Pfizer and BioNTech have announced positive safety, tolerability and immunogenicity data for two Omicron-adapted COVID-19 mRNA candidate vaccines – but for an earlier strain of Omicron than those that are currently globally dominant. 

The two Omicron-adapted vaccine candidates were given to 1,234 participants aged 56 years and older as boosters, and “elicited substantially higher neutralizing antibody responses against Omicron BA.1 when compared to the companies’ current COVID-19 vaccine,” according to the announcement. 

The monovalent vaccine candidate, which was designed to immunize against a single antigen, elicited a 13.5- and 19.6-fold increase in neutralizing titers against Omicron BA.1, Pfizer said in its release. 

The bivalent candidate, which is a combination of the traditional Pfizer vaccine and a vaccine targeting the spike protein of BA.1, exhibited a 9.1- and a 10.9-fold increase against Omicron.

However, the dominant strains of Omicron worldwide are currently BA.4 and BA.5. Preliminary laboratory studies show that the candidates neutralize BA.4 and BA.5, but to a lesser extent.

“Omicron has newly evolving sublineages that have outcompeted BA.1 and exhibit a trend of increasing potential for immune escape,” explained Prof Ugur Sahin, CEO of BioNTech. “We will therefore remain vigilant and are prepared to rapidly adapt our Omicron-adapted vaccine candidates to emerging sublineages if epidemiological and laboratory data suggest.”

Meeting with FDA

The companies will submit the results and discuss them with the US Food and Drug Administration (FDA) Vaccines and Related Biological Products Advisory Committee on 28 June and with the International Coalition of Medicines Regulatory Authorities on 30 June.

“Based on these data, we believe we have two very strong Omicron-adapted candidates that elicit a substantially higher immune response against Omicron than we’ve seen to date,” said Pfizer CEO Albert Bourla. “We look forward to discussing these data with the scientific community and health authorities so we may rapidly introduce an Omicron-adapted booster as soon as possible if authorized by regulators.”

The vaccines were also shown to be safe and have no additional side effects than the original vaccine.

Moderna Omicron vaccine also shown effective

Earlier this month, Moderna announced that it too had an updated COVID-19 booster shot that is more effective against stopping Omicron infection than its original jab. 

“We are thrilled to share the preliminary data analysis on mRNA-1273.214, which is the second demonstration of superiority of our bivalent booster platform against variants of concern and represents an innovation in the fight against COVID,” Moderna CEO Stéphane Bancel said in a company news release.

“Looking at these data alongside the durability we saw with our first bivalent booster candidate, mRNA-1273.211, we anticipate more durable protection against variants of concern with mRNA-1273.214, making it our lead candidate for a fall 2022 booster,” Bancel continued. “We are submitting our preliminary data and analysis to regulators with the hope that the omicron-containing bivalent booster will be available in the late summer.”

Like Pfizer, the company did not yet have any firm data on the vaccine’s effectiveness against BA.4 and BA.5.

Cases on the rise 

The Omicron variant was first spotted in Botswana and labeled as a variant of concern in April. BA.4 and BA.5 are its newest mutations and have been spotted in dozens of countries worldwide, causing a surge in cases because they can spread faster than other circulating variants.

On some days, more than 730,000 new daily COVID-19 cases are being reported daily, according to World O Meters – with more than 4.2 million reported in the last seven days.

The country with the highest number of new daily cases is the United States, followed by Germany and Brazil.

 

Monkeypox rash

Although the World Health Organization (WHO) has decided not to declare monkeypox a public health emergency of international concern (PHEIC), it could change its mind if there is evidence of “significant spread” in the next 21 days.   

This was announced over the weekend following the meeting of the WHO’s International Health Regulations (IHR) Emergency Committee. The Committee also recommended more aid to the 9-12 central and west African countries where the disease has long circulated, often as a result of contact with infected rodents, squirrels and other wild animals.  

According to the IHR, a public health emergency is “an extraordinary event, which constitutes a public health risk to other States through international transmission, and which potentially requires a coordinated international response”.

While the WHO conceded in its official statement that the outbreak was “unusual” in many aspects and that “a few” committee members felt it should be declared a PHEIC, it listed a number of requirements that might lead to a change in position in three weeks time. 

These would include: more cases both among and beyond the population groups currently affected; cases among sex workers; evidence of significant spread to and within additional countries; and an increase of cases in vulnerable groups, such people with poorly controlled HIV, pregnant women, and children.

Between 1 January and 22 June 2022, some 3413 laboratory confirmed cases and one death have been reported to WHO from 50 countries/territories in five WHO Regions, WHO reported on Monday, 27 June.     

‘Equitable access to lifesaving tools’

Reacting to the WHO announcement, Wellcome Trust’s Director of Infectious Diseases, Professor Gordon Dougan, urged all affected countries to “integrate their preparations and help those with limited capability”. 

“Governments do not need to wait for an official declaration to begin acting in a coordinated and measured way. Where cases have been identified, rapid public health responses such as enhanced disease surveillance, contact tracing and self-isolation will be crucial,” said Dougan.

However, he also called out the rush by some countries to acquire scarce vaccines despite mass vaccination not being recommended, urging the global community not to repeat mistakes made during the COVID-19 response.

“But while high-income countries are now paying attention to this virus, monkeypox has been affecting people in West and Central Africa for decades. And with new cases now being reported in other low- and middle-income countries, we must ensure that these lifesaving tools are equitably distributed to where they are needed most,” Dougan urged.

The response also required “establishing clinical trials of the required scale and design” to ensure improved  monkeypox vaccines and treatments, he added.

The WHO emergency committee also noted that monkeypox has been endemic in parts of Africa “for decades”, and that responding to the current outbreak should “serve as a catalyst to increase efforts to address monkeypox in the longer term and access to essential supplies worldwide”.

Cases plateauing?

Some of the issues influencing the WHO’s decision included “current observations of plateauing or potential downward trends in case numbers in some of the countries experiencing outbreak early on” as well as “the need for further understanding of transmission dynamics”.

“However, the committee unanimously acknowledged the emergency nature of the event and that controlling the further spread of outbreak requires intense response efforts,” added the WHO.

“The committee advised that the event should be closely monitored and reviewed after a few weeks, once more information about the current unknowns becomes available, to determine if significant changes have occurred that may warrant a reconsideration of their advice.”

Image Credits: US Centers for Disease Control.

The Prince of Wales and Rwanda’s President Paul Kagame meet at the Kigali Summit on Malaria and Neglected Tropical Diseases

As the Kigali Summit unfolds, Adrian Hill, director of Oxford University’s Jenner Institute, describes the great strides made in malaria control, and the contribution new malaria vaccines can make, including one designed at the Jenner Institute. He spoke to Health Policy Watch just ahead of this week’s meeting by heads of Commonwealth nations, which galvanized support for the fight against malaria and neglected tropical diseases.

Leaders of Commonwealth nations meeting in Rwanda’s capital have pledged more than US$4 billion towards global efforts to accelerate the fight against malaria and other neglected tropical diseases.

The heads of state also committed to redouble efforts on climate change and the COVID-19 pandemic, which continue to affect the lives of the 2.5 billion people in the 54 nations belonging to the Commonwealth association of one-time territories of the British Empire.

Thursday’s Summit on Malaria and NTDs, taking place on the sidelines of the broader Commonwealth meeting, also saw the signing the Kigali Declaration on neglected tropical diseases (NTDs), a political statement meant to galvanize support for some of the UN’s top health goals by 2030.

“Only through continued country ownership, political commitment, accountability and great partnership can we ensure progress is accelerated over the coming months,” the leaders concluded in their outcome statement.

Forty nations were certified malaria-free between 1955 and 2021, the World Health Organization (WHO) says. And while global efforts to fight malaria prevented an estimated 10.6 million deaths and 1.7 billion cases from 2000 to 2020, the disease still resulted in as many as 627,000 deaths and 241 million cases in 2020.

Ahead of the summit hosted by Rwanda’s President Paul Kagame, Health Policy Watch interviewed Adrian Hill, a professor of vaccinology and director of Oxford University’s Jenner Institute, which works on designing and developing vaccines for infectious diseases prevalent in developing countries. His answers have been edited for brevity and clarity.

Professor Adrian Hill.

Health Policy Watch: How will the Kigali Summit boost malaria control?

Adrian Hill:This key meeting could not have come at a better time for boosting the state of malaria control in Africa. The power of vaccines has been demonstrated strikingly by the response to the COVID-19 pandemic ─ well-illustrated by the Oxford-AstraZeneca-Serum Institute vaccine. And now vaccines for malaria that could have a huge impact on malaria control and save hundreds of thousands of lives a year will be available from next year. The challenge for the summit is to ensure that more lives are not lost because the world has failed to support the purchase and distribution of new malaria vaccines.

HPW: Why is it important to focus on the development of a malaria vaccine?

AH. Malaria is the biggest infectious killer of children from six months to five years of age in Africa. There are over 620,000 deaths from malaria a year, according to the latest WHO figures and this has been increasing. New interventions are crucial to reduce this unacceptable death rate and now malaria vaccination is at hand for the first time.

This map shows an approximation of the parts of the world where malaria transmission occurs.

HPW: What progress is being made to develop an effective, affordable and accessible malaria vaccine?

AH: There are two malaria vaccines that are close to licensure and should be available for use next year (2023). The older one is RTS,S/AS01, from GSK, that will be available at a scale of maybe 9-10 million doses. The other is the newer R21/MM that will be available, also next year, and was designed and developed by Oxford University with the Serum Institute of India. Importantly, this can be provided next year at a scale of 200 million doses a year, enough to vaccinate the 40 million children born each year in areas of Africa with high transmission of malaria and a high risk of death.

HPW: What progress has been made in the fight against malaria and NTDs in the last two decades?

AH: In 2000, there were about 1 million deaths each year globally from malaria. But with the improved use of bed nets, insecticides and chemoprevention drugs, deaths fell to about 500,000 people by 2015. Death rates are rising again, however, as these older types of interventions appear to be losing effectiveness. Fortunately, new malaria vaccines are becoming available from 2023 and one of these vaccines (R21/MM) appears more effective than any of these older interventions. However, the best approach will be to use all these interventions in parallel.

Malaria prevention tools (WHO).

HPW: Why is it important to scale up tools to eliminate malaria?

AH: The cost of malaria controls each year is now about US$3 billion. Adding the R21 vaccine will add about half a billion dollars to this cost, but this should be very cost effective. Importantly, adding new vaccines to other interventions should allow malaria to be eliminated in some countries very soon and eventually eradicated globally. Elimination and then eradication of malaria will reduce and then remove the costs of malaria control.

HPW: Why has it been so difficult to come up with a malaria vaccine?

AH: The RTS,S vaccine has not received regulatory approval as yet. It is just a WHO policy recommendation, but this should happen soon. And importantly, R21/MM should provide about 10-20-fold more doses and a less expensive vaccine. These two vaccines have emerged from over 140 candidates tested in clinical trials as the most effective to date. This reflects the great technical difficulty of making a vaccine against protozoan parasites, like malaria, which have thousands of genes, suppress natural immunity, and require exceptionally potent vaccines to provide protective efficacy. There are no licensed vaccines today against any parasite disease.

The Prince of Wales and Rwanda’s President Paul Kagame at the Kigali Summit on Malaria and Neglected Tropical Diseases.

HPW: What about the successful malaria vaccine trial with which you have been involved?

AH: The WHO has specified that a malaria vaccine should aim to show high efficacy of at least 75% over two years of follow-up. R21/MM, designed at Oxford University’ s Jenner Institute as part of a 30-year programme of vaccine research, is the only vaccine to demonstrate that level of efficacy in African children, the most important population to protect and the most vulnerable to malaria disease and death.

Image Credits: US Centers for Disease Control and Prevention, World Health Organization .

Pro-abortion protests have erupted in the US in the aftermath of the court decision.

Women’s rights activists and political opponents reacted with fury to the US Supreme Court’s stunning reversal of the fundamental right to abortion established almost 50 years ago in the landmark 1973 ruling of Roe v. Wade.

US President Joe Biden called it a “tragic error,” saying this is the first time the US Supreme Court has removed “a constitution right that is so fundamental to so many Americans.” He vowed his administration would defend a woman’s right to travel across state lines to seek an abortion.

“Now with Roe gone, let’s be very clear, the health and life of women across this nation are now at risk,” he said. “Let me be very clear and unambiguous. The only way we can secure a woman’s right to choose that exists is for Congress to restore the protections of Roe v. Wade as federal law. No executive action from the president can do that.”

Biden called on voters to elect more senators and representatives who support reproductive rights, and pointed out that the Supreme Court decision does not prevent women from crossing state lines to receive an abortion.

“My administration will defend that bedrock right,” he promised. “If any state or local official, high or low, tries to interfere with a woman’s exercising her basic right to travel, I will do everything in my power to fight that deeply un-American attack.”

Biden added his administration would also back the right of access to medication for medical abortions, which some anti-abortion states want to ban.

Trigger bans in 13 states

The Supreme Court decision triggered automatic abortion bans in 13 states that had such laws in place. This means that women living in Arkansas, Idaho, Kentucky, Louisiana, Mississippi, Missouri, North Dakota, Oklahoma, South Dakota, Tennessee, Texas, Utah, and Wyoming will no longer be able to get access to abortions. 

Some states like Mississippi make no exceptions for rape, incest or health considerations, and women and girls and doctors face jail sentences for induced abortions.

Another 13 states are also poised to curtail abortion rights, while only 16 states and the District of Columbia have laws that protect the right to abortion, according to the Guttmacher Institute, an NGO that advocates for sexual and reproductive health rights.

Abortion bans don’t work

Dr. Herminia Palacio, the institute’s president and CEO, said decades of research consistently show that abortion bans and restrictions don’t reduce unintended pregnancy or demand for abortion.

“And they certainly do not help people improve their health,” said Palacio. “Rather, they impose significant hurdles to obtaining care, causing stress for people in need of abortion and leading some to experience forced pregnancy and all its troubling consequences.”

Rep. Tim Ryan, Democrat of Ohio, said the ruling was “the largest overreach in history” as it removed a constitutional right for the first time, essentially introducing “government-mandated pregnancies.”

A tearful Rep. Cori Bush, Democrat of Missouri, who had an abortion after being raped as a 17-year-old, described the court as “far-right, racist and supremacist.”

Planned Parenthood’s CEO Alexis McGill Johnson said the decision amounts to “the removal of women’s rights to bodily autonomy” but her organization will continue fighting to ensure women can take care of themselves as best as possible.

“This is about power and control,” she said. “Abortion is still legal in some states, and Planned Parenthood will do whatever we can to ensure people have services.”

“This horrifying decision will have devastating consequences, and it must be a wake-up call, especially to young people who will bear the burden,” said former US First Lady Michelle Obama.

Friday’s Supreme Court ruling on the appeal of a case brought by the Mississippi Department of Health, Dobbs v. Jackson Women’s Health Organization, overturned the 1973 Roe v Wade decision, which held that the 14th Amendment of the US Constitution provides a “fundamental right to privacy” that protects women’s rights to seek an abortion “without undue restrictive interference from the government.” De facto, the decision also upended the Supreme Court’s 1992 decision in Planned Parenthood v. Casey, which barred states from enacting abortion restrictions expressly for “the purpose or effect of placing a substantial obstacle in the path of a woman seeking an abortion of a nonviable fetus.” 

Justice Samuel Alito Jr.’s opinion overruling Roe and Justice Brett M. Kavanaugh’s concurrence said the decision ending a woman’s constitutional right to abortion shouldn’t endanger other sexual and reproductive rights that the court has recognized such as contraception, interracial marriage and same-sex marriage.

But the concurrence by Justice Clarence Thomas calls for not just revisiting but “overruling” all of the court’s substantive due process precedents including Obergefell v. Hodges, which deals with same-sex marriage, Griswold v. Connecticut, a landmark contraception case, and Lawrence v. Texas, a major case that invalidated anti-sodomy laws.

“After overruling these demonstrably erroneous decisions, the question would remain whether other constitutional provisions guarantee the myriad rights that our substantive due process cases have generated,” he wrote – although he omitted reconsideration of interracial marriage — which would make his own marriage illegal.

States prepare for patient influx

Some states where abortion is legal are already preparing for an influx of people seeking abortion, as previously reported by Health Policy Watch.

Last month, New York State Governor Kathy Hochul announced a $35 million investment to directly support abortion providers in anticipation of Roe v. Wade being overturned.

“New York has always been at the forefront of the fight for abortion rights, and as the first female governor of New York, I will not let us go backwards,” said Hochul. “This landmark funding will get resources into the hands of clinics who need our help, safeguarding access to abortion in our state and setting an example for the rest of the nation to follow.”

Image Credits: Gayatri Malhotra / Unsplash.

Children show high immunity to COVID months after infection.

Children infected with COVID-19 maintained strong immunity against the virus for at least 18 months, according to a preprint study that was released on Wednesday.

The study, which has not yet been peer-reviewed, was conducted by Kahn-Sagol-Maccabi (KSM), the research and innovation center of Maccabi Healthcare Services in Israel, and was released on the preprint server MedRxiv.

The largest real-world observational research examining children’s immunity to date, it analyzed the Maccabi Health Services records of around 300,000 unvaccinated youth between 1 July  and 13 December 2021, when Delta was dominant in Israel.

Recovered children had to have been infected at least 90 days’ prior to inclusion date to capture reinfections.

According to the research, children and teenagers aged five to 18 who caught COVID-19 developed strong natural protection against reinfection with effectiveness levels of about 80% for at least 18 months.

‘Robust and long-lasting’

“Naturally acquired immunity in children and adolescents was found to be robust and long-lasting, which aligns with what we have witnessed in our day-to-day clinical practice,” said KSM head Dr Tal Patalon, who is both a physician and a researcher, and has been treating COVID-19 patients since the early days of the pandemic.

Although the researchers have not yet looked into natural immunity resulting from Omicron, Patalon said that she assumed “naturally acquired immunity will remain significant against the Omicron variant, this is currently under further research”.

Effectiveness of naturally acquired immunity against recurrent infection reached 89.2% three to six months after first infection, mildly declining to 82.5% nine months to one year after infection and then remaining steady for up to 18 months.

The protection was even stronger for the younger cohort; children up to age 11 showed no significant decline in protection during the study period, while those between 12 and 18 showed more decline.

The study was published just days after the US Food and Drug Administration and the Centers for Disease Control and Prevention approved vaccines for children under the age of five and as cases are on the rise throughout much of the Western world.

The study findings were validated twice, using two different statistical methods, strengthening the validity of the study results.

“As for public health policies, the demonstrated long-term protection of naturally acquired immunity has important implications regarding the decision to vaccinate convalescent children and adolescents, and to mandate self-quarantine after exposure, affecting all biopsychosocial aspects of life and well-being of children, adolescents and their families,” the study’s authors concluded.

They noted that this should be considered in light of evidence of increasing seroprevalence antibodies that indicate previous infection in as much as 70% of children and adolescents in the US.

Image Credits: Kelly Sikkema/ Unsplash.

COVID-19 vaccines are estimated to have saved almost 20 million lives – but mostly in high- and upper-middle class income countries that received the vaccines first.

COVID-19 vaccines prevented almost 20 million deaths worldwide in the first year of the vaccine programme, according to a modelling study published in The Lancet on Friday.

The first modelling study to quantify the global impact of COVID-19 vaccines estimates that 19.8 million out of a potential 31.4 million deaths were prevented in the first year after vaccines were introduced between 8 December 2020 and 8 December 2021.

“High and upper-middle income countries accounted for the greatest number of prevented deaths (12.2 million/ 19.8 million), highlighting inequalities in access to vaccines around the world,” according to The Lancet.

A further 599,300 deaths could have been averted if the World Health Organisation’s target of vaccinating 40% of the population in every country by the end of 2021 had been met.

The study is based on data from 185 countries, using COVID-19 death records and total excess deaths from each country, or estimates where official data was not available. 

To account for under-reporting of deaths in countries with weaker surveillance systems, they carried out a separate analysis based on the number of excess deaths recorded above those expected during the same time period. 

Where official data was not available, the team used estimates of all-cause excess mortality. These analyses were compared with an alternative hypothetical scenario in which no vaccines were delivered.

COVAX saved 7.5 million lives

“Our findings offer the most complete assessment to date of the remarkable global impact that vaccination has had on the COVID-19 pandemic. Of the almost 20 million deaths estimated to have been prevented in the first year after vaccines were introduced, almost 7.5 million deaths were prevented in countries covered by the COVID-19 Vaccine Access initiative (COVAX),” said Dr Oliver Watson, lead author of the study, from Imperial College London.

“Our findings show that millions of lives have likely been saved by making vaccines available to people everywhere, regardless of their wealth. However, more could have been done. If the targets set out by the WHO had been achieved, we estimate that roughly one in five of the estimated lives lost due to COVID-19 in low-income countries could have been prevented.”

COVAX has facilitated access to affordable vaccines for lower-income countries to try to reduce inequalities, with an initial target of giving two vaccine doses to 20% of the population in countries covered by the commitment by the end of 2021. 

The World Health Organization (WHO) expanded this target by setting a global strategy to fully vaccinate 70% of the world’s population by mid-2022, with an interim target of vaccinating 40% of the population of all countries by the end of 2021.

Despite the speed of the vaccine roll-out worldwide, more than 3.5 million COVID-19 deaths have been reported since the first vaccine was administered in December 2020.

“Quantifying the impact that vaccination has made globally is challenging because access to vaccines varies between countries, as does our understanding of which COVID-19 variants have been circulating, with very limited genetic sequence data available for many countries,” said Gregory Barnsley, co-first author of the study, from Imperial College London. 

“It is also not possible to directly measure how many deaths would have occurred without vaccinations. Mathematical modelling offers a useful tool for assessing alternative scenarios, which we can’t directly observe in real life.”

Image Credits: International Monetary Fund/Ernesto Benavides.

monkeypox
Monkeypox rash.

A World Health Organization emergency committee met Thursday to determine if the monkeypox outbreak spreading in non-endemic countries constitutes a Public Health Emergency of International Concern (PHEIC).

The closed door meeting, including 16 committee members and eight advisors, will make a recommendation to WHO Director-General Dr Tedros Adhanom Ghebreyesus, who will decide whether to designate it a public health emergency.

Tedros told a WHO media briefing last week the global outbreak of monkeypox “is clearly unusual and concerning.” His decision is not expected before Friday, according to a WHO media advisory.

Ibrahima Socé Fall, WHO’s deputy director for emergency response, said it is important to take preventive action now because the risk of spread in Europe is “high” and in other parts of the world it is “moderate,” though much is still unknown about how the virus is being transmitted.

“We don’t want to wait until the situation is out of control,” he said.

More than 3000 monkeypox cases globally, experts urge WHO to take action 

With 3,543 confirmed and suspected cases across 59 countries outside of central and western Africa as of Thursday, other global health organizations have already begun to declare monkeypox a public health emergency, with experts urging WHO to take immediate action to combat what some of them consider to be another pandemic.

Public health research coalition World Health Network declared monkeypox a pandemic on Thursday. 

“There is no justification to wait for the monkeypox pandemic to grow further. The best time to act is now. By taking immediate action, we can control the outbreak with the least effort, and prevent consequences from becoming worse,” said Yaneer Bar-Yam, WHN’s founder and president of New England Complex System Institute.

In places like New York City, public health clinics are offering vaccinations against the disease. 

Monkeypox has plagued Africa for years 

Cases of monkeypox in endemic countries between 15 December 2021 to 1 May 2022

Some experts in Africa have said the WHO consultation is long overdue, but for different reasons. Global concern has only arisen recently, despite the fact that monkeypox has plagued Africa for years.

In 2022 some 1536 suspected cases and 72 deaths have been reported by WHO in the eight countries where the disease is endemic in 2022.

In the case of the more lethal West African clade, the disease can have a fatality rate of up to 10%. 

The different responses to the disease in Africa and Europe have drawn growing attention. “When a disease affects developing countries, it is (apparently) not an emergency. It only becomes an emergency when developed countries are affected,” Emmanuel Nakoune, acting director of Institut Pasteur in Bangui, Central African Republic, told Reuters.

Nakoune, who is running a clinical trial for a monkeypox treatment, said that if WHO declares monkeypox a public health emergency, that would at least be an important step in the right direction. And each will be able to benefit, he said, “if there is the political will to share equitably the means of response between developed and developing countries.”

More intensive person-to-person transmission seen in Europe 

The clade of the virus spreading in Europe was previously seen largely in West African countries, with the exception of isolated cases carried abroad by travelers. But person to person transmission of the virus in African settings was typically limited, with outbreaks occurring largely as a result of contact with wild animal populations, including infected rodents and squirrels. 

In Europe, in contrast, the virus is spreading exclusively through person-to-person transmission, including as a result of men having sex with men or other forms of skin-to skin contact.

Meanwhile, a team of African researchers, including the acting director of the Africa Centers for Disease Control, proposed a new nomenclature for the virus out of concern that the current terms are racist and stigmatizating.  

The proposal calls for the virus to be named in terms of its variants, such as MPXV Clades 1, 2, and 3, in order of discovery.  Newer variants are more likely to be the ones carrying the disease abroad. 

If monkeypox is designated as a public health emergency, or PHEIC, under WHO’s International Health Regulations, it could help unlock more funding from WHO and governments that would help to get transmission under control.  Countries would have a legal obligation to implement their own public health measures.  

Such an emergency declaration also could underpin WHO plans to ensure an equitable distribution of available smallpox and monkeypox vaccines that are effective against the virus. Such vaccines are available now only in wealthy countries.

Only six disease outbreaks have been declared a PHEIC since 2007: swine flu, polio, Ebola, Zika, Kivu Ebola and COVID-19.  [See the WHO explainer about Monkeypox symptoms and treatment below.]

https://twitter.com/WHO/status/1535592685569986561?s=20&t=z9RSw1le1MRLn-9Lh0oxBg

Image Credits: Diverse Stock Photos , WHO, Disease Outbreak News, 21 May 2022 .

electron micrograph of methicillin-resistant Staphylococcus aureus (MRSA, brown), a deadly bacteria resistant to many antibiotics, surrounded by cellular debris

The World Health Organization (WHO) has once more raised the red flag over the lack of new antibacterial treatments being developed to address the mounting threat of antimicrobial resistance (AMR).

In its annual  ‘pipeline report’, which assesses those antibacterial drugs in preclinical and clinical development, WHO describes the pipeline as “stagnant” and “far from meeting global needs.”

Since 2017 only 12 antibiotics have been approved, 10 of which belong to existing classes with established mechanisms of AMR. The 2021 report shows that only 27 new antibiotics are in clinical development against priority pathogens, four less than were being developed in 2017.

“This presents a serious challenge to overcoming the escalating pandemic of antimicrobial resistance and leaves every one of us increasingly vulnerable to bacterial infections including the simplest infections,” said Dr Hanan Balkhy, WHO Assistant Director General on AMR.

Status of drugs in clinical trial development – WHO ‘Pipeline’ report 2021

The 2021 report, published in May and based on data from 2020, also highlights some of the barriers to drug development, foremost the lengthy pathway to approval, high cost and low success rates.

It takes 10 to 15 years to progress an antibiotic candidate from the preclinical and clinical stages and that only one in every 15 existing drugs in preclinical development and one in 30 for new classes reach patients.

“Time is running out to get ahead of antimicrobial resistance, the pace and success of innovation is far below what we need to secure the gains of modern medicine against age-old but devastating conditions like neonatal sepsis,” said Dr. Haileyesus Getahun, WHO Director of AMR Global Coordination.

Pipeline investment challenges and existing drug misuse

The Global Antimicrobial Research and Development Partnership (GARDP) has been created by WHO and the Drugs for Neglected Disease Initiative to accelerate the advancement of promising drug candidates in clinical trials.  However getting new drug candidates through costly Phase 2 and 3 trials remains challenging – with financial rewards insufficient for private industry even if a drug candidate succeeds.

The other problem is drug misuse and fake drug use. Worldwide, some 73% of antibiotics sold every year are used in animal health. That pattern, along with overprescription, misuse and use of weakened formulations in human medical settings all are increasing the prevalence of ‘superbugs’ and thus antimicrobial resistance (AMR) to some of the most common drug formulations.

AMR trends are most pronounced in low- and middle income countries of Asia and Latin America where regulations on both veterinary and human use of such drug are weak – with huge financial incentives to veterinarians who recklessly prescribe antibiotics to animals, and many antibiotics commonly available over-the-counter for human patients who then may use them to treat illnesses for which they are not effective. See related story:

Breeding Superbugs – Veterinary Drugs, More than Human Ones, Drive AMR 

 

Image Credits: NIAID, WHO .

Heiner Wedmeyer reports on Bulevirtide to treat and even cure Hepatitis D, with Maria Buti, EASL Public Health Chair and EASL Secretary General Thomas Berg,

The drug Bulevirtide can successfully treat and even potentially cure Hepatitis D – the most acute diseases of the hepatitis family and hardest to treat until now, according to the results of a Phase III trial of the drug announced on Thursday, the opening day of the International Liver Congress 2022 (ILC 2022). 

An estimated 12 million people worldwide have experienced HDV infection, also known as Chronic Hepatitis Delta. HDV is found in up to 5% of people worldwide living with Hepatitis B (HBV). HBV also has so far eluded a cure. But promising clinical trial results of other new drugs and drug combinations to treat HBV, and related to that, acute hepatic porphyria, also being discussed at the conference, could help advance that goal. 

“With Bulevirtide, an inhibitor of HBV and HDV entry into liver cells, we can for the first time successfully treat Hepatitis D,”  said EASL in a press statement.  Results from 48 weeks of treatment with the drug also showed HDV RNA at undetectable levels in a significant proportion of those treated, leading to hopes that the treatment could also lead to a cure.  

“This is almost a historic moment for heptatology,” said principle investigator, Heiner Wedemeyer, of Germany’s Hannover Medical School, of the findings. He speaking at an ILC press briefing about the Phase 3 trial,  undertaken in Germany, The Russian Federation, Italy and Sweden of 2 and 10 mg doses of the drug daily for a period of 48 weeks. “For us in the Hepatitis D field, this is really exciting times, completely novel data, and game-changing for treatments.”

Results of randomized, Phase 3 study of 2 mg or 10 mg dose of Bulevirtide in patients with HDV virus in four European countries, as presented at the International Liver Conference 23-26 June, 2022

Convened by the European Association for the Study of the Liver (EASL) in a hybrid format, the conference in London, 23-26 June saw 5,000 scientists, doctors, public health officials, and patient groups attending in-person for the first time since the beginning of the COVID pandemic. 

Other advances being discussed at the conference will include: new treatments for reducing liver fat and positive results from the largest human trial of preemptive drugs administered before transplantation of a hepatitis C compromised organ, which can fully protect a patient from risk associated with post operative infection.

“We may well be entering into a new golden age of hepatology science,” said Thomas Berg, Secretary-General of EASL and Head of the Division of Hepatology at Leipzig University Medical Center in Germany. “There is respite coming for those people living with Hepatitis D and we are making progress towards finding a cure for Hepatitis B which affects millions people around the world. The science is inching us towards a potential public health revolution.”

Event takes place against backdrop of increased liver disease 

This year’s EASL takes place against the backdrop of an increased prevalence of liver disease across the globe.

In Europe, chronic liver disease has a substantial impact on young and middle-aged individuals in their prime working years, with the peak age of death occurring in the late 40s and early 50s. Liver disease is now the biggest killer of 35–49-year-olds in the United Kingdom. 

This contrasts with mortality from smoking-related and other obesity-related illnesses, such as lung cancer or type 2 diabetes, for which deaths typically occur in the 60s and 70s. Consequently, data from the World Health Organization shows that liver disease is now second only to ischemic heart disease as the leading cause of years of working life lost in Europe. On average, two-thirds of all potential years of life lost due to mortality from liver diseases are years of working life.

New treatments for Non-Alcoholic Fatty Liver Disease (NAFLD) 

The Congress also will see reports on the results of the human trial of a new drug Pemvidutide with the potential to reduce both weight and liver fat; as well as results of a randomized-controlled trial on a low carbohydrate/high fat diet, and its potential impact on fatty liver disease.

The search for new treatments for Non-Alcoholic Fatty Liver Disease (NAFLD) has gained momentum over the past few years as countries worldwide grapple with a rise in the disease, just one  result of the worldwide increase in obesity levels. NAFLD is now the fastest growing disease in the world, and the most common cause of liver disease in many developed countries.  

In a proportion of people, NAFLD can cause progressive liver damage, and in some cases it may even lead to the development of liver cirrhosis and liver cancer. In the U.S. it is now the most common indication for a liver transplant, according to EASL.

It is estimated that if left unchecked, the annual predicted cost of NAFLD in Europe is estimated to be greater than €35 billion in direct costs to the health system, and a further €200 billion by way of wider costs to society.

–Updated 27 June 2022

Image Credits: Wedemeyer et al, EASL2022 presentation.

A man with symptoms of trypanosomiasis, a neglected tropical disease, is examined by Dr Victor Kande in the Democratic Republic of Congo (DRC).

The Kigali Summit has called for the renewal of commitments in the fight against neglected tropical diseases (NTDs) through the adoption of the Kigali Declaration on NTDs. 

Sponsored by the government of Rwanda, the Kigali Declaration on NTD is the successor to the ground-breaking London Declaration of 2012, which was a pledge made by governments, donors, pharma, research institutions, NGOs, and other stakeholders to collaborate in their efforts to stop NTDs. 

The new Kigali Declaration aims to mobilize political will and secure commitments to achieve the Sustainable Development Goal target on NTDs and to deliver the targets set out in the World Health Organization’s Tropical Disease Roadmap (2021 – 2030).

The summit, hosted on Thursday by President Paul Kagame of Rwanda and co-convened by The RBM Partnership to End Malaria and Uniting to Combat NTDs, builds on progress made in the last two decades, and even more so since the London Declaration, to galvanize action to end malaria and NTDs. 

The summit is also a critical moment to highlight how investments in fighting both malaria and NTDs have a much broader impact, and increased investments will strengthen health systems and protect against future pandemics. 

In conjunction with the summit, Swiss pharmaceutical company Novartis has endorsed the new declaration and has announced a $250 m five-year commitment in the fight against NTDs.

“Today, by endorsing the Kigali Declaration and pledging to invest USD 250 million, we aim to accelerate  progress toward elimination of these diseases, which continue to cause suffering and stigma  for millions of people around the globe, ” said Novartis CEO Vas Narasimhan.  

Ending NTDs is possible 

Ambitious global commitments over the years have shown that ending NTDs is an achievable goal, with 45 countries eliminating at least one NTD, 600 million people no longer requiring treatment for NTDs, and cases of diseases that have plagued humanity for centuries, such as sleeping sickness and Guinea worm disease, at an all-time low.

However, 1.7 billion people continue to suffer from NTDs, and 241 million people are impacted by malaria globally. 

Additionally, according to the annual G-FINDER report, funding for NTDs remained relatively stagnant, with only snakebite envenoming seeing increased investment in 2020. 

Novartis’ $250 million commitment will be used to advance research and development of new treatments to combat NTDs and malaria.  It includes $1 million to advance R&D, focusing on novel drug candidates for four diseases: Chagas disease, visceral leishmaniasis, dengue fever, and Cryptosporidium. 

Some $150 million will be invested to advance the clinical development of three drug candidates to combat emerging resistance to artemisinin, a well-established treatment for malaria.  

With both its adoption of the Kigali Declaration and this new investment, Novartis reiterated its commitment to the fight against NTDs and malaria.

“Over the past decade, great progress has been made against NTDs, but there is still a lot more work to be done. Novartis will continue progressing our longstanding commitment to helping realize a world free of NTDs,” said Narasimhan.

Image Credits: DNDi.