HIV Vaccine Candidate Does Not Sufficiently Protect Women Against HIV Infection

An investigational HIV vaccine tested in the “Imbokodo” clinical trial conducted in sub-Saharan Africa posed no safety concerns but did not provide sufficient protection against HIV infection, according to a primary analysis of the study data.

The Phase 2b proof-of-concept study, which began in November 2017, enrolled 2,637 women ages 18 to 35 years from five countries.

The Imbokodo primary analysis was conducted 24 months after participants received their first vaccinations.

The study’s primary endpoint was based on the difference in the number of new HIV infections between the placebo and vaccine groups from month seven (one month after the third vaccination timepoint) through month 24. When comparing the number of new HIV infections between study participants who were randomly assigned to receive either placebo or the investigational vaccine, statisticians found that 63 participants who received the placebo and 51 participants who received the experimental vaccine acquired HIV infection. Therefore, the investigational vaccine’s efficacy was 25.2% (95% confidence interval of vaccine efficacy -10.5% to 49.3%). The study vaccine was found to be safe with no serious adverse events associated with it. Study participants are being informed of the findings and will have follow-up visits with the study investigators. Further analysis of the Imbokodo study will continue, and the study is thought to have provided sufficient data for further immunological correlates research.

The Imbokodo study, also known as HVTN 705/HPX2008, is sponsored by Janssen Vaccines & Prevention B.V., part of the Janssen Pharmaceutical Companies of Johnson & Johnson. It is funded by two primary partners, the Bill & Melinda Gates Foundation (BMGF) and the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health.

“The development of a safe and effective vaccine to prevent HIV infection has proven to be a formidable scientific challenge,” said NIAID Director Anthony S. Fauci, M.D. “Although this is certainly not the study outcome for which we had hoped, we must apply the knowledge learned from the Imbokodo trial and continue our efforts to find a vaccine that will be protective against HIV.”

The investigational vaccine tested in the Imbokodo study is based on “mosaic” immunogens—vaccine components designed to induce immune responses against a wide variety of global HIV strains. The vaccine candidate used a strain of common-cold virus (adenovirus serotype 26, or Ad26), engineered to not cause illness, to deliver four (quadrivalent) mosaic antigens to spur an immune response. Earlier research indicated the vaccine was both well-tolerated and could induce an anti-HIV immune response. Imbokodo participants received four vaccinations during a one-year period. This included four doses of the investigational quadrivalent vaccine. The final two doses were administered together with doses of an HIV protein, clade C gp140, and an adjuvant to boost immune responses. Participants were followed for at least two years. The primary analysis occurred one year after the last study participant’s final vaccination.

Study participants were offered pre-exposure prophylaxis medication to prevent HIV infection during the clinical trial. The women who acquired HIV infection were directed to medical care and offered antiretroviral treatment.

NIAID provided funding for preclinical and early phase clinical development of the investigational mosaic HIV vaccine, which was initially developed by the laboratory of Dan H. Barouch, M.D., Ph.D., at Beth Israel Deaconness Medical Center, together with Janssen and other partners. The mosaic immunogens used in the experimental vaccine were designed by the Los Alamos National Laboratory. The Imbokodo study was conducted by the NIAID-funded HIV Vaccine Trials Network (HVTN), based at the Fred Hutchinson Cancer Research Center in Seattle. Additional support for the trial was provided by the U.S. Army Medical Research and Development Command; and the Ragon Institute of MGH, MIT and Harvard. The South African Medical Research Council helped to implement the study in South Africa.

Devastatingly pervasive: 1 in 3 women globally experience violence

Violence against women remains devastatingly pervasive and starts alarmingly young, shows new data from WHO and partners. Across their lifetime, 1 in 3 women, around 736 million, are subjected to physical or sexual violence by an intimate partner or sexual violence from a non-partner – a number that has remained largely unchanged over the past decade.

This violence starts early: 1 in 4 young women (aged 15-24 years) who have been in a relationship will have already experienced violence by an intimate partner by the time they reach their mid-twenties.

“Violence against women is endemic in every country and culture, causing harm to millions of women and their families, and has been exacerbated by the COVID-19 pandemic,” said Dr Tedros Adhanom Ghebreyesus, WHO Director-General. “But unlike COVID-19, violence against women cannot be stopped with a vaccine. We can only fight it with deep-rooted and sustained efforts – by governments, communities and individuals – to change harmful attitudes, improve access to opportunities and services for women and girls, and foster healthy and mutually respectful relationships.”

Intimate partner violence is by far the most prevalent form of violence against women globally (affecting around 641 million).  However, 6% of women globally report being sexually assaulted by someone other than their husband or partner. Given the high levels of stigma and under-reporting of sexual abuse, the true figure is likely to be significantly higher.

This report presents data from the largest ever study of the prevalence of violence against women, conducted by WHO on behalf of a special working group of the United Nations. Based on data from 2000 to 2018, it updates previous estimates released in 2013.

While the numbers reveal already alarmingly high rates of violence against women and girls, they do not reflect the ongoing impact of the COVID-19 pandemic.

WHO and partners warn that the COVID-19 pandemic has further increased women’s exposure to violence, as a result of measures such as lockdowns and disruptions to vital support services.

“It’s deeply disturbing that this pervasive violence by men against women not only persists unchanged, but is at its worst for young women aged 15-24 who may also be young mothers.  And that was the situation before the pandemic stay-at home orders. We know that the multiple impacts of COVID-19 have triggered a “shadow pandemic” of increased reported violence of all kinds against women and girls,” said UN Women Executive Director Phumzile Mlambo-Ngcuka. “Every government should be taking strong, proactive steps to address this, and involving women in doing so”, she added.

Though many countries have seen increased reporting of intimate partner violence to helplines, police, health workers, teachers, and other service providers during lockdowns, the full impact of the pandemic on prevalence will only be established as surveys are resumed, the report notes.

Violence disproportionately affects women living in low- and lower-middle-income countries.  An estimated 37% of women living in the poorest countries have experienced physical and/or sexual intimate partner violence in their life, with some of these countries having a prevalence as high as 1 in 2.   

The regions of Oceania, Southern Asia and Sub-Saharan Africa have the highest prevalence rates of intimate partner violence among women aged 15-49, ranging from 33% – 51%.  The lowest rates are found in Europe (16–23%), Central Asia (18%), Eastern Asia (20%) and South-Eastern Asia (21%).

Younger women are at highest risk for recent violence. Among those who have been in a relationship, the highest rates (16%) of intimate partner violence in the past 12 months occurred among young women aged between 15 and 24.

“To address violence against women, there’s an urgent need to reduce stigma around this issue, train health professionals to interview survivors with compassion, and dismantle the foundations of gender inequality,” said Dr Claudia Garcia-Moreno of WHO. “Interventions with adolescents and young people to foster gender equality and gender-equitable attitudes are also vital.”

What’s in the way of quality antenatal care for women in West and Central Africa

By Comfort Z. Olorunsaiye: Assistant Professor of Public Health, Arcadia University

Globally, nearly 300,000 women die from pregnancy-related causes each year. Most of these deaths are in the low-income countries of sub-Saharan Africa and South Asia.

The leading causes of maternal mortality include severe bleeding, hypertensive disorders, infection, unsafe abortion and embolism. There are also indirect causes such as HIV, malaria and anaemia. About three in four maternal deaths could be prevented if women had adequate access to quality care before, during and after pregnancy.

Quality antenatal care can save lives by identifying and addressing health problems that can cause pregnancy complications and poor birth outcomes. But the women most at risk tend to be the ones who do not access life-saving health services. Barriers to quality antenatal care include lack of information, cultural practices, poverty and distance to health services. Others are inadequate and poor health services.

There is already global evidence of social and economic differences in access to maternal health care and the quality of that care. We sought to understand the quality of antenatal care in sub-Saharan Africa. Countries in the West and Central African sub-region have notably poor reproductive health indicators, as well as high levels of poverty and civil unrest or political fragility.

Yet, the region has been largely underrepresented in empirical research. Research findings can help inform policy and programme interventions for improving the reach and quality of antenatal care. They can also contribute to reducing the unacceptable rates of maternal and newborn deaths in the region.

At the time of our study, household survey data from the same source were available for seven countries in the United Nations region of West and Central Africa: Central African Republic (CAR), Chad, the Democratic Republic of Congo (DRC), Ghana, Nigeria, Sierra Leone and Togo. We analysed the data on 32,718 women whose pregnancies resulted in a live birth, considering the levels of poverty in the households and communities where these women resided.

What we found

Our findings indicated that one in four pregnant women did not receive antenatal care. The majority of these women were in Chad (37%) and Nigeria (38%). Among women who had antenatal care, the majority received low-quality care. This means receiving fewer than five of six possible antenatal care services. The proportion of women who received high quality antenatal care ranged from 3% in Chad to 33% in Nigeria.

Among women who received antenatal care, the most common services provided across all seven countries were blood pressure monitoring and tetanus vaccination. The figures ranged from 79% in Chad to 99% in Ghana for blood pressure monitoring. For tetanus vaccination they ranged from 87% in the DRC to 97% in Sierra Leone.

Less frequently provided services included HIV testing, malaria treatment and blood tests. We also found that higher levels of household wealth increased the likelihood of women reporting high-quality antenatal care. Poorer households are in the top 20% of the household wealth index. This measures the living standard of a family, based on the possession of certain household goods and infrastructure. The relationship of household wealth with quality of antenatal care was more noticeable in the DRC, Ghana, Nigeria, Sierra Leone and Togo.

Similarly, women who had secondary or higher levels of education were between two and three times as likely to receive high-quality antenatal care as women without formal education. With the exception of Chad, women who had more antenatal care visits reported high quality care.

Our results indicate that the quality of antenatal care varied according to the level of poverty in communities. Women who lived in poor communities were between 15% and 52% less likely to report high-quality antenatal care. Poor communities are clusters of households headed by someone with no formal education, and in the lowest 20% of the wealth index. The poorest household wealth quantile is the lowest 20%.

The findings indicate that living in a poor household and in close proximity to poor households is a risk factor for low quality antenatal care. Poor women and their families are already vulnerable and may have underlying conditions that can increase their risks for experiencing pregnancy complications and poor birth outcomes. But these women may miss out on the benefits of antenatal care altogether because they face financial and social barriers to healthcare.

What should be done

In countries with low coverage of antenatal care, for instance Chad and Nigeria, policies should focus on expanding access to maternal health services. Educational policies that support the enrolment and retention of women in school can contribute to raising awareness on health and well-being. They also empower women to demand quality care. Although some countries provide free or subsidised health services for pregnant women and young children, it is evident that these policies do not adequately bridge the gap between need and access to services.

Therefore, additional economic policies that empower women financially to afford direct and indirect costs of services are needed.

Across all the countries in our study, there is a dire need to improve the quality of services. The health systems are clearly missing an important opportunity to intervene early in pregnancy to address behaviours and health problems that could cause serious complications or pregnancy-related deaths among the poorest women.

Targeted support for health systems should also be provided. These include ensuring adequate supplies of medicines and equipment, enhanced pre-service and in-service training and supervision of healthcare providers. Equitable distribution of healthcare resources, including providers, would also contribute to improved access and quality of antenatal care services in West and Central Africa.

These recommendations, if implemented, would significantly reduce maternal and newborn deaths and increase wellbeing and social capital in the region.

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The article was first publshed by THE CONVERSATION

Novartis announces new strategy to provide innovative medicines to more patients in sub-Saharan Africa

Novartis announced today a new strategy to broaden patient reach and availability of its portfolio of medicines in sub-Saharan Africa (SSA), which is home to the largest underserved patient population in the world.

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Novartis also aspires to be the partner of choice for governments and NGOs to strengthen healthcare systems across Africa.

“We are deeply committed to improving access to medicines around the world,” says Vas

Narasimhan, CEO of Novartis. “Building on our longstanding efforts to improving health in Africa, including on malaria and sickle cell disease, we’re taking a comprehensive approach to ensuring patients in sub-Saharan Africa, regardless of income, have access to our portfolio of medicines.” 

A quarter of the global disease burden weighs on Africa, but only 3% of the world’s health workers are based on the continent and the share of the world’s health expenditure for Africa is below 1%. Health systems frequently have to rely on NGOs and external donors to fund and provide services for the largest underserved patient population in the world.¹

As part of the new strategy, Novartis will pivot the current organizational focus in SSA from financial metrics such as sales performance and profits, to metrics that drive access to innovative medicines and strengthen health systems in the region. A new organizational unit will bring together the expertise and portfolio of our Sandoz Division, the Novartis

Pharmaceuticals and Oncology business units comprising our Innovative Medicines Division and Novartis Social Business. Racey Muchilwa is appointed Head of Global Health SSA, contributing her strong knowledge of the healthcare system and patient needs in the region.  The SSA unit aims to maximize patient reach across the full income pyramid by focusing on tiered pricing models, competitiveness in tenders and scaling social business models as well as affordability strategies. Novartis also will work to increase its clinical trial capabilities, and accelerate regulatory and administrative processes in the region to shorten the time between the development, approval and ultimately access to new medicines for patients across SSA. 

“I feel honored to lead our talented team in executing our new strategy. Our aspiration is to be the leading healthcare partner in sub-Saharan Africa and work with NGOs and governments to strengthen health systems,” says Racey Muchilwa, Head of Global Health SSA. “We aim to harness the power of digital and new technologies, to maximize the impact we can have on the health of people in sub-Saharan Africa where the population is expected to double by 2050 to 2.2 billion.” 

Novartis has a long-standing commitment to helping improve health of people in Africa. This includes communicable diseases such as malaria and leprosy as well as non-communicable diseases such as sickle cell disease (SCD), cardiovascular disease and cancer. Novartis has contributed nearly 900 million courses of malaria treatment at no-profit to patients in malariaendemic countries, including more than 380 million doses of our pediatric formulation.  Novartis is also pioneering research and development with clinical trials, utilizing novel biologic molecules and deploying new technologies to provide the benefits of cutting-edge innovation to the region. Most recently, the company announced a broad public-private partnership with the government of Ghana to tackle sickle cell disease, including access to available medicine, clinical research and use of digital technologies to achieve global standards of care.

Ebola vaccine approved in Europe

Ebola virus isolated in November 2014 from patient blood samples.

After more than two decades of research, the world finally has an approved Ebola vaccine.

The European Commission granted marketing authorization to Merck’s vaccine, known as Ervebo, on Monday, less than a month after the European Medicines Agency recommended it be licensed. I

is currently being used in the Democratic Republic of the Congo under a “compassionate use” or research protocol similar to a clinical trial.

“The European Commission’s marketing authorization of Ervebo is the result of an unprecedented collaboration for which the entire world should be proud,” Ken Frazier, Merck’s chairman and chief executive officer, said in a statement.

It is a historic milestone and a testament to the power of science, innovation and public-private partnership,” Frazier said, adding the company will work with the Food and Drug Administration in the United States and regulatory agencies in a number of African countries to license the vaccine. He said Merck will also work with the World Health Organization on vaccine prequalification, a process that would help countries that need the vaccine gain easier access to it.

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By HELEN BRANSWELL, courtesy of STAT

Words not enough to improve health outcomes – says World Bank President

World Bank Group President David Malpass’ has said at the 2019 UN High-Level Meeting on Universal Health Coverage (UHC) that accelerating progress toward Universal Health Coverage is critical to alleviating extreme poverty and boosting shared prosperity.

“Health is also an economic imperative as it is one of the global economy’s largest sectors, providing 50 million jobs—and the majority for women,” he said in his remarks.

Malpass said The World Bank latest figures show that every year, people pay over half a trillion dollars out-of-pocket for health care. This causes financial hardship for more than 925 million people and pushes nearly 90 million people into extreme poverty every year.

“Improving health outcomes is a key focus at the World Bank Group. Words are not sufficient – improved funding and health systems are vital. IDA – our fund for the poorest countries – is one of the most important tools to finance healthcare in lower income countries”.

He said over the last decade, IDA has provided US$13.5 billion to fund essential health interventions for 770 million people, and immunizations for 330 million children and that the share of IDA funding for health and nutrition has increased by 60% over the last decade, reflecting rising demand from countries.  

Malpass also said, “IDA funding is critical, but it is not nearly enough. Even in the most optimistic scenarios, we estimate that thefinancing gap to achieve UHC in the 54 poorest countries – home to 1.5 billion people – will be around $176 billion annually.

“To close that gap, we are focusing relentlessly on delivering good outcomes. I propose four priority areas where we can do more, and most importantly, where there is strong evidence on what works”.

Vaping: a potential public health crises in Africa

By Alpha Bedoh Kamara

530 confirmed or probable cases of serious lung injuries in the United States are linked to vaping, according to data released by the Centers for Disease Control and Prevention.

Eight deaths have also been tied to the illnesses. Many of the cases — which span 38 states and one territory in the United States — have been in young men.

According to STAT, Health officials haven’t found a culprit behind the illnesses and still aren’t certain whether they’re grappling with one or several conditions.

While health officials in the United States are grappling with a potential health crises affecting mostly young people, Africa could be worse if governments don’t move fast by acting on information from public health experts in developed countries to control and prevent the people from the growing vaping trend.

Developed countries have the infrastructure to map out the demographics and the number of people affected as well as probable victims, but in no way will Sub-Saharan Africa address the potential of a vaping crises if policies are not passed now to put a stop to the practice.

Few countries in Sub-Sahara Africa are looking at options to control vaping or totally ban the practice, yet for most countries it is left with the people to indulge into vaping or not. Thus a free-for-all place for manufacturers of E-cigarettes to flood the markets with their products.

The Vapers’ guide to vaping across Africa shows the level of lapses regarding vaping in the continent with few permitting vaping in designated smoking areas.

The picture shows how Sub- ahara Africa is vulnerable, especially young people whose lifestyles are influenced by developing trends in the West, but the latest discovery of the negative effect of vaping and subsequent warnings by health experts could make governments in the continent think of ways to stop a potential health crises.

There could already been cases, but unreported, because majority of the people seldom get access to standard healthcare. and without a WHO funded project aimed at public health issues, most African countries don’t have properly regulated and sustained public health monitoring systems to prevent and control public health threats.