Dr Ellen Johnson Sirleaf speaking at the launch of the report on Wednesday

A sweeping report on the global pandemic response has found that the World Health Organization should have taken a more “precautionary’ approach to the emerging SARS-COV2 virus in the early days of the pandemic, advising countries earlier on that it could be transmitted person-to-person — rather than only warning of such a “possibility”.

The report also says that the WHO Emergencies Committee dallied in declaring a global public health emergency – delaying a decision from its meeting on 22 January until 30 January 2020 – and losing another critical week in the first month of the pandemic battle. 

”The Panel’s view is that the outbreak in Wuhan is likely to have met the criteria to be declared a PHEIC by the time of the first meeting of the Emergency Committee on 22 January 2020,” said the final report of the Independent Panel, published Wednesday. 

“While WHO advised of the possibility of human-to-human transmission in the period until it was confirmed, and recommended measures that health workers should take to prevent infection, the Panel’s view is that it could also have told countries that they should take the precaution of assuming that human-to-human transmission was occurring. 

Air travel has exploded in past decades, increasing risks of rapid international pathogen transmission, the report notes.

“Given what is known about respiratory infections, there is a case for applying the precautionary principle and assuming that in any outbreak caused by a new pathogen of this type, sustained human-to-human transmission will occur unless the evidence specifically indicates otherwise,” states the panel report. 

The Independent Panel report, co-chaired by the former President of Liberia, Ellen Johnson Sirleaf, and Helen Clark, the former Prime Minister of New Zealand, sets out a wide-ranging set of recommendations for ending the current pandemic and preparing for the next one.  

“This must be the last pandemic to cause destruction on the scale we are seeing today,” said Sirleaf at the report’s launch. “A new deadly virus could arise tomorrow. The world was not prepared for this one. We must prepare for the next one.”

Said Clark, “almost 100,000 people died from COVID-19 last week around our world. It is a disaster which our panel believes coudl have been averted.”

In terms of ending the current pandemic, the Panel calls for a shake up in the vaccine manufacturing landscape; a World Trade Organization patent waiver; global support for establishment of new vaccine manufacturing hubs; over US$ 10 billion in new G-20 finance for medicines, tests and vaccines, and a commitment by high-income countries to provide the world’s 92 lowest-income countries with more than two billion doses by mid-2022.  

Helen Clark, former Prime Minister of New Zealand at the report launch.

Added Clark. “COVID-19 must not evolve into a neglected pandemic” where it is over in wealthy countries while poorer nations face border closures and years of wait to access vaccines,” adding that. “Covid-19 must not evolve into a neglected pandemic” where it is over in wealthy countries while poorer nations face border closures and years of wait to access vaccines.

But the long-awaited report is likely to be more scrutinized for it’s treatment of the pandemic narrative and its recommendations on preparedness for the next pandemic, when it is reviewed by the World Health Assembly, meeting 24 May- 2 June. 

Stronger & More Independent WHO

In that narrative, The Independent Panel in fact places most of the blame for a faulty, delayed, and ineffective pandemic response on WHO member states – rather than the organization or its current senior management.  

The report lays out a set of recommendations for a “stronger” and “more independent”  WHO – including extension of the Director General’s term from five to seven years  – ostensibly to protect the position from undue political influences. 

“The Independent Panel has found weak links at every point in the chain of preparedness and response. Preparation was inconsistent and underfunded. The alert system was too slow—and too meek. The World Health Organization was under-powered. The response has exacerbated inequalities. Global political leadership was absent,” the report concludes. 

COVID-19 cases as of 30 January 2020 – WHO’s global health emergency declaration came too late. .

 

COVID-19 cases as of 11 March 2020 – the date WHO declared a global pandemic.

Emergency Alert System ‘Two Worlds at Different Speeds’ 

The Independent Panel Team

Chief among the structural weaknesses exposed is infrastructure of the present emergency alert system. 

WHO responses were guided largely by the legally-binding international emergency system, the International Health Regulations (IHR), which “are a conservative instrument as currently constructed and serve to constrain rather than facilitate rapid action.’’ As a result, the “precautionary principle was not applied to the early alert evidence when it should have been,” the Panel concluded. 

To address that, the Panel calls for an overhaul of the IHR emergency alert rules – as well as a new Pandemic Framework Convention –  to make them more responsive to fast – moving pathogens and the rapid flow of modern information systems. 

“The Panel’s view is that the definition of a new suspected outbreak with pandemic potential needs to be refined, as different classes of pathogen have very different implications for the speed with which they are likely to spread and their implications for the type of response needed,” the report states. 

“The chronology of the early events in raising the alarm about COVID-19 show two worlds operating at very different speeds. One is the world of fast-paced information and data-sharing.

…. Digital tools are now core elements in disease surveillance and alert, sifting through vast quantities of instantly available information,” it notes. 

“The other world is that of the slow and deliberate pace with which information is treated under the IHR (2005), with their step-by-step confidentiality and verification requirements and threshold criteria for the declaration of a PHEIC, with greater emphasis on action that should not be taken, rather than on action that should.”

Redesign Surveillance and Alert Systems to Function at Near-Instantaneous Speed

Among a wide-ranging menu of solutions, The Independent Panel says that global, regional and national surveillance and alert systems need to be designed to ensure that “detection functions” and “relay functions – ensuring that signals are verified and acted upon” actions are synchronized. 

“Both must be able to function at near instantaneous speed,” The Independent Panel report states. 

China and Asian Pacific Countries Applauded for Early Action  

pandemic
Shoppers in Wuhan, China, post-COVID-19 lockdown

“The question we must ask ourselves is why the PHEIC declaration did not spur more action, when the impending threat should have been clearly evident? After a stuttering start to the global response in January 2020 by the end of that month it was clear that a full-scale response would be needed. It is glaringly obvious to the Panel that February 2020 was a lost month, when steps could and should have been taken to curtail the epidemic and forestall the pandemic,” the report finds. 

However, the report avoids assigning any specific blame for the failures to any single country – including China which has been widely criticized for failing to report early on the depth and breadth of the spreading virus. 

“The Panel’s analysis suggests that the failure of most countries to respond during February was a combination of two things. One was that they did not sufficiently appreciate the threat and know how to respond. The second was that, in the absence of certainty about how serious the consequences of this new pathogen would be, “wait and see” seemed a less costly and less consequential choice than concerted public health action.”

At the same time, it applauds China and a handful of other countries, mostly in the Asian Pacific region, such as New Zealand, Korea, Singapore, Thailand and Viet Nam, which recognized the threat early on and undertook an “aggressive containment strategy.”  

Seven Point Plan For Strengthening Preparedness 

Pandemic Preparedness Regional Response – The Panel’s Seven Point Plan includes a pre-negotiated platform for essential supplies.

Beyond a more agile, digitally-based alert and response system, much more also needs to be done, in terms of strengthening other aspects of pandemic preparedness – the Panel concludes, etching out seven key recommendations, including: 

Free WHO from national government controls. The report calls on the World Health Assembly to give WHO explicit authority to publish information about outbreaks with pandemic potential immediately – without requiring the prior approval of national governments, and the power to investigate pathogens with pandemic potential with short-notice access to relevant sites, provision of samples, and standing multi-entry visas for international epidemic experts to outbreak locations.

High-level political leadership. Adoption of a Pandemic Framework Convention within the next six months, as well as a United Nations General Assembly political declaration at the September 2021 meeting. 

Stronger, more independent WHO. Extend the Director General’s term to seven years, but with no option for re-election – with the same rule to apply to WHO’s six Regional Directors. “Depoliticize recruitment especially at senior levels”, prioritizing merit-based evaluation of performance. Increase WHO member state fees to two-thirds of the WHO base programme budget and abolish the “earmarking’ of donor funds so that they can be used more flexibly.  

Invest in pandemic preparedness.  Along with calls to national government to update their pandemic preparedness plans, WHO should formalize periodic peer reviews of country’s preparedness, and the International Monetary Fund should routinely undertake pandemic preparedness assessment 

Pre-negotiated Platform for supplies.  Institutionalize and transform the current Act Accelerator and COVAX platforms into a “truly global end-to-end platform to deliver the global public goods of vaccines, therapeutics, diagnostics, and essential supplies.” This would be accompanied by new donor and member state agreements to:  

  • “Secure technology transfer and commitment to voluntary licensing in all agreements where public funding has been invested in research and development.
  • “Establish stronger regional capacities for manufacturing, regulation, and procurement of needed tools for equitable and effective access to vaccines, therapeutics, diagnostics, and essential supplies, as well as for clinical trials.”

Financing pandemic preparedness and response. Create an International Pandemic Financing Facility to raise additional reliable funding for pandemic preparedness and for rapid surge financing for response in the event of a pandemic with the capacity to mobilize long term (10-15 year) contributions of approximately US$5-10 billion per annum to finance preparedness, with the ability to disburse up to US$50-100 billion at short notice in the event of a crisis

Appoint “National Pandemic” coordinators with direct line to heads of state. Heads of State and Government to appoint national pandemic coordinators who are accountable to them, and who have a mandate to drive whole-of- government coordination for pandemic preparedness and response.  

Access Advocates Laud Report’s Proposals On Vaccines & Medicines Access  

UNAIDS welcomed the report’s recommendations, particularly the “urgent need to establish at Global Health Threats Council at the highest political level in order to coordinate global action against pandemics and secure agreement between governments on aligning efforts to tackle the health, social and economic challenges of major pandemics.

“The IPPR recommendations are a wake-up call for transforming health systems across the world,” said Winnie Byanyima, Executive Director of UNAIDS, in a statement. “Health is a universal public good in this interconnected society—no one is safe until everyone is safe, so we must reimagine health to provide the same quality of care regardless of geography, income or social status.” 

Meanwhile, the advocacy group Medicines, Law and Policy, lauded the report’s “bold recommendations” including its support for the proposed waiver of intellectual property rights on Covid-19 vaccines.  

It cited Clark’s comments that the US support for the waiver, is “a game changer” and “a vital step in the right direction”noting that she also called for WHO to convene vaccine producing countries and companies to agree to voluntary licences and technology transfer for COVID vaccines immediately. 

 

Image Credits: IPPR, The Independent Panel , José Mauquer .

East African truck drivers will get access to one common COVID-19 testing system by mid-May.

Limitations in COVID-19 testing capacity and surveillance—as well as uneven demand for testing—are likely masking the true severity of COVID-19 on the African continent, fueling the dangerous myth that much of Africa has been unscathed by COVID-19.

Test positivity rates were above 10% across many African Union (AU) member states during the second wave—substantially higher than the 5% maximum warning level suggested by the WHO and suggesting that many cases have gone undetected – says new research from the Partnership for Evidence-Based Response to COVID-19 (PERC).

A survey of 24,000 people across 19 AU member states also found that 81% of survey respondents reported challenges in accessing food, 77% reported experiencing income loss and 42% reported missing medical visits since the start of the pandemic.

The report calls for targeted public health measures for high-risk populations, increased surveillance in light of new variants, and scaled-up vaccine supply from the global community to control the pandemic in Africa.

“As case counts surge across the world, new variants emerge and vaccine rollout remains slow, it will be crucial for African Union Member States to use evidence-based strategies to manage COVID-19,” said Dr John Nkengasong, Director of the Africa Centres for Disease Control and Prevention. “The PERC report provides valuable insights to countries to strategically tailor their ongoing responses.”

High Vaccine Acceptance, But Global Community Needs to Deliver Them to Africa

Though vaccine acceptance was high among survey respondents, with 67% of people saying they would get the vaccine when it’s available, there are several important caveats to consider.

At the time of the survey, access to vaccines and information about them was still being rolled out across the African Union, with lack of information the driving factor to vaccine hesitancy. Recent news about vaccine side-effects also is likely to have diminished vaccine confidence. 

“Vaccine hesitancy is driven by high levels of disinformation, misinformation, and lack of information, which erodes trust in the safety and efficacy of vaccines,” said Dr Richard Mihigo, Program Coordinator, Immunization and Vaccine Development,  WHO’s Regional Office for Africa. 

“Going forward, we must prioritize sustained and targeted campaigns which address the growing infodemic around vaccines while providing evidence-based information to dispel myths and build confidence in vaccines. Communication and engagement is key to building trust and creating a positive discourse around vaccines from the ground up.” 

The delayed rollout of vaccines and the rapidly growing threat posed by new variants does present the opportunity for African Union Member States to ramp up vaccine acceptance campaigns and logistics for efficient vaccine rollout – and continually monitor and address vaccine confidence – before vaccines arrive in the region. 

In addition, the report calls on the global community to deliver vaccines to member states as soon as possible. 

The Africa CDC recently called the United States’ reversal on the World Trade Organization Trade-Related Aspects of Intellectual Property (TRIPS) waiver a ‘positive development’, though also cautioned that the announcement did not guarantee global patent rules for COVID-19 vaccines would be lifted immediately. 

Scale-Up in Public Health Strategies to Prevent Potential COVID-19 Surge

africa
South Africa continues to drive reported COVID-19 cases in Africa; however, reported cases increased significantly in all African Union Member States during the second COVID-19 wave compared to the first

The African Union must also scale up effective testing strategies for detecting potential surges and sustaining the use of public health measures to prevent subsequent waves. 

Nearly nine in 10 respondents reported using masks near others in February 2021, but in some populous and hard hit countries, such as South Africa and Ethiopia, self-reported mask wearing trended downward, suggesting the need to redouble efforts to promote this low-cost and effective intervention in some countries. 

Overall, self-reported adherence to social distancing measures declined between August 2020 and February 2021. 

“Countries are most effective controlling the pandemic when they consider what measures people will actually follow at this stage in the pandemic and take steps to inform, partner with, and support communities,” said Dr Tom Frieden, President and CEO of Resolve to Save Lives, an initiative of Vital Strategies.

“Analysis of PERC data can help governments predict adherence to preventive measures, craft effective communications and mount a stronger response to COVID-19.”

Image Credits: EAC, WHO AFRICA, Partnership for Evidence-Based Response to COVID-19.

Overcrowding in refugee camps, mistrust of authorities including vaccination registration processes, and lack of access to vaccines are some of the most pressing problems preventing migrants, refugees and other “uprooted people” from getting COVID-19 vaccines.

A diverse, but also common set of issues are faced in refugee camps, informal settlements that house an estimated 79.5 million people living around, or fleeing the world’s conflict zones in Asia, the Middle East, Europe, and Latin America, panelists said at a Geneva Global Health Hub (G2H2) panel on Tuesday.  Among those, only about 26 million are officially registered as refugees according to UNHCR, The UN Refugee Agency.

Local and regional conflicts, such as the recent flareup of violence in Israeli-occupied East Jerusalem, further impede an already halting supplies of vaccines to Palestinians in the Israeli-occupied West Bank and Hamas-controlled Gaza, the latter now locked in a bloody battle with Israel, said Firas Jaber of the Palestinian social and economic policies monitor, Al-Marsad. 

“Today in the uprising against the settlers in Jerusalem, and the rest of the West Bank and Gaza, the situation is now a triple crisis: the occupation, COVID-19, and also the inability of providing the vaccination to our people,” said Jaber.  Power outages in health facilities, damaged or depleted hospitals, and an overall lack of health personnel also are contributing to low Palestinian vaccination rates, Jaber contended. 

Misinformation in Lebanon

In neighboring Lebanon, there is a high level of misinformation about vaccines among refugee communities, says Safaa Fawaz Tahhan, a Syrian refugee who works as an health outreach officer. It is difficult for people to register for vaccines on the Lebanese online platform, and vaccination centres are far away from refugee centres. 

Meanwhile, in Latin America, political instability in neighbouring Nicaragua had led to tensions and added health challenges for Costa Rica, which saw the exodus of Nicaraguans seeking to avoid both violence and the pandemic as a threat, observed Ana Quiroz,  director of the Center For Information and Advisory Services In Health (CISAS) in Costa Rica.

“Costa Rica has quite a centralised health system. They work a great deal on [COVID-19] prevention information, border control, promoting social distancing, etc,” said Quiroz.

“On the other hand in Nicaragua, the government preferred to deny the existence of the pandemic and instead, to call for political rallies with no preventive measures to prevent spread of the virus.”

This has caused conflict between Costa Rica and Nicaragua, with around 15,000 Nicaraguan refugees being denied access to Costa Rica, as a result of tighter border restrictions, designed to keep the virus at bay.

“This situation has led to an increase in xenophobia towards Nicaraguan people in particular, and poor people,” she added.

Greek Refugee Camps – Three Times More Exposed to COVID 

In Europe’s refugee camps, COVID prevention measures are impossible to maintain, asserted Apostolos Veizis from Intersos in Greece, where many refugees from Africa and the Middle East, attempting to enter the European Union, have been stranded in camps since 2016.

“The refugee camps in Greece are synonymous with overcrowding,” said Veizis. “During the COVID pandemic, we talk about keeping distance. This is a joke because there are 30 people in a tent. In less than two square metres, you find five to six people. When you are asking people to keep distance, that is not possible.

“You ask people to wash their hands, it is again not possible. So in reality, we are talking about measures that cannot be implemented, and people on the move are the ones to be punished.”

To make matters worse, since 17 March 2020, the camps have been under curfew from 7pm to 7am, making refugees even more vulnerable to COVID-19, he said.

“Our data shows that people living in the camps are three times more exposed to COVID-19 than the local population. When it comes to vaccinations, Greece is happy to present saying that one in four Greeks have had the first dose – about four million people – but that’s not the case and situation for asylum seekers and refugees,” said Veizis.

Vaccine registration has started, but there is a high level of mistrust of authorities, he added.

For Veizis, addressing the needs of refugees is largely a matter of “political will”; presently there are only 100,000 refugees arriving in the European Union each year, which is not a large number.

However, the pandemic is being used to put people in detention facilities when it would be better, health-wise and socially, for refugees to be integrated into the societies where they are now living, he said.

“When it comes to vaccinations, we have to include everybody from the beginning. If we want to control the pandemic, then the prevention and vaccination needs to take place for everybody in Europe, for everybody in Asia, for everybody in Africa, for everybody around the world.”

Image Credits: Mercy Corps.

India’s first ‘Oxygen Express’ train transports liquid medical oxygen from steel plants that produce oxygen to different parts of the country (23 April).

India’s COVID crisis has laid bare the health costs of inadequate access to medical oxygen supplies – faced by many other countries even before India’s pandemic surge began.  Already in February, WHO said that oxygen shortages to treat those seriously ill were impacting more than half a million people in low- and middle-income countries every day – with an estimated need of US$90 million to meet demand in 20 low- and middle-income countries (LMICs). Soon after, a COVID-19 Oxygen Emergency Taskforce was established “to measure oxygen demand, work with financing partners, and secure oxygen supplies and technical support for worst-affected countries.”  Meanwhile,  along with spiraling COVID cases, LMIC oxygen needs have more than tripled from less than 8 million cubic meters in late February, to more than 28 milion cubic meters today, according to the Taskforce “oxygen tracker.”

Oxygen needs: 24 February 2021
Oxygen needs: 10 May 2021

 

 

 

 

 

 

 

 

Geneva Health Files spoke to Robert Matiru, Director of Programmes at Unitaid, who also advises the WHO co-sponsored ACT- Accelerator initiative (ACT-A), to understand the logistical challenges countries face in ensuring oxygen supplies and the broader economics of access to medical oxygen.

Geneva Health Files: What has led to the difficulties in accessing medical oxygen in many parts of the world, including in India?   

Robert Matiru: It’s worth distinguishing between India and other LMICs. In India, there is a relatively well-developed health system and local oxygen supply is there, but a lack of planning for an outbreak at this scale, and limited prioritisation have resulted in oxygen not being where it is needed in the country. We are starting to see this improve now, with gas being diverted from industry and supplies arriving in parts of the country where it is needed most, helped by multilateral and bilateral responses.   

A patient, wearing an oxygen mask, sits outside Lok Nayak Jai Prakash Narayan Hospital (LNJP), New Delhi, one of India’s largest COVID treatment facilities.

For many other LMICs, the difficulties are more systemic and long-term. Even before COVID-19, oxygen supply in LMICs was inadequate. The problem is complex: tools to diagnose respiratory distress are often not well-embedded in health systems, and sustaining oxygen supplies is an expensive, long-term commitment, and equipment is poorly designed for use in low-resource healthcare settings. Oxygen concentrators are often not designed to withstand the difficult conditions found in many LMICs, oxygen piping systems needed to deliver oxygen to the bedside are lacking or often not well-maintained, and complex logistics mean oxygen cylinders don’t always reach their destination on-time. Medical oxygen [globally] is supplied by six major companies; in countries there is a lack of market competition, which often results in higher prices and access issues.  

All of these issues have been compounded by the impact of COVID-19. While oxygen is vital for the effective treatment – alongside corticosteroids – of patients with severe and critical COVID-19, access in LMICs is limited due to the cost, infrastructure and logistical barriers outlined above. In the COVID-19 response thus far, diagnostics, PPE and vaccines have been prioritised over medical oxygen, despite it being so essential.  

Robert Matiru, Unitaid

GHF: What could the international community have done to prevent such a crisis?  Were the mechanisms in the ACT Accelerator, deficient in anticipating and preparing for such a demand for medical oxygen?   

Matiru: It’s important to recognise that oxygen supply is a complicated space for the reasons highlighted in the previous response. COVID-19 outbreaks at this scale are unpredictable. Last year, global development agencies invested more than US$ 150 million in oxygen products and services for LMICs, but that is just a fraction of what is required for a comprehensive and sustainable response to address the unprecedented surge in demand for medical oxygen that we are seeing now due to COVID-19. At the end of last year ACT-A called on donor countries to invest in ten times this figure, at a minimum, for COVID-19 related annual oxygen needs in LMICs. We are far from receiving even a fraction of that. To amplify the urgency and size of the need, as well as accelerate efforts to support countries, the ACT-A Oxygen Emergency Taskforce was launched in February and is coordinating with global health partners and civil society to raise awareness and funding, plan better and ensure operational readiness to act when subsequent outbreaks occur, but also with a view to implementing resilient oxygen systems. This is already in action with O2 Taskforce partners actively supporting countries to assess and cost their context-specific needs and to access available funding through the Global Fund’s C19RM process and via the World Bank’s loan mechanism. In parallel, governments need to start prioritising oxygen as part of their COVID-19 response plans, but also for the long-term, so oxygen supply is available to those who need it.    

GHF: You have said that a lack of competition in the medical gas market has increased the costs of oxygen, and has resulted in countries having to pay a premium for an essential medicine. Can you elaborate? 

Matiru: The market is dominated by six major companies – the lack of competition between providers drives prices higher, and prices are quite variable from country to country. Certain companies dominate markets in certain countries, and across regions. This makes it hard for governments to negotiate on price and supply, particularly during times of surging demand. It’s worth noting that medical gas is not seen as hugely profitable compared to gas for industry, which is where most of these companies’ interests lie. There is little incentive to engage and supply medical oxygen, especially when there is red tape such as local regulations which can take time and cost money.  As a Taskforce, we would like industry to be part of the solution and are actively determining which market interventions are the most appropriate, high-priority and cost-effective, so that engagement with these companies is targeted and clear. A major focus of the investments the Taskforce is calling for, will need to be directed at addressing entrenched oxygen market failures. 

GHF: What should countries do domestically to prepare for demands for medical oxygen? In your assessment, why have certain countries done well on this, and why have certain countries failed on preparing for the demand for oxygen?  

Matiru: Countries need to follow the epidemiological data (which relies on having good testing in place – this is unfortunately not a given in many LMICs) and plan for surges, positioning oxygen supplies to meet anticipated demand, but also plan for the long-term. It’s important to have an appropriate mix of oxygen solutions in place that suits the country’s needs best.  

GHF: In the context of India, how quickly can international supplies rush in to help?  Have the offers of help there made a difference? 

Matiru: Other partners working on the ground, such as UNICEF, WHO, CHAI [Clinton Health Acccess Inititiative] and PATH are probably better-placed to answer this question. But as an overview – the response has been rapid and significant as reported in the media. Taskforce partners have contributed to the effort (e.g. WHO and UNICEF have supplied thousands of O2 concentrators; PATH/CHAI are helping instal PSAs (pressure swing absorption) plants and the global health community is engaging directly with the Government of India to ensure that any support meets the urgent need, and will have the intended impact. Due to the unprecedented level of demand, there are supply constraints and long lead times for certain commodities such as concentrators and PSA plants. The O2 Taskforce is working to improve supply conditions so that appropriate products and services can move as quickly as possible as cases continue to surge around the world. It is now crucial to collaborate with and support other at-risk countries in the regions and elsewhere with surge preparation to support LMICs through both the acute needs in the coming weeks and the more sustained needs we will inevitably see through this year and next. 

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

Image Credits: Flickr, Prasar Bharati News Services, PATH , https://www.path.org/programs/market-dynamics/covid-19-oxygen-needs-tracker/, Unitaid.

A Canadian pharmaceutical company, Biolyse, has agreed to provide Bolivia with 15 million doses of the Johnson & Johnson COVID-19 vaccine – as long as the Canadian government gives it a compulsory license to manufacture the vaccine.

In March, Johnson & Johnson rejected an application by Biolyse for a voluntary license to make a generic version of its vaccine. 

Biolyse is now seeking a compulsory license in terms of Canada’s Access to Medicines Regime (CAMR) in order to supply vaccines to Bolivia, which has only managed to vaccinate around 5% of its population.

But for this to succeed, the COVID-19 vaccine will have to be listed in Schedule 1 of the Canadian Patent Act as only medical products listed there are eligible for compulsory licenses in terms of CAMR.

“Although Schedule 1 can be amended to include additional products, Canadian authorities have refused to tell KEI and Biolyse whether COVID-19 vaccines will be added to the list or what the estimated time frame is for that amendment to take place,” said non-profit organisation Knowledge Ecology International (KEI), which has been advising the company on its compulsory license application.

Canada ‘Stonewalls’ Legitimate Attempt

According to KEI, Canada has claimed at the World Trade Organization (WTO) that existing TRIPS flexibilities are working “as intended,” and asked those in favour of a TRIPS waiver for “concrete” evidence of patent-related challenges in procuring COVID-19 goods.

“If Canada fails to expeditiously allow Bolivia to import vaccines manufactured by Biolyse under a compulsory license, they would be directly contradicting their own statements at the WTO,” said KEI.

“Canada cannot continue to claim that article 31bis of the TRIPS agreement and the CAMR function ‘as intended’ while it stonewalls a legitimate attempt to use this mechanism,” it added.

Biolyse has agreed to sell vaccines to Bolivia at an estimated manufacturing cost of $3 to $4 a dose.

Meanwhile, COVID-19 cases are rising in Bolivia, which has a population of almost 12 million people and around 43,000 official cases of COVID-19 and 13,228 deaths.

Bolivia’s daily COVID-19 cases

 

Image Credits: Johnson & Johnson.

KAMPALA – A chorus of human rights organizations, joined by the United Nations, have condemned Uganda’s controversial law that criminalizes same-sex relationships, sex work and imposes mandatory HIV testing on people accused of rape – calling on the east-central African country to amend the law as it would violate human rights standards and undermine public health.

The UN High Commissioner for Human Rights, Zeid Ra’ad Al Hussein, said in a statement that Uganda’s Sexual Offences Act 2019 raises serious human rights concerns and called upon President Yoweri Museveni to adopt a “legal framework that can support victim-centered approaches in the investigations and prosecution of sexual violence, including rape, in compliance with international law and standards.” 

Other human rights campaigners, including UNAIDS, described the new legislation, which was passed on 3 May, as “unjust laws” that will discriminate against vulnerable groups including LGBTQ+ people, sex workers, and those living with HIV.

In the amended bill, punishment for engaging in consensual same-sex relations has been reduced to 10 years in jail instead of life imprisonment, but UNHCR spokeman, Rupert Colville said: “The fact remains that such relations are still criminalized”. 

“This, in a country where stigma, discrimination, and violence against people based on their sexual orientation and gender identity is widespread and often committed with impunity, given that victims are frequently too afraid to report any attack against them,” he said.

UNAIDS Executive Director, Winnie Byanyima said in a statement on 6 May said she was “deeply troubled” by parts of the bill as it “marginalized vulnerable groups of fellow citizens and denied them their human rights, including their right to health”.

“Targeting people living with HIV, lesbian, gay, bisexual and transgender communities and sex workers increases stigma and discrimination, said Byanyima, adding that the bill further “undermines the HIV response by preventing people from receiving the HIV treatment, prevention and care services that they so urgently need”. 

President Museveni must still sign the bill before it can become law, but human rights campaigners are urging Ugandan parliamentarians to reconsider the contentious provisions.

In January this year, Museveni said that LGBTQ+ people are “deviated from the normal”.

Anti-gay Bill Infringes on Human Rights

Human rights organisations have called on Ugandan President Yoweri Museveni to amend the controversial anti-gay law as it would violate human rights standards and undermine public health.

The bill criminalizes homosexuality, bisexuality, and the transgender communities. It also criminalizes same-sex sexual relations, imposes mandatory HIV testing for sex offenders, and harsher sentences on people living with HIV than the general population accused of some similar crimes.

Adrian Jjuko, executive director of Human Rights Awareness and Promotion Forum (HRAPF),  slammed the law as unconstitutional and an “affront to basic human rights”, while Sylvia Nakasi, acting Executive Director of Uganda Network of AIDS Service Organisations (UNASO), said it was “not legally friendly” and “infringed on human rights”.

“If this bill is passed into law, it will erase many gains already attained. That said, the bill has clauses that will be hard to prove in case someone is sued. I wonder how it will be implemented,” Nakasi told Health Policy Watch.

Frank Mugisha, the executive director of Sexual Minorities Uganda, tweeted that the bill makes “same-sex acts criminal, as if the Penal Code wasn’t enough.”

In a statement condemning the passage of the bill, the group expressed concerns that some of its language “will enhance the already homophobic environment in Ugandan and consequently lead the way for further violation of the rights of sexual and gender minorities, including violations such as ‘corrective rape’ and other acts of violence.”

The Ugandan parliament’s adoption of the new law comes just weeks before the United Nations General Assembly High-Level meeting due to take place from 8 to 10 June 2021.

Initially described as a way to crack down on sexual violence, the bill doubles down on already-enacted laws that criminalize LGBTQ sex.

With regards to rape, the legislation excludes men who have sex with men and women who have sex with women from protection against rape and sexual violence. This amounted to discrimination based on sex and sexual orientation said Jjuko.

It also doesn’t recognize marital rape and provides for the death penalty for HIV-positive rape accused.

Human rights activists say the creation of different punishments for people living with HIV/AIDS is discriminatory and against public policy which promotes stigma and discrimination that PLWHIV already facing. 

Image Credits: Wikimedia.

 

Geneva Global Health Hub panel debates a proposal for a global pandemic treaty – to be put before WHO member states next week.

The draft of a landmark resolution to establish a global “Pandemic Treaty” will be put to World Health Organization (WHO) member states this week in preparation for the World Health Assembly beginning 24 May,  Jaouad Mahjour, WHO Assistant Director-General Emergency Preparedness, told a panel in Geneva Monday.

The proposal for the Pandemic Treaty – which aims to tighten global rules around disease outbreak response so that countries react rapidly and more transparently, was first tabled by WHO Director General Dr Tedros Adhanom Ghebreyesus in January.  It has garnered the support of some 25 global leaders ranging from President of the European Council Charles Michel, to Germany’s Angela Merkel, Prime Minister JV Bainimarama of Fiji; UK Prime Minister Boris Johnson and South African President Cyril Ramaphosa.

The concept has met with resistance in some quarters, as well – notably the United States has not yet signed onto the idea. And some civil society voices have said that absent of political will, a treaty would not necessarily have more clout than existing International Health Regulations governing emergencies.

However, the countries now pushing for the treaty represent every region of the WHO, and range from superpowers to small island states, Mahjour told a panel convened by the Geneva Global Health Hub (G2H2), saying that the time for a treaty is ripe

The countries pushing for a “legally binding international framework” see this as the only way to deal with the magnitude and impact of the pandemic, he underlined. And there are some fundamental principles that have garnered wide agreement already:

“The first issue [is] that everybody agrees on is national preparedness. The world cannot be safe if only one country is not prepared,” said Mahjour. 

The second issue [is] mechanisms to ensure global preparedness, including supply chains that can provide all countries with goods and control measures; an early pandemic warning and alert system lead by WHO and including those involved in animal health; and accelerating research, innovation and development.

Not Everyone is Convinced

However, other panelists appearing at the session were less convinced that a treaty would add value to existing IHR rules, which are already binding on member states. 

Panel moderator Nicolette Dentico, director of global health at the Society for International Development as well as G2H2 co-president, asked why a new treaty would be effective when the COVID-19 pandemic had shown that member states “are not capable of actually abiding by those binding norms that have been already negotiated, established and agreed upon” in 2005, namely the International Health Regulations. 

“So why should we create another tool? Shouldn’t we work on the legally binding instrument that exists already instead of creating a new one?” she asked.

Treaty Needs to be Based on Human Rights

Meanwhile, an influential group of activists and academics writing in the BMJ on Monday, said that a pandemic treaty, if adopted, needs to be “based on human rights”.

“Those in charge of drafting the treaty must begin with a clear look at the grave abuses that have characterised the COVID-19 pandemic: authoritarian power grabs; continuing monopolies in diagnostics, therapeutics, and vaccines; failure to resource health systems; staggering setbacks for women; and an upsurge in violence, including covid-related hate crimes,” wrote Meg Davis, senior researcher at the Geneva Global Health Centre and 21 others.

“States have all-too-easily sidelined the international human rights framework under cover of emergency responses,” they added, calling for such a treaty to address a range of key issues including the right to health, the decriminalisation of infections, workers’ rights, and gender inequalities.

One panelist at Monday’s event, echoed those sentiments.  Ana María Suárez Franco, director of the food security network, FIAN International, based in Honduras, said that any pandemic treaty needs to be aligned with UN Human Rights Council principles, and make transnational companies legally accountable for their actions.

“A pandemic treaty has to be built from the bottom up. It needs to prevent corporate abuse,” said Franco.

To be effective, a treaty just be able to curb abuses that have occured in the current pandemic – for instance cases in which COVID-19 vaccine manufacturers had tried to force countries to sign exclusionary clauses that protected pharma companies from claims of adverse vaccine effects, and provided sovereign resources as payment guarantees – including natural resources and even embassy buildings – ahead of vaccine orders.

Concerns about the timing of the pandemic treaty negotiations and capacity of WHO to implement a vast new treaty project, are other issues that have come up, panelists said. 

Some critics have worried the “timing of these negotiations,” could divert attention, resources and personnel from addressing the current pandemic, said Priti Patnaik, editor of the Geneva Health Files newsletter.

“Some even raised the question of whether there is enough capacity within the WHO Secretariat to service the needs of treaty negotiations among member states,” she added, noting that according to European Union internal timelines, ‘the treaty has to be imposed next year”. 

Dr Tedros Adhanom Ghebreyesus, WHO Director General.

The World Health Organization (WHO) has decided to classify the B1.617 variant first identified in India as a “variant of concern”, according to Maria Van Kerkhove, WHO lead on COVID-19.

“There is some available information to suggest increased transmissibility of B1.617,” Van Kerkhove explained to the WHO’s biweekly media briefing on Monday.

In addition, a preprint (a paper that has not undergone peer review) involving a limited number of patients suggested that there is also “some reduced neutralisation” [of antibodies] and as such we are classifying it as a variant of concern”, said Van Kerkhove.

However, she stressed: “We don’t have anything to suggest that our diagnostics or therapeutics and our vaccines don’t work. This is important as we will continue to see variants of concern around the world.”

Over the weekend, India reported over 4,000 deaths in 24 hours and it is recording over 400,000 new cases every day.

WHO Chief Scientist Soumya Swaminathan added that genomic surveillance was ongoing in India and scientists were looking at transmissibility, clinical security, and the response of the B1.617 variant to antibodies generated in people who have been vaccinated with the three main vaccines being used in India – Covaxin (developed by Bharat Biotech), Covishield (AstraZeneca) and Sputnik. 

“Over the coming weeks, there’ll be much more data forthcoming,” she added.

WHO Chief Scientist Soumya Swaminathan

Cases Plateau – But at Very High Rate

WHO Director General Dr Tedros Adhanom Ghebreyesus told the briefing that global COVID-19 cases have started to “plateau” – but at an “unacceptably high” rate with more than 5.4 million new cases and almost 90,000 deaths in the past week.

“Cases and deaths are still increasing rapidly in WHO’s South East Asia region and there are countries in every region with increasing trends,” added Tedros. 

“The spread of variants, increased social mixing, the relaxation of public health and social measures and inequitable vaccination, are all driving transmission,” he added.

Condemning vaccine diplomacy as “geopolitical maneuvering”, Tedros said that only global cooperation and solidarity can end the COVID-19 pandemic.

“High and upper-middle income countries represent 53% of the world’s population, but have received 83% of the world’s vaccines,” said Tedros. “In contrast, low and lower middle income countries account for 47% of the world’s population but have received just 17% of the world’s vaccines. Redressing this global imbalance is an essential part of the solution, but not the only part and not an immediate solution.”

Seychelles Surge in Cases Seem to Have Occurred After First Jab

Addressing reports that cases in Seychelles were surging despite the high vaccination rate of citizens, Dr Kate O’Brien, the WHO’s Director of Immunisation and Vaccines, said that some of the infections occurred after the first dose of the Sinopharm vaccine.

“The Sinopharm vaccine really requires two doses, and some of the cases that are being reported are occurring either soon after a single dose or soon after a second dose or between the first and second doses,” said O’Brien.

Approximately 60% of vaccinations on the island are of Sinopharm vaccines donated by the United Arab Emirates, while the remainder of doses are of the AstraZeneca vaccine, according to the Washington Post.

“When we see cases continuing to occur in the setting of vaccines, it really does require a very detailed assessment of what the situation is,” she stressed.

“First of all, what are the strains that are circulating in the country? Secondly, when do the cases occur relative to when somebody received doses? Third, what is the severity of the cases? Only by doing that kind of evaluation can we make an assessment of whether or not these are vaccine failures or whether it is more about the kinds of cases that are occurring, the milder end of cases, and then the timing of the cases relative to when individuals received doses.”

She stressed that this evaluation is “ongoing”, and the WHO was supporting and engaging with Seychelles to understand what was happening.

Image Credits: Adnan Abidi/Flickr, WHO.

A doctor administering the Johnson & Johnson COVID-19 vaccine candidate during the phase 3 clinical trials.

In a far-reaching statement, WHO and the International Coalition of Medicines Regulatory Authorities (ICMRA) called on the pharma industry to provide much wider access to clinical data for all new medicines and vaccines approved, or under review, and even those that had been rejected. 

“Clinical trial reports should be published without redaction of confidential information for reasons of overriding public health interest,” WHO said in the joint statement on Friday.

“The COVID-19 pandemic has brought into sharp focus the need for information and data to support academics, researchers and industry in developing vaccines and therapeutics; to support regulators and health authorities in their decision-making; to support healthcare professionals in their treatment decisions; and to support public confidence in the vaccines and therapeutics being deployed.”

WHO noted that while some initiatives to share data with regulators, and store it transparently have met with stakeholder support, such as the WHO International Clinical Trials Registry Platform, the US ClinicalTrials.gov database, and the EMA Clinical Trials Register, “not all past efforts have been successful,” WHO said, adding, “often this was because they were unsustainable due to reliance on goodwill or lack of appropriate resourcing.

“Regulators continue to spend considerable resources negotiating transparency with sponsors. Both positive and negative clinically relevant data should be made available, while only personal data and individual patient data should be redacted,” said WHO, adding that, “Lack of public access to negative trials has been identified as a source of bias, which weakens the conclusions of systematic reviews and provides a false sense of reassurance on the safety or efficacy of the medicine.”

“Providing systematic public access to data supporting approvals and rejections of medicines reviewed by regulators, is long overdue despite existing initiatives, such as those from the European Medicines Agency and Health Canada. The COVID-19 pandemic has revealed how essential to public trust access to data is.

“ICMRA and WHO call on the pharmaceutical industry to commit, within short timelines, and without waiting for legal changes, to provide voluntary unrestricted access to trial results data for the benefit of public health.”

Image Credits: University of Oxford, Johnson & Johnson.

Healthcare workers vaccinating at risk patients with the Pfizer-BioNTech COVID-19 vaccine in Lima, Peru.

Pfizer on Friday became the first pharma company to apply for full approval of its COVID-19 vaccine from the US Food and Drug Administration (FDA. The announcement also followed the publication of two studies which found that the Pfizer/BioNTech vaccine is highly effective against two major SARS-CoV2 variants of concern. Moderna plans to follow suit and apply for full approval from the FDA later this month, the company announced on Thursday.

Two peer reviewed studies published on Wednesday found that the Pfizer/BioNTech COVID-19 vaccine protects against severe disease caused by the B.1.1.7 variant, first identified in Britain, and the B.1.351 variant, first identified in South Africa. The studies were based on the real-world use of the vaccine in Qatar and Israel.

The Qatar-based study, published in the New England Journal of Medicine, used data on vaccinations, PCR tests, and hospitalization from the national COVID-19 databases between February and March.

Some 385,853 people received one dose since the launch of the immunization campaign and 265,410 people received both doses of the vaccine, as of the end of March. 

Efficacy of the vaccine in preventing infection was estimated to be 87% against the B.1.1.7 variant and 72.1% against the B.1.351 variant two weeks past the second dose. Protection was even higher against severe or fatal disease, with a total efficacy of 97.4%.

A second study based on Israeli data, and published in the Lancet, found that two doses of the Pfizer vaccine was highly effective against a range of SARS-CoV2 outcomes, including symptomatic (97%) and asymptomatic infection (91.5%), hospitalization (97.2%), and death (96.7%), in those aged 16 and older.

The B.1.1.7 variant was the dominant strain of SARS-CoV2 in the study period, from January to April. The variant accounted for 94.5% of the infections recorded by national surveillance data. 

As vaccine coverage increased in the study participants, the incidents of SARS-CoV2 outcomes declined. Other countries could “similarly achieve marked and sustained declines in SARS-CoV2 incidence if they can achieve high vaccine uptake” said the co-authors, from Pfizer and the Israeli Public Health Services.  

Israel has vaccinated a larger proportion of its population than any other country, with 61% of the population having received at least one jab as of early April. 

Positive Early Findings from Moderna Booster Shot Study

A doctor preparing the Moderna COVID-19 vaccine at the Naval Hospital in Bremerton, Washington, US.

In other vaccine news, Moderna announced on Thursday that initial data on its COVID-19 booster shots demonstrated that the boosters increased the neutralizing antibody responses of vaccinated individuals against two variants of concern.

The data is from an ongoing phase 2 study in which three strategies for boosting immune responses are being tested: a booster dose of Moderna’s existing vaccine, a booster candidate based on the B.1.351 variant, and a booster candidate that combines the two previous boosters.

After six to eight months following the administration of the second jab, the level of antibodies against the wild-type SARS-CoV2 remained high in the study participants, but antibodies against the B.1.351 and P.1 variants, first identified in Brazil, were much lower. 

“We are encouraged by these new data, which reinforce our confidence that our booster strategy should be protective against these newly detected variants,” said Stéphane Bancel, CEO of Moderna, in a press release.

While the findings are encouraging, the data has not yet been peer reviewed. According to the pharma company, the preliminary results have been submitted as a preprint and will later be submitted for peer-reviewed publication upon the completion of another arm of the study. 

Pfizer License Application 

The Biologics License Application (BLA) was initiated for the approval of the vaccine in individuals 16 years of age and above. Data will be submitted to the regulatory agency on a rolling basis and the review process will likely take several months.

“Following the successful delivery of more than 170 million doses to the US population in just a few months, the BLA submission is an important cornerstone of achieving long-term herd immunity and containing COVID-19 in the future,” said Ugur Sahin, CEO of BioNTech, Pfizer’s German manufacturer,  in a press release. 

Some 134 million doses of the Pfizer/BioNTech vaccine have been administered in the US, as of Thursday, according to the US Centers for Disease Control and Prevention (CDC).

The FDA is expected to issue emergency use authorization for the Pfizer vaccine in adolescents aged 12 to 15 early next week. 

Image Credits: BioNTech, International Monetary Fund/Ernesto Benavides, Flickr – Official US Navy.