COVID vaccination of older people.  The European Medicines Agency is now recommending boosters for people over 60,

With cases of Omicron BA.4 and BA.5 soaring in Europe and around the world, the European Medicines Agency (EMA) recommends everyone 60 and older get a second COVID-19 booster shot.

EMA’s recommendation came shortly before WHO reconvened its COVID Emergency Committee on Friday to reconsider its global recommendations for the pandemic – and if the state of global health emergency first declared on 30 January 2020, should be maintained.  So far WHO recommendations on a second booster, provided by another expert group in May, are limited to immunocompromised people. 

Speaking at a press conference Thursday, EMA’s head of vaccines, Marco Cavaleri said a fourth booster for people over 60 and other vulnerable groups is now warranted due to a regional increase in COVID cases. 

He said projections show the BA.4 and BA.5 sub variants are expected to become dominant across all European countries, likely completely replacing all other variants by the end of July.

COVID-19
Marco Cavaleri, head of vaccines for the European Medicines Agency

“As this new wave is unfolding over the EU, it is essential to maintain protection of vulnerable groups and avoid any postponement of vaccination,” Cavaleri said. “Although there is no evidence of increased infection severity in the BA.4 and BA.5 compared to other sub variants, the increased transmission among older age groups is starting to translate into severe disease.”

Globally, COVID-19 cases have increased by at least 30%, driven by variants BA.4 and BA.5 in Europe and the US, while a new sub-lineage of BA.2.75 is rising in India, WHO Director-General Dr Tedros Adhanom Ghebreyesus told a briefing on Wednesday. 

EMA and other regulators looking toward approval of “bivalent” COVID vaccines by September

While current vaccines offer “good protection” against hospitalization, severe disease and death, EMA and other regulatory agencies around the world are now looking closely at new “bivalent” COVID vaccine formulations, Cavaleri said.

EMA, the US Food and Drug Administration and other national regulatory authorities met last week under the auspices of the International Coalition of Regulatory Authorities (ICMRA) to examine available data on the new vaccines in light of the reduced protection that current vaccines offer against mild and moderate disease.

“Preliminary data from clinical trials indicate that adapted messenger RNA (mRNA) vaccines which incorporate an Omicron variant strain can increase and extend protection, when used as a booster,” Cavaleri said of ICMRA’s conclusions. “Bivalent mRNA vaccines which combine two strains of SARS-CoV-2, one of which is an Omicron strain … appear to offer an even wider immune response.”

But vaccines that include other variants or subvariants might also be considered for use as boosters, if clinical trial data demonstrate an adequate level of neutralization against Omicron and other variants of concern.

Cavaleri said his agency is evaluating initial data that mRNA vaccines manufacturers have submitted for review and is in close contact with manufacturers of vaccines based on different platforms other than mRNA, especially adjuvanted protein vaccines.

“Overall we expect to potentially have several vaccines to include … with an assortment of different platforms and technologies, and this is welcome,” he said.

EMA also is working towards approval of adapted COVID-19 vaccines in September, with an eye towards what Cavaleri described as “plans for an even broader rollout of vaccination campaigns in the autumn.”

Future Course of WHO Public Health Emergency Designation for COVID

WHO hasn’t changed its designation of COVID-19 as a pandemic, and it was not expected to do so at Friday’s COVID Emergency Committee meeting – although as of Sunday afternoon no statement by the Commitee had yet been made, raising questions about what directives might yet be issued.

Irregardless of current trends showing increased transmission in many parts of the world, there is growing acknowledgement that the COVID emergency is evolving into an endemic disease. 

That will likely mean further peaks and valleys, but be far less lethal than the initial waves of 2020. And sooner or later, that will prompt a re-evaluation of the status of COVID as a “Public Health Emergency of International Concern” (PHEIC), requiring countries to undertake special measures under the terms of International Health Regulations.  

At a press conference on Thursday, Dr Mike Ryan, WHO’s head of health emergencies, described it as more of “a series of national epidemics” and stressed the real work needed to take place “at the national level.”

In line with those trends, WHO and Gavi, the Vaccine Alliance acknowledged plans this week to “transition” the work of the Act Accelerator initiative for distributing COVID vaccines, tests and treatments into the work of key ACT-A partners and national health systems.  

Under the auspices of ACT-A, COVAX, the global vaccine facility has distributed hundreds of millions of doses of COVID vaccines to 92 low-income countries since March 2021 with the support of Gavi, UNICEF and WHO. Tthe vaccine facility was hampered early in the pandemic by severe vaccine supply shortages and later by widespread public uptake of vaccines as they became more available.

-Updated 10 July 2022

Image Credits: Flickr: IMF/ Raphael Alves.

Akinwumi Adesina, president of the African Development Bank, visits the ‘Mother and Child’ Hospital of Bingerville, Côte d’Ivoire, in 2020

The African Development Bank is establishing a foundation with the aim of spending at least $3 billion over the next decade to boost Africa’s access to technologies needed to make medicines, vaccines, and other pharmaceutical products.

The bank’s board approved the establishment of the African Pharmaceutical Technology Foundation with an eye to towards creating what the bank described in a statement on June 27 as “a new groundbreaking institution” for Africa’s 1.3 billion citizens.

AfDB President Akinwumi Adesina said Africa “must have a health defense system” that revamps its pharmaceutical industry while also building up its capacity to make vaccines and provide quality healthcare.

“Africa can no longer outsource the healthcare security of its 1.3 billion citizens to the benevolence of others,” said Adesina, a Nigerian economist.

AU priority to improve healthcare sector

African Union Headquarters, Addis Ababa 

The need for a foundation featured prominently at the African Union summit in February at Addis Ababa, where leaders called on AfDB to help Africa’s health care sector become more independent in light of the challenges it has faced from several devastating diseases and the COVID-19 pandemic.

WHO’s Dr Tedros Adhanom Ghebreyesus

The foundation’s creation signals a major shift in efforts to address inadequacies in the sector, including limited capacity to produce its own medicines and vaccines in part due to the intellectual property barrier.

Dr Tedros Adhanom Ghebreyesus, Director-General of the World Health Organization (WHO), said it “is a game changer on accelerating the access of African pharmaceutical companies to IP-protected technologies and know-how in Africa.”

Medicines and vaccines gap

The pandemic exposed Africa’s lack of capacity to manufacture and supply essential drugs and personal protective equipment (PPEs) needed to control the coronavirus.

Soon after the pandemic began in early 2020, many of the world’s top scientists scrambled to find a vaccine but government and business leaders paid less attention to how it would be made and delivered to low- and middle-income countries.

More focus was put on rapidly increasing supply to meet the surging demand, in a process largely driven by wealthier nations with greater purchasing power. In Africa, as in most other developing nations, citizens’ health care became dependent on the generosity of others.

Nigerian pharmacist Ezinne Victoria Chinemerem Onwuekwe, who works as a public health fellow for the Africa Centres for Disease Control and Prevention, said the main problem is that Africa’s pharmaceutical industry lacks manufacturing capacity.

“There are a few production companies here and there, and for it to be able to produce for these citizens, it will require the effort of public and private sector to bring together both the technical [and] financial support needed to push this forward,” she said.

The shortage of medicines and other pharmaceutical products has been a challenge to effective delivering quality healthcare services in Africa.

Pharmaceuticals are made in South Africa, Kenya, Morocco and Egypt, yet Africa spends US$16 billion to import 94% of its pharmaceutical and medicinal needs, according to the United Nations Economic Commission for Africa (UNECA).

As of 2019, the continent had roughly 375 pharmaceutical manufacturers, compared to about 5,000 and 10,500, respectively, in China and India.

And a 2019 study found many life-saving drugs are still inaccessible and unaffordable in low- and middle-income countries.

Game changer for medicines

Akinwumi Adesina, African Development Bank president, at the initiative launch,

The new foundation, which will raise its own funds and operate independently of AfDB, will be hosted in Rwanda and deal with IP rights and health policy.

One of its chief responsibilities will be mediating interests between Africa’s pharmaceutical sector and global companies with the aim of sharing IP-protected technologies, know-how and patented processes, according to documents on its establishment.

It also is being asked to prioritize technologies, products and processes aimed primarily at diseases widely prevalent in Africa, or those that involve current and future pandemics.

And it is expected to help build up the ranks of health care professionals and others who conduct research and development while upgrading manufacturing plant capacities and regulatory quality to meet WHO standards.

Challenges in the healthcare sector

Ezinne Onwuekwe

Small fragmented markets and weak regulatory frameworks, inadequate human resource capacity, poor procurement and supply chain systems, and policy incoherencies in countries’ trade, industry, health, and finance departments are some of the impediments to the growth of Africa’s pharmaceutical sector.

The continent is also burdened with fake and falsified medical drugs. In 2017, WHO revealed an estimated 116,000 additional deaths a year from malaria could be tied to substandard and falsified antimalarials.

To counter that, the foundation is being asked to help local pharmaceutical companies boost home-grown production with better technology in their manufacturing plants and to work with governments, research and development centers to improve their innovation capacities.

Onwuekwe said part of the problem is a lack of political will in some countries.

“This is about finding African solutions to African problems. That is the new public heath order,” Onwuekwe told Health Policy Watch. “The leadership of the countries have to invest financially and politically for there to be any progress in the sector.”

But the foundation, she said, also must become adept at negotiating with global pharmaceutical companies and must be “able to foster collaborations” with WHO, the African Union and other international organizations.

Image Credits: AfDB Group, IAEA.

With a 77% increase in new monkeypox cases in the past week, the World Health Organization’s (WHO) Emergency Committee is increasingly likely to declare the outbreak a public health emergency of international concern (PHEIC) when it reconvenes on or before 18 July.

By Thursday, 59 countries had reported monkeypox cases, with Spain (1804 cases), UK (1351), Germany (1304) and the US (605) recording the highest caseloads.

However, 10 countries have not reported new cases for over 21 days, which is the maximum duration of the incubation period of the disease, according to the WHO’s latest report.

So far, there have been 6027 laboratory-confirmed cases of monkeypox and three deaths, but most countries are unable to test for the virus.

However, the European Centre for Disease Prevention and Control (ECDC) reported on Wednesday that 5949 cases had been identified in 33 European countries alone through international health regulation mechanisms and public records.

The vast majority of cases (99%) were male and aged between 31 and 40 (42%). 

“The majority of cases presented with a rash (96.1%) and systemic symptoms such as fever, fatigue, muscle pain, vomiting, diarrhoea, chills, sore throat or headache (69%). No cases were reported to have died. Some (15) cases were reported to be health workers. However, further investigation is ongoing to determine whether infection was due to occupational exposure,” according to the ECDC.

Monkeypox cases, 6 July 2022 (Source: https://www.monkeypoxtally.info/)

Lack of testing 

Expressing his concern about the scale and spread, WHO Director-General Dr Tedros Adhanom Ghebreyesus acknowledged that “testing remains a challenge and it’s highly probable that there are a significant number of cases not being picked up”.

While most of the new cases have been identified in Europe and the US, Africa – where monkeypox was first identified in 1970 – has not recorded a huge jump in cases, and experts believe this could be due to a lack of proper testing. 

“I plan to reconvene the emergency committee so they are updated on the current epidemiology and evolution of the outbreak and implementation of countermeasures. I will bring them together during the week of 18 July or sooner if needed,” Tedros told the media briefing on Wednesday.

The emergency committee decided not to declare monkeypox a PHEIC when it met in late June.

Tedros also said that the WHO is working with countries and vaccine manufacturers to coordinate the sharing of “scarce” vaccines .

Tedros added that the WHO is also working closely with civil society and LGBTQI+ community in particular to “break the stigma around the virus and spread information so people can protect themselves”, and commended those sharing their stories on social media to inform others.

Child cases

According to the WHO’s latest report, the outbreak “continues to primarily affect men who have sex with men who have reported recent sex with one or multiple male partners, suggesting no signal of sustained transmission beyond these networks for now.”

However, WHO monkeypox expert Dr Rosamund Lewis confirmed that there were cases reported in children, about one-third of whom were under the age of 10.

“For older children aged 18 or 19, the mode of transmission may still be an open question, but for younger children, one would assume that that would be from exposure in the household setting,” said Lewis.

By Wednesday, 119 people had been diagnosed with monkeypox in New York City and city officials confirmed that the limited supplies of vaccines were usually snapped up in minutes by the group it was being offered to: men who have sex with men who had multiple sex partners, as well as close contacts of confirmed cases.

 

 

Image Credits: https://www.monkeypoxtally.info/.

In Pakistan, a healthcare worker listens to a child’s lungs for signs of pulmonary tuberculosis.

After year-long consultations, the Stop TB Partnership launched its global plan to end tuberculosis by 2030, which would involve the diagnosis and treatment of 50 million people at a cost of $250 billion.

TB, the second biggest infectious disease killer in the world after COVID-19, has been neglected by donors in the past – yet if the plan’s budget was realised, every $1 invested would yield an economic return of at least $40.

“If, instead, the status quo is maintained, TB is expected to continue to kill between 4,000-5,000 people every day, an additional 43 million people will develop TB and the cost in human life and disability would translate to a global economic loss of US$ 1 trillion,” according to Stop TB.

“The COVID-19 pandemic delivered a crystal-clear wake-up call: that we cannot ignore a disease just because it has been relegated only to the poorest parts of the world,” said Dr. Paula Fujiwara, who led the task force in charge of the development of theplan. 

“With our attention diverted—along with the absence of financial commitments—TB has strengthened its grip on our planet. But we can regain control and meet our commitments to end TB by 2030 as long as we assert our political will now.”

Tepid global response

Dr Lucica Ditiu, Executive Director of the Stop TB Partnership, said that while the global response to COVID-19 was to “plough money and resources into developing diagnosis tools, treatments and vaccines at lightning speed”, the response to TB, which infects 10 million people every year and kills 1.5 million,  “has been tepid at best”. 

“A similar airborne infectious disease, TB remains neglected, even though it is a health threat for every single person. It is in the interest of all of us to end TB,” added Ditiu.

However, she added that she was optimistic that the war against tuberculosis could be won by 2030. 

“A lot of optimism comes from what we have seen happening during COVID—it is possible to mobilize the resources –it is possible that researchers will work together, and share data to be able to develop new tools in such a short amount of time and it is possible to deploy and to organize amazing efforts at the grassroots level.”

The Global Plan highlights the need to invest in developing a new TB vaccine by 2025, and making sure that resources are available to reach adults and adolescents in countries where TB is most prevalent. 

The only TB vaccine currently available is the BCG vaccine, which was approved more than a century ago and has a very limited impact on disease prevention.

Dr Lucica Ditiu, Executive Director of Stop TB Partnership

“The proposed investment of $ 10 billion in new TB vaccines, a new tool we all are waiting for, is 10 times less than what was injected in the research and development for COVID-19 vaccines. It should be possible to have the TB vaccine,” said Ditiu.

Previous reports from the Stop TB Partnership noted that COVID-19 had cost the world 12 years of progress against TB. 

“Currently, almost 30% of funding per TB case comes from out-of-pocket costs and on average individuals with TB and their households lose 50% of their annual incomes as they suffer from and get treatment for the disease, even in places where TB services are provided free of charge,” according to Paul Mahanna, USAID’s Director of the Office of Infectious Diseases, 

“We cannot drive change without addressing the significant funding gaps that exist within high TB burden countries that result in lack of access to life-saving services and drive individuals, families and communities further into poverty.

Image Credits: Stop TB Partnership.

COVAX, the best-known part of the ACT-Accelerator, has delivered over a billion vaccines globally.

Organizers say they have no plans to “sunset” the support they offer countries through the Access to COVID-19 Tools (ACT) Accelerator, the global partnership to facilitate equitable access to COVID-19 tests, treatments, and vaccines.

The ACT-A, however, will undergo a “transition” when its strategic plan and budget ends in September, according to the World Health Organization’s (WHO) Dr Bruce Aylward, who represents the global body at the ACT-A.

Its COVID-19 response will likely be incorporated into the usual work of key ACT-A partners, including Gavi, the global vaccine alliance, which is a co-leader of COVAX, the vaccine arm of the ACT-A.

COVAX also is co-led by WHO and the Coalition for Epidemic Preparedness Innovations (CEPI), alongside key delivery partner UNICEF.

Dr Bruce Aylward

Aylward told a media briefing on Wednesday that ACT-A’s work to enhance equitable access to COVID-19 tools will continue, since the pandemic hasn’t ended.

“As countries are moving from managing COVID-19 as an acute emergency to integration into longer-term disease control programmes, the ACT-Accelerator partnership is adjusting its ways of working,” he said.

A Gavi spokesperson told Health Policy Watch that COVAX partners and other ACT-Accelerator organizations, mindful of the need to prepare the global health response for future pandemics, “are looking at how to transition temporary emergency response structures into an integrated approach that builds COVID-19 and pandemic preparedness and response capacity into existing global health architecture”.

Though WHO hasn’t changed its designation of COVID-19 as a pandemic, Dr Mike Ryan, WHO’s head of health emergencies, described it as more of “a series of national epidemics” and stressed that the real work needed to take place at the national level.

Globally, COVID-19 cases have increased by at least 30%, driven by variants BA.4 and BA.5 in Europe and the US, while a new sub-lineage of BA.2.75 is rising in India, WHO Director-General Dr Tedros Adhanom Ghebreyesus told the briefing.

ACT-A transition plan

Aylward indicated there is little appetite among ACT-A partners to develop another strategic plan.

Therefore the focus is on a “transition plan,” he said, to “make sure that this extraordinary collaboration that we’ve put together can continue to operate but in a mode and in a manner that allows us to make sure the core business of the [partner] organisations also gets attention”.

The pandemic’s strain on nations’ resources, financial markets and global supply chains have caused setbacks in key global health programmes, particularly childhood vaccinations and tuberculosis diagnosis and care.

“The ACT-A agencies will not sunset their support to the countries that rely on them for equitable access to these tools,” stressed Aylward. “What we will do is make sure that we work efficiently and effectively to deliver right across our mandates in the longer term.”

At the ACT-A’s Council Meeting, also held on Wednesday, some countries offered their views of what form this transition could take. India’s Dr Vinod Paul, for example, called for ACT-A to become “a long-term institutional mechanism to support countries in future health emergencies”.

Indonesia and South Africa called ACT-A’s evaluation to feed into international discussions on pandemic preparedness. France’s John Valadou, meanwhile, called for an assessment of ACT-A before any decisions were made about its future.

“We should avoid two risks when it comes to global governance,” Valadou said. “We shouldn’t make the existing architecture too complex, and secondly, we should not weaken the central role that should be played by WHO.”

Dr Fifa Rahman

Dr Fifa Rahman, a civil society representative on ACT-A, told the council that her sector looked forward to seeing the transition plans. She endorsed Germany’s call for “some kind of mechanism for coordinating and evaluating the global risk response to COVID”, describing this as essential.

Rahman also called for resources to build more resilient health systems, including community health systems, pointing out that only 14% of community health workers in Africa were paid, while health workers in many countries were grossly underpaid.

She also called for transparency in government procurement of COVID-19 goods during this transition phase. 

Norway’s Ambassador and ACT-A council co-chair John-Arne Rottingen closed the council meeting by noting that “members support a gradual transitioning” of ACT-A.

“We cannot go back to where we were before the pandemic,” he said. “We need to continue coordination and collaboration across the implementing agencies and ACT-A actors. And we also need to use the evaluation and other learning efforts to learn for the future both on the countermeasure side as well as long-term strengthening of health systems, primary health care capacities and supporting the health care workforce.”

Goodwill COVID-19 support does not mean equity

Reflecting on ACT-A’s future, Aylward said “what we’ve learned in this pandemic is that goodwill alone is not enough to get to equity”, which is why a pandemic accord or instrument is important.

And to address future pandemics, he said, more financing is needed to prepare so that low-and middle-income countries can purchase what they need, manufacturers are included, and supply chains keep flowing with the free trade of raw materials and finished products.

“All of this needs to be captured under something like a pandemic accord,” Aylward said. “This is not charity. This is not handouts. This is in everyone’s interest to end pandemics, like the one we’re in the midst of now has been going on much longer than it should have given the science that we had so early in this in this pandemic.”

Image Credits: UNICEF, Gavi .

A Bill that aims to improve access to sexual and reproductive health services for women and girls in six East African countries faces a tough uphill battle to approval, with opposition from conservatives who claim that it would promote abortion and LBGTQ rights

Over the past week, the East African Legislative Assembly (EALA) has conducted public hearings on East African Community Sexual and Reproductive Health Bill 2021 in its six member states, Burundi, Kenya, Rwanda, South Sudan, Tanzania and Uganda.

Various members of the legislative assembly have been trying for five years to pass a Bill to address the very high maternal mortality and teen pregnancy rates in region.

At the public hearings in the capital cities of the member states, the Bill received support from a range of maternal health and sexual and reproductive health practitioners, academics and activists, particularly in Kenya.

But it also faced opposition from a number of conservative and religious organisations, including international right-wing organisations such as CitizenGo and Empowered Youth Coalition, some of which made objections at public hearings claiming that the Bill is pro-abortion and pro-LBGTQ rights.

In the past, various Catholic organisations have opposed the Bill, and at the Nairobi hearings held last week, the Catholic Doctors Association was one of the groups opposing the Bill.

Ending female genital mutilation

The aims of the Bill are to protect and facilitate the SRH and rights of all people in the region, provide for the progressive realisation of SRH information and services and prohibit harmful practices such as female genital mutilation and forced sterilisation.

It also aims to prevent newborn, child mortality and maternal mortality and “facilitate and promote reduction and elimination of unsafe abortions, HIV and other sexually transmitted infections, early and unintended pregnancies”.

Article 16 of the Bill states that a woman should be able to terminate her pregnancy if, in the opinion of a health professional, there is a need for emergency treatment, it endangers her mental or physical health or life, or is the result of rape or incest.

But it also provides for member states to use their own laws to decide what to do in such situations.

The region is in desperate need of improved SRH services. According to a 2020 EALA scorecard (see below), many member states are lagging behind in agreed-on targets on reproductive health and HIV, particularly South Sudan, which is not on track to meet any targets.

South Sudan’s maternal mortality rate of 730 women per 100,000 is one of the worst in the world, while only Rwanda and Tanzania are on track to meet maternal mortality targets.

EALA has tried to introduce a Bill on SRH since 2017 but faced various obstacles, including having to start from scratch when the term of the previous assembly ended and new representatives were sworn in. 

The current Bill has been introduced by South Sudan’s EALA representative Kennedy Mukulia as a Private Members’ Bill.

However, Mukulia has faced vilification and online harassment including a CitizenGo petition calling for his removal for sponsoring the Bill.

The Bill aims to give expression to Article 118 of the East African Community (EAC) Treaty, in terms of which member states have committed to providing reproductive health services to their citizens. But a number of member states do not have laws or policies in regard to a number of issues and the Bill aims to provide guidance in cases where there are legal vacuums. 

The EALA General Purpose Committee has 30 days to send a report on the public hearings to the Speaker, and thereafter it should be tabled and debated. However, it still faces an uphill battle in the male-dominated legislature, where a number of members objected to earlier versions of the Bill. 

Should the Bill be passed, each member state will have to report to the secretary-general of the EAC on the status of its implementation every two years.

The secretary-general is obliged to report to the EALA on each country’s progress, and one state can even bring legal action against another at the East African Court of Justice.

Teen girls ‘desperately need’ SRH services

Almost one-third of women in developing countries had their first baby in their teens, a UNFPA  report released last week shows.

“When nearly a third of all women in developing countries are becoming mothers during adolescence, it is clear the world is failing adolescent girls,” said UNFPA Executive Director Dr Natalia Kanem. “The repeat pregnancies we see among adolescent mothers are a glaring signpost that they desperately need sexual and reproductive health information and services.”

“Complications in pregnancy and childbirth are the leading cause of death among girls aged 15 to 19 years, who are also far more likely to suffer a litany of other violations of their human rights, from forced marriage and intimate partner violence to serious mental health impacts of bearing children before they are out of childhood themselves,” according to UNFPA.

Image Credits: Reproductive Health Supplies Coalition/ Unsplash.

Pharmaceuticals, Diabetes
An exhibition marks the discovery of insulin, a life-saving treatment for diabetes, at the University of Toronto in 1921

French drugmaker Sanofi is the latest pharmaceuticals manufacturer to offer a package of essential medicines at cost to health systems in the world’s most impoverished countries – including much-needed cancer and diabetes treatments.

Sanofi on Monday announced the launch of the new nonprofit Impact® brand for dozens of medicines, that is supposed to ease support medicines procurement in 40 low-income countries. 

The new brand will enable the secure distribution of 30 Sanofi medicines, including glibenclamide and insulin for diabetes and oxaliplatin for chemotherapy, France’s largest drug company said in a statement.

The prevalence of diabetes has nearly doubled over the past three decades, with rates soaring in low- and middle-income countries beset by an epidemic of obesity related to higher processed foods and junk food cosumption and less physical activity. But high prices have limited people’s access to essential diabetes treatments, with a market dominated by three firms worldwide- including Sanofi.

Only about 50% of the estimated 100 million people requiring insulin worldwide are able to access treatment, according to a 2017 study led by Health Action International.  Human insulin, traditionally the least costly insulin treatment, is also gradually replaced in markets by longer-acting and often higher-priced “insulin analogues” – which can make treatment even harder to access  in low- and middle income countries and even in some high-income settings. 

Making essential medicines affordable for diabetes, cancer, malaria, tuberculosis and other areas

All of the medicines to be distributed by Sanofi Global Health, a nonprofit unit within the company, are on the World Health Organization’s list of essential medicines that is updated in consultation with experts worldwide every two years.

The list covers a wide range of therapeutic areas, including diabetes, cancer, cardiovascular disease, malaria, and tuberculosis, as well Hepatitis C and common bacterial infections.

Last year’s Model Lists of Essential Medicines (EML) from WHO – which provides a baseline of guidance to national health authorities on products and services that should be made the most widely available – included for the first time ever, long-lasting insulin analogues, also produced by Sanofi.

Previously, the EML expert committee had rejected their inclusion on the basis of fears that broader reliance on the higher-priced analogue formulations could restrict access to lower-cost human insulin products.

However, in view of increasing availability, WHO Director-General Dr Tedros Adhanom Ghebreyesus said the inclusion of insulin analogues is a step in the right direction towards affordable access to a lifesaving treatment.

The inclusion of four new cancer medicines also was a priority for the updated EML. Additional childhood cancer indicators were also added for 16 medicines already listed, including low-grade glioma, the most common form of brain cancer in children.

Underserved populations, startups and innovators

The launch of the Impact® brand is among the steps taken by Paris-based Sanofi since forming Sanofi Global Health last year to increase healthcare access by distributing medicines and to improve local healthcare systems among some of the poorest nations.  It has also launched a $25 million Impact Fund to support healthcare startups and other innovators to deliver “scalable solutions for sustainable healthcare in underserved regions,” according to the company.

“Sanofi Global Health aims to improve the lives of millions of people who now cannot get the help they need,” Sanofi’s CEO Paul Hudson said. 

Added Jon Fairest, who heads the Global Health Unit: “But we know that we cannot do this alone, and so we are building partnerships at global, regional and local levels that will help to improve and establish health systems to reach our goal of a healthier, more resilient world,” 

Towards a tiered pricing approach for pharmaceuticals

Sanofi’s moves follow on a other announcements by a number of leading drug companies expanding their use of “tiered pricing” to include drugs for common NCD treatments, including Pfizer, the world’s top pharma revenue earner, which is making billions from its COVID-19 vaccine.

The company announced last month at the World Economic Forum that it will begin selling 23 of its patented medicines and vaccines marketed in the United States and European Union on a non-profit basis to 45 of the world’s low-income countries.

The medicines and vaccines in Pfizer’s “Accord for a Healthier World” project include treatments for infectious and rare inflammatory diseases, and some cancers.

Thomas Cueni, director general of International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), said tiered pricing can help improve access to vital treatments, although it is not enough on its own. 

“This works on the basis that lowest-income countries have a pricing that reflects their reduced ability to pay, just as richer countries will pay more,” Cueni told Health Policy Watch.

“However, pricing needs to be understood in the broader context of access to treatments,” he said. “It also requires having in place the health systems to diagnose; the healthcare workers to treat patients; and mark up of medicine prices throughout the supply chain by medicine wholesalers.”

Ebola vaccination in Mbandaka, Équateur Province (DRC); swift response helped reduce the toll of the province’s most recent outbreak.

The Ebola outbreak that erupted on 23 April in the Democratic Republic of the Congo today was declared to be over  by DRC and WHO authorities – with fewer cases and deaths than previous episodes thanks to a swift response including vaccinations.

The outbreak erupted in Mbandaka, the capital of Equateur Province in the country’s northwest. It was the third outbreak seen in the province since 2018 and the country’s 14th overall.

While DRC is among those countries seeing outbreaks of Ebola and other zoonotic diseases with greater frequency, a swifter response using a new arsenal of Ebola vaccines, as well as stepped-up contact tracing and education around prevention, is also reducing the length of outbreaks and the deadly toll of the disease, the head of WHO’s African Regional Office said.

“Thanks to the robust response by the national authorities, this outbreak has been brought to an end swiftly withlimited transmission of the virus,” said Matshidiso Moeti, WHO Regional Director for Africa. “Crucial lessons have been learned from past outbreaks and they have been applied to devise and deploy an ever more effective Ebola response.”

In the most recent case, vaccinations were launched just four days after the outbreak was declared. In all, there were four confirmed one probable Ebola case – all of whom died. In comparison, in the previous outbreak in Equateur Province that lasted from June to November 2020, there were 130 confirmed cases and 55 deaths.

The recent outbreak saw a total of 2104 people vaccinated, including 302 contacts and 1307 frontline workers. To facilitate the vaccination rollout, an ultra-cold chain freezer was installed in Mbandaka which allowed for vaccine doses to be stored locally and safely and be delivered effectively.

The DRC has now recorded 14 Ebola outbreaks since 1976, six of which have occurred since 2018.

“Africa is seeing an increase in Ebola and other infectious diseases that jump from animals to humans impacting large urban areas,” Moeti warned. “We need to be ever more vigilant to ensure we catch cases quickly. This outbreak response shows that by bolstering preparedness, disease surveillance and swift detection, we can stay a step ahead.”

Image Credits: WHO/Junior D. Kannah.

Within a week of overturning the constitutional right to an abortion, the United States Supreme Court has now dealt a severe blow to the nation’s ability to strictly regulate and reduce carbon dioxide emissions from power plants that contribute to global warming, with escalating impacts on health and well-being.

US President Joe Biden described Thursday’s ruling as “devastating”, while China questioned the United States’ sincerity in tackling international carbon emission targets.

Voting along ideological lines, the court ruled 6-3 in favour of an appeal brought by 19 states and coal companies against the U.S. Environmental Protection Agency (EPA) that contended it only had narrow authority to regulate carbon emissions generated by power production. 

According to the ruling, the US Congress did not explicitly grant EPA the authority to cap greenhouse gas emissions across the sector in the Clean Air Act, but only to regulate actions at individual power plants.

Chief Justice Roberts, supported by five other conservative judges, stated in the judgement that “it is not plausible that Congress gave EPA the authority to adopt on its own such a regulatory scheme”.

“A decision of such magnitude and consequence rests with Congress itself, or an agency acting pursuant to a clear delegation from that representative body,” he added.

Dissenting opinion – emissions also contribute to air pollution that endanger public health

Health-harmful pollution emissions have declined sharply since 1990, but ozone emissions stalled a decade ago and some PM indicators slightly increased recently.

However, in her dissenting statement, Justice Elena Kagan wrote that “Section 111 of the Clean Air Act directs EPA to regulate stationary sources of any substance that ’causes, or contributes significantly to, air pollution’ and that ‘may reasonably be anticipated to endanger public health or welfare.’ “

Dirty coal and oil-fired power plants that emit the highest levels of CO2 also emit other pollutants harmful to health, including fine particulates (PM10 and PM2.5) , volatile organic compounds (VOCs) and nitrogen dioxide (NO2), which contribute to the formation of ozone. While there has been a decline in such emissions over the past 20 years, ozone emissions have plateaued in the past decade, and PM2.5 emissions even increased recently – and are above new WHO guideline standards of 5 µg/m3. New EPA rules to prompt broader, sector-wide shifts to cleaner power and more renewables would have also helped address those nagging pollution issues.

Higher levels of PM 2.5 and PM10, for instance, lead to more premature deaths from heart attack, stroke, cancers and lung disease, while ozone is closely associated with increased asthma, including childhood asthma cases. There are still an estimated 100,000-200,000 deaths annually from air pollution in the United States, according to a 2020 paper by a leading group of researchers. And one-half of those deaths can be attributed to just five activities, including heat and power production.

In addition to deaths directly attributed to power plant pollution emissions, there is a growing toll in the United States  in terms of deaths and injuries related to wildfires and other extreme weather events, also being exacerbated by climate change.

Power plants are one of the five core sources of health-harmful air pollution in the United States (Thakrar et al, 2020)

Green economy threatened

One of the cornerstones of US President Joe Biden’s administration is boosting the so-called ‘green economy’ of low carbon and low polluting energy technologies, and this ruling could undermine multibillion-dollar efforts underway to phase out fossil fuels and replace them with cleaner energy sources. 

“I have directed my legal team to work with the Department of Justice and affected agencies to review this decision carefully and find ways that we can, under federal law, continue protecting Americans from harmful pollution, including pollution that causes climate change,” Biden said in a statement.

“Since the Clean Air Act was passed by a bipartisan majority in Congress in 1970, the landmark law has enabled both Democratic and Republican administrations to protect and improve the air we breathe, cutting air pollution by 78% even as our economy quadrupled in size,” he said. “Yet today’s decision sides with special interests that have waged a long-term campaign to strip away our right to breathe clean air.”

China’s foreign ministry spokesman Zhao Lijian told a regular media briefing on Friday that his nation took note of the ruling and the international community’s “fair criticism” of it.

“As we always say, to address climate change, it is not enough to just chant slogans. It is about everyone doing their own part,” said Zhao.

“We urge developed countries, including the US, to earnestly abide by the principle of common but differentiated responsibilities, own up to their historical responsibilities and show greater ambition and actions,” he said. “At the same time, developed countries should effectively help developing countries enhance their capacity to cope with climate change in terms of funding, technology and capacity building.”

The main source of greenhouse gas emissions in the US is from electricity, which accounted for a quarter of the emissions in 2020. 

‘Disappointing and disheartening’

EPA Administrator Michael Regan said he was “deeply disappointed” by the decision but emphasised that EPA remains committed to protecting communities and cutting emissions that drive climate change.

“EPA’s number one priority is to protect people’s health, especially those who are on the front lines of environmental pollution. Make no mistake: we will never waiver from that responsibility,” Regan said in a statement. “We will move forward to provide certainty and transparency for the energy sector, which will support the industry’s ongoing efforts to grow our clean energy economy,” he added.

Regan said addressing climate change means putting the US economy on a more competitive footing by creating jobs in the clean energy sector, lowering costs for families and protecting people’s health and well-being.

“EPA will move forward,” he added, “with lawfully setting and implementing environmental standards that meet our obligation to protect all people and all communities from environmental harm.”

More court challenges by polluters? 

The global public health organisation Vital Strategies condemned the Supreme Court ruling, which it described as “an assault on the nature of government as much as nature itself, stripping agencies of their ability to act with scientific authority”. 

The organisation’s senior vice-president, Daniel Kass, warned the ruling would “accelerate our very real climate crisis, leading to more preventable illness and death”, and was likely to result in new challenges by “polluters” in state courts.

“Just this March, the EPA, under its authority from the Clean Air Act, re-enabled California and other states to regulate greenhouse gas emissions from [vehicle] tailpipes. We can now expect polluter-financed challenges to all state-level efforts to regulate CO2 emissions,” Kass said.

“Public health officials must pressure policymakers to join amica briefs to defend state regulations and to align with the overwhelming majority of the public that want to see CO2 regulated,” he said. “The urgency of climate change demands it. There is no time to wait for a generational swing back to centre.”

John Noel, a senior climate campaigner for Greenpeace USA, noted in a statement that air pollution from fossil fuel burning caused about one-in-five deaths worldwide in 2018. 

“Radicals in robes are severely restricting the federal government’s ability to protect people and the ecosystems that support life,” he said. “It is unconscionable that six Supreme Court Justices have ruled in favour of sacrificing more lives to enrich millionaire coal and oil barons.”

Image Credits: Ella Ivanescu/ Unsplash, US EPA, (Environ. Sci. Technol. Lett. 2020, 7, 9, 639-645), Us Environmental Protection Agency.

Dr Ahmed Ogwell Ouma, Africa CDC’s acting director, asserts the continent should be top priority for vaccine doses for monkeypox.

WHO and Africa CDC are trying to close a huge testing gap for monkeypox that has left some health workers reliant on symptomatic diagnosis.

The World Health Organization (WHO) and African Centres for Disease Control and Prevention (Africa CDC) acknowledge they will not be able to gain a clear understanding of the monkeypox outbreak in Africa until the continent improves its ability to test better and close the gap between confirmed and suspected cases.

Just 104 new cases of monkeypox have been confirmed compared with 1,678 suspected cases in Africa since the beginning of 2022, Africa CDC’s acting director, Ahmed Ogwell Ouma, announced during a press briefing on Thursday.

He told Health Policy Watch the gap is due to limited capacity at labs and lack of enough test kits.

“This usually means appropriate training is not yet widespread and the test kits are also not available,” he said, adding that health workers in Africa are resorting to “clinical acumen and high levels of high index of suspicion” to identify monkeypox cases “because of capacity issues.”

This will hopefully change soon, he said, as Africa CDC acquires and provides more training and test kits. In Europe, the Americas and elsewhere some 3414 cases had been confirmed as of 22 June, WHO reported on Tuesday.  

Monkeypox rash

WHO is also procuring test kits for Africa

Along with Africa CDC, the UN health agency is working on building up testing capacity on the continent.

All African countries have the polymerase chain reaction (PCR) equipment needed to test for monkeypox.  But many lack essential reagents and training in specimen collection, handling and test administration, Dr Matshidiso Moeti, WHO AFRO’s regional director, told a press briefing on Thursday.

WHO is working to procure 60,000 tests, she announced, including 2,000 that will be dispatched to the countries at highest risk.

“Over the past month, five African cities have received donations of reagents from partners, bringing to 12 the number with enhanced monkeypox diagnostic capacity, and another group of countries in West Africa receiving agents just after participating in the necessary training,” Moeti said.

Monkeypox virus genome sequencing in Africa

Seven African countries are sequencing the monkeypox virus genome and using an improved genomic sequencing capacity acquired during the COVID-19 pandemic, according to Moeti. That should improve understanding of how the monkeypox virus is spreading across countries and continents.

Some 300 samples have been sequenced since the beginning of the year, with most of the published sequences showing the West African clade of the virus.

WHO says it is working to accelerate capacity through training in monkeypox genome sequencing that it is offering to lab experts from 20 countries in coming weeks.

Image Credits: US Centers for Disease Control.