Display in Marburg Germany of the BioNtainer container that will be shipped to Africa to jump-start mRNA vaccine manufacturing on the continent.

The German-based BioNTech, which co-developed with Pfizer an mRNA COVID vaccine, said on Wednesday that it will set up modular “turnkey” mRNA vaccine facilities to produce the vaccine in Rwanda and Senegal in 2022 – with a fill-and-finish collaboration in Ghana as well.  South Africa, which is the new hub for the WHO-supported mRNA vaccine R&D and manufacturing hub focusing on open-access products- may also join the initiative later, said the company in a press release.

Speaking at a press briefing Wednesday morning, which included the presidents of Rwanda, Ghana and Senegal, as well as WHO and Africa CDC, BioNTech CEO Ugur Sahin, described the new cutting-edge BioNTainer initiative for vaccine production as  – following “the most elementary principle of reducing complexity by copying the manufacturing units having modular action unit and by copying the process and transferring it to another place.

“But this is not about innovation alone, it it is about collaboration,” Sahin added, “for example, implementation of the manufacturing side, about regulation, about supply of vaccines… no one can do it alone, we have to do it together,” Sahin said.

He said that the first containers would be delivered to Africa in mid-2022 “and we want to start with the manufacturing of the first vaccine batches in the first months after we deliver the containers.” The new production facilities are designed to produce not only COVID-19 vaccines, but other “future vaccines” in the planning for malaria, tuberculosis and HIV:

“If these vaccines are successful and approved they will be produced in Africa, and these containers can be useful.”

Welcomed by African leaders

Left to right: BioNTech CMO Özlem Türeci and CEO Ugur Sahin; with African heads of state, Nana Akufo-Addo (Ghana); Macky Sall (Senegal) and Paul Kagame (Rwanda) and WHO’s Director General Tedros Adhanom Ghebreyesus; and kNUP’s Holm Keller at BioNtech briefing on new BioNTainer plug-and-play facility.

The initiative was roundly welcomed by the heads of Ghana, Senegal, Rwanda  – all of whom were present at the briefing – as well as the heads of WHO and Africa CDC.

“Today is a historic day. Today, we are putting an end to the vaccine injustice that has occurred during the pandemic, where Africa was left by the wayside,” said Senegal’s President Macky Sall, who opened Wednesday’s public briefing in Marburg, Germany, where the three African heads of state had been meeting with BioNTech officials over the past several days on the BioNtainer concept.

“Thanks to the innovation of BioNtech, with the BioNtainer, we are going to transfer the technology to Africa, to produce the API for the mRNA vaccines, along with the fill-and-finish.  And  we can thus be able to produce COVID-19 vaccines, as well as having the potential to produce vaccines for other diseases,” he said.

“We commend this cooperation between Europe and Africa, between BioNTech and African countries, as well as foundations and development banks that are providing the financial backing, so that we can very soon produce these vaccines on our continent.”

Africa CDC head John Nkengasong also welcomes the new BioNTech initiative

Meanwhile, Africa CDC head John Nkengasong praised BioNTech for “showing leadership” on the innovative ‘turn key’ production facilities, saying, “You are teaching us how to fish, and not giving us a fish….The African Union and Africa CDC will continue to work with you in this journey.”

And Ghana’s President Nana Akufo-Addo, said his country would be dedicating it’s National Vaccine Institute to support the initiative to develop “partnerships for vaccine deployment and manufacturing in areas of funding, clinical trials and fill-and-finish capacity.”

Ghana will set up a fill-and-finish facility soon, he said, in order to perform the last step of the BioNTech process – to be completed outside of the modular vaccine factory containers.

BioNTainer concept explained at BioNTech press briefing on Wednesday 16 February 2022

WHO affirms initiative has African “ownership”

Meanwhile, WHO’s Director General Dr Tedros Adhanom Ghebreyesus expressed support for the new project – despite the criticism that had been levelled at it in a recent BMJ investigation, which had portrayed it as a potential competition to the new WHO-supported mRNA vaccine manufacturing hub set up in South Africa, which aims to promote an open-license approach to vaccine manufacturing – in contrast to collaborations built around the bilateral licensing of patented products, such as Pfizer’s.

Tedros visited the South African mRNA hub, which has replicated a version of the Moderna mRNA vaccine, just last Friday.

“Many colleagues have been discouraged about the success of this project,” said Tedros, in an oblique reference to the earlier criticism levelled at the notion of shipping ready-made vaccine facilities in containers to Africa. He underlined that the endorsement by African national and African Union leaders shows that the BioNTech initiative is viable:

“Their presence shows political commitment, their presence shows ownership. And when projects are owned and political commitment is provided from the leaders, projects normally succeed…. failure is not an option for this project, from what I observed,” said Tedros.

‘Miniaturized’ and standardized mRNA production

BioNTech COO Sierk Poetting at a meeting briefing on the BioNTainer initiative.

The new manufacturing systems effectively takes advantage of the comparatively small size of mRNA vaccines inputs, and their unique production technology, to “miniaturize” and standardise the vaccine production process, said BioNTech’s BioNTech Chief Operating Office (COO) Sierk Poetting at a press conference later Wednesday afternoon.

He said innovation had been developed at Pfizer’s Marburg, Germany facility, which is Pfizer’s largest manufacturing operation, and would also now serve as global quality control center for the plug-and-play systems sent to Africa.

The modular facilities would be built of ISO-standard 40 foot containers “We can put them on trucks, boats, or planes and ship those manufacturing BioNtainers to the world, to the target locations,” said Poetting.

“The power of the mRNA drug class is that it is versatile and can be prepared rapidly,” said Sahin, noting that the facilities would also serve the production of future mRNA vaccines under development by Pfizer for other diseases.

Turnkey facilities will be pre-approved as GMP complaint in Germany

Turnkey facilities will be pre-approved as GMP compliant in Germany and then shipped to Africa – BioNTech CEO Sahin

Sahin said that the modular facilities could be pre-approved as GMP compliant at Pfizer’s Marburg, Germany plant where the turnkey solution was developed – and which will supervise the initiative:

“The turnkey package includes the modular production unit, GMP compliance set up, and personnel training to ensure that we can transfer the technology,” he explained.

“The elements of the container-based, plug-and-play approach was modular design.. by having this standardized design, we can ensure that the facility, once approved somewhere, can be transferred to another place, and with a little additional work, the process can be GMP [compliant].

That means that the facility would be built and pre-approved to meet European manufacturing requirements, and once transferred to Africa, could be quickly approved by national regulatory processes as well, ensuring a quick start to manufacturing, said Sahin.

Turnkey facility includes “plug and play” production meeting GMP standards, said BioNTech’s Ugur Sahin, at the press conference.

 

There would be six containers  – six for producing the active pharmaceutical ingredient and six more for producing the final drug product. They would be set up in an air-conditioned factory hall, equipped with refrigeration and other basic infrastructure, Poetting explained.  ‘Fill and finish’ would take place at other sites in collaboration with national and local African partners.

Sahin said that the first facility would be set up in mid-2022, with the aim of being fully operational by the end of the year.  The facilities could produce up to 50 million doses a year – although actual production would vary by demand. Products would be sold at cost in African Union countries.

“The goal of the BioNtainer is to reduce the cost and the speed of the development of manufacturing facilities, and provide a solution which is suitable for the needs of people living in this region,” said Sahin.

Did BioNTech’s kENUP consultants try to undermine South Africa’s mRNA vaccine hub?

Tedros visits Stellenbosch University’s Biomedical Research Institute & Centre for Epidemic Response & Innovation on 11 February, 2022, part of South Africa’s WHO co-sponsored mRNA vaccine hub.

Asked why BioNTech had decided not to share Pfizer’s vaccine technology with the new WHO-supported mRNA vaccine tech transfer hub in South Africa, Poetting said that the company would collaborate by taking staff that are trained there to help manage the new BioNTech manufacturing facilities – which would initially be staffed by Pfizer’s European teams.

“We will onboard the local teams and do the knowledge transfer and the production together,” Poetting said, adding, “we are actually collaborating with the transfer hubs. We will work together with the transfer hubs on staffing the units, on training the units, and for distribution of the units” he said. But for actual production processes, the BioNTainer facilities could be set up and become operational sooner, he asserted.

Meanwhile, Sahin refused to comment on the recent allegations, published in The BMJ that the  kENUP Foundation, a BioNTech consultancy that helped develop the BioNTainer initiative, had actually sought to undermine the South African tech transfer hub – which along with training African scientists and technicians also aims to develop open-access versions of mRNA vaccines.

Holm Keller of the kENUP Foundation, moderating BioNTech’s launch of its new “BioNTainer’ initiative on Wednesday; kENUP is also alleged to have sought the “termination” of the WHO-supported South African mRNA hub.

According to The BMJ, kENUP had sent a mission report to the South African government after a visit last August, saying that the hub’s project “of copying the manufacturing process of Moderna’s COVID-19 vaccine should be terminated immediately. This is to prevent damage to Afrigen, BioVac, and Moderna . . .

“Provided that the release from patent cover will be granted by Moderna only during the pandemic, the sustainability outlook for this project of the WHO Vaccine Technology Transfer Hub is not favourable,” stated the report, obtained by The BMJ.  Scientists at Afrigen have since said that they managed to replicate the Moderna mRNA vaccine – without assistance from the US-based pharma firm, which has nonetheless promised not to enforce its patents on its COVID-19 vaccine during the pandemic.

“We can’t comment on behalf of kENUP, and also not on behalf of WHO,” Sahin said.  “We can just state that at the moment several projects with the same goal are underway, and we welcome any projects with the same goals.  What is important at the beginning, of course, to understand the overall framework, and what are the specific aspects of the individual partners, and identify ways to collaborate.”

New projects on African continent – a turning point…

In fact, the silver lining in the vaccine inequalities in Africa, sharply highlighted by the COVID pandemic, is the surge of new vaccine manufacturing initiatives, said Greg Perry, Assistant Director of the International Federation of Pharmaceutical Manufacturers and Associations, in a comment to Health Policy Watch.

“What is significant is how much is happening on the African continent, and much from private sector, from J&J ‘s agreement with Aspen Pharmacare, to the BioNTech- Biovac partnership on manufacturing and distribution activities, to the various BioNTech actions announced today,” he said.

He made his comment shortly after the new head of Tanzania, formerly one of the continent’s most COVID vaccine-hestitant countries, said that it, too, would like to set up a vaccine manufacturing plant to tackle COVD and other diseases.  New President, Samia Suluhu Hassan described her plans at a meeting with European Union President Charles Michel in Brussels, BBC reported.  Meanwhile, in Nigeria, a vigorous debate over the creation of a national vaccine manufacturing initiative is also underway.

“We should be open to all these initiatives,” Perry said. “But what is key is that are long term, sustainable, and based on voluntary  partnership.  Moreover  they will all face the same challenges,  needs for skills and regulatory support; long- term financing and demand stability. It’s these real challenges and solutions we are talking about in Brussels this week at the European-African Business Forum,” he said, referring to a pharma meeting ongoing this week ahead of European Union-African Union summit.

Ont the other side of the fence, pharma critics that have looked at the South African mRNA hub, as the seedling from which new patent-free modes of vaccines manufacture might take root and flourish on the continent, were not so enthusiastic about the new BioNTech initiative.

“When local production in Africa is done under monopoly control of Pfizer/BioNtec, how does that increase technological autonomy and resilience?” asked Els Torreele, a visiting fellow at the Institute for Innovation and Public Purpose at University College London, in a tweet.

https://twitter.com/ElsTorreele/status/1493974017967067142

Image Credits: BioNTech, BioNTech , @StellenboschUni, BioNTech Press conference .

depression homelessness
Street scene in Metro Manila, Intramurous district, Philippines. 80-90% of those with depression are left untreated or undiagnosed in low- and middle-income countries. Homelessness is one adverse experience that may cause depression.

With about half of people suffering from depression in high income countries untreated or undiagnosed, with this number rising to 80-90% in low- and middle-income countries, a Lancet and World Psychiatric Association Commission have called for a unified response against this global crisis to reduce the burden of depression.

Depression is estimated to impact 5% of adults globally, with its onset most frequent in young people. COVID-19 has caused ‘mass trauma’ worldwide and has further worsened mental health for millions, creating additional challenges with isolation, bereavement, uncertainty, hardship, and limited access to healthcare. 

To combat the crisis, the Commission’s ‘Time for united action on depression’ calls for a concerted and collaborative front from all – government, healthcare providers, researchers, and people living with depression, to improve care and prevention, fill knowledge gaps, and increase awareness for one of the leading causes of avoidable suffering and premature death worldwide. 

“Depression is a global health crisis that demands responses at multiple levels,” said Commision Chair Professor Helen Herrman.

“This Commission offers an important opportunity for united action to transform approaches to mental health care and prevention globally.”

The report is authored by 25 experts across 11 countries, from experts in neuroscience to global health. It is advised by people with experience of depression. 

Myths surrounding depression fuel inaction 

Myths surrounding mental health have fueled inaction.

While 70-80% of people who die by suicide in high income countries, and around half in LMIC, suffered from mental illness, with depression as the most common cause, myths surrounding this health condition have fueled global inaction towards depression. 

The myths include the misconception that depression is simply sadness, a sign of weakness, or restricted to certain cultural groups.

Depression also has an under-recognized social and economic toll, with the loss in economic productivity linked to depression costing the global economy an estimated $1 trillion a year. 

“There is arguably no other health condition which is as common, as burdensome, as universal, or as treatable as depression, yet it receives little policy attention and resources”, said Commission Co-Chair Associate Professor Christian Kieling, of the Brazil-based Universidade Federal do Rio Grande do Sul. 

The Commission does stress that depression is distinctly a health condition that is characterized by persistence, as it inhibits daily functioning and may lead to long-term health consequences. Depression may also impact anyone, regardless of gender, background, social class, and age, though symptoms and signs of depression may vary among groups.

Society and individual strategies proposed 

Mental health services for children and adolescents have been disrupted due to COVID-19. Solutions to reduce the global burden of depression need to prevent adverse experiences in childhood.

Whole-of-society and individual level strategies have been proposed by the Commission to prevent depression, focusing on reduced exposure to adverse experiences in childhood, lifestyle factors, and other stressful events, including financial crisis or bereavement. 

“Prevention is the most neglected aspect of depression. This in part because most interventions are outside of the health sector”, said co-author Dr Lakshmi Vijayakumar from SNEHA, Suicide Prevention Centre and Voluntary Health Services of Chennai, India.

Vijayakumar further noted how crucial these prevention efforts are. 

“In the face of the lifelong effects of adolescent depression, from difficulty in school and future relationships to risk of substance abuse, self-harm, and suicide, investing in depression prevention is excellent value for money. 

It is crucial that we put into practice evidence-based interventions that support parenting, reduce violence in the family, and bullying at school, as well promoting mental health at work and addressing loneliness in older adults.”

Current classification of depression is ‘too simplistic’ 

The current classification that places people with symptoms of depression into just two categories – either they have clinical depression or not – remains too simplistic, says the Commission. 

Instead, the Commission supports a personalized, staged approach to depression care that tailors and recommends interventions to the individual and the severity of their condition. These treatments range from self-help to lifestyle changes to psychological therapies. 

“No two individuals share the exact life story and constitution, which ultimately leads to a unique experience of depression and different needs for help, support, and treatment”, explained Commission Co-Chair Professor Vikram Patel from US-based Harvard Medical School. 

In addition, the Commission also proposes collaborative care strategies that incorporate locally recruited, widely available non-specialists such as community health workers and lay counselors. 

Ultimately, they conclude that greater investment is needed on behalf of the government to reduce the damaging impact of poverty, gender inequity, and other social inequalities on mental health.

Said Patel: “Tackling the climate emergency, the COVID-19 pandemic and other global and regional emergencies that exacerbate existing inequities and threats to health, including pursuit of the UN Sustainable Development Goals, must also be vital parts of efforts to prevent depression.”

Image Credits: Wayne S. Grazio, Nenad Stojkovic/Flickr, WHO/NOOR/Sebastian Liste.

US Secretary of State Antony Blinken

CAPE TOWN – The US and Africa intend to use the well-established community networks supported by the President’s Emergency Plan for AIDS Relief (PEPFAR) to improve the uptake of COVID-19 vaccines in Africa.  The initaitive would build upon the infrastructure developed since PEPFAR entered as a major player on the African AIDS scene in 2003. 

In addition, USAID has launched an initiative called Global VAX to support the World Health Organization (WHO) target of vaccinating 70% of the world’s population by mid-year against COVID-19, and will soon be announcing priority countries in Africa.

This is according to US State official Mary Beth Goodman, who briefed African journalists on Tuesday on the COVID-19 Global Action Meeting convened by US Secretary of State Antony Blinken on Monday.

“We’re leveraging opportunities through things like PEPFAR, which has an extraordinary network across the African continent in combating HIV/AIDS and has a network of community workers and leaders who are helping to work with us to also talk about some of the importance of COVID,” said Goodman, who is Acting Coordinator for Global COVID-19 Response and Health Security at the US Department of State.

“The same is true of our Presidential Malaria Initiative and other efforts that have long been in place on the continent.

“We actually have launched through USAID and the Centre for Disease Control, a programme that we’re calling Global VAX,” added Goodman. 

“The effort behind Global Vax is all about the uptake issues. How do we turn vaccines into vaccinations? How do we connect the dots to make sure that we are getting these vaccines distributed in a way that allows more people to have the opportunity to take the vaccine and that allows some of these countries which are lagging to meet the 70% target?”

Blinken’s six-point ‘GAP’ plan

Ghana, Africa
Ghanian health worker Evelyn Narkie Dowuona holds up her COVID-19 vaccination card.

Blinken presented a six-point COVID-19 Prioritized Global Action Plan for Enhanced Engagement (GAP) to foreign ministers and senior leaders from countries and international organizations invited to his virtual meeting.

“Together, we identified urgent gaps in response activities and aligned around specific roles to advance global efforts aimed at bringing this pandemic under control and strengthening readiness for future global health threats. We agreed that more political leadership is needed to save lives and end this pandemic cycle in 2022,” said Blinken in a statement issued late Monday.

He identified the “six lines of the global effort to respond to acute pandemic needs” as:

  • Getting Shots in Arms: coordinated efforts to improve vaccine readiness and logistics, in step with increased donations and procurement, toward the goal of at least 70% of the population fully vaccinated with quality, safe, and effective vaccines by September 2022. 
  • Bolstering Supply Chain Resilience: mechanisms to facilitate sufficient and steady supplies of critical products and materials to break this cycle of the COVID-19 pandemic, including establishing mechanisms to identify and remove medical supply chain bottlenecks.
  • Addressing Information Gaps: global efforts to enhance vaccine confidence and combat the spread of false information, enlisting regional champions and medical, civil society, young people, and faith leaders to use evidence-based, accurate, locally relevant messaging.
  • Supporting Health Workers: protecting the health, safety, and wellbeing of frontline health workers, including the need to improve their training and numbers to effectively support the COVID-19 response.
  • Ensuring Acute Non-Vaccine Interventions, including the provision of therapeutics, testing regimes, and oxygen where needed most.
  • Strengthening Global Health Security Architecture to end the current pandemic and. secure future preparedness for health emergencies at the national, regional and global level.

Blinken also announced a direct donation of 5 million doses of Johnson & Johnson’s COVID-19 vaccine to the African Vaccine Acquisition Trust (AVAT), the African Union’s vaccine procurement and distribution effort. The US has now donated more than 155 million doses to Africa and 435 million doses worldwide.

Praise for Uganda vaccine effort

Ugandan Health Minister Dr Jane Ruth Aceng (left) and French Ambassador to Uganda Jules-Armand Aniambossou with donated AstraZeneca COVID-19 vaccines.

In his address to the GAP meeting, Blinken praised Uganda for its massive vaccination effort in November and December last year as an example of what is possible.

“In early November, only 14% of all Ugandan adults had received their first dose of the vaccine,” said Blinken.

“Then a major team effort commenced. The Ugandan government led a mass vaccination campaign, carried out by hundreds of health care workers,” he added, and “by late December, almost half of all adults in Uganda had received their first shot – from 14 to 47% in just six weeks”.

Participants in the GAP meeting included  Australia, Canada, Colombia, France, Germany,  India, Indonesia, Italy, Japan, the Republic of Korea, New Zealand, Saudi Arabia,  Senegal, South Africa,Spain, UK, the African Union/Africa Centres for Disease Control, the European Commission, and the WHO.

They have all committed to coordinating parts of the six key areas identified.

Meanwhile, WHO Director-General Dr Tedros Adhanom Ghebreyesus told the meeting that “in some countries, high vaccine coverage, combined with the lower severity of Omicron, is driving a false narrative that the pandemic is over”.

However, the low vaccine coverage and low testing rates in other countries “are creating the ideal conditions for new variants to emerge”, warned Tedros, adding that 116 countries are off track to vaccinate 70% of the population by the middle of this year.

“We can bring the pandemic under control this year – but we are at increased risk of squandering that opportunity,” said Tedros, adding that “in many countries, the issues are not primarily a problem of absorptive capacity. We need to urgently support political leaders to accelerate the rollout of vaccines”.

Image Credits: WHO, Health Journalist Network.

A mother and her child in the Haji camp for internally displaced people in Kandahar, Afghanistan.

More and more children are losing their lives to a measles outbreak in Afghanistan as the country struggles with a humanitarian crisis under the US sanctions on the country’s Taliban regime.

Following the Taliban’s takeover of Afghanistan, the US Department of the Treasury froze Afghanistan Central Bank’s reserves, mostly held in US banks, as the Taliban has been on its “specially designated global terrorist group” since 2002, and any support for the group is illegal.

The measles outbreak has hit the malnourished children hard in some of the already marginalized and poor communities in Paktika, Ghor, Badakhshan and other provinces of Afghanistan.

The World Health Organization (WHO) last week confirmed that the number of cases and deaths increased by 18% in the week of 24 January, and 40% in the week of 31 January. Health Policy Watch reported last week that WHO Director-General Dr Tedros Adhanom Ghebreyesus met with the Taliban in Geneva to discuss Afghanistan’s health challenges.

Struggle for meals in the pandemic  

According to the global health body, as many as 35,319 suspected cases of measles and 156 deaths have been reported in Afghanistan between 1 January 2021 and 29 January 2022. Of these, 3,221 cases were laboratory confirmed while 91% of these cases and 97% of these deaths were in children under five years of age.

The WHO says that the rise in measles cases is especially concerning because of the extremely high levels of malnutrition in Afghanistan. This weakens immunity, making people more vulnerable to illness and death from diseases like measles – especially children.

Local civil society activist in Paktika, Abdul Bari, mentioned that with the fall of the previous government, thousands of people lost their jobs and could not support families for months now that ultimately led to malnourishment and spread of the diseases.

 “Many families who were doing relatively well in the past now find them among the so many very poor in the society that struggle to feed one or two meals in Paktika”, he said.

Authorities in Badakhshan province told the Health Policy Watch about an outbreak of measles worst affecting the remote Kuf Ab and Kohistan districts of the province where poverty is widespread.

“The measles outbreak has been spreading in the province for the past two months and has spread to ten districts, including the capital Faiz Abad”, he said, adding that so far no organization or health institution has come to their aid and many children have died due to the disease in Kuf Ab and Kohistan districts.

Equally remote and poor, Ghor province in the central highlands of Afghanistan is the second flashpoint for the measles outbreak according to the Afghan authorities. 

The provincial health department head, Mohammad Nazim, told the Health Policy Watch that more than a thousand children have been referred to the province’s central hospital recently and 21 of whom have died because of measles.

“The reason for the spread of measles is the non-implementation of the vaccination program firstly due to the coronavirus pandemic and then the security concerns and lack of funds”, he said.

 Crumbling Healthcare System

In December 2021, a measles outbreak response immunisation campaign was carried out with the support of the WHO in some of the most affected provinces, reaching 1.5 million children.

Battling for survival, Afghanistan’s fragile health system has been on the edge for months in the wake of the COVID-19 pandemic, the Taliban takeover of power and the subsequent US freezing of Afghanistan’s state reserves.

In Ghor, the regional public hospital sources said the doctors and support staff is so overstretched and under-paid that it can collapse any moment in the wake of mounting cases of COVID-19 and now the measles outbreak.

Kabul-based paediatrician Dr Zar Wali told the Health Policy Watch that malnutrition among children was severely compromising their immune system. “On a daily basis I am receiving dozens of child patients from the city (Kabul) as well as the nearby provinces, and there is this clear pattern of malnourishment in almost all, which makes them susceptible to all sorts of diseases”.

This was echoed by the UN Children Fund (UNICEF) last week when it warned that as the humanitarian crisis deepens in Afghanistan, hospitals were receiving so many cases each day of children suffering complications associated with severe acute malnutrition.

After relatively low transmission in 2019 and 2020, new infection cases have been increasing in all provinces since the end of July 2021, with the highest weekly toll observed so far occurring over the last four weeks.

The WHO has warned that although the number of deaths is relatively low, the rapid rise in cases in January 2022 suggests that the number of deaths due to measles is likely to increase sharply in the coming weeks.

Being endemic in Afghanistan, more than 25,000 children get killed by the measles virus annually, according to the Ministry of Public Health, and many more struggle with its impacts.

The WHO has expressed willingness to prepare a plan for a larger measles outbreak response immunisation campaign, which will start in May (or earlier, if possible), aiming to reach more than 3 million children in Afghanistan.

 

Image Credits: © UNICEF Afghanistan.

Margaret Ndomondo-Sigonda, Head of the African Medicines Regulatory Harmonisation Initiative at AUDA-NEPAD

The African Union could decide on the host country for the African Medicines Agency (AMA) as early as July, while the agency’s director-general should be appointed by the end of the year.

This is according to Margaret Ndomondo-Sigonda, Head of the African Medicines Regulatory Harmonisation Initiative at AUDA-NEPAD, the African Union’s development agency.

The AU Assembly had recently decided to “do an assessment of the countries that have offered to host the AMA headquarters”, she told a workshop convened by the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) on Monday ahead of the EU-AU Summit which starts in Brussels on Thursday.

“The AU Commission and AUDA-NEPAD are working together, and the teams are set to go out in the first week of March,” said Ndomondo-Sigonda, adding that the country visits may take two months to complete. 

“Once they are done, then the assessment report will be presented before the first meeting of the Conference of the State Parties that is planned to be held sometime in May,” she added.

Whatever decision is made by this body would have to go to the AU Assembly during its meeting in in June or July, “so by July we will know which countries actually hosting the headquarters for the African Medicines Agency,” she added.

The Assembly comprises of all Member State Heads of State and Government is the AU’s supreme policy and decision-making organ. 

Director-General may be appointed by year-end

As far as the appointment of the head of the AMA – its director general –  is concerned, this would take a little longer.

First, the Conference of the State Parties would have to consider the terms of reference for the position at its May meeting, and advertisements will only go out after that.

“By the time we get to know who has been appointed as the director-general, it will probably be quarter three or quarter four this year,” she said.

She added that AMA was being established as “a specialised agency of the African Union with its autonomy in terms of financial and human resources, so it’s going to be operating differently from what you see with Africa Centres for Disease Control at the moment”.

Meanwhile, UNAIDS Executive Director Winnie Byanyima welcomed the imminent establishment of the AMA.

“Since the very beginning of the COVID crisis, the multilateral response may have failed us but African leadership has been remarkable,” said Byanyima at a workshop on Monday. “The newly created African Medicines Agency will harmonise medicine regulations, and negotiate joint purchasing and the manufacture of our own medicines.”

A staff member at Afrigen, the mRNA hub in South Africa, prepares part of the vaccine.

The major players in the European and African pharmaceutical sectors have called on the European Union (EU) and the African Union (AU) to support the creation of a permanent “business platform” to foster the pharma industry’s development in Africa.

This emerged at a workshop Monday hosted by the the European Commission’s Directorate General for Internal Market, Industry, Entrepreneurship and SMEs (DG GROW) along with the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), and other European-based pharma associations. The workshop was part of the European African Business Forum (EABF) taking place ahead of, and along with, the European Union–African Union Summit, which begins Thursday in Brussels.

The business platform should support the development of EU and AU policies conducive to trade and “sustainable financing mechanisms models with access to low-interest capital” and appropriate incentives to encourage local, regional and international private sector investment, according to IFPMA Assistant Director-General Greg Perry, speaking at the Monday EABF session leading up to the Summit.

Businesses also want a “stable business environment that respects business ethics and incentivises local innovation and entrepreneurship, including through intellectual property, ensure development and retention of local skilled workforces”, said Perry, reading from a joint statement by the EABF’s Healthcare Working Group, which also includes the European Federation of Pharmaceutical Manufacturers and Associations (EPFIA) and Vaccines Europe.

The pharmaceutical sector also wants voluntary and mutually agreed upon technology transfers and joint ventures; timely product registration, harmonisation of regulation particularly through the African Medicines Agency, and the implementation of the African Continental Free Trade Area to eliminate non-trade barriers and foster international supply chain security.

“We believe that creating this platform with the support of the EU and the AU, we could facilitate African and European partnerships, support existing continental and regulatory initiatives and create a win-win for both Africa and Europe,” said Perry.

Where is the money that was promised?

Karim Bendhaou, who also chairs the IFPMA Africa Engagement Committee

Emmanuel Mujuru, representing the Federation of African Pharmaceutical Manufacturers (FAPMA), said that the African pharmaceutical industry was struggling to access affordable financing. 

“This financing has to both long-term in nature and have affordable interest rates, either in the form of loans or equity participation in already established African pharma management companies,” said Mujuru.

He added that there was a significant opportunity for European investors as between 70 and 90% of essential medicines consumed in Africa were imported and that the pharmaceutical sector was growing at over 10% per annum, second only to Asia. 

Merck’s Karim Bendhaou, who also chairs the IFPMA Africa Engagement Committee, said that while setting up fill and finish operations “is easy to implement in two years”, he had tried to do so in three different African countries but “local private sector investors have never been able to get access to any finance”. 

“Why? The International Finance Corporation has announced $4 billion for the local vaccine manufacturing and the European Commission has announced one billion Euros,” asked Bendhaou

“We also have to invest in the health system capacity because otherwise, you can have a nice factory in in South Africa, a beautiful factory in Egypt, producing hundreds of millions of doses but if you don’t have a health system in place for the uptake and to absorb this capacity,” he added.

What about Gavi subsidies?

Biovac CEO Patrick Tippoo

Meanwhile, Patrick Tippoo, CEO of the South African company, Biovac and part of the African Vaccine Manufacturing Initiative (AVMI) leadership, said that much of Africa’s vaccine supply “comes in a subsidised form, partially or completely by Gavi through UNICEF”. 

“We know that Gavi drives prices down to make vaccines more affordable so more vaccines can be purchased and therefore distributed,” said Tippoo

“We have a current situation where about 40 of the 54 countries depend on this mechanism. And therefore the market in Africa is actually in Copenhagen, as some people say. 

“This is a structural thing that will have to be addressed because, in order to stimulate and incentivize technology transfers, investment in skills, development, regulatory capacity building –  and all the things that we repeat ad nauseum – there needs to be an assurance that there’s going to be a market when all of this is built,” he stressed.

Tippoo added that African governments and other stakeholders had to understand that a “resilience premium” would need to be paid to ensure that pharmaceutical manufacturing capability is built in Africa.

“There is no way in which vaccines coming out of Africa in the next five or 10 years can compete on a cost of goods perspective, with Indian manufacturer factories, or even multinationals because they’ve monetised the investment over time, and they have economies of scale,” he added.

Diversification a ‘win-win’ for Africa, Europe and globally

However, other participants pointed out that over the long-term, diversification of sources for pharma procurement is going to be a win win, given the comparatively limited number of suppliers, for some key global health products. Interruptions to key medical supply chains were particularly evident during the early stages of the COVID pandemic, exposing their fragility, even for more affluent countries.

Sibilia Quilici, Executive Director, Vaccines Europe, pointed out that from the European perspective, too, it would be beneficial to reduce dependence on what is now a comparatively small number of suppliers, mainly from India and China, and integrate Africa’s supply chains with global ones:

“In the context of this discussion on improving manufacturing capacities in Africa, also for APIs [active pharmaceutical ingredients] it is good to be aware that the EU, the largest API importer in the world is looking for supply chain diversification for products where dependence on a small number of suppliers from India and China is a concern.

“This could be a win-win for Africa, EU, local and global industry”.

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

Scientific journals need to cut ties with breast-milk substitute makers and the formula industry if they want to protect infants and young children from being at risk of malnutrition, illness and death, according to a paper published by BMJ Global Health.

“The promotion and support of breastfeeding globally is thwarted by the USD $57 billion (and growing) formula industry that engages in overt and covert advertising and promotion as well as extensive political activity to foster policy environments conducive to market growth,” write the 16 authors, who are mostly paediatricians, nutritionists and child researchers based in South Africa.

“This includes health professional financing and engagement through courses, e-learning platforms, sponsorship of conferences and health professional associations and advertising in medical/health journals.”

The authors report on an exchange they have had with the journal, Nature, since 2018 about removing advertisements from formula companies.

Even when journals merely advertise formula company publications that imply formula is “close to mother’s milk” this could influence health professionals’ perceptions and infant feeding counselling, they assert, adding that these advertisements are misleading. 

“Given these vulnerabilities, scientific journals have a professional and ethical responsibility to put additional protections in place to ensure that their brands are not associated with misleading advertising claims and to warn readers of the high risks associated with suboptimal breastfeeding,” the paper said. The authors push for journals to prioritise public health over profits and thus to have content that is in line with the global public health guidance. 

According to the paper, the risks of promoting breast-milk substitutes are especially consequential in low-and middle-income countries where access to healthcare is poor, and malnutrition in all forms is prevalent. Breast-milk substitutes and formula are neither affordable nor sustainable in such regions and leads to increased infant morbidity and mortality and are causes of suboptimal breastfeeding, the paper said. Suboptimal breastfeeding has caused an estimated 823,000 deaths among children each year, according to the journal. 

Companies that advertise and directly or indirectly promote their breast-milk substitutes in ways that contradict the International Code of Marketing of Breastmilk Substitutes adopted 40 years ago, effectively violate the rights of children to be fed in the best possible way, assert the authors.

 

 

Image Credits: WHO.

 

WHO Director General Tedros Adhanom Ghebreyesus greets Afrigen CEO Petro Terblanche.

CAPE TOWN – “Our baby is in good hands and will get stronger,” World Health Organization (WHO) Director-General Dr Tedros Adhanom Ghebreyesus told Afrigen CEO Petro Terblanche during a visit to the South African company which was chosen by the WHO as a “hub” to make mRNA vaccines and then share the technology with other countries.

Tedros, accompanied by Meryame Kitir, Belgium’s Minister of Development Cooperation and Urban Policy, met a phalanx of South African officials during a tour of the hub and related facilities at the forefront of the country’s COVID-19 response on Friday.

The mood of the delegation was celebratory as Terblanche’s facility has recently completed an mRNA vaccine based on Moderna’s ‘recipe’, and is preparing for this vaccine to go enter clinical trials.

Tedros said that the WHO believed that the acute phase of the COVID-19 pandemic will end this year, but only if 70% of the global population is vaccinated.

“More than half of the world’s population is now fully vaccinated, and yet 84% of the population of Africa is yet to receive a single dose,” said Tedros.

“Much of this inequity has been driven by the fact that globally, vaccine production is concentrated in a few mostly high-income countries. One of the most obvious lessons of the pandemic is the urgent need to increase local production of vaccines, especially in low and middle-income countries,” said Tedros, explaining that this was why the WHO had decided to set up a hub to develop and share mRNA know-how for this pandemic and other diseases.

The central aim is to develop a training facility where mRNA technology is developed to the scale required for mass production of vaccines and then for that full package of technology to be transferrable to multiple recipients in low- and middle-income countries.

Tedros shrugs off BioNTech report

“If the owners of mRNA vaccine technology share their knowledge with the hub, we could expedite manufacturing, removing the need for large political trials and cutting development and approval time but at least one year,” said Tedros.

Tedros shrugged off a report that a BioNTech-related company had tried to undermine the mRNA hub, instead promoting a fill-and-finish operation for the Pfizer-BioNTech vaccine involving Europe and a South African company instead.

“To be honest, we need both,” he added. “They’re partnering with countries – I think three countries who would like to start with fill and finish start production – and have increased the availability of vaccines. Is that bad?  It’s not. It’s good,” but he appealed for them to also share their technology with the mRNA hub.

However, South African Health Minister Joe Phaahla said that half the country’s vaccine stock was bought from BioNTech-Pfizer and it would be “worrying” if the company wanted ti undermine the hub.

“We will not actually allow any private company to protect its interests by preventing others from accessing knowledge and know-how,” said Phaahla.

Meryame Kitir, Belgium’s Minister of Development Cooperation and Urban Policy, and Dr Tedros.

Better than TRIPS waiver, says Belgium’s Minister

Kitir described Afrigen’s vaccine development as a “breakthrough”, and said that the hub is “showing the world how to solve the fight against inequality”.

Belgium, France, Germany, Norway and the European Union have invested heavily in the mRNA hub, which is estimated to cost $100-million over the next five years.

“We must look beyond charity and seek structural solutions,” Kitir urged. “Donations are still important, but more is required, and that is why I have invested in projects that increase the local productions of vaccines, and I’m proud of this initiative in South Africa.

“The position of Belgium is that vaccines should be a public good. We have been having discussion about patent waiver for two years and the only conclusion that we can say today is that everyone is open for dialogue,” added Kitir. Belgium, which is home to many biotechnology companies, has been reluctant to support the TRIPS waiver proposed by South Africa.

Kitir said that the hub was a “better solution than the patent waiver because you make the country self resilient, and there is a there is a formula and it is open”.

When asked whether Belgian biotech companies were likely to support the mRNA hub and share their knowledge, Kirir could only name one – Universal Pharma – that had been in touch with Afrigen, adding that it was working in Senegal to share its know-how on vaccines.

According to the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA), which represents pharmaceutical companies around the world including Pfizer and Moderna, South Africa’s hub “adds to the options companies may choose in developing partnerships and needs to be weighed against an increasingly crowded landscape of other initiatives, including their own network of manufacturing partners”. 

However, it asserted that “experience has shown that technology transfers have higher chances of being successful if they are bilateral, business-to-business and voluntary”.

South Africa offered clear leadership

“I congratulate South Africa leadership throughout the pandemic in hosting this mRNA technology transfer hub, in chairing the ACT accelerator Facilitation Council and in initiating a resolution at the World Trade Organisation to temporarily suspend intellectual property rights on COVID-19 products. President Ramaphosa’s leadership was very clear continentally and also globally with leadership in ACT Accelerator facilitation council,” said Tedros.

For most of 2021, limited global vaccine supply led to huge disparities in COVID-19 vaccine access, leaving billions of people – especially in low- and middle-income countries – unprotected against serious disease and death from COVID-19. Low levels of vaccine coverage also provided the ideal conditions for new variants to develop.

While supply has now increased, access to any new formulations of COVID-19 vaccines – tailored specifically to new variants – will likely also be inequitable because manufacturing capacity remains limited to only a small handful of companies and countries.

 

 

 

 

 

 

 

 

Image Credits: WHO, Kerry Cullinan .

South African Health Minister Joe Phaahla, second from right, with WHO Director General Dr Tedros Adhanom Ghebreyesus (centre) at Stellenbosch Faculty of Medicine, a member of the WHO co-sponsored new mRNA vaccine hub, on 11 February

Speaking during a tour by WHO’s Director General of Cape Town’s new mRNA vaccine R&D hub that replicated the Moderna COVID vaccine, South Africa’s Health Minister affirms support for the continental-wide medicines regulatory authority. 

CAPE TOWN  – South Africa’s Health Minister signalled that his country intends to join the African Medicines Agency – but that the treaty’s ratification has to be approved by the country’s parliament. 

Speaking during a triumphal tour of top WHO officials Friday to the Cape Town research institutions credited with replicating the Moderna mRNA vaccine recipe, Dr Joe Phaahla, affirmed that: “There is no, in principle, hesitation. It’s more operational in terms of making sure that we do sign the Treaty on the African Medicines Agency. 

But he said that the treaty ratification could still be a “lengthy process” because it has to go through the legislative process: “It’s got to be processed through our parliamentary process and be approved.  So we will be following up in terms of just making sure that this process is concluded in our legislative processes.

“As you all know our president has been leading not only on the issue of access to vaccines, but also to diagnostics and therapeutics. 

“We are committed to a continental, Pan African approach in terms of sharing knowledge, sharing resources and technical note.

While some 30 countries have signed or ratified the treaty on the AMA, most of Africa’s largest countries and economies have not yet done so. The holdouts have included Nigeria, Kenya, Ethiopia and South Africa. Egypt and Senegal have, on the other hand, signed and ratified the treaty.   

WHO DG expresses AMA support during tour of Cape Town mRNA hub   

WHO Director General Dr Tedros Adhanom Ghebreyesus visit Cape Town’s new mRNA hub

WHO’s Director-General Dr Tedros Adhanom Ghebreyesus also appealed to African countries to join the AMA during a widely-publicized trip to Cape Town to celebrate scientists’ breakthrough there in replicating mRNA COVID vaccine technology.

“All African countries should support the rapid establishment of the African Medicines Agency,” said the WHO DG at a press briefing after he toured Afrigen Vaccines and Biologic’s R&D facility as well as Biovac, where the first batches of the new vaccine are to be manufacturered to GMP standards.    

Lab technicians at work in Cape Town’s Afrigen Vaccines & Biologics, during a high level tour 11 February by WHO officials. The company says it has replicated Moderna’s mRNA vaccine.

“Common platforms or institutions are important – because there are many shared issues in our continent that has to be addressed through unison. The Africa Medicines Agency is one of them.  

“The experience from the European Medicines Agency is that it helped actually in bringing the whole [European] Union together even in reducing the funding they invest in individual approvals because the approvals cuts close to at the country level approval that’s done.

He added that particularly in a pandemic, “every country cannot fight this cross border so the African Medicines Agency can help fight this also.”

“I believe that this institution will be very, very important for the continent.”

Africa CDC also was resisted initially – now has full-fledged support

Tedros compared the evolution of the AMA to the course taken by Africa Centres for Disease Control and Prevention – an idea he says he initiated during his term as Ethiopia’s foreign minister.

“When I proposed the Africa CDC in 2017 in Abuja, some people laughed at me,” he observed.  “…Now I see continent-wide support to Africa CDC, but it took many years for many people to understand its benefits.

“So I see the same thing with him with AMA, the same resistance and the same doubts and the same concerns.

“I know Africa Medicines Agency will be as beneficial as the Africa CDC. So I would like to use this opportunity actually appeal to all countries who haven’t ratified to ratify, to speed up the establishment,” he said.  

Along with helping to speed up medicines approvals, the AMA can also play a role in stimulating manufacturing in Africa, he added, linking to the focus of his tour Friday of the Cape Town’s new mRNA vaccine hub. “I think we need to identify institutions that can bring us all together… that’s why the continental and global institutions are more important than before.”

See our special covereage of the African Medicines Agency Countdown here:

African Medicines Agency Countdown

 

Image Credits: @elmimuller, WHO, Rodger Bosch for MPP/WHO.

Matshidiso Moetic, WHO Regional Director for Africa

A partnership between Africa CDC and MasterCard Foundation, which has included visits to countries with model vaccination programmes, such as Rwanda and Morocco, is making a difference to other African countries facing challenges in getting jabs into arms.  

That and other measures aimed at supporting more rapid African roll out of COVID-19 vaccines are proving effective, said Dr John Nkengasong, Director of the Africa Centres for Disease Control and Prevention (Africa CDC) on Thursday. 

Meanwhile, WHO African Regional officials said that only 0.5% of COVID-19 vaccines received on the continent had actually gone to waste  — despite the fact that another recent  report suggesting that up to 35% of doses so far received are still awaiting distribution. 

Addressing journalists on Thursday, Nkengasong said the Saving Lives and Livelihoods initiative —  involving Africa CDC and MasterCard Foundation — have demonstrated results in at least four countries so far. 

“We have data from Sierra Leone, South Sudan, Cameroon and Tanzania where uptake of the vaccination really increased significantly once we sent in teams as part of the initiative,” Nkengasong said.

Delegations from those and other countries visited Morocco and Rwanda, where about 63% and 55% of the population respectively have been fully vaccinated, to learn about their model for success, he said.

“A set of countries, about 16, have actually been to Morocco to see their experience. Another set was in Rwanda. And as we speak, micro planning is going on for about 40 countries in Africa as part of that initiative,” Nkengasong told Health Policy Watch.

Along with site visits, the initiative is supporting countries to review their procurement processes; develop and finalize rollout plans; and ensure faster deployment of vaccines that are due to expire soon. 

 0.5%  Wastage 

africa cdc
Airfinity estimates of donated doses that have actually been adminsitered

On Wednesday, Health Policy Watch reported that only 65% of donated COVID-19 vaccine doses have been administered so far – with the remaining 35% yet to be used.  The largest proportion of donations, although by no means all of them, have gone to countries in Africa. 

However, Dr Richard Mihigo, WHO Africa Coordinator of Immunization and Vaccine Development, said that while there may be doses still awaiting distribution, actual wastage remains very small. 

Out of 635 million doses received so far, wasted doses have amounted to only about 3.5 million, representing only about 0.5% of the doses received, Mihigo said.

“If we look at the bigger picture, the continent has not done that bad at 0.5%,” Mihigo said.

He noted that the wastage that has occurred, is also due to the fact many donated doses have also arrived too close to their expiration date – making rapid rollout a huge challenge.

“So we cannot really condemn African countries because if you look at developed countries, we have also seen vaccines that have been destroyed,” Mihigo added.

To further ensure that vaccines are not being destroyed by African countries, Mihigo said the COVAX initiative has updated its engagement with African countries, ensuring that it only supplies the amount of doses requested by the countries according to their timelines — responding to country demands instead of pushing out vaccines through a top-down agenda.

“I think that the prospects in the future are looking quite good because countries are requesting vaccines that they can use. 

“But, also, WHO, UNICEF, GAVI, Africa CDC, are also putting out a strong statement on vaccines for each country to only receive vaccines that have a quite extended shelf life so that the country can be able to plan and deliver those vaccines on time,” he said.

Despite spread of new Omicron sub-variants, Africa on track to control COVID-19 pandemic in 2022

Meanwhile, Nkengasong, in his briefing, confirmed that the more infectious Omicron BA.2 subvariant now has become dominant in South Africa – and is slowly spreading elsewhere on the continent – after first being detected last month in Denmark and India. However, while the subvariant appears to be even more infectious than the original Omicron, experts have said it is not more deadly.  See related Health Policy Watch story. 

But WHO’s Regional Director for Africa, Dr Matshidiso Moeti, did not express undue concern over the continued mutation of the SARS-CoV2 virus, saying that Africa is on track to control COVID-19 pandemic in 2022 if current trends continue.

She said that over the past two years, African countries have become smarter, faster and better at responding to each new surge in cases of COVID-19.

“Against the odds, including huge inequities in access to vaccination, we’ve weathered the COVID-19 storm with resilience and determination, informed by Africa’s long history and experience with controlling outbreaks. But COVID-19 has cost us dearly, with more than 242, 000 lives lost and tremendous damage to our economies,” Moeti said.

While admitting that COVID-19 will be around for the long-term, she noted that there is optimism as 2022 can see the end of the disruption and destruction the virus has left in its path, and gain back control over lives on the continent. 

“Controlling this pandemic must be a priority, but we understand no two countries have had the same pandemic experience, and each country must, therefore, chart its own way out of this emergency,” she said.

The Rwanda experience

Albert Tuyishime, Head of Diseases Prevention and Control at Ministry of Health/Rwanda Biomedical Centre

The East African country of Rwanda has been recognised as one of the African countries that has been a model of vaccination progress. With 54% of its eligible population fully vaccinated – Rwanda has raced ahead of more developed South Africa – and ranks only second to Morocco in terms of coverage.   

Speaking at the Thursday Africa CDC briefing,  Dr Albert Tuyishime, Head of Diseases Prevention and Control at Ministry of Health/ Rwanda Biomedical Centre talked about how the country had achieved those results – driven by the highest level of the country’s leadership. 

“We also built on in-country multisectoral collaboration, effective partnerships, regional collaboration, and, especially, community engagement and research, science- and evidence-based decisions as well as interventions,” he said.

He noted that 66% of the Rwandan population had been vaccinated with at least one dose while 55% have received two doses, and 8% of the population have already received their booster dose. In addition, the country is now expanding vaccine access to children aged 5 to 11 years.

Image Credits: https://mcusercontent.com/2fe57162f164ecead64629b83/files/1d4e2b0b-bbe2-6050-0281-6e10c66eb3b2/1_billion_donated_v2.pdf?utm_source=Airfinity&utm_campaign=d1db73af86-EMAIL_CAMPAIGN_2021_08_02_12_31_COPY_01&utm_medium=email&utm_term=0_41a531e556-d1db73af86-517334173.