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 .

In Pakistan, a healthcare worker listens to a child’s lungs for signs of pulmonary tuberculosis.

On the 100th anniversary of the world’s only vaccine for tuberculosis, the Stop TB Partnership has urged world leaders and other stakeholders to prioritise the development of an effective, safe and affordable tuberculosis vaccine by 2025. 

But there is a financial shortfall to achieve this goal, with only around a fifth of the target funding having been raised so far. In 2019, US$117 million was invested in TB vaccine research against a target of at least US$550 million per year over the next four years to achieve the 2025 deadline. In contrast, COVID-19 vaccine research received over US$100 billion in funding over the past year.

“What the world has achieved in the past year with regards to the development of safe and effective COVID-19 vaccines is astonishing and worth celebrating,” said Dr Lucica Ditiu, executive director of the Stop TB Partnership.

Ditiu noted that the same level of energy and funding that went into new vaccines for COVID-19 should also go into vaccines for TB, another airborne, deadly infectious disease that has been around for millennia and kills 4,000 people every day, including 700 children. 

“Today, we call on the world to provide sufficient financial resources and political will by 2023 to allow for the rollout of an effective TB vaccine by 2025. Lessons learned from recent pandemics clearly show that it is possible,” Ditiu added.

Carol Nawina, a TB survivor and person living with HIV noted that prior to COVID-19, TB advocates had come to the conclusion that there may not be a new vaccine again. 

“For me, it’s really outrageous that the world, for 100 years, could not come together and develop an effective vaccine for TB. But here we are, within two years, we already have several vaccines for COVID-19,” she told a briefing on Thursday convened by Stop TB.

Nawina, who is a Zambian, also said that Zambia and other TB-high burden countries should declare TB a national priority for investment and that political will is operationalised. 

“COVID-19 has shown us that we can do with investment. We must leverage the COVID-19 investment to end TB. The global community must now invest funds and allocate domestic resources for this purpose,” she added.

BCG ‘isn’t doing what we need it to do’

David Lewinsohn, professor of medicine at Oregon Health and Science University, and chair of Stop TB Partnership’s working group on new TB vaccines

David Lewinsohn, professor of medicine at Oregon Health and Science University, and chair of Stop TB Partnership’s working group on new TB vaccines, described the BCG vaccine that was first administered in July 1921 as a good vaccine that has been effective in preventing the really severe complications of childhood TB including meningitis and disseminated TB. 

“I don’t think the BCG vaccine has failed. One of the reasons why we have been reluctant to discard the vaccine is because it works in preventing severe forms of TB in children. It hasn’t failed, but it isn’t really doing what we needed it to do,” Lewinsohn said.

But the BCG vaccine has not been able to bring about dramatic reduction in the number of TB cases among the populations like the vaccines against measles, mumps or polio as a leading infectious disease worldwide, killing thousands of people, including hundreds of children, daily.

Lewinsohn said that there were 15 TB vaccine candidates in the pipeline currently.

In September 2018, the results a Phase 2b clinical trial were announced that showed GSK’s M72/AS01E candidate vaccine significantly reduced the incidence of pulmonary TB disease in HIV-negative adults with latent TB infection with an overall vaccine efficacy of 54%.

“Now, that was 2018, and working our way backwards, the actual discovery and development of that vaccine took place in the late 1990s. And so it really took about 20 years to go from vaccine development to the first promising results in humans, and we contrast that to the enrollment of the COVID vaccines which took something less than 100 days. Admittedly that benefited greatly from defense investments in SARS and MERS. But nonetheless, that’s a pathetically short timeline, ” Lewinsohn said.

In addition to upstream investments into TB vaccine development, Lewinsohn said there is also the need for far greater capacity to evaluate and license the vaccines to ensure equitable TB vaccine distribution.

A challenging disease for vaccine development

Even with the availability of funds and political will, in comparison with COVID-19, TB has been described as a challenging disease for vaccine development. 

While SARS-CoV-2 is highly transmissible and capable of causing disease in most individuals infected, the situation is different for TB where most people who get infected do not fall sick in the short term.

“So we need to think about vaccines in different contexts and it’s very likely we’re going to need more than one vaccine,” Lewinsohn said.

He noted that the vaccine that is efficacious among children may be different from the ones for adolescents. In the same vein, the vaccine that prevents infection may be different from the one that prevents people from falling sick.

“I think there’s really good science that supports vaccines for all of those indications, but it just highlights the idea that we’re going to need to pursue different vaccines with different indications as rapidly as we can,” the professor said.

In March 2021, Health Policy Watch reported that 12 months of COVID-19 have eliminated 12 years of progress in the global fight against tuberculosis. At Thursday’s briefing, Sahu Suvanand, Stop TB Partnership’s Deputy Executive Director said COVID-19 has been a major setback in the global fight against TB. 

“We are not on track to end TB,” he said.

He noted that dealing with the limitations of the BCG vaccination will improve the realisation of global TB goals. 

“It offers mostly variable or poor protection against other forms of TB. It particularly doesn’t prevent TB transmission, and disease in adolescents,” he added.

Going forward, he said the world needs to recover from the impact of COVID-19 and come back on track towards ending TB.

“It will require the existing tools to be applied at scale and with some innovations to get over the barriers that COVID has faced. Also, the new tools that are in the pipeline need to come in and be rolled out, and then we should be able to end TB by 2030,” Suvanand added.

Image Credits: Stop TB Partnership.

Many people turned to video gaming as a way of connecting with others during COVID-19 lockdown.

The isolation of COVID-19, especially during the early stages of the pandemic, has forced many people to turn to alternative methods of communication and engagement, such as video games, speakers noted during a Thursday event, organized by video games industry associations.

At the event, panelists discussed the role of video games on health and well-being, and the potential for video games to be used as a positive force in the field of mental health. The event was hosted by the Interactive Software Federation of Europe, in collaboration with the Entertainment Software Association (ESA), and other video game associations.  

People found solace in video games during the COVID-19 pandemic, as players used the medium to share and keep in touch with peers while playing together, said panelist Andrew Przybylski, director of research at Oxford Internet Institute, who led a recent study that exampled the impacts of video game playing on well-being during the pandemic.

Other recent research has found that video games can be used to reinforced connections between parents and children, when they play together during pabdemic lockdowns. 

“Video games proved their relevance with its audience, facilitating a medium to connect and share experiences,” said Eduardo Mena, Research Director at the UK-based Ipsos Mori, another one of the panelists who appeared at the event.

But while video games have become a dominant source of entertainment for children and adults alike, the industry itself continues to be misunderstood. Media continues to rely on old research,  stereotypes, and broad generalizations to report on this hobby, resulting in the misinformed engaging with video games in a “uniform, monolithic way,” said Gene Park of The Washington Post, moderating the event.

“[Video games] remains woefully understudied as an industry,” said Park.

Pandemic Interrupted “Circadian Rhythm of Play” 

Andrew Przybylski, Director of Research, Oxford Internet Institute

The pandemic interrupted the “circadian rhythm of play”, leading people to play video games more on a daily basis, especially online multiplayer ones, when national lockdowns first began in the UK in 2020 when compared to 2019. 

A study, conducted by the Oxford Internet Institute, examined the top 500 games on Steam, a video game distribution service, and compared daily play data for 2019 and 2020, to determine whether the COVID-19 pandemic was related to an uptick or change in behavior for players worldwide. 

Typically, video games engagement is subjected to what Przybylski called the “circadian rhythm of play”, with people normally playing during weekends, or on days of rest. However, the pandemic interrupted this circadian rhythm, prompting a “weekend effect” that led to increased gameplay. 

“The pandemic erased the weekends, leading people to play more year-round,” said Przybylski.

While the heightened video game engagement led to concerns of possible addiction, the study also found that when lockdowns eased, the engagement also waned again, although some aspects of the ”weekend effect” persisted, when people continued to work from home.    

Video Games May Contribute to Well-Being, Says Ground Breaking New Study

A previous study, also conducted by the Oxford Internet Institute, examined industry data on actual play time for two popular video games, Plants vs Zombies: Battle for Neighborville and Animal Crossing: New Horizons.

This groundbreaking study suggests that experiences of competence and social connection with others through play may contribute to people’s well-being. 

The experiences during play could even be more important than the actual amount of time a player invests in games and could play a major role in the well-being of players. 

Przybylski sees these studies as an opportunity for the video game industry to go further in understanding the connection between video games and behavior and health, as opposed to jumping to “fast, cheap narratives that miss the big picture.” 

“We need to take care not to forget the basics behind human behavior and how we understand health, in light of the digital world, in light of video games.”

He emphasizes that going forward, industries and researchers alike should collect data that “acts as a rising tide for all ships.” 

“If you want to understand how human collaboration plays into specific types of narratives, feeds into the human story and into mental health….it means you have to dig a bit deeper. Players themselves need to be part of that process.” 

Supportive Role of Video Games During the Pandemic 

Around 30% of players appreciated the supportive role of video games during pandemic restrictions, the number increasing with those who played multiplayer online games.

The COVID-19 pandemic accelerated video game engagement, with players appreciating the supportive role of video games during pandemic restrictions, another new study found.

This study, conducted by Ipsos Mori, examined the impact of the pandemic on people who play video games. 

Around 30% of surveyed players said that playing video games helped their mood and allowed them to feel less isolated as they stayed in contact with friends and family, this number increasing to almost 50% with multiplayer online games. 

One in four players also improved their perception about the link between video games and mental health. 

There was also an increase in parents who played video games. Parents who played video games with their children found the experiences helpful in connecting with their children and in facilitating their learning. 

Normalizing Mental Health Discussions Through Video Games 

Cornelia Geppert, CEO of Jo-Mei Games. Jo-Mei Games is a German game developer of Sea of Solitude.

The video game Sea of Solitude allowed players to normalize mental health conversations through an active form of storytelling, leading many fans to say that the game “changed their life for the better,” said game developer Cornelia Geppert, CEO of Jo-Mei Games.

Many have written to Geppert, saying that they now “hope to have a better future for themselves, for the first time in decades. They now want to seek therapy and feel hopefully [in overcoming] their own issues.” 

The game tells an intimate story of a young woman’s emotional journey to overcome loneliness. 

Several different manifestations of loneliness are depicted throughout the game – from bullying, family, relationships and mental health issues. The main character, Kaye, turns into a monster as she suffers from strong feelings of worthlessness and hopelessness. 

Players experience what she and the other characters are going through as they help her turn back into a human, with the key message of the game not only to chase joy and happiness, “but to embrace all your angles, to bring all your emotions into balance,” said Geppert.

“[Sea of Solitude] shows that sometimes it is most important to focus on your own well-being first.” 

Image Credits: MaxPixel, ISFE, ISFE .