Scenes like this at Puerto Rico’s airport, January 2022, are now rare as countries drop COVID measures – but WHO says the pandemic remains a public health emergency says WHO.

With a surge in cases and the rapid rise of new subvariants, the COVID-19 pandemic continues to be a global health emergency posing significant risks to public health, a WHO committee of public health experts has concluded.

The statement by the COVID-19 Emergency Committee, was published Tuesday, four days after experts gathered for their 12th meeting since a COVID-19 global health emergency was first declared on 30 January 2020 under the terms of the WHO International Health Regulations.

“This is in no way over,” WHO’s Director General Dr Tedros Adhanom Ghebreyesus told a media briefing. He and his team pointed to the worldwide surge in cases driven by the Omicron BA.5 subvariant in particular.

“As the virus pushed at us, we must push back — we are in a much better position than at the beginning of the pandemic,” he said. “We have safe and effective tools that prevent infections, hospitalization and deaths. However, we should not take them for granted.” 

COVID Cases increased by 30% in last two weeks

The WHO committee cited the 30% global  increase in COVID cases over the last two weeks and the still-unpredictable evolution of key SARS-COv2 variants driving infections as key to its decision to maintaining the current level of emergency alert.

Dr Michael Ryan

It noted that “both the trajectory of viral evolution and the characteristics of emerging variants of the virus remain uncertain and unpredictable,” according to the statement.

“The resulting selective pressure on the virus increases the probability of new, fitter variants emerging, with different degrees of virulence, transmissibility, and immune escape potential,“ the committee added.

Other concerns, it said, are the “steep reductions in testing, resulting in reduced coverage and quality of surveillance as fewer cases are being detected and reported to WHO, and fewer genomic sequences being submitted to open access platforms.”

The decline in testing, the committee noted, also could “hinder the detection of cases and the monitoring of virus evolution,” citing remarks by Dr Mike Ryan, WHO’s Executive Director of Health Emergencies.

Along with that,  “inequities in access to testing, sequencing, vaccines and therapeutics, including new antivirals; waning of natural and vaccine-derived protection; and the global burden of post COVID-19 condition,” were other factors considered. 

Dr Maria Van Kerkhove

Speaking at the press briefing, Maria Von Kerkhove, WHO’s health emergency technical lead, said the BA.5 subvariant of Omicron is spreading “at a very intense rate at a global level” that far outpaces the other subvariants.

“We are seeing countries become concerned about this, but we feel that countries should be concerned about SARS COV-2 overall,” she said. 

Monkeypox Emergency Committee to reconvene next week

The statement on the continuing COVID emergency comes just ahead of a critical meeting of a WHO Emergency Committee on Monkeypox scheduled for the week of 18 July to determine if that outbreak should also be categorized under the IHR as a Public Health Emergency of International Concern (PHEIC).

As of today, there were some 9,200 Monkeypox cases in 63 countries, Tedros told the briefing.  

That means cases have increased by 50% in the week since WHO issued its last report on 6 July, which confirmed 6,027 cases in 59 countries. 

Those numbers represent cases reported largely outside of the the central and western African areas where the disease is endemic.  Altogether some 1,597 suspected cases were reported in WHO’s Africa Region as of mid-June, but most were unconfirmed due to a lack of testing capacity. 

Criteria for determining a monkeypox global emergency 

Tedros said the Monkeypox emergency committee will convene against next week to look at trends, counter-measures and recommendations on what countries can do. If it decides Monkeypox also constitutes a global health emergency, it would be a rare instance of WHO simulatenously confronting three global health emergencies, including Polio, designated a global health emergency since 2014. 

Key to their deliberations will be an assessment of the evolving situation in light of nine criteria, said Dr Sylvie Briand, who heads WHO’s Global Infectious Hazard Preparedness department. 

Dr Sylvie Briand

Those include questions of “increasing cases, deaths, diseases spreading outside of the initially affected community, changes in the virus and so on,” she said, noting the situation has evolved since the committee last met on June 25. “We see an increasing number of cases, we have also seen new geographies affected. So it’s worth looking at it again and see if we need to reinforce the advice.”

At the same time, Ryan said, it appears that “sexual contact is what is driving the outbreak” of Monkeypox infections in Europe and elsewhere that have occurred in circles of men who have sex with men.

He also cited evidence that transmission can occur as a result of contact with the virus on infected surfaces, particularly in health care settings.

Wild animals hunted for food are an infection risk – not supermarket purchases

Contact with virus-contaminated wild animals, hunted and killed for food, also is an important source of Monkeypox infection in central and western Africa which frequently experiences such  “zoonotic spillover” events. But food-based contamination is not an issue elsewhere, Ryan and others stressed. 

“You are not going to get the virus from food you buy in a supermarket,” Ryan stressed. 

Dr Rosamund Lewis, WHO’s Monkeypox lead, said the virus circulates in rodent populations, but also in primate populations in central Africa. “So there is potential of being exposed in the course of hunting and preparing wild game involving an infected animal,” she said.

Dr Rosamund Lewis

Von Kerkhove added there are many known pathogens that are zoonotic that spill over from animals to humans, and that have epidemic and pandemic potential. Identifying and targeting such risks, she said, requires “improved surveillance in communities and on farms, and improved laboratory capacity.”

WHO recently launched a 10-year strategy for improving the genomic sequencing of pathogens with epidemic and pandemic potential. That included bringing together veterinary and public health teams in countries to figure out what Ryan described as “how can we make these two systems work better together.”

Accelerating access to genomics – first ever WHO report

The statements about the importance of genomic tracking of both COVID and Monkeypox coincided with the release of a first-ever WHO report on “Accelerating Access to Genomics for Global Health” by the new WHO Science Council.

The report, also released Tuesday, calls for less-developed countries to gain better access to genomics technologies, which not only are critical to disease surveillance but also drives much of the groundbreaking research into health treatments today.

The field of genomics uses methods from biochemistry, genetics, and molecular biology to understand and use biological information in DNA and RNA, with benefits for medicine and public health. That has especially proven relevant during the COVID-19 pandemic and with agriculture, biological research and other such uses. 

While the costs of establishing and expanding genomic technologies are declining, making them increasingly feasible for all countries to pursue, those costs can and should be further lowered, the report finds.

Dr Harold Varmus

The report suggests using making genomic technologies more affordable for LMICs through tiered pricing; sharing of intellectual property rights for low-cost versions; and cross-subsidization, which involves using profits in one area to fund another.

“Genomic technologies are driving some of the most groundbreaking research happening today. Yet the benefits of these tools will not be fully realized unless they are deployed worldwide.” said WHO’s Chief Scientist Dr Soumya Swaminathan in a press release on the report.  

Harold Varmos, head of WHO’s Science Council., said the benefits of genomics have been illustrated in the COVID pandemic, namely, in the development of vaccines and tests and the identification of variants that continue to pose serious problems for the world.

“Genomics has been adopted in many poor countries” as costs decline, said Varmos. Nevertheless, he said, “we are concerned that the already widespread use of genomics in advanced countries should not leave low- and middle-income countries behind. WHO and member states can do more to promote the adoption of genomics.” 

Image Credits: Kevin Torres Figueroa/ US Army National Guard/ Flickr.

AMR Pathogens
A USAID-led session in Bangkok trains laboratory workers to identify drug resistant pathogens in food samples.

NAIROBI — With antimicrobial resistance (AMR) on the rise globally, the World Health Organization (WHO) Tuesday issued an urgent call to step up investment and research into vaccine candidates that can tackle the problem of drug-resistant bacteria in a new report that looks at key research gaps and opportunities. 

Antimicrobial resistance, which refers to bacteria, viruses and parasites that are resistant to drug treatment, results from factors such as the overuse and misuse of antibiotics and other antimicrobials in human and animal health.

But along with new drugs, the development of new vaccines can also help counter the problem, experts say.

AMR Pathogens
WHO consultant Isabel Frost

“Vaccines are highly vital tools in fighting AMR,” Isabel Frost, lead author of the analysis, told a virtual press briefing on Monday. “This analysis was needed to understand where opportunities for development were, and where there might be some vaccines available in the near future to fight some pathogens.”

Infections from drug resistant pathogens are the third leading cause of death after cardiovascular diseases. Some 1.27 million deaths were attributable to AMR in 2019, while nearly 5 million deaths were somehow associated with drug-resistant infections, according to a major study published in January  2022 in The Lancet. That is more people than the number of deaths from either HIV or malaria.

The death rate was highest in western Sub-Saharan Africa, where there were 27.3 deaths per 100,000 people. It was lowest in Australia, where there were 6.5 deaths per 100,000 people, according to the Lancet study of January 2022, published by the Global Burden of Disease Collaborative Network, led by the Seattle-based Institute of Health Metrics and Evaluation (IHME).

The World Bank estimates that by 2050, infections associated with AMR will cause 28 million more people to fall into poverty, as a result of catastrophic illness, as well as adding US$1 trillion in healthcare costs.

WHO Press Technical Briefing 11 July 2022

AMR pathogens are a silent pandemic that threaten global public health 

The report is the first to provide a detailed analysis of vaccines in development that have the potential to address drug resistance from priority pathogens. It also draws attention to a need to accelerate trials in AMR vaccines, and makes a case for increased investment that can lead to more global health equity.

For instance, vaccines with varying degrees of efficacy already exist for dealing with four priority pathogens: Streptococcus pneumoniae, Haemophilus influenza type B, Salmonella Typhi, and microbacterium tuberculosis. (In the case of the latter, there are advanced trials underway of new  TB candidate ‘subunit’ vaccines which could also be given in combination with the old BCG vaccine). But their uptake and access vary globally, in yet another example of the enormous inequities found in global public health.

On the other side of the spectrum, there are no vaccine candidates in clinical development against six bacterial infections on WHO’s list of priority list of drug resistant pathogens, including ones that commonly cause severe and chronic gastro-intestinal illness or blood, urinary track and lung infections: C. Jejuni, H. pylori, E. faecium, Enterobacter spp, A. baumanii and P. aerungi.

WHO Press Technical Briefing 11 July 2022

Having identified AMR as a silent pandemic, and in response to this major public health threat, WHO developed a global action plan in 2015 to combat AMR. 

The plan, adopted by the World Health Assembly (WHA) in May 2015, identifies five key strategic areas: 1) increasing awareness, surveillance and monitoring; 2) combating infection through control measures; 3) reducing inappropriate use of antimicrobials; 4) making an economic case for more investment in diagnostics, antimicrobials and new treatments; and 5) the need for vaccines to combat AMR.

WHO priority pathogen list for research and development of new vaccine candidates 

In 2017, WHO developed the first list of bacteria  for which new antibiotics are urgently needed. The intent was to curb AMR and develop an analysis to inform R&D, investment decisions and policy actions globally.

Those considered to be “priority pathogens” are ones that pose the greatest global health threat because of their widespread resistance to common drugs, according to Frost, who also works as a WHO consultant for the Department of Immunization, Vaccines and Biologicals.

“We have identified 61 vaccine candidates in active clinical development against these pathogens,” she told Health Policy Watch, but noted some pathogens in this list are challenging targets for vaccine development.

WHO Press Technical Briefing 11 July 2022

Vaccine equity still hampered by poor distribution, access and uptake in most vulnerable regions

Streptococcus pneumoniae remains the leading cause of death from resistant bacteria; it caused 122,000 deaths in 2019. “These deaths are concentrated in countries that have the lowest levels of access not only to vaccines but to antibiotics and other health services,” Frost said.

“The good news is there are several vaccine candidates in late stage clinical development that have the potential to impact AMR. These include TB, e-coli and gonorrhea,” she added.

But vaccine development is expensive, and failure rates are high, Frost noted, so even getting some of the vaccines into advanced stages of development doesn’t mean all of them will reach the market. Clinical trials also typically need large populations and take years to complete before vaccines reach the licensing and manufacturing stages.

And she laments the fact that there are still no vaccine candidates in clinical development against six key bacterial pathogens on WHO’s list of priority list.: C. Jejuni, H. pylori, E. faecium, Enterobacter spp, A. baumanii and P. aerungi.

Dr. Dr. Mateusz Hasso Agopdowicz, a WHO technical officer, noted many challenges remain to increase coverage of existing vaccines, especially for vulnerable populations in low- and middle-income countries where they are needed most.

“To introduce new vaccines and increase coverage of existing vaccines,” he said, “we need sufficient funding for vaccination campaigns [and to] look for cheaper methods of developing vaccines, alternative ways of vaccine administration, and delivery as well as addressing vaccine hesitancy.”

AMR Pathogens
Dr. Mateusz Hasso Agopdowicz. WHO

Investment in research and development vital to keep priority pathogens in check

More resources are needed to continue R&D for vaccines in clinical development. And for pathogens with new vaccines in late-stage clinical trials, like microbacterium tuberculosis, funds are needed to accelerate these trials so tthey’re finished and the vaccines made available for use.

And last month WHO raised the red flag over the lack of new antibacterial treatments being developed to address the mounting threat of antimicrobial resistance (AMR).

Agopdowicz emphasised the need for further analysis to establish demand trends for vaccines so researchers can determine the number of doses needed when vaccines are ready to be used. “For the next 10 years, we need to use alternative approaches to contain resistant pathogens and use disruptive ways of vaccine manufacturing like mRNA,” he said.

Even with promising vaccine candidates in the pipeline, questions remain around IP rights and trade issues that could hinder global vaccine equity.

“No one benefits unless vaccines are created and then delivered to everyone who needs them,” said Boston University law professor Kevin Outterson, who is executive director at Combating Antibiotic Resistant Bacteria Biopharmaceutical Accelerator (CARB-X). “This is exactly why every CARB-X-supported product is backed by a contractual promise to avoid the issues with access to COVID vaccines.”

Image Credits: Richard Nyberg, USAID.

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.