Israeli couple receives fourth dose of COVID vaccine in Israel
Israeli couple receives fourth dose of COVID vaccine in Israel

In still evolving data, yet another Israeli study has found that health workers who received a fourth dose of a Pfizer mRNA vaccine were half as likely to contract Omicron seven days after receiving the shot in comparison to people who only got three doses.  The study released Thursday came less than one week after another major hospital research center cast doubt on the effectiveness of the extra jab after providing it to several hundred health workers in a controlled clinical trial.

The evolving data reflects some of the ongoing debate among experts the world over over the effectiveness of additional doses of the same vaccine against the current variant wave – something few countries and hospitals have tested so far outside of Israel.

Tel Aviv Sourasky Medical Center released data from its real-world study of 6,863 medical workers who were vaccinated with a third dose of the Pfizer coronavirus vaccine between August and December 2021 and had not previously been infected with corona, including 1,316 workers who received the fourth dose as of January 3, 2022. During this period, 608 workers tested positive – but only 42 of them were diagnosed with the virus seven days or more after receiving the fourth vaccine.

From the analysis of the data using a regression model, the hospital concluded that “the risk of contracting the virus is twice as low seven days after receiving the fourth dose.”

Tel Aviv Sourasky Medical Center reveals real-world results of fourth dose campaign
Tel Aviv Sourasky Medical Center reveals real-world results of fourth dose campaign, showing that medical workers who took the shot were half as likely to contract COVID after seven days.

However, Sourasky added in a press release, these results “must be interpreted with caution” due to the short follow-up period of just 15 days after innoculation.

Other trial tested both Pfizer & Moderna

Sourasky’s report comes only days after Sheba Medical Center at Tel Hashomer shared preliminary results of its Helsinki-approved fourth shot clinical trial, indicating that a fourth dose of Pfizer or Moderna does not provide enough of a boost to significantly protect against Omicron.

Prof Gili Regev-Yochay, who is leading Sheba’s research on the matter, told reporters on Monday that two weeks after receiving a fourth Pfizer vaccine and one week after receiving a fourth Moderna jab that “the increase in antibodies is nice” but not enough to stop infection.

Some 154 medical workers from Sheba are participating in a trial of the a fourth Pfizer vaccine and another 120 in the Moderna arm of the experiment.

Although Regev-Yochay would not share numbers, she said that only slightly fewer people who received the fourth dose caught coronavirus than those in a control group, who were fully vaccinated with two shots and a booster.

Majority of seriously ill or hospitalized people continue to be those who are unvaccinated at all

In all cases, the researchers have stressed that while Omicron might break through the vaccines more than previous strains, the vaccines continue to stop severe disease. Regev-Yochay said that none of the study participants who got Omicron developed a severe or life-threatening case and the majority of serious patients in Israeli hospitals continue to be unvaccinated or people vaccinated with only two shots more than six months ago.

Israel’s Health Ministry approved giving a fourth shot for immunocompromised people in late December and soon after expanded its decision to include people over the age of 60 and medical workers. So far, more than half-a-million citizens have taken the fourth dose.

A handful of other countries have also approved offering its citizens fourth doses, including Greece, Chile and Brazil, though no other countries have started full campaigns nor released research on the effectiveness of the protocol.

The World Health Organization has spoken out against fourth shots, saying earlier this month that “a vaccination strategy based on repeated booster doses of the original vaccine composition is “unlikely to be appropriate or sustainable.”

But WHO’s Chief Scientist Dr Soumya Swaminathan also has said that more studies are needed to understand the duration of protection in different population groups after vaccines and boosters.  And, rather than pursuing boosters or vaccines for each new variant, she has called for R&D into vaccines that can hit at all “beta-coronaviruses”.

And rather than develop more variant-specific vaccines, Swaminathan and other leading vaccine experts, such as Peter Hotez of Texas Children’s Hospital have said work should be focused on more broadly neutralizing beta coronavirus vaccine – hitting not only at SARS-CoV2 but other SARS or SARS-like viruses that are circulating in the wild and likely to emerge at a later date.

https://twitter.com/PeterHotez/status/1460596460026748938

Image Credits: Maccabi Health Services, Tel Aviv Sourasky Medical Center.

Novak Djokovic holding the 2019 Wimbledon men’s trophy – his departure from Australia was not as glorious

A World Health Organization Emergencies Expert Committee has once again re-asserted a recommendation to abolish vaccine requirements for international travel – going well against the grain of current trends – particularly in light of the brouhaha seen over Sunday’s deportation of Serbian tennis star Novak Djokovic  from Australia.

The WHO expert group, made of some 19 representatives from different WHO regions and another dozen advisors, also recommended that all restrictions on  international travel between countries be removed –  or at least eased – saying that “they do not provide added value and continue to contribute to the economic and social stress” of various WHO member states.

While that latter recommendation is something that countries are already implementing in practice – the one regarding vaccine passports has received far less  support among WHO’s own member states so far – many of which have strengthened vaccine mandates for travel, work and leisure activities over past months, including moves by France on Sunday – stimulating more protests by anti-vax groups.

Tennis Star Case Highlights Clashing Approaches

The most vivid illustration of the starkly clashing approaches of the world health body and many of its leading donor governments was Australia’s deportation on Sunday of the vaccine-hesitant Djokovic, after he entered the country to compete in the Australia Open on the basis of his recent infection and recovery from COVID-19, only to be deported by Immigration Minister Alex Hawke after a nine-day long legal battle.

Now, it appears that the 20-time Grand Slam title holder may also be barred from attending the upcoming French Open tennis tournament, after France  tightened its travel rules to bar unvaccinated arrivals – and the Sports Ministry said Monday there would be no exemptions.

The current WHO recommendation, issued by the International Health Regulations Emergency Committee Wednesday evening, states bluntly in bold typeface that it recommends member states:

“Do NOT require proof of vaccination against COVID-19 for international travel as the only pathway or condition permitting international travel.”

But rather than concern about celebrities’ international access, the WHO expert group argues that such limitations are unfair, “given limited global access and inequitable distribution of COVID-19 vaccines.” It elaborates those concerns further in an interim paper on “considerations regarding proof of COVID-19 vaccination for international travellers.”

In addition, WHO also recommended a re-evaluation of testing and quarantine measures related to international travel, something the Agency has never supported wholeheartedly either.

The advice states: “State Parties should consider a risk-based approach to the facilitation of international travel by lifting or modifying measures, such as testing and/or quarantine requirements, when appropriate, in accordance with the WHO guidance.”

WHO experts also recommend lifting of travel bans on other countries

As for even more drastic travel bans, WHO’s recommendation is perhaps more in step with the current trends – that have seen countries lifting the bans after seeing that they failed to keep the new Omicron variant at bay.

In the WHO statement Wednesday, the Expert Committee recommended that countries, “Lift or ease international traffic bans as they do not provide added value and continue to contribute to the economic and social stress experienced by States Parties.

The Omicron wave has highlighted how such travel bans can boomerang.  Travel bans in November and December hit particularly hard and visibly against the South Africa and its neighbors – the very countries that first identified the variant – and announced it transparently to the world.  The result was global pummeling of their tourism-dependent economies and hamstrung travelers desperately trying to visit family for holidays from different corners of the globe.  Some countries imposed continent-wide bans against Africans before they were applied to Europe and the United States – even cases quickly appeared all over the world, prompting leaders like South African President Cyrus Ramaphosa to refer to “health apartheid” with respect to the travel rules, while UN Secretary General Antonio Guterres called it “travel apartheid” outright.

The WHO advice underlines those points stating that: “The failure of travel restrictions introduced after the detection and reporting of Omicron variant to limit international spread of Omicron demonstrates the ineffectiveness of such measures over time.”

That advice, however, also reiterates the Agency’s ambivalence over a range of other travel-related preventative measures as well, noting that “masking, testing, isolation/quarantine, and vaccination” should be based on “risk assessments, and avoid placing the financial burden on international travellers in accordance with Article 40 of the IHR.” It refers to the WHO advice for international traffic in relation to the SARS-CoV-2 Omicron variant for further guidance.

WHO uneasy with vaccine mandates generally

Katherine O’Brien, Director WHO Vaccines, Immunizations and Biologicals

While WHO has been adamant that every country in the world needs to get to a 70% vaccine coverage goal by mid-2022 – it has been equally reticent about using vaccine mandates domestic as well as international – as a carrot or stick to reach such ambitious vaccine goals.

In early December, WHO’s European Regional Director, Dr Hans Kluge declared that vaccine mandates even in countries with universal access to vaccines should only be an “absolute last resort, and only applicable when all other feasible options to improve vaccination uptake have been exhausted.”

Last week, in response to the Djokovic controversy, WHO’s Director of Immunization, Vaccines and Biologicals, was quoted by the Sydney Morning Herald saying that “Free and full access to safe and effective vaccines is the absolute precondition before a mandate is made and that is a grounding principle,” she said.

“It’s also a grounding reason why there is not a requirement from WHO, [there is not] a recommendation around any requirement for crossing international borders, although the status of somebody’s vaccination may be considered with respect to other conditions that may be imposed on people through the course of their travel.”

Image Credits: Wikipedia , AFP/Issouf Sanogo.

Merck laboratory that developed the new oral COVID treatment, molnupiravir

The Medicines Patent Pool (MPP) said Thursday that it had already signed agreements with 27 generic manufacturing companies for the manufacturing of the oral COVID-19 antiviral medication molnupiravir and supply in 105 low- and-middle-income countries (LMICs).

The sublicense agreements are the result of the voluntary licensing agreement signed by MPP and MSD in October 2021 to facilitate affordable global access for the new COVID treatment, one of two that has recently received approval from the US Food and Drug Administration.

In comparison with Pfizer’s Paxlovid, Monulpiravir emerged with lower efficacy ratings and more potential adverse effects, in the FDA’s final reviews of clinical trial results. This has dampened enthusiasm about the drug in some countries, including India which has so far refrained from recommending it as a COVID treatment. even though the drug is already in production with a local manufacturer.

Even so, experts also the Merck drug is still regarded as an important new tool in countries’ arsenals because it can be administered to certain patients unable to tolerate Paxlovid.

MPP licenses come even before WHO issues recommendation on use of new oral drugs

Strikingly, WHO has yet to approve either Paxlovid or monulpiravir – a step that is usually regarded as preliminary to the negotiation of manufacturing licenses by a UN-supported group like the MPP.

A WHO Guidelines Development Group meeting that is scheduled to review Paxlovid [nirmatrelvir] on 9 February, a WHO spokesperson told Health Policy Watch last week, but declined to comment on when the Merck drug will be reviewed.

The non-exclusive licenses allow generic manufacturers to produce the raw ingredients for molnupiravir and/or the finished drug itself.

In a press release, the Geneva-based MPP said that the companies that were offered the sublicense successfully demonstrated their ability to meet MPP’s requirements related to production capacity, regulatory compliance, and the ability to meet international standards for quality-assured medicines. Five companies will focus on producing the raw ingredients, 13 companies will produce both raw ingredient and the finished drug and 9 companies will produce the finished drug. The companies span 11 countries, Bangladesh, China, Egypt/Jordan, India, Indonesia, Kenya, Pakistan, South Africa, South Korea, and Vietnam.

While MSD negotiated an agreement with MPP that establishes the terms and conditions, the requests for sublicences from generic producers were reviewed solely by MPP and presented to MSD. Neither MSD nor its collaborators in the R&D at Ridgeback Biotherapeutics, nor Emory University, which invented the drug, will receive royalties from sales of molnupiravir from the MPP sublicensees while COVID-19 remains classified as a Public Health Emergency of International Concern by the World Health Organization.

“We are encouraged by the large number of new and existing partners that have moved quickly to secure a sublicence for molnupiravir through MPP,” said Charles Gore, MPP Executive Director. “This is a critical step toward ensuring global access to an urgently needed COVID-19 treatment and we are confident that, as manufacturers are working closely with regulatory authorities, the anticipated treatments will be rapidly available in LMICs.”

“Accelerating broad, affordable access to molnupiravir has been a priority for MSD from the start, which led us to partner with MPP on a licensing agreement to expand access to quality-assured generic versions of molnupiravir, subject to local regulatory authorisation,” said Paul Schaper, Executive Director, Global Public Policy, MSD. “We are pleased to see this vision come to life, with strong geographic diversity in MPP’s selected generic manufacturing sublicensees.”

More on MPP’s licence on molnupiravir and on the sublicence agreements : https://medicinespatentpool.org/licence-post/molnupiravir-mol

Image Credits: Merck .

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.”

UN Secretary General Antonio Guterres addresses the opening day of the World Economic Forum.

International financial institutions need to extend widespread debt relief to developing countries, and private sector companies need to mend “social contracts” with societies, and in order to “beat climate, beat COVID” fight hunger – and global financial instability, said UN Secretary General António Guterres. He was speaking on the opening day of the World Economic Forum, taking place online this week for the second year in a row, rather than at the posh Alpine ski resort of Davos.  

“I’ve been calling it a new global deal – the reform of international financial institutions and the way that international finance works,” Guterres said in a keynote address Monday evening.

Despite the virtual venue, the messages coming out of the conference were urgent, and at times  frenetic, with Guterres warning of massive economic woes and financial insecurity, as well social unrest and more climate disasters, if developing countries are unable to access sufficient debt relief to recover from the pandemic – and embark on a greener recovery. 

“If you fail to provide debt relief and financing to developing countries, we create a lopsided recovery that can send an interconnected global economy into a tailspin,” Guterres warned.

“And if you fail to match climate rhetoric with climate actions, we can then ourselves to a hotter, more volatile hers, with worsening disasters and mass displacement.”

“And at the core of these failures is a global inequities… Without immediate action to support developing countries, inequalities and poverty will be this will result in more social unrest and more violence,” Guterres said. 

Earlier in the day, a new WEF Global Risks 2022  report warned about “a world on fire” with climate change, ballooning debt in lower income countries, and linked to that social and food inecurities – while countries still battle pandemic flames.  

‘Our planet is on fire and we have to deal with it – this is a risk we know, we are not faced with a blind spot,’ said WEF president Borge Brende at a press briefing early Monday on the new Global Risks report, which tracks perceptions of risk among risk experts as well as world leaders in business, government and civil society.

‘Humans not good in the boiling frog scenario’ 

WEF president Borge Brende (left) at special address by UN Secretary General

We are faced with supply chain challenges, inflationary pressure and looming debt crises. I believe if we’re going to deal with these, with inequality and nature challenges, we need more private-public cooperation,” Brende added, of the report projections. 

Others expressed concerns that global solidarity on climate action has been far weaker than what has been seen in the fight against COVID-19 – however the fraught the latter may be with failures, including the lack of adequate vaccine coverage in Africa.

While countries continue reeling financially and socially from the COVID pandemic, “climate action failure and extreme weather events are seen as the most critical long-term risks,” said Peter Giger of the Swiss insurance giant Zurich. “And the strains of combatting the pandemic have limited even more countries’ abilities to respond. 

“Humans are not good in the boiling frog scenario, which is climate change; they’re much better in the fight or flight scenario, which has been the pandemic,” he added. 

Key Asks – Vaccine equity now; No new coal plants; Massive support & coalitions for green transition

Poverty and social inequity – Global Risks Report – 2022

Guterres, meanwhile, called upon countries to ensure that all nations reach the WHO 70% vaccination goal by mid-year – saying high income countries are “shamefully seven times higher than in African countries” in vaccine rates – and “we need vaccine equity now.”

To address the fractures seen at the Glasgow Climate Conference (COP26), he called upon the global community to support public-private “coalitions” that would muster “massive support” for investments in renewable energy, and channel those, along with technologies, to emerging economies. 

More action in Asia and Africa, along with momentum in developed economies, is critical to head off a projected 14% rise in climate emissions by 2030 under current scenarios – even if all current climate commitments are met, he asserted.

The aim should be clear, “phase out of coal… no new coal plants,” he said.

 “But let’s not go into blame and shame,” he added of countries such as India that have argued that they cannot afford a faster pace of change. “Let’s assist, help the emerging economies to accelerate the transition.

“I’m calling for the creation of coalitions – coalitions with countries, public and private financial institutions, investment funds, and companies that have the technological know-how to provide targeted financial and technical support for every country that needs the systems. 

“The governments of Vietnam and Indonesia have just announced their intention to get out of coal and to have a transition to renewable energy. But they need support.

“South Africa now has in place a ‘just energy transition’ with a partnership that involves a number of key countries and international financial institutions to support accelerating their moving out from coal. So we see a clear role for businesses and investors in supporting our net zero role.” 

India resists term “coalition” – but has accepted support for green energy transition 

Global Risks Report 2022

Not everyone has responded positively to his overtures, he admitted, saying that India had “doesn’t like” the idea of a “coalition” very much.  

At the same time, he added, “India has accepted several bilateral forms of support. And I’ve been in close contact with the US, the UK and several other countries to make sure that there is a strong project to support India, namely in their investment of 450 gigawatts of solar energy.” 

Whatever its name, the net results of such initiatives should be clear Guterres declared: “No new coal plants should be built. This must be a priority for us all.” 

“1.2C degrees of warming has already brought devastating consequences and price tags measured in dollars and despair. 

“Over the last two decades, the economic toll from climate related disasters skyrocketed by 82%.  Extreme weather in 2021 cost US$120 billion in insured losses and killed 10,000 people.  Climate shocks forced 30 million people to flee their homes in 2020 alone – three times more than those displaced by war and violence. 

And one billion children are at an extremely high risk of the impacts of climate change.” 

Environmental risks—in particular, “extreme weather” and “climate action failure”—appear as top risks in both the short-, medium-and long-term outlooks, according to the report. 

Social and environmental risks have worsened since the start of the COVID pandemic 

Among the other top findings of the Global Risks report were perceptions that along with health, climate and environment and the debt crisis, a broad range of other social risks have worsened since the start of the pandemic, with “social cohesion erosion”, “livelihood crises” and mental health also taking top spots. Other risks identified included, as having worsened significantly were migration, “cybersecurity failures”, “digital inequality” and an overall “backlash against science”.

Only 11% of respondents thought the world would be characterized by an accelerating global recovery towards 2024, while 89% perceived the short-term outlook to be volatile, fractured, or increasingly catastrophic.

Alongside those, are worries about a looming debt crises and “geoeconomic confrontations” between global and regional powers.  

Guterres – calling for expanded business partnerships in health, stronger WHO, more preparedness 

Gutteres also called for expading partnerships between the pharmaceutical industry and lower-income countries to transfer valuable medical know-how needed not only to fight this pandemic – but to prepare better for the future.  But he suggested that should be done voluntarily, through pharma’s voluntary expansion of licenses for vaccines and medical technologies. 

“We need pharmaceutical companies to stand in solidarity with developing countries by sharing licenses and new technology. So we can all find a way out of this pandemic,” he added. 

He also said that countries need to invest in primary health care, a stronger World Health Organization – and through those systems, “to prepare for the next pandemic.”

“We need to confront the pandemic with equity and fairness,” he stressed. “The last two years have demonstrated a simple but brutal truth if we leave anyone behind. In the end, we leave everyone behind. We fail to vaccinate every person, we give rise to new variants that spread across borders, and bring daily life and economies to a grinding halt. 

Global Risks Report 2022

World Economic Forum – taking place under a shadow 

“This year’s World Economic Forum takes place in the shadow of an enormously difficult period for economies for people and for the planet,” Guterres added in his address. “According to the UN’s economic report released last week, the world is emerging from the depths of a paralyzing economic crisis, but recovery remains fragile,” Guterres said. “

And then even the lingering pandemic, persistent labor market challenges, ongoing supply chain disruptions, rising inflation, and looming debt traps, not to mention the geopolitical divide. 

“And as a result, we see recovery slowing down quite substantially. And all of this threatens our own progress in advancing the 2030 agenda, and the Sustainable Development Goals, our key projects.” 

Image Credits: Global Risks Report 2022 – World Economic Forum , World Economic Forum .

An Israeli woman gets a COVID-19 vaccine.

A fourth COVID-19 booster mRNA vaccine has proven ineffective against Omicron infection, according to preliminary research from Israel released on Monday.

“Despite a significant increase in antibodies after the fourth vaccine, this protection is only partially effective against the Omicron strain, which is relatively resistant to the vaccine,” lead researcher Prof Gili Regev-Yochay, told a media briefing on Monday.

Some 154 health workers at Sheba Medical Center received their fourth Pfizer shot two weeks ago. A week ago, 120 healthworkers received a shot of Moderna following three doses of Pfizer one week ago.

They were matched with a control group of around 6,000 health workers who have been being followed by the hospital since the start of Israel’s vaccination campaign in December 2020. 

According to Regev-Yochay, the third dose resulted in “much higher antibodies, neutralization and the antibodies were not just higher in quantity but also in quality” than the second dose – but the fourth vaccine did not show  significant antibody increase.

”Maybe there are a few more antibodies but not much more compared to the third dose,” said Regev-Yochay.

Last week, she told Israeli Prime Minister Naftali Bennett that there had been a five-fold increase in antibodies in people who took the fourth dose, but she later told a radio station that “the amount of antibodies returns to the level it was after the third vaccine, not more. It’s nice, but it’s not what we expect from a booster.”

In addition, around the same percentage of hospital workers who received the fourth dose caught the virus as those who didn’t get the fourth booster. 

Booster demand may affect global supply

Meanwhile, the European Medicines Agency (EMA) cautioned last week that there was no evidence to back a fourth booster, warning that repeat boosters every four months might actually weaken people’s immune systems.

Boosters “can be done once, or maybe twice, but it’s not something that we can think should be repeated constantly,” said Marco Cavaleri, the EMA head of biological health threats and vaccines strategy, said at a press briefing last week, as reported by Bloomberg.

Instead, the agency recommended that boosters should be tied to the cold season with longer intervals.

The World Health Organization (WHO) has also warned repeatedly against boosters while a high percentage of people in low and middle-income countries – estimated to be over 40% of the world’s population – are unvaccinated, fearing boosters will lower the number of vaccine doses available to these countries.

“With near- and medium-term supply of the available vaccines, the need for equity in access to vaccines across countries to achieve global public health goals, programmatic considerations including vaccine demand, and evolution of the virus, a vaccination strategy based on repeated booster doses of the original vaccine composition is unlikely to be appropriate or sustainable,” the WHO said on 11 January.

Vast majority of Omicron patients in hospitals are unvaccinated

Meanwhile, the latest research from South Africa, New York City and California show that the vast majority of people hospitalised by the COVID-19 Omicron variant are unvaccinated – but that they still experienced less severe disease than those infected with Delta.

South Africa reported that around 82% of those hospitalised during its Omicron-fueled fourth wave were unvaccinated.

Hospital statistics of over 128,000 patients with Delta and almost 35,000 patients with Omicron, showed those with Omicron fared significantly better than those with Delta. 

In the Delta group, 26.4% of patients, 14.6% were admitted to ICU and 63% had severe disease.

South Africa Omicron vs Delta, NICD January 2022

In comparison, only 9.7% of those with Omicron died, while 5.8% were admitted to ICU and 31.7% had severe illness, according to a presentation by the National Institute of Communicable Diseases delivered at a media briefing hosted by South African Department of Health last Friday.

A similar trend was reported by the New York City (NYC) Health Department, which reported that about 2% of Omicron cases were hospitalised in comparison to around 5% of Delta cases.

About half the proportion of NYC hospitalized patients required intensive care during the Omicron wave compared to the peak of the winter 2020-2021 wave – about 11% versus about 20%, according to a NYC health department report released late last week. 

“In NYC, those most likely to be hospitalized are people who are not vaccinated, and a higher proportion of Black New Yorkers and people age 75 and older were hospitalized,” according to the report.

“New Yorkers who were not vaccinated were more than eight times more likely to be hospitalized compared to New Yorkers who were fully vaccinated, early in the Omicron wave. Differences in health outcomes among racial and ethnic groups are due to long-term structural racism, not biological or personal traits,” it added.

In addition, a pre-print study of COVID-19 cases in southern California compiled by Kaiser Permanente of over 52,000 Omicron infections and almost 17,000 Delta infections, found 0.5% of hospital admissions for Omicron patients and  1.3% for those infected with the Delta variant.

Rates of ICU admission from Omicron patients were 0.26 fold those of Delta, while mortality for Omicron patients was 0.09 fold that of Delta patients.

No Omicron patients received mechanical ventilation in comparison to 11 Delta patients, and Omicron patients stayed in hospital on average 3.4 days less than Delta patients.

 

Image Credits: Maccabi Health Services, Clalit Health Fund .