-malaria regions where the vaccine was tested.

As soon as she’s able to get a dose for her daughter, Ms. Walucho said, “I will run” to get it.
In Malawi’s capital, Lilongwe, Jenala Mwafulirwa, a 52-year-old mother of five, welcomed the news of the vaccine, saying that too many children in her family had been lost to the disease, particularly in rural areas where access to health care is limited.

“This vaccine has come at the right time,” she said.

But in some places, people voiced skepticism about the vaccine, in part because of mistrust of the World Health Organization.

“I wonder why they want to help Africa,” said Mamadou Tounkara, a 40-year-old-teacher in Senegal’s capital, Dakar. He asked why the W.H.O. did not instead fund better hygiene and sanitation systems. “If W.H.O. wants to help eradicate this disease, they can do it without the vaccine.”

Yet public health officials say the vaccine, which has been in development for more than 30 years, has already proved to be an important weapon in the war against the disease.

Lilyana Dayo, a malaria program officer in Kisumu county, said the pilot testing reduced the effects of malaria by 18 percent.

At the Kisumu County hospital, the vaccine has helped free up beds that could be used for other ailments, said Salome Situma, a pediatric nurse. Hospitals in the county had been overwhelmed a few months ago as the third wave of the coronavirus pandemic, fueled by the Delta variant, swept Kenya and the continent.

“I feel privileged to be part of the system that is achieving and heading in the right direction,” Mr. Situma said.

Dr. Gitahi says the main challenge facing the malaria vaccine will be how to efficiently distribute it, not just to regions with moderate to high transmission, but also to conflict zones where malaria is endemic. Health officials will also have to figure out, he says, how best to balance and match malaria vaccination with other child immunization campaigns like polio and measles.
“That’s really the big policy question,” he said.

It is unclear how soon the vaccine will be widely available in Africa, said Dr. John Nkengasong, the director of the Africa Centers for Disease Control and Prevention, at a news conference on Thursday. He said the Africa C.D.C. will be talking with the W.H.O.

But many hope that when the vaccine is available, it will turn the tide on the disease once and for all.

When he was 5 years old, George Owino said he got so sick with malaria that his parents worried whether he would ever recover. Two of his three children — now ages 24, 21 and 18 — also got severely ill with the disease over the years.

“When people are told the vaccines are being rolled out, they should come out,” Mr. Owino said. “It’s a huge relief.”

Novel vaccination regimen shown to be effective in preventing malaria [European Pharmaceutical Review, 5 May 2021]

By Hannah Balfour

A three-dose regimen of Plasmodium falciparum sporozoites under chemoprophylaxis (PfSPZ-CVac) was shown to be safe, well tolerated and highly effective in a Phase II trial.

Researchers have shown that a new, condensed immunisation with Plasmodium falciparum (Pf) sporozoites under chemoprophylaxis (PfSPZ-CVac) regimen is highly effective and immunogenic, as well as safe and well tolerated.

Sanaria’s PfSPZ-CVac is a live vaccine consisting of Pf malaria parasites in the sporozoite phase of life and is administered at the same time as patients receive an antimalarial drug. The sporozoites quickly enter the liver after the injection, where they develop and multiply for 6 days, and then emerge into the blood. The drugs kill the parasites as soon as they emerge from the liver and thus, prime the immune system against many parasitic proteins, leaving the individual’s immune system highly effective at killing malaria parasites in the liver, preventing infection and disease.

While immunisation with PfSPZ-CVac is the most efficacious approach to malaria vaccination, so far, its implementation has been hampered by the complex chemoprophylaxis regimen, with patients requiring 13 visits to achieve immunisation, and missing evidence for efficacy against heterologous infection.

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In a new double-blinded, randomised, placebo-controlled study, investigators evaluated a condensed PfSPZ-CVac immunisation regimen in malaria-naive volunteers. The new regimen only requires three vaccinations, instead of 13.

The study enrolled 18 patients, 13 to receive direct venous inoculation of 1.1 × 105 aseptic, purified, cryo-preserved PfSPZ (PfSPZ Challenge) of the PfNF54 strain and five to receive placebo (saline), both with simultaneous oral administration of 10 mg/kg chloroquine base. The primary endpoints of the trial were safety and vaccine efficacy tested by controlled human malaria infection (CHMI) using the highly divergent, heterologous strain Pf7G8 found in South America.

Twelve weeks following immunisation, 10 participants in the vaccine group were protected against heterologous CHMI, while all participants receiving placebo develop parasitaemia, thus the risk difference was 77 percent. Immunisation was shown to induce 18-fold higher anti-Pf circumsporozoite protein (PfCSP) antibody levels in protected than in unprotected vaccinees, with such antibodies shown to be strongly associated with protection by protein microarray assessment.

PfSPZ-CVac was found to be well tolerated, with self-limiting grade 1–2 headaches, pyrexia and fatigue that diminish with each vaccination. As a result, the investigators concluded that their condensed regimen is highly efficacious, safe, well tolerated and highly immunogenic.

“With this study, we have reached a new important milestone in the development of an effective malaria vaccine. With only three immunisations over four weeks, we achieved very good protection against malaria,” explained Professor Peter Kremsner, who has helped to advance the malaria research field at the German Center for Infection Research (DZIF) since its inception.

DZIF co-ordinates translational infection research in Germany and provides strategic direction. It has 35 research institutions working together against the global threat of infectious diseases, the Tübingen site co-ordinates the research area Malaria.

The study was published in Nature Communications.

Tubingen study raises hope for effective malaria vaccine [EurekAlert, 5 May 2021]

Sanaria PfSPZ-CVac" is a live vaccine consisting of infectious Plasmodium falciparum (Pf) malaria parasites that are injected into the subject at the same time as they receive an antimalarial drug. The parasites quickly enter the liver where they develop and multiply for 6 days, and then emerge into the blood As soon as the parasites leave the liver, the drug kills them immediately. Thus, the immune system of the vaccinated subject is primed against many parasite proteins and becomes highly effective at killing malaria parasites in the liver to block infection and prevent disease.

"With this study, we have reached a new important milestone in the development of an effective malaria vaccine. With only three immunizations over four weeks, we achieved very good protection against malaria," explains Prof. Peter Kremsner, who has helped to advance the malaria research field at the DZIF since its inception. His team was able to develop a new immunization regimen that significantly reduces vaccine administration compared to previous studies. The number of visits required by a subject for complete immunization has been reduced from 13 to three. Importantly, the team showed that vaccination with parasites from Africa could protect against genetically diverse parasites from South America.

Proof of efficacy was provided using the controlled human malaria infection (challenge) regimen developed by the Tubingen and Sanaria teams. Here, the test subjects were infected with parasites after immunization. If immunization against the parasites was successful, the parasites would be specifically killed by the immune system. If the immune protection is incomplete and the parasites multiply, the test subjects are treated before any symptoms of disease appear. Ten of 13 subjects vaccinated in this study were completely immune to the infection.

"The vaccine produces a high level of different antibodies and immune cells in the body that can recognize both the injected parasites and antigens of the subsequent liver stage. These antibodies and immune cells contribute to the strong protective immunity" explains Dr. Rolf Fendel.

With an estimated 229 million infections and 409,000 deaths worldwide in 2019, malaria is one of the world's most important and dangerous infectious diseases. It is caused by parasites transmitted to humans through the bites of infected female mosquitoes. Children under the age of five are the most vulnerable group affected by malaria, accounting for 67 percent (274,000) of all malaria deaths worldwide in 2019.

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About Sanaria Inc.
Sanaria is a biotechnology company based in Rockville, Maryland (USA) that is developing whole parasite PfSPZ vaccines to protect against malaria in collaboration with the University Hospital of Tubingen, Germany. Sanaria's vaccines have been shown to be highly protective against Plasmodium falciparum infections in humans. Sanaria's vaccines will be used to prevent malaria in individuals and in combination with other malaria control measures to stop malaria transmission and eliminate malaria.

About the DZIF

The German Center for Infection Research (DZIF) coordinates translational infection research in Germany and provides strategic direction. Its mission is to translate results from basic infectious disease research into clinical research and bring them to patients. 35 DZIF research institutions work together against the global threat of infectious diseases. The Tubingen site coordinates the research area Malaria with site spokesperson Prof. Peter Kremsner, and co-coordinators are active at the site for Gastrointestinal Infections, Hospital Germs and Antibiotic-Resistant Bacteria and New Antibiotics.

Promising malaria vaccine enters final stage of clinical testing in West Africa [EurekAlert, 5 May 2021]

R21/Matrix-M becomes the second malaria vaccine candidate ever to start a phase III licensure trial

? R21/Matrix-M becomes the second malaria vaccine candidate ever to start a phase III licensure trial
? This builds on the recent finding of high level efficacy of this vaccine in a phase IIb trial in children in Burkina Faso, published today in The Lancet
? The first phase III trial doses were administered by the team at the Malaria Research and Training Centre, Bamako, Mali, one of five trial sites across West and East Africa
? The malaria vaccine was designed at the Jenner Institute, University of Oxford, who have partnered with the Serum Institute of India for commercial development

The annual death toll from malaria is over 400,000, with most of these deaths amongst children in sub-Saharan Africa. There has been little improvement noted in the last 5 years despite the large amounts of funding allocated to bed nets, insecticide spraying and antimalarial drugs. An efficacious vaccine is needed to try and reach the WHO goal of reducing malaria deaths by at least 90% by 2030.

R21/Matrix-M, a malaria vaccine developed at the Jenner Institute, University of Oxford, showed efficacy of 77% over 12 months in a recently reported phase IIb trial. First vaccinations have now begun in Mali in a larger phase III trial which is hoped to lead to licensure of this malaria vaccine by 2023. This phase III trial will assess efficacy and safety in 4800 children across five sites in Burkina Faso, Kenya, Mali and Tanzania. This is a double-blind, randomised, controlled trial where participants, aged 5-36 months, will receive three vaccinations 4 weeks apart and a booster vaccination 1 year later. The vaccine is being assessed in areas of differing malaria transmission and seasonality.

The University of Oxford has partnered with Serum Institute of India Pvt Ltd. (SIIPL) for the manufacturing of R21/Matrix-M to ensure provision of low high volumes of low-cost vaccine, and access in countries where it is required the most. SIIPL has confirmed its commitment to the provision of >200 million doses per year after licensure, which will be adequate supply for children most at risk of malaria in sub-Saharan Africa.

Quotes

Professor Adrian Hill, Director of the Jenner Institute, University of Oxford said: "The start of a phase III licensure trial is always an import milestone in the development of a vaccine. This large malaria trial is the culmination of many years of laboratory research and assessment of numerous candidate vaccines in early-stage clinical trials with large numbers of collaborators."

Professor Alassane Dicko, Head of the Bougouni Clinical Research Unit, MRTC-P, USTTB and Malian Principal Investigator said: "We are very pleased to see the enthusiasm with which the communities of Bougouni received the first doses of this new candidate malaria vaccine. We are hopeful that the encouraging Phase 2 results will be confirmed in this larger Phase 3 trial".
Professor Abdoulaye Djimde, Director of the Malaria Research and Training Centre - Parasito (MRTC-P), University of Science, Techniques and Technologies of Bamako (USTTB), said: "We are thrilled to be the first site to enroll volunteers in the Phase 3 trial of this very promising R21 vaccine. We will utilize our more than two decades of experience in malaria vaccine testing towards successful completion of this trial"

Professor Halidou Tinto, Principal Investigator of the Nanoro, Burkina Faso trial site, said: "This is a very important moment in the development of the R21 malaria vaccine candidate. We hope that the public-private partnership behind this pivotal Phase III trial will confirm the high efficacy and good safety profile seen in our phase II trial in Nanoro. The five African institutions involved in this partnership have here a historic role to play. We are all committed to work hard in order to generate data that will provide regulators and policy makers with the evidence needed to support the registration of this vaccine. If successful, this vaccine should be made available as quickly as possible to complement existing malaria prevention tools''

Professor Jean Bosco Ouedraogo, Principal Investigator at The Institute of Sciences and Techniques in Bobo-Dioulasso, Burkina Faso said: "The R21 vaccine is a promising malaria prevention tool to help accelerate malaria elimination, particularly in high burden countries in Africa. The Phase II trial demonstrated high vaccine efficacy in children and I'm proud that it was done in Burkina Faso. I am really happy to be part of this key new trial to evaluate the vaccine's safety and efficacy in an area of perennial transmission near Bobo-Dioulasso."

Dr Umesh Shaligram, Chief Scientist at the Serum Institute of India said: "Malaria has been one of the most difficult diseases to make an effective vaccine against. We are committed to ensuring that the supply of this very promising vaccine, manufactured here in Pune, India, meets public health needs by supplying over 200 million doses annually."

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About Malaria
The World Health Organisation (WHO) estimates that malaria causes over 400,000 deaths each year globally and progress in reducing malaria mortality has stalled in recent years. Most deaths are amongst children in Africa where very high transmission rates are found in many countries. 229 million cases of clinical malaria were reported in 2019. Current malaria control measures include the use of insecticide treated bed net, insecticide spraying and seasonal malaria chemoprevention where drug are administered monthly to children at time of highest transmission. No vaccine has been licensed for widespread use although efforts to develop vaccines have spanned over fifty years. Over 100 malaria vaccine candidates have entered clinical trials over recent decades but none has previously shown the >75% efficacy targeted by World Health Organization's Malaria Vaccine Technology Roadmap. It is likely that an effective vaccine could add to the current control measures and have significant impact. Vaccines could have many applications: reduction of disease and death in malaria endemic areas; contributions to malaria elimination and eventual eradication; protection of malaria-naive travellers to malaria-endemic regions.

About Vaccine Clinical Trials

Vaccine clinical trials are used to test if new vaccines are safe and effective. A phase I trial aims to test the safety of a new vaccine, a phase II tests the new vaccine to see if it is safe and effective and a phase III tests this in larger numbers to provide further safety and efficacy data.

About the University of Science, Techniques and Technologies of Bamako, Mali

The Malaria Research and Training Center - Parasitology Section (MRTC-P) within the University of Science, Techniques and Technologies of Bamako, is a renowned African-led research institution which is divided into several research units, including the Bougouni and Ouelessebougou Clinical Research Units and many others. During the past 20 years, MRTC-P in collaboration with the US National Institutes of Health, University of Maryland, EDCTP, Wellcome Trust, London School of Hygiene and Tropical Medicine, University of Oxford, African Academy of Sciences, WHO and others has built state-of-the-art facilities including several clinical research sites, parasite culture facilities, insectaries, genomic data storage and bioinformatics facilities.

About the Jenner Institute:
The Jenner Institute is based within the Nuffield Department of Medicine, University of Oxford, and is headquartered at the Old Road Campus Research Building, in Headington, Oxford. The Jenner Institute also supports senior vaccine scientists, known as Jenner Investigators, within many other departments across the University of Oxford, as well as externally within The Pirbright Institute and the Animal and Plant Health Agency.

The Jenner Institute brings together investigators who are designing and developing numerous vaccines to generate an exceptional breadth of scientific know-how and critical mass, whilst still allowing the individual investigators to remain independent and accountable to their funders and stakeholders.

The Jenner Institute is supported by the Jenner Vaccine Foundation, a UK registered charity and is advised by the Jenner Institute Scientific Advisory Board.

About the University of Oxford

Oxford University has been placed number 1 in the Times Higher Education World University Rankings for the fifth year running, and at the heart of this success is our ground-breaking research and innovation.

Oxford is world-famous for research excellence and home to some of the most talented people from across the globe. Our work helps the lives of millions, solving real-world problems through a huge network of partnerships and collaborations. The breadth and interdisciplinary nature of our research sparks imaginative and inventive insights and solutions.

Through its research commercialisation arm, Oxford University Innovation, Oxford is the highest university patent filer in the UK and is ranked first in the UK for university spinouts, having created more than 200 new companies since 1988. Over a third of these companies have been created in the past three years.

Malaria vaccine 'first to meet WHO efficacy target' [Medical Xpresst, 5 May 2021]

by Abdel Aziz Nabaloum

A malaria vaccine candidate tested on children in West Africa has shown an efficacy of around 77 percent, say scientists, hailing it as a breakthrough in the fight against the disease.

Malaria causes more than 400,000 deaths a year globally, according to the World Health Organization (WHO), mostly among children in Sub-Saharan Africa.

The R21/Matrix-M vaccine, developed by the Clinical Research Unit of Nanoro (CRUN),Burkina Faso and their partners at the University of Oxford in the UK, is the first malaria vaccine to reach the 75 percent efficacy target set by the WHO.

Researchers recruited 450 children aged five to 17 months in the area of Nanoro, central Burkina Faso, and divided them into three groups for the Phase IIb trial.

One group of 150 received the vaccine with a low dose of the Matrix-M adjuvant, which helps create a stronger immune response. Another group of 150 received the vaccine at a higher dose of adjuvant, while the last group of 150 received the rabies vaccine as a control vaccine.

Halidou Tinto, principal trial investigator at the CRUN, said: "Once we vaccinated them with three doses one month apart […], we followed them in each group to see how they were going to behave in terms of vaccine safety, tolerance, but also efficacy."

The subjects in the study reported no serious side effects from the vaccine, which was found to be safe and can be manufactured at low cost on a large scale, they added.

Despite more than 100 vaccine candidates entering clinical trials in recent decades, none have previously reached the target of 75 percent efficacy which the WHO set as a target to be achieved by 2030.

The Serum Institute of India, which has manufactured the vaccine, says it will be able to deliver more than 200 million doses of the vaccine once it is approved by regulators.

Epidemiologist Gauthier Tougouri, coordinator of the National Malaria Control Program in Burkina Faso, hailed the study as a great achievement in the fight against malaria.

Last year the country recorded more than 11 million cases of malaria and almost 4,000 malaria-related deaths, including pregnant women and children, official figures show.

A larger Phase III trial will now be conducted involving 4,800 children aged five to three years in four countries.

"I hope that the forthcoming results will confirm phase two of the study so that we can reach the 2030 target for the elimination of malaria," said Tougouri.

In Burkina Faso, children will be recruited for the next phase in Nanoro and Dande, in the south-west of the country from next month.

"It is important for us to see if such a vaccine, tested in an area like Nanoro which has a transmission of medium duration, will give the same effectiveness in an area like Dande where the transmission is much longer," explained Tinto.

Researchers hope that by testing the vaccine in different contexts on a larger number ofchildren, its efficacy will be confirmed and the vaccine can be considered for registration.

Charlemagne Ouedraogo, Minister of Health for Burkina Faso, said the findings offer hope for the elimination of malaria in the country and across the continent.

"We believe that the solution against malaria will come from Burkina.We encourage the team to continue the thirdphase to give us results that will allow us to go further so that a vaccine is put on the market that will allow us to reduce morbidity and mortality from malaria," he said.

Ida Sawadogo, program officer atthe Access toEssential Medicines Network, said: "We have been waiting for this for years and we are happy that at last a vaccine is being found against this disease which is the number one killer in our country."

Malaria vaccine development since 27 Apr till 4 May 2021

Malaria vaccine WHO-approved for Africa [The Northern Daily Leader, 7 Oct 2021]

By Maria Cheng

The world's first malaria vaccine should be given to children across Africa, the World Health Organization has recommended, in a move that officials hope will spur stalled efforts to curb the spread of the parasitic disease.

WHO director-general Tedros Adhanom Ghebreyesus called it "a historic moment" after a meeting in which two of the UN health agency's expert advisory groups endorsed using the vaccine.

"Today's recommendation offers a glimmer of hope for the continent, which shoulders the heaviest burden of the disease. And we expect many more African children to be protected from malaria and grow into healthy adults," said Dr Matshidiso Moeti, WHO's Africa director, on Wednesday.

WHO said its decision was based largely on results from ongoing research in Ghana, Kenya and Malawi that tracked more than 800,000 children who have received the vaccine since 2019.

The malaria vaccine known as Mosquirix was developed by GlaxoSmithKline in 1987. While it's the first to be authorised, it does have challenges: the vaccine is only about 30 per cent effective, requires up to four doses and its protection fades after several months.

Still, given the extremely high burden of malaria in Africa - where the majority of the world's more than 200 million cases a year and 400,000 deaths a year occur - scientists say the vaccine could still have a major impact.

"This is a huge step forward," said Julian Rayner, director of the Cambridge Institute for Medical Research, who was not part of the WHO decision. "It's an imperfect vaccine, but it will still stop hundreds of thousands of children from dying."

Rayner said the vaccine's impact on the spread of the mosquito-borne disease was still unclear, but pointed to coronavirus vaccines as an encouraging example.

"The last two years have given us a very nuanced understanding of how important vaccines are in saving lives and reducing hospitalisations, even if they don't directly reduce transmission," he said.

WHO said side effects were rare, but sometimes included a fever that could result in temporary convulsions.

Azra Ghani, chair of infectious diseases at Imperial College London, said she and colleagues estimate that the introduction of the malaria vaccine in African children might result in a 30 per cent reduction overall: up to 8 million fewer cases and as many as 40,000 fewer deaths per year.

WHO Approves First-Ever Malaria Vaccine: 'A Historical Event' [Yahoo Eurosport UK, 7 Oct 2021]

By Julie Mazziotta

The World Health Organization approved the first-ever vaccine to prevent malaria on Wednesday, a shot that could save tens of thousands of lives each year, particularly in sub-Saharan Africa where cases of the mosquito-borne disease are high.

The new vaccine, called Mosquirix, helps the immune system fight off a malaria pathogen common in Africa. It not only is the first vaccine to prevent malaria, but the first to prevent a parasitic disease.

WHO endorsed the vaccine for children in sub-Saharan Africa and other regions with malaria.

The disease kills around half a million people each year, mostly in Africa. The majority of those deaths — 260,000 — are in children under age 5.

The vaccine was 50% effective at preventing severe malaria in clinical trials during the first year of testing. That efficacy dropped down to nearly zero after four years, but the immediate impacts of the vaccine on areas struggling with malaria cases made it worthwhile.

"I do expect we will see that impact," said Dr. Mary Hamel, the lead of WHO's malaria vaccine implementation program, according to The New York Times.

Dr. Pedro Alonso, director of the WHO's global malaria program, said in a statement that news of the vaccine's effectiveness is "a historical event," after a hundred years of research into a parasite vaccine.

"It's a huge jump from the science perspective to have a first-generation vaccine against a human parasite," he added.

The vaccine requires three doses in babies between 5 and 17 months, followed by a fourth dose around 18 months later. After initial clinical trials, it was added to the usual immunization courses in Kenya, Malawi and Ghana, and more than 2.3 million doses have been administered so far, to more than 800,000 children. Hamel said that more than 90% of children in those areas are now protected against malaria.

"We have long hoped for an effective malaria vaccine and now, for the first time ever, we have such a vaccine recommended for widespread use," said Matshidiso Moeti, WHO's regional director for Africa. "Today's recommendation offers a glimmer of hope for the continent which shoulders the heaviest burden of the disease and we expect many more African children to be protected from malaria and grow into healthy adults."

First malaria vaccine could be rolled out to billions as World Health Organisation experts give approval [Sky News, 7 Oct 2021]

By Thomas Moore

The new jab prevents 30% of severe cases of malaria, even in areas with high uptake of other measures, such as bed nets impregnated with insecticide.

The first vaccine against malaria could be rolled out to billions of people after key advisers to the World Health Organisation (WHO) gave it the green light.

Experts on the WHO's advisory bodies for immunisation and malaria concluded the vaccine Mosquirix could save tens of thousands of lives every year.

Recommended byDr Tedros Adhanom Ghebreyesus, WHO's director-general, said he had started his career as a malaria researcher and had "longed for the day that we would have an effective vaccine against this ancient and terrible disease".

He said: "Today is that day. An historic day. Today the WHO is recommending the broad use of the world's first malaria vaccine.

"This long-awaited malaria vaccine is a breakthrough for science, child health and malaria control. Using this vaccine in addition to existing tools to prevent malaria could save tens of thousands of young lives each year."

The vaccine is now expected to get the nod from WHO itself and funding for millions of doses will then be considered by Gavi, the Vaccine Alliance, which ensures low-income countries have access to life-saving jabs.

Meanwhile, Gavi along with global health agency Unitaid and the Global Fund to Fight AIDS, Tuberculosis and Malaria have welcomed WHO's recommendation, adding that it "marks a historic acheivement in our fight against malaria".

The decision by the Strategic Advisory Group of Experts on Immunization and the Malaria Policy Advisory Group to back widespread deployment follows a pilot roll-out in Ghana, Kenya and Malawi.

More than 800,000 children in the three countries have been given at least one dose of the vaccine since 2019 as part of the normal childhood immunisation programme

Dr Matshidiso Moeti, WHO's regional director for Africa, said: "Today's recommendation offers a glimmer of hope for the continent.

"We expect many more African children will be protected from malaria and grow into healthy and productive adults."

The real-world test of the jab showed it prevented 30% of severe cases of malaria even in areas with high uptake of other measures, such as bed nets impregnated with insecticide.
It also proved safe, with high acceptance by families.

Malaria resulted in 409,000 deaths in 2019, the vast majority of them in sub-Saharan Africa.
The disease kills one child every two minutes.

Mosquirix acts against Plasmodium falciparum, which is carried by the Anopheles mosquito and is the deadliest of all the malaria parasites.

Developing a vaccine has proved a major challenge because the parasite is far more complex than a virus or bacteria.

The vaccine primes the immune system to fight the malaria parasite the moment it's been injected into the blood by a mosquito bite.

ANALYSIS BY THOMAS MOORE, SCIENCE CORRESPONDENT Forget lions, tigers and sharks. It’s the tiny mosquito that kills more people than any other creature. The insect is a flying incubator of viruses and parasites – and the most feared of all is Plasmodium falciparum. The organism is just a single cell, a protozoa, but it’s far more complex than a bacteria or virus. It takes on several forms in its shape-shifting life cycle that flits from mosquito to humans and back again. For vaccine developers it has proved an elusive foe. It’s able to slip past the immune system by using a combination of stealth and deception. But has it now finally met its match?

It stops the parasite infecting liver cells where it would normally mature and multiply before causing potentially deadly disease.

The vaccine's effectiveness is low compared to jabs for other diseases, but malaria claims so many lives that the WHO believes it will still prevent tens of thousands of deaths every year.

Professor Dyann Wirth, chair of WHO Malaria Policy Advisory Group said: "This is the first ever vaccine for a human parasite and demonstrates that a vaccine is possible for this challenging infection.

"While ongoing threats to our existing tools, drug-resistant parasites and insecticide resistant mosquitoes, innovation is needed not just to create new tools but to better tailor our current tools to achieve maximum impact.

"The malaria parasite is a formidable foe and while we are excited by this recent development, major battles remain."

Bed nets have been the main means of preventing malaria until now, with deaths falling 60% in the first 15 years of this century as they became widely distributed.

But progress has stalled with under half of all African households having enough nets for the whole family.

The pilot study of the vaccine showed it was given to two-thirds of children without a net, adding another layer of protection.

More effective vaccines are in development, including one by the same Oxford University team behind the AstraZeneca COVID jab.

A trial on several hundred children released earlier this year showed it prevented 77% of cases, making it even more effective than the Mosquirix shot.

A larger phase three study involving 5,000 children is now being planned.

WHO recommends malaria vaccine for use in children [Ars Technica, 7 Oct 2021]

By JOHN TIMMER

While the efficacy is under 50 percent, it should still save numerous lives.

On Wednesday, the World Health Organization (WHO) announced a first: it was recommending a vaccine against malaria for administration to children. The decision follows a program started in 2019 in three African countries, which eventually saw over 800,000 children vaccinated.

The vaccine itself is called RTS,S/AS01, or Mosquirix, and it checks all the boxes for conspiracy theorists, having been developed by a large pharmaceutical company (GlaxoSmithKline) with support from the Gates Foundation. The vaccine is based on proteins found on the surface of the most common malarial parasite, and it requires four doses starting when children are less than a year old. Development of the vaccine started in 1987, and testing of its efficacy dates back to 2014. With over 2.3 million doses administered, it has a solid safety profile, and it has shown an efficacy between 30 and 50 percent in different trials.

That may not seem all that great, especially compared to the numbers we've all watched many of the COVID-19 vaccines produced. But the WHO estimates that over a quarter-million children under the age of 5 die of malaria every year in Africa alone, with many others falling seriously ill. As such, even a 30 percent efficacy can have a substantial impact.

The WHO analysis also considered a number of additional factors, all of which weighed in favor of its use. These include its cost effectiveness and the ability to deliver the vaccine to even difficult-to-reach populations.

Mosquirix's wider distribution, however, will now be dependent on the international health community, which is already struggling with finding the funding and resources to ensure that developing nations get sufficient COVID-19 vaccines.

Meanwhile, there have been some very early trials of additional vaccines that are reporting higher efficacy levels. If those results hold up in larger trials and in actual use in Africa, RTS,S could just be the first in a string of good news for one of humanity's deadlier plagues.

UPDATE 1-WHO backs rollout of malaria vaccine for African children [Reuters.com, 7 Oct 2021]

By Maggie Fick, Aaron Ross

NAIROBI (Reuters) -The World Health Organization (WHO) said on Wednesday the only approved vaccine against malaria should be widely given to African children, potentially marking a major advance against a disease that kills hundreds of thousands of people annually.

The WHO recommendation is for RTS,S - or Mosquirix - a vaccine developed by British drugmaker GlaxoSmithKline.

Since 2019, 2.3 million doses of Mosquirix have been administered to infants in Ghana, Kenya and Malawi in a large-scale pilot programme coordinated by the WHO. The majority of those whom the disease kills are under age five.

That programme followed a decade of clinical trials in seven African countries.

“This is a vaccine developed in Africa by African scientists and we’re very proud,” said WHO director-general Tedros Adhanom Ghebreyesus.

“Using this vaccine in addition to existing tools to prevent malaria could save tens of thousands of young lives each year,” he added, referring to anti-malaria measures like bed nets and spraying to kill mosquitoes that transmit the disease.

One of the ingredients in the Mosquirix vaccine is sourced from a rare evergreen native to Chile called a Quillay tree. Reuters reported on Wednesday here that the long-term supply of these trees is in question.

Malaria is far more deadly than COVID-19 in Africa. It killed 386,000 Africans in 2019, according to a WHO estimate, compared with 212,000 confirmed COVID-19 deaths in the past 18 months.

The WHO says 94% of malaria cases and deaths occur in Africa, a continent of 1.3 billion people. The preventable disease is caused by parasites transmitted to people by the bites of infected mosquitoes. Symptoms include fever, vomiting and fatigue.

The vaccine’s effectiveness at preventing severe cases of malaria in children is only around 30%, but it is the only approved vaccine. The European Union’s drugs regulator approved it in 2015, saying its benefits outweighed the risks.

“This is how we fight malaria, layering imperfect tools on top of each other,” said Ashley Birkett, who leads global malaria vaccine work at Path, a non-profit global health organization that has funded development of the vaccine with GSK and the three-country pilot.

Another vaccine against malaria called R21/Matrix-M that was developed by scientists at Britain’s University of Oxford showed up to 77% efficacy in a year-long study involving 450 children in Burkina Faso, researchers said in April. It is still in the trial stages.

GSK welcomed the WHO recommendation.

“This long-awaited landmark decision can reinvigorate the fight against malaria in the region at a time when progress on malaria control has stalled,” Thomas Breuer, GSK’s chief global health officer, said in a statement.

GSK shares held steady in New York following the announcement, which came after the close of trading in its London-listed shares.

FUNDING CHALLENGE
The recommendation was jointly announced in Geneva by the WHO’s top advisory bodies for malaria and immunization, the Malaria Policy Advisory Group and the Strategic Advisory Group of Experts on Immunization.

Experts said the challenge now would be mobilising financing for production and distribution of the vaccine to some of the world’s poorest countries.

GSK has to date committed to produce 15 million doses of Mosquirix annually up to 2028 at a cost of production plus no more than 5% margin.

A global market study led by the WHO this year projected demand for a malaria vaccine would be 50 to 110 million doses per year by 2030 if it is deployed in areas with moderate to high transmission of the disease.

The GAVI vaccine alliance, a global public-private partnership, will consider in December whether and how to finance the vaccination programme.

“As we’ve seen from the COVID vaccine, where there is political will, there is funding available to ensure that vaccines are scaled to the level they are needed,” said Kate O’Brien, director of WHO’s Department of Immunization, Vaccines and Biologicals.

A source familiar with planning for the vaccine’s development said the price per dose was not yet set, but would be confirmed after GAVI’s funding decision and once there is a clear sense of demand.

The WHO’s decision had personal meaning for Dr. Rose Jalong’o, a vaccinology specialist at the Kenyan health ministry.

“I suffered from malaria as a child, and during my internship, and during my clinical years I attended to children in hospital because of severe malaria who needed blood transfusion and unfortunately some of them died,” she said.

“It’s a disease I have grown up with and, seeing all this in my lifetime, it’s an exciting time.”

World's First Malaria Vaccine Approved By WHO [NDTV, 7 Oct 2021]

"Today, WHO is recommending the broad use of the world's first malaria vaccine," the agency's director general Tedros Adhanom Ghebreyesus said.

Geneva, Switzerland:
The World Health Organization on Wednesday endorsed the RTS,S/AS01 malaria vaccine, the first against the mosquito-borne disease that kills more than 400,000 people a year, mostly African children.

The decision followed a review of a pilot programme deployed since 2019 in Ghana, Kenya and Malawi in which more than two million doses were given of the vaccine, first made by the pharmaceutical company GSK in 1987.

After reviewing evidence from those countries, the WHO said it was "recommending the broad use of the world's first malaria vaccine", the agency's director general Tedros Adhanom Ghebreyesus said.

The WHO said it was recommending children in sub-Saharan Africa and in other regions with moderate to high malaria transmission get four doses up to the age of two.

Every two minutes, a child dies of malaria, the agency said.

More than half of malaria deaths worldwide are in six sub-Saharan African countries and almost a quarter are in Nigeria alone, according to 2019 WHO figures.

Symptoms include fever, headaches and muscle pain, then cycles of chills, fever and sweating.
Findings from the vaccine pilot showed it "significantly reduces severe malaria which is the deadly form by 30 percent," said Kate O'Brien, Director of WHO's Department of Immunization, Vaccines and Biologicals.

The vaccine is "feasible to deliver", she added and "it's also reaching the unreached... Two thirds of children who don't sleep under a bed net in those countries are now benefiting from the vaccine."

Many vaccines exist against viruses and bacteria but this was the first time that the WHO recommended for broad use a vaccine against a human parasite.

The vaccine acts against plasmodium falciparum -- one of five malaria parasite species and the most deadly.

"From a scientific perspective this is a massive breakthrough," said Pedro Alonso, Director of the WHO Global Malaria Programme.

'Glimmer of hope'
Matshidiso Moeti, the WHO regional director for Africa said Wednesday's recommendation "offers a glimmer of hope for the continent which shoulders the heaviest burden of the disease."

The estimated cost of malaria in sub-Saharan Africa is over 12 billion dollars a year, Alonso said at a news conference following the announcement.

Before the newly recommended vaccine can reach children in need, the next step will be funding.

"That will be the next major step... Then we will be set up for scaling of doses and decisions about where the vaccine will be most useful and how it will be deployed," said O'Brien.

Gavi vaccine alliance said in a statement after the WHO announcement that "global stakeholders, including Gavi, will consider whether and how to finance a new malaria vaccination programme for countries in sub-Saharan Africa."

The fight against malaria received a boost in April when researchers from Britain's Oxford University announced that their Matrix-M vaccine candidate had become the first to surpass the WHO's threshold of 75-percent efficacy.

Germany's BioNTech, which developed a coronavirus vaccine with US giant Pfizer, also said it aimed to start trials for a malaria vaccine next year using the same breakthrough mRNA technology.

The WHO also hopes this latest recommendation will encourage scientists to develop more malaria vaccines.

1CommentsThe RTS,S/AS01 is "a first generation, really important one," said Alonso, "but we hope... it stimulates the field to look for other types of vaccines to completement or go beyond this one."

The World May Finally Have a Malaria Vaccine That Works [Interesting Engineering, 6 Oct 2021]

By Brad Bergan

For thousands of years, malaria has wrought havoc. But it could be nearing its end.
We may finally have an effective vaccine against malaria.

A novel drug called RTS,S has finally received approval from the World Health Organization, and will soon roll out across sub-Saharan Africa, according to an initial report from the BBC.

The vaccine's effectiveness was proven six years ago, and now it's finally ready to save lives.

New Malaria vaccine could save 'tens of thousands' of lives The vaccine's pilot programs took place in Ghana, Kenya, in addition to Malawi, and the World Health Organization's (WHO's) Director-General Tedros Adhanom Ghebreyesus said this marked a "historic day," adding that "tens of thousands of young lives could be saved" by the vaccine every single year, according to the BBC report. Malaria is an extremely dangerous parasite that invades and body, subsequently destroying blood cells to reproduce and spread via blood-sucking mosquitoes. There have been ways to reduce the spread, like drugs that kill the parasite, insecticides that kill the means of transfer (the mosquitoes), and bed nets to prevent the parasitic bugs from injecting or sucking the malaria parasite into and out of human bloodstreams.

But there remain roughly 230 million cases of malaria linked to 400,000 deaths from the vicious illness, roughly 95% of which is centered in Africa, where more than 260,000 kids have died from infection in 2019 alone. Immunity takes years upon years of repeated infection to build immunity to malaria, and this immunity is only minimal, merely reducing your chances of becoming extremely ill from contraction. The recently approved vaccine was put through a pilot program, during which Kwame Amponsa-Achiano assessed the vaccine for effectiveness and feasibility, according to the report. "It is quite an exciting moment for us, with large scale vaccination I believe the malaria toll will be reduced to the barest minimum," said Amponsa-Achiano, in the report.

The malaria vaccine takes four doses, administered at a young age
Amponsa-Achiano regularly contracted malaria as a child, and this spurred his will to become a doctor in Ghana. "It was distressing, almost every week you were out of school, malaria has taken a toll on us for a long time," he said in the BBC report. There exist more than 100 variants of the malaria parasite, but the RTS,S vaccine specifically targets the most common and deadly one in the entire continent of Africa: plasmodium falciparum. Back in 2015, trials showed that the vaccine can prevent four in 10 malaria cases, leading to a sharp drop of one-third in the number of kids needing blood transfusions. But not everyone had full confidence in the novel vaccine, since it takes four full doses to become fully effective.

The first three doses are administered one month apart from one another, at five, six, and seven months old, with a final booster shot given at the age of roughly 18 months, according to the report. The results of the pilot revealed that the vaccine is safe, and linked to a 30% reduction in severe cases of the illness, and it showed no substantially negative side effects apart from those expected from routine vaccines. Most crucially, it's cost-effective, which means it has the potential to be accessible by official bodies capable of helping the general populations most at-risk in Africa. This is a gigantic step in the right direction in the fight to end malaria. Time will tell whether the vaccine proves effective against future variants of the parasite.

WHO backs rollout of malaria vaccine for African children [Thomson Reuters Foundation, 6 Oct 2021]

By Maggie Fick and Aaron Ross

NAIROBI, Oct 6 (Reuters) - The World Health Organization (WHO) said on Wednesday the only approved vaccine against malaria should be widely given to African children, potentially marking a major advance against a disease that kills hundreds of thousands of people annually.

The WHO recommendation is for RTS,S - or Mosquirix - a vaccine developed by British drugmaker GlaxoSmithKline.

Since 2019, 2.3 million doses of Mosquirix have been administered to infants in Ghana, Kenya and Malawi in a large-scale pilot programme coordinated by the WHO. The majority of those whom the disease kills are aged under five.

That programme followed a decade of clinical trials in seven African countries.

"This is a vaccine developed in Africa by African scientists and we're very proud," said WHO director-general Tedros Adhanom Ghebreyesus.

"Using this vaccine in addition to existing tools to prevent malaria could save tens of thousands of young lives each year," he added, referring to anti-malaria measures like bed nets and spraying.

Malaria is far more deadly than COVID-19 in Africa. It killed 386,000 Africans in 2019, according to a WHO estimate, compared with 212,000 confirmed deaths from COVID-19 in the past 18 months.

The WHO says 94% of malaria cases and deaths occur in Africa, a continent of 1.3 billion people. The preventable disease is caused by parasites transmitted to people by the bites of infected mosquitoes; symptoms include fever, vomiting and fatigue.

The vaccine's effectiveness at preventing severe cases of malaria in children is only around 30%, but it is the only approved vaccine. The European Union's drugs regulator approved it in 2015, saying its benefits outweighed the risks.

"This is how we fight malaria, layering imperfect tools on top of each other," said Ashley Birkett, who leads global malaria vaccine work at Path, a non-profit global health organization that has funded the development of the vaccine with GSK and the three-country pilot.

Another vaccine against malaria, developed by scientists at Britain's University of Oxford and called R21/Matrix-M, showed up to 77% efficacy in a year-long study involving 450 children in Burkina Faso, researchers said in April, but it is still in the trial stages.

GSK also welcomed the WHO recommendation.

"This long-awaited landmark decision can reinvigorate the fight against malaria in the region at a time when progress on malaria control has stalled," Thomas Breuer, Chief Global Health Officer, said in a statement.

GSK shares held steady in New York following the announcement, which came after the close of trading in its London-listed shares.

FUNDING CHALLENGE
The recommendation was jointly announced in Geneva by the WHO's top advisory bodies for malaria and immunization, the Malaria Policy Advisory Group and the Strategic Advisory Group of Experts on Immunization.

Experts said the challenge now would be mobilising financing for production and distribution of the vaccine to some of the world's poorest countries.

GSK has to date committed to produce 15 million doses of Mosquirix annually, in addition to the 10 million doses donated to the WHO pilot programmes, up to 2028 at a cost of production plus no more than 5% margin.

A global market study led by the WHO this year projected demand for a malaria vaccine would be 50 to 110 million doses per year by 2030 if it is deployed in areas with moderate to high transmission of the disease.

The GAVI vaccine alliance, a global public-private partnership, will consider in December whether and how to finance the vaccination programme.

"As we've seen from the COVID vaccine, where there is political will, there is funding available to ensure that vaccines are scaled to the level they are needed," said Kate O'Brien, Director of WHO's Department of Immunization, Vaccines and Biologicals.

A source familiar with planning for the vaccine's development said the price per dose was not yet set, but would be confirmed after GAVI's funding decision and once there is a clear sense of demand for the vaccine.

The WHO's decision had personal meaning for Dr. Rose Jalong'o, a vaccinology specialist at the Kenyan health ministry.

"I suffered from malaria as a child and during my internship, and during my clinical years I attended to children in hospital because of severe malaria who needed blood transfusion and unfortunately some of them died."

"It's a disease I have grown up with and, seeing all this in my lifetime, it's an exciting time."
(Reporting by Maggie Fick in Nairobi and Aaron Ross in Dakar; Editing by Katharine Houreld, Mark Potter and Emelia Sithole-Matarise)

The World Health Organization Approves First Malaria Vaccine [Technology Networks, 6 Oct 2021]

The World Health Organization (WHO) is recommending widespread use of the RTS,S/AS01 (RTS,S) malaria vaccine among children in sub-Saharan Africa and in other regions with moderate to high P. falciparum malaria transmission. The recommendation is based on results from an ongoing pilot programme in Ghana, Kenya and Malawi that has reached more than 800 000 children since 2019.

“This is a historic moment. The long-awaited malaria vaccine for children is a breakthrough for science, child health and malaria control,” said WHO Director-General Dr Tedros Adhanom Ghebreyesus. “Using this vaccine on top of existing tools to prevent malaria could save tens of thousands of young lives each year.”

Malaria remains a primary cause of childhood illness and death in sub-Saharan Africa. More than 260 000 African children under the age of five die from malaria annually.

In recent years, WHO and its partners have been reporting a stagnation in progress against the deadly disease.

"For centuries, malaria has stalked sub-Saharan Africa, causing immense personal suffering,” said Dr Matshidiso Moeti, WHO Regional Director for Africa. “We have long hoped for an effective malaria vaccine and now for the first time ever, we have such a vaccine recommended for widespread use. Today’s recommendation offers a glimmer of hope for the continent which shoulders the heaviest burden of the disease and we expect many more African children to be protected from malaria and grow into healthy adults.”
WHO recommendation for the RTS,S malaria vaccine

Based on the advice of two WHO global advisory bodies, one for immunization and the other for malaria, the Organization recommends that:

WHO recommends that in the context of comprehensive malaria control the RTS,S/AS01 malaria vaccine be used for the prevention of P. falciparum malaria in children living in regions with moderate to high transmission as defined by WHO. RTS,S/AS01 malaria vaccine should be provided in a schedule of 4 doses in children from 5 months of age for the reduction of malaria disease and burden.

'A Historical Event': WHO Endorses First-Ever Malaria Vaccine [The Daily Beast, 6 Oct 2021]

By Corbin Bolies

The World Health Organization endorsed the first vaccine to prevent malaria Wednesday, giving an important stamp of approval in the quest to eradicate the deadly disease. The vaccine, made by GlaxoSmithKline, works by targeting the deadliest malaria pathogen, with studies showing it is 50 percent effective at preventing serious malaria in the first year. No data has emerged on its efficacy in preventing deaths, but a WHO expert told The New York Times its efficacy in preventing severe malaria is “a reliable proximal indicator of mortality.” The vaccine is also the first known vaccine produced against parasites, which cause diseases much more severe than bacteria or viruses. Some countries have shown consternation over whether to adopt a vaccine with a lower efficacy level, but Dr. Pedro Alonso, the head of WHO’s global malaria program, called the release “a historical event.”

“It’s a huge jump from the science perspective to have a first-generation vaccine against a human parasite,” Alonso said. The disease kills about 500,000 people a year, most of them kids in Africa.

UN: African children should get world's 1st malaria vaccine [Santa Rosa Press Democrat, 6 Oct 2021]

By MARIA CHENG

LONDON — The World Health Organization on Wednesday endorsed the world's first malaria vaccine and said it should be given to children across Africa in the hope that it will spur stalled efforts to curb the spread of the parasitic disease.

WHO Director-General Tedros Adhanom Ghebreyesus called it “a historic moment” after a meeting in which two of the U.N. health agency’s expert advisory groups recommended the step.

"Today’s recommendation offers a glimmer of hope for the continent, which shoulders the heaviest burden of the disease. And we expect many more African children to be protected from malaria and grow into healthy adults,” said Dr. Matshidiso Moeti, WHO's Africa director.
WHO said its decision was based largely on results from ongoing research in Ghana, Kenya and Malawi that tracked more than 800,000 children who have received the vaccine since 2019.

The vaccine, known as Mosquirix, was developed by GlaxoSmithKline in 1987. While it’s the first to be authorized, it does face challenges: The vaccine is only about 30% effective, it requires up to four doses, and its protection fades after several months.

Still, scientists say the vaccine could have a major impact against malaria in Africa, home to most of the world’s more than 200 million cases and 400,000 deaths per year,
“This is a huge step forward,” said Julian Rayner, director of the Cambridge Institute for Medical Research, who was not part of the WHO decision. “It’s an imperfect vaccine, but it will still stop hundreds of thousands of children from dying.”

Rayner said the vaccine’s impact on the spread of the mosquito-borne disease was still unclear, but pointed to those developed for the coronavirus as an encouraging example.

“The last two years have given us a very nuanced understanding of how important vaccines are in saving lives and reducing hospitalizations, even if they don’t directly reduce transmission,” he said.

Dr. Alejandro Cravioto, head of the WHO vaccine group that made the recommendation, said designing a shot against malaria was particularly difficult because it is a parasitic disease spread by mosquitoes.

“We’re confronted with extraordinarily complex organisms,” he said. “We are not yet in reach of a highly efficacious vaccine, but what we have now is a vaccine that can be deployed and that is safe.”

WHO said side effects were rare, but sometimes included a fever that could result in temporary convulsions.

Sian Clarke, co-director of the Malaria Centre at the London School of Hygiene and Tropical Medicine, said the vaccine would be a useful addition to other tools against the disease that might have exhausted their utility after decades of use, like bed nets and insecticides.

“In some countries where it gets really hot, children just sleep outside, so they can’t be protected by a bed net,” Clarke said. “So obviously if they’ve been vaccinated, they will still be protected.”

In recent years, little significant progress has been made against malaria, Clarke said.

“If we’re going to decrease the disease burden now, we need something else,” she explained.

Azra Ghani, chair of infectious diseases at Imperial College London, said she and colleagues estimate that giving the malaria vaccine to children in Africa might result in a 30% reduction overall, with up to 8 million fewer cases and as many as 40,000 fewer deaths per year.

“For people not living in malaria countries, a 30% reduction might not sound like much. But for the people living in those areas, malaria is one of their top concerns,” Ghani said. “A 30% reduction will save a lot of lives and will save mothers (from) bringing in their children to health centers and swamping the health system.”

The WHO guidance would hopefully be a “first step” to making better malaria vaccines, she said. Efforts to produce a second-generation malaria vaccine might be given a boost by the messenger RNA technology used to make two of the most successful COVID-19 vaccines, those from Pfizer-BioNTech and Moderna, she added.

“We’ve seen much higher antibody levels from the mRNA vaccines, and they can also be adapted very quickly,” Ghani said, noting that BioNTech recently said it would begin researching a possible malaria shot. “It’s impossible to say how that may affect a malaria vaccine, but we definitely need new options to fight it.”

WHO Backs Widespread Use Of First Malaria Vaccine [Forbes, 6 Oct 2021]

By Kimberlee Speakman

TOPLINE

The World Health Organization endorsed the safety and efficacy of the world’s first malaria vaccine on Wednesday, clearing the way for it to be rolled out to treat children in sub-Saharan Africa and other regions that are hard-hit by the disease, which is one of the leading killers in low-income countries.

KEY FACTS

WHO expert advisory groups on vaccines and malaria said the RTS,S/AS01 vaccine, also known as Mosquirix, which was developed by GlaxoSmithKline, was recommended based off results of a pilot program involving more than 800,000 children in Ghana, Kenya and Malawi.
The pilot program showed the vaccine was cost effective and helped to reduce the incidence of life-threatening severe cases of malaria by 30% in areas where other preventative measures were being taken.

BIG NUMBER

More than 260,000. That is approximately how many children under the age of 5 die of malaria in Africa annually, according to the WHO.

CRUCIAL QUOTE

“Today’s recommendation offers a glimmer of hope for the continent which shoulders the heaviest burden of the disease, and we expect many more African children to be protected from malaria and grow into healthy adults,” said Dr Matshidiso Moeti, WHO Regional Director for Africa.

WHAT TO WATCH OUT FOR

The WHO said it will make funding decisions for a broader rollout of the vaccine, and countries will need to decide whether they want to adopt the vaccine.

KEY BACKGROUND

GlaxoSmithKline, said it has been working to create a vaccine that would help protect against malaria for 30 years. The company first made a breakthrough in 1996 with the RTS,S/AS01 vaccine, which protected six out of seven volunteers in an initial trial. Additional studies in 1999 on adults in Gambia and in 2004 on Mozambique children also proved that the vaccine was effective. Based on various trials, the company submitted a regulatory application with the European Medicines Agency last year, taking the first step to getting the vaccine approved for widespread use.

WHO approves first malaria vaccine [Spectrum News, 6 Oct 2021]

By Rachel Gotbaum

Regina Rabinovich, the director of the Malaria Elimination Initiative at ISGlobal and a visiting scholar at Harvard University, joined The World's host Marco Werman to discuss the advancement.

Malaria kills hundreds of thousands of people every year. Most of them live in sub-Saharan Africa, and overwhelmingly, it's children younger than 5 years old who die of malaria.
But on Wednesday, Dr. Tedros Ghebreyesus, the head of the World Health Organization, made an announcement that he called "historic."

"Malaria has been with us for millennia, and the dream of a malaria vaccine has been a long-held, but unattainable, dream," he said. "Today, the RTS,S malaria vaccine — more than 30 years in the making — changes the course of public health history."

It's a vaccine against malaria that is safe for children. To discuss the latest advancement, Regina Rabinovich, the director of the Malaria Elimination Initiative at ISGlobal and a visiting scholar at Harvard University, joined The World's host Marco Werman.

Marco Werman: So, this vaccine for malaria has been called a game changer. Why is that?

Regina Rabinovich: It's been called a game changer, well, it's the first malaria vaccine we've ever been able to develop. And then, it adds a totally different approach to attacking the disease by strengthening the immune system of children so that they are protected from the severe effects of an infection.

But, this vaccine does not prevent transmission of malaria. Is that important?

It is important, and we have other tools. It's important to note that all of the trials have been done on top of giving children bed nets and sprays where that is the recommended approach with insecticides. Those kill the mosquito. But this protects the baby.

And it's a vaccine that's safe for children. Remind us why this focus on children getting this vaccine is so significant.

Well, over time, as children get a number of infections, they develop partial immunity. And as adults in Africa who have been exposed frequently, they tend to get very mild disease, unless they are immunocompromised or pregnant. So, the ones that get very severe disease tend to be children in highly endemic areas, where there's a lot of disease, are the children less than five. So, protecting them from severe disease, from hospitalization and from dying is a huge value for global health and for impact on child health.

So, I had malaria several times, once really bad, and it lays you out, leads to massive lack of productivity. Not to mention, lives lost, if that happens. How many lives could be saved by this vaccine?

That part is still an evolving story. This pilot program that they are doing will continue its ongoing evaluation for two more years. The indication is that it does decrease mortality. It clearly prevents severe malaria, and it decreases the need for hospitalization in children.

Remind us, who are the people around the world who continue to be affected by malaria in 2021? Where are they and how many are there?

There are approximately 200 million cases reported a year — 200 million. And of those, about 400,000 die. So, this is not a disease that is everywhere, like a pandemic, like COVID-19. There are countries in Asia, Latin America and Africa — especially Africa — that bear the highest burden.

Well, we heard Dr. Tedros earlier calling this malaria vaccine historic. How excited are you by this news today?

Well, I'm extremely excited. I think it's overwhelming, actually. It is a dream for the community that we would be able to tackle this disease, not only with partially effective nets and insecticides and treatments, but also with the creation of immunity in those most fragile.

UN endorses world's 1st malaria vaccine, experts estimate it could prevent 40000 deaths per year [4029tv, 6 Oct 2021]

By MARIA CHENG

The World Health Organization on Wednesday endorsed the world's first malaria vaccine and said it should be given to children across Africa in the hope it will spur stalled efforts to curb the spread of the parasitic disease.

WHO Director-General Tedros Adhanom Ghebreyesus called it "a historic moment" after a meeting in which two of the U.N. health agency's expert advisory groups recommended the step.

"Today's recommendation offers a glimmer of hope for the continent, which shoulders the heaviest burden of the disease. And we expect many more African children to be protected from malaria and grow into healthy adults," said Dr. Matshidiso Moeti, WHO's Africa director.

WHO said its decision was based largely on results from ongoing research in Ghana, Kenya and Malawi that tracked more than 800,000 children who have received the vaccine since 2019.

The vaccine, known as Mosquirix, was developed by GlaxoSmithKline in 1987. While it's the first to be authorized, it does face challenges: The vaccine is only about 30% effective, it requires up to four doses, and its protection fades after several months.

Still, scientists say the vaccine could have a major impact against malaria in Africa, home to most of the world's more than 200 million cases and 400,000 deaths per year.

"This is a huge step forward," said Julian Rayner, director of the Cambridge Institute for Medical Research, who was not part of the WHO decision. "It's an imperfect vaccine, but it will still stop hundreds of thousands of children from dying."

Rayner said the vaccine's impact on the spread of the mosquito-borne disease was still unclear, but pointed to those developed for the coronavirus as an encouraging example.

US revokes emergency use of malaria drugs vs. coronavirus
"The last two years have given us a very nuanced understanding of how important vaccines are in saving lives and reducing hospitalizations, even if they don't directly reduce transmission," he said.

Dr. Alejandro Cravioto, head of the WHO vaccine group that made the recommendation, said designing a shot against malaria was particularly difficult because it is a parasitic disease spread by mosquitoes.

"We're confronted with extraordinarily complex organisms," he said. "We are not yet in reach of a highly efficacious vaccine, but what we have now is a vaccine that can be deployed and that is safe."

WHO said side effects were rare, but sometimes included a fever that could result in temporary convulsions.

Sian Clarke, co-director of the Malaria Centre at the London School of Hygiene and Tropical Medicine, said the vaccine would be a useful addition to other tools against the disease that might have exhausted their utility after decades of use, like bed nets and insecticides.

"In some countries where it gets really hot, children just sleep outside, so they can't be protected by a bed net," Clarke said. "So obviously if they've been vaccinated, they will still be protected."

Study finds no benefit, higher death rate in patients taking malaria drug for COVID-19
In recent years, little significant progress has been made against malaria, Clarke said.

"If we're going to decrease the disease burden now, we need something else," she explained.
Azra Ghani, chair of infectious diseases at Imperial College London, said she and colleagues estimate that giving the malaria vaccine to children in Africa might result in a 30% reduction overall, with up to 8 million fewer cases and as many as 40,000 fewer deaths per year.

"For people not living in malaria countries, a 30% reduction might not sound like much. But for the people living in those areas, malaria is one of their top concerns," Ghani said. "A 30% reduction will save a lot of lives and will save mothers [from] bringing in their children to health centers and swamping the health system."

The WHO guidance would hopefully be a "first step" to making better malaria vaccines, she said. Efforts to produce a second-generation malaria vaccine might be given a boost by the messenger RNA technology used to make two of the most successful COVID-19 vaccines, those from Pfizer-BioNTech and Moderna, she added.

"We've seen much higher antibody levels from the mRNA vaccines, and they can also be adapted very quickly," Ghani said, noting that BioNTech recently said it would begin researching a possible malaria shot. "It's impossible to say how that may affect a malaria vaccine, but we definitely need new options to fight it."

The world's 1st malaria vaccine gets a green light from the World Health Organization [Iowa Public Radio, 6 Oct 2021]

By Jason Beaubien

AILSA CHANG, HOST:
The World Health Organization has given the green light for the rollout of the world's first vaccine against malaria. The WHO's director general calls it a historic moment. Malaria kills hundreds of thousands of people every year, and most of those deaths are children under the age of five in Africa. Joining us now to talk about this development is NPR global health correspondent Jason Beaubien.

Hi, Jason.

JASON BEAUBIEN, BYLINE: Hey, Ailsa.

CHANG: So tell us more about this vaccine. Like, just how big of a deal is this?

BEAUBIEN: You know, it is a big deal. Malaria - it not only kills a quarter of a million children in sub-Saharan Africa every year, it makes a lot of other people sick. It hurts the economy. You know, it's a major burden on some of the poorest countries in the world. So for lots of reasons, a malaria vaccine has been this huge goal of health officials. The head of the WHO, Tedros Adhanom Ghebreyesus, who you just mentioned - he knows a lot about malaria. And he was one of the people gushing about the significance of this today.

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TEDROS ADHANOM GHEBREYESUS: I started my career as a malaria researcher. And I longed for the day that we would have an effective vaccine against this ancient and terrible disease. And today is that day - an historic day.

CHANG: Whoa, what is he saying there? Are we talking about eradicating malaria completely - like, wiping it out entirely with this vaccine?

BEAUBIEN: No, not at all.

CHANG: OK.

BEAUBIEN: And that's where this story gets a little bit messy.

CHANG: What do you mean by that?

BEAUBIEN: So yes, this vaccine is a first. But it's got some significant drawbacks. First, it's only about 30% effective at preventing kids from getting hospitalized. Overall, it's only roughly 40% effective in blocking infection, so that's fairly low.

CHANG: Yeah.

BEAUBIEN: Second, it's a complicated vaccine to administer. It's a series of four injections, and the first three shots - they have to be given a month apart to infants after the infants have reached five months of age, and the fourth one - the final injection - then has to be given a year later. And then after all that, the protection from the vaccine wanes fairly quickly.
CHANG: OK. So it's complicated. Why is there so much excitement about this then? Like, why is the WHO calling this historic?

BEAUBIEN: Yeah. I mean, to be clear, this is the first vaccine ever developed against a parasitic human disease. So that's a big deal. Many vaccines - they work against infections from viruses or bacteria. Parasites are far more complex organisms. GlaxoSmithKline has been working on this vaccine since the 1980s, so you can see some of how difficult it has been to develop a vaccine...

CHANG: Yeah.

BEAUBIEN: ...Like this. The other reason there's so much excitement about this is that malaria is so devastating in many of these places. You know, if you could cut out 30% to 40% of the cases, that's a massive win on the public health front. You know, and there's the potential to be saving hundreds of thousands of lives in the years to come.
CHANG: Absolutely. OK, so what happens now? Like, is this vaccine going to be widely available all across Africa?

BEAUBIEN: And again, that's where things are also a bit complicated. It's still not clear where the money's going to come from to fund a wide-scale rollout, particularly in sub-Saharan Africa. GlaxoSmithKline says they're going to be making doses available at just over cost. You know, but many of these countries - they don't have the money to be buying one more vaccine right now. So the next step is for the WHO, Gavi, the Vaccine Alliance and other international actors to try to raise money so that it can be widely deployed, particularly in sub-Saharan Africa.

CHANG: That is NPR's Jason Beaubien.
Thank you, Jason.

BEAUBIEN: You're welcome, Ailsa.

WHO greenlights the world's first malaria vaccine — but it's not a perfect shot [WYPR, 6 Oct 2021]

By Jason Beaubien

The world's arsenal against malaria just got a fancy new bazooka. But it's not the easiest weapon to deploy, it only hits its target 30 to 40% of the time, and it's not yet clear who's going to pay for it.

The weapon in question is the RTS,S vaccine from GlaxoSmithKline, which on Wednesday got the green light from the World Health Organization for widespread use.

This is not only the first authorized malaria vaccine, it's also the first vaccine ever approved for use against a parasitic disease in humans.

The recommendation comes after RTS,S showed positive results in a pilot program in Ghana, Kenya and Malawi. The vaccine cut malaria cases by 40% and reduced hospitalizations of the potentially deadly disease by nearly a third.

Tedros Adhanom Ghebreyesus, WHO's director general, called the approval of RTS,S a historic moment.

"The long-awaited malaria vaccine for children is a breakthrough for science, child health and malaria control," he said.

RTS,S won regulatory approval from the European Medicines Agency back in 2015 but WHO wanted to wait for the results of this latest pilot program before recommending it for use in countries with moderate to high levels of malaria transmission. The expectation is that it will be used primarily in sub-Saharan Africa, where the mosquito-borne disease is one of the top killers of children, claiming nearly a quarter of a million lives each year.

"This opens up a whole new avenue for malaria control," says David Schellenberg of WHO's Global Malaria Program, who says that RTS,S gives health officials a new powerful tool to fight the disease.

Combined with bed nets, spraying for mosquitoes and new drugs, the vaccine could have a major impact in places where malaria remains a chronic problem, Schellenberg says.

Matshidiso Moeti, WHO regional director for Africa, says she's delighted by the new recommendation.

"For centuries, malaria has stalked sub-Saharan Africa, causing immense personal suffering," Moeti said during the announcement. Nearly 95% of all malaria cases globally occur in Africa.

"Now for the first time ever, we have a [malaria] vaccine recommended for widespread use.
Today's recommendation, therefore, offers a glimmer of hope for the continent," she said.

But the vaccine won't be rolling out across Africa tomorrow. It's still unclear where the money to purchase doses will come from. Also it's a complicated vaccination to administer, requiring four injections spread out over the first two years of a child's life. And given that it only prevents malaria 30 to 40% of the time, this vaccine is far less effective than health officials had hoped.

Pedro Alonso, head of WHO's Global Malaria Program, says part of the problem is that malaria is a complicated disease. "This is a parasitic disease," he points out. The parasite life cycle plays out in multiple stages in different parts of the human body and in the mosquito hosts.
"This is orders of magnitude more complex in terms of the biology of the causative organism [than a virus]," he says.

Decades of research have gone into developing RTS,S. Alonso would love to see a vaccine that's 95% effective in preventing malaria but says the scientific community is still a long way off from developing that: "But what we do have right now is a vaccine that can be deployed, that is accepted, that is safe and that can have a massive impact in terms of lives saved and episodes of malaria averted."

Countries that decide to move forward with administering RTS,S still need to figure out how to pay for it and how to integrate it into their childhood immunization schedules. GlaxoSmithKline had donated 10 million doses of the vaccine for pilot programs and has now pledged to deliver 15 million doses a year at a price of 5% above cost. Eventually GSK says it plans to transfer production to a producer in India.

World's first malaria vaccine gets WHO recommendation : Goats and Soda [NPR, 6 Oct 2021]

By JASON BEAUBIEN

The world's arsenal against malaria just got a fancy new bazooka. But it's not the easiest weapon to deploy, it only hits its target 30 to 40% of the time, and it's not yet clear who's going to pay for it.

The weapon in question is the RTS,S vaccine from GlaxoSmithKline, which on Wednesday got the green light from the World Health Organization for widespread use.

This is not only the first authorized malaria vaccine, it's also the first vaccine ever approved for use against a parasitic disease in humans.

The recommendation comes after RTS,S showed positive results in a pilot program in Ghana, Kenya and Malawi. The vaccine cut malaria cases by 40% and reduced hospitalizations of the potentially deadly disease by nearly a third.

Tedros Adhanom Ghebreyesus, WHO's director general, called the approval of RTS,S a historic moment.

"The long-awaited malaria vaccine for children is a breakthrough for science, child health and malaria control," he said.

RTS,S won regulatory approval from the European Medicines Agency back in 2015 but WHO wanted to wait for the results of this latest pilot program before recommending it for use in countries with moderate to high levels of malaria transmission. The expectation is that it will be used primarily in sub-Saharan Africa, where the mosquito-borne disease is one of the top killers of children, claiming nearly a quarter of a million lives each year.

"This opens up a whole new avenue for malaria control," says David Schellenberg of WHO's Global Malaria Program, who says that RTS,S gives health officials a new powerful tool to fight the disease.

Combined with bed nets, spraying for mosquitoes and new drugs, the vaccine could have a major impact in places where malaria remains a chronic problem, Schellenberg says.

Matshidiso Moeti, WHO regional director for Africa, says she's delighted by the new recommendation.

"For centuries, malaria has stalked sub-Saharan Africa, causing immense personal suffering," Moeti said during the announcement. Nearly 95% of all malaria cases globally occur in Africa.
"Now for the first time ever, we have a [malaria] vaccine recommended for widespread use.
Today's recommendation, therefore, offers a glimmer of hope for the continent," she said.
But the vaccine won't be rolling out across Africa tomorrow. It's still unclear where the money to purchase doses will come from. Also it's a complicated vaccination to administer, requiring four injections spread out over the first two years of a child's life. And given that it only prevents malaria 30 to 40% of the time, this vaccine is far less effective than health officials had hoped.

Pedro Alonso, head of WHO's Global Malaria Program, says part of the problem is that malaria is a complicated disease. "This is a parasitic disease," he points out. The parasite life cycle plays out in multiple stages in different parts of the human body and in the mosquito hosts.
"This is orders of magnitude more complex in terms of the biology of the causative organism [than a virus]," he says.

Decades of research have gone into developing RTS,S. Alonso would love to see a vaccine that's 95% effective in preventing malaria but says the scientific community is still a long way off from developing that: "But what we do have right now is a vaccine that can be deployed, that is accepted, that is safe and that can have a massive impact in terms of lives saved and episodes of malaria averted."

Countries that decide to move forward with administering RTS,S still need to figure out how to pay for it and how to integrate it into their childhood immunization schedules. GlaxoSmithKline had donated 10 million doses of the vaccine for pilot programs and has now pledged to deliver 15 million doses a year at a price of 5% above cost. Eventually GSK says it plans to transfer production to a producer in India.

First Malaria Vaccine Approved by W.H.O. [The New York Times, 6 Oct 2021]

By Apoorva Mandavilli
Malaria kills about 500,000 people each year, about half of them children in Africa. The new vaccine isn’t perfect, but it will help turn the tide, experts said.

A ‘Historic Day’: W.H.O. Approves First Malaria Vaccine

Dr. Tedros Adhanom Ghebreyesus, the World Health Organization’s director general, said the long-awaited vaccine was a breakthrough for science and could save tens of thousands of young lives each year.

As some of you may know, I started my career as a malaria researcher, and I longed for the day that we would have an effective vaccine against this ancient and terrible disease. And today is that day — an historic day. Today, W.H.O. is recommending the broad use of the world’s first malaria vaccine. This recommendation is based on results from an ongoing pilot program in Ghana, Kenya and Malawi that has reached more than 800,000 children since 2019. This long-awaited malaria vaccine is a breakthrough for science, child health and malaria control. Using this vaccine, in addition to existing tools to prevent malaria, could save tens of thousands of young lives each year.

The world has gained a new weapon in the war on malaria, among the oldest known and deadliest of infectious diseases: the first vaccine shown to help prevent the disease. By one estimate, it will save tens of thousands of children each year.
Malaria kills about half a million people each year, nearly all of them in sub-Saharan Africa — including 260,000 children under 5. The new vaccine, made by GlaxoSmithKline, rouses a child’s immune system to thwart Plasmodium falciparum, the deadliest of five malaria pathogens and the most prevalent in Africa.

The World Health Organization on Wednesday endorsed the vaccine, the first step in a process that should lead to wide distribution in poor countries. To have a malaria vaccine that is safe, moderately effective and ready for distribution is “a historic event,” said Dr. Pedro Alonso, director of the W.H.O.’s global malaria program.

Malaria is rare in the developed world. There are just 2,000 cases in the United States each year, mostly among travelers returning from countries in which the disease is endemic.

The vaccine, called Mosquirix, is not just a first for malaria — it is the first developed for any parasitic disease. Parasites are much more complex than viruses or bacteria, and the quest for a malaria vaccine has been underway for a hundred years.

“It’s a huge jump from the science perspective to have a first-generation vaccine against a human parasite,” Dr. Alonso said.

In clinical trials, the vaccine had an efficacy of about 50 percent against severe malaria in the first year, but the figure dropped close to zero by the fourth year. And the trials did not directly measure the vaccine’s impact on deaths, which has led some experts to question whether it is a worthwhile investment in countries with countless other intractable problems.

But severe malaria accounts for up to half of malaria deaths and is considered “a reliable proximal indicator of mortality,” said Dr. Mary Hamel, who leads the W.H.O.’s malaria vaccine implementation program. “I do expect we will see that impact.”

A modeling study last year estimated that if the vaccine were rolled out to countries with the highest incidence of malaria, it could prevent 5.4 million cases and 23,000 deaths in children younger than 5 each year.

A recent trial of the vaccine in combination with preventive drugs given to children during high-transmission seasons found that the dual approach was much more effective at preventing severe disease, hospitalization and death than either method alone.

The malaria parasite, carried by mosquitoes, is a particularly insidious enemy, because it can strike the same person over and over. In many parts of sub-Saharan Africa, even those where most people sleep under insecticide-treated bed nets, children have on average six malaria episodes a year.

Even when the disease is not fatal, the repeated assault on their bodies can permanently alter the immune system, leaving them weak and vulnerable to other pathogens.

Malaria research is littered with vaccine candidates that never made it past clinical trials. Bed nets, the most widespread preventive measure, cut malaria deaths in children under 5 only by about 20 percent.

Against that backdrop, the new vaccine, even with modest efficacy, is the best new development in the fight against the disease in decades, some experts said.

“Progress against malaria has really stalled over the last five or six years, particularly in some of the hardest hit countries in the world,” said Ashley Birkett, who heads malaria programs at PATH, a nonprofit organization focused on global health.

With the new vaccine, “there’s potential for very, very significant impact there,” Dr. Birkett said.
Mosquirix is given in three doses between ages 5 and 17 months, and a fourth dose roughly 18 months later. Following clinical trials, the vaccine was tried out in three countries — Kenya, Malawi and Ghana — where it was incorporated into routine immunization programs.

More than 2.3 million doses have been administered in those countries, reaching more than 800,000 children. That bumped up the percentage of children protected against malaria in some way to more than 90 percent, from less than 70 percent, Dr. Hamel said.

“The ability to reduce inequities in access to malaria prevention — that’s important,” Dr. Hamel said. “It was impressive to see that this could reach children who are currently not being protected.”

It took years to create an efficient system to distribute insecticide-treated bed nets to families. By contrast, including Mosquirix among routine immunizations made it surprisingly easy to distribute, Dr. Hamel added — even in the midst of the coronavirus pandemic, which prompted lockdowns and disrupted supply chains.

“We aren’t going to have to spend a decade trying to figure out how to get this to children,” he said.

This week, a working group of independent experts in malaria, child health epidemiology and statistics, as well as the W.H.O.’s vaccine advisory group, met to review data from the pilot programs and to make their formal recommendation to Dr. Tedros Adhanom Ghebreyesus, director-general of the W.H.O.

“We still have a very long road to travel, but this is a long stride down that road,” Dr. Tedros said at a news conference on Wednesday.

The next step is for Gavi, the global vaccine alliance, to determine that the vaccine is a worthwhile investment. If the organization’s board approves the vaccine — not guaranteed, given the vaccine’s moderate efficacy and the many competing priorities — Gavi will purchase the vaccine for countries that request it, a process that is expected to take at least a year.

But as with Covid-19, problems with vaccine production and supply could considerably delay progress. And the pandemic has also diverted resources and attention from other diseases, said Deepali Patel, who leads malaria vaccine programs at Gavi.

“Covid is a big unknown in the room in terms of where capacity is currently in countries, and rolling out Covid-19 vaccines is a huge effort,” Ms. Patel said. “We’re really going to have to see how the pandemic unfolds next year in terms of when countries will be ready to pick up all of these other priorities.”

New vaccine candidate provides breakthrough in the fight against malaria [News-Medical.Net, 4 May 2021]

A malaria vaccine candidate tested on children in West Africa has shown an efficacy of around 77 per cent, say scientists, hailing it as a breakthrough in the fight against the disease.

Malaria causes more than 400,000 deaths a year globally, according to the World Health Organization (WHO), mostly among children in Sub-Saharan Africa.

The R21/Matrix-M vaccine, developed by the Clinical Research Unit of Nanoro (CRUN), Burkina Faso and their partners at the University of Oxford in the UK, is the first malaria vaccine to reach the 75 per cent efficacy target set by the WHO.

Researchers recruited 450 children aged five to 17 months in the area of Nanoro, central Burkina Faso, and divided them into three groups for the Phase IIb trial.

One group of 150 received the vaccine with a low dose of the Matrix-M adjuvant, which helps create a stronger immune response. Another group of 150 received the vaccine at a higher dose of adjuvant, while the last group of 150 received the rabies vaccine as a control vaccine.
Halidou Tinto, principal trial investigator at the CRUN, said:
Once we vaccinated them with three doses one month apart […], we followed them in each group to see how they were going to behave in terms of vaccine safety, tolerance, but also efficacy."

The subjects in the study reported no serious side effects from the vaccine, which was found to be safe and can be manufactured at low cost on a large scale, they added.

Despite more than 100 vaccine candidates entering clinical trials in recent decades, none have previously reached the target of 75 percent efficacy which the WHO set as a target to be achieved by 2030.

The Serum Institute of India, which has manufactured the vaccine, says it will be able to deliver more than 200 million doses of the vaccine once it is approved by regulators.

Epidemiologist Gauthier Tougouri, coordinator of the National Malaria Control Programme in Burkina Faso, hailed the study as a great achievement in the fight against malaria.

Last year the country recorded more than 11 million cases of malaria and almost 4,000 malaria-related deaths, including pregnant women and children, official figures show.

A larger Phase III trial will now be conducted involving 4,800 children aged five to three years in four countries.

"I hope that the forthcoming results will confirm phase two of the study so that we can reach the 2030 target for the elimination of malaria," said Tougouri.

In Burkina Faso, children will be recruited for the next phase in Nanoro and Dande, in the south-west of the country from next month.

"It is important for us to see if such a vaccine, tested in an area like Nanoro which has a transmission of medium duration, will give the same effectiveness in an area like Dande where the transmission is much longer," explained Tinto.

Researchers hope that by testing the vaccine in different contexts on a larger number of children, its efficacy will be confirmed and the vaccine can be considered for registration.

Charlemagne Ouedraogo, Minister of Health for Burkina Faso, said the findings offer hope for the elimination of malaria in the country and across the continent.

"We believe that the solution against malaria will come from Burkina. We encourage the team to continue the third phase to give us results that will allow us to go further so that a vaccine is put on the market that will allow us to reduce morbidity and mortality from malaria," he said.

Ida Sawadogo, program officer at the Access to Essential Medicines Network, said: "We have been waiting for this for years and we are happy that at last a vaccine is being found against this disease which is the number one killer in our country."

Novel vaccine 77 percent effective in preventing malaria, finds study [European Pharmaceutical Review, 27 Apr 2021]

By Hannah Balfour

The R21 vaccine candidate, when administered with 50mg of adjuvant, was found to be 77 percent effective in preventing malaria in children over 12 months.

New data suggests that Novavax’s malaria vaccine candidate, R21, is 77 percent effective in preventing malaria in children. According to the company, such high protective efficacy could make it an important tool for the eradication of malaria globally. The Phase IIb trial data was published in Preprints with The Lancet.

The Phase IIb randomised, controlled, double-blind trial was conducted in Burkina Faso and recruited 450 participants from an area called Nanoro, with highly seasonal malaria transmission.

In three study arms, participants aged five to 17 months received 5mg of R21 with either 25mg or 50mg of Matrix-M adjuvant, or a rabies vaccine (control). Participants were given three doses at four-week intervals and a final, fourth dose one year later. The safety, immunogenicity and efficacy of the vaccine were evaluated over one year.

The researchers reported that the vaccine efficacy at six months was 77 percent in the higher adjuvant dose group and 71 percent in the lower adjuvant dose group. After a year, the efficacy in the higher adjuvant dose group remained at 77 percent. This is significantly higher than the RTS,S/AS01 vaccine, the most effective malaria vaccine candidate to date, which was found to have 55.8 percent efficacy over 12 months in African children.

Both adjuvant dosage levels were reportedly well tolerated, with no severe reactions. In addition, participants vaccinated with R21/Matrix-M showed high titers of malaria-specific anti-NANP antibodies 28 days after the third vaccination, which were almost doubled with the higher adjuvant dose. Though antibody titers waned over time, after the fourth dose administered one year later, they were boosted to levels similar to the peak titers achieved following the primary series of vaccinations.

“These significant results support our high expectations for the potential of this vaccine, which included reaching the World Health Organization (WHO)-stated goal for a malaria vaccine with at least 75 percent efficacy,” said Adrian Hill, Lakshmi Mittal and Family Professorship of Vaccinology; Director of the Jenner Institute at the University of Oxford; Co-Director, Oxford Martin Programme on Vaccines and co-author of the publication. “With the commitment by our commercial partner, Serum Institute of India, to manufacture at least 200 million doses annually in the coming years, we believe this vaccine could have a major public health impact.”

Under the licensing agreement, the Matrix-M component of the malaria vaccine will be manufactured by Novavax and supplied to SII, which has rights to use Matrix-M in the vaccine in regions where the disease is endemic and will pay Novavax royalties on its market sales of the vaccine. Additionally, Novavax will have commercial rights to sell and distribute the SII-manufactured vaccine in certain countries, primarily in the travellers’ and military vaccine markets.

There were an estimated 229 million cases of malaria worldwide in 2019, with an estimated 409,000 deaths. Children under the age of five are the most vulnerable, accounting for 67 percent of deaths worldwide in 2019. A Phase 3 trial of the vaccine has begun recruitment across five trial sites in four countries of differing malaria transmission rates and seasonality in Africa to study large-scale safety and efficacy.

R21 was created by the University of Oxford and includes Novavax’ Matrix-M adjuvant. It is licensed and manufactured by the Serum Institute of India (SII).