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.

Almost seven million people are estimated to have died of COVID-19 globally based on  “excess mortality” statistics, according to the Institute for Health Metrics and Evaluation (IHME), which announced on Friday that it would now be using these statistics rather than official death rates.

This “major change in how we think about the number of deaths” had occured after the institute had completed an analysis of all-cause mortality for 59 countries and 198 states and provinces within countries, said IHME Director Dr Christopher Murray from the University of Washington.

Using the new estimates, the US has the highest deaths in the world – over 900,000 – followed by India with over 650,000. Egypt’s death toll of around 170,000 is the highest in Africa – and way higher than official statistics.

New global death estimates, based on excess mortality.

Murray said that using excess mortality as a metric allowed IHME “to get closer to the true number of COVID deaths”, and the institute noted that “most excess mortality is likely misclassified COVID-19 deaths”.

Murray acknowledged that factors inflating excess mortality included deaths of people who had avoided healthcare during the pandemic, and deaths related to increased depression and drug use.

But “injuries are down perhaps about 5% globally due to reductions in mobility”, and so were flu deaths because of lockdowns. 

“When you put all that together, we conclude that the closest estimate for the true COVID-19 death is still excess mortality because some of those things are on the positive side, some of those other factors are on the negative side,” said Murray.

“Once we have completed this analysis, our understanding of the magnitude of COVID up to date, is that it’s been much worse than we have been thinking so far, and we have estimated that today 6.9 million people have died from COVID already,” he added.

Rival Spanish Flu

“Given our expectation of continued deaths, COVID is going to rival Spanish flu at the global level in terms of the count before we see the end of this epidemic.”

An analysis by the Netherlands statistical agency suggested that all excess deaths in the Netherlands were directly due to COVID-19, according to IHME.

“Their analysis actually suggested that direct COVID-19 deaths may be higher than estimated excess deaths because deaths due to some other causes have declined during the pandemic,” it added.

“Given that there is insufficient evidence to estimate these contributions to excess mortality, for now we assume that total COVID-19 deaths equal excess mortality,” said the IHME.

“For the reasons presented in this section, we believe that this is likely an underestimate. As the evidence is strengthened in the coming months and years, it is likely that we will revise our estimates of the total COVID-19 death rate upward in future iterations of this work, once we can properly take into account the drivers described in this section.”

 

 

Production of Sinopharm’s inactivated COVID-19 vaccine candidate.

The Chinese-made Sinopharm vaccine became the latest COVID-19 vaccine to receive an Emergency Use Listing from the World Health Organization (WHO) on Friday; experts said the vaccine showed an overall efficacy rate of 79% in preventing symptomatic and serious disease. 

The WHO approval positions Sinopharm to become a major player in the COVAX global facility. The facility, co-sponsored by WHO and Gavi, the Vaccine Alliance, is struggling to provide desperately needed vaccine supplies to low- and middle-income countries in the wake of India’s COVID surge – which forced Indian vaccine manufacturers to divert production to domestic needs.  

It remains to be seen, what kind of deal the Beijing-based pharma company might negotiate with COVAX. The vaccine’s state-controlled developers, Beijing Bio-Institute of Biological Products, have so far pursued only bilateral vaccine donations or deals – with an official sales price exceeding that of the pricey Pfizer and Moderna vaccines – whose efficacy is much higher. 

At a press briefing on Friday, it was clear that WHO officials are keen to call on Sinopharm’s participation.

“This expands the list of vaccines that COVAX can buy, and gives countries confidence to expedite their own regulatory approval, and to import and administer the vaccine,” said Dr Tedros Adhanom Ghebreyesus, WHO Director General, at a Friday press briefing announcing the move.  

Dr Tedros Adhanom Ghebreyesus, WHO Director General.

“We urge the manufacturer to participate in the COVAX Facility and contribute to the goal of more equitable vaccine distribution,” said Dr Mariângela Simão, WHO Assistant-Director General for Access to Health Products, said in a press release.

“From the very beginning, in all of our conversations with this company, it has been very interested in looking at playing a role to help with the global response, which is encouraging,” said Bruce Aylward, WHO Senior Advisor to the Director-General and lead on the ACT-Accelerator. 

He noted that the pharma company has also made significant efforts to expand its manufacturing capacity from the low double digit numbers to high three digit numbers to be positioned to export large numbers of doses. 

Appeal to G-7 to Close Grave, Immediate Vaccine Shortfall in LMICs

Meanwhile, WHO officials issued their second plea this week to the G-7 group of industrialized nations, meeting 11-13 June, to share excess vaccine doses with COVAX that they are holding in reserves – so the highest risk groups in low-income countries can be vaccinated. 

“Nearly 1.25 billion doses of COVID-19 vaccines have been administered globally, however, only 5 million of those have been in the lowest income countries” said Aylward. “Over 80% of the vaccines distributed have gone to high income countries and only 0.3% have been delivered to low income countries.”

Dr Bruce Aylward, WHO Senior Advisor to the Director General, at the press conference on Friday.

“We need the help of the G7 to change that equation and raise the proportion of the populations that are vaccinated,” Aylward said.  

A bigger G-7 financial commitment is also required to combat the current “unacceptable” divide in vaccine distribution, stressed WHO officials at the biweekly press conference. 

“For G-7 now, the most important and the immediate support we need is vaccines [and] vaccine equity,” said Dr Tedros.

“The industrial and financial weight of the G-7 in supporting that is going to be absolutely crucial,” said Alyward. He warned that “we could be in a different position much faster globally than we will [otherwise] be, if we get that support through the financing, the sharing, and the scaling up of these products.”

The ACT-Accelerator, a global collaboration to accelerate the development, production, and equitable access to COVID-19 vaccines and technologies, currently is facing a financing gap of US$19 billion, which is slowing the procurement and delivery of vaccines to countries in dire need, the WHO officials said. 

Along with vaccines, funding is also needed to  scale-up of up production of other countermeasures, including diagnostics, oxygen, and PPE. 

“Without that financing or without those donations, there simply aren’t the doses that are needed to assure that countries that are really [relying on] the COVAX facility can achieve the impact” of immunity, said Dr Kate O’Brien, WHO Director of the Department of Immunization, Vaccines and Biologicals.

The comments came as WHO also reported on the first meeting of  a new “Health for All” collaboration of 11 top economists and health experts – tasked with articulating new strategies for injecting health goals into the heart of global finance, not only for medicines and vaccines access but also in terms of economic recovery. 

Professor Mariana Mazzucato, Chair of the Council on the Economics of Health for All, at the press conference on Friday.

Sinopharm Approved For Older People – Although Clinical Trials Included Few People 60+ 

The Sinopharm vaccine had an efficacy rate of  79% in clinical trials, with respect to prevention of symptomatic disease and hospitalizations, the WHO review by the Strategic Advisory Group of Experts on Immunization (SAGE) found. Their review also included on-site inspections of the production facility.

The sixth vaccine to receive WHO’s approval, it is based on a traditional vaccine technology that delivers an inactivated form of the virus to provoke immunity. It’s cold chain storage requirements make it suitable for distribution in low-income countries. 

“The addition of this vaccine has the potential to rapidly accelerate COVID-19 vaccine access for countries seeking to protect health workers and populations at risk,” Simão said. 

WHO’s approval included a recommendation for use in adults of any age over the age of 18 – despite the admittedly scarce data from clinical trials on adults over the age of 60. 

“There is no reason to think that the vaccine would behave differently in this older age group, and in fact, in many countries in the world where the vaccine is already being used, this group has already been vaccinated,” said Dr Alejandro Cravioto, Chair of WHO’s Strategic Advisory Group of Experts on Immunization (SAGE).

Dr Alejandro Cravioto, Chair of WHO’s Strategic Advisory Group of Experts on Immunization (SAGE), the body that recommends vaccines for WHO approval.

However, WHO officials said that they would encourage those in charge of country vaccination programs to implement strong followup programs to monitor the safety and efficacy of the vaccine in those over 60 years old, as well as in people with comorbidities, and pregnant women. 

“Once we have this information then, as with any other vaccine that SAGE has reviewed, we will look at the new evidence and make changes in our interim recommendations for this vaccine,” said Cravioto. “But for now, after getting an EUL approval we see no reason why this vaccine should not be recommended fully for use in people 18 years and above, in a dosage of two doses, from two to three weeks apart.”

The Sinovac vaccine, another Chinese developed COVID-19 vaccine, was also expected to receive WHO Emergency Use Listing this week, according to a statement made by Simao at the press conference on Monday. But on Friday, officials said it remains under review.

The Sinovac vaccine has in the past reported varying efficacy results in its clinical trials, ranging from 50% to 84%. SAGE had requested additional information from the manufacturer and was awaiting a response, WHO said.

Image Credits: Sinopharm, WHO.