Pakistan is the second Asian country after the Philippines with a rapid increase in HIV/AIDS cases. In just one year Pakistan registered 25,000 new HIV infections and 6,800 AIDS deaths.

ISLAMABAD – Faced with one of the sharpest increases in HIV/AIDS rates in Asia, Pakistan will ban the manufacture and import of conventional syringes from next month, government officials have told Health Policy Watch

The move is in an effort to stem a three-year increase in HIV cases – 39% of which are estimated to be due to needle-sharing among injecting drug users.

Over the past year alone, there have been 25,000 new infections and 6,800 registered AIDS deaths – one of the fastest rates of rising infections in Asia. 

As of 31 July, the country will shift over exclusively to the purchase and use of  auto-disabled syringes, said a senior government official, who asked not to be named.

“The import of conventional syringes is already stopped and now in this budget, auto disable syringes and raw materials are exempted from duties and taxes to incentivize importers and manufacturers,” the official said. 

Auto disable syringes will be imported in the open market for both public and private sectors – a major decision to help prevent hepatitis and HIV/AIDS, according to the official. 

In terms of the broader AIDS battle, health experts are  also closely watching how a recent decision by the Global Fund to Fight AIDS, Tuberculosis and Malaria giving the United Nations Development Program (UNDP) responsibility for managing millions of dollars in HIV/AIDS funding will impact the country’s fight against the spread of the epidemic.

In March,  the Global Fund suspended direct HIV/AIDS funding to all of Pakistan’s government and non-governmental stakeholders, appointing UNDP as the channel through which funding would be received and disbursed to government and NGOs. 

Informed observers say that the decision was made to ensure more direct supervision of the funding, and in particular, to stimulate more collaboration between national and NGO entities in the battle against the disease.  

The Global Fund has invested $697 million  in Pakistan since 2003 and is the country’s biggest donor for HIV/AIDS and TB.  A total of $72 million of the funding is allocated to fight HIV/AIDS. The Global Fund awarded $17,4 million  to the National AIDS Control Program (NACP) from January 2018 to June 2021. 

Pakistan’s HIV/AIDS Burden Rising More Rapidly Than Almost Any Asian Country 

Recently released data from the  Pakistan Economic Survey (PES) show that there are 197,943 people living with HIV/AIDS in Pakistan, with 25,000 new infections and 6800 registered deaths, which experts fear is a rapid increase in the number of cases in the past few years.

“Cases are increasing and in Asia, Pakistan is the second country after the Philippines with a rapid increase in HIV/AIDS cases, which is alarming,” said Asghar Satti, national coordinator for the Association of People Living with HIV (APLHIV) – a nationwide network of people living with HIV. 

Satti said above 90% of HIV/AIDS cases are from just two provinces: Punjab and Sindh.  While Satti says the data is collected by the government following validated methods, others say that the numbers could be even higher. 

Among those are Nausheen Hamid,  Parliamentary Secretary for the Ministry of National Health Services Regulations & Coordination (NHSR&C).  

Speaking on World Blood Donor Day on Monday, Hamid suggested that the numbers could be even higher, saying, “people are getting infected with HIV rapidly, while we do not have all data on the disease”.

Lack of Government Resources and HIV-testing Pose Major Problems

People Who Inject Drugs (PWID) make up the largest share (39%) of Pakistan’s HIV/AIDS population.

Satti believes the lack of government resources for HIV testing is one of the main factors contributing towards the surge of new cases in the country.

HIV/AIDS prevention  programs are almost entirely  supported by the Global Fund, while the government’s own resources in providing services are limited.

“Lack of political commitment, awareness, domestic resources, low on priority and weak infrastructure of providing services are gradually contributing to rising cases of HIV,” said Satti.

In key populations,  People Who Inject Drugs (PWID) make up the largest share (39%) of HIV/AIDS population, while disease surveillance in Men Sex with Men (MSM), Female Sex Workers (FSW) and migrants is also increasing. HIV testing in other key at-risk populations is only estimated to be only about 5-6 %.

A senior official at the ministry of NHSR&C, speaking on condition of anonymity, told  Health Policy Watch that despite the huge financial injections made by the Global Fund to curb the spread in PWIDs, the disease surveillance rate in drug users is still high.

“In the last tranche of the $71 million grant for AIDS, 75% of the fund was given to a private NGO ‘Nai-Zindagi’ to control the infection rate in PWIDs,” said the official. “But still that NGO is looking for government’s aid and tax exemption to get auto-disable syringes.” 

Currently, the government has no program on PWIDs.

The head of the NGO ‘Nai Zindagi,  Malaika Zafar, failed to respond to a list of questions sent to the NGO by Health Policy Watch.

Failed Management in HIV Programs

The Global Fund’s decision to appoint UNDP as the managing agent for Pakistan’s HIV/AIDS programs follows extensive consultations with key stakeholders in the country.

Communication seen by Health Policy Watch from the Global Fund to members of the organisations’ Country Coordinating Mechanism (CCM) detail how the Secretariat chose UNDP as the principal recipient of funding as a last resort, following the failure of other  potential organizations that were initially considered for this role to measure up in a capacity assessment.

The Global Fund found that “the lack of collaboration between different stakeholders could have  a negative impact on finalization of grants, mirroring the risk of a gap in service provision and ultimately affect people who need this support”.

The communication, however, stresses that the UNDP role is temporary until “national capacities are sufficiently enhanced”. 

According to Satti there are only 49 HIV treatment centres around the country providing diagnostic tests and lifelong support of Antiretroviral Therapy (ART) medicines free of cost.

According to the UNAIDS data, there are currently 22, 947 Pakistani’s on ARTs and 53, 000 women (including 3,600 pregnant women) living with HIV/AIDS.

Government’s Ambition for HIV/AIDS Response – Far from Today’s Reality 

At the recent UN High Level Meeting on HIV/AIDS, the Prime Minister’s Special Assistant for the National Health Services Ministry, Dr Faisal Sultan contended that Pakistan had worked hard to overcome the setbacks of the COVID-19 pandemic, in its battle against HIV/AIDS over the past year:  

“The government of Pakistan undertook rapid steps to modify our strategy, including staffing & smart outreach, provision of PPE for all field staff and multi month dispensing of ARV treatments. 

“Resultantly, we were able to ensure uninterrupted supply of services during these unprecedented times, and we aim to continue to adhere to these revised protocols in close coordination with all partners, communities and relevant stakeholders”.

Sultan also said that Pakistan plans to integrate HIV/AIDS as part of the Community and Primary Health Care level interventions. Interventions to be covered eventually, he said, would include HIV/AIDS testing, counselling & referral for antiretroviral treatment, provision of prophylactics & syringes to high-risk groups as well as health education. 

“We believe Universal Health Coverage is crucial for ensuring rights to health for everyone without any discrimination,” he said. 

However, presently, the country’s UHC programmes remain weak, and the ambition for including HIV/AIDS interventions is far from the reality today. 

For example, Pakistan has not yet even appointed a full-time national coordinator for the government’s HIV/AIDS control programme.  Rather, the activities are being managed by a deputy national coordinator, Ayesha Esani, in addition to her other duties.  Contacted by Health Policy Watch, Esani declined to comment.   

Image Credits: Flickr, UNAIDS.

Infecting mosquitoes with Wolbachia could be an effective and self-sufficient manner of controlling dengue.

In a “groundbreaking” trial conducted in Indonesia, lab-grown mosquitoes infected with Wolbachia bacteria reduced the rate of symptomatic dengue infections by 77%, and hospitalizations by 86%, in communities where the bacteria-armed mosquitoes were released.  

The three-year study, which was led by the World Mosquito Program, provides compelling evidence for a new method of controlling dengue. The study was published in the New England Journal of Medicine last week.

Dengue is a mosquito-borne viral infection with approximately 100 million to 400 million infections recorded per year. Some 70% of the global burden of dengue is in Asia, where severe dengue has become the leading cause of hospitalisation and death among children and adults. 

The incidence of dengue has grown dramatically around the world in recent decades. 

Indonesia is a global hotspot for dengue, which is present in all provinces of the country and endemic in many large cities. 

Disease modelling studies have predicted that the Wolbachia-mediated blocking of dengue virus infection in Aedes aegypti mosquitoes could be sufficient to eliminate dengue in low or moderate transmission settings.  However, the Indonesia trial is one of the first to demonstrate efficacy in a large population setting.  

In the wake of the results of this and other trials, the World Health Organization is reportedly developing recommendations for Wolbachia mosquitoes as a method of dengue control. 

Bacteria-infected Mosquitoes Curbed Dengue Infections and Hospitalizations

Researchers infected lab-grown Aedes aegypti mosquitoes in the city of Yogyakarta with the Wolbachia bacteria, which is found naturally in many insects and blocks the dengue virus from replicating and spreading to humans.  Aedes aegypti mosquitoes are the main transmitters of dengue virus.

The city was separated into 24 clusters. Eggs of the disease-fighting mosquitoes were released in 12 of the clusters every 2 weeks for 18 to 28 weeks – while in the other half of the city the mosquito populations were not treated. 

Ten months after the releases began, the prevalence of Wolbachia among the local mosquito population in the treated clusters reached over 80%. 

The researchers then studied disease outcomes among some 6,306 people who came to primary care clinics with a fever in the treated and the untreated areas. Of the patients who lived in treated clusters, only 2.3% tested positive for dengue virus, compared to 9.4% of those in control areas. 

The incidence of symptomatic dengue cases was reduced by 77% and hospitalizations dropped by 86%. 

“This result is groundbreaking,” said Dr Katie Anders, Director of Impact Assessment at the World Mosquito Program. “We think it can have an ever greater impact when it is deployed at scale in large cities around the world, where dengue is a huge public health problem.”

In 11 of the 12 treated clusters, the proportion of participants with dengue was lower than in the control groups. 

There were 67 cases recorded among the participants residing in the intervention clusters and 318 recorded among those who lived in the control clusters. Some 13 hospitalizations for dengue were reported among participants in intervention clusters as compared to 102 hospitalizations in the control clusters.

The efficacy of the lab-grown mosquitoes was similar in reducing incidence of four dengue virus serotypes. 

“[This study] provides the gold standard of evidence that Wolbachia is a highly effective intervention against dengue,” said Oliver Brady, a dengue expert at the London School of Hygiene and Tropical Medicine, who was not involved in the study. 

“It has the potential to revolutionize mosquito control,” Brady added. 

Wolbachia as Possible New Dengue Control Measure

Following the positive trial results, the World Mosquito Program and Yogyakarta’s District Health Office deployed Wolbachia-infected mosquitoes throughout untreated areas of Yogyakarta city in January 2021. 

Releases are also now underway in the neighbouring districts of Sleman and Bantul. 

Trials are meanwhile also ongoing in Colombia, Sri Lanka, India, and countries in the Western Pacific. 

“I am confident that Wolbachia can complement other methods in controlling dengue,” said Rhamawati Ningrum, a study nurse at Puskesmas Health Center. “I expect that this Wolbachia program continues, not only in the city of Yogyakarta, but in other cities across Indonesia.”

According to the researchers, once mosquitoes are infected with the Wolbachia bacteria, the infection is maintained in the mosquito population and doesn’t need reapplication, which makes it a cost-effective strategy for controlling dengue. 

The Wolbachia method is also considered to be harmless to ecosystems, as 60% of insect species already carry the bacteria anyway. 

The results are consistent with findings from non-randomized Wolbachia deployments in northern Australia and Brazil, suggesting that the results could be replicated in different epidemiological settings. 

So far seven million people are under the protection of Wolbachia and the World Mosquito Program aims to cover at least 75 million by 2025 and half a billion by 2030. 

Wolbachia has the potential to also be effective against other diseases that Aedes aegypti mosquitoes carry, including Zika and yellow fever.

Image Credits: Commons Wikimedia.

One of the lucky few: A woman shows her vaccination card after getting the AstraZeneca vaccine.

Twenty-two African countries are experiencing a surge in COVID-19 infections, yet the vaccination rollouts on the continent have ground to a halt because of lack of supply.

African vaccination figures, as recorded by the Africa Centers for Disease Control and Prevention, are dismal. Apart from the tiny island state of Seychelles, only Morocco’s vaccination rate is in the double digits with 16.7% of its population fully vaccinated.

The next highest are Equatorial Guinea (6,26%), Tunisia (2,93%) and Zimbabwe (2,6%).

In terms of numbers, Egypt has delivered the most vaccinations, which by Monday had topped 3,3 million. But in a country with a population of over 100 million, and each person needing two vaccinations, this means that only 0,39% of Egyptians are fully vaccinated.

Meanwhile, Uganda has virtually run out of vaccines and oxygen, as COVID-19 cases increased by 2,800% in the past month. Its test positivity rate is 21.5%. Last week, the country entered a new 42-day lockdown in a bid to contain cases.

South Africa officially entered its third wave last week and is reporting over 5000 new cases per day with a test positivity rate of over 15%. On Tuesday night, President Cyril Ramaphosa announced that the country would move immediately to lockdown Level Three with a longer curfew, more limits on public gatherings and curbs on the sale of alcohol. The Democratic Republic of Congo, Namibia, Zambia and Kenya are also battling increased cases.

“The steep increase in Africa is especially concerning because it is the region with the least access to vaccines, diagnostics and oxygen,” World Health Organization (WHO) Director-General Dr Tedros Adhanom Ghebreyesus told the global body’s biweekly COVID-19 briefing on Monday.

“A recent study in the Lancet showed Africa has the highest global mortality rate among critically ill COVID-19 patients, despite having fewer reported cases than most other regions,” he added.

Most African countries have relied on the COVAX-facility for vaccines, but these supplies dried up in late March when the global vaccine platform’s key supplier, the Serum Institute of India, redirected all its AstraZeneca vaccines to address India’s pandemic.

To date, COVAX has supplied 37 of the 55 African states with vaccines. Almost 60% of African countries are reliant solely on AstraZeneca, according to the Africa Centres for Disease Control, and many countries have only administered a single dose to citizens with no idea of when they will receive supplies to administer the second dose.

Countries that have been able to reach more than 1% of their populations have done so largely because they have had other vaccine sources besides COVAX – primarily China’s Sinopharm, which is available in Morocco, Egypt, Tunisia, Seychelles, Zimbabwe and Equatorial Guinea among other countries. Some of the north African countries also have access to Russia’s Sputnik V vaccine.

Two Million J&J Vaccines Destined for South Africa Have to be Destroyed

South Africa decided not to use the AstraZeneca vaccine following research which showed diminished efficacy against the Beta variant (B1.351) dominant in the country and has bought Pfizer vaccines – reportedly at great cost – as well as Johnson & Johnson vaccines.

However, South Africa’s worst fears were realised over the past weekend when all two million Johnson & Johnson COVID-19 vaccines ready for distribution in the country were found to be made from batches that the US Food and Drug Administration (FDA) ruled unsuitable last Friday.

Last week, the country officially entered a third wave of the pandemic but it has only administered 1,350,000 vaccines – which translates into 0,5% of its population being fully vaccinated as two-thirds of these are the two-dose Pfizer vaccine.

With a drip supply of the costly Pfizer COVID-19 vaccines arriving every week, doses have been strictly rationed to health workers and those over the age of 60. 

Johnson & Johnson has undertaken to replace the two million doses by the end of June – but they were expected to have been dispensed in early May, which means that the rollout is running two months behind schedule.

However, Ramaphosa said on Tuesday night that “the pace of vaccinations has steadily picked up, and we are now vaccinating around 80,000 people a day at over 570 sites in the public and private sector. This number will grow rapidly in the weeks to come, as we aim to protect as many vulnerable people as possible.”

Officially, South Africa has been the worst affected on the African continent with over 1,7million COVID-19 cases. The official COVID-19 death toll is over 57,000 but “excess deaths” of 166,794  were recorded between 3 May 2020 and 5 June 2021, according to the SA Medical Research Council (SAMRC). The peaks and troughs of these excess deaths correlate almost exactly with the COVID-19 waves.

Huge ‘Excess Deaths’ in Egypt 

Meanwhile Egypt appears to have completely under-reported the impact of COVID-19. Between March 2020 and May 2021, it claimed a death toll of little more than 13,000 – yet its excess mortality for this period was over 175,000, according to the University of Washington’s Institute for Health Metrics and Evaluation (IHME). This means that it has more deaths than South Africa, even when that country’s excess deaths are taken into account.

Egypt has the highest obesity rate on the continent, so its death rate is in keeping with global trends.

It is likely that the impact of the pandemic is much greater in a number of other African countries, but only a handful have functioning civil death registration systems – namely Egypt, South Africa, Tunisia, Algeria, Cape Verde, São Tomé and Príncipe, Seychelles and Mauritius.

In a preprint article based on the world mortality dataset, academics Ariel Karlinsky and Dmitry Kobak report that they found the highest undercounts of excess mortality in Uzbekistan (30), Kazakhstan (12), Belarus (15), Egypt (13), and Russia (6.7). 

“Such large undercount ratios strongly suggest purposeful misdiagnosing or underreporting of COVID-19 deaths,” according to the authors.

Countries Need Logistical Support to Prepare for Vaccine Rollouts

Ghaanian President Nana Akufo-Addo gets vaccinated against COVID-19 with the first COVAX vaccine to be distributed in the world.

Last Sunday, the G7 countries announced that they would be donating 870 million doses to countries in need – primarily through COVAX. However, many of these will be Pfizer vaccines that need to be stored at ultra-cold temperatures.

Dr Mike Ryan, WHO’s Director of Health Emergencies, warned that the logistics around cold chain management and vaccination rollouts was complex.

“Countries need assistance in preparing for that. A second tragedy will be to have vaccines and not be able to use them properly,” Ryan told Monday’s WHO press briefing on COVID-19.

“There is underfunding right now of basic preparedness in many, many countries. We would urge donors and others to not only just fund vaccines, but to fund the operations needed to deliver those vaccines, and to fund the agencies like UNICEF, like ourselves and other NGOs who are working very closely with governments to improve their capacity to deliver vaccines,” urged Ryan.

Meanwhile, a statement from the COVAX partners this week in response to the G7 donation also urged support for countries for rollouts.

“Facing an urgent supply gap, COVAX is focused on securing as many shared doses as possible immediately, as the third quarter of this year is when the gap between deliveries and countries’ ability to absorb doses will be greatest,” said the partners in a media statement.

“In anticipation of the large volumes available through the COVAX Facility deals portfolio later in the year, COVAX also urges multilateral development banks to urgently release funding to help countries prepare their health systems for large-scale rollout of vaccines in the coming months,” it added.

The Democratic Republic of the Congo has already sent some of 1.7 million of its COVAX-donated vaccines to other countries because it was unable to distribute them before their expiry date. Meanwhile, South Sudan intends to destroy 59,000 vaccines that have expired and Malawi earlier destroyed 20,000 expired vaccines despite being told by Africa CDC and other bodies that they could be used. 

Image Credits: WHO, WHO African region .

A new WHO study found that 18 million children, some as young as 5 years of age, are actively involved in the informal e-waste sector – and are being exposed to toxic e-waste that is endangering their lives.

Electronic waste (e-waste) is increasing at three times the pace of the world population, impacting badly on the health of those wading through electronic dump sites, according to the World Health Organization’s (WHO) landmark report – Children and Digital Dumpsites – released on Tuesday.

Led by Marie-Noël Bruné Drisse, a children’s health expert of the WHO, the report found that 18 million children, some as young as 5 years of age, are actively involved in the informal e-waste sector – and are being exposed to toxic e-waste that is endangering their lives.

In 2013, the WHO launched its e-waste and child health initiative, which led to a series of evidence gathering missions to bring together knowledge and awareness on the detrimental health impacts.

“Recycling is quite expensive,” said Drisse.  “Because it is expensive, [rich countries] circumvent the domestic recycling regulations, and it seems to be cheaper to do this than to recycle the waste themselves.”

This is triggering a crisis of e-waste health risks to millions of children globally, mostly in low and middle income countries that are recipients to the hazardous material. In East and South-East Asia alone the volume of the electronic waste increased by 63% between 2010 and 2015, according to the report.

As the wealthy citizens of the world throw out their old devices, each year about 250,000 tonnes of the 53.6 million metric tonnes of e-waste is discarded in Agbogbloshie,located in the buzzing commercial district on the Korle Lagoon of the Odaw River, in the centre of Ghana’s capital city Accra. Nicknamed Sodom and Gomorrah, Agbogbloshie is one of the world’s most prolific destinations for electronic scrap materials as hundreds and thousands of tonnes of e-waste is dumped at the site by mostly wealthy nations.

In the 2020 Global E-waste Monitor report, only 17.4 % of the 50 million figure was officially documented as formally collected and recycled.

According to the WHO, e-waste refers to any electronic equipment and components which become waste, including medical devices and toys. 

The majority of e-waste is recycled by informal waste sector workers, including children and pregnant women, exposing these populations to toxic materials including brominated flame retardants, lead, mercury and dioxins.

Children at Greater Harm

“As many as 12.9 million women are working in the informal waste sector, which potentially exposes them to toxic e-waste and puts them and their unborn children at risk,” the WHO said in a press statement on Tuesday.

“Meanwhile more than 18 million children and adolescents, some as young as 5 years of age, are actively engaged in the informal industrial sector, of which waste processing is a sub-sector.”

Young children are often used in the informal recycling sector as “they have small hands, which are useful for extracting the materials,” said Drisse.

Children working in the dump sites are more vulnerable than adults as their organs are less developed, and the toxins could “impair neurological and behavioural development” as well as other negative birth outcomes connected to the lung and respiratory function and immune system damage, said the WHO.

Beyond health, there are environmental consequences including the pollution of air, water and soil, critical for agricultural means.

The ‘Most Toxic’ Dumpsite in the World

A man from Ghana burns electronic waste to reveal the metals at the Agbogbloshie electronic waste site in Accra, Ghana(2018)

Arriving at the port of Tema, about 20 miles east of Agbogbloshie, thousands of tonnes of used electronic materials are delivered by high income nations such as those in the European Union and North America, often burdening the local waste management infrastructure.

Up to 8,000 workers wade through the discarded materials for recycling at temperatures of about 35°C without masks or personal protective equipment.

Ghana makes an estimated $105 to $268 million annually from materials sourced from e-waste and as many as 200,000 people benefit from e-waste recycling activities, according to Drisse.

“How can we ask a family who depend on informal recycling as their source of income to stop this activity?” asks Dr Julius Fobil, head of the School of Public Health at the University of Ghana, who has been researching the impact of informal e-waste recycling on health for years. 

Fobil said until alternatives jobs are offered and appropriate measures are implemented, e-waste will remain a complex issue. “Their respiratory health is impacted, they have breathing problems, back problems and sores on their skins which could lead to long-term ailments,” he explained.

Workers source the materials needed, such as copper, by burning the electronic materials. As a result, “naked fires at low temperatures are widespread, which is extremely dangerous, particularly for children as they can get burnt.” 

Also, the smoke “emanating from burning goes into the lungs of those in surrounding areas and causes environmental and air pollution, significantly impacting the air quality,” particularly for the 80,000 people living on-site and adjacent to the site.

A vibrant economy surrounds Agbogbloshie, which is home to one of Accra’s largest food markets. Livestock also graze on the waste materials, enabling toxins to enter the food chains. 

The highest ever reported levels of brominated dioxin and second- highest level of chlorinated dioxins were found in eggs in Agbogbloshie, Drisse explained. Adult chicken eggs gathered around the area have 220 times more toxins than the safety limits prescribed and, if ingested, could cause cancer, reproductive problems and interfere with hormones. With all these health warnings the practice still remains extremely difficult to curb.

Why International Conventions and Policies are not Working

The WHO report found that about 53.6 million metric tonnes of e-waste is disposed worldwide every year.

Attempting to curb the practice, international treaties like the Basel Convention (1992)  and  Bamako Convention (1998) came into force to reduce and prevent the export of hazardous waste, including radioactive materials to low-middle income countries. However, this waste still ends up in countries like Ghana.

Although both Drisse and Fobil believe these conventions are “really important” to discourage the shipment of hazardous waste, they both note their limitations. 

“These international conventions remain at the global level making it difficult to implement locally. They are signed by governments at a high level and there is a long lag between when the decision at the global level is made and implemented locally,” said Fobil.

 “In addition, when adopted at an international level they can become ineffective locally because they do not apply as the policies remain inflexible,” he added.

As part of the e-waste and child initiative a group of 10 UN agencies and international organisations have come together to increase collaboration and provide more effective support to countries to address the e-waste and adapt international policies to local contexts to ensure more successful waste management systems. 

Electronic-waste refers to any electronic equipment and components which become waste, including medical devices, toys and cellphones.

Drisse also explained that organisations such as Pure Earth and its partners are thinking of locally adapted interventions to recycle and dismantle these materials without harming people’s health – such as getting machines to strip the wires to retrieve the copper.  

As part of the ongoing efforts to offer training in safer recycling practice, a football pitch for entertainment and clinic have been located near-by, bringing together informal and formal groups on how to appropriately manage e-waste.

“The clinic is providing basic health care for e-waste workers and other residents in the area. It is also used as an onsite research centre for collecting biological samples needed to disseminate information about the health impacts of improper waste management,” Fobil explained.

Despite all these interventions, people’s appetite for electronics keeps growing, and this has detrimental and long-term effects on people like those living in Agbogbloshie.

Image Credits: WHO, EPA/CHRISTIAN, Global E-waste Monitor.

Wearing masks, social distancing, travel restrictions: the WHO plans to study social and behavioral interventions that have kept COVID-19 away.

The World Health Organization (WHO) is planning to study the public health and social measures that countries have used to keep COVID-19 at bay successfully – in case there is no quick vaccine for the next pandemic.

A special working group has been set up with the support of Norway to study these measures, WHO Director-General Dr Tedros Adhanom Ghebreyesus told Monday’s WHO COVID-19 media briefing.

“The emergence of more transmissible variants means public health and social measures may need to be more stringent and applied for longer, in areas where vaccination rates remain low,” said Dr Tedros.

“To improve the evidence base on the effectiveness of public health and social measures, WHO is collecting data from around the world on which measures are used and the level at which they are applied.”

However, he warned that it was hard to study these measures because countries typically use a range of them at the same time, and “untangling the precise impact of each individual measure can be challenging”. 

Norway’s Minister of Health and Care services, Bent Høie, told the briefing: “We have been lucky this time. The next pandemic may behave differently from COVID-19 and we may have to depend on public health and social measures for a much longer time in the next pandemic before vaccines are available.” 

Although thousands of scientific papers have been produced about the science of COVID-19, very few have examined the impact of measures such as wearing masks, social distancing, testing-and-tracing and travel restrictions, said Høie.

“Even though most countries have been using these restrictive measures extensively for more than a year, our knowledge on the precise effects of each of these measures is unclear, and the effects are difficult to research,” he added.

The WHO working group will examine the impact, social and economic costs of the different measures used, and develop better tools that can be deployed during the next pandemic, he added.

Countries Need Help with Vaccination Preparedness

People waiting to register for COVID-19 vaccines in the Pakistan Institute of Medical Science.

“Globally, the number of new cases of COVID-19 reported to WHO has now declined for seven weeks in a row, which is the longest sequence of weekly declines during the pandemic so far,” said Tedros.

However, he added that the decline masked a “worrying increase” in many countries.

“The steep increase in Africa is especially concerning, because it is the region with the least access to vaccines, diagnostics and oxygen,” said Tedros, pointing out that around 420 people would have died of COVID-19 during the hour-long briefing.

While Tedros welcomed the G7 Summit’s announcement on Sunday that it would donate 870 million vaccine doses, he stressed that “we need more, and we need them faster”.

A wide range of civil society organisations have condemned the G7 for failing to agree to the UK’s call to donate one billion vaccine doses. Former UK Prime Minister Gordon Brown told Sky News that the G7 leaders were guilty of an “unforgivable moral failure” for failing to donate the vaccines.

The majority of the vaccine donations will be Pfizer vaccines, which need to be transported and stored in ultra-cold conditions – although once they have been taken out of cold storage, they can be kept in normal refrigeration for up to three months, according to Mariangela Simao, WHO’s Assistant Director General for Access to Medicines. 

But Dr Mike Ryan, WHO’s Director of Health Emergencies, warned that the logistics around cold chain management and vaccination rollouts was complex.

“Countries need assistance in preparing for that. A second tragedy will be to have vaccines and not be able to use them properly. And there is underfunding right now of basic preparedness in many, many countries. We would urge donors and others to not only just fund vaccines, but to fund the operations needed to deliver those vaccines, and to fund the agencies like UNICEF, like ourselves and other NGOs who are working very closely with governments to improve their capacity to deliver vaccines.”

Addressing the $16 billion shortage faced by COVAX, the global vaccine platform, Ryan pointed out that this was around 1% of a year’s spending on global military defence. 

“Surely we can afford 1% of that to save lives, and bring this pandemic to an end?” asked Ryan.

Image Credits: Cross River State Primary Health Care, Nigeria , Flickr: Joseph Gage, Rahul Basharat Rajput.

A PREVENT-19 phase 3 trial volunteer receives the Novavax vaccine at a trial site in Plano, Texas.

Biotech manufacturer Novavax announced on Monday it would be able to manufacture 100 million doses of its two-dose COVID-19 vaccine every month by the end of the third quarter of 2021 and 150 million doses per month by the end of the year – once it has secured regulatory approval for its vaccine.

This follows a successful Phase 3 trial, which showed that the vaccine, NVX-CoV2373, had an overall efficacy of 90.4% and showed 100% protection against moderate and severe COVID-19 disease, according to the company.

Almost 30,000 participants across 119 sites in the US and Mexico participated in the trial. Trial participants were representative of communities and demographic groups most impacted by the disease, according to the company.

The recombinant nanoparticle protein-based vaccine acts by inducing antibodies that block the binding of spike protein to cellular receptors.

“These clinical results reinforce that NVX-CoV2373 is extremely effective and offers complete protection against both moderate and severe COVID-19 infection,” said Stanley C. Erck, Novavax President and Chief Executive Officer. 

“Novavax continues to work with a sense of urgency to complete our regulatory submissions and deliver this vaccine, built on a well understood and proven platform, to a world that is still in great need of vaccines.”

Efficacy of Over 90%

NVX-CoV2373 demonstrated overall efficacy of 90.4%. In all, 77 cases were observed: 63 in the placebo group and 14 in the vaccine group. All cases observed in the vaccine group were mild. Ten moderate cases and four severe cases were observed, all in the placebo group, yielding a vaccine efficacy of 100% against moderate or severe disease.

“NVX-CoV2373 also showed success among ‘high-risk’ populations (defined as over age 65, under age 65 with certain comorbidities or having life circumstances with frequent COVID-19 exposure): vaccine efficacy was 91.0%, with 62 COVID-19 cases in the placebo group and 13 COVID-19 cases in the vaccine group,” Novavax stated.

Regarding strains of SARS-CoV-2, the vaccine demonstrated 100% efficacy against variants not considered Variants of Interest (VoI) and Variants of Concern (VoC). 

Novavax also stated that of the sequenced cases, 35 (65%) were VoC, 9 (17%) were VoI, and 10 (19%) were other variants. Against VoC/VoI, which represented 82% of the cases, vaccine efficacy was 93.2%, achieving a key exploratory endpoint of the study. Thirty-eight of the VoC/VoI cases were in the placebo group and 6 were in the vaccine group.

Preliminary safety data also showed the vaccine to be generally well-tolerated considering serious and severe adverse events were low in number and balanced between vaccine and placebo groups. 

Adverse reactions were restricted to less than 1%. Fatigue, headache and muscle pain were the most common symptoms, lasting less than two days.

Ready to File by Third Quarter

Before the vaccine can be included in the panel of vaccines that will become available for use in the fight against the pandemic, it needs to complete the final phases of process qualification in addition to assay validation which is required for it to meet chemistry, manufacturing and controls (CMC) requirements.

According to Novavax’s estimates, it will be ready to file for regulatory authorizations in the third quarter of 2021. Of particular interest will be authorizations by the European Medicines Agency (EMA) and the World Health Organization’s Emergency Use Listing.

Even though several steps are still ahead before NVX-CoV2373 joins the list of approved vaccines for use, Gregory M. Glenn, President of Research and Development at Novavax expressed confidence that the results from the PREVENT-19 clinical trial are strong indications on the candidate vaccine making it to the end users. 

“PREVENT-19 confirms that NVX-CoV2373 offers a reassuring tolerability and safety profile. These data show consistent, high levels of efficacy and reaffirm the ability of the vaccine to prevent COVID-19 amid ongoing genetic evolution of the virus. Our vaccine will be a critical part of the solution to COVID-19 and we are grateful to the study participants and trial staff who made this study possible, as well as our supporters, including the U.S. Government,” Glenn said.

There is also a green light for the vaccine getting added to the list of vaccines that are available to countries through the COVAX Facility. In a statement, the Coalition for Epidemic Preparedness Innovations (CEPI) said Novavax’s COVID-19 vaccine will be “a critically important addition to the armamentarium”.

CEPI said it invested up to $384 million, in early research and development, in testing the potential of Novavax’s vaccine technology.

CEPI also announced agreements with its partner GAVI to supply vaccines to COVAX. As part of the agreement, Novavax will supply 350 million doses of its COVID-19 vaccine, from as soon as it has secured regulatory approval.

“A total of 1.1 billion doses of the Novavax vaccine are expected to be made available to COVAX, with the remaining volumes set to be supplied through the Serum Institute of India,” CEPI stated.

 

 

Image Credits: Matt Feldman, Novavax.

A child works in a tobacco field in Indonesia

Over the past several decades, the tobacco industry has tried to influence policy by partnering with various United Nations (UN) agencies. Many of these agencies, however, have since cut ties with the industry, thus safeguarding their initiatives and policies from Big Tobacco’s commercial interests. One notable exception remains and must be addressed: the continued membership of the tobacco industry-funded Eliminating Child Labour in Tobacco-Growing Foundation (ECLT) in the UN Global Compact (UNGC). More than 170 civil society organizations have now called on UNGC to end ELCT’s participation.

Tobacco industry benefits from UN partnerships 

The advantages the tobacco industry gains from these types of collaboration are not imagined or hypothetical. There is evidence that shows how it has benefited.

For decades, the tobacco industry nurtured its alliance with the International Labour Organization (ILO). Transnational tobacco companies financially supported the agency’s work, and Philip Morris International even displayed the ILO logo on its website. The closeness was reciprocated. In 2002, the ILO produced a glowing report about trends and prospects in the tobacco industry, and in 2017, included praise for its work with the tobacco industry in its Governing Body’s reference document.

The industry also sought to influence the Food and Agriculture Organization (FAO), positioning experts on various FAO/World Health Organization (WHO) committees and working to direct funding to research and policy groups sympathetic to the industry. And its work with United Nations International Children’s Emergency Fund (UNICEF) in the late 1990s (both directly and via front groups) on youth smoking prevention initiatives was revealed via industry documents to be a way to avoid meaningful tobacco control measures.

BAT used International Chamber of Commerce co-operation to get closer to WHO

An especially concerning example of attempted industry interference in health policy was British American Tobacco (BAT) allegedly using its ties to the International Chamber of Commerce (ICC) to influence WHO. As the “world’s largest business organization,” the ICC is regularly consulted by the UN on business issues. In 2000, then-BAT CEO, Martin Broughton, joined the ICC UK’s governing body; one of the listed membership benefits being “preferential access to the UN and its constituent organisations.”

In July 2000, the WHO published an exposé, Tobacco Company Strategies to Undermine Tobacco Control Activities, based on internal industry documents, claiming that the industry subverted its efforts to control tobacco use. 

The exposé did not stop the tobacco industry. Even as the WHO Framework Convention on Tobacco Control (FCTC) was being prepared, Broughton wrote to the ICC requesting that the organisation get involved in the negotiating process, from which the tobacco industry had been officially excluded. The WHO went on to coordinate and successfully complete the FCTC negotiations which, among other things, set the guidelines for preventing tobacco industry influence in public policy.

Other UN agencies have cut ties with the tobacco industry

In 2019, after a multitude of efforts from sustainable development and public health groups and several international non-governmental organisations, the ILO finally ended tobacco industry funding. The FAO has since moved to demand transparency and accountability from its expert consultants (an effort about which the full effect is still unknown), and UNICEF has stated that it has developed a policy on tobacco, though the policy has yet to be published on UNICEF’s website. These are all important steps in keeping the tobacco industry out of the UN.

The UNGC must end the ECLT’s membership to cut ties with tobacco industry

The UNGC is a voluntary UN initiative made up of businesses, public sector organisations, cities and non-governmental organisations committed to socially responsible business practices in the areas of human rights, labour, the environment, and anti-corruption. Recognizing that “tobacco products are in direct conflict with UN goals, particularly with the right to public health, and undermines the achievement of SDG 3,” the UNGC’s 2017 move to exclude membership from organisations that “derive revenue from the production and/or manufacturing of tobacco” was a smart one.

However, the ECLT remains a member of the UNGC. While its supposed pursuit of ending child labour (which it has yet to accomplish) looks good from the outside, the ECLT is actually an alliance of tobacco companies and growers—an industry front group—and its UNGC membership provides “the industry with the opportunity to have a seat at the policy table among respected organisations and sometimes Member State Delegations…” As we’ve seen with other UN agencies, this type of cooperation can hinder tobacco control and instead provide benefits to the tobacco industry. After two decades of ECLT’s work, child labor remains entrenched in many tobacco-growing regions.

That is why the UNGC should uphold the Model Policy for Agencies of the United Nations System on Preventing Tobacco Industry Interference, which affirms that “engagement with the tobacco industry is contrary to the United Nations system’s objectives, fundamental principles and values,” and look to FCTC Article 5.3 Guidelines for the necessary steps to prevent industry influence.

Ending child labor should not be in the hands of an industry whose supply chain allegedly benefits from practices that keep leaf prices low. A continued partnership promises to only hinder the elimination of child labor and continues to allow tobacco industry influence to stream into the UN.

The fight to eliminate tobacco industry influence within the UN system isn’t over—but UNGC excluding the ECLT would be an important step.

* Mary Assunta is Head of Global Research and Advocacy at the Global Center for Good Governance in Tobacco Control and a Partner in STOP.

 

Image Credits: Human Rights Watch.

Some of the first SARS-COV-2 cases emerged around Wuhan’s “wet markets” selling wild animals for slaughter and meat consumption; such markets can be a flashpoint for pathogen transmission to humans.

Chinese researchers have this week published two papers that shed new light into the likely bat origins of SARS-CoV2 and related foodborne risks – even as pressures from the United States and the European Union grow for a more complete investigation into the origins of SARS-CoV2. 

The US and EU are expected to issue a joint statement on the issue next week calling for “progress on a transparent, evidence-based and expert-led WHO -convened Phase 2 study on the origins of Covid-19, that is free from interference.” 

Speaking at a Thursday press conference ahead of this weekend’s G7 Summit, European Council President Charles Michel set the stage with a declaration that “the world has the right to know exactly what happened in order to be able to learn the lessons.”

Added European Commission President Ursula von der Leyen: “Investigators need complete access to the information and to the sites” to “develop the right tools to make sure that this will never happen again.”

Preemptive Chinese Moves? 

The EU statements followed this week’s release of two papers by Chinese academics in peer-reviewed journals on bat coronaviruses and Wuhan market pathogen risks.  

One study, published in the journal Cell,  reviews previously unreported data on the genome sequences of about two dozen novel coronaviruses harborned by bat species in southwestern China’s Yunnan province, including one that may be the most similar yet, genetically speaking, to SARS-CoV2.

A second paper, published in Scientific Reports highlights the poor hygiene and animal market conditions, and a range of pathogen risks associated with Wuhan’s live animal markets, which included many illegally traded species, in a survey of 47,000 live animals sold at 17 Wuhan markets between May 2017 and November 2019.  During the two-and-half years, one of the study’s co-authors conducted monthly surveys of all 17 shops in Wuhan markets that sold live wild animals for food and pets. Seven of the shops were at the Huanan seafood market, one of the first sites around which a cluster of novel coronavirus cases was first identified in December 2019 and early 2020. 

No Smoking Guns – But… 

Experts contacted by Health Policy Watched noted that papers add weight and nuance to the origins investigation, although neither resolves the polarized debate over whether the virus emerged via “natural” contact between bats and humans, or bats and another  intermediate food or animal host.  

“This shows why we should fully examine the natural spillover origin hypothesis, but it’s in no way the ‘smoking gun’ that Bob Gerry described as in the Wall Street Journal,” said Jamie Metzl, a senior fellow at the Atlantic Council. Metzl is one of the co-authors of a series of open scientific letters that have criticized the WHO-led investigation as inadequately exploring the possibility that the SARS-CoV2 could have “escaped” from the Wuhan Institute of Virology, where scientists were studying horseshoe bat coronaviruses from Yunnan Province, just prior to the pandemic.

Another scientist expressed doubt that the timing of the publications represented any kind of a trend by Beijing to drive the narrative against US and European pressures, saying other studies of bat coronavirus sequences have been published previously and: “this is just science, slowly and methodically being published. I have no doubt more will come out.” 

Twenty-four Full-Length Coronavirus Genomes 

Infographic describing research published in the journal Cell, in June 2021, which mapped the genomes of 24 coronaviruses harborned by bats in China’s Yunnan province, including four close relatives of SARS-CoV2, the virus that causes COVID-19.

The paper on the new set of bat coronaviruses, published in Cell by 15 Chinese and Australian researchers, sequenced 24 full-length coronavirus genomes out of a collection of 411 bat saliva and excrement samples collected in Yunnan province between May 2019 and November 2020 – including four novel viruses that researchers said were closely related to SARS-CoV2.  

One virus, dubbed “Rhinolophus pusillus virus” (RpYN06), was found to be the  closest relative of SARS-CoV-2 in most of its genome, among the group of viruses collected “although it possessed a more divergent spike gene. 

“The other three SARS-CoV-2 related coronaviruses carried a 41 genetically distinct spike gene that could weakly bind to the hACE2 receptor in vitro” – referring to the receptor in humans to which SARS-CoV2 attaches so effectively. 

None of the samples, however, appeared to be quite as genetically similar to SARS-CoV2 as a previously identified bat virus (Rhinolophus affinis) RaTG13 – which the researchers admitted still “shares the greatest sequence identity with SARS-CoV-2 across the viral genome as a whole (Zhou et al., 2020b).” That  coronavirus, as well, is believed to have been harbored by bats in remote parts of Yunnan province in southwestern China, bordering Myanmar. 

The study suggests that “bats across a broad swathe of Asia harbor coronaviruses that are closely related to SARS-CoV-2 and that the phylogenetic and genomic diversity of these viruses has likely been underestimated.

“Ecological modeling predicted the co-existence of up to 23 Rhinolophus bat species, with the largest contiguous hotspots extending from South Laos and Vietnam to southern China. Our study highlights the remarkable diversity of bat coronaviruses at 45 the local scale, including close relatives of both SARS-CoV-2 and SARS-CoV.” 

Market Risks Abounded – But Pangolins Not Among Species Sold 

Wuhan’s shuttered live animal markets in April 2020, including (a) Huanan Seafood market, (b) Qiyimen live animal market, (c) Baishazhou market and (d) Dijiao outdoor pet market.

The second study, conducted by scientists from the China West Normal University, as well as Oxford University and the University of British Columbia, found 47,000 live animals sold in Wuhan’s live animal markets between May 2017 and November 2019,

“Serendipitously, prior to the COVID-19 outbreak, over the period May 2017–Nov 2019, we were conducting unrelated routine monthly surveys of all 17 wet market shops selling live wild animals for food and pets across Wuhan City,” the authors report. 

“This was intended to identify the source of the tick-borne (no human-to-human transmission) Severe Fever with Thrombocytopenia Syndrome (SFTS), following an outbreak in Hubei Province in 2009–2010 in which there was an unusually high initial case fatality rate of 30%.”

“While we caution against the misattribution of Covid-19’s origins, the wild animals on sale in Wuhan suffered poor welfare and hygiene conditions and we detail a range of other zoonotic infections they can potentially vector,” lead author Xiao Xiao, from the Lab Animal Research Centre at Hubei University of Chinese Medicine in Wuhan,wrote.

No Pangolins At Wuhan’s Markets 

Significantly, while some 38 species were sold in 17 markets in Wuhan between May 2017 and November 2019, no pangolins were sold in the markets at all, the study also found.

That, the authors conclude, rules out pangolin, an endangered species known to be a carrier of coronaviruses, as a potential host of the first SARS-CoV2 virus cases transmitted to humans.  

“Circumstantially, the absence of pangolins (and bats, not typically eaten in Central China; media footage generally depicts Indonesia) from our comprehensive survey data corroborates that pangolins are unlikely implicated as spill-over hosts in the COVID-19 outbreak. This is unsurprising because live pangolin trading has largely ceased in China.”

However, badgers, porcupines, red foxes, masked palm civets, raccoon dogs, Siberian weasels, snakes, Siamese crocodiles and Chinese bamboo rats were among 38 animal species sold at the Huanan seafood and fresh produce market in central Wuhan. Almost all of the animals were “sold alive, caged, stacked and in poor condition,” and were often butchered on site, the researchers wrote.

Masked palm civets were discovered to be the host of the SARS-COV virus that caused the 2003 SARS outbreak, the authors acknowledge, warning against “false attribution” of the virus to any species, as of yet. 

“We should therefore not be complacent, because the original source of COVID-19 does not seem to have been established,” the authors wrote. “This is doubly important because false attribution can lead to extreme and irresponsible animal persecution. For instance, civets were killed en masse following the SARS-CoV outbreak, and any unwarranted vilification or persecution of pangolins and bats in relation to COVID-19 would risk undermining otherwise very successful efforts to better protect and conserve wildlife in China.”

Animals Sold at Wet Markets Kept in Poor Conditions 

Caged animals held for sale and slaughter in unsanitary conditions at Wuhan’s Huanan Seafood Market, prior to the outbreak of COVID-19, including: (a) King rat snake (Elaphe carinata), (b) Chinese bamboo rat (Rhizomys sinensis), (c) Amur hedgehog (Erinaceus amurensis) (the finger points to a tick), (d) Raccoon dog (Nyctereutes procyonoides), (e) Marmot (Marmota himalayana) (beneath the marmots is a cage containing hedgehogs), and (f) Hog badger (Arctonyx albogularis).

None of the 17 vendors in Wuhan selling the wild-caught and farmed non-domesticated species posted required origin or quarantine certificates, “so all wildlife trade was fundamentally illegal”, they said.

Along with the sale of the animals as luxury meat items,  some of the wild animals were also sold as pets – another prestige item in China, the authors noted. 

“We thus make an ethical distinction here between the subsistence consumption of bush meat in poorer nations, versus the sort of cachet attached to wild animal consumption in parts of the developed world, notably China, but also Japan,” the authors stated. 

Although the survey pre-dates the discovery of SARS-CoV2, other “potentially lethal viruses” were found in the wildlife tested, including rabies, SFTS, H5N1, as well as common bacterial infections that, nevertheless, represent a risk to human health (e.g., Streptococcus). 

Many of the earliest cases of human COVID-19 infection were linked to the Huanan seafood market, initially identified as where SARS-CoV-2 first crossed to humans. However, other early clusters of cases elsewhere in the city also suggest that the novel coronavirus did not exclusively emerge from the Huanan marketplace either. 

The study challenges some of the assumptions in a recent WHO report on its mission to Wuhan noting that: “The WHO reports that market authorities claimed all live and frozen animals sold in the Huanan market were acquired from farms officially licensed for breeding and quarantine, and as such no illegal wildlife trade was identified.” 

“In reality, however, because China has no regulatory authority regulating animal trading conducted by small-scale vendors or individuals it is impossible to make this determination.”

The authors also note the gunshot and trapping wounds found on the bodies of live animals or their carcasses following slaughter, suggesting illegal hunting and trapping of many of the species sold in the market. 

China Crackdown – But More Steps Needed

After the first COVID-19 outbreak in Wuhan, China cracked down on wildlife trafficking, banning the consumption and trading of wild animals for food in February 2020, although it still allows some animals to be reared for fur or traditional Chinese medicine.

However, the study cites a series of other measures that still may be needed, stating that: “Legislative reform is also vital to clarify unequivocally which species are considered ‘wild’ and cannot be traded legally and safely.”

Another problem, as encountered by the WHO report is that, retrospectively, it proved difficult to ascertain which species were on sale, even to the genus level, relying solely on the responsible market authority’s official sales records and disclosures. 

Sales of wild animals, including squirrels, birds and turtles, as pets, are another concern, the authors note, saying, “While not currently the vector of any major viral epidemics, it would be naive to imagine that unconventional pets do not still also pose a serious concern for public health26. This potential for disease is likely exacerbated by poor sanitary and welfare conditions.

The authors also cite physical infrastructure reforms in China’s open air markets, and other hygienic practices, in line with new WHO co-authored guidance, on “Reducing public health risks associated with the sale of live animals on mammalian species in traditional food markets’, stating that, “adopting these more responsible practices has the potential to save countless lives in the future.”

Origins of COVID-19 Unsolved: More Investigations Needed

More than a year into the pandemic, the question of the virus’s origins remains largely unresolved.

A World Health Organization-led research mission in March found that SARS-CoV-2 most likely spilled over to humans from a live animal — either directly through a bat infection, or via another mammal, possibly one sold at Wuhan’s wet markets. 

But other scientists have charged that the virus may instead have escaped from the Wuhan Institute of Virology – and calling for further exploration of that hypothesis.

Last month President Joe Biden administration asked US scientists to “redouble efforts” to find the origins of the virus, asking for another update in 90 days.

Image Credits: Breaking Asia, Cell.com , Scientific Reports, Nature .

Johnson and Johnson single-dose vaccine

The US Food and Drug Administration (FDA) has authorised the release of two batches of the Janssen/ Johnson & Johnson COVID-19 vaccine – about 10 million doses – manufactured at the Emergent BioSolutions facility in Baltimore, according to a statement on Friday.

However, it also “determined several other batches are not suitable for use” while “additional batches are still under review,” it added.

The rejected doses amount to around 60 million doses, according to the New York Times.

For weeks, the future of the Johnson & Johnson vaccines have been up in the air as the FDA conducted “a thorough review of facility records and the results of quality testing performed by the manufacturer”.

This follows the discovery of serious breaches at Emergent, including the cross-contamination of Johnson & Johnson and AstraZeneca vaccines and mould in the Baltimore plant.

The Emergent problems have hampered severely South Africa’s vaccine rollout, as a local company, Aspen, is contracted to fill and finish for Johnson & Johnson, and was due to supply over two million vaccines to the national vaccination programme.

It is unclear how many of the South African vaccines are affected by the FDA decision.

“The FDA’s decision to include these two batches of vaccine drug substance in the Emergency Use Authorization (EUA) for the Janssen COVID-19 vaccine means that Janssen vaccine made with this drug substance can be used in the U.S. or exported to other countries,” said the FDA.

“A condition on any export of these batches, or of vaccine manufactured from these batches, is that Janssen and Emergent agree that the FDA may share relevant information about the manufacture of the batches under an appropriate confidentiality agreement, with the regulatory authorities of the countries in which the vaccine may be used.”

The FDA has also extended the expiration date for refrigerated Janssen COVID-19 vaccines from 3 months to 4.5 months.

“These actions followed an extensive review of records, including the production history of the facility and the testing performed to evaluate the quality of the product. This review has been taking place while Emergent BioSolutions prepares to resume manufacturing operations with corrective actions to ensure compliance with the FDA’s current good manufacturing practice requirements,” said Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research. 

“Additionally, the action to extend the shelf life for the refrigerated Janssen vaccine means that jurisdictions that have doses on hand now have additional time to administer vaccine.”

 

G7 leaders pose ahead of their meeting in Cornwall

Before the G7 leaders sat down on Friday afternoon in Cornwall to discuss how to “build back better” a world devastated by COVID-19, UK Prime Minister and summit host Boris Johnson challenged the Group to accept a target of providing one billion doses to developing countries.

But the People’s Vaccine Alliance, a network of over 50 organisations, has called on the G7 to “agree on a global goal to vaccinate 60% of the world by the end of 2021, with everyone reached in the next 12 months”. 

This would mean that 4.8 billion single-dose vaccines are needed – or 9.6 billion of the two-dose vaccines such as Pfizer, AstraZeneca and Moderna.

In an article published on Thursday, Johnson urged the Group “to adopt an exacting yet profoundly necessary target: to provide one billion doses to developing countries in order to vaccinate everyone in the world by the end of next year”.

According to Johnson: “Our scientists devised vaccines against COVID-19 faster than any disease had ever been overcome before. Britain and many other countries are inoculating their populations more swiftly than anyone thought possible,” he added.

“Now we must bring the same spirit of urgency and ingenuity to a global endeavour to protect humanity everywhere. It can be done, it must be done – and this G7 summit should resolve that it will be done.”

Some 42% of G7 Residents Are Already Vaccinated

By the end of May 2021, 42% of people in G7 countries had received at least one vaccine dose, compared to less than 1% in low-income countries, according to the alliance. COVID-19 cases are surging in large parts of Latin America and Africa.

The US this week committed to donating half a billion Pfizer vaccines to the world’s poorest countries in the next year, according to a White House announcement on Thursday. Deliveries will start in August, and the US has undertaken to deliver 200 million doses this year and the remaining 300 million by mid-2022. Two doses of this vaccine are needed, so the donation will cover 250 million people.

Saturday’s agenda for G7 – which comprises the UK, US, Canada, France, Italy, Germany, Japan and the European Union – will focus on global resilience, foreign policy (including aid) and health.

Leaders are expected to get into the details of vaccine distribution in the health session that will be addressed by the Gates Foundation’s Melinda French Gates and the UK’s Chief Scientific Adviser, Sir Patrick Vallance.

India and South Africa – co-sponsors of the TRIPS waiver proposal at the World Trade Organization (WTO) – have also been invited to the summit, along with South Korea, which has significant vaccine manufacturing capacity, and Australia. 

The World Health Organization, WTO, International Monetary Fund, Organisation for Economic Co-operation and Development and World Bank Group will also be in attendance.

But the People’s Vaccine Alliance has warned that any G7 promise to vaccinate the world by 2022 will not happen if governments continue to block proposals to waive patents and transfer technology and know-how.

It also wants the Group to “support the immediate suspension of intellectual property rules and enforce the transfer of vaccine technology to all qualified vaccine manufacturers in the world” and “pay their fair share of the money needed to manufacture billions of doses as fast as possible”.

‘Fantastic” French Support for TRIPS Waiver 

French President Emmanuel Macron and UK Prime Minister Boris Johnson greet each other at the G7 Summit.

“Of the G7 nations, only the US has explicitly supported waiving patents for vaccines – though not for treatments or diagnostics – and Japan has said it will not oppose the moves if they are agreed,” according to the People’s Vaccine Alliance.

“Germany and the UK continue to vehemently oppose the plan, despite its potential to massively increase vaccine production and save millions of lives, while Canada, Italy and France remain on the fence,” it adds.

However, following a quick visit to South Africa late last month, French President Emmanuel Macron appears to have climbed off the fence and stated on Thursday that he would support the TRIPS waiver.

Oxfam’s Health Policy Manager, Anna Marriott, described this news as “fantastic”, and called on the rest of the G& countries to follow suit.

“It doesn’t make sense for the entire world to be dependent on just a handful of pharmaceutical corporations that cannot make enough vaccines for everyone,” said Marriot. 

“Developing countries do not want to be dependent on donations of leftover vaccines from rich nations, most of which won’t even be given until next year. They simply want the rights and the recipes to make these vaccines themselves as fast as possible and this is what must be agreed at the G7 summit this week.”

Ahead of the summit, the US and the UK agreed to a new effort to combat future pandemics, through a partnership between the UK Health Security Agency (UKHSA) and the US National Centre for Epidemic Forecasting and Outbreak Analysis, run by the US Centers for Disease Control and Prevention (CDC).

The partnership will bolster “disease surveillance, as well as genomic and variant sequencing capacity worldwide” and establish an early warning system to detect diseases, particularly in low and middle-income countries that do not yet have the same capabilities.

This international approach to future pandemics builds on the Prime Minister’s recent launch of a new ‘Global Pandemic Radar’ to identify emerging COVID-19 variants and track new diseases around the world.

 

Image Credits: G7/UK.