A COVID-19 outreach program in Karnataka state, India.

Despite a series of controversies, Bharat Biotech, which produces Indian homegrown vaccine Covaxin, hopes for World Health Organization (WHO) emergency use listing (EUL) soon, following last week’s publication of its promising Phase 3 results.

The vaccine was given emergency authorisation by the Indian government in early January – even before it had concluded a Phase 3 trial or published its Phase 2 results.  It has since been accused of irregularities during its Phase 3 trial and of being involved in a corrupt deal in Brazil.

However, Bharat finally published a preprint of its Phase 3 trial results via the BMJ’s reputable preprint service last week, which showed that Covaxin had 93.4% protection against severe COVID-19, and 65.2% protection against the Delta variant. 

The trial involved 25,798 people between the ages of 18 to 98 years in 25 sites across India. But trialists at the Bhopal site reported that they had been paid $10 to take part and some had been unable to read the consent form as they were illiterate, according to media reports. 

While these results still have to be peer-reviewed, the company is in the process of submitting “rolling data” to the WHO, according to the WHO EUL status report.

Over the weekend, Bharat company chairperson and managing director Dr Krishna Ella said that that the trial results had established India and developing world countries’ ability to “focus on innovation and novel product development”.

The Indian Council of Medical Research (ICMR) has worked with the company to develop the vaccine, and Balram Bhargava, ICMR Director and India’s Secretary of the Department of Health Research, welcomed the results.

Describing the trial as India’s largest COVID-19 Phase 3 clinical trial, Bhargava said that Covaxin “has consolidated the position of Indian academia and industry in the global arena”.

Corruption Allegations in Brazil

However, the company has also been embroiled in a corruption scandal in Brazil, which resulted in the suspension last week of a 20 million-dose order of the vaccine worth $324-million pending the outcome of investigations. The allegations of irregularities reach as high as President Jair Bolsanaro, according to Quartz.

The issue was raised by India’s opposition Congress Party last Friday, which accused the Modi government of being “conspicuously silent” about the deal with Brazil despite the fact that public money had been used to develop the vaccine.

“Taxpayers’ money was put into this and which is why we have a right to question: what has happened with that money and why is the government conspicuously silent on it?” according to Congress spokesperson Supriya Shrinate, who claimed that the ICMR was to get 5% from the sale of the vaccine.

Part of the Brazilian scandal centres on a company linked to Bharat, which is apparently tried to act as a ‘broker’, selling the vaccines on to the Brazilian government at the vastly inflated price of $15 per dose. This is more expensive than the Pfizer vaccine, which has WHO EUL.

A whistleblower in the Brazilian Health Department told a Senate panel that he was facing pressure from an aide of a close ally of Bolsonaro to sign a contract for the vaccines at a massively inflated price, according to the Guardian

Ministry head of imports Luis Ricardo Miranda, told the panel that he had not approved an import license for the vaccine because an invoice for the first shipment asking for upfront payment had been sent by a company not mentioned in the contract.

Wagner de Campos Rosário, of the federal office of the comptroller general, said in a press briefing reported by CNN Brasil last week that the deal had been suspended “as a simple preventive measure, since there are complaints that could not be explained well by the complainant”. He expected the investigation to take around 10 days.

However, both Bharat and Bolsonaro have denied wrongdoing.

Image Credits: Flickr – Trinity Care Foundation, Flickr – Trinity Care Foundation.

Antibiotics are commonly used in animals to boost their growth and keep them from picking up infections.

Their consensus was inevitable. As the 74th World Health Assembly (WHA) discussed a solution in May to contain the grave and growing threat of antimicrobial resistance (AMR), one mandate emerged: any action must take a multisectoral One Health approach to human, animal, and environmental health. 

Antibiotics are commonly used in animals – often without the input of veterinarians – to boost their growth and keep them from picking up infections. Estimates indicate that more than 70% of the antimicrobials sold globally are used in animals, and in some countries up to 80%, mostly for growth promotion. This indiscriminate antimicrobial use fuels resistance. 

Drug-resistant germs can cross over from animals to humans through direct contact with farm animals or through meat handling or consumption. Inappropriate antimicrobial use in animals is now recognized as a major contributor to drug resistance. 

Some 700,000 people already die due to antimicrobial resistance each year, and that may increase to millions per year if we don’t do more to stop inappropriate use of antibiotics. Meanwhile, rising incomes and growing urban populations throughout the world have increased the demand for meat, which means more livestock farming.

Many countries are eager to contain AMR. According to a WHA-related report, 144 countries now have a national action plan to do so. However, sectors differ in the amount of progress they’ve made. While there is general awareness and progress in the human health sector, work in the animal sector is lagging, and work in the environmental sector has only begun.

As the WHA affirmed, six years after it launched a Global Action Plan on AMR, we need collaborative, multisectoral coordination to address public health threats at the intersection of humans, animals, and the environment. It’s the only way to effectively address this widespread issue. 

The global health nonprofit I work for is supporting Global Health Security Agenda (GHSA) activities aimed at improving multisectoral coordination on AMR as part of the USAID Medicines, Technologies, and Pharmaceutical Services Program. We’ve worked in multiple countries, using WHO-recommended benchmarks to improve their capacity to detect, assess, report, and respond to public health events per International Health Regulations.

As my colleagues and I explained in a paper, “Strengthening multisectoral coordination on antimicrobial resistance: a landscape analysis of efforts in 11 countries,” it’s critical to help countries establish national multisectoral task forces and ensure that they function effectively. They must include high-level governmental officials and other stakeholders from both human and animal health, along with the agricultural, environmental, and food sectors.

Multi-sectoral Collaboration Needed to Tackle AMR

In some countries, these coordinating bodies lacked adequate political support and the authority to act. Ethiopia had weak coordination among its AMR stakeholders, no monitoring and evaluation capability to measure progress, no central reporting mechanism on AMR-related activities, and no functional technical working groups in line with One Health to actually implement activities against AMR. We convened national stakeholders to address these issues and improve overall functionality of the multisectoral coordination body on AMR and its technical working groups.

Countries need enabling environments such as administrative and financial support, adequate human resources, and practical know-how on the process and parameters of how these multi sectoral bodies operate. They also need ways to gather, analyze, and monitor data.

Support pays off: with our collaboration, the human, animal, agriculture, and environmental sectors in Cameroon collaborated on a plan to execute the country’s national action plan on AMR. Bangladesh and Kenya developed multisectoral monitoring and evaluation frameworks to track their action plans.

In Uganda, the Ministry of Agriculture, Animal Industry and Fisheries released its first-ever guidelines in February for antimicrobial use in animals.

Previous efforts by stakeholders to address AMR have largely been siloed. To get diverse sectors and disciplines to the table at the central level and to form mutual trust, frank discussions about why collaboration is critical, explaining the science, and finding common ground among sectors are needed.

The private sector has a stake in outcomes, too, especially as they relate to maintaining the effectiveness of medicines or protecting livestock.

Increasing drug resistance in E. coli, Salmonella, and other bacteria prompted Côte d’Ivoire to embark on an ambitious multi sectoral antimicrobial stewardship plan. Health and vet facilities began to monitor drug prescribing and  infection prevention and control procedures, while another committee looked into the sale of medicines without prescriptions and the sale of fake or substandard drugs. Greater attention to hygiene and prescribing also helped health facilities deal with the COVID-19 pandemic.

Every country needs the same inclusive approach. It is a big undertaking, and many lower-income countries are just beginning to achieve liftoff in implementing their national AMR plans. However, as we struggle to contain the COVID-19 pandemic, we cannot take our eyes off of the creeping global problem of AMR, which threatens to claim even more lives.

Dr Mohan P. Joshi

Mohan P. Joshi is a physician and senior principal technical advisor at the global health nonprofit Management Sciences for Health, where he is the technical lead for issues related to antimicrobial resistance and global health security.

Image Credits: Commons Wikimedia.

India’s Stelis Biopharma manufacturing site, where the Russian Sputnik V vaccine will be produced

Despite the emergence of new WHO concerns over quality control at Sputnik V’s domestic production facilities, the Russian Direct Investment Fund (RDIF) is pushing ahead with a massive international “open-license” manufacturing effort for its Sputnik V vaccine – which breaks the traditional model of vaccine production and leverages existing capacity in poorer countries, desperate for doses.

As such, RDIF has “broken the model of closed intellectual property” and adopted a vaccine scale-up model that is “fundamentally different” to most vaccine developers, Leena Menghaney, Global IP Advisor for MSF’s Access Campaign, told Health Policy Watch in an interview.

But at the same time, a recent WHO review of manufacturing practices at one of the vaccine’s nine Russian plants identified a number of substandard manufacturing practices – illustrating how challenging quality control may be for the wider Russian model. 

The WHO review is not the only one to have found issues. 

Earlier this year, Brazil’s medicines regulator rejected Sputnik V’s request for approval, due to the contamination of some batches of the adenovirus vector, among other issues. 

Meanwhile, Slovakia’s regulator also has voiced concerns that the batches of Sputnik V it received did “not have the same characteristics and properties” as the version of Sputnik V reviewed in a Lancet study, which published favourable Phase III trial results for the vaccine earlier in February – with an efficacy of 91 % against symptomatic COVID-19 disease and 100% against severe COVID.

And the European Medicines Agency (EMA) has delayed Sputnik V’s approval following the RDIF’s failure to submit additional clinical trial data by a deadline that was initially set for early June.

At the same time, low- and middle-income countries, desperate for vaccines, have largely ignored such concerns. Since Russia’s own approval last August, almost seventy, mostly low- and middle-income countries have greenlighted the vaccine, which features a low price and easy storage requirements – and is even more attractive after India’s Serum Institute halted its AstraZeneca vaccine exports via the Global COVAX facility in March.

Even more significantly, a number of countries, including India, Serbia, Argentina, and Iran, have already begun their own mass production of Sputnik V vaccines. That includes half a dozen manufacturers in India, which are set to produce 65%-70% of Sputnik V’s global supply, or about 850 million doses or more a year, according to RDIF projections. 

Should those aims indeed be reached, the RDIF and its partners could potentially produce nearly 10% of the world’s total vaccines for 2021.


Non-Exclusive Deals With Multiple Manufacturers 

“The RDIF did what most vaccine developers and global health actors like the Bill and Melinda Gates Foundation should have done, which is to adopt a non-exclusive and open approach to vaccine manufacturing,” said Menghaney.

Instead of sealing exclusive licenses with a handful of manufacturers, the RDIF has shared its vaccine technology and know-how with some 27 manufacturers, predominantly based in India or upper middle income countries, according to the Geneva Graduate Institute’s COVID Vaccine Manufacturing Tracker.

That sets the RDIF apart from most other major pharma vaccine developers, which are primarily manufacturing, as well as distributing, vaccines in high-income countries – according to the Geneva Graduate Institute’s COVID Vaccine Manufacturing Tracker.

Pfizer and Moderna, for instance, have signed a total of 6 and 9 agreements, respectively, with manufacturers. All are based in high-income countries like France, Switzerland, or Germany – except for one deal between Pfizer/BioNTech and China’s Shanghai Fosun Pharmaceutical Group. Even Johnson & Johnson, which recently struck an expanded manufacturing deal with Aspen Pharmacare in South Africa, is primarily producing vaccines in the US and Europe.  And in the case of AstraZeneca, which has been the most aggressive in licensing production in low- or middle-income countries, including the Serum Institute of India, those licenses are exclusive.  

“The RDIF did not limit itself to one manufacturer,” added Menghaney. “If anyone wants [to produce] Sputnik V, they can go to RDIF and get it.”

The RDIF has sealed deals with manufacturers from upper middle income countries, in contrast to the rest of Western vaccine developers, which are primarily manufacturing, as well as distributing vaccines in high-income countries

Sharing Regulatory Dossiers within Countries

Another aspect of RDIF’s approach, also evidenced in India, has involved the sharing of the same vaccine “regulatory dossier” with multiple manufacturers. In India, those companies include: Dr. Reddy’s; Panacea Biotech; Stelis Pharma (Strides arm); Hetero; Gland Pharma; Virchow; and the Serum Institute of India, said Menghaney.

Sharing of dossiers is rarely done, due to trade secret and non-disclosure issues, Menghaney noted: “Instead of making manufacturers compete with each other, the RDIF encouraged them to produce the same common technical dossier and to work together to improve the yield of the vaccine.” 

The use of a common dossier not only hastened India’s regulatory approval of multiple new manufacturing facilities, but it has also allowed manufacturers to work together to optimise the yield of Sputnik V and to address quality control issues, such as contamination, which are common bottlenecks in the mass-production of adenovirus-based vaccines like Sputnik V. 

“The RDIF took a collaborative approach to manufacture the vaccine but also to scale it up,” said Menghaney, adding that no other company has adopted such a collaborative regulatory process for a COVID vaccine to date.

She contrasts that with AstraZeneca, which signed about a dozen exclusive deals with manufacturers, including the Republic of Korea and the Serum Institute of India, effectively blocking other manufacturers in the same country from bidding to produce the vaccine. 

The problems around such exclusivity, became more evident last spring, when the Serum Institute of India halted its exports of the AstraZeneca “Covishield” vaccine to over 100 low-income countries in Africa and elsewhere participating in the WHO co-sponsored COVAX vaccine facility after Indian COVID cases began to skyrocket. That, in turn, set off a domino effect, stalling vaccine campaigns that had only just begun in LMICs around the world, and leaving them more dependent than ever on vaccine donations from rich countries, or alternatively vaccines from China or Russia.

“The Serum Institute has an exclusive deal with AstraZeneca, and not just for India,” she said. “This probably means that these countries won’t be receiving any doses of the Oxford vaccine from other sources unless the agreement between AZ and SII is reviewed.”

The RDIF’s approach, she said, is all the more welcome to access advocates against the backdrop of still limited vaccine sharing pledges to the global COVAX facility and continuing reluctance by the big mRNA pharma firms, like Pfizer and Moderna to freely share their vaccine know-how.

RDIF Refuses To Reply On Manufacturing Quality Control Issues 

Despite that bright assessment, the preliminary WHO report, published last week, unearthed a number of concerning contamination issues at the Russian “Ufa Vitamin Plant” which manages the domestic Sputnik vaccine’s “fill and finish” process – where vaccine active ingredient is transformed into an injectible product.

WHO voiced six concerns with the plant, including: “integrity of data and test results”; potential “cross-contamination” of the batches; and poor hygiene standards. The report followed a WHO-led inspection between the 31st of May and the 4th of June. 

The Ufa Vitamin Plant asserted in a statement on June 23 that the WHO concerns were addressed “within 48 hours”. 

“Following the receipt of the comments from WHO, Ufa VITA responded to all the questions and concerns raised within 48 hours,” the firm announced last week. “We invite WHO for another inspection. We remain fully transparent and will continue with the WHO prequalification process.”

RDIF, however, has so far remained mum on the quality control issues raised by WHO – including non-response to queries by Health Policy Watch. 

And the WHO-reported concerns still remain outstanding, according to the public WHO dossier on the vaccine. 

WHO’s prequalification team flagged six concerns following its inspection of the Russian Ufa Vitamin Plant – a “fill-and-finish” facility

Sputnik V Approval Process: “Additional Data Required”

In response to a Health Policy Watch’s query, WHO declined to provide further clarifications, pointing only to its latest EUL update, dated 29 June, which continues to state, with respect to Sputnik V: 

“Additional data (Non-CLIN, CLIN, CMC) Required. Following up on inspection observations; Anticipated date [of approval] will be set once all data is submitted and followup of inspection observations completed.”

“Subject to certain requirements being met, WHO will continue to assess Sputnik V vaccines from different manufacturing sites and will publish decisions on their EUL status when all the data are available and the review is concluded,” WHO’s latest news update on Sputnik also stated.

Contamination Is a Common Concern 

Contamination is a common challenge faced by manufacturers of adenovirus-based vaccines, Ian Jones, Professor of Virology at the University of Reading in the UK, told Health Policy Watch. Potentially such contamination can make the adenovirus, which is supposed to remain non-infective, “replication-competent.” 

“The Sputnik V vaccine technology is basically just growing a virus,” he said. “However, it is not as trustworthy as the RNA as it is a biological, as opposed to chemical process. There are issues with yields, the risk of contamination and, for the adenovirus vectors [which deliver the vaccine], the need to measure the levels of ‘real’ adenovirus, a small amount of which is generated as part of the process. So, in many ways the older technology is a less good technology than mRNA technology.”

Ensuring high hygiene standards in all vaccine production facilities, including fill-and-finish facilities, remains “very important”, emphasized Jones, to avoid contamination of batches with other pathogens as well.

“High hygiene is very important in all such facilities to avoid bacterial contamination. The material will be injected, so passes the skin that normally acts as a barrier to pathogen entry,” he observed.

Contamination is a common issue in the scale-up of adenovirus-based vaccines

Pharma Manufacturers Say RDIF Issues Illustrate Challenges They Face 

Pharma leaders have repeatedly asserted that quality control issues, such as the ones identified by WHO at the RDIF plant, are illustrative of the challenges that they would face were they to issue open licenses as a means of scaling up vaccine production – as per the RDIF model.   

“It’s a very complex sector, with complicated science, very complicated manufacturing processes, we have to be very careful to whom we transfer the know-how, in particular because of the imperative of safety and quality,” said Bharat Biotech’s Executive Director of Quality Operations Sai Prasad, who is also President of the Developing Countries Vaccine Manufacturers’ Network (DCVMN), at an IFPMA-hosted webinar in late April. Bharat Biotech developed India’s first indigenous COVID vaccine – although that, too, has yet to gain WHO approval.  

“…. Don’t underestimate the requirements of standardized, manufacturing, quality control, and quality assurance,” Thomas Cueni, Director General of the International Federation of Pharmaceutical Producers (IFPMA), told Health Policy Watch in a recent interview.  

Stephane Bancel, CEO of Moderna

Speaking at an April 2021 event, Moderna’s Stephane Bancel noted that technology transfers are a “matter of trust – trust between the partners but also patient trust: 70% of vaccine manufacturing is about quality control and quality assurance.” 

“That is why we should not get lost into thinking that intellectual property is the bottleneck. The limiting step is manufacturing know-how and capacity, ability to find skilled workers who can take part in the complex manufacturing process, as well as the raw materials.”

“Basically companies have the responsibility for the quality of their products….Companies really need to have the ability to pick their partners on the basis of checklists, which is really about quality, quality, quality…”

RDIF’s Has Little To Lose from Open Approach 

The Sputnik V vaccine uses twenty-year-old adenovirus technology, which lacks substantial intellectual property protections

In fact, the RDIF has significant built-in incentives to try the open license approach – which western manufacturers may often lack, Knowledge Ecology International’s Director James Love told Health Policy Watch.

“The RDIF lacks significant manufacturing capacity, does not think it is protecting a highly proprietary manufacturing platform, and sees a political benefit if having its vaccine being used,” emphasized Love.

That is in contrast to companies such as Pfizer, Moderna, and other vaccine front runners, which already have significant manufacturing capacity – as well as novel technologies that they wish to protect, he said.  

And RDIF’s open license approach clearly has its limits as well. For example, the company has not shared its vaccine recipe to the WHO-backed COVID-19 Technology Access Pool (C-TAP), Love noted. Even though C-TAP was launched over a year ago, it remains empty to date of vaccine recipes from pharma developers in east or west, north or south.

The RDIF also has given no signal, to date, about whether it would join the WHO co-sponsored global COVAX facility should its vaccine finally be approved by the WHO.  

“I don’t think the RDIF has suddenly become cuddly and philanthropic,” added Jones. “They want the hard currency the sales will bring…I think they also want to demonstrate that they can be a world player in the vaccine business [to become] a more permanent global supplier.”

“Had they [Russia] invented a novel technology, it is not clear to me their current stance would have been taken.”

-Elaine Ruth Fletcher contributed to this story.

Image Credits: RDIF, Stelis BioSource, Wikimedia Commons.

cuba biden
The Biden administration has been asked to clarify its sanctions policy vis a vis Cuba, with respect to COVID vaccines.

The Biden administration has been asked to clarify that sanctions against Cuba would not extend to collaborations in the development, manufacturing, distribution and sale of COVID-19 vaccines that the island nation is in the process of developing.

A memorandum, sent by Knowledge Ecology International (KEI) on 28 June to the White House, asks the US government to “clear the air” regarding its economic sanctions policies – and thus ensure that private companies and other organizations can work with Cuba on its vaccine programme. 

“Over the past year and a half, U.S. sanctions against Cuba have cast a cloud over the ability of companies and non-profit organizations to work with Cuba on its vaccine program. The Biden administration needs to clear the air and reassure the WHO, suppliers of inputs, and others that none of the U.S. sanctions against Cuba extend to activities to make, sell or distribute its vaccines,” said KEI Director James Love in his memo.  

The ongoing economic blockade of Cuba during the pandemic was described by Argentina’s President Alberto Fernandez, as “obscene” in his closing remarks to the 74th World Health Assembly (WHA) in May. He called for it to be lifted – alongside the removal of patent protections for COVID vaccines. 

Cuba scientists are facing challenges in the development and scale-up of the manufacture of their vaccine candidates, which have been reported to have significant potential, due to restrictions imposed by the longtime US economic sanctions against the communist island state. 

Cuba’s Vaccines in Late Stages of R&D; Abdala Vaccine 92% Effective Against Coronavirus 

Cuba’s COVID-19 vaccines are seen as Latin America’s hope.

Despite ongoing challenges, Cuba is in its late stages of research and development with two out of five of its indigenous COVID-19 vaccines – Abdala and Soberana 2.  

On 21 June, Cuba announced that its three dose Abdala vaccine against COVID-19 was 92% effective. Earlier, it said that its Soberana 2 vaccine was 62% effective with two doses, with its efficacy expected to rise with administration of the third dose.  

“This is excellent news and fills us with optimism in the region, where there is still a great deficit of vaccines,” said Jose Moya, WHO Pan American Health Organization (PAHO) representative in Cuba as quoted by El Pais. 

Once trial data is published, Cuba will then file for regulatory approval with its national medicines authority.  Health officials meanwhile aim to have 70% of the island’s inhabitants vaccinated by this fall.  

The Cuban government is also in the process of engaging the WHO in the evaluation of its vaccine candidates, for WHo regulatory approval.

“If all goes well, the Cuban vaccines will be able to join the eight already prequalified in the world before the end of the year,” Moya added.

Cuban Vaccines – Potential Importance to Latin America

These announcements could mean good news for neigehboring Latin American states, which have been unable to access sufficient vaccines from big suppliers in the US, Europe, India, China, or Russia – even as Latin America has been the global epicenter of the pandemic in recent weeks.

PAHO has meanwhile called for urgent donations of vaccines in light of the growing spread of COVID in Latin America and the Caribbean, also uging G7 nations to expedite delivery of promised donations, especially since vaccine rollouts have progressed more slowly than hoped-for in Latin America.   At a recent meeting in the United Kingdom, the Group of Seven (G7) pledged one billion COVID vaccine doses to countries around the world,

Calls on US to Support Evaluation and Registration of Cuba’s Vaccines 

The KEI letter also asked that the National Institutes of Health (NIH), the Biomedical Advanced Research and Development Authority (BARDA), and other federal agencies directly engage with Cuban research institutes to fund expanded or additional clinical trials, and support them in achieving global regulatory approval.  

Love cites a 13 June 2016 Memorandum of Understanding between the US Department of Health and Human Services and the Ministry of Public Health of Cuba, which called for deepening public health cooperation on communicable diseases – understandings put in place during the administration of former US President Barack Obama  – but frozen during the term of US President Donald Trump. 

The KEI letter also refers  to a January White House memorandum published in January, just after President Joe Biden took office, outlining COVID-related sanctions relief measures that it would take. That memorandum states: 

“The Secretary of State, the Secretary of the Treasury, and the Secretary of Commerce, in consultation with the Secretary of HHS and the Administrator of USAID, shall promptly review existing United States and multilateral financial and economic sanctions to evaluate whether they are unduly hindering responses to the COVID-19 pandemic, and provide recommendations to the President, through the APNSA and the COVID-19 Response Coordinator, for any changes in approach.”

Despite this statement, Biden’s campaign promises to “go back” to the Obama policy of engagement with Cuba remains unfulfilled, with the US currently focused on its own interests, a senior administration official was recently quoted as saying by the Washington Post.

“We have an entire world and a region in disarray,” the official said, speaking on the condition of anonymity. “We are combating a pandemic and dealing with a breaking down of democracy in a whole host of countries. That is the environment we are in. When it comes down to Cuba, we’ll do what’s in the national security interest of the United States.”

Image Credits: News Prensa Latina/Twitter, C-Span.

Rwanda
COVAX made promises of 700 million doses but delivered 30-40 million, says African Union Special Envoy.

The African Union (AU) Special Envoy on COVID-19 has bluntly blamed the WHO co-sponsored COVAX facility for the dire vaccine shortage on the continent, saying that it had failed to disclose its vaccine supply problems early enough.

Strive Masiyiwa, AU Special Envoy and head of the African COVID-19 Vaccine Acquisition Task Team (AVATT) said that had COVAX been honest about its lack of vaccine supplies at the start of the year, the continent might not be facing such a dire shortage of vaccines.

When AVATT met COVAX “back in January”, said Masiyiwa, “we were given a schedule in writing that we would receive vaccines from the end of February, going through to December”.

“But COVAX failed to disclose that they were still trying to get money, that pledges [of $8.2 billion] which had been made by certain donors had not been met,” said Masiyiwa, in his most forthright condemnation of the global vaccine platform yet.

“That’s pretty material information. Had we known that actually this was hope and not reality, we may have acted very differently,” Masiyiwa told the Africa CDC weekly COVID briefing on Thursday, which also disclosed that AVATT had procured 400 million COVID-19 single-dose vaccines from Johnson & Johnson that will start to arrive next month.

Early Indications that Serum Institute of India Could Not Deliver

Strive Masiyiwa, African Union Special Envoy and head of the AU COVID-19 Vaccine Acquisition Task Team (AVATT)

He also questioned the global vaccine programme’s reliance on the Serum Institute of India (SII), revealing that AVATT had met with the SII late in 2020 – well before India’s COVID crisis – and decided not to do business with it because it was clear it would be unable to meet its orders.

“We found ourselves in March, scrambling. Now we are told that is India’s problem. And we think the problems are much deeper than that,” said Masiyiwa.

“We will not solve our problem because of donations. We will solve our problem because we’ve gone out and we have bought our vaccines,” he added, disclosing that all but two African countries had secured loans to pay for the AVATT-acquired vaccines.

“The price we pay for any vaccine is exactly the same price as COVAX. I can tell you on this platform because I’ve heard silly rumours. We purchase the Johnson & Johnson vaccine at $7.50 per dose,” he added, saying that AVATT would be “transparent” about vaccine prices.

Masiyiwa said that the Johnson & Johnson order – to be delivered over the course of a year – would cover half the continent’s people, while donors had undertaken to come up with the other half.

“We are moving hard ahead on our commitment. We always said we would start around about August, and the shipments are being prepared. The countries are being prepared. But we are calling on the donor community to stop making pledges, pay up your money and meet the commitments you’ve made. Because we’ve heard the pledges. We just need to see the vaccines now.”

Meanwhile, Kate Elder, Medecins sans Frontieres policy advisor on vaccines, described COVAX as having been “constructed to work within the current parameters of the pharmaceutical market, where you see how much money you can raise and then see what you can negotiate with industry for it”. 

“COVAX was not set up to succeed,” said Elder, speaking shortly before a recent board meeting of the global vaccine body, Gavi, which manages COVAX. “COVAX was left behind as wealthy governments secured their doses through bilateral deals with an industry that acted as expected: selling doses first to the buyers who could afford to pay the most.”

“COVAX is currently grossly behind on achieving its goals. COVAX had aimed to provide two billion doses by the end of 2021, but so far has only distributed 88 million (the goal by the end of June was to distribute around 337 million),” said MSF.

“Less than half of one percent of total populations of COVAX countries have received at least a first dose of vaccine through COVAX. As the global health community increasingly discusses models to be prepared for future pandemics, MSF cautions that the shortcomings of the COVAX model must not be replicated.”

 

Image Credits: WHO.

In Portugal, where all illicit drugs are decriminalized, drug disorders claim the lives of just 0.8 in 100,000 people, a figure that pales in comparison to Brazil, the Philippines – or even the US where the death toll stands at a staggering 18.75 in 100,000 people, or 23 times higher than Portugal.

High death tolls, experts say, are largely preventable through policies rooted in robust evidence and human-rights, yet their adoption remains lackluster from north to south.

Carl Hart, Professor of Psychology at Columbia University and drug advocate

“Drug policy can be done better if we had a desire,” said Carl Hart, Professor of Psychology at Columbia University. “There are great models around the world, if only we cared enough to observe those models and learn from those models.”

“Portugal has decriminalized all drugs. They’re not arresting people for what they put in their bodies. People are allowed a 10-day supply of drugs without fearing criminal prosecution.” 

He was speaking last week on the eve of International Day Against Drug Abuse and Illicit Trafficking, at a panel hosted by the Graduate Institute’s Global Health Centre on the global day of action for the grassroots Support Don’t Punish campaign.

“I am advocating for the legal regulation of drugs,” stressed Hart. “If we legally regulate those drugs, we increase the safety of that activity.” 

“We as a society should invest in people, and not investigate what substance people are ingesting. That isn’t our business.”

His comments come on the heels of a shocking US CDC report that reveals overdose-related deaths in the US increased by nearly 30% between November 2019 and 2020 with over 90,000 deaths during this period, almost double the death toll in 2015.

Aside from the millions of lives that drugs claim every year, drug-related health issues account for 5.5 % of all Disability Adjusted Life Years (DALYs). That equates to 131 million healthy years of life lost due to ill-health and lifelong disability.

Drug overdose deaths in the US rose by nearly 30% between November 2019 and 2020

Drug Problems Relate to Prohibitive, Stigmatizing Policies 

Rather than drugs themselves, prohibitive and stigmatizing drug policies result in unnecessary incarcerations, murder, and the arrest of one American every 25 seconds, or 1.5 million Americans a year.

“Most of the problems related to drugs are related to prohibition,” stressed Hart. “All of these people in jail, all of this murder, all of these horrible things that are often promulgated by the state itself – reverse these policies and then you will deal with a lot of that carnage.”

If drugs were regulated rather than prohibited, a million Americans a year wouldn’t go to jail, he added.

If countries decide to opt for legalization, regulation, and other smart drug policies, thousands of potentially lethal overdoses and accidents could be avoided, said Hart, mainly due to illicit drugs that are more potent than users think and can be spiked with potentially lethal contaminants.

“If we legally regulate those drugs, we increase the safety of that activity, we make sure that those drugs are not tainted with potentially harmful substances and we can control who is allowed to purchase those substances.”

About a fifth of illicit drugs are laced with contaminants that users did not intend to take, surveys from New Zealand and England have found, sometimes with potentially deadly heavy metals, bath salts, or even horse tranquilizers. 

Studies, mainly from New Zealand and England, indicate that cheap policies, like drug-testing programmes at parties and festivals, could prevent drug users from taking contaminated drugs bought on the illicit market.

According to one study of a drug-testing programme at a four-day festival in the UK, drug-related hospitalizations dropped by 95% the year it was introduced. One-fifth of festival attendees used the free testing service, and one-fifth of drugs were contaminated. Strikingly, two thirds of attendees’ whose drugs were contaminated disposed of these drugs. These results suggest that screening programmes have potential to prevent drug users from taking contaminated drugs bought on the illicit market – and to reduce drug-related injuries, deaths, and drug consumption as a result.

Legalizing drugs could also reduce the appetite for synthetics like fentanyl, an opiate that is 50-100 times more potent than morphine, whose rising consumption has been fuelled by the pharmaceutical industry, regulatory failures, but also scarce access to heroin, said Hart.

“There is not a real need for illicit fentanyl,” he said, emphasizing that fentanyl consumption could be reduced if drug users had access to heroin – an opiate they prefer.

“Most heroin users would much prefer heroin to fentanyl, for a number of reasons: the euphoria, in my view, is better with heroin…Heroin is relatively short-acting [and] the hangover effects are minimized.”

In the US, 36 out of 50 states have legalized cannabis products for medical conditions from severe forms of epilepsy, back pain, to nausea and vomiting during chemotherapy. 

And a wealth of studies have revealed that US states who legalized cannabis saw sharp drops in violent crime, fatal traffic accidents, opioid use and opioid overdoses – without leading to a spike in teenage cannabis consumption. 

Last December, the UN Office on Narcotic Drugs recommended that countries remove cannabis from the “most dangerous” list. 

Switzerland’s Forward-Looking Policies to Address Illegal Drug Trafficking

Should drugs be legalized, policies will need to target low-income groups and young people, especially those who face mental health issues or violence, as they are most at risk from harm as a result of taking drugs, Thomas Zeltner, Chair of the Swiss Research Institute for Public Health and Addiction, told Health Policy Watch in an interview.

Thomas Zeltner, Chair of the Swiss Research Institute for Public Health and Addiction

One way to do that, he explained, is through targeted screening programmes in those groups – instead of screening whole populations.

“Only 1 in 20 kids or young people who use drugs will develop drug issues. And many of those who develop issues are children from divorced single mothers, children who have difficulties in school reading difficulties, and children with pre-existing mental health problems,” he said, adding that the consumption of drugs like cocaine tends to lead to few problems in rich people, at least in Switzerland.

“We’ve done quite a number of studies and shown that giving vulnerable kids intensive support is much smarter than to spend the money on targeting all the kids in a class.”

Once upon a time, Switzerland’s approach on drugs used to be “amazingly open” and evidence-based, emphasized Zeltner.

In the late 90’s, the sale and cultivation of the cannabis plant was legal in the Alpine nation, including plants with the so-called “Tetrahydrocannabinol” (THC) compound that is known to trigger a “high”. That policy, he says, helped cut illegal drug trafficking as well as criminal and social problems.

“In the 80’s and 90’s, 100% of the cannabis market was in the hands of North Africans. Many of them were here illegally, and many of them had no other opportunity than to deal with cannabis. And so we had a lot of criminal and social problems.” 

“But after the Swiss authorities allowed shops to sell cannabis and to grow their own plants to satisfy their needs, what happened was that the cannabis market moved from North Africans to Switzerland, criminality went down and social problems went down.”

Switzerland, added Zeltner, is also well known to have spearheaded research that was ahead of its time, leading to substantial benefits in drug users who did not respond to methadone – an oral drug that is still commonly used for opioid dependence.

“We saw that there were many drug users in the 80’s and 90’s,” emphasized Zeltner. “We could not offer a treatment with methadone, which is the standard treatment for drug-using persons who want to get into treatment but cannot abstain from taking substances, because there were people who actually needed to inject drugs.”

In the mid-90’s, Swiss researchers designed a landmark double-blind trial to address that. Strikingly, the Zurich-based trial revealed that addicts could distinguish between heroin and morphine – and that small doses of heroin were more effective than morphine in treating addicts.

“The results from the double-blind clinical trial in Zurich were clear,” he said. “Drug users could feel the difference between heroin and morphine, even though pharmacologists will tell you ‘that’s not possible’, which was a very interesting finding.”

Those results, said Zeltner, led to a groundbreaking shift in Swiss policy that would eventually position heroin as a standard treatment option for drug users in the country. Today, almost 10% of people with opioid dependence are prescribed heroin in Switzerland –  a unique policy that has only been adopted in a few countries to date, despite robust evidence that it works.

“Heroin is actually a standard treatment in Switzerland,” said Zeltner. “We are one of the very few countries where heroin prescription for drug users is legally allowed and is part of our legal drug policy.”

“At least in the 90s, there was an amazing openness to try evidence-based policies to say – listen, if we want to make a further step forward, we just need to pilot new ideas.” 

Growing Conservatism has Reversed Evidence-Based Policy

In Switzerland, cannabis is considered illegal if its THC content is above 1%

In past decades, however, conservative political winds have reversed Switzerland’s open and evidence-based approach to drug policy, warned Zeltner.

“It used to be possible in Switzerland to have scientific-driven discussions, but this has not been the case in the country,” he said.

He was referring to Switzerland’s current cannabis policy, which considers any cannabis product illegal if its THC content is above 1%.

While that drug policy is progressive in some ways, it has failed to resolve illicit cannabis trade, and reflects increasingly rigid views on drugs that have hampered progress in drug rehabilitation programs, Zeltner said. Cannabis, according to the Federal Office of Public Health, is still the most commonly used illicit drug in the country.

“It’s evident that a large number of people in Switzerland are still buying and smoking illict cannabis with a high THC content,” he said. “These days, it is very hard to get through and we should really get back to evidence-based policy.”

Image Credits: Felix Brönnimann, Wikipedia, US CDC.

The use of antibiotics in farming has decreased sharply in Europe, and antibiotic consumption in livestock is now proportionally lower than in humans, a new report by three European Union agencies has found.

The report, published by the European Food Safety Authority (EFSA), the European Medicines Agency (EMA) and the European Centre for Disease Prevention and Control (ECDC), includes data on antibiotic consumption (AMC) and development of antimicrobial resistance (AMR) in Europe for 2016-2018.

The significant drop in antibiotic use in monogastrics (animals like pigs and poultry that only have one stomach) and ruminants (animals like cattle, sheep and goats with four-compartment stomachs) suggests that the measures taken at country level to reduce the use of antibiotics such as polymyxins are proving to be effective.   

This, according to the report, “is a positive development, as polymyxins are also used in hospitals to treat patients infected with multidrug-resistant bacteria”.

“Combating antibiotic resistance remains a top priority for EMA and we will continue collecting veterinary antimicrobial consumption data to guide policy and research,” said Emer Cooke, EMA’s Executive Director.

The main aim of the report was to provide an integrated analysis of possible relationships between AMC in humans and farm animals and the occurrence of antimicrobial resistance in bacteria from humans and farmed animals. “This is the first time that the EU/ European Economic Area (EEA) population-weighted average AMC in humans overall exceeds AMC in food-producing animals when measured in mg/kg biomass,” states the report.

The data was collected from five different surveillance and monitoring networks coordinated by the agencies as part of ongoing clinical and epidemiological surveillance/monitoring and not specifically for the report. It covered the EU member States, Iceland, Norway and Switzerland.

The authors of the report found that human resistance to bacteria was associated with resistance in bacteria from food-producing animals which, in turn, was related to the animals’ antimicrobial consumption. The findings suggest the need to continue to promote the careful use of antimicrobial agents in terms of infection control and prevention in both humans and farmed animals.

“The high levels of AMC and AMR still being reported in bacterial isolates from both food-producing animals and humans from several countries show that these interventions should be reinforced.”​

The report called for detailed and comprehensive AMC data to allow for more refined analyses in relation to AMR data. It also states that the development of the mandatory monitoring of AMR in animals will provide even more robust datasets for analysis.

“AMC data should preferably be collected so that analysis for relevant sub-groups is possible. For example, AMC in the hospital sector versus the community for all EU/EEA countries, or AMC in animal categories that are likely to have characteristic treatment patterns, such as sows and sucklers, slaughter pigs, calves, dairy production, beef production, laying hens, broilers and turkeys.” 

Image Credits: Commons Wikimedia.

frontline workers
Nurses are on the frontline of the COVID-19 response.

In the wake of COVID-19, both the needs and the skills of frontline healthcare workers need to be made integral to the design of global mental health services, said experts at a Wednesday webinar, sponsored by the Geneva-based Global Self-Care Federation (GSCF).    

While mental health issues have come more to the forefront during the COVID pandemic, including among WHO member states, much still needs to be done to ensure that countries build strong systems of mental health services at community level, while also recognizing the mental health needs of health care workers themselves, said Dr Fahmy Hanna, of the WHO Department of Mental Health and Substance Abuse, speaking at the session.  

Involving frontline health workers in building awareness can also help destigmatize mental health conditions, he added, during the panel discussion on ‘COVID-19 and Frontline Workers’. Healthworkers, who have undergone trial by fire during the pandemic, are well-placed to share testimonies about their own experiences and challenges at the frontlines, he added, saying:  

“It is key and evidence-based that sharing and involving those who are affected by mental health conditions through campaigns is an effective tool to reduce stigma.” 

Nurses as Leaders: From Bedside to Boardroom

Nurse treating a child at a medical center in Baghdad, Iraq

Nurses, as skilled professionals at the cornerstone of primary health care systems, can become movers and shakers in building better mental health services – if only given the chance, added Dr Michelle Acorn of the International Council of Nurses (ICN). 

“Nurses are the life, blood, and stewards of the health system and should be recognized for what  they are,” she said. “[Nurses] are the glue and connectors holding the healthcare system together.” 

Underpaid, and overworked, nurses have a range of skills from “bedsides to the boardroom” that need to be recognized and harnessed more effectively in mental health services and support to health care workers and the communities that they serve, said Acorn.

Too often, however, nurses are often left out of policy debates and choices – preventing them from becoming fully and actively engaged in leadership, governance, and decision-making, especially in issues around gender and inclusivity in health service provision. 

“They do the work but they’re kept at arm’s length, around the periphery or fringes, not being fully enabled or empowered to maximize their contributions or knowledge to support mental health and deliver safe, competent care,” she said.   

The pandemic has also profoundly impacted the mental and physical health of nurses themselves, she added, despite the fact that COVID-19 highlighted how critical nurses and other frontline workers have been in leading pandemic response.  

Global Shortage of Nurses Exacerbated by Pandemic 

The largest shortages of nurses are seen in some parts of Latin America, Africa, and Southeast Asia

Additionally, the global nursing shortage, the result of rising rates of mental distress, poor working conditions, personal protective equipment shortages, and more, has been further exacerbated by the pandemic.

An expected six-million shortfall of nurses  is likely to increase by more than 4 million  nurses retiring by 2030, with this influx caused by the cumulative influence of mass trauma from COVID-19, said Acorn.

In addition over 115,00 health workers have died as a result of contracting COVID-19, according to the WHO.

Acorn called this a “complex form of trauma with devastating consequences” that will cause millions to leave the nursing profession.  

“Trauma is like an iceberg – you can maybe see above the ice but you don’t know what’s below that iceberg.” 

She advocated for increased investments in nursing. “Investing in nursing is not actually a cost; it’s an investment in our future.” 

Self-Care of Patients and Providers is Necessary 

The pandemic has also highlighted the importance of ”self-care”, as complementary to formalized medical care, and this goes for mental health as much as for other areas of health, like diet, exercise and sleep, the panel experts underlined.  

“We need greater recognition, and for people to jump on the bandwagon [to recognize the importance of self care],” said Director-General of GSCF Judy Stenmark. “We need to really work together to demonstrate the value of self-care, particularly in terms of mental health.” 

For healthcare workers, who have devoted most of their time to the frontline response of the pandemic, caring for patients and communities, in addition to the needs of their family, there’s little time for them to focus on their own wellbeing. 

“How much time do we actually truly devote and prioritize to self-care?” asked  Acorn. 

Those with family members who are on the front lines can support their loved ones through continued social contact, support, and empathy, encouraging positive coping mechanisms as opposed to negative ones during these stressful situations, said Hanna.

This can include supporting positive self-care approaches, like meditation and physical exercise, and discouraging negative habits, like tobacco use or alcohol abuse, he said, observing:  

“You cannot take care of others until you really take care of yourself.” 

WHO Expands Mental Health Action with Member States    

In the wake of the COVID crisis, the May meeting of the World Health Assembly, the WHO’s member state governing body, included a dedicated discussion on the “mass trauma” triggered by the pandemic, in which member states agreed to extend WHO’s 2013-2020 Mental Health Action plan for another decade – including a bold new set of global targets for 2030, Hanna said.

The global 2030 targets include calls for:

  • Mental health to be integrated into primary health care services by 80% of countries – and increased mental health service coverage by 50% of countries;
  • 80% of countries with at least two national mental health promotion and prevention programmes;
  • 80% of countries with a system for mental health and psychosocial preparedness for emergencies;
Examples of WHO mental health resources during COVID-19

In addition, WHO has developed a range of new tools for primary care and self-care responses.  Those include a new  WHO guidance for healthcare workers and other COVID-19 responders, which supports front-line workers in providing mental health and psychological ”first aid” as part of their emergency response. 

Other guides have been developed to address groups that are often overlooked by the mental health community, such as older adults and their caregivers. 

A children’s storybook has also been produced for children ages 6 – 11 years to help them cope with COVID-related stressors. 

The recently-launched report, ‘Guidance on community mental health service: promoting person-centered and rights-based approaches’, featured over two-dozen peer-reviewed examples of mental health services around the world that have developed high quality and cost-effective alternative models of care, anchored in communities. These systems, which exist in countries ranging from the United Kingdom, to Myanmar, Kenya, Zimbabwe and India, rely heavily on front-line workers as well as peer support systems, and avoid compulsory hospitalization and forced medication, whereever possible. 

Hanna highlighted Zimbabwe’s Friendship Bench, as just one example, which utilizes the expertise of lay volunteers, often older women, to support people in distress with problem-solving interventions, provided under the guidance of other front-line health workers.  As its name implices, Friendship Bench is “an actual wooden bench, placed in front of some of the healthcare facilities and building on local resources in local communities in Harare, Zimbabwe,” said  Hanna.

“The guide provides simple solutions [like the Friendship Bench] and many others, that can be used by countries to scale-up.”

Image Credits: Public Services International/Madelline Romero, International Labor Organization/Flickr, WHO, GSCF.

AstraZeneca’s Covishield is not recognised by the EU COVID vaccine certificate although its European equivalent, Vaxzevria, is.

Travellers who are fully vaccinated with vaccines authorised in the European Union (EU) “should” be allowed entry for non-essential travel – even if these vaccines were not “produced in facilities covered by the marketing authorisation in the EU”, a European Commission spokesperson for health, food safety and transport told Health Policy Watch on Wednesday.  

At the same time,  it remains up to individual EU member states to decide if they wish to interpret that European Council policy recommendation, adopted by EU member states on 20 May, so as to authorize entry to vaccinated recipients of the Indian-made Covishield vaccine, said the EC spokesperson, Stefan de Keersmaecker.

Covishield, the AstraZeneca vaccine produced by the Serum Institute of India, has the same biological composition as the European vaccine branded Vaxzevria.  However, unlike Vaxzevria, Covishield never received European Medicines Agency marketing approval since it is not being manufactured on the European continent. 

The EC spokesperson was speaking in response to Health Policy Watch’s recent report that the Indian-made “Covishield” vaccine would not be recognised by the EU digital COVID vaccination certificate, which launched on Thursday, 1 July.

“As set out in the Council Recommendation on the temporary restriction on non-essential travel to the EU, adopted by Member States on 20 May,  entry into the EU should be allowed to people fully vaccinated with one of the vaccines authorised in the EU. This does not mean that the vaccines has to be produced in facilities covered by the marketing authorisation in the EU,” Keersmaecker stated, adding that,  “Member States could also allow entry for people vaccinated with vaccines having completed the WHO Emergency Use Listing process.

Specifically with respect to Covishield, while it is “not authorised for placing on the market in the EU…. it has completed the WHO Emergency Use Listing process.,” he added. “On the basis of the relevant Council Recommendation on the temporary restriction on non-essential travel to the EU, Member States may allow travellers (without an essential reason) fully vaccinated with this vaccine to enter the EU.”

At the same time, he cautioned that while member states might take various approaches to recognizing vaccines administered, or vaccine certificates issued, outside of the EU, they are not required to do so as part of the new EU digital COIVD pass policies:

“Member States are, however, not required to issue certificates for a vaccine that is not authorised on their territory, ” he stated.

Clarification Comes After Week of Growing Protest In LMICs over EU Vaccine Pass Policies

The EU clarification comes after it emerged last week that Covishield, the only vaccine available in most African countries, would not be recognised by the EU digital COVID vaccination certificate as the European Medicines Agency had only authorised Vaxzevria – and not the Covidshield counterpart.

The new certificate aims to enable safe and free movement of people by providing proof that travellers have had COVID vaccinations, received a negative test result or recovered from the virus.

Earlier in the week, the African Union Commission and the Africa Centres for Disease Control and Prevention (Africa CDC) urged the EU Commission to include “vaccines deemed suitable for global rollout through the EU-supported COVAX facility”.

“The current applicability guidelines put at risk the equitable treatment of persons having received their vaccines in countries profiting from the EU-supported COVAX Facility, including the majority of the African Union (AU) member states,” they noted.

News of the EU’s exclusion of Covishield has also sparked concerns in various African countries that the Indian version of the vaccine is sub-standard, prompting vaccine hesitancy at a critical moment when the continent faces a major new wave of the virus – and scarce vaccines remain precious resources.

Member States Could Allow Vaccines with WHO Emergency Use Listing

In his responses, De Keersmaecker acknowledged that while “Covishield is not authorised for placing on the market in the EU”, it had been given Emergency Use Lising (EUL) by the World Health Organization (WHO) – which grants it a certain status.

“Member states could also allow entry for people vaccinated with vaccines having completed the WHO Emergency Use Listing process,” he noted.

He added that an EU Digital COVID certificate also is not an absolute prerequisite for non-essential EU travel – but rather “a practical tool that can facilitate travel in those cases where restrictions are lifted.”

In fact, EU member states have gradually been lifting their overall restrictions on non-essential travel at a varying pace – and with respect to a diversity of approaches to visitors from non-EU countries.  Those also may include recognition of certificates of COVID recovery alongside vaccines, as well as requirements for PCR tests, as conditions for entry.

While the new EU digital pass attempts to set out a more standardized system, that does not preclude recognizing certificates from other countries, should member states choose to do so, Keersmaecker said:

“Member states are free to accept the documentation issued in third countries for vaccination. These should contain information that at least allows [the country] to identify the person, the type of vaccine and the date of the administration of the vaccine,” he added.

Travellers from abroad who were fully vaccinated with an EU-authorised vaccine also could be issued with certificates “on a case by case basis”.

Over the coming weeks and months, the European Commission may also opt to adopt, on a country by country basis, “an equivalence decision for a third country COVID-19 certificate, which will then be considered as equivalent to EU Digital COVID certificates issued by member states”, said De Keersmaecker. 

“This is only possible when a third country’s certificates are interoperable with the digital COVID certificate technical standards,” he stressed.  He did not elaborate on which countries’  certificates had already been recognized as equivalent.  

The European Council and European Parliament adopted the COVID digital certificate policy on 20 May, with the issuance of certificates on a systematic, EU-wide basis beginning this week. Countries have six weeks to phase in the system. Some 15 EU member states have already done so. They include Austria, Belgium, Bulgaria, Croatia, Czech Republic, Denmark, Estonia, Germany, Greece, Latvia, Lithuania, Luxembourg, Poland, Portugal and Spain. They are joined by Iceland, one of the four European Economic Area member states also eligible for the scheme. . 

The certificates are available as a smartphone app, or on paper. For EU/EEA residents, the certificate includes a QR code with the necessary data showing vaccination, PCR test, or recovery status, as well as a digital signature. Along with that, citizens or residents of third countries that have been vaccinated with one of the four EMA-approved vaccines, can use the vaccine cerficates to make non-essential trips to EU countries, according to the new EU-wide policies.  The EMA approved vaccines include:  Pfizer/BioNTech, Moderna, Johnson & Johnson, along with AstraZeneca’s Vaxzevria version.   

In contrast, WHO has granted emergency use listing to four other vaccines that are not on the EMA list. Those include AstraZeneca’s Covishield and SK-Bio versions, produced in India and the Republic of Korea respectively, along with the Chinese made, Sinopharm and Sinovac vaccines.

 

-Updated 1 July, 2021

Evidence of the existence of malaria in China has been found carved into bones from the Shang Yin era estimated to be 3000 years old – yet on Wednesday, the country beat this thousands-year-old scourge by getting certified “malaria-free” by the World Health Organization (WHO).

WHO Director-General Dr Tedros Adhanom Ghebreyesus, said China’s success was “hard-earned and came only after decades of targeted and sustained action”. 

At its zenith in the 1940s, malaria affected an estimated 90% of the Chinese population with 30 million cases and 300,000 deaths annually, according to a report from Harvard University.

China established a National Malaria Control Programme in 1955, and q2 years later, it launched the “523 Project” – a nationwide research programme aimed at finding new treatments for malaria, according to the WHO – in 1967. 

“This effort, involving more than 500 scientists from 60 institutions, led to the discovery in the 1970s of artemisinin – the core compound of artemisinin-based combination therapies (ACTs), the most effective antimalarial drugs available today,” the WHO added.

Professor Tu Youyou of the Academy of Traditional Chinese Medicine, who isolated artemisinin in 1971, was awarded the Nobel Prize for Physiology or Medicine in 2015 for her discovery. 

Thinking ‘Outside the Box’

“Over many decades, China’s ability to think outside the box served the country well in its own response to malaria, and also had a significant ripple effect globally,” notes Dr Pedro Alonso, Director of the WHO Global Malaria Programme.

“The government and its people were always searching for new and innovative ways to accelerate the pace of progress towards elimination.”

Aside from discovering artemisinin, China was one of the first countries in the world to extensively test the use of insecticide-treated bed nets to preventi malaria during the 1980s – well before nets were recommended by WHO for malaria control.  

In 2010, the country resolved to end malaria within a decade, and 13 ministries – including the health, education, finance, research and science, development, public security, the army, police, commerce, industry, information technology, media and tourism sectors – joined forces to do so.

It adopted a “1-3-7” strategy – a one-day deadline for health facilities to report a malaria diagnosis; confirmation of the case by the end of day three, and take measures to prevent its spread within seven days.

“By the end of 1990, the number of malaria cases in China had plummeted to 117 000, and deaths were reduced by 95%,” said the WHO.

“With support from the Global Fund to Fight AIDS, Tuberculosis and Malaria, beginning in 2003, China stepped up training, staffing, laboratory equipment, medicines and mosquito control, an effort that led to a further reduction in cases; within 10 years, the number of cases had fallen to about 5000 annually.”

In 2020, China applied for an official WHO certification of malaria elimination in after four years of zero cases, and members of the independent Malaria Elimination Certification Panel visited the country last month to verify the country’s malaria-free status and progamme to prevent re-establishment of the disease, according to the WHO.

China has undertaken to assist African countries to eliminate malaria, and it has signed agreements with Burkina Faso, Cameroon, Cote d’Ivoire, Sierra Leone, Tanzania, and Zambia to set up Institutional-based Networks of Cooperation between Africa and China on Malaria (INCAM).