United States cancer patients protesting the price of a prostate cancer drug that costs up to five times more in the US than in other high-income countries have recently revived a petition to lower it’s price – a battle that was lost during the administration of US President Barack Obama but seems to be gaining more political momentum now.

The petition, submitted to the Department of Health and Human Services, is callling upon the administation of another Democratic President, Joe Biden, to exercise its so-called “march-in” rights that would enable generic competition to lower the drug’s price – as provided for in legislation covering drugs that received government R&D funding. 

Xtandi (enzalutamide), which is co-licenced by Japan’s Astellas Pharma and Pfizer, costs US patients about $156,000 a year on average – five times more than it costs in Japan and Canada, according to Knowledge Ecology International, which is champining the new appeal.  In Denmark, the drug costs about $45 per capsule, as compared to $113-130, in the US, while in some countries generic vesions are available for as little as $1.72. 

The differential is particularly striking insofar as Xtandi was developed at the University of California Los Angeles (UCLA) with the support of grants from the US National Institutes of Health (NIH) and the Department of Defense (Army).

Charitable foundations, including the Prostate Cancer Foundation, the National Cancer Institute, the Howard Hughes Medical Institute and Doris Duke Charitable Foundation, also assisted with research and development costs.

Back in 2016, the Union for Affordable Cancer Treatment (UACT) and Knowledge Ecology International (KEI) failed in their quest to get the National Institutes of Health (NIH) and Department of Defense (DoD) to use their “march in” authority under the Bayh-Dole Act to authorize the generic production of the expensive prostate cancer drug.

Under the Act, the federal government is able to award third-party licenses if the patent holder does not make the product “available to the public on reasonable terms.”

Support growing in United States for reducing drug prices?

However, since then, the high cost of many drugs in the US – as compared to Europe and other high-income countries –  has received more public attention recently, and there are some signs that the petition could be picking up political steam – at least among Democrats.

Last week, Senators Elizabeth Warren and Angus King and Representative Lloyd Doggett wrote to HHS Secretary Xavier Becerra, urging him to move forward with the “march-in” petition and consider authorising generic production for government programmes.

“Xtandi is not the only case where Americans are paying exorbitantly high prices for prescription drugs – there are legions of examples. But the Xtandi costs are particularly galling because the drug’s research and development were underwritten by American taxpayers,” according to their letter.

The high cost of the drug means that insurers often require its pre-approval, at repeated intervals, which can delay treatment, the petition’s supporters say.  That is without reference to the high insurance co-payment charges that may be required, even if the drug is covered, which can be a big financial burden to many patients.  

A statement by Astellas, dated 9 February, claimed stated that, “while the U.S. government contributed approximately $500,000 to the initial discovery of the molecule that eventually became XTANDI, Astellas has invested more than $1.4 billion to date in research and development efforts for XTANDI.”

A response by KEI said “that is a lot to unpack,” noting that  “Charles Sawyers, the lead inventor on the Xtandi patents, is listed as the principal investigator for $27.7 million in NIH-funded projects and $8.3 million in subprojects, beginning in 1985.  Michael Jung, another of the Xtandi inventors, was the principal investigator for 42 NIH grants involving $5.99 million….

“Once Xtandi was approved by the FDA on August 31, 2012, it became a commercial and profitable product that has generated more than $20 billion in global sales,” added the KEI statement – calling for a more transparent accountancy of the R&D costs of the drug pre-approval, and how those costs were covered.

GUWAHATI – Amid sharply falling COVID-19 cases, the streets in the largest city in north eastern India have started to resemble pre-pandemic days, crowded with pedestrians, vehicles, roadside vendors and hawkers jostling for space with scarcely anyone wearing masks.

This follows the decision by Assam state to lift all restrictions from 15 February, removing curfews and  restrictions on public gathering of people, and even mandatory testing for passengers at airports and railway stations, according to the chief minister of the state, Himanta Biswa Sarma. 

Across the rest of the country other states have followed Assam’s lead, by easing restrictions. The Delhi Disaster Management Authority (DDMA) has allowed schools and gyms to reopen in the national capital. In Andhra Pradesh, Meghalaya, Rajasthan, the night curfews imposed to check the spread of coronavirus, have been lifted. 

India’s surge in coronavirus surge began on 27 December, and peaked in mid-January with more than 340,000 daily cases. But by 13 February, that number had dipped to 44,877 cases, according to India’s health ministry. Across south Asia, cases are also falling including in Nepal and Bangladesh. 

Cases subsiding rapidly

Dr Abhijit Sarma, superintendent at the Gauhati Medical College Hospital (GMCH), the largest government hospital in Assam state, said there has been a sharp decline in daily cases and the positivity rate shows that the wave is “subsiding and retreating”. “It is coming down,” he said. 

This surge, fueled by the highly transmissible Omicron variant, was termed the third wave of the pandemic in India by experts. It was predicted that the wave will be short-lived and its impact will not be as severe as that of the first and the second waves. 

“The symptoms for Omicron stay for three days and by the fifth day, it usually goes down. So, the severity is less compared to Delta,” Dr Sarma said, but added that it had been more serious for those who were unvaccinated or partially, and senior citizens with comorbidities.  

The country has so far given more than 1.7 billion doses of vaccines and about 76% of eligible adults have been fully vaccinated. In reaction to the third wave, the country began administering a precautionary booster dose of vaccine to healthcare workers, frontline workers including personnel deployed for election duty and those aged 60 and above with comorbidities from 10 January onwards. It also started vaccinating 15-18-year-olds from January.

Professor K Srinath Reddy, president of the Public Health Foundation of India (PHFI), said that the vaccination drive in India is going “fairly well in terms of intended coverage from whatever has been reported in the media.” 

India’s battle with the Omicron variant was surely aided by the large scale vaccination programme, which reduced the severity of the disease, along with apparently milder Omicron symptoms. “Two doses of the vaccine is highly effective,” Chennai-based virologist Dr Jacob T John said.

“We must recognise another fact that vaccines are meant only to protect against severe illness and death, not against infections, per se,” Reddy explained. “The Omicron wave has resulted in not as much severe infection and illness, partly because the virus itself appears to be milder and partly because a lot of our population has acquired immunity through natural infection, vaccines or both.” 

Most restrictions have been lifted in India, but experts urge people to still wear masks.

For its vaccination drive, although India has approved seven vaccines it is currently using only three – Covishield (AstraZeneca), Covaxin (Bharat Biotech) and Sputnik V (Russia), with  Covishield accounting for more than 85% of the doses administered so far.

When asked which of these vaccines was functioning well, Reddy explained that there are two ways of assessing whether the vaccines performed well or not. One is through lab tests by studying T cell immunity and the other way of assessing is by identifying how many breakthrough infections are occurring. 

“We do not have adequate data to analyze what the amount of breakthrough infections or the amount of hospitalization in vaccinated people are,” said Reddy, but added that the National Institute of Virology in Pune had demonstrated that both Covishield and Covaxin had continued protection against even the Omicron variant. 

Lack of testing and underreporting confound diagnoses 

Dr Angkita Barman, a Guwahati-based doctor who specialises in anesthesiology, and works at a private hospital in the city, said that in smaller cities such as Guwahati it had been difficult to determine whether a person is infected by Omicron or Delta . “An assumption is made based on the symptoms of a patient as we don’t have a proper lab here which will suggest what variant it is,” she said. 

To confirm whether a suspected case is Omicron requires a full genetic analysis, which can take between four and five days. 

“We have come across severe cases in this third wave as well and that could be due to Delta as well but we do not know. We are not investigating on that front due to lack of a proper lab,” Barman explained. 

Virologist John said most current cases are Omicron and that although official case figures for the Delta wave appeared higher than the Omicron wave, this was contrary to international trends and due to an “undercount”.

“Everybody knew that this disease did not cause pneumonia and hypoxemia, therefore a lot of people did not bother to get themselves tested,” said John, adding that the government was also not enthusiastic about following up on cases due to the state elections in five Indian states. 

Death toll may be six or seven times higher

India also reported a surge in the use of home testing kits with 200,000 home tests used in the first 20 days of January in comparison to 3,000 in all of 2021, the director general of the Indian Council of Medical Research, Balram Bhargava said on 20 January.

In Mumbai, the sale of self-testing kits also rose but the municipality made it compulsory for purchasers to provide their individual identification number when buying kits in an attempt to keep track of cases.

 Six to seven times more people could have died of COVID-19 in the first and second waves of the pandemic than officially reported in India, according to a study published in Science last month. 

The study estimates that as many as 3.2 million people could have died from the disease, whereas the government-recorded number is 419,000 deaths between June 2020 and July 2021. 

“India’s reported COVID death totals are widely believed to be under-reports,” the authors wrote in the study, “because of incomplete certification of COVID deaths and misattribution to chronic diseases and because most deaths occur in rural areas, often without medical attention”.

Reddy urged people not to abandon masks, noting that the virus “could still mutate to a more virulent form particularly if it mixes up with other viruses in what’s called an antigenic shift”.

 

Image Credits: Deepak Choudhary/ Unsplash, Govind Krishnan/ Unsplash.

TDR-supported postgraduate fellows during a conference on implementation research in Dhaka, Bangladesh, in June 2019

In a village in eastern Ghana where Comfort Tetteh grew up, many people thought it was normal for a child to urinate blood. But after studying public health, Tetteh recognized this as a sign of schistosomiasis, one of the many neglected tropical diseases that affect her community.

“In the districts that I’ve worked in, everything is about tropical diseases,” said Tetteh, who became a disease control officer after graduating with a Bachelor of Science degree. “I saw Buruli ulcers, I saw leprosy, I saw schistosomiasis, I saw yaws and many other diseases. My job was to implement disease control measures, and my interest grew to go beyond treatment and help people to apply community-level measures to prevent the appearance of these diseases,” Tetteh said.

Comfort Tetteh

Tetteh, now a senior public health officer in Greater Accra, recently had the opportunity to learn how to do exactly that through postgraduate training in implementation research at the University of Witwatersrand in South Africa, with a scholarship from TDR, the Special Programme for Research and Training in Tropical Diseases. The University of Witwatersrand is one of seven universities in low- and middle-income countries partnering with TDR on the Postgraduate Training Scheme.

TDR is a global programme aimed at combating infectious diseases of poverty and is based at the World Health Organization (WHO) headquarters in Geneva. TDR is co-sponsored by the United Nations Children’s Fund (UNICEF), the United Nations Development Programme (UNDP), the World Bank and WHO.

Focusing on infectious diseases of poverty

 Infectious diseases of poverty include tuberculosis (TB), neglected tropical diseases (NTDs), malaria and other vector-borne diseases. These diseases are prevalent in low- and middle-income countries (LMICs), where they mostly affect poor communities and disproportionately affect women and children. The pandemic has also prompted research on how COVID-19 is affecting control efforts for these diseases.

While HIV, TB and malaria have been the priority for two decades of global efforts and billions of dollars in investments, NTDs have often received less attention. And this is despite the fact that these diseases impose a devastating human, social and economic burden on more than 1 billion people worldwide. WHO recently launched a new road map to end this neglect.

Implementation research: the research-to-community link

TDR was established almost 50 years ago, and in the early years, it led the development of critical new NTD treatments – from the first modern treatments for sleeping sickness and river blindness to bednets for malaria.

But with many other agencies now involved in the laboratory development of actual treatments for NTDs, TDR has shifted its focus to implementation research to understand and address barriers to effective implementation of health interventions, strategies and policies.

“The focus of our work is to teach the researchers and scientists in low- and middle-income countries to better address the implementation bottlenecks that prevent the uptake of products and strategies,” said Dr Mahnaz Vahedi, who has been managing TDR’s flagship postgraduate training programme since 2017.

Barriers to uptake include social, political and cultural issues, she points out. These barriers are often grossly underestimated by the innovators of new tests, treatments and vaccines. Thus, there is growing recognition among public health and global health stakeholders that these barriers need to be addressed systematically in order for health programmes to be successful.

Iconic component of TDR’s mission

 Support for postgraduate training in LMICs has been an iconic component of TDR’s mission since the beginning – fostering cadres of skilled professionals in infectious diseases of poverty across Africa, Asia and Latin America, who have become influential in research, public health and policy positions. 

WHO’s Director-General, Dr Tedros Adhanom Ghebreyesus, has spoken out about the importance of such support in building cadres of health professionals and policy leaders from Africa and other developing regions, noting that he himself is “living proof” of the value of such programmes – as the recipient of a WHO scholarship that financed his studies towards his Master’s degree in immunology and infectious diseases, earned in 1992.  

Originally, TDR offered individual scholarships for students to study NTDs – usually in wealthy developed countries. This was expensive and time-consuming – and it also had some unintended consequences.

“The one big lesson we learned is that we weren’t strengthening the capacity of the institutions in the South,” said Dr Pascal Launois, head of TDR’s Research Capacity Strengthening unit.

“This kind of training actually led to a lot of brain drain because people went to do postgraduate training in the UK, Europe or the US and then they didn’t go back to their own countries, and if they did, in many countries there was no institutional commitment for many of them to continue with their work,” he added.

Repositioning to strengthen institutional capacity in the Global South

To correct this, in 2015, TDR issued a call inviting institutions in the Global South to host students for PhD and Masters programmes in implementation research, with TDR providing the course material and full scholarships for the students.

 A flood of institutions applied, and after a careful vetting process, including site visits with independent experts, seven universities were selected: BRAC University (Bangladesh), Universidad de Antioquia (Colombia), the University of Ghana, Universitas Gadjah Mada (Indonesia), American University of Beirut (Lebanon), the University of the Witwatersrand (South Africa) and the University of Zambia. In 2020, Cheikh Anta Diop University in Senegal was added to cater to French-speaking students in Africa.

Cheikh Anta Diop University students conducting fieldwork in Fatick, Senegal

 “The institutions like it a lot because they get visibility, they are able to host international students and it provides the opportunity for South-South networking, which means we are strengthening the capacity of institutions in the south,” Vahedi said.

The aim is to ensure that the research is done by the researchers based in the disease-endemic countries and for the institutions and students to network.

“The old-fashioned style where research was done by a lead researcher in the North with data collected in the South doesn’t work anymore,” stressed Vahedi.

Students are selected both from health ministries and academia, as the aim is to bolster the country’s capacity in government and its research capacity in institutions.

More than 400 students – with an equal number of men and women – have been trained in Southern institutions since 2015 in programmes lasting from one to two years, and the second phase of the programme is due to start this year after a new call was issued in 2021 for new partners.

There are a few changes in the second phase. The India Institute of Health Management in Jaiphur has joined the group. If funds allow, the University of Technology of Science in Bamako in Mali will also be included to provide back-up for Senegal given the high demand from French-speaking African countries. And BRAC University in Bangladesh will now also train students from the Eastern Mediterranean Region.

Close-up on Wits School of Public Health

 Professor Tobias Chirwa, Dean of the School of Public Health at the University of Witwatersrand (Wits) in South Africa, said that hosting the postgraduate training programme has been a boost for both his institution and sub-Saharan Africa.

“The Wits School of Public Health has benefited from the long-term investments from TDR, including the recent funding on implementation research capacity building to support sub-Saharan African postgraduate students,” Chirwa said.

Prof Tobias Chirwa

“Through its extensive network and rich postgraduate programmes, the School will continue to provide regional training on implementation research and collaborate with research and academic institutions in Africa and beyond to develop and implement interventions that are relevant and contextual.”

Professor Latifat Ibisomi, the academic coordinator of the training programme at Wits University, said that TDR has enabled the school to “host outstanding students from multi-disciplinary backgrounds across 12 sub-Saharan Africa countries.”

“These students have conducted country-specific implementation research, thereby transferring their skills to several countries across the continent,” Ibisomi said. “We are thus contributing to the building of a critical mass of implementation researchers who are working to unblock implementation barriers that abound in the region.”

Lymphatic filariasis – why so high despite years of interventions?

Alfred Manyeh recently graduated with a TDR-sponsored PhD focused on lymphatic filariasis, a parasitic disease transmitted by mosquitoes that he became fascinated with back in 2015 when he was first exposed to it.

“I conducted my study in the northern part of Ghana in a district called Bole, where the transmission of lymphatic filariasis is highest in the country, although a lot of interventions happen there,” said Manyeh, who is currently a research fellow at the University of Health and Allied Sciences at Ho in Ghana.

Alfred Manyeh

Through his research, Manyeh wanted to uncover why the transmission of the disease was still so high despite years of interventions in the area.

“Based on the findings of my initial assessment, I put an intervention in place with strong stakeholder engagement. Then I went in there to evaluate the process and the impact of the intervention on the people’s knowledge about the disease and then their willingness to participate in the mass drug administration,” Manyeh said.

He found that the programme implementers – drug distributors and health workers – were not following protocols and that local people had various misconceptions about both the disease and its treatment.

Driving real change from implementation research findings

“We dealt with this by organising videos, community meetings and social mobilisation programmes in the community to educate the people about the disease and also about the medication, as well as training for the implementers,” Manyeh said, adding that people were more willing to take the drug after the intervention.

While the impact of his PhD research has only been felt in one area of Ghana, Manyeh is teaching a new generation of young scientists how to do implementation research and is confident that this will improve the uptake of health products in his country.

Meanwhile, Charity Hungu, a Masters graduate from Wits, has taken her new skills back to Kenya’s Kenyatta University Teaching Referral and Research Hospital, where she is a research officer.

Charity Hungu

 “The main focus of the hospital is on cancer. My work entails coordinating research projects within the hospital as well as with partner institutions from our region and internationally,” Hungu said.

“Sub-Saharan Africa has a great need for implementation scientists to address the daunting health issues that have set us back over the decades,” added Hungu. “We need to effect a turnaround, making our health systems work better and change the reality and narrative of our continent to one of healthier and more vibrant communities.”

 Adapting for COVID times

During the pandemic, more than  400 TDR-trained researchers and programme officers have adapted the research skills they have learnt to help their countries to combat COVID-19, according to a recent survey of graduates.

The activities they have been involved in include pandemic preparedness and response, situation analysis, surveillance, infection control and clinical management.

 As the senior public health officer in Greater Accra, Tetteh has been involved in the COVID-19 case management and vaccination rollout activities in her district.

Although the Kenyan hospital where Hungu is based focused on cancer, it also served as one of the main COVID-19 isolation centres in the country in the earlier part of the pandemic, and she has been drawn into some of the COVID-19 studies.

TDR has also developed several online implementation research tools to assist students who can’t travel to their universities to study during the pandemic.

“The pandemic created an opportunity for us to adapt our programme by providing hybrid and virtual training,” Vahedi said. “We are also looking forward to embarking on the development of a Masters degree in implementation research as well as a postdoctoral programme,” Vahedi said.

Developed in collaboration with TDR, as the first in a series of stories on strengthening implementation research capacity in low- and middle-income countries to tackle infectious diseases of poverty. For more information on TDR’s Postgraduate Training Scheme, please contact Dr Mahnaz Vahedi.

Image Credits: Cheikh Anta Diop University.

COVID patient in hospital
COVID patient in hospital

Immunosuppressed individuals living in the United States and Israel have been among the first to receive a novel new “vaccine” that preventively boosts their defenses against COVID-19 infection with a cocktail of long-acting antibodies.

The vaccine by AstraZeneca, branded as Evusheld, works on the principle of “passive immunization”, and contains two long-acting monoclonal antibodies (tixagevimab and cilgavimab) that bind to the SARS-CoV-2 spike protein preventing the virus from interacting with the human ACE2 receptor, thus reducing the risk of developing symptomatic disease.

The US Food and Drug Administration issued an Emergency Use Authorization for the vaccine in December 2021, for use in individuals who do not develop an adequate immune response after receiving other conventional COVID vaccines.  The US government reserved 700,000 doses at the time, but last week increased the purchase of the antibody combo to 1.7 million doses – at a cost of $855 million. Such treatments could be particularly important in the US, which has had comparatively higher death rates from COVID, per capita, than most other high income countries – something experts link to its comparatively lower vaccination rates.

Israel also has approved the drug and is deploying it through its local health funds, while Bahrain is reportedly about to do so. The European Medicines Agency is evaluating the treatment, which is unlikely to be available quickly in most low- and middle-income countries because of its high price tag of around $500 a dose – in comparison to about $28 for an mRNA vaccine dose.

Evusheld: Targeted at people who do not respond well to vaccines

Evusheld is intended for immunosuppressed people, to directly increase the amount of antibodies in their bodies. The treatment, given in two consecutive intramuscular injections, was reported in clinical trials reviewed by the FDA to have reduced severe morbidity and mortality from COVID by 83%. The trials were before the Omicron variant.

The shots are given prior to exposure to COVID, unlike other monoclonal antibody treatments for COVID, including those produced by Regeneron, GlaxoSmithKline and Eli Lilly.

Eli Lilly researchers developing a COVID-19 antibody treatment.

“Vaccines have proven to be the best defense available against COVID-19. However, there are certain immune-compromised individuals who may not mount an adequate immune response to COVID-19 vaccination, or those who have a history of severe adverse reactions to a COVID-19 vaccine and therefore cannot receive one and need an alternative prevention option,” said Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, in the December announcement of Evusheld’s approval.

“Today’s action authorizes the use of the combination of two monoclonal antibodies to reduce the risk of developing COVID-19 in these individuals.”

She stressed the treatment is not a substitute for vaccination in individuals for whom COVID-19 vaccination is recommended.

‘Passive immunization’

The jabs operate on the principles of what experts describe as “passive immunization.”

“When we give a regular vaccine, we expect to train the immune system,” Prof. Cyrille Cohen, head of the Immunology Lab at Israel’s Bar-Ilan University, told Health Policy Watch. “We are showing the immune system a pathogen and asking the body to generate antibodies or T-cells against that pathogenic-like substance.”

“In other words, ‘active immunization’ means we are giving the body the opportunity to generate its own antibodies. In contrast, passive immunization is when we take laboratory-made antibodies or those from recovered patients and inject them into the highest risk population to give them an extra layer of protection.

“We are giving them an artificial way to fight the virus because we don’t expect them to generate antibodies on their own,” Cohen explained.

Treatment aimed at stopping hospitalizations of the most vulnerable

The treatment arrived on the market at a time when many fully-vaccinated individuals with underlying medical conditions are being hospitalized with Omicron at the same or even higher rates than the unvaccinated.

“People have to understand that people with deficient immune systems are at mercy of germs that healthy people are not worried about,” Cohen said.

Evusheld is available for people over the age of 12 who weigh at least 40 kg, are not infected with the virus or who have not been recently exposed to the virus, and who suffer from a pre-existing medical condition, including having undergone a bone marrow or organ transplant, as well as undergoing CAR-T or B-cell depletion therapy for cancer or other conditions.  It can be administered regardless of whether an individual was vaccinated previously or not with a conventional jab.

Not all antibody treatments are the same

The first monoclonal antibody treatments entered the public arena with a splash in October 2020, after then-US President Donald Trump, who had been infected with COVID-19, took Regeneron’s polyclonal antibody cocktail, REGEN-COV, a combination of two monoclonal antibodies (casirivimab and imdevimab) designed specifically to block the progress of a COVID-19 infection. At about the same time, the drug was approved by the FDA for compassionate use, and soon after, the treatment received an Emergency Use Authorization.

However, Regeneron and other similar treatments have since failed to perform against Omicron. As a result, in January, the FDA revised its authorization of REGEN-COV and another antibody treatment (bamlanivimab and etesevimab administered together), limiting their use to only when an individuals has already been infected with or exposed to another variant – one that is susceptible to these treatments.

“Because data show these treatments are highly unlikely to be active against the Omicron variant, which is circulating at a very high frequency throughout the United States, these treatments are not authorized for use in any US states, territories and jurisdictions at this time,” Cavazzoni said in a statement.

“In the future, if patients in certain geographic regions are likely to be infected or exposed to a variant that is susceptible to these treatments, then use of these treatments may be authorized in these regions.”

Despite its FDA approval, some researchers have also questioned the use of Evusheld against Omicron:  “Most antibody-based treatments are not effective against Omicron,” said Dr. Erez Garty, head of science communications at Israel’s Davidson Institute of Science Education, located in the Weizmann Institute of Science, saying he is not yet convinced.

“There is lab evidence that Evusheld has a better neutralizing effect against Omicron than some [other] antibody based treatments,” Garty explained. “But this type of treatment is very sensitive to change in variants. With the Omicron subvariant BA2.  now rising we don’t know how effective [the vaccine] will be.”

WHO Recommended treatments

WHO timetable for reviewing new COVID treatments. While monulpiravir was recently approved, three other treatments, including monulpiravir and Paxlovid, are still under review, as of 20 February, while Evusheld is not on the calendar at all,

WHO recommended treatments also don’t yet include the so-called passive vaccine of Evusheld – although the Organization has recently approved another monoclonal antibody treatment for already infected patients.

That was Sotrovimab, which received a WHO approval in mid-January, for patients with non-severe COVID-19, but who are at risk for developing severe disease.

François Lamontagne, Professor of Medicine at the Université de Sherbrooke, who sits on WHO’s Guideline Development Group, told Health Policy Watch that Sotrovimab consists of antibodies directed against a specific part of the virus that prevents entry of the virus into cells. This drug is given intravenously, requiring one infusion.

Lamontagne noted, however, that the panel only provided a “weak” recommendation of the treatment because the effectiveness of sotrovimab against Omicron is still uncertain.

WHO also has yet to make a recommendation on two other COVID treatments, Merck’s monulpiravir and Pfizer’s Paxlovid – which operate on different principles.  This despite the fact the drugs are already being widely sold in high income countries.  The pharma companies also have made commitments to sell the drugs at cost to many low- and middle-income countries either bilaterally or via the UN-supported Medicines Patents Pool (MPP), which negotiates licenses with pharma for the use of drugs in resource-constrained settings.

Image Credits: Wikimedia Commons, Eli Lilly.

disability
Wheelchair users are often left to grapple with inaccessible services.

From barriers to treatment for people with hearing disabilities to preconceptions about albinism and inaccessible COVID testing for wheelchair users, participants in the Global Disability Summit took a fresh look at the wide range of discriminatory practices that an estimated 1 billion people – 15% of the world’s population – living with disabilities have to face.

This summit, the second of its kind, was sponsored by the International Disability Alliance, the governments of Norway and Ghana, and the World Health Organization, drew some 5500 participants during two days of online proceedings, 16-17 February. The conference covered issues associated with a wide range of physical and mental health disabilities.

Speakers talked about the massive challenges of tackling physical and emotional barriers, as well as the legal policies and stigmatization they face in their day-to-day lives.

Olive Namutebi, Executive Director of Albinism Umbrella, Uganda

“Somebody looks at someone with albinism and thinks that their only problem is skin,” said Olive Namutebi, Executive Director of the Albinism Umbrella, Uganda.

“There is a temperature, malaria, fever, they put me to the skin doctor. I have other issues, I’m a human being. Can I be allowed to express myself instead of you having the precognition, thinking that the only problem I have is skin because I am different?”

Across the summit, speakers and world leaders cried out for more “disability-inclusive” healthcare, education, employment, and livelihoods.

“Social and economic development must be right based and disability inclusive. We must leave no one behind,” said Norway Prime Minister Jonas Gahr Støre at the opening ceremony of the summit. 

Commiting to inclusivity

The summit called for all – governments, world leaders, health organizations, people with disabilities – to collaborate and commit towards this goal of inclusivity.

“All stakeholders, including governments, civil society, multilateral organisations, the private sector, and other partners, must collaborate on taking a disability inclusive approach. We must design equitable programmes, including health services, to ensure persons with disabilities achieve the highest attainable standard of health, as demanded by the World Health Assembly in 2021,” said the WHO Director-General, President of Ghana, Prime Minister of Norway and President of the the International Disability Alliance in an op-ed in the BMJ. 

People with disabilities are three times more likely to be denied access to healthcare, four times more likely to be treated inadequately in the healthcare system, and twice as likely to suffer catastrophic health expenditure, the op-ed authors stated. Some 80% of people with disabilities live in low- and middle-income countries, where access to basic social and economic services may be especially limited for persons with disabilities.

Accessible healthcare and increased disability training

Ashura Michael, IDA-UNICEF Youth Fellow

Speakers called for more accessible, quality healthcare that combats against ignorance mindsets and lack of information.

“Information is power. So many women die because of the wrong prescription. Some go through with operations when they’re not supposed to [do so],” said Ashura Michael, IDA-UNICEF Youth Fellow, speaking about how sight and hearing disabilities can be a barrier to appropriate diagnosis and treatment.

Michael called for doctors and health practitioners to be trained in sign language, so that they can communicate with deaf people and prescribe the correct treatment and medication.

She also advocated for more funds for resources for people with disabilities in schools, and to make disability training more mainstream.

“We have diversity in our disabilities. Let us come together for betterment of persons with disabilities.”

Namutebi called it ‘everyone’s business’ to get involved, especially for people with disabilities to speak up.

“This is not an isolated case of exclusivity. When you exclude me, you are excluding yourself from advancement or enjoying better services… We need to unlearn some of the thing that we’ve grown up knowing.”

Pandemic disruption 

Antonio Guterres, Secretary-General, United Nations

The COVID-19 pandemic has brought to light “significant inequalities” in the way persons with disabilities and other marginalized groups in many countries have been underserved in the provision of COVID-19 related health, social protection and financial services, said Nana Akufo-Addo, President of the Republic of Ghana, speaking in a keynote address.

The way in which the COVID-19 pandemic exacerbated the day-to-day obstacles that may be encountered by disabled individuals was echoed by António Guterres, Secretary-General, United Nations.

“Persons with disabilities are losing their lives at vastly higher rates into persistent barriers in our system,” he said.

For instance, when the pandemic led to widespread school closures, many students with disabilities in low- and middle-income countries were left without access to technology and assisted devices for effective remote learning, Guterres pointed out. 

Workers with disabilities faced added worries since they are typically the first to lose their jobs and the last to be rehired, he pointed out.

Disabled women’s health 

Students with disabilities perform dance in rural Bangladesh. Women and girls with disabilities face higher risk of violence and abuse.

One crosscutting theme of this year’s conference was gender – as women with disabilities are even more acutely impacted by discriminatory practices.  The GDS 2022 emphasized the need for gender equality as a key to empowerment of all women and girls with disabilities.  

“Women and girls with disabilities who were already experiencing double discrimination are facing even higher risk of violence and abuse,” said Guterres.

Dr Natalia Kanem, Executive Director, United Nations Population Fund, said that women with disabilities were up to 10 times more likely to experience sexual violence. “Shouldn’t a young woman with disabilities decide what she wants for her own body? Shouldn’t she live free from the harm caused by violence, coercion and abuse?” she said. 

Young women and girls with disabilities are among those groups with the least access to reproductive health information and education, Kanen said, noting that women with disabilities are up to 10-times more likely to experience gender-based violence. 

Said Guterres, “We need to act decisively to realize and promote the rights of persons with disabilities in every corner of the world and in every facet of life. Global inequalities reverberate at the local level when developing countries have struggled financially.” 

The Nairobi-based Bridge Academy helps people with a range of disabilities to build and launch IT careers – paving a way to better livelihoods.

US’ ‘historic’ commitment 

The summit also saw the U.S making a commitment of $25 million over the next five years to the Global Partnership for Assistive Technology, founded by a consortium of partners, including the International Disability Alliance, Norway, Kenya, USAID, WHO and others in 2018.

“We’re committing to disability inclusion as a requirement in all of our humanitarian assistance. This means partnering with persons with disability organisations who all already have the expertise and relationships to make our aid more accessible,” said Samantha Power, of USAID, announcing the commitment. 

The United States made 23 new commitments on disability rights – a vast improvement from the 2018 inaugural summit, when the US made zero commitments. 

Altogether the summit saw over 1250 commitments from national governments, donors, NGOs and the private sector to take concrete steps improving disability rights in areas including: health, education, livelihoods social protection, and capacity building, summit organizers said.

Susceptibility to poverty

People with disabilities are more susceptible to poverty.

Individuals with disabilities are more susceptible to poverty than those without any disabilities.

“Without a disability inclusive approach to recovery and building resilience, persons with disabilities are at an increased risk of being left behind and falling further into poverty,” said Mari Pangestu, Managing Director of Development Policy and Partnerships at the World Bank. 

The theme of poverty and disability was also echoed by Jordan’s King Abdullah II, another featured speaker at the summit. “The political engagement of persons with disabilities is by no means less important than their economic engagement,” he said.

“They are part of societies everywhere, and that must be reflected in education, healthcare, business, sports tourism, in all facets of life. None can be dismissed as a luxury.” 

Examples of other commitments made by countries at the summit included and announcement by the Maldives to increase social protection of people with disabilities, and Angola to strengthen  processes supporting people with disabilities to vote in this year’s election.

Image Credits: Sightsavers.org, Rasmus Gerdin/ Unsplash, GDS, ILO Asia-Pacific, Adam Howarth/Flickr.

South African President Cyril Ramaphosa at announcement of six African countries to receive mRNA vaccine technology

South African President Cyril Ramaphosa Friday called on Gavi, The Vaccine Alliance, and COVAX, the global COVID vaccine consortium to begin procuring African-made versions of vaccines for COVID and other diseases, as soon as a network of new African manufacturing facilities, now in the making, are in full production.

He spoke in Brussels at an event where WHO announced that Egypt, Kenya, Nigeria, Senegal and Tunisia, as well as South African manufacturers, are to receive technology and training in mRNA vaccine manufacturing from the new WHO-supported Technology Transfer Hub in Cape Town South Africa, where scientists at Afrigen Biologics and Vaccines say they have replicated the Moderna mRNA vaccine formulation.

WHO Director General Dr Tedros Adhanom Ghebreyesus named the new partner countries at a ceremony hosted by the European Union-African Union Summit, and attended by all six recipient countries, as well as European Commission President Ursula Von der Leyen, European Council President, Charles Michel, and French President Emmanuel Macron, who holds the rotating EU Council Presidency.

Ramaphosa said that the new hub-and-spoke system of of vaccine R&D development and tech transfer should change the way vaccines are procured in Africa – as well as produced.

COVAX
COVAX vaccine deliveries in Africa – stark supply shortages and dependency on imports from India, the US and Europe were key features of the 2021 vaccine rollout.

“Organizations such as COVAX and Gavi need to commit to buying vaccines from local manufacturers,” Ramaphosa declared, “Instead of going outside of those hubs, they need to buy from the locally-produced hubs once they get going.”

Gavi, established in 2000 by the Bill and Melinda Gates Foundation, has been procuring vaccines in bulk for over 90 low income countries for over two decades. COVAX, the ambitious global COVID vaccine facility that was co-founded by WHO and managed by Gavi, UNICEF, and others has been the procurement and distribution channel for vaccines during the pandemic.

But those giant Geneva-based agencies and their partners, like the Global Fund, traditionally have raced after the bottom dollar in bulk purchases from big generic producers in Asia, from Europe and the United States.  And their procurement preferences, in turn, have actually driven more industry consolidation and monopoly control over not only vaccines, but a range of much more basic health products from PPE to insecticide treated malaria bednets, UN insiders say  – making it difficult for African manufacturers to even get a foothold.

Now, Ramaphosa and other African leaders are beginning to call that out.  They say that a shift in procurement preferences among the big UN and donor-funded procurement agencies is critical to enable African producers to be sustainable; it would also stimulate African R&D and economies, and eventually reduce the net cost of products that must now be imported.

“This would enhance the spirit of Africa’s determination to enhance biotech sovereignty” said Ramaphosa, and end the era of “Africa being consumers of medical countermeasures for disease produced at high prices that are not affordable to our country.”

Left to right: EC President Ursula von der Leyen, South Africa’s Cyril Ramaphosa, EU Council President Charles Michel, French President Emannuel Macron and WHO’s Tedros Adhanom Ghebreyesus at today’s announcement of six African countries to receive mRNA vaccine technology.

South Africa – approve IP waiver

Ramaphosa also called upon European countries to approve an intellectual property waiver on COVID technology – a so-called “TRIPS waiver” that was proposed by South Africa and India over a year ago at the World Trade Organization.

“Now I come to an uncomfortable point,” said Ramaphosa, “Governments that are really serious about ensuring that the world has access to vacccines should ensure that we approve the TRIPS waiver as we’ve put it forward rather than hide behind IP an the profitability of the originators,” he asserted.  ” When we are talking about the lives of hundreds of milllions of people, rather than the profitability of a few companies, it is not acceptable that Africa is consistently at the back of the queue in relation to access to medicines.

“While we appreciate the donations, they are never a sustainable way or mechanism to build resilience,” said Ramaphosa, adding, “I’m been amazed plesantly at the number of scientists we’ve got on the African continent.  They have just come out of the woodwork, and they are demonstrating enormous capability. And those are the people whose energy we need to unleash…

“And all we need to do that is to approve the TRIPS waiver to empower them, and just give them the energy and that oxygen so that they can surge forward.”

His comments led to some awkward moments on the stage with European Commssion President von der Leyen and other EU officials struggling to respond.

Ursula von der Leyen, president of the European Commission

Directing her reply to Ramaphosa, von der Leyen suggested that the EU sees the mRNA Tech Transfer initiative as a countervailing force in the industry landscape – limiting “the profitability of the IP owners. That is the companies, that …you were blaming – while protecting a very precious good, and this is the intellectual property, what scientists have developed.

“And here I think we can find the bridge,” she added, saying that both sides share the same goal but have different ways of reaching it.

“The goal is really to make sure that the technology is transferred and dismantled and shown in full scope,” she said in her remarks.  “And for that, we think that compulsory licensing with limited, deeply-cut profits might be a bridge we go together” said Von der Leyen pressing, in live time, an EU alternative to the IP waiver that major European countries have sought to advance in the World Trade Organization, where the issue has been debated behind closed doors for over a year.

African-European friction on intellectual property measures evident at opening

mRNA hub – South Africa: Lab technicians work in laboratories in Afrigen, a Cape Town R&D firm that is part of the WHO mRNA Vaccine Hub

Ramaphosa  also charged that “full operationalization of [South Africa’s ] mRNA hub has been hampered by intellectual property barriers. This could occur in other countries,” he added, referring to the designated recipients of the vaccine technology that South Africa’s has been developing.

There has been a “failure to transfer technology to the hub through non-exclusive licenses to produce, as well as to export and distribute, the COVID-19 vaccines in low- and middle-income countries, including through the COVAX facility,” he added, referring to Moderna’s refusal to share know-how with the hub, which is seeking to replicate their version of an mRNA COVID vaccine.

This, Ramaphosa said, is important to ensuring that the South African hub teams “have all the necessary operating procedures and know-how to manufacture mRNA vaccines at scale and according to international standards…. to support manufacturers in low- and middle-income countries to produce their own vaccines. ”

Two weeks ago, scientists at Afrigen in South African’s tech hub said they believed they had replicated the Moderna jab, based on publicly accessible data. However, they said that scaling up manufacturing would take much longer without Moderna’s assistance. Moderna has so far pledged to not enforce patents during the pandemic – but it also has not proffered a hand to Afrigen.

“Publicly available information, this is not enough,” agreed von der Leyen, in her reply back to the South African leader. “There needs to be in-depth information about a technology. So we have a common goal,” adding that the EC aims to “create the regulatory frame that is really necesssary to make it happen.”

WHO Sidesteps IP Issue

In his remarks at the Belgium ceremony WHO’s Dr Tedros sidestepped the delicate and unresolved IP issues around the hub, saying:

“The aim of the hub is so that manufacturers can receive training in how to produce certain vaccines and the license to do so.”

Primarily set up to address the COVID-19 emergency, the hub – as well as the “spokes” in the six country network, announced today, offer the potential to expand manufacturing capacity for other vaccine products as well, “putting countries in the driver’s seat when it comes to the kinds of vaccines and other products they need to address their health priorities,” said WHO in a press release.

“Depending on the infrastructure, workforce and clinical research and regulatory capacity in place, WHO and partners will work with the beneficiary countries to develop a roadmap and put in place the necessary training and support so that they can start producing vaccines as soon as possible,” WHO said.

Earlier this week, BioNTech announced another major initiative in Africa, shipping ready-made vaccine production facilities in containers to Rwanda and Senegal.

BioNTech it would collaborate with the WHO hub in the employment of trained personnel at its facilities.  But it remains unclear about how BioNTech, which is producing its own proprietary Pfizer-BioNTech vaccine, will collaborate with the WHO-supported mRNA hub, which aims to develop and produce vaccines using a competitor’s technology (Moderna) and one that can be freely licensed to boot.

Asked by Health Policy Watch, how the WHO-supported mRNA network is being funded, a WHO spokesperson said, “We need €100 million over 5 years, and we have secured 80% of that from the countries Dr Tedros mentioned in his speech,” without elaborating further.

In her remarks, meanwhile, Von der leyen said that the European Commission, together with Germany, France and Belgium, are investing €40 million in the mRNA technology transfer network, “because we are deeply convinced that it’s the right way to go… It’s a major step forward in Africa’s strategic sovereignty when it comes to vaccines.

“We all know the state of play today. Today of all the vaccines applied in Africa. 1% is produced in Africa, of all the vaccines, and rightly so the goal is in 2040 to have reached a level of 60% of vaccines produced in Africa that are administered in Africa. And this is the precondition.

Turning to Ramaphosa she added, “And here indeed, dear Cyril, I think it is important that, as you said, we limit with this technology transfer, the profitability of the IP owners. ”

In a closing statement Friday, afternoon von der Leyen said that the African Union Commission and the European Union Commission would organize a “college to college meeting” this spring in Brussels with WTO Director General Dr. Ngozi Okonjo-Iweala, to try to define a way forward on the IP issue, adding that the two sides “share the same goal” but have “different ways to reach the goal – there must be a bridge between the two ways.”

Image Credits: UNICEF, Rodger Bosch for MPP/WHO.

Individuals who recovered from COVID-19 and then received at least one shot of the Pfizer mRNA COVID-19 vaccine had a significantly lower risk of reinfection, according to a new study published Wednesday’s New England Journal of Medicine,.

The study was conducted by researchers at Israel’s Clalit Health Services, in collaboration with Ben-Gurion University and Sapir Academic College.

Specifically, the research showed there was an 82% reduction in the risk of reinfection with the virus among recovered and vaccinated 16- to 64-year-olds, and a 60% risk reduction among those aged 65 and older.  Contrary to recommendations in some countries, however, the study also suggested that one shot was sufficient in preventing re-infection with two shots performing no better.

“The results of our study unequivocally show that giving a coronavirus vaccine to people who have recovered is significantly associated with reducing the risk of re-infection,” said Dr. Doron Netzer of Clalit Health Services. However, she said the findings only covered peoples’ risks of re-infection during the Delta wave, and not necessarily Omicron. The latter variant has been less deadly but also more resistant to vaccine-induced protection.

The researchers noted that the results were consistent with data from studies that have shown strong immunologic responses to vaccination in previously infected persons.

Study applicable to Delta not Omicron

The study was conducted from March 1, 2021, the date on which Israel’s Ministry of Health approved the vaccination of people who recovered from COVID-19, through November 26, 2021 – at the height of the Delta wave. Although the study thus only covers the Delta wave, it also provided an opportunity to draw out some general principals on COVID vaccines, the researchers said.

“The surge of the Delta variant provided an epidemiologic opportunity to assess whether the vaccination of patients who had recovered from COVID-19 would provide extra protection against recurrent infection,” the researchers explained in their article.

The team analyzed the data of Clalit patients using advanced statistical methods to test the effectiveness of the vaccine in preventing re-infection with the virus among Covid-recovered people  who received the vaccine at least three months after being ill. their infection. They compared reinfection rates among patients who had subsequently received the vaccine and those who had not.

Clalit is Israel’s largest health fund.

In total, 149,032 people over the age of 16 who had recovered from coronavirus were included in the study – 83,356 who received at least one shot after infection. Reinfection occurred in 354 of the vaccinated patients (2.46 cases per 100,000 persons per day) and in 2,168 of the 65,676 unvaccinated patients (10.21 cases per 100,000 persons per day).

“Although vaccine effectiveness was lower among patients who were 65 years of age or older than among younger patients, the vaccine still offered substantial protection among older patients,” the researchers wrote. “However, among the unvaccinated patients, the reinfection rate among the older patients was much lower than that among the younger patients (3.02 cases per 100,000 persons per day vs.10.79 cases per 100,000 persons per day). This observation may be explained if we assume that older patients who had already been infected with SARS-CoV-2 would have observed enhanced social distancing and other required precautions, especially during the surge of the Delta variant, even if they had decided against vaccination.

“Therefore, the differences in reinfection rates between vaccinated and unvaccinated older patients were lower than those in the younger population,” they concluded.

One dose is enough

The research did not show a significant difference in vaccine effectiveness for one dose as compared with two doses.

That is a striking finding in light of the fact that many countries required two COVID jabs, even among recovered people, after a certain interval of time, to gain access to COVID vaccine passes that facilitated entry to leisure sites and travel. Though in Israel, there was a one shot recommendation at the time of the study, and to date, people who have recovered and have received only one vaccine dose before or after recovery are eligible for the pass.

“If you recovered from COVID-19, it is like you got a primary vaccination,” said Dr. Ronen Arbel, the senior researcher and the head of the Maximizing Health Outcomes Research Lab at Sapir Academic College. “It would be best to get vaccinated to boost the infection-induced immunity, but one shot is enough.”

Image Credits: Maccabi Health Services.

noise pollution
Ho Chi Minh City street traffic. The city is one of many that have surpassed acceptable noise levels.

Urban noise pollution, wildfires, and disruptions of life cycles in natural systems are all growing environmental problems with ecological consequences that require greater attention, according to the new Frontier Report published Thursday by the UN Environment Programme (UNEP). 

The fourth edition of the report, ‘Noises, Blazes and Mismatches: Emerging Issues of Environmental Concern’, was released days before the resumed fifth session of the UN Environment Assembly (UNEA), to start on 28 February – 2 March. 

The report was first published in 2016 with an alert to the growing risk of zoonotic diseases, four years before the outbreak of the COVID-19 pandemic. 

“The Frontiers Report identifies and offers solutions to three environmental issues that merit attention and action from governments and the public at large,” said UNEP Executive Director Inger Andersen. 

“Urban noise pollution, wildfires and phenological shifts – the three topics of this Frontiers report – are issues that highlight the urgent need to address the triple planetary crisis of climate change, pollution and biodiversity loss.”

Urban noise pollution is a growing public health menace 

Algiers is another city where the noise levels have surpassed acceptable levels.

Acceptable noise levels have been surpassed worldwide – in Algiers, Bangkok, Damascus, Dhaka, Ho Chi Minh City, Islamabad, and New York, and more. 

Additionally, one in five EU citizens are affected by the growing public health menace of noise pollution, which already contributes 12,000 premature deaths and almost 50,000 new cases of ischemic heart disease  each year in the European Union. 

Unwanted, prolonged and high-level sounds from road traffic, railways, or leisure activities impair human health and wellbeing – with issues including chronic annoyance and sleep disturbance. This can result in severe heart diseases and metabolic disorders such as diabetes, hearing impairment, and poorer mental health. 

Most vulnerable to noise pollution are the very young and the elderly, as well as marginalized communities near high traffic roads and industrial areas, and those far from green spaces. 

It is also a threat to animals, altering the communication and behavior of various species of birds, insects, and amphibians. 

The Frontiers report has called for urban planners to reduce noise at the source; invest in alternative mobility; and create urban infrastructure that creates positive soundscapes such as tree belts, green walls, green roofs, and more green spaces overall in cities.  

Positive examples include London’s Ultra-Low Emission Zone, Berlin’s new cycle lanes on wide roads, and Egypt’s national plan to combat noise. 

Climate change disrupts natural rhythms in plants and animals 

The monarch butterfly’s migration is delayed as a result of climate change, impacting its natural rhythm.

Climate change has increasingly pushed plants and animals out of sync with their natural rhythms, causing interacting species to work off-balanced with each other, or no longer at the same rate. 

Plants and animals in terrestrial, aquatic, and marine ecosystems use temperature, day-length, or rainfall as cues for when to unfold leaves or flower, bear fruit, breed, nestle, pollinate, or transform in other ways. Phenology is the timing of these recurring life cycle stages that are driven by environmental forces and interacting species in ecosystems. 

However, as a result of climate change, these timings are becoming increasingly disrupted, such as when plants shift life cycles faster than the herbivores that consume them. 

Long-distance migratory species are particularly vulnerable to phenological changes, as climate cues that trigger migration may no longer accurately predict the conditions at their destination and resting sites along the way. 

For example, the 6-day delayed migration of the Eastern Monarch butterfly has impacted their breeding and access to food, and the resilience of the overall species is weakened as a result, impacting other parts of an interconnected ecosystem. 

Crops and commercially important marine species may also shift in their natural rhythms, creating additional challenges for food production that already occur as a result of climate change and COVID-19. 

The report proposes further research be conducted to understand the implications of these phenological mismatches, as well as maintaining suitable habitats and ecological connectivity, strengthening biological diversity, and above all, limiting the rate of global warming by reducing CO2 emissions.

Chief UNEP Scientist Andrea Hinwood

  

“All governments and all countries need to consider their environmental impacts and they all certainly need to consider the multiple health activities which impact ecosystems and biodiversity and subsequently health,” said Chief UNEP Scientist Andrea Hinwood during a launch of the report.

“All of the actions that will make a difference in terms of protecting the resilience of our ecosystems ultimately protect us because we’re protecting against climate change.”

Wildfires projected to get worse 

Forest wildfires have gotten worse in recent years, with climate change prompting hotter temperatures and drier conditions.

Dangerous wildfire weather conditions are projected to become more frequent, more intense, and more severe, including in areas previously affected by fires. 

This is the result of climate change, including hotter temperatures and drier conditions with more frequent droughts. Intense wildfires can trigger thunderstorms in smoke flumes, generating lightning that ignites other fires beyond the original fire – a hazardous feedback loop.

Already an average of about 423 million hectares or 4.23 million square km of the Earth’s land surface – an area about the size of the entire European Union – has burned each year, between 2002 and 2016. 

In addition, an estimated 67% of annual global area burned by all types of fires, including wildfires, was on the African continent. 

Long-term effects on human health extend beyond those fighting wildfires, evacuated, or suffering losses. 

Downwind settlements, sometimes thousands of kilometers from the source, are still vulnerable to health consequences from fires, especially those with pre-existing illnesses, women, children, elderly and the poor.

Maarten Kappelle, Head of Thematic Assessments at UNEP

The report calls for greater investment in reducing the risks of wildfires; development of prevention and response management approaches to wildfires that address vulnerable, rural, traditional, and indigenous communities; and further refinements in remote sensing, including satellites, radar, and lightning detection. 

“To manage wildfires more successfully, we must take measures that would prevent them from becoming uncontrollable,” said Maarten Kappelle, Head of Thematic Assessments at UNEP.

Image Credits: tph567/Flickr, hyde/Flickr, Paul VanDerWerf/Flickr, UNEP, Project LM/Flickr.

Charles Michel, President of the European Council

European Union President Charles Michel congratulated African countries for their efforts to stimulate more vaccine manufacturing capacity on the continent, in a upbeat opening address at the European Union-African Union Summit, which began Thursday.  

But in a more sobering note Wednesday, Stella Kyriakides, the European Commissioner for Health and Food Safety, called on global health players to prioritize preparations for the next pandemic. 

“The pandemic has been a challenge for all of us. For our citizens, for our societies,” Michel said in his opening remarks at the Summit in Brussels. “It opened our eyes and showed us our strengths, our weaknesses, our successes, our failures.”

European Union-African Union Summit opens, 17 Feb 2022

Against those challenges, he lauded the recent AU moves on achieving more vaccine self-sufficiency:  

“We have to look at what you have been doing in the African Union. In less than a year, you launched the manufacture of four vaccines to reduce pharmaceutical dependence on the African continent. And this is a project you devised for Africans, by Africans. Vaccine production capacity has been set up in South Africa, Senegal and Rwanda.” 

“For us as Europeans, we should be looking at a new way of working, of cooperating with you.” 

Michel was referring to BioNTech’s announcement Wednesday that it would set up modular “BioNTainer” vaccine production facilities in Rwanda and Senegal by mid-2022. 

That, in addition to South Africa’s production of the J&J vaccine, and a new WHO-backed mRNA vaccine hub in South Africa, which was the focus of a high-level WHO visit last week. 

In its gala event in Marburg, Germany on Wednesday, BioNTech executives said they will ship the plug-and-play vaccine facilities to Rwanda and Senegal in 2 modules of six standard freight containers, by mid-2022. 

The BioNTech announcement has been praised by leading African Union figures, including Africa CDC’s John Nkengasong and special envoy Michel Sidibé.

South Africa’s dilemma

But not everyone may be as delighted about the BioNTech initiative.   

Although South Africa was explicitly mentioned as a third “possible” participant in a BioNTech press release – President Cyril Ramaphosa was noticeably absent from the stage of Wednesday’s launch in Marburg – which featured the heads of state of Senegal, Rwanda and Ghana – alongside WHO and Africa CDC.  

Entering the Brussel’s summit on Thursday, Ramaphosa told reporters that he remains interested in pushing ahead on discussions about a temporary waiver of intellectual property restrictions on  COVID-19 vaccine production.

“We are going to discuss the TRIPS waiver,” he shouted back to a press pool – in reference to the hotly-debated waiver that has been sitting before the World Trade Organization TRIPS for over a year now. 

‘Not yet’ convinced by Europe’s moves

While Ramaphosa acknowledged that Europe had stepped up its vaccine donations, he said that  he was “not yet” convinced by the European moves. 

“We need to move through the TRIPS dispensation where we can make our own vaccines, and that will be very important,” said the South African leader who has placed his vaccine production bets on a new WHO-supported mRNA vaccine technology transfer hub, that would develop open-access brands of mRNA vaccines for not only COVID, but other diseases. 

That hub is centered around a group of Cape Town research and manufacturing institutions. 

But some of the hub’s success will depend on how easily it can navigate around existing patent rules on some cutting edge products, like mRNA COVID vaccines. 

Meanwhile, the TRIPS waiver has been staunchly opposed by leading EU countries, such as Germany, as well as by pharma groups that say bilateral deals between country and the private sector are a more stable basis for sustainable expansion of production capacity.  

Invest in health systems – prepare for the future 

Stella Kyriakides, the European Commissioner for Health and Food Safety

Speaking Wednesday on the eve of the Summit at the 7th EU-Africa Business Forum 2022, Kyriakides stressed that governments need to invest now in measures that can help prepare for future threats, which are sure to come. 

“We must not wait and be complacent. But we need to prepare today for future health emergencies,” Kyriakides said.

Kyriakides noted that while on its part, the EU has been introducing reforms to strengthen a “European Health Union”, the pandemic has expanded awareness that regional preparedness is no longer sufficient.  

 “In order for us to be truly prepared for emerging health threats, we need to be prepared globally,” she said.

In a related move, the European Investment Bank also pledged Thursday to commit some €500 million to a joint WHO-EU initiative strengthening African health systems on the continent.  Most countries continue to fall far short of the longstanding Abuja Declaration to allocate 15% of national government spending on health – and the pandemic has created further setbacks.

Partnering with the African Union 

Against that context, the EU wants to partner more with the African Union on challenges highlighted by the pandemic, such as the need to reinforce global disease surveillance, and building capacity to undertake emergency countermeasures. 

She also pledged the EU’s readiness to assist in building up preparedness by supporting the African Medicines Agency (AMA) and the African Preparedness and Response Authority (APRA). 

She called for the diversification of international supply chains and the resolution of bottlenecks in addition to the expansion of global production of vaccines and therapeutics. 

“Team Europe”, which includes the EU, EU Member states and European financial institutions, is supporting Africa in this regard with more than €1 billion to create an enabling environment for African vaccine manufacturing, and to tackle barriers related to supply chains and demand, she noted.

She also highlighted that the ongoing partnership between the European Centre for Disease Prevention and Control (ECDC) and the Africa CDC is resulting in mutual learning and improved health security for everyone.

The COVID-19 pandemic has also strengthened the mandate of the ECDC so it will be able to support epidemic and outbreak responses, and establish a more structured cooperation with public health actors in Africa.

Pledging the EU’s contined support for the AMA, she described its creation as a crucial moment in Africa’s journey towards a strengthened regulatory system, which will ultimately contribute to the promotion of sovereignty in Africa.

The COVID-19 pandemic has highlighted the need to build healthier, more resilient and more equitable societies, Kyriakides also underlined. But to achieve this, a number of ingredients are essential: 

“They include the availability of vaccines and therapeutics, but also innovation, data and information sharing. And equally important are the sustainable and locally led development as well as a reformed Global Health architecture. The key ingredient though, are partnerships, trusted and effective collaboration, which needs to be based on the exchange of ideas of experiences and perspectives,” she concluded. 

Summit – focus on health systems and vaccine production 

Health is just one of about eight themes of focus at the two-day Summit – along with education, agriculture, climate change, finance and global governance. 

But in the wake of the destabilization created by the pandemic it clearly has even greater importance to participants now – in comparison with past years. 

The EU and AU leaders also are meeting against the backdrop of high regional geopolitical tensions – posed by the continuing threat of a Russian invasion of Ukraine.

A Summit press briefing reaffirmed the prior EU commitment to provide 700 million vaccine doses by mid-2022 to developing countries, of which at least 450 million would go to Africa. 

“Team Europe has exported more than half of its production since the crisis began; it supported the creation of ACT-A [the WHO-supported Act Accelerator] which has delivered more than one billion doses (including 350 million vaccines for Africa). And European countries have shared doses destined for their own citizens, including 125 million to African countries where it is the principal donor.” 

Emmanuel Macron, President of France

Along with Charles Michel, the Summit is being hosted by the President of the European Commission, Ursula von der Leyen and French President Emmanual Macron, whose country currently holds the rotating presidency of the EU Council. 

In his keynote remarks before the Summit, Macron also reaffirmed the need to support African health systems, wrought by the COVID-19 pandemic.

“The COVID-19 pandemic has thrown all of our agenda into the air. It’s been more difficult for African countries to deal with COVID because it is a health, economic and social crisis which has been brought to bare on more fragile economies which are on the verge of development, making it even more costly. African budgets do not have the ability to absorb these shocks as ours do,” said the French president.

european investment bank
WHO DG Tedros Adhanom Ghebreyesus and EIB President Werner Hoyer.

The European Investment Bank said Thursday that it would commit €500 million to improving African health systems, as part of a new initiative with the World Health Organization and the European Union.

The joint EIB-WHO-EU statement coincided with the start of an EU-African Union Summit, which is set to talk about how to improve health systems in Africa, as well as stepping up vaccine production.

While there have been some recent, big strides to jump-start more African vaccine manufacturing and related R&D, including in the WHO-supported South African mRNA hub and a BioNTech modular vaccine manufacturing initiative, announced only yesterday (hyperlink please to those two stories), much less attention has been focused on health systems, which are the backbone for service delivery.

And recent data suggests that African health systems, like others worldwide, continue to suffer setbacks in delivery of other routine services, due to the pandemic.

That, along with being chronically underfinanced – with most countries far from the Abuja goal of investing 15% of GDP in health services.  Only two countries – Rwanda and South Africa – had reached the 15% target in 2011, while seven had actually reduced their health budgets proportionate to their national budgets.

The situation had deteriorated further in 2016, with 19 African countries spending less on health as a percentage of their public spending than in the early 2000s. According to the 2016 WHO report, countries with high per capita income such as Algeria, Botswana, South Africa, and Seychelles, do not systematically spend more of their budgets on health, while lower income countries such as Ethiopia, Gambia, and Malawi – have in fact surpassed the 15% goal.

The new initiative aims to address both the pandemic-related and more systematic issues, said a WHO press statement on the EIB investment.

It noted that the investments would be focused on “restoring, expanding and sustaining access to essential health services and increasing financial risk protection; access to vaccines, medicines, diagnostics, devices and other health products; scaling innovative primary health care service delivery models and investing in a health workforce to deliver effective quality care.

“The shared goals of the partnership will achieved by applying a country-led and country-driven approach, identifying gaps in national health systems, designing strategies for interventions and their corresponding investments plans, investing in health system projects and programmes, convening capital providers, supporting implementation and monitoring impact,” said WHO.

EIB President Werner Hoyer, said that the goal of the initiative is to mobilize €1 billion of new investment “to strengthen public health across Africa.”

Said WHO Director General Dr Tedros Adhanom Ghebreyesus: “The COVID-19 pandemic is a powerful demonstration that when health is at risk, everything is at risk. Investing in health across Africa is therefore essential not just to promote and protect health, but also as a foundation for lifting people out of poverty and driving inclusive economic growth.”

Image Credits: EIB/Twitter.