A quiet street in Cape Town, South Africa, during one of the hard lockdown periods of 2020, which helped curb the spread of COVID-19 last year.

A “terrible third wave” of the COVID-19 pandemic is now hitting Africa in full force – with about 20 of the continent’s 54 countries experiencing particularly sharp rises in new infections, African Centers for Disease Control director, John Nkengasong told Health Policy Watch at a press briefing on Thursday. 

Per-capita rates of new SARS-CoV2 cases in South Africa and Tunisia now outstrip those in the United Kingdom – and spiralling 5-6 times higher than those in the United States and India. 

Although the continent-wide average is still only about 27 new cases per million, below the current US average, (34/million), the increases seen are prompting worries that Africa could even become a new global epicentre for the pandemic. That after nearly a year when it managed to maintain comparatively low case counts. 

Daily new cases per million people in Tunisia and South Africa are now running at nearly 200 infections/million. In comparison, in the United Kingdom new cases now stand at 149/million and in hard-hit India at 40 per million, over the last week. 

The new wave has already stretched several health systems on the continent beyond their limits,  Nkengasong said.

“This is the first time that we are seeing countries report that their health systems are completely overwhelmed,” he said.

Zambia, Uganda & DRC 

In Zambia, daily new infections are averaging 138/million the highest ever recorded since the pandemic was declared.  That, in turn, is biting health systems hard, Nkengasong said.

According to the latest figures, on June 23, the country reported 3,367 new cases of COVID-19 over the past 24 hours – the highest number of daily reported cases yet in the country. It was also nearly double the number of cases (1,796) reported on 16 January 2021 when the country reached the peak of its second wave.

Nkengasong revealed that aside from the already dispatched commodities, Africa CDC will also be sending a team of experts to Zambia to help the country cope with the third wave. “They are completely overwhelmed,” he  said.

The health systems of Uganda and the Democratic Republic of Congo are facing similar crises, he added. 

In conflict-ridden DRC, meanwhile, the lack of strong systems for COVID testing and case reporting may also be keeping the numbers artificially low, inside observers told Health Policy Watch.

DRC has also been one of the most vaccine hesitant countries – turning back a large shipment of COVAX vaccines that it received to Africa CDC in April because it did not have the means to administer the doses. Even among the country’s large presence of UN forces and support teams, who have ready access to dedicated vaccine donations from India, vaccinations have progressed at painfully slow rates, observers told Health Policy Watch.  

Steepest COVID-19 Surge Yet — WHO

WHO Regional Director for Africa Dr Matshidiso Moeti believes Afric can still blunt the impact of the currently fast-rising infection wave if precaution is taken against transmitting the virus.

At a separate WHO briefing, WHO Regional Director for  Africa Matshidiso Moeti described the third wave as the pandemic’s steepest surge yet continent-wide.

According to WHO’s data, the number of cases have risen for five consecutive weeks since 3 May. 

As of 20 June—day 48 into the new wave—Africa had recorded around 474 000 new cases—a 21% higher rate as compared with the first 48 days of the second wave. At the current rate of infections, the ongoing surge is set to surpass the previous one by early July, WHO stated.  

“With rapidly rising case numbers and increasing reports of serious illness, the latest surge threatens to be Africa’s worst yet,” Moeti warned.

But even though the window of opportunity may be closing, she noted that Africa can still blunt the impact of the currently fast-rising infections. 

“Everyone everywhere can do their bit by taking precautions to prevent transmission,” she said. For instance, after Uganda slapped on new restrictions last week, new cases there appeared to be plateauing. 

Vaccine Supplies May Not Arrive In Time 

Africa CDC director Dr John Nkengasong

Despite promises of hundreds of millions of doses from different partners, including the United States government, the timeline for the delivery of the doses may not see their arrival in time to really help African countries combat the third wave, both WHO and Africa CDC officials warned.

Globally, of the 2.7 billion vaccine doses administered, under 1.5% have been in the arms of Africans.

According to the Africa CDC, 61.4 million COVID-19 vaccine doses have been received so far  by 51 African member states out of which 48.6 million doses have been administered (79.52%). So far, only 1.12% of the African population has been fully vaccinated.

Most of those supplies were received in March & April this year through the WHO co-sponsored COVAX vaccine facility – before COVAX supplies produced by the Serum Institute of India dried up as a result of India’s COVID infection spike.

“Cases are outpacing vaccination, leaving more people exposed. Now we need international solidarity and innovation to increase our supply,” Moeti said.

Nkengasong agreed: “What we need is rapid access to vaccines to member states. It is extremely frightening to look at the graphs from some African countries. We just really need vaccines to get into people’s arms very quickly.”

Without any intentional actions to speed up vaccine dose supply to Africa, Nkengasong said member states may have to wait until August when doses are expected to start becoming available through African Union’s COVID-19 Africa Vaccine Acquisition Task Team (AVATT).

Delta Variant Spreading Across Africa

WHO and Africa CDC also called attention to the rapid spread of the Delta variant of the virus that was first reported in India, across the African continent. 

The Delta variant, has already been reported in 14 countries in Africa, rapidly catching up with other variants, Moeti said.

“In the Democratic Republic of the Congo and Uganda that are experiencing COVID-19 resurgence, the Delta variant has been detected in most samples sequenced in the past month,” she noted. 

“We have seen that variant really aggressively taking over from other variants, not just in Uganda, but in other countries like the DRC,” Nkengasong added. 

In addition, the Beta variant which was first identified in South Africa, has since been reported in 29 African countries.  And the Alpha variant that was first reported in the UK and is now being reported in 30 African countries, according to the Africa CDC.

WHO said it is taking steps towards expanding the capabilities of various African countries to track the spread and evolution of the virus in order to guide epidemiological decisions.

“We are supporting South Africa-based regional laboratories to monitor variants of concern,”  Moeti said. “WHO is also boosting innovative technological support to other laboratories in the region without sequencing capacities to better monitor the evolution of the virus. In the next six months, WHO is aiming for an eight- to ten-fold increase in the samples sequenced each month in Southern African countries.”

Dr Rifaat Safadi, director of the Liver Unit at Hadassah Hebrew University Medical Center, in Jerusalem, Israel.

Patients who had liver transplants or those with advanced liver fibrosis may not be adequately protected against COVID-19 after two doses of the Pfizer-BioNTech vaccine, in light of the findings of a new study presented Wednesday on the opening day of the International Liver Congress(ILC) 2021.

Presenting abstracts from the soon-to-be-released study on Wednesday, Dr Rifaat Safadi, director of the Liver Unit at Hadassah Hebrew University Medical Center, in Jerusalem, Israel, said the study suggests that such patients with low levels of antibodies to the SARS-CoV-2 virus should get a third booster Pfizer shot to increase their chances of protection against the virus.

The global virtual conference, convened by the European Association for the Study of the Liver (EASL), is taking place Wednesday – Saturday.  This year’s conference brings together leading liver disease researchers from around the world to explore new science around the prevention and treatment of liver disease caused by Hepatitis C, alcohol abuse and other risk factors, as well as the  impact of the COVID-19 pandemic on people living with liver diseases and on liver disease medications.

This year’s conference proceedings are highlighting the extreme vulnerability of people with liver disease to COVID – with one new study finding the chronic liver disease increased the odds of COVID-19 death by  80%.

On the more positive side, another study however, found that the antiretroviral drug, tenofovir, prevented serious COVID-19 illness amongst people living with chronic Hepatitis B.

Research on the impact of COVID-19 on alcohol-related liver disease is also being showcased at this year’s conference session, along with new or improved treatments for people suffering from HCV. 

“We are beginning to understand  more clearly just how disproportionately COVID-19 is impacting on people living with liver-related diseases and the studies presented at  ILC 2021 advance  our knowledge on multiple fronts, knowledge that can potentially help inform policy responses to the  pandemic going forward,” said Philip Newsome, General  Secretary of EASL and Director of the Centre for Liver Research at the University of Birmingham in the UK, at Wednesday’s opening session. 

Pfizer-BioNTech Vaccine Offers Low Immunity for People with Advanced Liver Disease

Data from an Israeli study found that patients with advanced liver fibrosis may not be adequately protected against COVID-19 after two doses of the Pfizer-BioNTech vaccine.

With regards to the Pfizer vaccine on patients with liver disease, Safadi, who will present the full results of the Israeli study on Saturday, explained that “older age”, advanced fibrosis and decreased steatosis appear to be risk factors for lower vaccine response among people with related forms of liver disease.

The study analysed data from 88 patients living with hepatic fibrosis who had tested positive for COVID-19  and who had received both doses of Pfizer’s-BioNTech vaccine.

It found that elderly patients with advanced liver fibrosis had a lower response to Pfizer’s vaccine, with Safadi suggesting that those patients may need a third booster shot.

“Therefore, we have to think about the booster vaccination… we are thinking now about boosting the third shot, especially those with high risk for non responsiveness or lower response,” said Safadi.

The study’s recommendation, however, goes beyond current US Food and Drug Administration (FDA) recommendations.  The FDA has so far not recommended the use of  antibody tests to check the effectiveness of vaccination against the virus, nor has it  approved a three-dose regimen or booster of any SARS-CoV-2 vaccine.

Tenofovir Reduces Severity of COVID-19 in Patients with Chronic Hepatitis B  

Encouraging data from another new study found that antiretroviral drug, tenofovir, prevented serious COVID-19 illness amongst people living with chronic Hepatitis B.

A study conducted in Spain found that antiretrovira drug tenofovir reduced the severity of COVID-19 in patients with chronic Hepatitis B.

Beatriz Mateos Muñoz, PhD Specialist in Gastroenterology and Hepatology at the Hospital Universitario Ramón in Spain, said the study analysed data from 4736 patients from 28 Spanish hospitals. 

Of the 117 COVID-19 positive patients who were identified, 67  were taking  tenofovir  and 50 were on entecavir, an antiviral drug in the treatment of hepatitis B virus infection.  Muñoz said the incidence of COVID-19 in patients on tenofovir or entecavir were similar, but that patients on entecavir “more often had severe COVID-19, required ICU, ventilatory support, had longer hospitalization or died”.

The study found that tenofovir seemed to offer some protection in patients with chronic  hepatitis B infected by COVID-19.

“In multivariate logistic regression adjusted by age, sex, obesity, comorbidities and fibrosis stage, tenofovir reduced by 6-fold the risk of severe COVID-19. Patients with chronic  hepatitis B on tenofovir have a lower risk of severe COVID-19 infection than those on entecavir.”

COVID-19 Related Alcohol Sales May Have Increased Alcohol-related Liver Disease

Abdel-Aziz Shaheen, assistant professor at the Gastroenterology and Hepatology at the University of Calgary in Canada, said a large population-based study found a significant increase in the number of patients with alcoholic hepatitis who were hospitalised last year in Alberta, Canada  last year, with the highest admission rate recorded in April 2020.

Shaheen said a significant increase in alcohol sales across Europe and North America during the early months of the pandemic had alarming consequences for patients with alcoholic hepatitis. He said most of the newer patients with alcoholic hepatitis were younger and mainly from rural areas.

“There was a significant 9% increase in alcoholic hepatitis admissions per month between March and September and the average rate of alcoholic hepatitis hospitalizations compared to overall hospitalizations rate doubled from 11.6/ 10,000 general hospitalizations to 22.1/ 10,000 general hospitalizations for the same period,” said Shaheen.

More worrying, said Shaheen was that: “Our results show that the increase in alcohol sales post pandemic will significantly impact the natural history of alcoholic liver disease in Canada”. 

Chronic Liver Disease Increased the Odds of Covid-19 Death by 80%

Vincent Mallet, Managing Senior Physician and Professor, Hepatology Unit, Cochin University

Another study that used the French National Hospital Discharge database for patients who were hospitalised for COVID-19 found that chronic liver disease increased the odds of COVID-19 death by  80%.

Vincent Mallet, Managing Senior Physician and Professor, Hepatology Unit, Cochin University said the hospital records showed that  3, 943 of the 16,338 patients diagnosed with chronic liver disease who were admitted for Covid-19 in France in 2020 died, including 2518 after liver-related complications.

He said liver complications and alcohol use disorders may have contributed to the COVID-19 deaths of patients with chronic liver disease.

People with Obesity & Diabetes Related Fatty Liver Disease Also at Higher Risk from COVID-19

Similarly, a small study in Mexico of 348 patients found that people living with Metabolic Associated  Fatty Liver Disease (MAFLD) were five times more likely to die during hospitalization for COVID-19 than people without these factors.  

The patients studied were admitted with the SARS-COV-2 infection to a number of  tertiary referral hospitals between 4 April and 24 June 2020, said Martin Uriel Vázquez Medina, Researcher at the Laboratory of Biomathematical and Biostatistical Modelling for Health Escuela Superior de Medicina, México. 

Major risk factors for the chronic conditions are obesity and type-2 diabetes, common conditions in many parts of Latin America, also closely associated with unhealthy diets, including high sugar consumption, and lack of physical activity. 

Medina added: “We also want to show with this result that [patients in] Latin American countries that have this overhead problem of obesity, diabetes, and pre-diabetes, could also be associated with increased risk from COVID-19”.

The ILC continues until Saturday.

The African Medicines Agency’s framework would help combat falsified products and by ensuring harmonized drug standards and approvals, ease access to more affordable medicines and vaccines for people throughout the continent.

Michel Sidibé, Special Envoy of the African Union and Minister of Health of Mali has high hopes that 15 African countries will have finally ratified the African Medicines Agency (AMA) Treaty in time for the 35th African Union (AU) Summit, scheduled for early 2022.

Fifteen is the magic number of countries that must ratify the treaty creating the AMA – in order to birth the agency into operational existence.

By the time of the summit, Sidibé also predicts that 30 or more countries will also have signed the framework agreement on the creation of the agency – an agreement that was first approved by the African Union in February 2019. He was speaking at a virtual session on Tuesday,

From civil society to the pharma industry, establishment of the continent-wide AMA is regarded as an important step forward that would help improve the functioning of national medicines regulatory agencies – combating fake medicines and streamlining approval of new medicines and vaccines. That, in turn, should also help reduce prices and boost access for people throughout the continent, observers predict.  

Snail Speed Pace of Ratification So Far

However, snail-speed ratification of the treaty by the legislatures and parliaments of the AU’s 54 member states has become a major hurdle to actually opening the doors of the new agency. This is despite the strong support displayed by global health actors actors ranging from the World Health Organization, Africa Centres for Disease Control, as well as other regional drug regulatory agencies such as the European Medicines Authority.  

However, Sidibé said he is confident the new agency, once it finally begins operations, can build upon the continent’s existing  expertise in pharmacovigilance – developed by  national agencies  such as the Moroccan agency for medicines and the Nigerian Agency for Foods, Drugs Administration and Control (NAFDAC).

As for concerns regarding the slow pace of country approvals of the framework agreement and formal ratification, Sidibé said the plan has been to first target a balance of countries in diverse African regions as “low-hanging fruit” – followed by others. In fact, so far most of the countries signing and then ratifying the agreemeht have been West African and/or Francophone.  But as the critical mass of ratifications is approached, momentum elsewhere is also building.   

“Our strategy was to go for different regional balances… , to make sure that we can have a low hanging fruit so we can get quickly the 15 countries,” he said. “Now we are almost there. I am sure by the next meeting of the African Union, we can come and present to the leaders that we managed to have 15 countries,” he said, adding that the priority is to ensure that all African countries are soon on board.

Getting buy-in from all African countries will involve actively engaging with governments that are yet to sign and/or ratify the treaty, one by one. Top countries earmarked now for the next stage include north and west African regional leaders such as Ethiopia and Nigeria, as well as the Democratic Republic of Congo.

“We are learning from different experiences and ensuring that we are not losing time. We are making sure we bring different partners together to implement the agenda quickly,” Sidibé  added.

The Long Road to Ratification

In October 2020  Health Policy Watch reported that only 18 of Africa’s 55 countries had signed the framework agreement to establish the agency, while only 5 countries – Rwanda, Mali, Burkina Faso, Ghana and Seychelles –  had actually ratified the agreement.

At the time, Africa CDC Director John Nkengasong,  told Health Policy Watch the delay in the treaty ratification was due to the COVID-19 pandemic.

“I don’t think it is because countries do not want to sign on. I think it is because of the process that is required to make them sign that treaty, and the countries are currently focusing more on COVID-19,” said Nkengasong. “I think it’s a much needed institution. If we had the AMA, it would be working very closely with the WHO and other bodies to facilitate regulatory issues on drugs to help control the COVID-19 pandemic.”

Since then,  Zimbabwe and the Seychelles have signed the AMA framework treaty, raising the total number of signatories to 20.  Guinea, Namibia and Sierra Leone have ratified the treaty, followed by Algeria this month, raising the number of countries that have fully completed the two-step approval process to nine.

In order to get across the finish line, a new  African Medicines Agency Treaty Alliance (AMATA) has also recently been created, said Kawaldip Sehmi of the International Alliance of Patients Organizations (IAPO), at Tuesday’s session.  The Alliance, led by IAPO and including patient groups, researchers and academics, and industry, will advocate for rapid AMA ratification continent wide. It will also work to establish meaningful engagement with patients, industry and other relevant parties once the Agency becomes operational.

The WHO is also actively supporting the emergence of the AMA, with its Director-General, Dr Tedros Adhanom Ghebreyesus describing the lack of strong national regulatory systems as “one of the biggest obstacles to improving access to medical products in Africa”.

WHO Regional Director in Africa, Dr Matshidiso Moeti, has also reiterated the importance of the agency, telling Health Policy Watch: “AMA is a very important platform for medicines to be available and affordable equitably, and to be of good quality so that we have both good outcomes for the money that people and countries are spending, and that we prevent problems.” 

Other Benefits – International Partnerships and Support for Local Production

The AMA will also help strengthen global collaborations, including participation of African researchers and patients in clinical research trials of new medicines, especially in the area of cancer, said Emer Cooke, Executive Director of the European Medicines Agency, speaking at Tuesday’s event. 

“We’re already collaborating with a number of initiatives on clinical trials with African regulators, particularly in the context of the African Vaccines Regulatory Forum. We can use forums such as this to build on the collaborative activities that take place to share our experiences and to help us to work on training and capacity building initiatives,” Cooke said.

“I think we should be heartened by the fact that there’s already good discussion and collaboration in the context of clinical trials.”

Fighting Fake Medicines

Meanwhile, Lotfi Benbahmed, minister of the pharmaceutical industry of Algeria, said the AMA can help improve the reliability of Africa’s medicines — a feat that he said requires the existence of a regional framework to fight fake drugs.

“So what we need to do is to harmonise rules and regulations, and enable countries to fight the illegal markets, and the informal markets,” Benbahmed said, who spoke alongside other African ministers of health from Algeria, the Democratic Republic of Congo, Egypt and Cape Verde. .

According to him, a similar framework can be deployed to tackle the challenge of low quality drugs on the continent from the point of production, including setting up measures to inspect and control equipment in laboratories. 

At the same time, delays being encountered in the finalisation of the agency are “understandable”, said Dr Margareth Ndomondo-Sigonda, African Union Development Agency-New Partnership for Africa’s Development (AUDA-NEPAD), who highlighted the  extensive harmonisation processes that needs to be undertaken between national governments to birth the new agency.

“It takes time to get to the point where you’ve achieved regulatory harmonisation of African medicines and harmonization of regulatory standards. You have to make sure that through harmonization of these technical requirements, you know the quality standards and practice and  you build trust,”  Ndomondo-Sigonda said.

She was however hopeful that once AMA comes into force,  it will be able to deal with many outstanding issues regarding the harmonisation of Africa’s medicines landscape.

Image Credits: Marco Verch/Flickr.

Launch of the AMR Preparedness Index Panel – left to right – James Anderson, Susan Schwarz, Neil Clancy, Anand Anandkumar, Christine Ardal, Mike Hodin, Norio Ohmagari, Tiemo Wolken

Government action against the threat of “superbugs” in most of the world’s leading economies gets a score of less than 50%, according to a new AMR Preparedness Index, released today by a global coalition committed to fighting current trends. 

Great Britain, the United States, Germany and France rated highest on a score of 1-100 in an assessment of responses in 11 of the world’s leading economies to antimicrobial resistance (AMR) threats.  

Meanwhile, emerging economies such as Brazil, China, and India scored the worst in the assessment that looked at national strategy; awareness and prevention; innovation; access; appropriate and responsible use; AMR and the environment; and collaborative engagement. 

The index was launched today by the Global Coalition on Aging (GCOA) and the Infectious Diseases Society of America (IDSA), to shine more light on how the governments are living up to their commitments to address antimicrobial resistance (AMR). 

“We need health systems and policymakers to really step up and advocate that federal, state, and local governments prioritize AMR,” said Neil Clancy of the AMR Committee, Infectious Disease Society of America, during an event Wednesday launching the Index.

“Without significant national and global coordination and multi-party interventions in this area, our efforts are not going to succeed.”

action
The AMR Preparedness Index ranked 11 countries across 7 categories in a 1-100 point scale.

UN Report Warns That AMR Could Cause As Many as 10 Million Deaths/ Year 

Livestock applications of antibiotics in metric tons/year, among countries reporting use. (The Antibiotic Footprint)

An estimated 700,000 people already die each year from drug-resistant infections and the lack of antimicrobials to treat them. A 2019 UN report warned that if trends are ignored, AMR could  cause as many as 10 million deaths per year, and GDP losses of more than US $100 trillion by 2050. 

The report assigns scores to each of the 11 countries across seven categories for needed and achievable policy action. 

Although the assessment considered national policies on “AMR and the Environment” it was unclear how heavily weighted that issue was in the overall index.  Per capita, the US agricultural industry is one of the heaviest users of antibiotics in the world. 

COVID-19 Is a Warning Light to Act Preemptively on AMR  

The cost of AMR action pales in comparison to the future costs of inaction, participants underlined, drawing comparisons with the COVID-19 pandemic. Delays in responding to urgent public health crises have deadly consequences.  

“If the pandemic has taught us one thing, it is that we are not well-prepared to combat the serious threat that emerging infectious diseases can pose to human health and our economies,” said Tiemo Wölken, member of the European Parliament, Germany. 

In Europe, AMR causes the annual death of 33,000 people and costs 1.5 billion Euros in regards to healthcare costs and productivity losses. 

COVID-19 has highlighted the need for increased monitoring tools, more improved detection, prevention, and control practices, said Wölken. 

“The time to act is now. COVID already put our healthcare systems under extreme pressure, and this could only be a foretaste of what we could expect from a world where antibiotic microbials are no longer effective.” 

All Countries Fail in Awareness & Prevention of AMR  

Testing for antimicrobial resistance at the Liverpool School of Tropical Science.

The analysis identified critical opportunities for all governments to act upon to slow the growth of drug resistant bugs. 

“Despite the progress that’s being made and despite the good work being done in countries throughout the world, we need to do more,” said Clancy. 

Several trends have emerged from an analysis of the different indices that went into the combined score. 

All countries performed insufficiently with regards to awareness and prevention of AMR, with India lagging furthest behind. 

More developed countries tended to fare better in the appropriate and responsible use of existing antibiotics and other antimicrobial agents – as compared to developing country counterparts.  

Outside of the UK and US, most other countries performed poorly in assessments of the quality of national strategies, innovations, and collaboration.  

Innovation Important  

Training on standardized and harmonized surveillance methods for antimicrobial resistance in food animals in Southeast Asia

Innovation is another area that requires more significant action going forward, said James Anderson, Executive Director of Global Health at the International Federation of Pharmaceutical  Manufacturers and Associations (IFPMA).

“We do need to really drive pipelines. We do need investments in AMR.” 

In the fight against the borderless threat of drug resistance, the Index included key insights and guidance for governments to immediately prioritize in order to fulfill their commitments on AMR. 

Overall, the top-level priorities identified in the Index were to: Strengthen and fully implement national AMR strategies; and raise awareness of AMR and its consequences. 

Along with that, other key priorities were to: 

  • Bolster surveillance and leverage data across AMR efforts;
  • Enable a restructured antimicrobial marketplace to stimulate innovation;
  • Promote responsible and appropriate use of antibiotics;
  • Enable reliable and consistent access to needed and novel antimicrobials;
  • More effectively integrate the One Health Approach, including environmental concerns, into national strategies;
  • Better engage with other governments, third-party organizations, and advocacy groups 

Despite AMR being one of the top five global health challenges, as cited by the WHO, a large majority of the public remains unaware of their role. Local, national, and international efforts are needed in raising awareness and investment in AMR. 

“All of us have a stake in preserving antibiotics and assuring the development of new antibiotics,” said Clancy. 

Vaccinating Older Groups Against COVID – Can Help Fight AMR 

93-year-old Lebanese actor Salah Tizani, who falls into the elderly priority group, receives his first vaccine dose against COVID-19 in Beirut on Feb. 14, 2021.

In terms of the battle against COVID and AMR, the report underlines how vaccinating older adults can help fight overuse of antibiotics during the pandemic. 

That is because people who become seriously ill with COVID, are often given antibiotics preventively in order to ward off secondary infections.  Adequately vaccinating older populations against other infections such as pneumococcal pneumonia and tuberculosis, and even infections like influenza is also critical step to combatting AMR. 

In other ways, too, older adults have a key stake in fighting AMR, because they tend to be major consumers of health services, and also may be more vulnerable to drug resistant bacteria and viruses overall. 

“We are at a time now when the megatrend of aging is at the top of our agenda, not just the public health agenda but the economic and social agenda as well,” said GCOA CEO Michael Hodin. 

As the UN Decade of Healthy Aging was launched in January, AMR needs to be a central part of this initiative, applied not only to older people but to all of us for a healthy and active aging, Hodin added. 

Coordination and Collaboration Across Low- and Middle-income Countries and High-Income Countries  

Most countries examined in the report are not making adequate investments to combat the AMR threat, with the lack of commitment felt globally. Huge disparities in total public AMR research funding remains an issue across high, middle, and low-income countries.  

“We cannot afford to be only US-centric, or only LMIC centric. It takes a very globalized approach,” said Anand Anandkumar, Founder and CEO of Bugworks Research, India. 

Greater support and collaboration is necessary to increase capacity for AMR initiatives, such as monitoring and surveillance in many low and middle-income countries (LMICs). 

Consequently, high income countries must collect and provide more complete data to increase the robustness of international, regional, and domestic efforts.  

“Access and equity are global challenges and the central tilt to competitive AMR,” said Clancy. 

“[We need to ensure] that we get antibiotics and access to these drugs in an equitable fashion. We’re all at risk from AMR.” 

 

Image Credits: USAID Asia/Flickr, GC, antibioticfootprint.net, Flickr – UK Department for International Development, World Bank: Mohamed Azakir.

COVAX
COVAX vaccine deliveries in Africa – a much trumpeted solution to vaccine inequalities in troubled waters.

As the board of Gavi, The Vaccine Alliance is set to meet this Wednesday and Thursday, the COVAX global vaccine facility – a cornerstone of the global health sector response on vaccine access – is coming under increased fire for its shortcomings.

A bitter opinion piece by Médecins Sans Frontières, published today, has called for a “drastic change of model” in the global procurement mechanism “that was supposed to deliver COVID-19 vaccine equity.”

Co-launched by a range of partners, including WHO, the COVAX facility is legally administered by GAVI. What started out with a much-trumpeted bang of vaccine distributions across African nations has fizzled after the primary vaccine supplier, the Serum Institute of India, began redirecting its available COVID doses to domestic vaccine needs.

Massive commitments by rich countries for further vaccine sharing, made at the recent G-7 meeting, are supposed to be funnelled through COVAX. Yet most of those donations will likely only be realized in the latter part of 2021 or early 2022, leaving the current shortfalls over the summer, as Africa faces yet another COVID wave.

“COVAX is currently grossly behind on achieving its goals,” said MSF’s Katie Elder, senior vaccines policy advisor. “COVAX had aimed to provide 2 billion doses by the end of 2021, but so far has only distributed 88 million (the goal by the end of June was to distribute around 337 million). Less than half of one percent of total populations of COVAX countries have received at least a first dose of vaccine through COVAX.”

She blames the fundamental model of the facility – in which it has been forced to compete on the open market for COVID vaccines – which were still often subsidized by public and government players – for the failings.

Africa, Ethiopia
AstraZeneca vaccine doses are unloaded at Bole International Airport in Addis Ababa, Ethiopia.

Not Set Up to Succeed

“COVAX was not set up to succeed,” she said. “It was constructed to work within the current parameters of the pharmaceutical market, where you see how much money you can raise and then see what you can negotiate with industry for it. 

“Loud calls early in the pandemic to depart from a business as usual approach were ignored—pharmaceutical corporations developing vaccines received billions in government money without any strings attached, so were free to charge prices they chose and to sell to the highest bidder. Unsurprisingly, this led to the very same governments that had touted the importance of equity …. and the governments that Gavi spent so much time courting to join the COVAX Facility – ultimately pursuing national interests and securing the bulk of future promised vaccines.

“COVAX was left behind as wealthy governments secured their doses through bilateral deals with an industry that acted as expected: selling doses first to the buyers who could afford to pay the most.”

The net result now leaves the Gavi Board struggling with how to continue the participation of upper income countries in the facility at all.

“The fact that Gavi’s board is now reviewing the way in which wealthier countries (so called ‘Self-financing participants’) can continue to participate in the facility is in part a recognition that the set up does not work,” she added. “Allowing wealthy countries so much flexibility to decide how they join COVAX and how many vaccines they procure, has caused delays and undermined its objectives. A more equitable model would have encouraged regional leadership with decentralized methods of procurement at their core. In the future, we must support these regional initiatives that aim for self-sufficiency and self-determination.”

A Beautiful idea: How the COVAX has Fallen Short

To date, COVAX has distributed over 20 million doses to rich countries and 80 million doses to poorer countries.

The result has been an awkward legal situation for the facility which is still required to provide 20% of its doses for higher income countries – even though most have now met their vaccine needs and hoarded even more, notably Canada, which bought enough vaccine doses to cover its population four times over.

“The failure to entice wealthy countries to join COVAX in large numbers has left the managers of the facility in an awkward situation,” said global health journalist Ann Aanaiya Usher in a critique published by The Lancet.

“On one hand, not enough self-financing participants joined COVAX to give it the massive buying power that was hoped. On the other, even though COVAX is desperately short of vaccines, the facility is now contractually obliged to reserve one in five doses for a few rich countries, she said, adding that so far, COVAX has distributed 80 million doses to LMICs and over 20 million doses to high-income countries (HICs), including the UK and Canada.

She slams the COVAX facility for its “naive” set-up that failed to anticipate widespread vaccine nationalism that has locked up most of the vaccine doses that are available. 

“It was a beautiful idea, born out of solidarity”, Duke University’s Gavin Yamey was quoted as saying. “Unfortunately, it didn’t happen…Rich countries behaved worse than anyone’s worst nightmares.”

COVAX should have also diversified its portfolio earlier on, in anticipation of supply shortages that crippled the facility after India’s Serum Institute halted vaccine exports to fend off a tragic second wave on the subcontinent that has claimed the lives of almost 400,000 people.  

“Supply shortages should have been anticipated and ramping up supplies should have been baked into the design of COVAX from the start,” observed Georgetown University’s Lawrence Gostin.

He added, however, that it would be “literally impossible” to ramp up vaccine supplies without greater investments in manufacturing hubs in lower-income countries, as well as broad waiver on intellectual property rights to vaccine know-how. 

In its struggle to get rich countries to sign up, the COVAX facility’s offer to allow rich countries to choose which vaccines they would receive has also drawn widespread criticism for leading to “double standards” – which seemingly defy the very purpose of the facility, critics have said.

Facility Needs Equity Funds to Compete in the Marketplace

Even Gavi, the Vaccine Alliance, has acknowledged that its slow mobilization of resources has hampered its ability to quickly procure, and thus deliver as many doses as possible to those who need them most. 

“If we had secured financing earlier, then we could have locked in doses earlier, as opposed to the second half of this year when COVAX’s volume will start ramping up,” a Gavi spokesperson said. The spokesperson was referring to the fact that most of the funds to procure and distribute vaccines for the 92 low- and middle-income countries (LMICs) that signed up for the scheme were pledged in late December or early 2021 – after high-income countries had already snapped up large vaccine pre-orders.   

That is a point of view shared by some independent observers as well as industry leaders, who maintain that the facility needs fine-tuning for the next pandemic. 

“Had COVAX had sufficient and readily available early funding it would have been better able to secure enough immediate supply to meet its aim,” said the Independent Panel for Pandemic Preparedness said, which reviewed the global pandemic response, under a mandate from the World Health Organization. 

Going forward, what COVAX needs is a “pot of money” to be able to pre-order vaccine doses earlier on in a global health emergency, said Thomas Cueni, director general of the International Federation of Pharmaceutical Manufacturers and Associations, in a recent Q&A with Health Policy Watch. That, he maintains, would allow the global facility to compete on a more equal footing with rich countries in the vaccines marketplace.  

Added Peter Hotez, a prominent vaccine scientist and dean at Baylor College of Medicine in Texas: “I think it’s important that we don’t sell COVAX short.  It still has a lot going for it, and is innovative in its design. But it needs more vaccines to share,”

Asked for comment by Health Policy Watch, GAVI did not respond.

Image Credits: UNICEF, WHO, WHO.

A new initiative by UNESCO and WHO aims to promote healthier school environments for all learners.

A new initiative by the United Nations Educational, Scientific and Cultural Organization (UNESCO) and the World Health Organization(WHO) on Tuesday aims to help countries to promote healthier school environments – including nutritious school lunches, opportunities for more physical activity, and mental health support – for 1.9 billion school-aged children and adolescents worldwide.

An estimated 365 million primary school children have globally suffered from hunger and increased rates of stress, anxiety and other mental health issues due to school closures during the COVID-19 pandemic, according to WHO, which announced the joint initiative today.

The Global Standards for Health-promoting Schools resource package includes eight “health promoting schools” standards developed to ensure all schools promote life skills, cognitive and socio emotional skills and healthy lifestyles for all learners. 

“Schools play a vital role in the well-being of students, families and their communities, and the link between education and health has never been more evident,” said WHO Director-General Dr Tedros Adhanom Ghebreyesus in the announcement of the new initiative.

The new standards cover school and government policies and resources, school governance, leadership and community partnerships, a curriculum that supports health and wellbeing such as nutrition and safety, a social-emotional environment fostering equity and diversity and delivering school-linked health services.

The global standards will be piloted in Botswana, Egypt, Ethiopia, Kenya and Paraguay.

“These newly launched global standards are designed to create schools that nurture education and health, and that equip students with the knowledge and skills for their future health and well-being, employability and life prospects,” said Dr Tedros.

UNESCO Director-General Audre Azouley said schools that do not promote healthy lifestyles, is “no longer justifiable and acceptable”. 

“Education and health are interdependent basic human rights for all, at the core of any human right, and essential to social and economic development,” said Azouley.

COVID-19 resulted in emotional distress and mental health of school children

Overview of the health-promoting school implementation cycle

According to the two global bodies, comprehensive health and nutrition programmes in schools have significant impacts among school-aged children. Examples include Malaria prevention interventions resulting in a 62% reduction in absenteeism; provision of school meals increasing enrolment rates by 9% on average, and attendance by 8%; how free screening and eyeglasses have led to a 5% higher probability of students passing standardised tests in reading and mathematics.

Another example is how comprehensive sexuality education encourages the adoption of healthier behaviours, promotes sexual and reproductive health and rights, and improves sexual and reproductive health outcomes such as the reduction of HIV infection and adolescent pregnancy rates.

Professor Susan Sawyer, one of the researchers at the Centre for Adolescent Health at the Murdoch Children’s Research Institute who led the two-year project at the invitation of UNESCO and WHO, in a statement said links between children’s health, wellbeing and learning have been demonstrated through the impact of COVID-19 on school closures.

“In addition to the disruptive effects on student engagement, learning outcomes and educational transitions, there is growing global evidence of the impact of school lockdowns on children’s and adolescents’ emotional distress and mental health,” she said.

“There are concerns that students with major mental health disorders are at greater risk of permanently disengaging from education. While negatively affecting their future career prospects, early school leaving becomes a risk factor for poor health in adulthood.

The global standards contribute to WHO’s 13th General Program of Work target of ‘1 billion lives made healthier’ by 2023 and the global Education 2030 Agenda coordinated by UNESCO.  

 It was first articulated by WHO, UNESCO and UNICEF in 1995 and adopted in over 90 countries and territories.

“However, few countries have implemented it at scale, and even fewer have effectively adapted their education systems to include health promotion,” said WHO in a statement.

Image Credits: Commons Wikimedia, WHO.

The World Health Organization formally declared an end to Guinea’s second Ebola outbreak.

The Ebola outbreak in Guinea which claimed 12 lives and infected 12 people has officially been declared over, more than four months after the deadly virus broke out in the West African country.

Guinean health authorities declared the outbreak on 14 February 2021 after three cases were detected in Gouecke, a rural community in the southern N’zerekore prefecture, the same region where the 2014–2016 outbreak first emerged before spreading into neighbouring Liberia and Sierra Leone and beyond.

“I commend the affected communities, the government and people of Guinea, health workers, partners and everyone else whose dedicated efforts made it possible to contain this Ebola outbreak,” said Dr Tedros Adhanom Ghebreyesus, WHO Director-General on Saturday.

“Based on the lessons learned from the 2014–16 outbreak and through rapid, coordinated response efforts, community engagement, effective public health measures and the equitable use of vaccines, Guinea managed to control the outbreak and prevent its spread beyond its borders. Our work in Guinea continues, including supporting survivors to access post-illness care.”

A total of 16 confirmed and seven probable cases were reported in Guinea’s latest outbreak in which 11 patients survived and 12 lives lost. Shortly after the infections were detected, national health authorities, with support from WHO and partners, mounted a swift response, tapping into the expertise gained in fighting recent outbreaks both in Guinea and in the Democratic Republic of the Congo.

Read more here…

Image Credits: WHO AFRO.

Six new cancer treatments for children are among the draft recommendations for this year’s update of the WHO Essential Medicines List.

Proposals to incorporate some 40 new medications in WHO’s Essential Medicines List – from complex cancer treatments to new medicines for hepatitis C and rabies – will be examined over the coming two weeks by the EML Expert Committee. 

The Committee, which kicked off its deliberations on Monday with a public hearing, also will consider revised or amended recommendations on some 16 treatment indications. Those include recommendations to incorporate new childhood medicines for treatment of cancer, antibiotics for use in neonatal meningitis and intra-abdominal infections. 

But there is also a recommendation against the use of antibiotics in most cases of acute bronchitis among healthy people – one of a number measures under consideration as part of the progressive WHO drive to make more rational use of antibiotics and fight antimicrobial resistance. 

Strikingly, COVID drugs are one issue not on the EML agenda, said Benedikt Huttner, Secretary of the Expert Committee, at the outset of the public session. Rather, a separate WHO process is being devoted to the consideration of guidelines on essential COVID treatments – although certain COVID diagnostics are being considered by the EML expert group for inclusion in a related Essential Diagnostics List (EDL). 

Monday’s wide-ranging public session saw detailed presentations by two dozen experts and civil society groups on issues ranging from the highly technical to the politics of medicines access – with the two often deeply intertwined. The EML is used as a baseline reference point for national governments and insurance providers in considering medicines to prioritize in health systems and services.  Final recommendations from the Committee for 2021 updates to the EML  are expected in August. 

Expanding Antibiotic Use – while Fighting Antibiotic Resistance  

Mike Sharland, chair of the EML Working Group on Antibiotics, presents vision on fighting AMR while expanding essential medicines use

Mike Sharland, chair of the EML Working Group on Antibiotics focused on the delicate choices facing the committee in terms of ensuring access to essential antibiotics – while rationalizing use to stem the tide of drug resistant pathogens – also known as antimicrobial resistance (AMR). 

A key WHO aim is to ensure wider access to the most basic life-saving antibiotics in parts of the world where vital drugs may not be widely available – while reserving certain classes of antibiotics for treating more resistant bacterial infections, said Mike Sharland, Chair of the EML Antibiotics Working Group, and a professor at St. George’s University of London. 

Those more sensitive drugs are typically “broad spectrum”  antibiotics that are on special WHO “Watch” and “Reserve” lists, which indicates that they should be used in only specific, limited indications or when all other treatments have failed. In contrast, antibiotics listed on the WHO’s “Access” list can and should be used more widely for common bacterial infections. The three-tiered system, known as “AWaRe” was developed by WHO in 2017.  

Said Sharland, the group’s draft recommendations would fine-tune EML guidance so that “for most common primary fare infections, sore throats, ear infections, sinusitis, simple infections…can be treated by ‘Access’ antibiotics.:” 

This is in contrast to the global trends towards use of stronger antibiotics in the primary health care sector, he said noting a “a doubling in the use of broad spectrum or “Watch” antibiotics in the primary care sector, in recent years.   While inappropriate antibiotic use cuts across high- and low- or middle-income countries, it tends to be more prevalent in LMICS, he noted. 

There is indiscriminate use of antibiotics in both high- and low-income settings – although use of non-recommended antbiotics to inappropriately treat certain conditions is higher in LMICs as compared to HICs.

This year’s recommendations include provisions that the Essential Medicines List recommendations can be used to discourage inappropriate antibiotic use for many forms of “milder” illness among patients who are “not ill with underlying disease”, he added.  

This, in line with the WHO goal that some 60% of antibiotics used at country level by 2023 should belong to the WHO “Access” group.  

One new draft EML recommendation under consideration would nix the use of antibiotics at all for acute bronchitis among otherwise healthy children – unless there is “clear evidence for, or a strong suspicion of a secondary bacterial infection.” 

This, as Sharland said, comes as part of a wider effort by the EML to “think about… whether it’s clinically appropriate” to recommend antibiotics at all for some conditions.  

The Dilemma of Cancer Medicines – Effective but Expensive 

Elisabeth de Vries presents on the higher rates of mortality in low- and middle income countries due to lack of access to treatment – at the WHO Essential Medicines List committee’s public session Monday, 21 June.

This year’s EML expert group had received proposals for the inclusion of 16 new cancer drugs as well as 6 new indications in the EML basket, said Elisabeth de Vries, chair of the WHO EML Working Group on Cancer Medicines, Notably, six of the 23 submissions were for children’s cancer drugs.

A key concern of the committee in this year’s expert reviews has been the affordability of many of the new cancer treatments – in which newer and more effective treatments are often be far beyond the range of many low- and middle-income countries to pay, said De Vries, who also chairs the cancer medicines committee of the European Society of Medical Oncology. 

This, she noted, comes against a landscape in which the number of new cancer patients is expected to increase from 19.3 million to some 30 million by 2040 – and cancer mortality remains significantly higher in low- and middle-income countries of the world.  

Cancer cases are expected to increase from some 19.3 million annually in 2020 to 30.2 million in 2040.

She called out monoclonal antibodies in particular – for which there are now 41 US-FDA approved treatments for cancer indications – as “difficult to produce and they’re very expensive.” 

“There are many good cancer medicines, and there are more good cancer medicines to come.  But unequal access to cancer medicines and high prices of cancer medicines make them currently, often unaffordable,” she said. 

An increasing number of monoclonal antibodies are being used to treat cancers – despite their high expense

Access Advocates Call for New EML Category – ‘Essential but Expensive’  

The challenges faced by the EML in recommending new cancer treatments are symptomatic of a broader dilemma, stressed civil society groups in a series of follow-up presentations. 

And in light of those challenges of efficacy versus cost, the WHO Essential Medicines List, first conceived in the 1970s as a guidance for national governments, needs to be “completely re-evaluated”, contended Knowledge Ecology International’s Kavian Kulasabanathan. 

“Today the EML often plays a negative role in debates over access to medicines,” said Kulasabanathan. “The low number of patented medications on the EML is frequently cited as demonstrative that patents are not a barrier to global access to essential medicines. It is not surprising that many patients and patient advocates chafe at the paucity of newer drugs on the EML as a result of this policy tension.

He called for the creation of a list for drugs that are “medically essential, but face challenges regarding affordability,” reviving a proposal pitched in past years to the EML expert committee, which last met in 2019.  

“KEI’s position is that the earlier framework for the EML needs to be completely re-evaluated, to take into account changes in the health infrastructure worldwide, the disparity of resources between developing countries, scientific progress, and new global norms to “promote access to medicines for all….. 

“”The WHO Expert Committee has been asked, several times, to create a category in the EML for products that would be essential, if available at affordable prices. A pathway for affordable antineoplastics would expand treatment options for patients, including the inclusion of second-line treatments…. 

“If drugs are medically effective, but expensive, they should be placed in an EML category for drugs that are medically essential but face challenges regarding affordability. Governments and patients would take this as a signal to implement policies to make these medically effective therapies affordable. A system of WHO guidance that consistently ignores or excludes new drugs for cancer needs to be reformed, and new options for dealing with affordability and access are needed if we are serious about achieving equality of health outcomes.”

Identify Promising Treatments Earlier On – MPP

Another way tht the EML could use its leverage would be to identify promising new treatments earlier on  – and then demanding more detailed data on costs and access which can help drive voluntary deals with manufacturers, added Esteban Burrone, head of policy and advocacy at the Medicines Patents Pool, which negotiates voluntary licenses with industry for the manufacture of vital drugs in low- and middle-income countries.

“Over the years, I have repeatedly heard the frustration from members of this Committee or other stakeholders: a medicine gets listed on the WHO EML, but access to that drug continues to be limited in LMICs, causing unacceptable morbidity or mortality.  I would like to state that it doesn’t have to be that way.  We can plan for future access now,” Burrone said.

“If the Committee decides not to list them [a promising drug] for now and asks for further data, will it also make an ask on cost?  Will it recommend what needs to happen so that these clinically important medicines can become widely available and cost-effective in LMICs?” he asked, citing the case of the HIV drug dolutegravir – in which MPP, supported by WHO, negotiated a manufacturing license for a generic version only a year after the patented drug was first approved by the FDA.

“Will it be forward looking, as WHO was in the case of dolutegravir?  If you would like to see affordable generic versions being developed for use in LMICs, you can contribute to making that happen.

“You can ask for it and give a mandate to WHO and other stakeholders to make that happen,” he said, adding that MPP stands ready to support such efforts through its voluntary license model – and demonstrated track record with opening up access to lifesaving hepatitis and HIV medicines for millions of people in the developing world.

IFPMA Asks EML Experts to Recognize Countries’ Right to Choose 

On the other side of the fence, Sara Amini of the International Federation for Pharmaceutical Manufacturers and Associations (IFPMA), argued that while the WHO Essential Medicines List can be a “useful tool” guiding drug choices by countries and procurement agencies – it should not be portrayed as the final word on treatment choices by health-care providers. 

“IFPMA recognizes EML’s value as a foundational list of medicines that meets the priority healthcare needs of health systems and their populations,” Amini stated, “However, such decisions, while guided by EML, should also reflect each nation’s unique health landscape, taking into account national disease burden, health system capacities, and socio-cultural characteristics of the population. 

“As such, the EML should not be used as an impediment for governments, healthcare professionals or patients to adopt other treatment options, which may not be listed on the EML, but are deemed appropriate at a national level.”

Defining Biologically Similar Drugs & Quality Assurance

Another issue of concern for industry, Amini added, remains the WHO’s recommendations for the use of  “biosimilar” versions of patented biological medicine treatments – often seen in the cancer arena as well as in other noncommunicable disease treatments.  

She said that the EML expert group should develop more refined terms of reference to such drugs in the EML context, including more precise definitions of what constitutes biologically equivalent drug formulations of certain biologically-based medications. 

EML recommendations for leading anti-cancer drugs, or their biosimilars, such as rituximab (RituxanⓇ)  and trastuzumab (HerceptinⓇ) should also contain better definitions as to what constitutes a “quality-assured biosimilar”, she contended. 

Those definitions, Amini said, would be made in line with “WHO’s commitment to supporting globally acceptable principles for licensing biological products that are claimed to be similar to biological products of assured quality, safety, and efficacy on the basis of proven similarity.”

 

Image Credits: WHO, Mike Sharland , Presentation by Mike Sharland, chair of the EML Working Group on Antibiotics .

KAMPALA – As Uganda battles its worst COVID-19 outbreak, the  government has called on a researcher who is selling a herbal remedy to treat COVID-19 to provide clinical proof that it works.

Professor Patrick Engeu Ogwang is a renowned researcher in herbal medicines, head of pharmacy at Mbarara University of Science and Technology (MUST) and a former executive member of the Pharmaceutical Society of Uganda. 

He is also the founder of the herbal remedy which is being marketed as Covidex, a COVID-19 treatment although there is no proof that it works.

The government has said it is willing to provide financial support to Ogwang to enable Covidex to go through proper clinical trials but that he should present scientific evidence of its efficacy and safety before marketing it as a treatment for the virus.

“He is a very good researcher. We know him very well but he did this particular work alone. He has not shared it with anyone,” said Dr  Monica Musenero, the Presidential Advisor on Epidemics and COVID-19. 

“We want to work with him and we are waiting for him to bring evidence. We are even willing to provide him with funding and even patients so that other people other than him tell us if the drug works and is safe,” she added.

With the current second wave of the pandemic and a steep rise in COVID-19 cases, the government says people are desperate and they have a duty to protect the public.

“All we see is information on social media of pictures of people lining up to buy the drug. We are not saying that the vaccine is bad or it does not work or is harmful. We just need evidence. Science is designed in a way that no single individual can claim that something works without convincing a panel of other people,” said Musenero.

“The drug has not gone through clinical trials and as a person working with the World Health Organisation (WHO) I cannot make any more comments about it,” said WHO vaccines medical officer Dr Phiona Atuhebwe. “We all know what happened in Madagascar and Tanzania.”

Dr Ambrose Talisuna, WHO Africa’s team leader on emergency preparedness, said that the remedy must undergo rigorous testing before being rolled out on the market. 

“People are gullible in a situation like this where there is a pandemic. My recommendation is for the Professor to take his drug through rigorous testing,” said Talisuna.

Meanwhile, the Pharmaceutical Society of Uganda (PSU) has applauded Ogwang’s efforts to develop Covidex “considering that no proven cure for the pandemic has yet been established globally”.

The PSU says it will stand by Ogwang and has already put in place a taskforce to provide him with technical support to develop Covidex in compliance with the established guidelines for research and development of herbal medicines.

The PSU also said that it is engaging with Uganda’s drug regulatory body, the National Drug Authority (NDA), to ensure support for Ogwang.

No Approval Given for Covidex, says NDA

However, the NDA warned the public against using Covidex: “Uganda Drug Authority (NDA) has learnt with concern the promotion and sale of Covidex manufactured by Jena Herbals (U) Ltd that claims to prevent and treat COVID-19.”

“NDA informs the public that it has not undertaken any assessment or approved Covidex, nor has it received any application from the innovator of the Covidex as required by National Drug Policy and Act cap 206,” said the NDA’s public relations manager, Abiaz Rwamwiri.

The NDA has authorized a number of products from Jena Herbals, including an anti-malaria product, and notes that the company is aware of the process required for clinical trials, authorization, drug promotion and licensing before production and sale of herbal medicine.

The NDA confirmed that it had met a team from Jena Herbals led by Ogwang and it had agreed to follow these necessary processes. 

After the meeting, Ogwang issued a statement saying that more proof was needed that Covidex worked to relieve the symptoms of COVID-19, and that the agency had advised him ti change the product;s name so it could not be associated with COVID-19.

Ogwang told Health Policy Watch that his team was busy writing the clinical trial protocol which will be presented to the government. 

Earlier in this week there was a rush to buy Covidex and social media exchanges heightened after the statements from the government said it wanted scientific evidence. 

Covidex costs about UGX3,000 ($0.8) a unit pack, while a seven-day supply is UGX 21,000 ($6).

Afrigen is the lead partner in the South African mRNA hub

Africa could start producing its own cutting-edge COVID-19 vaccines within a year via an mRNA technology transfer hub that is being set up in South Africa, the World Health Organization (WHO) announced on Monday.

But the speed at which the new hub may be able to swing into full-scale vaccine production depends on whether pharmaceutical companies with proven mRNA vaccines will commit to supporting the initiative, according to WHO Chief Scientist Soumya Swaminathan.

WHO is in discussions with “the larger companies that have proven mRNA technology”, and is “hoping very much that they will come on board”, Swaminathan revealed.

If a big pharma partner does indeed come forward, vaccines could be produced in South Africa ”within nine to 12 months”, she declared at a WHO media briefing Monday.

South African President Cyril Ramaphosa described the hub as a “landmark initiative” that “will put Africa on a path to self-determination” in terms of vaccine development and manufacturing capacity.

“We just cannot continue to rely on vaccines that are made outside of Africa because they never come. They never arrive on time. And people continue to die,” Ramaphosa told the WHO briefing.

The hub consists of South African companies Afrigen Biologics and Vaccines and Biovac, a network of universities, and the Africa Centre for Disease Control.

Afrigen will manufacture the mRNA vaccines and provide training to Biovac, according to WHO Director General Dr Tedros Adhanom Ghebreyesus.

“In time, Afrigen could provide training to other manufacturers in Africa and beyond,” said Tedros.

Timelines Depend on Big Pharma Support

WHO Chief Scientist Soumya Swaminathan

If the major mRNA manufacturers – primarily Pfizer and Moderna – do not support the South African hub, the WHO was considering “several options” from smaller biotech companies” that are further back in the development pathway – but this would mean running clinical trials. 

“The timelines of when vaccines can be produced in the country will depend on whether there’s a tried and tested technology that can be much more easily transferred to the facility in South Africa, which by the way already exists,” said Swaminathan.

“There’s already a pilot plant there, so all we would need is to put in some equipment and train the workforce on this new process, and … [source] all the raw materials and things that are going to be needed for this.”

Running trials would delay manufacture, but “the good thing is South Africa has huge capacity in clinical trials in R&D and the regulatory agency there is very strong and up to speed,” she added. 

French Welcome Hub to ‘Respond to Variants’

The hub has the support of the French government, and President Emmanuel Macron said in a recorded message that it would “allow for a rapid response to develop new vaccines to address new variants of COVID-19 or newly emerging pathogens on the African continent, and for the benefit of the entire world”.

The announcement follows the recent visit to South Africa by Macron, who said his country was committed to supporting African efforts to scale up their local manufacturing capacity of COVID-19 vaccines and other medical solutions.

However, Ramaphosa stressed at the briefing that the hub needed to go hand in hand with the TRIPS waiver that his country and India are pushing for at the World Trade Organization, to ensure that “real intellectual property can be transferred”.

The hub stems from a call made by the WHO in April for Expressions of Interest (EOI) to establish COVID mRNA vaccine technology transfer hubs to scale up production and access to COVID vaccines. 

“Technology transfer hubs are training facilities where the technology is established at industrial scale and clinical development performed,” according to the WHO.

“Interested manufacturers from low- and middle-income countries can receive training and any necessary licenses to the technology. WHO and partners will bring in the production know-how, quality control and necessary licenses to a single entity to facilitate a broad and rapid technology transfer to multiple recipients.”

WTO is Addressing Vaccine Production Bottlenecks, Local Production Forum Hears

World Trade Organization Director-General Ngozi Okonjo-Iweala

Earlier in the day, governments, agencies and the private sector met virtually for the start of the World Local Production Forum, a global arena to discuss “opportunities and mechanisms for the promotion of local production and technology transfer”.

Addressing the opening of the forum, WTO Director-General Ngozi Okonjo-Iweala said that “before the pandemic, 10 countries accounted for 80% of global vaccine exports”. 

“We have now seen that over-centralization of vaccine production capacity is incompatible with equitable access in a crisis situation,” said Okonjo-Iweala.

“At the same time, the complexity of global supply chains necessary to manufacture COVID-19 vaccines makes clear that it is difficult for any one nation to produce everything in the entire value chain,” she added.

She and other speakers promoted the idea of regional production hubs, pointing out that Africa is already working with the European Union and other partners to advance such a hub involving South Africa, Senegal and Rwanda.

“Regional hubs can combine economies of scale with increased geographical diversification as called for by the World Health Assembly Resolution on strengthening local production,” she added.

“In the current crisis, the WTO can help by freeing up supply chains, by removing export restrictions and facilitating cross border trade.”

The WTO is hosting a supply chain transparency symposium later this month to identify blockages in supply. Next month it will co-host a meeting with WHO and vaccine manufacturers “to explore potential partnerships and investment opportunities particularly in emerging markets and developing countries”. 

Meanwhile, UNICEF executive director Henrietta Fore told the forum: “When products are manufactured closer to the people who need them, supply chains are more efficient,  shipping costs are lower, shipping times are faster, and our operations have a much smaller environmental impact.”

South Africa’s Director-General of Health, Sandile Buthelezi, said that Africa is reliant on India and China for generic medicine and active pharmaceutical ingredients. 

“Importation of medical commodities from these countries, while critical for meeting the healthcare needs of many low-income countries, has an impact on the trade balance of African countries,” said Buthelezi.

He identified training of personnel – particularly chemical engineers, pharmaceutical scientists and technicians –  and a supportive regulatory environment that included the “removal of obstacles related to intellectual property” as being priorities to enable local production.

Image Credits: Afrigen.