A new survey shows that the use of family planning services in Kenya increased from 56% in 2019 to 61% despite curfews and lockdowns.

Kenya’s family planning services experienced a 5% increase in the uptake of modern contraceptives at the height of the COVID-19 pandemic last year, possibly contributing to a decline in unwanted pregnancies in the country, a new survey has shown.

The survey, conducted by Performance Monitoring for Action (PMA), shows that the use of family planning services increased from 56% in 2019 to 61% in 2020 in married women and from 40% to 46% in all women, despite curfews and lockdowns.

The PMA generates surveys of key health indicators in nine countries in Africa and Asia, whose open-resource data is available for research, programme planning and policymaking. 

The increased use of contraceptives is likely to have contributed to the decline of unintended pregnancies over the same period from 42% to 37%. 

The survey – done between November and December last year in 11 counties (Nairobi, Kilifi, Nandi, Nyamira, Kiambu, Bungoma, Siaya, Kericho, Kitui, Kakamega and West Pokot) – also found that unmarried women prefer short-acting methods, while their married counterparts chose longer-acting methods.

The most popular method for unmarried women were male condoms (29%), injectables and implants (both at 26%). The married women, on the other hand, preferred injectables (39%) and implants (37%).

Family Planning is an Essential Service 

Albert Ndwiga, the National Family Planning Program manager in the Ministry of Health, said family planning was an essential service and that the country “had to come up with guidelines quickly to ensure continued care in public health facilities during the pandemic”.

Family planning services are offered free of charge in public health facilities in Kenya. The guidelines were formulated in April last year, giving directives to facilities on how to protect the client and the service provider.

The government is now collaborating with the private sector, which supplies over a quarter of Kenyans (28%) with their family planning methods and commodities. 

“Some may choose to get services from the private sector because of the convenience it offers to them, therefore reducing the burden on government-owned facilities,” Ndwiga said, adding that the health ministry has formulated a “total market approach” as a result. 

The ministry has also actively engaged with communities “because issues around culture and religious beliefs have for a long time affected the uptake of family planning,” observes Josephine Kinyua, the director of Delivering Equitable and Sustainable Increases in Family Planning (DESIP) in Kenya, a program funded by the UK.

The DESIP program is implemented in 19 counties where the modern method contraceptive prevalence rate is less than 45%.

Commodity Financing and Economic Empowerment

Ndwiga said family planning was going to be included as one of the government’s four key agendas, of which universal health coverage is a key component. The agendas include food security, affordable housing, manufacturing and affordable healthcare for all.

Kenya’s government has committed to financing 100% of family planning commodities by 2023, and Ndwiga said they were now able to use health insurance to fund family planning.

Linking family planning with economic empowerment has contributed to increased uptake, according to Kinyua, who said some counties were now introducing bills geared towards funding maternal and child health alongside family planning.

“This will ensure that later, even if the programme is no longer there, some funding will be available to support maternal and child health,” she said.

However, cutting back on family planning commodities wastage would also go a long way towards saving money. This could be achieved by improving the quality of family planning services.

Ndwiga said an example of preventing wastage would be if a mother is counseled properly so that if she chooses to have a long-term contraceptive method, she will not change her mind after two months to have it removed.

“Because if that implant is meant to last for five years, but is removed after only two months, you lose four years and 10 months that it could have been used,” he says.

Data is Important to Inform Policies and Programs

Contraceptive use is known to be one of the determinants that influence fertility, according to Dr Anne Akonyo, senior lecturer and director of population studies at the University of Nairobi.

“It is one of the greatest inhibitors of fertility when used properly,” she explains.

Professor Peter Gichangi, the lead investigator of the PMA, says that the data collected should not just be used to inform programmes, policies and scientific publications, but as data sets that can be used for different purposes.

The data presented also posed some questions that need further investigating such as stock-outs for Intrauterine Devices (IUDs), which increased from 7% in 2019 to 11% in 2020.

Image Credits: iStock.

A “human error” at a Johnson & Johnson production facility caused millions of doses of its COVID-19 vaccine to be spoiled and unusable.

A mix-up with vaccine ingredients at a production site in Baltimore, Maryland, which is manufacturing both the Johnson & Johnson and AstraZeneca COVID-19 vaccines, has led to the contamination of 15 million J&J doses, which risks delaying national and global deliveries of the recently-approved vaccine. 

The pharma company, which is producing the world’s first single dose COVID-19 vaccine, announced Wednesday that a batch of doses failed its “rigorous quality control” standards. The doses were manufactured at a facility run by Emergent BioSolutions, which has production deals with both J&J and AstraZeneca.

Federal officials have described the issue as human error, as workers at the plant reportedly confused components for the two vaccines in late February. It took several days for the mistake to be recognised, ruining a batch of millions of doses.

The Emergent Bayview Facility in Baltimore has not yet, in fact, been authorised by the US Food and Drug Administration (FDA) to manufacture the J&J drug substance, but is currently under review for Emergency Use Authorization. 

The authorization has been held up by the FDA’s investigation into the site’s lapse in quality control.  

J&J will send experts in manufacturing, technical operations, and quality monitoring to supervise and support activity at the facility and gain more control over the manufacturing processes to avoid another public hiccup in production.

The production of Johnson & Johnson’s one-shot COVID-19 vaccine, delivered through an inactivated adenovirus.
Potential Delays in Vaccine Shipments

J&J stressed, however, that the error won’t impact its upcoming delivery to the US of 11 million doses, forecasted to arrive this week from a manufacturing site in the Netherlands. However, the company had been expected to deliver 24 million more doses to US destinations from the Baltimore site in April.

Although J&J officials said that they intend to remain on schedule with deliveries, US health officials said that they anticipate fluctuations in the vaccine delivery timetable, saying it could still take weeks to get the facility up to regulatory standards.

The US has ordered a total of 100 million doses from J&J, which are to be shipped by the end of June.

As of Thursday, approximately 7.8 million J&J doses were delivered and 3.4 million doses administered, according to the US Centers for Disease Control and Prevention.

The J&J vaccine has widely been regarded as essential to speed up vaccination campaigns globally due to the fact it is a one-jab vaccine as well as its logistical advantages: it can be stored for at least three months at temperatures of 2-8°C and can be transported using existing cold chain technologies and standard vaccine distribution channels.

“Changing the trajectory of the pandemic will require mass vaccination to create herd immunity, and a single-dose regimen with fast onset of protection and ease of delivery and storage provides a potential solution to reaching as many people as possible,” said Mathai Mammen, Global Head of Research and Development at Janssen Pharmaceuticals – a Belgian pharma company owned by J&J and responsible for developing the vaccine – in a press release published in late February.

J&J expects to deliver one billion doses globally by the end of 2021, including some 400 million doses to African Union member states beginning in the third quarter of 2021. An agreement is also underway between J&J and Gavi, the Vaccine Alliance to provide 500 million doses to the WHO co-sponsored global COVAX Facility through 2022. The facility is trying to ensure more equitable distribution vaccines to low- and middle-income coutnries.  

However, insofar as J&J has already faced previous manufacturing delays in January, it remains to be seen if J&J will succeed in scaling up production to meet its commitments. 

CDC Warns – US Facing Fourth Wave of COVID-19 In ‘Critical Moment’ for Pandemic

Meanwhile, the US could be facing an imminent fourth wave in the pandemic, with COVID-19 cases increasing in 25 states, and an average of 64,000 new cases reported daily over the past week, officials from the US Centers for Disease Control warned. The rise in cases coincides with multiple states loosening COVID restrictions on social distancing and other measures.

Cases have increased by 12% from last week, accompanied by higher hospitalisation and death rates, with a seven day average of deaths at 940 per day. 

“This is a critical moment in our fight against the pandemic. As we see increases in cases, we can’t afford to let our guard down,” said Dr Rochelle Walensky, Director of the CDC, at a White House press briefing of the COVID-19 Response Team.  

“We need to keep taking the mitigation measures, like wearing a mask and social distancing, as we continue to get more and more Americans vaccinated every single day,” Walensky added, speaking at a White House press briefing on Wednesday. 

The B.1.1.7 variant, first identified in the United Kingdom, is responsible for 26% of the SARS-CoV2 variants circulating across the US, and it is the predominant strain in at least five regions of the country. 

“We do know it’s more transmissible – somewhere between 50 and 70 percent more transmissible than the wild-type strain,” said Walensky. “So to the extent that people are not practising those standard mitigation strategies, we do think that more infections will result because of B.1.1.7.”

At the same time, however, several states have begun abandoning mask mandates and allowing for more social gatherings, which may provide an opportunity for the virus to spread as well as to mutatey, developing new deadly variants. 

“The failure to take this virus seriously [is] precisely what got us in this mess in the first place [and] risks more cases and more deaths,” said President Joe Biden at a press conference on Monday.

Joe Biden, US President, delivering his presidential remarks on COVID-19 response and vaccinations on Monday.

BIden pledged that the US will continue scaling up its vaccination campaign, setting the goal of having a vaccination site within five miles of every American by 19 April.

“We are in a ‘life-and-death race’ against the virus. We are facing an accelerating threat,” said Andy Slavitt, Acting Administrator of the Centers for Medicare and Medicaid Services, at the White House press briefing on Wednesday.

This will simultaneously require continued adherence to public health measuring and the improvement of vaccine access nationally.

Image Credits: Johnson & Johnson, Johnson & Johnson, C-Span.

Community health worker distributes ivermectin – the mainstay treatment against onchocercisasis (river blindness) – for the past several decades.

A recent trial of ivermectin, a mainstay treatment for the parasitic disease onchocerciasis for the past three decades, has failed to show significant impacts against COVID-19, a new study,  published in JAMA, reports. The study by a group of researchers in Cali, Colombia found that the use of the antiparitic drug, typically used to treat onchocersiasis  (river blindness) endemic to West Africa, did not not significantly shorten the durationof COVID symptoms in patients with mild disease.

The study of some 400 people found that those trated with the drug had a resolution of symptoms in 10 days, on average, as compared to 12 days – but the two day difference was not deemed statistically significant. “Further trials of ivermectin as a treatment against COVID-19 are, however, still underway. The ANTICOV Consortium, for example, is considering adding ivermectin – in combination with another drug – as an additional arm of its ANTICOV series of clinical trials underway in Africa.  The clinical trials, coordinated by DNDi, are testing the efficacy of different drugs as a potential treatment against mild to moderate cases of COVID-19.”

In light of the inconclusive evidence, WHO, meanwhile, has issued a recommendation that use of ivermectin be limited to clinical trials, until more data is available. This recommendation, which applies to patients with COVID-19 of any disease severity, is now part of WHO’s guidelines on COVID-19 treatments.

Ivermectin is a broad spectrum anti-parasitic agent, included in WHO essential medicines list, and a mainstay of treatment against river blindness for the past four decades or more. Following the breakthrough discovery of efficacy in trials conducted by WHO in the 1970s, it was put into widespread use in West Africa, where river blindness is endemic, under programmes of preventative, mass community administration of the drug once a year.  Only in the past several years has a new treatment for river blindness, moxidectin emerged, which shows promise of even greater efficacy against onchocerciasis. Ivermectin is also used for the tratment of scabies, strongyloidiasis and other diseases caused by soil transmitted helminthiasis.

Ivermectin is traditionally used against onchocerciasis and scabies

The current WHO guidance on ivermectin was issued following a review of the evidence by an international panel of experts. The group reviewed pooled data from 16 randomized controlled trials (total enrolled 2407), including both inpatients and outpatients with COVID-19. They determined that the evidence on whether ivermectin reduces mortality, need for mechanical ventilation, need for hospital admission and time to clinical improvement in COVID-19 patients is of “very low certainty,” due to the small sizes and methodological limitations of available trial data, including small number of events. The panel did not look at the use of ivermectin to prevent COVID-19, which is outside of scope of the current guidelines.  Other WHO recommendations on COVID-19 treatments include:

  • Strong recommendation for the use systemic corticosteroids (e.g. dexemethesone) for severe or critically ill COVID-19 patients; with a conditional recommendation against their use in patients with mild/moderate COVID-19;
  • Conditional recommendation for the use of low dose anticoagulants in hospitalized patients (this recommendation is part of the clinical management guidelines). We suggest the use of low dose anticoagulants rather than higher doses, unless otherwise indicated;
  • Conditional recommendation against administering remdesivir in addition to usual care;
  • Strong recommendation against the use of hydroxychloroquine or chloroquine for treatment of COVID-19 of any severity;
  • Strong recommendation against administering lopinavir/ritonavir for treatment of COVID-19 of any severity.

Updated on 6 April 2020. 

Image Credits: Mectizan Donation Programme, Sarang.

The debate around technology transfer is proving to be critical in addressing shortages in the production of vaccines. We wanted to know from developing country manufacturers on the challenges they face in making vaccines for COVID-19. Geneva Health Files brings you an interview with Abdul Muktadir, Chairman and Managing Director of the Dhaka-based company Incepta Pharmaceuticals Limited.

Established in 1999, Incepta specialises in biosimilars and vaccines, employing nearly 10,000 people and producing about 1000 different medicines and vaccines – including oral cholera vaccines, vaccines for influenza, measles, rubella, and Hepatitis B. Incepta exports to 67 countries across the world, has 3 manufacturing sites, and 17 factories and research facilities.

Geneva Health Files (GHF): What, according to you, are the real impediments for technology transfer in the process of production of vaccines in the developing world? 

Abdul Muktadir (AM): The innovator companies are preoccupied with the supply commitments to the governments from which they have taken advance payment. They have successfully transferred the technology to all the Contract Research Organizations (CROs) so the technical difficulties that are often referred to may not be a big impediment. The innovator companies are at ease working within their comfort zone and do not want to deal with unknown companies.

This is the real barrier that the innovator companies do not feel comfortable working with many companies from the developing world.

Abdul Muktadir, an industrial pharmacist by training, who is Chairman & Managing Director for Incepta Pharmaceuticals Limited

GHF: In policy debates in Geneva, developed countries argue that intellectual property has not been a barrier for the production of vaccines. What are your thoughts on this? 

AM:  In the current context, the IP right is not the impediment as the companies from the developing world would act either as a CRO or as a license holder. The innovator companies should utilize as many manufacturing bases as possible and then increase their production. In this case there is no issue of IP violation.  

GHF: It has also been argued that developing country manufacturers may not have the skills and equipment to engage in technology transfer. What are your views on the expertise and manufacturing capacities in the developing world?

AM: There are several technological platforms for production of currently approved COVID-19 vaccines, and for each platform there are differences in upstream and downstream processes. The vaccine manufacturing is not very widely distributed but the companies that manufacture vaccines – they understand the process fairly well.

So, the capacity and expertise are available with the manufacturers of the developing world – otherwise Serum Institute and other Indian manufacturers would have faced difficulties. The equipment might require some re-tooling to accommodate the new process but certainly it is possible. 

GHF: As a developing country manufacturer, what in your view is a preferred way for technology transfer: non-exclusive licensing or bilateral arrangements? And why?

AM: Here, the primary objective is to increase the volume of production. My argument is: if a company can deliver 1 billion doses a year then we should try to increase that capacity to 4 billion using the same principle. No company was prepared to deliver 1 billion doses a year, but the companies are doing this now. The task of manufacturing should be distributed based on the capability of each manufacturing partner.

The best way should be to mass manufacture antigen [vaccine active ingredient] bulk in a few places and then the antigen could be distributed for fill/finish wherever the capacity is available. 

We are referring to any licensed Covid-19 vaccine such as Moderna, Pfizer, Astrazeneca, Johnson & Johnson. If we receive the active bulk ingredient, we have the capacity to fill and finish.

This way we can involve many companies in many different countries. This would also eliminate impediments on cross border transportation. We observe now that most of the manufacturing countries are putting barriers in previously agreed supply commitments. 

The above process would involve both non-exclusive licensing and bi-lateral arrangements. We can avoid non-exclusive licencing if the innovator company can make the agreements through multi-party contract manufacturing. In such a case the technology transfer requirement would be as per the requirement of each task. If the bulk antigen can be produced in a few places then the requirement of tech transfer would be very minimal, and the innovator company’s technology can remain very well guarded.

The current technology of manufacturing the COVID-19 vaccine is probably known to many vaccine companies, including companies from the developing world like ours. The biggest challenge in introducing a new vaccine is to successfully conduct an efficacious clinical trial and this remains the main barrier for a new vaccine. So, our best option would be to manufacture the already-approved vaccines on a massive scale and provide them fair reward for their innovation.

GHF: Can you share specific details on your operations in Bangladesh in terms of capacity for technology transfer? What would be the easiest vaccines to produce and what are the potential areas for improvements in your manufacturing plants?

Incepta Pharmaceuticals has full-scale vaccine manufacturing facilities – including antigen production lines, bioreactors, and fill-and-finish capacity.

AM: We have full-scale vaccine and biosimilar manufacturing facilities. We can manufacture bulk antigen using almost all technology platforms. 

We have the bulk antigen production facilities which could be utilized to adapt almost all technology platforms (e.g. mRNA, DNA, adenoviral & insect/baculoviral etc ) available for COVID-19 vaccine. 

For example, we have developed a meningococcal polysaccharide subunit vaccine (ACYW135), hepatitis B sub-unit vaccine (VLP based), and whole cell oral cholera vaccine from our own bulk, and obtained licensure for these vaccines in Bangladesh. Moreover, a cell culture-derived rabies vaccine that we developed is in a clinical trial now. A pre-clinical study for typhoid conjugate vaccine is on-going. In addition, we have more vaccines in the pipelines.

Depending on a particular process we have to re-tool the facility to accommodate the manufacturing of a new vaccine. Once we have a process in hand, then we would know the extent of re-tooling requirements. Once the facility is ready then we have to optimize the manufacturing process and it requires some time.

For us the easiest COVID vaccine technologies  would be the protein subunit vaccines [such as the one produced by Novavax] and mRNA vaccines [such as those produced by Pfizer/BioNTech and Moderna]. We would also be able to manufacture adenovirus vaccines.

We have the bulk antigen production facilities which could be used to adapt technology related to mRNA vaccines and protein subunit vaccines for COVID-19. 

We have a 500L bioreactor which could be used to produce insect cells/baculovirus based protein sub-unit vaccines like the one from Novavax. 

At the moment, we have a licensed protein sub-unit vaccine for hepatitis B which we developed using the yeast technology platform. 

If we have access to mRNA technology, we believe we can easily adapt this technology. We have all the reactors and purification tools required for mRNA vaccine production.

If we get the antigen then the production can start immediately, as we have two and a half production lines sitting idle. In one line we can handle multiple dose vials, and with 20 doses a vial, we can deliver about 500 million doses a year. If we re-tool the other two lines for larger, multiple vial capability then we would be able to deliver another 600 million doses. But this would require a lead time for the supply of tools from machine manufacturers, and this may require a lead time of 6-8 months. But we now have one line fully ready to deliver about 500 million doses a year in multiple dose vials (the lines we have are suitable to fill any type of vaccine).

At the moment we don’t have any deals with any innovators.

Priti Patnaik is the founding editor of Geneva Health Files – a reporting initiative that tracks power and politics in global health. This interview is a part of a series under a collaboration arrangement between Geneva Health Files and Health Policy Watch.

Image Credits: Incepta.

Dr. Tedros Adhanom Ghebreyesus, WHO Director General, at the press briefing on Thursday.

The World Health Organization (WHO) is hopeful that all healthcare workers can be vaccinated by mid-April, but the clock is ticking away, leaving rich countries only nine days to donate surplus COVID-19 vaccines to the global COVAX facility – which has run out of doses at a crucial time.

So far, the WHO has not received any donations since it called on countries last week to donate surplus doses they have accumulated, said Dr. Tedros Adhanom Ghebreyesus at a press conference on Thursday. 

“Last week, I made an urgent request to countries with surplus vaccines that have WHO emergency use listings to share 10 million doses with COVAX,” said Dr. Tedros. “This challenge has been heard, but we’re yet to receive commitments for those. I’m still hopeful that some forward looking and enlightened leaders will step up.”

COVAX Facing “Serious Challenges” 

Although the global COVAX facility has already delivered 35 million doses to more than 78 countries across the globe, it is facing “serious” shortfalls in doses – mainly because of India’s recent move to halt vaccine exports to the rest of the world as it attempts to fend off an outbreak that has grown to some 70,000 cases a day from only 15,000 since early March – an increase in cases by a factor of four in just a month. 

Despite the WHO’s call on rich countries and vaccine manufacturers to donate surplus vaccine doses last week, a whopping 100 countries still lack adequate access to vaccines, said Turkey’s Health Minister Fahrettin Koca, who also spoke at the press conference. Of those, two dozen countries that have signed up to the WHO co-sponsored COVAX initiative are ready to begin vaccinating healthcare workers – but they lack the supplies to begin before the 100th day of 2021 – the target date WHO had said for vaccine campaigns to start everywhere in the world. These include Cameroon, Haiti, Congo, Burkina Faso, Niger, Vanuatu, Papua New Guinea, Kyrgyzstan, the Dominican Republic and Mauritania, among others. 

“I know this is a challenging time for many countries as cases and hospitalization are spiking, but conversely, it’s when cases are spiking that it’s the most important time to share vaccines equitably and protect our workers, and at-risk communities,” Dr Tedros said.

Going forward, the concerning gaps in equity “could be addressed” by increasing local and regional vaccine production capacity and by moving forward on the intellectual property waiver spearheaded by South Africa and India, said the WHO Director General. 

“I think we should be able to produce vaccines everywhere, all over the world without intellectual property rights being a problem,” added Koca. “So that’s why I think we need to be taking concrete steps about this issue.”

Turkish Health Minister Fahrettin Koca at the press briefing on Thursday.

Turkey Announces Digital Platform To Commemorate Healthcare Workers

Meanwhile, in celebration of the International Year of Health and Care Workers, Koca announced the creation of a digital platform to tell the stories of the heroic and essential work carried out by healthcare workers since the pandemic began. The platform will be run in collaboration with WHO. 

“The whole of humanity is grateful to you right now,” said Koka. “[Your] stories need to be told in the common language of humanity. For this purpose, as a first step, we are working on creating a digital platform with WHO, to serve as a memorial dedicated to health and care workers.”

Since the start of the pandemic, millions of healthcare workers have been infected with the coronavirus and thousands have died. Those that have survived are struggling with a range of mental health issues, including heightened stress, anxiety, depression, insomnia, and exhaustion. 

That toll, said Dr Tedros, has been far too great – but it can be reversed by strengthening the capacity of the healthcare workforce, improving salaries, and ensuring healthcare workers are equipped with adequate personal protective equipment so they can do their job safely and effectively. 

“Far too many health and care workers have died in the pandemic,” he said. “As we work to end the pandemic and recover together….We must ensure that they are trained, protected, and supported to do their job safely and effectively.”

Image Credits: Our World In Data, WHO.

A man with symptoms of the deadly NTD African trypanosomiasis (sleeping sickness), is examined by Dr Victor Kande in the Democratic Republic of Congo (DRC). Kande was principle investigator for clinical trials of fexinidazole, the first oral sleeping sickness treatment approved by the European Medicines Agency (EMA) in 2018. Developed by DNDi, it is being rolled out in  DRC.

Global health experts expressed their frustration with the lack of research and attention towards neglected tropical diseases (NTDs) and vulnerable populations, calling for health systems to address NTDs in a more sustainable and holistic way.

Speaking at the launch of a new strategic plan for the Geneva-based Drugs for Neglected Diseases initiative (DNDi) on Tuesday, DNDi Executive Director Bernard Pécoul said greater emphasis should be placed on expanding access and developing treatments for patients in low- and middle-income countries (LMICs) affected by neglected tropical diseases (NTDs), as well as neglected viral diseases like HIV/AIDS, and also pandemic-prone and climate-sensitive diseases.

“Treatments were abandoned for years or decades because they fell outside commercial markets,” said Pécoul, at the launch of the plan that charters an eight-year journey to 2028, aiming to deliver 15 – 18 additional treatments, in addition to eight already developed, for a total of 25 new or improved, and highly effective, NTD treatments. 

“The frustration is where the idea was born – from the experience of humanitarian doctors, frustrated, while treating patients with vaccines that were ineffective, unsafe, or unaffordable, or never developed at all because the research and development was abandoned,” Pecoul added, speaking of his own experience in the past working with Medecins Sans Frontieres (MSF). 

DNDi, a WHO-supported organization of private and public sector actors, has committed to five strategic imperatives for the next eight-years: to deliver new treatments and expand access for neglected patients of NTDs and related viral diseases; join with public health leaders and Research and Development (R&D) stakeholders in low- and middle-income countries to advance sustainable health systems; contribute to building a proactive agenda for maternal, child health, and gender-responsive R&D; champion open science and transparency; and leverage new technologies to accelerate R&D. 

“It is our hope that we will identify safe, effective, and affordable medicines to help countries fight the health and social burden put on them by COVID-19. While all global attention is focused on development and purchase of COVID-19 vaccines, we should not forget about treatment and diagnostics,” said Marie-Paule Kieny, Director of Research, INSERM and DNDi Board Chair, at the Tuesday DNDi launch.

Challenging The Status Quo

DNDi
DNDi’s Strategic Plan launch event panel: clockwise: Patricia Amira, moderator; Dr Somya Swaminathan; Dr Marie-Paule Kieny; Dr Jeremy Farrar; Dr Bernard Pecoul; Dr Berhards Ogutu

Also appearing at the event, Jeremy Farrar, director of the Wellcome Trust. also expressed frustration with the ‘status quo’ that has defined R&D for global health, and called for more attention to be brought to three areas that would ‘define the 21st century’ – neglected and infectious disease, climate change, and mental health. 

“These three things are going to define our time – which have a focus on youth, and which have an inequitable impact on societies around the world. [DNDi is committed to] not just doing the science, but making sure that science is shared equally with everybody in the world,” he said. 

Over the next decade, DNDi will work to accelerate sustainable disease elimination in diseases with existing treatments, such as sleeping sickness and Chagas disease, and increase access to lifesaving and safer treatments for HIV and leishmaniasis. 

DNDi –  founded in  2003 to discover, develop, and deliver safe, effective, and affordable treatments for neglected and marginalized patients –  will also work with leaders and institutions in LMICs to bolster research capacity and generate more sustainable production and supply of NTD treatments. 

The initiative has grown into a network of over 200 partner institutions, and has so far delivered eight new treatments for people with sleeping sickness, visceral leishmaniasis, Chagas disease, HIV, and malaria.  

Clinical Trials for Mild COVID Cases Launching in 13 African Countries

Africa launches largest COVID clinical trial

COVID-19 has highlighted the need to prioritize and finance research in LMICs, as well as government preparedness to ensure both transparency and equitable access.  

In addition to working on NTDs and viral illnesses, DNDi will also address unmet medical needs, utilizing its ‘dynamic portfolio’ approach to explore new interventions in diseases with clear R&D gaps, including snakebite, dengue fever, schistosomiasis, and pandemic-prone diseases. 

At the start of the strategic planning period, DNDi also is coordinating ANTICOV – the largest African-led clinical trial testing for mild-to-moderate COVID-19. 

The ANTICOV platform  deals with the outpatient population, which is the majority of people with COVID, and is trying to answer the question of how to treat people to prevent them from getting ill and needing hospitalization, said Dr Soumya Swaminathan,  WHO Chief Scientist.

Carried out by a group of 26 prominent African and global R&D organizations in 13 countries, ANTICOV will simultaneously test and adjust treatments for COVID-19, and identify new treatments, fast-tracking research for patients and health systems in resource-limited settings. 

Swaminathan said that the high costs of the COVID-19 pandemic should not come at the expense of cutting or reducing budgets for NTDs, saying that the ‘collaborative science’ seen over the past year as proof that knowledge could be shared openly and freely. 

“Because of this vision, and the collective mission to solve the problem of COVID and develop new tools, it is possible to [share knowledge more widely].”

Though DNDi is primarily focused on R&D, the organization will also identify gaps in access to care, and build the partnerships needed to overcome them, laying the groundwork for more affordable care.  

Said Swaminathan: “When there’s a new technology, which can make a big impact, especially when it’s related to health and disease, it should be considered a global public good, and be made available to people who need it, regardless of their ability to pay.”

Image Credits: DNDi, DNDi, ClimateWed/Twitter.

A patient getting tested for COVID-19 at the Paris Charles de Gaulle Airport in January 2021. French President Emmanuel Macron imposed strict lockdown measures amid of surge of new coronavirus cases.

France is going into its third national lockdown since the start of the COVID-19 pandemic, after a deadly third wave hit Europe, causing soaring infection and death rates. With an average of more than 37,000 daily new cases over the past week, tougher restrictions have become inevitable. 

French President Emmanuel Macron announced the new restrictions in a televised address on Wednesday, saying that the government had waited “until the last moment” to impose the latest lockdown. 

The daily death toll reached 355 on Wednesday and health authorities recorded 569 new intensive care patients in 24 hours on Tuesday, the highest since April 2020. Over 5,000 COVID-19 patients are currently in intensive care units.

Infections have doubled since February, likely due to the spread of the more transmissible B.1.1.7 SARS-CoV2 variant, first detected in the United Kingdom. France “risks losing control” without strict measures, said Macron. 

France is approaching the grim milestone of 100,000 total COVID deaths, with 95,798 deaths recorded as of Wednesday. 

Lockdown Measures Put in Place

Lockdown restrictions include classes being taught remotely for the next three weeks, non-essential businesses will be closed, and travel within the country will be banned for a month after the Easter weekend (2-4 April). Residents will be limited to a 10 kilometer radius from their homes and will be subject to a curfew between 7pm and 6am. 

“We must limit all contact as much as we can, including family gatherings. We know now: these are where the virus spreads,” said Macron. 

Some 3,000 additional intensive care beds will be added to hospitals in the hardest-hit regions in an attempt to prevent health systems from becoming overwhelmed. 

The national lockdown will begin on Saturday and will last four weeks.

Emmanuel Macron, the French President, in a televised address on Wednesday announcing the country’s third COVID-19 lockdown.

Over a dozen regions were put under partial lockdown in early March with night-time curfews. The regional restrictions avoided closing schools or stores in an effort to keep the economy open. 

The existing restrictions at the regional level, which were implemented in early March in an attempt to avoid stricter measures, were unable to curb the spread of the virus. Macron was hesitant to impose nationwide restrictions, resisting calls from experts for tougher measures since January.  

“The outlook is worse than frightening. We’re already at the level of the second wave, and we’re quickly getting close to the threshold of the first wave,” said Jean-Michel Constantin, head of the intensive care unit at the Pitié-Salpêtrière hospital in Paris, in an interview on RMC radio on Monday. 

According to the French Health Minister, Olivier Veran, France could reach the peak of the epidemic in seven to 10 days, “then we need two extra weeks to reach a peak in intensive care units (ICUs) that could occur at the end of April,” he told Inter radio on Thursday.

“We have endured a year of suffering and sacrifice, but if we stay united and organized, we will reach the end of the tunnel,” said Macron. “April will be a critical month.” 

France’s vaccination campaign is seen as the path out of the pandemic and will be accelerated in the coming weeks, according to Macron. France, along with the rest of the European Union, was plagued by a slow rollout of vaccines due both to shortages as well as a lack of a well-coordinated health sector response in many countries, with systems that are either highly fragmented or else too centralized to permit for smooth and efficient rollouts at the local level.   

WHO Calls Europe’s Vaccination Program “Unacceptably Slow”

Amidst rising infection and death rates in the WHO European region, which encompasses 53 countries, the region’s vaccine “rollout is unacceptably slow,” said Hans Kluge, the WHO Regional Director for Europe, in a statement released on Wednesday.

Europe has recorded 1.6 million new cases and close to 24,000 deaths in the last week, quickly nearing one million total deaths. It is the second most affected region by SARS-CoV2 in the world. The B.1.1.7 variant has a greater public health impact and requires numerous measures in place to control it, said the statement. 

Currently, 27 countries in Europe are under partial or nationwide lockdown and 23 have tightened restrictions over the past two weeks. However, some 13 countries have ease measures and nine plan to follow suit. 

“My message to governments in the region is…that now is not the time to relax measures. We can’t afford not to heed the danger,” said Kluge. “We must keep reining in the virus.”

Hans Kluge, WHO Regional Director for Europe.

“Vaccines present our best way out of this pandemic,” Kluge said. However, “as long as coverage remains low, we need to apply the same public health and social measures as we have in the past to compensate for delayed schedules.”

In addition to implementing public health measures to limit transmission, efforts must be made to scale up vaccine production and administer as many jabs as possible, as quickly as possible. 

“We must speed up the process by ramping up manufacturing, reducing barriers to administering vaccines, and using every single vial we have in stock, now,” said Kluge. 

Only 10% of the region’s population have received one dose of a COVID-19 vaccine. While there has been a shortage of vaccines, countries must avoid vaccine nationalism and hoarding supplies, the statement said. 

Once a nation’s healthcare workers and vulnerable individuals have been vaccinated, Kluge urged governments to “share excess doses of WHO-approved vaccines with COVAX or with countries in need” in order to ensure that healthcare workers and older individuals in every country are inoculated. 

This message was echoed by Dr Tedros Adhanom Ghebreyesus, WHO Director-General, at a press conference on Thursday, who made an “urgent request to countries with surplus vaccines that have WHO emergency use listings to share 10 million doses with COVAX.”

In order to reach the goal of vaccinating all healthcare workers in the first 100 days of 2021, rich countries have nine days remaining to to donate excess doses to the COVAX facility, which has run out of doses at a critical time.

WTO Head Says Pharma Companies Should Either Scale Up Manufacturing Or Share Know-How with LMICs

Meanwhile, the new Director-General of the World Trade Organization (WTO), Ngozi Okonjo-Iweala, called it “unacceptable” that low- and middle-income countries (LMICs) were being left at the “end of the queue” for COVID-19 vaccines. 

“The kind of inequities we see in vaccine access are really not acceptable, you can’t have a situation in which…10 countries have administered 70% of vaccine doses in the world, and there are countries that don’t have one single dose,” said Okonjo-Iweala at a WTO trade forecast press conference on Thursday. 

Ngozi Okonjo-Iweala, Director-General of the WTO, at a press conference on Thursday.

She urged pharma companies to follow AstraZeneca’s lead in making deals with production facilities in LMICs to expand the manufacturing capacity for their vaccines. 

“Let’s have the same kind of arrangement that AstraZeneca has with the Serum Institute of India,” the world’s largest vaccine manufacturer and the main source of COVID-19 vaccines for LMICs, Okonjo-Iweala said. 

Voluntary licensing of technology could begin to address the inequity in access to vaccines, she said. 

While an intellectual property waiver for certain COVID-19 tools and technology – designed to allow more drug manufacturers to make the vaccines and improve access – is under consideration by WTO member states, Okonjo-Iweala said this was an issue for the next pandemic. 

Instead of pursuing the WTO TRIPS waiver, the focus now to meet the threat from COVID should be put on enlarging manufacturing capacity, she said.

Image Credits: France24, Flickr – International Monetary Fund, BBC.

The obesity pandemic is in “the same room” as the COVID pandemic in terms of its threats to health – putting people at greater risk of premature death from multiple causes, including SARS-CoV-2, the virus that leads to COVID-19. And ever since stay-at-home measures became routine, people have gained even more weight – up to 1.5 pounds a month according to one recent US study. Yet countries have the tools to address obesity, note Trish Cotter and Dr. Nandita Murukutla at Vital Strategies, a global public health NGO. We spoke to Ms. Cotter and Dr. Murukutla to find out more: 

Health Policy Watch (HPW): A third of the global population now suffers from overweight, and rates of obesity are growing across the world, including in poor countries. How can we explain these trends? 

Vital Strategies (VS): Over the last 40 years, obesity rates around the world have ballooned. High-income countries, like the United States, were the first to experience substantial weight gains of their populations, but the 21st century has seen that phenomenon spread to all parts of the globe. Now, the average adult is three times as likely to be overweight as the average adult in the 1970s.

There are a number of reasons for this alarming trend, which began well before COVID-19, starting with the environments in which people live, as well as poverty, discrimination, increasing availability of unhealthy foods in schools, dwindling levels of physical activity, and a lack of knowledge of unhealthy diets and products.

However, the fundamental reason is the rapid change in our diets and the broader food environment. Ultra-processed products or “junk food”, such as soft drinks, ice creams, or prepared frozen dishes, are one of the key drivers of growing obesity worldwide. They are high in sugar, salt and fat and, unfortunately, widespread in most societies. Yet their harmful effects are poorly understood.

One in three people worldwide are overweight

HPW: Why are ultra-processed foods so ubiquitous? 

VS: They are cheap, easily available, and because of additives and preservatives, they have a long shelf-life. They’re made to feel and look attractive, and they’re made to taste good. Importantly, they’re also hyper-marketed by the food industry. 

Advertising campaigns are very good at making unhealthy products seem part of the fabric of society: unhealthy foods are made to seem crucial to family gatherings and entertainment, so they become part of the social norm that normalizes unhealthy foods. And much of the advertising around unhealthy foods is so enticing that it gets children hooked at a young age.

In what ways is advertising of ultra-processed products misleading? 

Unhealthy products are often marketed cleverly as convenient substitutes for healthy, minimally processed options that include whole grains, fruits and vegetables. They are marketed as convenient breakfast foods, snacks, juices, and sometimes they are also marketed as being more sanitary than fresh fruits and vegetables. But that’s misleading, because current evidence demonstrates that ultra-processed products result in worse diets and ultimately overweight and obesity, which exacerbates the risk of contracting a range of chronic diseases as well as suffering poorer outcomes from infectious diseases like COVID-19. Claims that ultra-processed products are healthy alternatives are untrue. 

 Can you give a concrete example of a strategy that misleads customers into thinking they’re buying healthy products? 

Labels on the front and back of food packages are often really hard to accurately decode. And many of these labels use clever algorithms to hide unhealthy levels of sugar, salt, and saturated fat. Customers may not always realize that the product they are buying is unhealthy.  

Late last year, you co-authored a guide to help policymakers introduce clear, yet highly effective warning labels on foods and beverages to nudge customers away from unhealthy foods. How do these warning labels work?

Front-of-Package (FOP) nutrient labels, sometimes called warning labels, tell consumers immediately, on the front of products, and simply when a product contains high levels of unhealthy nutrients. That means customers don’t need to spend several minutes trying to work out whether each product is healthy or not. This system is simple, visual, and easy to understand. And it is effective, as seen from studies across the world, in triggering immediate behavior change.

The front-of-package labels serve as behavioral nudges, protecting people from making unintended unhealthy purchases. In other words, the warning labels work by reminding consumers that the products they are purchasing are unhealthy, thus nudging them to make healthier choices. But they also have important knock-on effects: they help change social norms around unhealthy eating.   

Example of warning labels on food products in Chile to nudge customers away from unhealthy foods. Translation from top-left to bottom-right: high in calories; high in sugars; high in sodium; high in saturated fats. Source: Ministry of Health of Chile.

You mentioned that warning labels can help change social norms that promote the consumption of unhealthy foods. Can you unpack that?

One study found that children pestered their parents to buy healthier products that did not have warning labels, partially because teachers at school would not accept unhealthy snacks. In some cases, teachers would even confiscate unhealthy snacks brought by children. This suggests that something as simple as a warning label can challenge the idea that ultra-processed products are desirable, and start to change the social norm.  

It’s also important to reiterate that warning labels are a highly cost-efficient approach because you’re able to target consumers rapidly, constantly, and at the point of decision making to make a purchase or not, with little to no cost to the government. 

And the costs of not addressing obesity during the pandemic could amount to $US 7 trillion by 2025, according to the latest review by the World Obesity Federation. Furthermore, out of a total of 2.5 million deaths from COVID reported as of February, 2021, 2.2 million were in countries where over half of the population is overweight. 

Countries with high proportions of overweight people had coronavirus death toll that were ten times higher than those with low proportions of overwheight people

So far, six countries including Chile have legally mandated warning labels, although many have put in place “voluntary” systems. How well do the voluntary systems work ?

The voluntary systems, which do not legally mandate warning labels on every single food product, are not effective. As warning labels may reduce sales of unhealthy foods, the food industry is unlikely to take them up. That’s why mandatory regulations on warning labels are crucial if we want to make a real dent into obesity and overweight. We’ve seen these warning labels work very well in Chile where they contributed to a decrease in the consumption of sugar-sweetened beverages by almost 25%. This was achieved through a comprehensive approach to addressing obesity, which also included: restrictions on child-directed marketing of unhealthy foods and beverages on the radio, television, cinema, and internet; a ban of unhealthy foods and beverages in schools and daycare; and a tax on sugary drinks.

 What kinds of labels work best?  

There are two broad categories of labels. The first category, the so-called “reductive” labels, outline how much of each nutrient is contained in foods, but they don’t help the consumer decide whether the product is healthy or not. These labels are less effective. The second category of labels, the so-called “interpretive” labels, are much more effective. They draw attention to the nutrients of concern or summarize the overall healthfulness of the product. Thus, they can help consumers distinguish between healthy and unhealthy products immediately through clear visual cues. 

The so-called “interpretive” labels can help consumers quickly identify nutrients of concern in food products to make healthier decisions

What are the challenges to getting countries to act? 

Although a number of high-level commitments have been made to fight obesity, including the inclusion of a target in the SDGs , The UN High-Level Meetings on NCDs as well as the UN Decade of Action on Nutrition, a lot more can and needs to be done. But that said, there is very strong industry pushback, and that’s also not surprising. We have seen decades of this with regard to other issues like tobacco control. Industry pressure cannot be underestimated and industry interference is often what holds governments back. However, governments should not feel powerless to take on food policy. The tools are out there to help them do this effectively and cheaply.  

Are there any other policies that can be used alongside mandatory warning labels to cut obesity and overweight?  

Sugary drinks taxes are among the most effective and cost-efficient ways to reduce access to unhealthy foods. Marketing restrictions and the removal of misleading advertising, especially in schools and environments in which children reside, is crucial. Bans on unhealthy products in schools can also help. 

We also need to ensure that healthy food becomes the default option by making sure that it’s easily available and cheap enough to buy – and at the same time ensure that unhealthy foods like ultra-processed foods are less available. 

And as mentioned earlier, it’s important to change those social norms around unhealthy foods so that they’re not associated with what marketers want you to associate them with – families, warmth, love, sports –  and all of the things that bring people together. 

Where do we go from here? And let’s be honest that food labels are not a panacea – what about access to healthier diets generally, which are often more expensive than unhealthy diets. And what about environments where people can be physically active?

With more than one-third of the world’s population overweight or obese, and the COVID-19 pandemic revealing deep structural inequities in food environments, the push to combat obesity has become more urgent than ever. Many individuals are powerless in the face of food shortages and the over-availability of cheap ultra-processed foods. The onus is on governments to act, and to act now. There were a number of factors, from environmental, structural to social, that brought us where we are today, and we will likewise need a concerted and cohesive set of actions to reverse these trends. FoP warning labels are a strong place to start.

Read more here on Vital Strategies’ new guide to help policymakers design and implement warning labels on foods and beverages.

Trish Cotter, MPH, Global Lead, Food Policy Program and Senior Advisor, Vital Strategies
Dr. Nandita Murukutla, Vice President for Global Policy and Research, Vital Strategies

Image Credits: University of Michigan, World Obesity Federation, Vital Strategies, Food Standard Agency, Vital Strateggies, Vital Strategies.

The Nigerian government has ditched the AstraZeneca COVID-19 vaccine and will soon shift to the Johnson & Johnson’s one-shot vaccine.

 

EXCLUSIVE – IBADAN – The Nigerian government has quietly ditched the AstraZeneca COVID-19 vaccine meant to vaccinate tens of millions of citizens, and will gradually shift to the Johnson & Johnson’s one-shot vaccine, saying it is easier to administer.

Documents from the Nigerian Primary Healthcare Development Agency (NPHCDA) obtained by Health Policy Watch show that the agency intends to begin rolling out the J&J vaccine to almost 30 million people as soon as it can obtain the vaccine supplies. 

While denying that safety concerns are an issue, the Nigerian government’s move also comes amidst growing global concerns about AstraZeneca’s efficacy against the SARS-CoV2 virus variant first identified in South Africa, as well as safety concerns that have led to the suspension of AstraZeneca vaccines for people under the age of 60 in Germany, and elsewhere (see related story).  

Nigeria had already commenced the rollout of  the AstraZeneca vaccine, with vaccines supplied by the WHO co-sponsored COVAX initiative. The country was meant to get more AstraZeneca supplies though the African Medical Supplies Platform (AMSP) – having already placed the largest order on the continent through the AMSP, as previously confirmed by the Africa Centres for Disease Control (CDC).

However, according to the documents, the AstraZeneca vaccine doses reserved through the AMSP will be replaced with Johnson & Johnson vaccines. “Based on this, Nigeria’s total allocation is now 29,850,000 of Johnson & Johnson (Janssen) COVID-19 vaccine which is one dose shot to cover 29,850,000 eligible Nigerians as originally planned,” the agency stated. That would be enough to cover about 15% of Nigeria’s population of 200 million people.  

Government Says J&J ‘One Jab’ Vaccine, not Safety Worries, Are Behind Shift 

Government officials in Nigeria attributed the shift to J&J’s to the vaccine’s single jab technology – which will make it much easier to administer as compared to AstraZeneca’s two-dose shot – as well as ensuring the vaccine coverage stretches even further. They denied that it was linked to issues of safety and efficacy. 

However, behind the scenes, another factor is the J&J vaccine’s documented efficacy against the B.1351 virus variant identified in South Africa – and now spread to some 16 other countries on the continent, including nearby Ghana. 

South Africa on Monday announced that it has secured 30 million J&J vaccines after a small  clinical trial and genomic surveillance showed the AstraZeneca vaccine was not strongly effective against that variant. 

In an earlier advisory, the Africa CDC stated that African countries where the B.1351 variant is the predominant SARS-CoV-2 strain should consider swapping the AstraZeneca vaccine for others that have shown more efficacy.

Neither the AMSP or the Africa CDC could confirm when the J&J doses will become available.  A recently announced J&J commitment to supply some 400 million vaccines to Africa is only scheduled to get into motion in the third quarter of 2021. Meanwhile, the continent continues to call for vaccine equality, fair distribution and local vaccine production.

Nigerian Regulator’s Nod

Government officials have continued to assure citizens of the safety of the vaccine despite global concerns – as  it continues to roll-out the available AstraZeneca doses while it awaits the J&J vaccines.  

On Feb 18, just a few days after Nigeria received its first shipment of the AstraZeneca vaccine, the country’s drug regulator, the National Agency for Food and Drug Administration and Control (NAFDAC) approved the vaccine for emergency use. 

“The recommendation for Emergency Use Authorization was based on rigorous scientific considerations,” NAFDAC stated.

Addressing a recent webinar on COVID-19 Vaccines, Dr. Faisal Shuaib, Executive Director/CEO of NPHCDA, acknowledged that the controversy around the vaccine’s safety, but urged countries in Europe and globally to continue vaccine administration as it is safe and effective.

Prof Mojisola Christianah Adeyeye, NAFDAC’s Director General added that safety of the vaccine is primary to the agency and that it would be using its Med Safety App for Active Pharmacovigilance of the vaccine. 

Immunisation Drive Continues

As at March 31, over 718,000 Nigerians had received the first doses of the available AstraZeneca vaccine supplies; coverage ranges from an over-the-top 104% target of priority patients reached in Kwara state to none at all in Kogi state – where a vaccine-hesitant  government is only just now succumbing to pressure to allow citizens to receive the vaccine. 

But a cross section of health experts speaking at the recent Nigerian Academy of Science webinar said the bad publicity around the AstraZeneca vaccine might also have harmed vaccination in general. Recent news emanating from Europe has made the general public more suspicious of the potential lethal effects of the jabs – in addition to widespread misinformation circulating on social media. 

Dr Yahya Disu, Head of Risk Communication at the Nigeria Center for Disease Control (NCDC), said recent surveys show broad acceptance of vaccines among Nigerians and this is expected to ensure the country quickly achieves herd immunity – provided sufficient vaccines are made available.  Disu said 86% of respondents of the surveys said they would still continue preventive measures such as wearing face masks, handwashing and social distancing even after receiving the vaccines.

Pfizer and its German partner BioNTech say their COVID-19 vaccine is safe and protective in children as young as 12.

The Pfizer-BioNTech COVID-19 vaccine is safe and protective in children as young as 12 with no serious side effects in adolescents who received the vaccination, the company said on Wednesday.

Interim results of a recent clinical trial of some 2,260 adolescents ages 12-15 years old was published by the pharma company – although it has not yet undergone peer review. The adolescents who participated in the trial produced strong antibody responses and experienced no serious side effects, the company said, saying the vaccine had demonstrated “100 % efficacy”.

Pfizer and its German partner BioNTech plan to ask the U.S. Food and Drug Administration and European regulators to allow emergency use of the shots among adolescents, beginning at age 12. Pfizer’s vaccine is already authorised by regulatory authorities for teens ages 16 and older.“We share th e urgency to expand the use of our vaccine,” Pfizer CEO Albert Bourla said in a statement. He expressed “the hope of starting to vaccinate this age group before the start of the next school year” in the United States.

Pfizer isn’t the only company seeking to lower the age limit for its vaccine. Results also are expected soon from a U.S. study of Moderna’s vaccine in 12- to 17-year-olds. Another vaccine study of safety and efficacy in children ages 6 months to 11 years is also underway, but that has yet to yield preliminary results.

See the full release here.