In a milestone deal for Africa, Pfizer/BioNTech announced Wednesday that it would partner with the Cape Town-based pharma firm Biovac to produce over 100 million doses annually of it’s cutting edge mRNA vaccine – for distribution within the African Union.  

The deal was quickly hailed as a major breakthrough on a continent that is desperately short of vaccines, and so far has had no capacity to manufacture highly efficacious mRNA vaccines against COVID. 

But the plan to produce 100 million doses, beginning in early 2022, won’t solve the here-and-now problems of vaccine supply shortages in a region where only about 1.5% of the population is fully vaccinated, public health advocates also stressed. That, in comparison to 40-60% vaccine rates in high-income countries, and even 30% coverage in emerging economies such as India.  

“It’s great to see that doses will be made closer to where they’re needed the most.  But they won’t be ready until next year.  Until then, rich countries need to share doses ASAP,” said the Wellcome Trust in a statement summing up the current state-of-play.  

Under the deal, announced by the US-based Pfizer and the German firm BioNTech in a joint statement, Biovac will manufacture at the ”fill-and-finish” stage of the company’s mRNA COVID vaccine, using active ingredients produced from facilities in Europe. 

“To facilitate Biovac’s involvement in the process, technical transfer, on-site development and equipment installation activities will begin immediately,” the pharma announcement said.

“The facility will be incorporated into the vaccine supply chain by the end of 2021. Biovac will obtain drug substance from facilities in Europe, and manufacturing of finished doses will commence in 2022. At full operational capacity, the annual production will exceed 100 million finished doses annually. All doses will exclusively be distributed within the 55 member states that make up the African Union.”

Said Pfizer CEO Albert Bourla, “From day one, our goal has been to provide fair and equitable access of the Pfizer-BioNTech COVID-19 Vaccine to everyone, everywhere. Our latest collaboration with Biovac is a shining example of the tireless work being done, in this instance to benefit Africa. We will continue to explore and pursue opportunities to bring new partners into our supply chain network, including in Latin America, to further accelerate access of COVID-19 vaccines.”

Albert Bourla, Pfizer CEO

“We are thrilled to collaborate with Pfizer and BioNTech to produce and distribute the Pfizer-BioNTech COVID-19 Vaccine within Africa,” said Biovac CEO Morena Makhoana,  “This is testament of the long-standing relationship we have had with Pfizer through the Prevenar 13 vaccine,” he added referring to Biovac’s production of a pneumococcal vaccine now used widely around the world to protect infants and young children against bacterial pneumonia. 

“This is a critical step forward in strengthening sustainable access to a vaccine in the fight against this tragic, worldwide pandemic,” Makhoana added. “We believe this collaboration will create opportunity to more broadly distribute vaccine doses to people in harder-to-reach communities, especially those on the African continent.”

South African President Cyril Ramaphosa also welcomed the deal in a special statement. Speaking in his capacity as African Union Champion on COVID-19, Ramaphosa said: “Today’s agreement will contribute significantly to health security and sustainability on our continent, which currently has the least access to vaccination in the world.”

Pharma heaps praise – vaccine advocates level more criticism on deal 

Meanwhile, the new license agreement doesn’t appear likely to break the ice between medicines access advocates – who support a World Trade Organization waiver on all vaccine-related IP and trade secrets – and pharma voices contending such a move is impractical, and advocate voluntary license deals like the Pfizer/BioNTech-Biovac one as the preferred route.  

 “This is a far cry from full technology transfer to allow independent manufacture of mRNA vaccines and therapeutics,” said Professor Brook Baker, a law and medicines specialist at Northeastern University, of the Pfizer/BioNTech accord with Biovac.

“This agreement is nothing more or less than a contract manufacturing agreement for sterile formulation, fill, and finish.  Biovac will not be an ‘independent producer’- it will instead be a contract ‘subsidiary’ facility, subject to rigid control by Pfizer. In addition to the vaccine having a BioNTech/Pfizer ‘brand’, it will have a price set by them,” he noted in a blog posted on the list-serv IP-Health. 

“The announcement does not indicate the technology transfer/sharing agreement would ever result in the ability of Biovac to produce the mRNA active ingredient,” Baker added. “Thus, the underlying mRNA tech platform continues to be exclusively controlled by BioNTech/Pfizer, and Biovac will not be given the ability to further develop its own internal technical capacity and expertise that might allow it to manufacture other mRNA vaccines and therapeutics in the future.”  

“A somewhat more favorable aspect of the agreement is that the Biovac-produced BioNTech/Pfizer vaccine will be distributed only to 55 countries in Africa,” he conceded. “At least vaccine manufactured in Africa will stay in Africa, unlike the initial J&J agreement with Aspen Pharmacare.”

He was referring to the first Johnson & Johnson deal in South Africa, where most of the initial Aspen fill-and finish doses were contracted for delivery abroad. A subsequent deal with the African Union has secured 400 million J&J doses for use specifically on the continent. But there, too, production will only ramp up fully in the last quarter of 2021. 

IFPMA – more dose-sharing urgently needed as immediate solution to vaccine shortages

Meanwhile, Thomas Cueni, director-general of the International Federation of Pharmaceutical Manufacturers and Associations, hailed the deal as “great news demonstrating the vaccine innovators’ huge contribution to tackling the pandemic”.  

“It is in line with our industry’s commitment from the first days of the pandemic where we recognised that collaborations would be needed to achieve the massive ramping up production of any COVID-19 vaccine.  Indeed, the first ones were agreed in April 2020; and today there are more 200 collaborations underway, many of which involve technology transfer. Industry is on track to producing 11 billion doses by the end of this year. 

“This would be enough to vaccinate the world’s adult population, if doses are shared equitably. But this will only happen if the world wakes up. Since May, we have been calling for five steps to urgently advance COVID-19 vaccine equity – top of the list is dose sharing, lives depend on it.”  

The COVID-19 pandemic has carried secondary impacts on children orphaned or bereft of their caregivers, adding to the “hidden pandemic of orphanhood.”

An estimated 1.5 million children worldwide have lost a parent, grandparent, or caregiver due to COVID-19, according to a new study published in The Lancet on Tuesday. 

The study, which was conducted by international researchers, including scientists from the World Health Organization (WHO), US Centers for Disease Control and Prevention (CDC), and the University of Oxford, offers the first global estimates of the secondary impacts of the pandemic on children.

Worldwide, the COVID-19 pandemic caused over 190 million cases and four million deaths. Beyond morbidity and mortality, the pandemic carries indirect impacts, such as robbing children of their caregivers. 

Children who lose a primary caregiver have a higher risk of experiencing mental health problems; physical, emotional and sexual violence; and family poverty. These raise the risk of suicide, adolescent pregnancy, infectious diseases, and chronic diseases, such as heart disease, diabetes, cancer, or stroke. 

Children that go into institutional care can experience developmental delays and abuse.

Modelling to Estimate Magnitude of Hidden Impact of Pandemic on Children

The researchers used mortality and fertility data to model minimum estimates of COVID-related deaths of primary and secondary caregivers of children younger than 18 years of age in 21 countries. The data collected accounted for nearly 76.4% of global COVID deaths as of late April. 

A primary caregiver was defined as parents and custodial grandparents and secondary was considered co-residing grandparents or older kin. Caregivers provide psychosocial support; feeding, teaching, or supervising; and financial support.

In 21 countries, the researchers estimated that by April 2021, 862,365 children had been orphaned or lost a custodial grandparent due to COVID-19-associated death. Of these, 788,704 children lost one or both parents; 73,661 lost at least one custodial grandparent; and 355,283 lost at least one co-residing grandparent or older kin. 

South Africa, Peru, the US, India, Brazil, and Mexico were the countries with the highest numbers of children losing primary caregivers. In Peru, 14.1 children lost a primary or secondary caregiver per 1000 children, compared to 6.4 children in South Africa and 5.1 children in Mexico.

In India, the researchers estimated a 8.5-fold increase in the number of children newly orphaned between March 2021 and April 2021. This was associated with India’s catastrophic surge from the end of March to mid-June. 

COVID-related deaths were more common in men than women, particularly in middle-aged and older parents, leaving a greater number of paternal versus maternal orphans. 

Between two and five times more children had deceased fathers than mothers. 

The model was used to extrapolate global figures. 

Over a Million Children Globally Left Behind by COVID Deaths

Between March 1, 2020 and April 30, 2021, the researchers estimated that 1.5 million children experienced the death of primary or secondary caregivers, 1.13 million experienced the death of primary caregivers, and 1.04 million were orphaned by their parents. 

“For every two COVID-19 deaths worldwide, one child is left behind to face the death of a parent or caregiver,” said Dr Susan Hillis, one of the lead authors of the study and senior advisor to the CDC. 

“By April 30, 2021, these 1.5 million children had become the tragic overlooked consequence of the 3 million COVID-19 deaths worldwide, and this number will only increase as the pandemic progresses,” said Hillis.

A rapid escalation in the study estimates was observed between March 2021 and April 2021, with the total number of children that lost a caregiver increasing by 220,000. This coincides with third waves of the pandemic across Europe and Southeast Asia. 

The more transmissible SARS-CoV2 variants are driving the current global increase in both cases and deaths, after the world saw a nine consecutive week decline in the number of weekly deaths. 

“Our study establishes minimum estimates…for the numbers of children who lost parents and/or grandparents. Tragically,…the true numbers affected could be orders of magnitude larger,” said Dr Juliette Unwin, a lead author and member of the Imperial College COVID-19 response team. 

The under-reporting of deaths around the world could underestimate the number of at-risk children.

For instance, in Brazil, the actual number of deaths at the start of the pandemic are estimated to be 33.5% higher than the officially reported deaths. 

“In the months ahead, variants and the slow pace of vaccination globally threaten to accelerate the pandemic, even in already incredibly hard-hit countries, resulting in millions more children experiencing orphanhood,” said Unwin. 

The increase in orphanhood associated with COVID adds to the existing 140 million orphans worldwide, who are in need of global health and social care prioritisation, said the authors.

The adverse psychosocial consequences of children bereft of caregivers can be compounded by the COVID mitigation measures, leading to school closures, isolation, and disruptions to bereavement practices. 

Solutions to the ‘Hidden Pandemic of Orphanhood’

The study authors called for urgent investment in services to support children who lost their caregivers, specifically focusing on strengthening family-based care. Programmes should combine economic interventions, positive parenting, and education support, said the authors. 

“Our findings highlight the urgent need to prioritise these children and invest in evidence-based programmes and services to protect and support them right now and to continue to support them for many years into the future – because orphanhood does not go away,” said Hillis. 

“We need to support extended families or foster families to care for children, with cost-effective economic strengthening, parenting programmes, and school access,” said Lucie Cluver, study author and Professor of Child and Family Social Work at Oxford University and the University of Cape Town.

In addition, deaths of caregivers can be prevented by accelerating equitable access to diagnostics, therapeutics, and vaccines.

“We need to vaccinate caregivers of children – especially grandparent caregivers. And we need to respond fast because every 12 seconds a child loses their caregiver to COVID-19,” said Cluver. 

The global community needs to capitalise on the momentum from the pandemic to mobilise resources and implement systemic, sustainable support for bereaved youth around the world, said the authors. 

“The hidden pandemic of orphanhood is a global emergency, and we can ill afford to wait until tomorrow to act,” said Dr Seth Flaxman, one of the study’s lead authors and a lecturer in statistics at Imperial College London.

Image Credits: Unicef.

The World Trade Organization (WTO) Secretariat has issued a list of bottlenecks and trade-facilitating measures on critical COVID-19 products, ahead of Wednesday’s  High-Level Dialogue between itself and the World Health Organization (WHO) on how to expand COVID-19 vaccines manufacturing to ensure equitable access.

“One common theme that emerges from the list is that essential goods and inputs need to flow efficiently and expeditiously to support the rapid scaling up of COVID-19 production capacity worldwide,” according to the WTO. 

“The delay of a single component may significantly slow down, or even halt, vaccine production given the globally integrated supply chains that underpin COVID-19 vaccine manufacturing.”

The list is based on issues raised at two WTO meetings last month, ‘Regulatory Cooperation during the COVID-19 Pandemic’ (2 June) and  ‘COVID-19 Vaccine Supply Chain and Regulatory Transparency’ (29 June). 

Below is a summary of the key points:

BOTTLENECKS 

Vaccine manufacturing 

  • There are no expedited procedures for vaccines, which are subject to standard import and export procedures, including rigorous documentation and frequent renewal of licences and certificates. 
  • Vaccine manufacturers may find it difficult to send non-commercial samples to specialized laboratories located abroad for testing, as these samples are subject to the same import and export procedures as commercial shipments.
  • Exports by vaccine manufacturers to foreign ‘fill and finish’ sites can be subject to export restrictions, both for sites owned by the manufacturer and the contract development and manufacturing organisations (CDMOs). 
  • Donations of supplies and vaccines (eg to COVAX) can be subject to stringent controls as well as tariffs and internal taxes. 
  • Some embassies and consulates are closed as a result of lockdowns, making it impossible to complete consular transactions or to submit documents needed for cross-border trade of vaccine inputs. 
  • Tariffs are high for certain inputs in some manufacturing countries. 
  • Complicated visa entry requirements and closed borders make it hard for highly qualified personnel to move across borders to support vaccine manufacturing. 

Vaccine regulatory approval 

  • Differences between countries in terms of regulatory frameworks, procedures and timelines adds complexity for manufacturers. 
  • Significant variation among registration requirements across different regions can make it onerous for manufacturers to apply for registration in multiple locations. 
  • Some national regulatory authorities (NRAs) require local retesting of vaccines or bridging clinical trials, which can lead to delays and spoilage. 
  • The rapid development of COVID-19 vaccines has led to additional challenges and burdens for vaccine manufacturers following the initial emergency use authorization (EUA), such as gathering data and optimizing processes. 
  • Some NRAs have not established accelerated pathways for post-approval changes to vaccines under EUA, which could hinder availability due to delays in approval. 
  • There can be uncertainty about when EUA will expire and the accompanying processes to move to regular approval and registration of vaccines (including against new coronavirus variants). A particular concern is that rules and accompanying data and legal requirements will differ between regulatory agencies. 

Vaccine distribution

 While few obstacles were identified for the distribution and border clearance of COVID-19 vaccines, border clearances for related products to administer vaccines (eg syringes, refrigerators) was flagged as a potential problem. 

Therapeutics and pharmaceuticals

  • There can be different technical requirements for the same product between countries (e.g. 3.5 ml versus 3.51 ml, different sterilization requirements). This requires vaccine manufacturers to establish separate production lines, which increases costs and compromises speed of delivery. 
  • NRAs request different process changes to approved products in an uncoordinated manner, which requires manufacturers to carry multiple manufacturing processes. 
  • Some NRAs require local population-based studies for medicines with no evidence of ethnic pharmacokinetic differences
  • Applied tariffs are high in many countries, making it costly to import essential therapeutics to treat COVID-19 patients. 

Diagnostics and other medical devices 

  • Divergent regulations and barriers to accessing viral samples that are needed to develop effective diagnostic tests. 
  • Some NRAs may still require a consularized apostille of the original paper document to confirm information already provided to the NRA and available online. 
  • Duplication of rigorous local testing can lead to delays and uncertainty for suppliers. 
  • An unclear process for regulatory approval of diagnostics can lead to diagnostics of varying quality. Inefficient and overly complex regulatory systems slow down activation of clinical trials and hamper the adoption of results.

TRADE-FACILITATING MEASURES 

General import, export and transit procedures 

  • Implementation of the provisions in the Trade Facilitation Agreement (TFA), such as those concerning pre-arrival procedures, could help to expedite the movement of essential products to combat COVID-19.
  • The digitalization and simplification of import, export and transit procedures (e.g. paperless trade) should be accelerated. 
  • Identification of Harmonized System (HS) codes for medical goods essential for the treatment of COVID-19 by the World Customs Organization (WCO) and the WHO helps to ensure expedited procedures for border clearance. 

Vaccine manufacturing 

  • Bilateral and regional agreements could ease import and export restrictions on key routes. 
  • A communication channel between vaccine manufacturers and other relevant stakeholders can raise awareness about bottlenecks at domestic and regional levels 
  • A national dialogue with manufacturers and other relevant stakeholders could be established to understand the current conditions for trade in critical vaccine inputs. 

Vaccine regulatory approval 

  • Measures can include the facilitation of Emergency Use Authorization (EUA) based on the prequalification procedure of the WHO EUL and regional networks
  • WHO special procedures can be used to share regulatory dossiers under confidentiality agreements and to promote the use of reliance to allow low and middle-income countries to authorize emergency use of vaccines quickly and efficiently.
  • Authorization of COVID-19 vaccines could be fast tracked. 
  • Rapid approval of clinical trials (phases undertaken in parallel in real time) could expedite approval of vaccines.
  • The pharmaceutical industry could improve transparency and data integrity by providing better access to clinical data for all new medicines and vaccines 
  • Sharing data between regulators can facilitate multi-country approvals. 
  • Regulatory systems in developing countries can be strengthened for scaling up the local manufacture of vaccines. 

Therapeutics and pharmaceuticals 

  • Global harmonization with guidelines set by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use would allow pharmaceuticals to be developed faster and to move more quickly between countries by overcoming conflicting or varying pharmacopeia requirements. 

Diagnostics and medical devices

  • The Medical Device Single Audit Program of the International Medical Device Regulators Forum (IMDRF) could be used to overcome barriers to on-site inspection during a pandemic. 
  • The IMDRF could establish guidance for the regulatory flexibility needed during a pandemic. 
  • The WHO provides recommendations in Global Model Regulatory Frameworks and Regulatory Reliance for Medical Devices. • NRAs could implement a good regulatory practice (GRP) policy and related standard operating procedures. 
  • WHO guidance on recognition and reliance for pre- and post-market activities could be implemented. 
  • National standards and conformity assessment procedures (based on international standards) could be developed for local manufacturing of PPE. 
  • The streamlining of existing EUA pathways in the context of pandemics could result in diagnostics being registered and made accessible with less delay. 
  • Multiple-source supply chains can ensure that trade flows as freely as possible and with minimal export restrictions. A delay in the shipment of a single component could halt the entire production in a factory. 

General regulatory aspects 

  • Mutual recognition agreements could be promoted, as well as the recognition of marketing authorization procedures and the unilateral recognition of marketing authorizations.
  • Inspection Co-operation Scheme could help to avoid duplication, and inspections could be further harmonized through enhanced cooperation between regulators.
  • Global alignment of clinical trial requirements can increase the pace at which vaccines, therapeutics and diagnostics can be developed. 
  • Timelines for the evaluation and approval of medical products and clinical trials could be shortened if approval has already been granted by trusted regulatory authorities. •
A Tanzanian mother and her baby.

Children living with HIV in six African countries will soon get access to the antiretroviral (ARV) drug, dolutegravir (DTG), which is more effective, easier to take and has fewer side effects than many other ARVs.

DTG will soon be recommended for children in Uganda, Benin, Kenya, Malawi, Nigeria and Zimbabwe, Kenyan AIDS activist Jacque Wambui told Health Policy Watch. Wambui has been advocating for DTG for a number of years following her own struggles with ARV side effects.

“The drug I was using before was giving me dizzy spells and nightmares and I could not sleep. So when I heard about dolutegravir, I told myself, this is the kind of drug that I would like to use and I also want it in my country as soon as possible,” said Wambui, who is as an alternate representative for Kenya on the African Community Advisory Board (AfroCAB), a network of African HIV treatment advocates.

“We are excited that what happened for us will now happen to the children. With dolutegravir, treatment outcomes are better and you notice you are no longer lethargic. We’re having more productive lives,” said Wambui.

Drug also suitable for toddlers

DTG also has a high genetic barrier to developing drug resistance, which is important given the rising trend of resistance to efavirenz and nevirapine-based regimens.

The World Health Organization (WHO) last week welcomed results of a study presented at the International Pediatric HIV Workshop on the superiority of dolutegravir (DTG)-based regimens in young children.

Last year, the ODYSSEY trial demonstrated superior treatment efficacy for DTG plus two nucleoside analogue drugs versus standard-of-care (SoC) ARVs in children over 14 kg with an average age of 12.

A follow-up study completed last month found that DTG is also superior for toddlers with a median age of 1.4 years. Only 28% had treatment failure by 96 weeks in the DTG arm in comparison to 48% in the SoC arm, and 76% of children in the DTG arm had undetectable viral loads (<50copies/ml) compared with half in SOC. 

“​​Children living with HIV continue to be left behind by the global AIDS response,” according to the WHO. “In 2020, only 54% of the 1.7 million children living with HIV received antiretroviral therapy compared to 74% among adults living with HIV.” 

WHO recommends dolutegravir back in 2018

The WHO has recommended DTG as a first-line treatment for adults and children with HIV since 2018, but this has not been rolled out properly in many African countries, according to a presentation at the International AIDS Society (IAS) HIV science conference that opened on Sunday.

Of the 20 sub-Saharan countries with the highest burden of HIV treatment guidelines, only eight – Uganda, Rwanda, Botswana, Eswatini, South Africa, Tanzania, Zimbabwe, and Zambia – recommend DTG for adults in line with the current WHO guidelines.  

Five countries – Kenya, Malawi, Namibia, Côte d’Ivoire and Ethiopia – recommend DTG except for pregnant women.

Lesotho and Nigeria only recommend it as an alternative regimen, while Angola, Mozambique, Cameroon, Democratic Republic of Congo and South Sudan do not recommend it at all, according to researchers Somya Gupta and Dr Reuben Granich.

An initial study in Botswana had highlighted a possible link between DTG and neural tube defects (birth defects of the brain and spinal cord that cause conditions such as spina bifida) in infants born to women using the drug at the time of conception.

This potential safety concern was reported in May 2018 from the Botswana study that found four cases of neural tube defects out of 426 women who became pregnant while taking DTG.

Based on these preliminary findings, many countries advised pregnant women and women of childbearing age to not take it. Activists who met in Kigali and interrupted a meeting in Amsterdam helped to press for more research on DTG.

“There is a lot of exciting science, both in treatment and in prevention, but that is not why we do this work. It’s how people like Jacque and other advocates make it happen in terms of policies and programmes and actual work on the ground,” said Mitchell Warren, the executive director of AVAC, the non-profit HIV prevention organisation. 

The researchers called for speedy processes to translate scientific research into policy and services at the IAS meeting.

“We are going to send out this information to caregivers. We’re even starting to develop materials for advocacy for DTG for children. We are also going to ask different ministers of health across countries to adopt it,” said Wambui. 

Image Credits: WHO.

Gian Gandhi, UNICEF COVAX Coordinator for Supply Division

As an official partner of the COVAX Facility, UNICEF is responsible for procurement, logistics and delivery of COVID-19 vaccines. PRITI PATNAIK spoke with Gian Gandhi, who coordinates COVAX operations for UNICEF, to get a sense of the challenges faced by the organization during the pandemic in the context of production shortages and realities at the national levels. He also discusses the procedures around the donations of vaccine doses.

Priti Patnaik: Can you elaborate on the role of UNICEF in the delivery of COVID-19 vaccines via COVAX? We want to get a sense of the scale of the operations. How many countries have signed procurement contracts with UNICEF?

Gian Gandhi: Through the COVAX Facility, UNICEF is working with manufacturers and partners on the procurement of COVID-19 vaccine doses, as well as ancillary supplies such as injection devices and cold chain refrigerators/freezers. In addition, UNICEF is managing freight, logistics and storage – coordinating the world’s largest vaccine procurement and supply operation. In collaboration with the PAHO Revolving Fund, we are leading the procurement and delivery for 92 low- and lower-middle-income countries while also supporting procurement for more than 97 upper-middle-income and high-income nations. Together, these represent more than four-fifths of the world’s population. 

In doing this, UNICEF has drawn on its experience as the world’s largest single vaccine procurer, wherein normal times, we supply the vaccine needs of around 45% of the world’s youngest children. Even so, procuring and delivering COVID-19 vaccine doses on behalf of COVAX could double the volume of vaccines that UNICEF would normally handle annually and involve a mammoth logistics exercise with freight companies, governments, and partners. 

The first COVAX vaccine consignment landed in Ghana on 24 February 2021. By mid-July 2021, in spite of severe restrictions in vaccine availability and other challenges, COVAX had delivered more than 126 million vaccine doses to 136 countries and territories around the world.

PP: What were some of the key lessons for UNICEF in the past year in the context of procurement and deliveries of COVID-19 vaccines?

GG: In the first phase of the pandemic, during the first half of 2020, UNICEF Supply Division’s pandemic response predominantly focused on the supply and procurement of personal protective equipment (PPE) and COVID-19 diagnostics. At that time, we experienced delays in access to PPE driven in large part [by] bidding against higher-income countries – and export controls imposed by country governments where the largest manufacturers were located. 

We pre-empted these challenges for safe injection equipment by building a stockpile of around half a billion syringes in anticipation of the arrival of the first COVID vaccines. As a result, UNICEF has avoided some of the shortages for most syringes that have plagued some countries. Unfortunately, given the limited number of vaccine manufacturers, we haven’t had a viable means of mitigating the analogous risks for doses.

The demand and revealed preferences for particular COVID-19 vaccines, or platform technologies, have been much less stable as compared to most other vaccines that UNICEF supplies. Driven by a combination of new data emerging on an almost daily basis, decisions by regulators elsewhere in the world, we’ve seen government and community demand rise and fall. This has made supply chain operations difficult as plans constantly change.

Dose donations are proving to be a good medicine for vaccine nationalism. The pledges by G7 and EU countries, in particular, look set to help COVAX get back on track in the remainder of 2021. However, managing the supply and logistics for donations are more complicated than ‘regular’ procured doses. There are a series of legal, administrative, contractual, and operational barriers that must be navigated for each paid or donor-recipient transactions. UNICEF has been managing vaccine donations for decades so we are well-placed to navigate these issues. But, it’s critical to ensure UNICEF and, more importantly, recipient country governments are able to absorb the doses that will be at their disposal.

PP: Top UNICEF officials have said that contracts with vaccine manufacturers will be published after consent from manufacturers. When will these be published? It was also mentioned that UNICEF has had a practice of publishing contracts. Can you explain the importance of publishing supply contracts?

GG: We don’t publish the actual contracts and never have. However, for more than a decade, UNICEF has published prices secured under our long-term framework agreements including those on behalf of Gavi, the Vaccine Alliance. However, we have done this with the consent of our suppliers. In addition, we summarize the outcome of previous tenders and market outlooks for vaccines and other commodities. These can be found here: www.unicef.org/supply/pricing-data and here: www.unicef.org/supply/market-notes-and-updates.  

We are striving to do this for COVID vaccines, but rely on manufacturers’ consent here too. This information can be found in UNICEF’s COVID-19 Vaccine Market Dashboard – a dynamic tool for countries, partners, and industry to follow the developments of the rapidly evolving COVID-19 vaccine market and the efforts of the COVAX Facility to ensure fair and equitable access for every country in the world.

UNICEF’s provision of market information including the COVID-19 market dashboard is a testament to UNICEF’s commitment to transparency, and our recognition that the free flow of information and correcting information asymmetries is critical to underpin efficient markets.

PP:  How important are the issues of liability and indemnification in delivering COVID-19 vaccines to countries? Have they been addressed? Does UNICEF bear any liability in the context of delivering vaccines for the pandemic?

GG:  Most COVID-19 vaccine manufacturers have made it clear that appropriate indemnity and liability (I&L) coverage, including appropriately capitalized no-fault compensation (NFC) schemes, are critical to facilitate access to COVID-19 vaccines that are being made available exceptionally under emergency use authorizations/listings.  All manufacturers that have agreed to provide vaccines to COVAX are indemnified against compensation claims that might come from individuals receiving their vaccines.  To that end, COVAX has created an NFC to cover the financial risk associated with any potential compensation claims in the 92 low- and middle-income countries that receive a COVID-19 vaccine funded by the COVAX Advance Market Commitment (AMC). In order to access COVID-19 vaccines including via COVAX, country governments sign I&L agreements (with individual COVID-19 vaccine manufacturers).

PP: The UNICEF supply dashboard predicts nearly 15 billion doses of vaccines by the end of 2021. Does UNICEF anticipate an oversupply of vaccines for the pandemic later this year? (We understand that UNICEF is in touch with manufacturers worldwide.) 

GG: The UNICEF market dashboard reports all available market intelligence that we are able to collate from the public domain. We do not risk-adjust the information (for example to predict possible manufacturing problems, or delays in regulatory approvals). But rather, we publish the information that manufacturers, government, and/or funders release. UNICEF has not published a market prediction, but it is fair to say that we do not anticipate global over-supply in 2021. We do expect that several higher-income countries have excess doses (compared to their need) either already or will have excess doses later in 2021. Accordingly, we have been aggressively advocating for dose sharing – particularly by G7 and EU countries as early as possible (noting the aforementioned challenges in processing donations). 

PP: How does UNICEF plan to service both commitments to the COVAX Facility and the African Vaccine Acquisition Trust (AVAT) simultaneously? 

GG: Increased and more equitable access of vaccines remains UNICEF’s priority. The African Union [AU]/AVAT initiative is a home-grown and country-owned initiative that puts Member States firmly in the driver’s seat of their own purchasing and access decisions. UNICEF’s support to COVAX is complementary and supplemental to the doses that have already been secured via the AU/AVAT initiative. Coordination is crucial to ensure there is no unnecessary competition for the vaccines. UNICEF is happy to coordinate and support around 100 countries including to organise the transportation of doses purchased by AU/AVAT, COVAX, or bilaterally, or donated.

Adapted from the article first published in Geneva Health Files by Priti Patnaik, GHF founder and publisher.

Image Credits: WHO, UNICEF.

The health system in Indonesia is being battered by the surge in COVID-19 cases, with hospitals reaching capacity and oxygen supplies running low.

Indonesia has overtaken Brazil and India to claim the highest number of new COVID-19 cases and deaths, becoming the new epicenter of the pandemic. The surge is part of a third wave hitting all across Southeast Asia.

Countries in Southeast Asia emerged from the first year of the pandemic relatively unscathed, but SARS-CoV2 variants, inconsistent enforcement of public health measures, and slow vaccine rollouts have led to large outbreaks in Vietnam, Malaysia, Myanmar, Thailand, and Indonesia. 

As the highly transmissible Delta variant, first identified in India and classified as a WHO variant of concern in mid-May, sweeps across the world, cases, deaths, and nationwide restrictions are increasing. 

The Delta variant has been recorded in 111 countries. The three other variants of concern (Alpha, Beta, and Gamma) have been found in Malaysia, Thailand, Philippines, Singapore, and Indonesia. 

Indonesia Facing Massive Surge and Overwhelmed Health System

Over the past month, daily new cases in Indonesia have increased five-fold and the number of new deaths has doubled since the beginning of July. On Sunday, the country of 276,5-million recorded 44,721 new cases and 1,093 deaths, bringing the total cumulative cases to 2.8 million and deaths to 73,582, according to the Indonesia Health Ministry. 

The figures, however, are likely underestimated due to the limited testing capacity. 

“We predict that the real number of those who died from COVID-19 should be three to five times higher than the official number,” Irma Hidayana, Co-founder of LaporCOVID19, a citizen coalition for data disclosure on COVID, told Al Jazeera.

“We miss many cases and we don’t identify maybe 80% of these cases in the community,” Dr Dicky Budiman, an Indonesian epidemiologist at Griffith University in Australia, told the Guardian. 

“In Indonesia, the testing is passive, it’s not active. The one who comes to the healthcare facility is the one who gets tested if they show symptoms, or if they also identify as the contact,” said Budiman. 

According to WHO, one indicator that the epidemic is under control in a country is a positive rate of less than 5%. In Indonesia, some 29.3% of tests conducted return positive results. This suggests that the level of testing in the country is inadequate relative to the size of the outbreak. 

The health system is being battered by the third wave, and hospitals on the island of Java have reached capacity, oxygen supplies are running low, and four of the five designated COVID burial grounds are nearly full. 

Some 33 patients at Dr. Sardjito General Hospital in Yogyakarta died this month after the supply of oxygen ran out. 

Hospitals have set up large tents and added thousands of beds to increase capacity and meet the demands of the surge, but there is also a shortage of healthcare workers which has been exacerbated by healthcare workers succumbing to the virus. 

Tents have been set up outside of hospitals on the island of Java to treat the surge in COVID patients.

Some 114 doctors in Indonesia have died so far this month, accounting for 20% of the 545 total health worker deaths from SARS-CoV2 since the beginning of the pandemic. 

Many expect the situation to worsen, but government officials say they have the situation under control. 

“If we talk about the worst-case scenario, 60,000 or slightly more [daily cases], we are pretty OK,” said Luhut Pandjaitan, a senior minister assigned to tackle the COVID-19 pandemic. “We are hoping that it will not reach 100,000, but even so, we are preparing now for if we ever get there.” 

The government has implemented restrictions on the islands of Java, Bali, and 15 other cities, closing places of worship, schools, shopping malls and sports facilities, reducing public transit capacity, and limiting restaurants to takeout. 

The restrictions are set to end on Tuesday, but officials are considering extending them.

Malaysia Experiences Dual Health and Economic Crisis

As of 13 July, the Southeast Asia region saw a 16% increase in new cases and a 26% increase in new deaths over the course of one week. India, Indonesia, and Bangladesh are responsible for the greatest numbers of cases and deaths from the region. 

Malaysia has recorded the worst COVID infection rate per capita, with 354 new cases per million people, compared to 182 in Indonesia, 137 in Thailand, and 97 in Myanmar. 

On Monday, Malaysia recorded 10,972 new cases and 129 deaths, bringing the total cumulative cases to 927,533 and 7,148 deaths, according to the Malaysian Ministry of Health. 

Fatalities have tripled since early May.

Malaysia is also facing an economic crisis and thousands are in need of assistance from the government after the most recent lockdown, which was introduced on 1 June. 

“Generous and comprehensive welfare protection to support nutrition, mental health and the ability to stay home for all Malaysians” is needed, Dr Khor Swee Kheng, an independent health policy consultant for WHO, told the Guardian. 

Health experts have blamed the continued rise in cases on the government’s inconsistent implementation of restrictions and failure to close loopholes.  

Frustration Mounting Over Government’s Handling of COVID-19 in Thailand

Thailand recorded 11,784 new cases and 81 deaths on Sunday, marking the third consecutive day of cases over 9,000. As the country attempts to tackle its worst outbreak to date, a protest was held to criticize the government’s handling of the pandemic. 

The country has recorded a total of 415,170 cases and 3,422 deaths since the pandemic started. Over 90% of cases and deaths have occurred since April. 

COVID restrictions were expanded on Sunday to include limits on travel, shopping mall closures, and a curfew in 13 provinces, making these the strictest social and public health measures implemented in over a year. 

On the same day, protesters, armed with N95 masks, gloves and hand sanitizer, broke the ban on gathering of more than five people, to call for the Prime Minister’s resignation. Prime Minister Prayut Chan-o-cha has been criticized for his failure to secure adequate supplies of COVID vaccines and his inability to prevent the mounting infections and deaths. 

The police used teargas, water cannons, and rubber bullets to disperse protesters.

Areas of Vietnam Experiencing ‘Very Complicated Epidemics’

Vietnam has put its southern region in a two-week lockdown starting on Sunday after three consecutive days of record cases, deemed “very complicated epidemics,” by Vietnam’s Prime Minister Pham Minh Chinh.

On Sunday, Vietnam recorded 3,218 new cases and 16 deaths, the majority of which took place in the Mekong Delta and Ho Chi Minh City. Some 84% of the COVID deaths have occurred since April, after months of no recorded cases.

“The situation is getting serious with a high rate of transmission, especially with the dangerous Delta variant,” said Vietnam’s Prime Minister Pham Minh Chinh. “We have to put the health and safety of the people as the top priority.”

“We have to keep the transmission rate at the lowest possible to ensure the health system functions effectively and is not being overloaded,” said Vu Duc Dam, Deputy Prime Minister and head of the Committee for COVID-19 Pandemic Prevention. 

The surge has come as Vietnam struggles to speed up its vaccine rollout.

Booster Shots Planned to Bolster Sinovac

Vaccination rates across Southeast Asia remain low, with 30.3% of Malaysia’s population having received one dose, 15.4% of Thailand’s, 15.2% of Indonesia’s, 4% of Vietnam’s, 3.5% of Bangladesh’s, and 3.3% of Myanmar’s. 

Even Malaysia, which has done the best out of this group of Southeast Asian countries, has only fully vaccinated 9.6% of its population, compared to 52.9% in the United Kingdom and 48.1% in the United States.

Not only have fewer people across Southeast Asia received COVID jabs, but there are growing concerns that the Chinese-made Sinovac vaccine may not be performing as well as expected – particularly against rapidly spreading variants of SARS-CoV-2.

Both Indonesia and Thailand, which have vaccinated their healthcare workers with Sinovac, have announced plans to offer a booster dose of the Moderna or Pfizer/BioNTech vaccines. 

“There’s a lot of doctors and medical workers who have been vaccinated twice but endured medium and severe symptoms, or even died,” said Slamet Budiarto, Deputy Chief of the Indonesian Medical Association, to Parliament in early July. 

“It is the time for medical workers to get a third booster to protect them from the impact of more vicious and worrying new variants,” said Melki Laka Lena, Deputy Chairman of the Indonesian Parliamentary Commission Overseeing Health.

Image Credits: Sky News, ABC News (Australia), ABC News (Australia).

Max Appenroth of Global Action for Trans Equality (GATE)

Almost one in five trans women globally are living with HIV – 49 times greater than the general population – while HIV in trans men is woefully understudied. 

Yet trans and gender-diverse (TGD) people are “frequently and often systematically left out of HIV prevention research and responses”, according to No Data No More, a global HIV prevention manifesto launched on Monday with the support of the non-profit HIV prevention organisation, AVAC.

“Forty years into the global HIV pandemic, which is endemic to most trans communities, it’s beyond time to align HIV prevention research with trans and gender-diverse realities,” Max Appenroth of Global Action for Trans Equality (GATE), told the launch.

“The best way to reduce HIV in TGD communities is to invite our communities to participate meaningfully in the response. The ‘No Data No More’ manifesto is an invitation to recognize the fundamental and critical role that empowered TGD communities can play in protecting our own wellbeing and reducing the global toll of HIV.”

Warning to Academia

Even when TGD people are included in research, they are considered as subjects rather than collaborators with agency, according to Leigh-Ann van der Merwe, from the Social, Health and Empowerment Feminist Collective of Transgender Women in South Africa.

“I want to caution academia that transgender people are no longer willing to be recruited as as data collectors only,” said Van der Merwe, adding that transgender people needed to be included in all the various stages of decision-making from research design, to implementation and dissemination.

The manifesto, which was written by TGD advocates from South Africa, Europe and the United States, argues for an HIV TGD research agenda that “considers diversity, including the full range of participants along the gender spectrum” and accurately tracks epidemiological data on HIV incidence and prevalence in TGD populations.

Immaculate Nyawira Mugo, consultant on gender, intersectional sexual and reproductive health and rights in South Africa, also called for more research into drug interactions between gender-affirming hormone therapy and antiretroviral drugs, including ARVs taken to prevent HIV as pre-exposure prophylaxis (PrEP)

“Much work remains to make the perspective and participation of trans and gender diverse communities central to HIV response, but this manifesto charts an essential path forward for researchers, advocates and implementers worldwide,” said AVAC Senior Manager for Partnerships Cindra Feuer.

The manifesto was launched in association with the International AIDS Society’s Conference on HIV Science which started on Sunday and runs until Wednesday.

 

Relief supplies that were stockpiled through the UN Humanitarian Response Depot hub in Brindisi, Italy were sent to Somalia in the wake of Cyclone Gati. The new project plans to utilise this existing infrastructure for health emergencies.

The World Food Program (WFP) and World Health Organization (WHO) launched a health emergencies project, INITIATE2, on Monday.

The joint INITIATE2 project will gather health emergency actors, research and academic institutions, and international and national partners to facilitate knowledge sharing and skills transfer to improve emergency health responses. 

The project will develop innovative solutions to health crises, including disease-specific facilities and kits. Healthcare workers and those working in logistics will be trained to implement and adjust the solutions to local contexts. 

The agencies plan to leverage existing infrastructure, such as the UN Humanitarian Response Depot (UNHRD) – a global network of hubs that procures, stores, and transports emergency supplies for the humanitarian community – to stockpile relief items. 

Currently, there are six strategically located hubs around the world in Italy, Ghana, Malaysia, Panama, Spain, and the United Arab Emirates. 

The UNHRD Lab will be used to research and develop improved logistics support equipment, cost-effective and sustainable solutions, and standardised field items for health responses. 

“Health emergencies like the West Africa Ebola response and the current COVID-19 pandemic have shown just how crucial working together as a humanitarian community is, and so we’re extremely pleased to be able to further cement our role as an enabler of humanitarian response through this collaboration with WHO,” said Alex Marianelli, WFP Director of Supply Chain, in a press release. 

COVID Health Emergency Program

During the COVID-19 pandemic, WHO and WFP developed the COVID-19 Supply Chain System to address the acute shortage of essential supplies, including personal protective equipment (PPE), biomedical equipment, and diagnostics supplies. 

WHO has worked with partner agencies to provide a channel for countries to request critical healthcare supplies. 

“The WHO-WFP-led COVID-19 Supply Chain System has already illustrated an end-to-end integration of technical and operational capacities for impact,” said Dr Ibrahima Soce-Fall, WHO Assistant Director General for Emergencies Response. 

“With INITIATE2, WFP and WHO are now extending the collaboration to build synergies among different actors and foster innovation in this critical field, to quickly respond to health emergencies and create a conducive environment for knowledge sharing and skills transfer,” said Soce-Fall.

This is an excellent example of how we can scale and harmonise emergency preparedness, readiness, and response,” he added.

Image Credits: UNHRD.

Almost half of Sudanese households are concerned about food security.

KHARTOUM – A telemedicine programme is helping Sudanese medical students to both treat community members with mild COVID-19 in their homes and educate their communities about the pandemic.

Many medical students, who have been sitting at home since medical schools were closed last year due to the pandemic, joined the community medical response teams (CMRT) established earlier this year by US-based Sudanese physician Dr Nada Fadul, an infectious disease physician at University of Nebraska, and Dr Reem Ahmed from Emory University.

Over the past five months, Fadul,  Ahmed and other Sudanese physicians outside the country, have trained more than 120 medical and healthcare students in over 50 Sudanese neighborhoods to manage patients with COVID-19 in their homes. 

“The students wanted to do something, but they didn’t know what to do or how to do it safely,” said Dr Fadul.

“In addition to the impact they’re having on patients, students benefit from pursuing their learning in a hands-on way. When they return to their classrooms, they will be better equipped to take on new challenges.” 

The CMRT training focuses on the principles of home management for mild to moderate cases; home isolation and quarantine methods; and identifying life-threatening symptoms that require immediate medical attention.

Access to up-to-date information

Last month, the CMRTs linked up with Project ECHO, a US-based initiative that connects the students to medical experts who offer case-based telementoring and collaborative problem-solving.

Asmaa Alhadi, a fifth year medical student studying at the National Ribat University in Khartoum, joined the first cohort of CMRT facilitators in January, and said that the programme has enabled her to access up-to-date information on scientific studies and data on the pandemic.

“All this has made it easier for me to speak comfortably to community members

since I am equipped with a huge amount of knowledge and skills to overcome community hesitancy and fears towards the disease and vaccines,” she said.

Alhadi explained that there is a lot of stigma surrounding the virus in Sudan, particularly in rural areas where there is greater vaccine hesitancy. 

“The real change I believe the project has had is through the number of awareness and educational campaigns held in different local neighbourhoods,” she said.

These campaigns, she maintains, have played a big role in convincing people to get the vaccine by sharing with them the benefits of being vaccinated and how it will help in saving lives.

“From my point of view, even changing only one individual’s misconceptions about COVID-19 is quite satisfying, especially in a closed country like Sudan,” she said.

The CMRT, with support from ECHO, hopes to reach 400 students in Sudan by the end of 2021.

Rising hardship caused by pandemic

A World Bank report published in May highlighted the massive economic impact of the pandemic on the country, with 67% of people reporting that they had been unable to return to work, almost half of households (47%) concerned about food security and one-fifth unable to buy basics such as bread and milk because of rising prices.

The country has vaccinated approximately 0.8% of its population against COVID-19 using vaccines provided by COVAX, according to Reuters. 

Project ECHO was founded in 2003 at the University of New Mexico in the US, and has launched about 1000 programmes in nearly 50 countries, addressing more than 70 health conditions. 

In Sudan, the University of New Mexico is collaborating with the University of Nebraska Medical Centre (UNMC) and the Sudanese Federal Ministry of Health (MoH). It is also working with the Sudanese American Medical Association (SAMA) and Sudan NextGen (SNG), both of which are coalitions of Sudanese organisations against COVID-19.

Dr Bruce Baird Struminger, senior associate director of the ECHO Institute at the University of New Mexico, said that the pandemic had challenged Sudan’s health system that was already weakened by years of civil war and unrest. 

“We hope to continue to expand the use of ECHO more broadly in future years to enable the CMRT volunteers to target other priority communicable and non-communicable diseases,” Struminger told Health Policy Watch.

One of the main challenges facing the initiative is power outages and poor internet connectivity. The programme is seeking solutions to strengthen internet connectivity and power access at local medical schools and other sites to transform these locations into local ECHO learning sites. 

Students can either join learning sessions remotely or at the Sudanese American Medical Association main office and at the Federal Ministry of Health offices.

Almost 50 community outreach activities have been conducted in Sudan by volunteers in the programme. This includes education sessions on COVID-19 prevention and vaccination in schools, local mosques and neighbourhood clubs.

Alhadi believes that attracting more players, not only medical field partners like the Federal Ministry of Health, could help improve the initiative.

“I do believe that being in touch with different partners from different fields will make it similar to a multidisciplinary team who are working side-by-side to achieve the project”s goals, starting from democratisation of medical knowledge through to reaching community members and changing their thoughts and practices towards the disease,” she said.

Since April 2020, more than 180,000 people have participated in ECHO video-conference-based virtual learning sessions across Africa, most of which have been focused on COVID-19. 

 

Image Credits: Sarah Farhat/World Bank.

Vaccine supplies have dried up in most African countries after COVAX was unable to procure supplies from India.

Burkina Faso, Djibouti, and Ethiopia will be the first African countries to benefit from the US donation of COVID-19 vaccines, with a million doses expected “in the coming days” as part of the US pledge to provide 25 million vaccines to the continent, US officials and the global vaccine alliance, Gavi, said on Friday.

This comes amid a surge in cases on the continent, which has seen COVID-related deaths increase by 43% in the past week.

The Johnson & Johnson vaccines are being delivered via the Africa Union’s African Vaccine Acquisition Trust (AVAT) and the global vaccine delivery platform, COVAX.

The World Health Organization (WHO) has urged the vaccination of 10% of the world’s population by the end of September, but Africa has only vaccinated 1.3% of the continent’s population, according to the Africa Centre for Disease Control and Prevention (CDC).

African Vaccination Figures, July 2021

Donated vaccines will go to 49 African countries in the coming weeks as part of a collaboration between the African Union and Africa CDC, AVAT, financing bank AFreximbank, COVAX and the US government.

“We appreciate the US Government for their support in helping contribute to the AU target to vaccinate 60% of the population in Africa especially at this moment when we are witnessing the third-wave in a number of African countries,” said Strive Masiyiwa, AU Special Envoy and head of AVAT.

“In partnership with the African Union and COVAX, the United States is proud to donate 25 million COVID-19 vaccines to 49 African countries,” said Gayle Smith, Coordinator for COVID-19 Recovery and Global Health, US Department of State.

“The Biden Administration is committed to leading the global response to the pandemic by providing safe and effective vaccines to the world.  Working together, we can save lives and bring the COVID-19 pandemic to an end.”

The African allocation is part of the 80-million dose donation recently announced by US President Joe Biden.

Financial institution Afreximbank has put in place a US$2 billion Advance Procurement Commitment (APC) Guarantee facility to buy 400 million J&J doses, according to Prof Benedict Oramah, President of Afreximbank.

“These combined efforts give reason to be optimistic that the African Union’s goal of at least 60% vaccination coverage will be achieved soon,” said Oramah.

COVAX  “expects to deliver 620 million doses to Africa by the end of 2021, rising to 1 billion doses by the end of the first quarter of 2022”, according to Gavi.

Meanwhile, the Partnerships for African Vaccine Manufacturing (PAVM) launched in April, recently reported that Senegal, the European Union, the US and other partners, have signed an accord to finance vaccine production at the Institut Pasteur of Dakar.

Earlier in July, Morocco and Swedish company Recipharm signed a memorandum of understanding to establish and scale up COVID-19 vaccine manufacturing capacity in the country. 

In late June, the South African government, Biovac, Afrigen Biologics & Vaccines, a network of universities, the World Health Organization (WHO), COVAX, and Africa CDC announced the establishment of the first COVID-19 mRNA vaccine technology transfer hub in Africa.

 

Image Credits: WHO African Region .