Surveillance for antimicrobial resistance (AMR) in Southeast Asia – much more is needed to combat rising mortality from drug resistant diseases in low-income countries.

Antibiotic-resistant bacterial infections killed 1.27 million people in the world in 2019, according to a one-of-a-kind study in The Lancet.

According to the study, led by the Institute of Health Metrics and Evaluation (IHME) at the University of Washington, with dozens of authors worldwide, the increased resistance of many common pathogens to treatment, known as antimicrobial resistance (AMR), was a leading cause of death worldwide in 2019.

AMR caused more fatalities than HIV/AIDS or malaria, which caused 860,000 and 640,000 deaths respectively, in the same time period.  More people than ever are dying from previously treatable infections since the bacteria causing such infections have become resistant to previously life-saving drugs.

Deaths from AMR were estimated to be highest in sub-Saharan Africa and South Asia, at 24 deaths per 100,000 and 22 deaths per 100,000 people respectively. Children were among those most likely to die of antibiotic-resistant pneumonia strains. In contrast, in high-income countries, the death toll from AMR was about 13 deaths per 100,000.

The study is the first to comprehensively estimate annual deaths from AMR – a global risk that so far has lacked systematic quantification, including by the World Health Organization (WHO). The study highlights how a number of common respiratory pneumonia and bloodstream infections that were previously treatable – have become antibiotic-resistant to treatment causing hundreds of thousands of deaths a year.

Action is needed now to combat the rising threat

The health impact of pathogens varied widely based on location, with deaths attributable to AMR in sub-Saharan Africa most often caused by S. pneumonia (16% of deaths) or K. pneumonia (20%) – the latter is portrayed here.

“These new data reveal the true scale of antimicrobial resistance worldwide, and are a clear signal that we must act now to combat the threat,” said study co-author Chris Murray, director of IHME.

“Previous estimates had predicted 10 million annual deaths from antimicrobial resistance by 2050, but we now know for certain that we are already far closer to that figure than we thought. We need to leverage this data to course-correct action and drive innovation if we want to stay ahead in the race against antimicrobial resistance.”

The 10 million deaths refers to data from a UK government-commissioned study. That number was a benchmark for the landmark 2019 UN report on AMR that warned of a looming crisis, called “No Time to Wait”. But it has been widely criticized inside WHO and elsewhere as lacking precise current data. The Lancet study should fill that gap. 

The study included a review of nearly 10,000 sources, including literature, lab data, household surveys and national mortality data. The research and modelling of trends extend across 204 countries and territories – thus covering virtually every place on the planet. It assessed some 88 pathogen–drug combinations. Of the 23 pathogens studied, lower respiratory and thorax infections, bloodstream infections, and intra-abdominal infections accounted for 78.8% of the deaths caused by AMR in 2019.  

While 1.27 million deaths were directly attributable to AMR, 4.95 million deaths were somehow associated with drug-resistant infections in 2019, the study also found – meaning that drug-resistant infections were a factor in morbidity, even if they could not be deemed as the cause of death.

The paradoxical reasons cited for growing resistance to treatment include both problems of excessive and inappropriate use of antibiotics, but also insufficient access to the drugs even in the same geographical areas. This is a particular problem in low-income settings where access to a wide array of medicines is more restricted. 

Which pathogens are the most resistant? 

Six pathogens were associated with the greatest burden of AMR deaths: E coli, Staphylococcus aureus, K pneumoniae, S pneumoniae, acinetobacter baumannii, and Pseudomonas aeruginosa. These collectively accounted for over 900,000 of the 1.27 million deaths caused by drug resistance in 2019. 

S.aureus and E.coli were the leading cause of deaths in high-income regions in 2019, while resistance to  S pneumoniae and K pneumoniae were the biggest killers in sub-Saharan Africa. 

Meanwhile, resistance to two main antibiotics considered the go-to responses for severe infections – fluoroquinolones and beta-lactam antibiotics, including penicillins and cephalosporins – was responsible for over 70% deaths

Global deaths (counts) attributable to and associated with bacterial antimicrobial resistance by infectious syndrome, 2019

Poorer countries have it worse  

The study also highlights the large regional disparities in the worldwide scale and spread of bacterial-related AMR.

Western sub-Saharan Africa accounted for the highest burden of such resistance with 27.3 deaths per 100,000 directly attributable to the resistance while 114.8 deaths per 100,000 were associated with bacterial AMR. Contrast this with the Australasia region which saw the lowest AMR burden in 2019 at 6.5 deaths per 100,000 attributable to AMR and 28 deaths per 100,000 associated with AMR. 

The entire sub-Saharan Africa region, and south Asia region had an estimated all-age death rate of 75 per 100,000 associated with bacterial AMR. 

All-age rate of deaths attributable to and associated with bacterial antimicrobial resistance by GBD
region, 2019

According to the study, the higher AMR burden is both a function of the prevalence of resistance as well as the underlying frequency of critical infections such as lower respiratory infections, bloodstream infections, and intra-abdominal infections –which are seen to be higher in these regions. 

“Some of the AMR burden in sub-Saharan Africa is probably due to inadequate access to antibiotics and high infection levels, albeit at low levels of resistance, whereas in south Asia and Latin America, it is because of high resistance even with good access to antibiotics,” commented Dr Ramanan Laxminarayan, founder and Director of the Center for Disease Dynamics, Economics & Policy, in Washington, DC, writing in a linked Comment.

In November, WHO’s Africa Region said that over four million Africans a year could die as a result of antimicrobial resistance by 2050. 

The way forward: Vaccines, better infrastructure and more data 

Along with more appropriate use of antibiotics, insure both access but not excessive use, vaccinations also are paramount for combating AMR, the study’s authors underlined. 

And this includes vaccines against viral pathogens like influenza, respiratory syncytial virus, and rotavirus  – which in turn reduce the risks of secondary bacterial infections and subsequent treatment, which means less dependency on inappropriate antibiotic consumption. 

At the same time, there is an urgent need to reduce the use of antibiotics as a first-line treatment for viral infections, in which case antibiotics are not effective.  

Given that AMR affects low-and-middle-income countries more than higher-income ones, the study also recommends scaling up and building stronger diagnostics infrastructure that allow clinicians to diagnose infection more accurately and rapidly.  At the same time, the study shows, maintaining investment in the development pipeline for new antibiotics, and access to second-line antibiotics in locations without widespread access is essential. 

“From being an unrecognised and hidden problem, a clearer picture of the burden of AMR is finally emerging,” Laxminarayan said in his comment, noting that spending on HIV “attracts close to US$50 billion each year. However, global spending on addressing AMR is probably much lower than that. This needs to change.

“Spending needs to be directed to preventing infections in the first place, making sure existing antibiotics are used appropriately and judiciously, and to bringing new antibiotics to market. Health and political leaders at local, national, and international levels need to take seriously the importance of addressing AMR and the challenge of poor access to affordable, effective antibiotics.”

Data gaps hinder assessment – particular in low-income countries

Testing for antimicrobial resistance among a variety of different bacterial strains

This study was funded by the Bill & Melinda Gates Foundation, Wellcome Trust, and Department of Health and Social Care using UK aid funding managed by the Fleming Fund.

But the international consortium that authored the study, the Antimicrobial Resistance Collaborators, identified serious data gaps in many low-income countries, underlining the importance of increasing laboratory capacity and data collection in these locations.

This is all the more critical insofar as resistance varies substantially by country and region – both in terms of what bacteria are more resistant and what drugs are more or lesss effective, researchers stressed.

“Improving the collection of data worldwide is essential to help us better track levels of resistance equip clinicians and policymakers with the information they need to address the most pressing challenges posed by antimicrobial resistance,” said Professor Christiane Dolecek, at Oxford University’s Centre for Tropical Medicine and Global Health and the Mahidol Oxford Tropical Medicine Research Unit.

In his comments, Laxminarayan also emphasized the need for more AMR data collection in low-income countries saying: “Progress ahead will depend on projects such as those supported by the Fleming Fund, which aim to improve laboratory capacity in LMICs while also uncovering resistance data that lie on dusty shelves and in long-forgotten hard drives.”

Report is ‘wake-up call’

Senior WHO officials, including Chief Scientist Soumya Swaminathan,  welcomed the new IHME report as filling a critical knowledge gap and highlighting the long-neglected issues around AMR.

“Lack of robust global data and evidence of the impact of drug-resistance has been a critical knowledge gap and has hampered efforts to advocate for policies and practices to control antimicrobial resistance,” said WHO in a series of tweets. “This study now clearly demonstrates the existential threat”.

Meanwhile, pharma voices described it as a ”wake up call”:

“Left unchecked, AMR could undermine the foundation of modern medicine,” said Thomas Cueni, director general of the International Federation of Pharmaceutical Manufacturers and Associations.

“This is a wake-up call for us all, industry has been a first mover in finding solutions.  Now the focus has shifted to governments who must deliver new economic incentives, pragmatic antibiotic value assessments, and reimbursement reforms to enable access, that are needed to meet the needs of patients of today and tomorrow.”

  • Updated 23 January 2022

Image Credits: WHO, USAID Asia/Flickr, The Lancet, DFID – UK Department for International Development.

The WHO Executive Board discussion on the coronavirus outbreak in early February 2020 – the last full-scale face-to-face meeting in Geneva of the governing body before WHO declared an international health emergency.

One of the more complicated tasks facing next week’s World Health Organization (WHO) Executive Board (EB) is how to take forward negotiations on an ‘instrument’ to address future pandemics – and even the report to the board about this has been slashed.

The past two years of vaccine hoarding, nationalism and fights about the origins of SARS-CoV2 have made it plain that finding global agreement on how to address future pandemics might be impossible.

Although the special session of the World Health Assembly late last year agreed that the WHO would actually try to do this, the working group charged with trying to develop a negotiation plan has struggled to find consensus.

The EB report from the Working Group on Strengthening WHO Preparedness and Response to Health Emergencies (WGSWP) was nine pages at the start of the group’s meeting last week – but the latest version is down to six pages.

The entire clause that suggested that the WHO should have speedy access to disease outbreak sites has been removed – at the insistence of China, diplomatic sources told Health Policy Watch.

The entire clause 11 has been removed from the original report

The report identifies two key priorities to frame future pandemic response – equity and building systems and tools, including strengthening the International Health Regulations (IHR) and adopting a ‘One Health’ approach.

It proposes that IHR be tightened up to “provide clear guidance for action in the event of a public health emergency of international concern with the potential to establish immediate alerts”.

However, that is as close as it gets to the original report suggesting that the WHO might be empowered to get to outbreaks in countries as speedily as possible.

The WGSWP report, part of EB agenda item 15 on public health emergencies preparedness and response, is due to be addressed on the first day, Monday 24 January.

The board will be expected to “provide further guidance” on the report. It will also consider the creation of a Standing Committee on Pandemic and Emergency Preparedness and Response “to provide guidance and, as appropriate, make recommendations to the Board regarding ongoing work on policy proposals on pandemic and emergency preparedness and response”.

Agenda focuses on four pillars 

The agenda of EB, meeting for the 150th time, has been organised around four pillars:

  • One billion more people benefitting from universal health coverage;
  • One billion more people better protected from health emergencies;
  • One billion more people enjoying better health and well-being;
  • More effective and efficient WHO providing better support to countries. 

A significant focus of the board meeting will be on non-communicable diseases (NCDs). By Wednesday, the EB is expected to have adopted a “draft implementation road map 2023–2030” to prevent and control NCDs. 

Proposals to reduce the harmful use of alcohol, better control diabetes, improve oral health and ensure that people with NCDs can still access treatment during humanitarian emergencies form part of the draft policies.

The NCD Alliance is calling on member states to put the draft policies related to NCDs forward for adoption to the 75th WHA.

The EB will also appoint the Director-General for the next four years – and the only candidate officially nominated so far is the current office-bearer, Dr Tedros Adhanom Ghebreyesus.

 

Image Credits: HPW/Catherine Saez.

South African President Cyril Ramaphosa and US billionaire Dr Patrick Soon-Shiong

CAPE TOWN – South African-born US biotech billionaire Patrick Soon-Shiong launched a vaccine manufacturing plant in the country of his birth on Wednesday, aimed at producing “second generation” vaccines to address COVID-19 and other diseases.

Soon-Shiong, who has made his fortune from developing successful cancer treatments, has committed an initial $195 million to NantSA – the South African operation that aims to produce one billion vaccine doses a year by 2025.

Soon-Shiong said that he had been moved to invest in improving South Africa’s vaccine capacity after witnessing “vaccine apartheid” during the COVID-19 pandemic.

Unlike current vaccines that are based on stimulating the body to produce antibodies, Soon-Shiong’s approach is based on stimulating the body’s T-cell responses – something he has done successfully in cancer immunotherapy treatment.

His US company, NantKwest, has been developing “natural killer” (NK) cells used by the immune system to identify and destroy cells under stress, including cancerous or virally-infected cells.

NantKwest describes itself as “a pioneering, next-generation, clinical-stage immunotherapy company” that is focused on “harnessing the unique power of our immune system using natural killer (NK) cells to treat cancer, infectious diseases and inflammatory diseases”. It has not yet developed a commercial product based on NK cells.

‘Vaccine apartheid’ prompted investment

“We have spent 10 to 15 years trying to show that, while antibodies are important, T cells are what kill. We came from the position of cancer, and we took that same technology and have actually put it into vaccines,” Soon-Shiong told the launch in Cape Town.

But he admitted that this approach has been “really difficult for people to grasp at the regulatory level, at the science level, at the implementation level”.

“We started this in the US, but then when I saw the need, the inequities that I call vaccine apartheid, that was happening here on this continent and within the encouragement of [South African] President Cyril Ramaphosa, I said this is what we needed to do and we’ve moved our focus to South Africa.”

‘Part of Africa plan’, says South Africa’s President

Opening the facility, Ramaphosa said that the “state-of-the-art vaccine manufacturing campus” was “part of a far broader initiative to propel Africa into a new era of health science”.

“Today we are marking the establishment of a company that aims to develop next-generation vaccines that will reach patients across the continent,” added Ramaphosa.

“This new entity, we understand, will collaborate with the [World Health Organization] mRNA hub by providing RNA enzymes they need to produce vaccines.”

Ramaphosa also praised the $6.7million investment made by Soon-Shiong’s family foundation to train young Africans in biotechnology and life sciences.

Part of this investment involves the establishment of the Chan Soon-Shiong Centre for Epidemic Response and Innovation at the University of Stellenbosch, which includes the donation of two large DNA sequencers.

 “South Africa’s capabilities in genomic surveillance are recognised worldwide and have been vital in our response – and indeed the global response – to the emergence of new COVID-19 variants,” said Ramaphosa.

The event also marked the launch of the Coalition to Accelerate Africa’s Access to Advanced Healthcare (AAAH Coalition) which, together with NantSA, “aims to accelerate domestic production of pharmaceuticals, biologics and vaccines that will reach patients across the African continent”, according to the South African Presidency.

This would accelerate self-reliance and Africa’s preparedness to face the next pandemic, added Ramaphosa.

Soon-Shiong, one of the wealthiest medical doctors in the world, has also been described as a “blowhard” and a “showman” by Forbes magazine – although the magazine also quoted a patient who said that his experimental pancreatic cancer treatment had saved his life.

 

 

 

Maria van Kerkhove

World Health Organization (WHO) researchers and partners are “constantly looking at” animals’ susceptibility to COVID-19, and transmission both from humans to animals and vice versa, WHO’s Dr Maria van Kerkhove told the global body’s weekly briefing on Tuesday.

“We understand there are a number of species that can be infected with SARS-CoV2 and then there’s the possibility – we call that a reverse zoonosis – it goes from humans back to animals, and then it’s possible for the animals to reinfect humans,” said Van Kerkhove, WHO’s lead on COVID-19.

“That risk remains low, but it is something that we are constantly looking at because what we don’t want is to have, as this virus circulates you know, it has the opportunity to infect people as well as animals,” she said.

However, she added that there needed to be better surveillance of which animals are susceptible, tracking this and infected animals over time.

Working groups are researching animal-human interface

Of the seven million COVID-19 genome sequences that had been shared by scientists, around 1 500 were from animals, she added.

“This is not something we talk about very much, but we have many working groups at the looking in animals at the animal-human interface to look at the possibility of human infecting animals as well as animals infecting humans back again.”

This follows news that COVID-19 (Delta variant) had been detected in a Hong Kong pet shop owner, a customer and at least 11 hamsters, resulting in officials deciding to cull around 2000 hamsters, rabbits and other mammals, according to media reports. 

Hong Kong’s assistant director of agriculture, fisheries and conservation, Thomas Sit Hon-chung, told a press conference that while no animal-to-human transmission has been recorded, the hamsters could infect other animals and these could in turn infect humans, according to Hong Kong’s The Standard newspaper.

Not the time to make a ‘massive shift’ on COVID tests

Van Kerkhove also said that the WHO had been COVID-19 tests globally – based on nasal, throat and saliva samples – to ensure their sensitivity to the Omicron variant. 

“We do know that the tests that are in use right now remain sensitive to the Omicron variant,  including the antigen-based tests, the PCR tests, and saliva-based tests that are out on the market.”

She added that this was not the time to “make a massive shift to recommend one or the other”, but rather to “ensure that testing is accessible, affordable, and is reliable in all countries”. 

Patients being tested needed to know what to do, while governments and global organisations needed to know where the virus is and where the virus is spreading, she added. 

There was a 20% increase in recorded COVID-19 cases in the past week – around 19 million new cases – but deaths were holding steady at about 45,000.

Narrative that Omicron is mild ‘hurting response’

WHO Director-General Dr Tedros Adhanom Ghebreyesus. 

WHO Director-General Dr Tedros Adhanom Ghebreyesus said he was concerned about the impact Omicron was having on “already exhausted health workers and overburdened health systems”.

“I remain particularly concerned about many countries that have low vaccination rates, as people are many times more at risk of severe illness and death if they’re unvaccinated,” said Tedros.

He added that while Omicron may be less severe, on average, “the narrative that it is mild disease is misleading and hurts the overall response”.

“Make no mistake, Omicron is causing hospitalizations and deaths and even the less severe cases are inundating health facilities. The virus is circulating far too intensely with many still vulnerable. for many countries, and the next few weeks remain really critical for health workers and health systems,” he added.

The inequitable distribution of COVID-19 vaccines is the result of the “complete collapse of global co-operation and solidarity”, Dr John Nkengasong, Director of the Africa Centres for Disease Control and Prevention (Africa CDC), told a panel on vaccine equity at the World Economic Forum on Tuesday.

“The moral failures that we witnessed over the last two years cannot be repeated in 2022,” he added.

“We have to remain optimistic in Africa that, as a continent, we should strive to get to the 70% [global vaccination] target, but we are on 10%. How do we get from 10% to 70%? We really have to bring all forces to bear to increase our global cooperation, partnership, solidarity and coordination to try to move from where we are to 70%, recognising that it is only through that massive coordinated efforts that we could all be safe.”

Nkengasong added that Omicron’s rapid spread had borne out predictions that global safety involved global vaccination.

“We’ve seen what Omicron has done. We all said this at the start: that if we did not protect and invest at speed, even those who have been vaccinated will be challenged. We truly don’t know what the next variant will look like and the only way to prevent other variants is to vaccinate at scale and that includes Africa.”

COVAX hit ‘barrier after barrier’

Seth Berkley CEO of Gavi, the vaccine alliance that manages COVAX, said that “the original plan was to have every high-risk person in the world vaccinated at the same time, and every health worker and then moving to low-risk people”.

“Of course, that’s not what happened,” said Berkely, noting that while COVAX had managed to deliver the first vaccine to a developing country 39 days after high-income countries, the vaccine platform then “hit barrier after barrier”.

“We had export bans, we had vaccine nationalism, we had companies not meeting their requirements to put doses forth,” said Berkley.

He also warned that delays had also fuelled vaccine hesitancy and complicated delivery.

“The good news is that, in general, developing countries actually appreciate vaccines more because they see the diseases and so the vaccine demand has always been higher, and vaccine hesitancy is actually been lower. But it’s more complicated at this point,” said Berkley.

More COVID deaths related to inequality than old age

Gabriela Bucher, Executive Director of Oxfam International

Gabriela Bucher, Executive Director of Oxfam International, told the WEF session that research showed “inequality is a higher predictor of COVID-19 deaths than age”.

“We have seen vaccine hoarding over and over again, and [governments protecting pharmaceutical monopolies”, said Bucher.

Oxfam published a report this week on COVID-related inequity, including that the wealth of the world’s 10 richest men has doubled since the pandemic began, while the incomes of 99% of humanity are worse off because of COVID-19.

Bucher said that lifting intellectual property rights from the beginning of the pandemic and allowing vaccines to be produced at scale across the world would have been “a game danger”.

“We would have avoided not only deaths directly from COVID but all the deaths that have been associated with growing inequality and crippled health systems across the world,” she added.

Breakdown of trust

Dr Michael Ryan, Executive Director of the World Health Organization (WHO) Health Emergencies Programme, said that while COVID-19 would not be eliminated this year–  and SARS-CoV2 might never be eliminated – “we can end COVID as a public health emergency”. 

But, said Ryan, the global pandemic response system was not “fit for purpose” to end this or future pandemics.

“What is very clear is that the current mechanisms that are in place for the production of vaccines do not lead to the equitable distribution of these vaccines,” said Ryan.

“One of the most scarce commodities in this whole pandemic response has been trust: trust between communities and government, trust between countries, trust between manufacturers,” he added.

Serum Institute of India appeals to African countries to ‘get in touch’

Adar Poonawalla CEO of the Serum Institute of India (SII), said that his company had 1.5 billion vaccine doses in the past year, and “actually have to stop production in December because we had 500 million in stock”.

“Vaccine supply is no longer a constraint,” said Poonawalla. “We’ve supplied vaccines to the African continent and it supported over the last many decades. We are ready to support you again. Please get in touch.”

SII was supposed to be the key supplier for COVAX of a generic version of the AstraZeneca vaccine, but stopped its supply to attend to India’s domestic vaccine needs. This generated bad blood between the company and African countries.

However, according to Poonawalla, the SII will “probably supply a billion-plus doses in the first quarter of 2022 through COVAX to the African continent.”

protest fine
Tens of thousands of people protested against COVID-19 vaccine passes across France

France’s newest measure to tackle COVID-19 – requiring a certificate of vaccination at public places such as restaurants, cafes, cinemas, and long-distance trains – was approved by its parliament on Sunday. 

With lawmakers in the lower house of parliament voting 215 to 58 in favour, the law is set to be enforced in coming days.

President Emmanuel Macron told Le Parisien paper in an interview this month that he wanted to “piss off” unvaccinated people by making their lives so complicated they would end up getting the COVID vaccine. 

“The unvaccinated, I really want to piss them off. And so we’re going to continue doing so until the end. That’s the strategy,” said Macron.

Currently, unvaccinated people can enter these places with recent proof of a negative COVID-19 test. 

The new law is part of a string of mandates that have been implemented across the European Union (EU) in an effort to quell the rise in cases. Greece, Italy, and Austria have begun to implement fines or mandatory vaccinations for adults. 

France is experiencing its fifth COVID-19 wave, with daily cases hitting record highs of over 300,000. However, the number of serious hospitalizations is much lower than compared to the first wave in March and April 2020. 

Unvaccinated Greeks to pay monthly fines

Individuals 60 and over will be fined if they do not receive their COVID vaccination in Greece.

Greeks over the age of 60 who have not yet scheduled an appointment to get their first jab against COVID-19 will be fined every month, starting on Monday, o boost lagging vaccination rates and reduce pressure on healthcare in Greece.  

The monthly fine will be 50 euros ($57) in January, but will rise to 100 euros ($115) in subsequent months.

Speaking on Greece-based Skai Television, Health Ministry General Secretary Marios Themistocleous said there would be no extension to the rule for those over 60: “Whoever does not get vaccinated will pay the fine every month,” he said.

This decision follows a rise in cases as Omicron sweeps through Greece, with 20,409 new cases reported in the last 24 hours. 

Authorities have also decided to extend other COVID-19 measures, including midnight curfew for bars, restaurants and cafes; no music at venus; and mandatory high-protection masks at supermarkets and on public transport until 23 January. 

Prime Minister Kyriakos Mitsotakis told seniors that the simplest way to avoid the fine is to get vaccinated. Greek authorities say the non-vaccinated remain at high risk for hospitalization from coronavirus.

Some 90% of COVID-19 related deaths have been among people 60 and above, while 70% of those hospitalized from the virus are over 60, and of those 80% are unvaccinated. 

Over 50 fined in Italy without booster shot 

Italy is implementing a similar fine with its population – people 50 and over could be fined 100 euros ($115) if they fail to get their booster shot, according to the country’s latest COVID restrictions.

The government’s 5 January decree now requires people over 50 to have a ‘super green pass’ health certificate showing that they are either vaccinated or recently recovered from COVID, in order to enter the workplace. Anyone in this age group, employed or not, is also at risk of being fined 100 euros if they do not get vaccinated by 1 February. 

In addition, those who do not get their booster shot also could face a 100 euro fine.  

“We are working in particular on the age groups that are most at risk of being hospitalized,” said Italian Prime Minister Mario Draghi. 

This new mandate applies to anyone currently 50 or over living in Italy, or anyone due to turn 50 by 15 June. 

The fines will be collected by Italy’s Agenzie delle Entrate (Inland Revenue-Recovery Agency). 

People notified they are in violation will have ten days to communicate to their local health office, the reason for their vaccination status. 

COVID-19 vaccinations to become mandatory for 18 and over in Austria 

Protests in Vienna, Austria over compulsory vaccination.

Austria plans to make COVID-19 vaccinations mandatory from February for Austrian residents 18 and older, the government confirmed on Sunday. 

Presenting the final version of a draft law at a press conference on Sunday, Chancellor Karl Nehammer sought to reassure Austrians that the vaccine works.

“It’s not about fighting the vaccinated against the unvaccinated,” but rather to underscore that “vaccination is the best guarantee that we can live together in freedom.” 

The mandate will apply to Austrian residents 18 and older, with exemptions for pregnant women and people who cannot receive the vaccine due to medical reasons. 

While the law will take effect 1 February, police checks won’t be carried out until 15 March. Unvaccinated people then face a penalty of around 600 euros (US $684) and up to 3600 euros (US $4105). 

Those noncompliant with the mandate will be fined up to four times a year; however, the fine will be dropped if the recipient is vaccinated within two weeks of receiving the penalty notice.

Though the Austrian parliament still has to vote on Thursday on the vaccination mandate, the law is expected to pass. Around 74% of Austria’s population is vaccinated against COVID. 

Image Credits: akilligundem/Twitter, John Perivolaris/Flickr, Ama Bushman/Twitter.

On 24 February 2021, a plane carrying the first shipment of COVID-19 vaccines distributed by COVAX landed in Ghana.

Rwanda became the recipient of the one-billionth COVID-19 vaccine delivered by COVAX, the global platform set up to ensure equitable access to the vaccines,announced last Friday.

After numerous supply problems – most seriously when its key supplier, the Serum Insitute of India, was banned from exporting its vaccines by the Indian government – COVAX was forced to slash its 2021 delivery target from two billion to 930 million doses.

However, since mid-December, COVAX delivery has escalated substantially, and 100 million vaccine doses were delivered in the last week of December alone.

“COVAX is leading the largest vaccine procurement and supply operation in history, with deliveries to 144 countries to date,” said the World Health Organization (WHO) over the weekend.

“But the work that has gone into this milestone is only a reminder of the work that remains. As of 13 January 2022, out of 194 Member States, 36 WHO Member States have vaccinated less than 10% of their population, and 88 less than 40%,” said the WHO.

“COVAX’s ambition was compromised by hoarding or stockpiling in rich countries, catastrophic outbreaks leading to borders and supply being locked. And a lack of sharing of licenses, technology and know-how by pharmaceutical companies meant manufacturing capacity went unused.”

Dr Seth Berkley, CEO of Gavi – the vaccine alliance that manages COVAX – said he was “proud that nearly 90% of the first billion doses COVAX has delivered have been fully-funded doses sent to the low and lower-middle countries supported by the Gavi COVAX Advance Market Commitment (AMC)”.

 

This had been made possible thanks to donations of over $10 billion to COVAX, added Berkley.

“Inequality in vaccination is enormous with 41% of the world not yet vaccinated with even one dose,” added Berkley. “In 2022, Gavi will be fundraising to make sure lower-income countries are able to access variant-adapted vaccines, boosters or additional doses as needed. COVAX will be focusing on supporting lower-income countries’ vaccination objectives – that means also raising money to ensure tailored support for preparedness and delivery, particularly for the highest-risk countries, to increase their ability to absorb the doses delivered as rapidly as possible.”   

Richard Hatchett, CEO of the Coalition for Epidemic Preparedness Innovations (CEPI), which is a COVAX partner, also welcomed the milestone, but warned that while supply constraints had eased, “booster programs and the potential production of Omicron-specific vaccines may yet create pressure on supply”.  

Meanwhile, Eva Kadilli, director of UNICEF’s supply division, which carries out the COVAX deliveries, also welcomed the billionth delivery and thanked her teams throughout the world.

 

 

 

 

 

Image Credits: WHO, UNICEF.

COVID patient in hospital
COVID patient in hospital

Two new treatments for COVID-19 were recommended on Thursday by the World Health Organization’s Guideline Development Group of international experts – one for severely ill patients and the other for those patients who are not severely ill but most likely to develop severe disease.

The recommendations were announced Friday morning in the BMJ. Both drugs, however, are patented and could be expensive and lack accessibility for some low- and middle-income countries, some advocates warned.

The first drug, baricitinib – a type of drug known as a Janus kinase (JAK) inhibitor – was “strongly recommended” for patients in severe or even critical condition from COVID-19. The drug has been used to treat rheumatoid arthritis and it is recommended that four milligrams be given once daily for 14 days in addition to previously-recommended corticosteroids.

“The strong recommendation is based on evidence that it reduces mortality, shortens hospital stays and reduces the risk of requiring mechanical ventilation, with no observed increase in adverse effects,” explained François Lamontagne, Professor of Medicine at the Université de Sherbrooke, who sits on the panel, in an interview with Health Policy Watch.

He explained that JAK inhibitors modulate the body’s response to an infection.

The WHO experts noted that two other JAK inhibitors – ruxolitinib and tofacitinib – should not be used to treat patients with severe disease because “low certainty evidence from small trials failed to show benefit and suggests a possible increase in serious side effects with tofacitinib.”

COVID-19 treatments and vaccines
COVID-19 treatments and vaccines

‘Uncertain’ effectiveness against Omicron

The second treatment that the panel recommended is a monoclonal antibody called sotrovimab, which is meant for patients with non-severe COVID-19 but who are at risk for developing severe disease.

Sotrovimab, Lamontagne said, consists of antibodies directed against a specific part of the virus that prevents entry of the virus into cells. This drug is given intravenously, requiring one infusion.

Lamontagne noted, however, that the panel only provided a “weak” recommendation of the treatment because the effectiveness of sotrovimab against Omicron is still uncertain.

The recommendations are based on evidence from four trials (three for baricitinib and one for sotrovimab) involving several thousand people, Lamontagne said. WHO noted that “the panel considered a combination of evidence assessing relative benefits and harms, values and preferences and feasibility issues.”

Baricitinib and sotrovimab join a concise list of drugs recommended by WHO experts, including the use of interleukin-6 receptor blockers and systemic corticosteroids for patients with severe or critical COVID-19, and conditional recommendations for the use of casirivimab-imdevimab in selected patients. WHO has recommended against the use of convalescent plasma, ivermectin and hydroxychloroquine.

No formal recommendation yet from WHO on new oral drugs – Paxlovid and monulpiravir

Significantly, WHO has not yet made a formal recommendation on the two new oral drug treatments that have now come on the market – Pfizer’s Paxlovid or Merck’s Molnupiravir. This is despite the fact that both drugs have been approved by the US Food and Drug Administration, and the Medicines Patent Pool has also contracted with Pfizer and Merck to produce generic versions of each drug for low-income countries.  Countries around the world are rushing to secure doses of Paxlovid, in particular, due to its high efficacy and safety profile in the FDA reviews – where it has been reported to be 90% effective in preventing severe disease when administered early in the course of infection.

Asked why the Organization had not yet made a recommendation on either drug, a WHO spokesperson pointed to a WHO Guidelines Development Group meeting that is scheduled to review Paxlovid [nirmatrelvir] on 9 February.

“Based on an assessment of the totality of the evidence, WHO will make a recommendation,” the spokesperson said, saying that safety monitoring, affordability and access all need to be considered in any WHO recommendation on either drug.

The WHO spokesperson, also stressed that “even if proven safe and effective, these drugs will not be an alternatives to vaccines.”

The spokeperson also stressed that any new oral drugs also “should be made available and affordable in all countries”.

Access advocates have complained that the current generic production arrangements for Paxlovid, aimed at 95 low-income countries, still leaves many gaps in affordability and access among lower-middle and middle-income countries which cannot afford the high prices of patented versions.

‘Baricitinib example of why TRIPS Waiver urgently needed’

Similarly, the cost and availability of both of the newly WHO-recommeded drugs could still also be barriers to their use in low- and middle-income countries, Lamontagne said.

“These additional therapies are newer, not produced on the same scale [and some other drugs], not as available and are more costly,” Lamontagne said. “The panel that makes those favorable recommendations is aware of this and is aware there is a risk that these interventions won’t be available similarly everywhere and that this could worsen the differences in access to healthcare.

“But at same time, in making those recommendations and stating that those are potentially life-saving and important therapies, the panel hopes to stress how important it is to strive to improve the accessibility of these emerging therapies across the board – in lower income areas just like in higher income areas,” he continued.

Médecins Sans Frontières/Doctors Without Borders (MSF) reacted to the recommendations by calling on governments to “take immediate steps to ensure that patent monopolies do not stand in the way of access to this treatment.”

The organization said that in many countries, generic baricitinib will not be available as the drug is under patent monopoly, including in some countries hit hard by the pandemic, such as Brazil, Russia, South Africa and Indonesia. In most cases, the patents do not expire until 2029.

“Baricitinib is another example of why the TRIPS Waiver is urgently needed,” MSF said in a statement.

“As new treatments emerge, it will be simply inhumane if they remain unavailable in resource-limited settings, just because they are patented and too expensive,” stressed Dr.  Márcio da Fonseca, an infectious disease medical advisor who spoke on behalf of MSF. “With these proven therapeutics recommended by the WHO, it’s time now for low- and middle-income countries to finally access these therapies that are already in routine use in many high-income countries.”

Image Credits: Wikimedia Commons, Bicanski on Pixnio.

WHO’s Dr Bruce Aylward

Over 15 million new cases of COVID-19 were reported globally in the past week – by far the most cases ever reported – but deaths have remained constant since last October at about 48,000 a week, according to World Health Organization (WHO) Director-General Dr Tedros Adhanom Ghebreyesus.

“While the number of patients being hospitalised is increasing in most countries, it’s not at the level seen in previous waves. This is possibly due to the reduced severity of Omicron as well as widespread immunity from vaccination or previous infection,” said Tedros, addressing the WHO’s weekly COVID-19 briefing on Wednesday.

However, he stressed that while Omicron may cause less severe disease than Delta, it remains a dangerous virus particularly for those who are unvaccinated. 

Referring to the statement made on Tuesday by the WHO’s Europe director, Dr Hans Kluge,  that 50% of Europeans would be infected with Omicron in the coming weeks, WHO lead on COVID-19, Dr Maria van Kerkhove, said this was based on modelling.

“This variant is that it transmits incredibly efficiently between people,” said Van Kerkhove, but stressed that people could still protect themselves through vaccinations, masking and physical distancing.

Van Kerkhove added that the new cases were literally off the charts – the WHO had to readjust the scale of its latest graph to accommodate the explosion of cases.

WHO COVID-19 cases (11 January 2022)

WHO special advisor and COVAX representative Dr Bruce Aylward described the case increase as “absolutely staggering”. 

“We have not, in 30 years working on infectious diseases, seen an epidemic curve like this before, certainly not with a pandemic-prone virus,” he said.

“In the face of a staggering upsurge in a disease, we’re hearing two responses. One group is saying,’ Gosh, throw in the towel, let this thing immunise the world’. While the other group, led by Maria [van Kerkhove], is saying: wear a mask and get vaccinated. And the first response is the wrong choice.”

Kluge reported that there were over seven million new cases of COVID-19 in the first week of January, more than doubling over a two-week period.

“As of 10 January, 26 countries report that over 1% of their population is catching COVID-19 each week,” said Kluge.

“At this rate, the Institute for Health Metrics and Evaluation (IHME) forecasts that more than 50% of the population in the Region will be infected with Omicron in the next six to eight weeks.”

Main barriers to vaccine rollouts

Dr Kate O’Brien

Thirty-six countries have vaccinated less than 10% of their populations while 90 have not reached 40%, said Tedros.

Dr Kate O’Brien, WHO Director of Immunisation and Vaccines, said the “foundational issue” hampering these countries was the constrained and uncertain supply of vaccines.

However, O’Brien cited a number of other issues including lack of financing to roll out vaccines, weak health services, conflict and other humanitarian emergencies.

Aylward decried the “dangerous narrative” emerging in many high-income countries that some lower-income countries can’t use the vaccines or did not want them.

“If you look at the map of polio or measles [elimination] and you see that the same countries that have gotten very low coverage for COVID-19 have eliminated or eradicated polio or eliminated measles or achieve very high routine immunisation for some other diseases,” said Aylward.

“We’ve made it twice as hard or three times as hard for low-income countries to be able to achieve high coverage. We did not share vaccines for six, seven, eight months. What we did share was a lot of misinformation, a lot of bad practice, a lot of false problems.”

COVAX had recently been able to increase its vaccine deliveries to low and middle-income countries and has delivered 980 million doses.

Aylward also criticised vaccine donations with short expiry dates “which make them very, very difficult to use in complex environments”.

“These countries know how to run vaccination at scale. It’s a really tough environment they’re operating in right now. How do we fix that? Number one, we have to provide full support for the financing, for the delivery, the information support, the right products, right time frames.”

A Medical Diagnostic staff member works on the antigen tests.

CAPE TOWN – A locally produced COVID-19 rapid antigen test that was recently approved by South Africa’s medicines regulator is able to detect Omicron, according to its developer.
This follows some controversy about whether antigen tests were able to detect Omicron, and suggestions that throat swabs might be more effective than nasal swabs as Omicron affects the upper respiratory tract rather than the lungs.
But Dr Lyndon Mungur, COO of Medical Diagnostech, said that his company’s antigen test has been able to detect every COVID-19 variant, including Omicron.
“Most antigen tests detect the nucleoprotein and not the spike protein. There are only two mutations on the nucleoprotein for the Omicron variant, and both mutations are embedded in the centre of the protein, and not on the antigenic sites,” explained Mungur, a biotechnologist who helped with the research and development of the local antigen test.
“We have an ongoing clinical study program so that we can be abreast of new variants as they become evident. Our antigen tests were able to detect every one, and we also compare results to PCR tests on the same specimens,” said Mungur, adding that the Medical Diagnostech test used nasal swabs.

Cheaper than imported tests

“If current tests were able to detect at a lower sensitivity, this would only affect the very beginning and very end stages of infection. There is a very small window at the start and at the end in terms of low viral load.”
The Medical Diagnostech test is likely to be around 35% cheaper than imported tests, and it was approved by the South African Health Products Regulatory Authority (SAHPRA) in December.
Company CEO Ashley Uys said that his company “has a production capacity of 20 million units per annum”.
The company received funding from the South African Medical Research Council (SAMRC) to develop its test.
Medical Diagnostech had already developed a prototype antigen detection test, but required support to increase its sensitivity and complete the testing and approvals for market entry, according to SAMRC official Dr Michelle Mulder,
“The local ownership and manufacture of these test kits will not only increase South Africa’s self-sufficiency in a time of high demand, but also contribute to reducing the trade imbalance with respect to medical devices and local economic development and job creation,” added Mulder.
“This [antigen test] not only benefits the country but will also be made available to the rest of Africa,” said Dr Phil Mjwara, Director-General of the Department of Science and Innovation.

A few months earlier, the country’s regulator approved a locally produced PCR test.

Image Credits: MedicalDiagnostic.