Major pharmaceutical companies have offered to reserve a “real-time allocation” of vaccines and treatments upfront for “priority populations in lower-income countries” in future pandemics – providing the G7 and G20 also help low-income countries finance and make effective use of the products.

Launching its Berlin Declaration on Tuesday, the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) acknowledged that there has been an inequitable distribution of COVID-19 products, which it attributed to “inadequate financing mechanisms upfront and a lack of country readiness”.

It calls for  “strong, fully funded international procurement mechanisms”  for pandemic vaccines, therapeutics and diagnostics (VTD) for lower-income countries that can forecast demand and sign advanced purchase agreements with industry early in a pandemic. 

“Each company will take measures, in partnership with governments, to help ensure that authorized pandemic vaccines and treatments are available and affordable in countries of all income levels, including via donations, not-for-profit supply, voluntary licenses or equity-based tiered pricing based on countries’ needs and capabilities, or any other innovative mechanism as during COVID-19,” according to the IFPMA.

Stronger health systems

However, a “prerequisite” for the success of more equitable access rests on improving health systems in lower-income countries to ensure that they “are better prepared to absorb and deliver vaccines and treatments”  – and the willingness of high-income countries to “provide the necessary political and financial support” to achieve this, says the IFPMA. 

The IFPMA also says that the success of its declaration depends on “a strong innovation ecosystem, grounded in intellectual property rights, and the removal of trade and regulatory barriers to export”.

“Intellectual property rights should be respected since society depends on them to stimulate innovation and the scale-up of supply,” according to the declaration, which has been named “Berlin” in recognition of Germany’s leadership role as President of the G7.

The pharmaceutical industry has lobbied vehemently against any relaxation of IP rights for COVID-19 products, putting it at loggerheads with health activists and a number of governments in low and middle-income countries.

Better protected

The IFPMA’s future pandemic preparedness plan, which it aims to sell to world leaders in upcoming meetings, is based on “innovation, manufacturing scale-up, and planning ahead for equitable access”.

“With all stakeholders collaborating and playing their part, we can make sure that the efforts, investments, learnings and losses seen during COVID-19 are not in vain, but rather help shape a future where everyone is better protected from the threat of pandemics,” said Thomas Cueni, Director General of IFPMA.

“Our proposal is just a first step along the way to what I believe has the potential to be a transformational solution for future pandemics.” 

The declaration commits pharma to three key issues:

  • working with regulators and other stakeholders to establish streamlined approaches to develop and deliver new quality, safe and effective vaccines and treatments even faster in the future;
  • supporting collaborations, a geographically diverse sustainable manufacturing footprint and mechanisms for rapidly scaling-up supply in a future pandemic; 
  • planning ahead to ensure equitable access and delivery of pandemic products, including identifying priority groups such as health workers and high-risk individuals, who “should be vaccinated first, regardless of the country they live in”.

“We will build on existing manufacturing partnerships, business-to-business agreements set up in advance, ongoing capability development and voluntary licensing and/ or early, voluntary technology transfer where this will facilitate rather than impede scale up and global supply,” says the IFPMA. 

It also appealed to governments to commit to unrestricted trade, no export bans across the vaccine-treatments-diagnostics supply chain and expedited processes for import and export during a pandemic.

 Pharma proposes to work with G7 and G20 on a joint solution for better access to vaccines and treatments around the world for future pandemics 

Jean-Christophe Tellier, IFPMA President and CEO of UCB, said “we applaud Germany’s leadership of the G7’s pandemic response and trust that our declaration is seen by world leaders as a practical proposal to build greater equitable access into future pandemic response. 

“For this potentially life-saving concept to become reality, we will need to work with G7, and later this year in Bali with G20 to flesh out how to make it work. The reward if successful will help shape a future where everyone has a chance to be better protected from the threat of pandemics from the outset, no matter where they live.”

José Manuel Barroso, Gavi chair and co-chair of COVAX, the global COVID vaccine access platform, applauded the IFPMA and industry leaders for “seizing the initiative”. 

“We saw effective innovation and manufacturing scaling up with this pandemic; but we also saw the challenges we had to overcome to get the vaccines to all those who needed them,” said Barroso.

“The industry’s commitment to reserve part of production of vaccines and treatments at real time for vulnerable populations in low-income countries provides an opportunity to work together strategically to forge a new social contract. I hope that political leaders will do their part and engage with industry on how to make this work.”

Image Credits: Glsun Mall/ Unsplash.

member state
WHO member states meet to discuss details of a proposed international pandemic convention or other legal accord 18 July 2022 in Geneva

The first day of WHO member state talks on a proposed new Pandemic Convention or Treaty opened with broad agreement that the new legal instrument should complement – but not repeat – provisions of the existing International Health Regulations – while respecting national sovereignty in terms of public health responses. 

But the hours of debate over the definitions, principles and scope of an initial “working draft” developed by a “Bureau” of six member states from every WHO region, reflected the enormity of the task they face in reaching beyond high-minded rhetoric about how the new instrument  should align to principles of equity, preparedness and “One Health”, to binding rules and obligations acceptable to all 194 WHO member states. 

Member states are meeting under the auspices of the second meeting of the WHO Intergovernmental Negotiating Body (INB) to try move along the initial framing of the new legal accord – which is expected to take two years or more to actually negotiate.

“The new instrument should seek to address clearly identified gaps that cannot be resolved through IHR amendments…  Otherwise there would be no need for a new instrument,” said Kenya’s delegate at the outset of the meeting – echoing a point that had wide agreement among member states. 

Other points that won wide agreement included the importance of linking the new accord to the fight against antimicrobial resistance as well as better application of “One Health” principles of preserving ecosystem balances that can also limit the spillover of animal pathogens into human communities.   

However fissures on other simmering issues, such as rights over R&D related to pandemic response as well as national rights to genomic sequences of pathogens, soon became apparent.  A range of Asian, African and Latin America  member states, including South Africa, stressed that public health responses to the pandemic, as well as “investments in research and development for countermeasures” should be “treated as public goods and accounted for as such.”

Genomic ‘information’ also sure to be a hot topic

Delegate from Malaysia at INB meeting, 18 July 2022.

South Africa, as well as other countries, including Malaysia, also stressed that pathogens’ genomic sequence data – or as Malaysia requested “genomic information” – should be shared in exchange for the promise of benefits from those entities, primarily pharma, which make use of such data to develop new vaccines and treatments then sold commercially. 

“It is critical for us to specify from the outset that data, and genomic sequencing sharing and benefits will be shared equitably,” South Africa’s delegate stated at the meeting. 

Those statements cut to the heart of a smoldering controversy over pending revisions in the Nagoya Protocol to the Convention on Biodiversity – to be considered at the Montreal Conference of Parties 5-15 December.  Those revisions could see the genomics information of pathogens included as part of a country’s biodiverse natural resources – entitling national governments to demand benefits if they share that genomics sequences or similar data with researchers for medicines and vaccines development. 

On the other end of the spectrum, a number of developed countries, including the European Union, stressed the importance of strengthening references to “better collaboration, surveillance and early detection”  – as key pillars of any new agreement.   

How legally ‘binding’ will the new instrument really be? 

China’s delegate to the INB

At this week’s meeting member states have been asked to decide whether the new legal instrument would be formally positioned as a legally-binding convention under Article 19 of WHO’s Constitution, or new, legally binding regulations under Article 21. The implications of those choices are outlined in a WHO background document, made available to member states last week. 

Regardless of which route is chosen, the final document could still include a mix of “both legally binding and non-legally binding provisions, with the non-binding provisions being, for example, recitals, principles, recommendations or aspirations,” stated the background document, drafted by WHO’s legal team, noting that, “This practice is, in fact, standard both in WHO1 and with other international instruments.”

Speaking at the meeting, both Russia and China said that the final stance of member states on many of the articles contained in the working draft, may be based upon the final decision by member states of “how legally binding” the new instrument will indeed be. 

“Whether it’s under Article 19 or 21, should the nature of the instrument be a Framework Convention, containing only guidance in principle or a regulation with detailed and implementable actions?” China asked in Monday morning’s session.  

Added Russia, in the afternoon session.  “We must decide by the first of August what kind of document this will be,” although it added that “we see a general trend or direction that we’re moving in, looking at the structure of the document, which is a reminder of the Framework Convention on Tobacco Control.

“But all the same, we need some clarification.  Will there be another opportunity to comment on the content of the document after we adopt the decision on the fate of this document – of the kind of Article of the WHO Constitution that will be applied here?”

In terms of defining the new agreement’s scope, Beijing also recommended that the “Bureau conduct an in-depth investigation of the deficiencies found in the current pandemic and to past emergencies, and to analyze existing international instruments such as the IHR to clarify the issues to be addressed by the pandemic treaty.. In other words, the scope of work.”

That demand seemed to ignore the fact that no less than three external review bodies, including and IHR review committee, a WHO health emergencies review committee and the Independent Panel, have already conducted such reviews over the past two years. 

Wordsmithing – a massive task 

What remains clear is that the INB “Bureau” together with the WHO legal team face a massive task of redaction – not only of thorny substantive issues – but also of countless ‘editorial’ issues ‘related to definitions, organization and wordsmithing of the draft text – before it is submitted to member states as a “Zero Draft” over which countries would begin formal negotiations.   

Over the course of Monday, delegates from several dozen states went  paragraph by paragraph with proposed textual changes to what has been drafted by the INB “Bureau” as a preliminary, working draft.  

Many delegates requested extensive new framing terminology in the documents’  initial sections – to make stronger reference to equity, human and gender rights, for instance. 

At the same time, others pointed out that the lengthy preliminaries – which include both a Preamble, a Vision statement, followed by an Introduction – with a set of as yet incomplete definitions of terms including what constitutes a ‘Pandemic’ – was unduly bulky.

The document, its WHO drafters acknowledged, incorporated numerous texts and references not only from the WHO documents including the: IHR, FCTC, and Pandemic Influenza Preparedness Framework (the PIP), but also from the Paris Climate Agreement, the UN Framework Convention and Climate Change (UNFCCC) and the Convention on Biological Diversity, and the CBD’s related Nagoya Protocol.  

Loyce Pace, US Assistant Secretary for Global Affairs

“It’s nice to have a living document.  It’s not quite a Zero draft,” said US Assistant Secretary for Global Affairs Loyce Pace, who attended the meeting along with Colin McIff, Deputy Director, of the US Health And Human Services Office of Global Affairs.  “The Preamble, vision Parts 1 and 2  overlap and risk being repetitive,” she added.  

“‘There is a saying that ‘less is more’ and we are inclined to think that a shorter and more targeted preamble could work better,” said New Zealand’s delegate, noting that some of the best known UN instruments like the UN Convention on the Law of the Sea include a preamble of less than a dozen paragraphs. 

The African Union executive council meeting has selected Rwanda to host the AMA.

Rwanda has been selected to host the headquarters of the African Medicines Agency (AMA) by the Executive Council of the African Union (AU) at a meeting held in the Zambian capital of Lusaka on Saturday.

The council agreed that AMA will enhance the capacity of AU state parties and the continent’s Regional Economic Communities (RECs) to regulate medical products, and to improve Africa’s access to quality safe, and efficacious medical products.

“AMA will also support the creation of an enabling environment for pharmaceutical manufacturing on the continent,” AU announced, describing the agency as the second specialized health agency of the AU after the Africa Centres for Disease Control and Prevention (Africa CDC).

Rwanda had submitted an expression of interest in hosting the AMA headquarters along with Uganda, Algeria, Egypt, Morocco, Tanzania, Tunisia and Zimbabwe, as Health Policy Watch reported in June.

The World Health Organization’s (WHO) Director General, Dr Tedros Adhanom Ghebreyesus, congratulated Rwanda and pledged the WHO’s support for the AMA.

“Congratulations Rwanda on the selection to host the African Medicines Agency (AMA). WHO will continue to provide technical & financial support to the AMA to ensure all people across the continent have equitable access to safe, quality medicines & medical products,” he tweeted.

Nuur Mohamud Sheekh, Spokesperson for the Executive Secretary of the Intergovernmental Authority on Development (IGAD), a regional development organization in East Africa, described hosting the AMA Headquarters as the latest achievement for Rwanda, which is already a leading technology destination on the continent.

Valens Munyabagisha, former president of Rwanda’s Olympic Committee, also attributed the selection of Rwanda as host country for AMA Headquarters as “good news and undoubtedly [the] result of good leadership”.

But Dr Ereck Chakauya, network manager of the AUDA NEPAD Southern Africa Network for Biosciences, noted that the priority should now be on delivering the promises of the initiative which includes boosting Africa’s manufacturing capacities for vaccines, drugs and others products.

“Congratulations Rwanda. Lets get on with making stuff. We have gone round the mountain for too long, now is the time to make vaccines for ourselves. Let’s give ourselves five years to make five drugs for the top five diseases of importance in Africa,” he said.

Next step: Finances and staff

 

“It’s encouraging to see progress made in the operationalisation of the AMA, and we must build on this momentum to ensure that more countries ratify the treaty establishing the agency. The next step is to ensure the AMA has the financial resources and is adequately staffed to deliver on its ambition,” said Greg Perry, Assistant Director-General of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA).

“Africa’s 55 nations and nearly 1.4 billion people need to benefit from a harmonized regulatory system for medical products – vaccines, treatments, diagnostics and other healthcare products. The AMA can make good on that promise,” he added.

“The AMA will facilitate collaboration, work-sharing and the use of reliance procedures between regulators that will enable faster approval processes, allowing a better allocation of resources and cutting down on the waiting time for patients to access medicines and ensuring a steady supply of medicines.”

The IFPMA  is part of the African Medicines Agency Treaty Alliance (AMATA), and works with regulatory authorities, the pharmaceutical industry in Africa, and relevant regulatory stakeholders to encourage greater harmonization and convergence of regulatory requirements.

Meanwhile, AMATA said the COVID-19 pandemic has “highlighted the importance of regulatory harmonisation in the context of public health emergencies and the need for a competent continent-wide regulatory authority to approve and monitor vaccines, repurposed medicines, innovative medicines and health technologies, in a timely manner”.

“The AMA will reduce the complexity of regulatory frameworks and hence enable all patients in Africa to have timely access to quality medicines that are safe and effective. We now call upon the remaining African Union Member States who have yet to ratify and deposit their AMA Treaty instruments to do so urgently so we can build on the current momentum gained with this major milestone,” said AMATA.

Thirty-one of the African Union’s 55 member states have now signed and/or ratified the AMA Treaty, with Ethiopia the latest to sign as of May 2022.

As the countdown for other nations to sign continues, Health Policy Watch is tracking progress on our AMA Countdown, website developed in collaboration with the African Medicines Agency Treaty Alliance.

Africa CDC granted autonomous status

The AU’s Executive Council also adopted the amended statute of the Africa Centres for Disease Control and Prevention as an autonomous health body

Prof Stanley Okolo, CEO of the West African Health Organization (WAHO), described the development as “a milestone which enhances Africa CDC’s ability to safeguard the health of the African population and contribute to global health security.”

Dr Matshidiso Moeti, WHO’s Regional Director for Africa,– also congratulated the Africa CDC on the adoption of its amended statute.

“A big congratulations to Africa CDC for their statute as an autonomous health body. I look forward to our continued collaboration in support of health security on the continent, as well as many other pressing health issues,” she tweeted.

Previously, Health Policy Watch reported that the WHO expressed concerns regarding the inclusion of power to declare a Public Health Emergency of Continental Security in Africa CDC’s amended statute.

Ahmed Ogwell Ouma, Africa CDC’s Acting Director, spoke at the AU’s recently held Executive Council meeting

However, Ahmed Ogwell Ouma, Africa CDC’s Acting Director, said the move is necessary to ensure that the Africa CDC does not have to wait for a long time for a public health emergency of international concern (PHEIC) pronouncement to be made by the WHO before swinging into full action. 

“That is our expectation indeed. And that is the expectation of the African Union. That is why this request has been made,” Ouma said.

See our coverage on the development of the African Medicines Agency and the countdown for AU member states to formally ratify the AMA Convention here:

African Medicines Agency Countdown

vaccinations
Healthcare workers in Nigeria fight to maintain routine childhood vaccination services during the COVID-19 pandemic.

The World Health Organization and UNICEF have sounded the alarm on the largest sustained decline in global childhood vaccinations in approximately 30 years, with 25 million infants missing out on lifesaving routine vaccines. 

The percentage of children who received three doses of vaccine against diphtheria, tetanus and pertussis (DTP3) – a marker for immunization coverage within and across countries – continues to decline, falling 5 percentage points between 2019 and 2021 to 81%. 

As a result, 25 million children missed out on one or more doses of DTP through routine immunization services in 2021 alone. This is 2 million more than those who missed out in 2020 and 6 million more than 2019, highlighting that there are a growing number of children at risk from devastating but preventable diseases. 

“This is a red alert for child health. We are witnessing the largest sustained drop in childhood immunization in a generation. The consequences will be measured in lives,” said Catherine Russell, UNICEF Executive Director, in a joint WHO and UNICEF news release. 

The decline has been attributed to many factors, including an increased number of children living in conflict and fragile settings where immunization access may be difficult; increased misinformation; and COVID-19 related issues such as service and supply chain disruptions. 

Russel acknowledged the disruptions caused by COVID-19, but stated that this “was not an excuse.”

“We need immunization catch-ups for the missing millions or we will inevitably witness more outbreaks, more sick children and greater pressure on already strained health systems.”

Majority of children who missed DTP doses from low- and middle-income countries 

18 million of the 25 million children did not receive a single dose of DTP during the year, the vast majority from low- and middle-income countries. India, Nigeria, Indonesia, Ethiopia, and the Philippines recorded the highest numbers of unvaccinated children. 

Myanmar and Mozambique are among countries that recorded the largest relative increases in the number of children who did not receive a single vaccine between 2019 and 2021. 

Overall, vaccine coverage has dropped in every region, with the East Asia and Pacific region recording the steepest reversal in DTP3 coverage, falling 9% in just two years. 

While many thought that 2021 would be a year of recovery in which strained immunization programmes would rebuild and those children missed in 2020 immunizations would be caught up, instead, DTP3 coverage was set back to its lowest levels since 2008. 

This has pushed the world off-track to meet global goals, including the immunization indicator for the Sustainable Development Goals. 

HPV vaccine coverage progress lost in 2021 

A young girl gets vaccinated against HPV in Sao Paulo, Brazil.

In addition to declining DTP vaccinations, over a quarter of the global coverage of HPV vaccines that was achieved in 2019 has been lost. 

3.5 million children had missed the first dose of the HPV vaccine, which protects girls against cervical cancer, in 2021. 

This has grave consequences for the health of women and girls, as global coverage of the first dose of human papillomavirus (HPV) vaccine is only 15%, despite the first vaccines being licensed over 15 years ago.

Uganda and Pakistan resisted coverage declines 

Children in Pakistan show proof of vaccination against polio.

However, some countries were able to hold off declines in vaccination coverage. Uganda maintained high levels of routine immunization programs whilst rolling out a targeted COVID-19 vaccination programme to protect priority populations, including health workers.

Pakistan also returned to pre-pandemic levels of coverage thanks to high levels of commitment and significant catch-up immunization efforts. 

“To achieve this in the midst of a pandemic, when healthcare systems and health workers were under significant strain, should be applauded,” the joint WHO and UNICEF press release reads. 

Avoidable outbreaks of measles and polio result from inadequate coverage 

Health worker vaccinates young child against measles

In the past twelve months, avoidable outbreaks of measles and polio have occurred as a result of inadequate coverage levels, underscoring the vital role of immunization to keep children, adolescents, adults, and societies healthy. 

First dose measles coverage had dropped to 81% in 2021, also the lowest since 2008, which meant 24.7 million children missed their first measles dose in 2021, 5.3 million more than 2019. 6.7 million children had also missed a third dose of the polio vaccine in 2021. 

The drop in measles coverage had led to declaration of a measles outbreak in the southern African country of Malawi in March. In response, WHO had launched a mass vaccination campaign in order to reach 23 million children across five countries – Malawi, Mozambique, Tanzania, and Zambia, and Zimbabwe.

“Planning and tackling COVID-19 should also go hand-in-hand with vaccinating for killer diseases like measles, pneumonia and diarrhea,” said Dr Tedros Adhanom Ghebreyesus, WHO Director-General. “It’s not a question of either/or, it’s possible to do both”.

WHO and UNICEF are working with Gavi, the Vaccine alliance, and other partners to deliver the global Immunization Agenda 2030 (IA2030), a strategy for all countries and global partners to achieve set goals on preventing diseases through immunization and vaccines for everyone. 

Gavi had also launched a $100 million initiative to identify and reach zero-dose children – those without a single routine shot, earlier in June 2022. 

“It’s heart-breaking to see more children losing out on protection from preventable diseases for a second year in a row,” said Dr Seth Berkley, CEO of Gavi, the Vaccine Alliance.

“The priority of the Alliance must be to help countries to maintain, restore and strengthen routine immunization alongside executing ambitious COVID-19 vaccination plans, not just through vaccines but also tailored structural support for the health systems that will administer them,”

Image Credits: Twitter: @WHOAFRO, WHO PAHO, UNICEF Pakistan, WHO/John Kisimir.

Methicillin-Resistant Staphylococcus aureus (MRSA), a notorious bacteria resistant to many antibiotics.

Researchers worldwide are searching for ways to reduce dependence on antibiotics to preserve these life-saving medicines in the face of the rise in antibiotic-resistant bacteria.

Drug resistance is currently implicated in 700,000 deaths each year, and the World Health Organization (WHO) raised the red flag last month over the lack of new antibacterial treatments being developed to address the mounting threat of AMR.

A new study conducted at Israel’s Ben-Gurion University and published recently in the peer-reviewed journal Pharmaceutics, showed that a substance found in broccoli called 3,3′-diindolylmethane (DIM) can reduce resistance to certain antibiotics.

The study was led by Prof Ariel Kushmaro and Dr Karina Golberg of BGU’s Avram and Stella Goldstein-Goren Department of Biotechnology Engineering.

What is DIM?

DIM is a natural substance that is already used in high doses in the treatment of some cancers. The new study found that DIM in low concentration can disrupt “quorum communication” among bacteria and prevent them from doing human harm.

Quorum communication allows bacteria to share information about cell density and adjust their gene expression accordingly, forming bacterial biofilms that protect bacteria from being eradicated by antibiotics.

“Drug-resistant biofilm-forming bacteria are known to pose an even greater threat once they have already infected and damaged healthy tissue, therefore the addition of an anti-biofilm compound to traditional antibiotic treatments may improve treatment outcomes,” the researchers wrote in their paper.

DIM could help, they showed.

Pharmaceutics 14 00967 g001
Figure 1. Prevention of the formation of biofilm by A. baumannii (A) and P. aeruginosa PA01 (B) in a flow system during 48 h of incubation with continuous supplementation of 50 μM DIM. Biofilms were stained with the live/dead bacterial viability kit. Quantification of live, dead, and total bio-volumes (μm3/μm2) based on image analysis and data from the IMARIS software together with % biofilm inhibition. Images were acquired from three different areas in each treatment, three independent repetitions. Asterisks indicate significant differences compared to control (independent samples t-test; *** p < 0.001).

The research findings show that the biofilm formation of two of the most prioritized bacterial pathogens, Acinetobacter baumannii and Pseudomonas aeruginosa, was inhibited by 65% and 70% respectively.

When tested in combination with the antibiotic Tobramycin, it was found that the DIM improved its ability to work and helped eliminate the bacterial resistance to it, suggesting that DIM may play a role in salvaging antibiotic potency. Specifically, combining the antibiotic with DIM enabled a 94% inhibition of P. aeruginosa biofilm.

Finally, the study also showed that DIM has an anti-inflammatory effect.

Effective on wounds

In a separate experiment, the scientists used DIM on infected wounds in an animal model and found that the wounds healed faster and more effectively than with antibiotics.

“When you are using antibiotics, your aim is to kill the bacteria,” Kushmaro told Health Policy Watch. “When we are using other materials, like DIM, we are only blocking the communication… If you are using antibiotics you will eventually have resistance. If you use materials that are just jamming communication, then you are more likely to have less resistance to this material.”

He said that what is also important is that DIM is already a known material that has passed all the necessary clinical safety trials in human beings, so developing it as a treatment or a food additive will be faster than other drugs or materials.

“Drug repurposing, involving the identification of new applications of an approved medication beyond the scope of its original specification, is gaining considerable attention in recent years,” the researchers wrote in their paper.

For animals first

Further development and commercialization of the technology is being done by a startup company, LifeMatters. Kushmaro said the business model is to get DIM approved first as a food additive and treatment in the agriculture arena, such as an additive to chicken, goat and cow feed, which could improve animal health. Only afterwards would they work towards approval for use in humans.

Presently, animals are the largest consumers of antimicrobial drugs – and thus the leading factor driving antimicrobial resistance, Health Policy Watch reported in May.

Kushmaro believes DIM could be approved for animal use within the next five years, and human use in the next 10 to 15.

“Today, after many years of research, we are confident that in the future DIM and other microbial communication disruptors will completely replace antibiotics,” Kushmaro said. “Our findings show promise for other avenues of research in addition to known classes of antibiotics.”

Image Credits: NIAID.

Young men under 40 are most at risk of harm after drinking more than a mere 10th of a standard drink

Alcohol has no benefits for people under the age of 40, but drinking a small amount of alcohol by healthy people over 40 might have some health benefits, according to a study conducted by the Global Burden of Disease study, published in The Lancet on Friday.

The study – the first to report alcohol risk by region, age and sex – suggests that the strictest drinking guidelines should be targeted at young men, who are at the greatest risk of harmful alcohol consumption worldwide.

Around 60% of alcohol-related injuries occur in people under 50, including motor vehicle crashes, suicides and homicides. 

For those over 40, consuming a small amount of alcohol (for example, less than two small glasses of red wine per day) can provide some health benefits, such as reducing the risk of cardiovascular disease, stroke, and diabetes.  

Using estimates of alcohol use in 204 countries, researchers calculated that 1.34 billion people consumed harmful amounts in 2020. In every region, and the group drinking the most unsafe amounts of alcohol were men aged 15–39.

Young men could only consume one-tenth of a standard drink and young women a quarter of a standard drink before incurring health risks, according to the study. It defines a standard drink as 10 grams of pure alcohol – the equivalent of a 100ml glass of red wine (13% alcohol by volume), a 375ml can of beer (3.5% alcohol volume), or a single 30ml shot of spirits (40% alcohol by volume).

“Our message is simple: young people should not drink, but older people may benefit from drinking small amounts,” said senior author Dr Emmanuela Gakidou, from the University of Washington’s Institute for Health Metrics and Evaluation (IHME).

“While it may not be realistic to think young adults will abstain from drinking, we do think it’s important to communicate the latest evidence so that everyone can make informed decisions about their health.”

Risk calculations from 204 countries

The researchers looked at the risk of alcohol consumption on 22 health outcomes, including injuries, cardiovascular diseases, and cancers using 2020 Global Burden of Disease data for males and females aged 15–95 years and older between 1990 and 2020, in 204 countries and territories. 

From this, they could estimate the average daily intake of alcohol that minimises risk to a population, as well as how much alcohol a person can drink before taking on excess risk to their health in comparison to someone who does not drink any alcohol.

There were substantial variations in risk across regions. For example, for people aged 55–59 years in North Africa and the Middle East, 30.7% of alcohol-related health risks were due to cardiovascular disease, 12.6% were due to cancers, and less than 1% were due to tuberculosis. 

In this same age group in central sub-Saharan Africa, 20% of alcohol-related health risks were due to cardiovascular disease, 9.8% to cancers, and 10.1% to tuberculosis. 

Overall, the recommended alcohol intake for adults remained low, at between zero and 1.87 standard drinks per day, regardless of geography, age, sex, or year.

“Even if a conservative approach is taken and the lowest level of safe consumption is used to set policy recommendations, this implies that the recommended level of alcohol consumption is still too high for younger populations,” said lead author Dana Bryazka, a researcher at IHME.

“Our estimates, based on currently available evidence, support guidelines that differ by age and region. Understanding the variation in the level of alcohol consumption that minimises the risk of health loss for populations can aid in setting effective consumption guidelines, supporting alcohol control policies, monitoring progress in reducing harmful alcohol use, and designing public health risk messaging.”

Image Credits: Taylor Brandon/ Unsplash.

Vaccine manufacturers are in a race to develop or tweak COVID-19 vaccines to address the Omicron variants that are sweeping through the globe – and get them ready for use as boosters when the weather cools in the northern hemisphere.

More infectious Omicron strains BA.4 and BA.5 have become dominant in many parts of the world and while they appear less virulent, they have mutated to be more capable of evading neutralizing antibodies generated by vaccinated people.

BA.4/5 showed 4.2-fold more resistance to sera from vaccinated and boosted people according to research from Qian Wang, David Ho and colleagues published in a recent preprint article.

Pfizer and Moderna dominate 

Nine candidate vaccines are in the pipeline that offer “multi-variant vaccines, booster vaccines, or vaccines targeting Omicron”, according to UNICEF’s COVID-19 Vaccine Market Dashboard.

But market leaders Pfizer-BioNTech and Moderna have the upper hand and are racing ahead with tweaks to their vaccines to ensure Omicron-ready boosters can be manufactured and ready within months.

In late June, Pfizer-BioNTech announced preliminary results for their vaccine tweaked to combat Omicron BA.1 that “elicited a 13.5 and 19.6-fold increase in neutralizing geometric titers against Omicron BA.1” – and was also effective in neutralising BA.4/BA.5 – but “with titers approximately three-fold lower than BA.1”. 

Moderna booster targets Omicron BA.4 and BA.5 

This week, Moderna announced preliminary results from trials of its Omicron candidate booster vaccine – mRNA-1273.214  – which showed a 6.3-fold rise in neutralizing antibodies against BA.4 and BA.5 strains in comparison to a 3.5-fold increase elicited by the original vaccine.

“One month after booster, BA.4/5 neutralizing titers were 776 for mRNA-1273.214 and 458 for the currently authorized booster,” according to Moderna, which is also working on a second booster called mRNA 1273.222, that specifically targets BA.4/ 5.

“This superior breadth and durability of immune response following a bivalent booster has now been shown in multiple Phase 2/3 studies involving thousands of participants,” said Moderna CEO Stephane Bancel. “We are working with regulators to advance two bivalent vaccine candidates, mRNA-1273.214 and mRNA-1273.222, based on different market preferences for Omicron subvariants, clinical data requirements, and urgency of starting fall booster campaigns for vulnerable populations.”

The race to develop Omicron-specific boosters accelerated after the US Food and Drug Administration (FDA) recommended the inclusion of an Omicron component in COVID-19 booster vaccines after a meeting of its Vaccines and Related Biological Products Advisory Committee on 28 June.

“As we move into the fall and winter, it is critical that we have safe and effective vaccine boosters that can provide protection against circulating and emerging variants to prevent the most severe consequences of COVID-19,” said the FDA.

The “overwhelming majority” of independent experts on the FDA advisory committee had voted in favour of boosters including an Omicron component to be ready for use in the US in fall 2022, it added.

“We have advised manufacturers seeking to update their COVID-19 vaccines that they should develop modified vaccines that add an omicron BA.4/5 spike protein component to the current vaccine composition to create a two-component (bivalent) booster vaccine, so that the modified vaccines can potentially be used starting in early to mid-fall 2022,” added the FDA.

However, it has not advised manufacturers to modify vaccines for primary vaccination.

India and South Korea approve local vaccines 

A COVID-19 vaccine developed by SK bioscience in South Korea, in partnership with GlaxoSmithKline and the University of Washington, was been approved in South Korea.

Among the candidate vaccines targeting Omicron are two Chinese vaccines, one from the Beijing Institute of Biologic Production, and the other from Sinocell.

Meanwhile, three new vaccines have been approved in various parts of the world. On Wednesday, the US finally approved Novavax which was approved in the European Union late last year. Novavax is also in the process of testing a booster to deal with Omicron.

Meanwhile, India approved the first mRNA vaccine developed by an Indian company, Gennova, in late June. 

At the same time, South Korea approved a recombinant protein-based vaccine, SKYCovione, developed by local company SK bioscience in partnership with GlaxoSmithKline (GSK) and the University of Washington’s School of Medicine.

SK bioscience has already signed an advance purchase agreement with the Korea Centers for Disease Control and Prevention for 10 million doses of the two-dose SKYCovione.

SK bioscience announced on Wednesday that its candidate booster had proven to be effective against Omicron in a small Phase I/ II trial involving 81 adults who received the booster seven months after completing primary vaccination.

“Neutralizing antibody titres against the Omicron variant BA.1 were 25 times the titres right after the second dose, and 72 times the titres seven months after the second dose,” according to the company.

Meanwhile, SK bioscience was recently approved to manufacture Novavax for European Union markets.

Image Credits: Pixabay.

hepatitis
Distribution of probable cases of severe acute hepatitis of unknown aetiology in children by country, as of 8 July 2022 (n=1010), 5 PM CEST

Over 1000 probable cases of severe acute hepatitis of unknown cause in children have been reported across 35 countries in five World Health Organization (WHO) regions as of 8 July 2022, including 22 deaths.

Since the previous WHO Disease Outbreak News, published on 24 June 2022, 90 new probable cases and four additional deaths have been reported, bringing the new total of probable cases to 1010. The Disease Outbreak News provides updates on the epidemiology of the outbreak, as well as updates on the response to the event

Two new countries, Costa Rica and Luxemburg, have also been added to the list of countries with probable cases. 

Hepatitis is an inflammation of the liver, and acute hepatitis is a sudden onset of hepatitis. While the disease usually passes on without the need for special treatment, according to WHO, in rare cases, it can result in severe liver failure or even death.

Of the probable cases, 46 (5%) of children have required transplants. 

Between 5 April (when the outbreak was initially detected) and 8 July 2022, almost half of the probable cases have been reported from the WHO’s European Region (21 countries reporting 484 cases), including 272 cases from the United Kingdom. 

The second highest number of cases have been reported from the WHO Americas region (435 cases), including 334 (33%) of global cases from the US. This is followed by the Western Pacific region (70 cases), the Southeast Asia region (19 cases), and the Eastern Mediterranean region (2 cases).

Age and gender distribution of reported probable cases of severe acute hepatitis of unknown aetiology with available data, as of 8 July 2022 (n=479) 5 PM CEST

The majority of cases (76%, 364 cases) involve children under six years old. 

However, the Disease Outbreak News does note that “the actual number of cases may be underestimated, in part due to the limited enhanced surveillance systems in place.”

“The case count is expected to change as more information and verified data become available,” it reads. 

The WHO has assessed the global risk level to be moderate, which has been the case since May 2022. 

Adenovirus and SARS-COV-2 detected in some hepatitis cases 

Distribution of probable cases of severe acute hepatitis of unknown aetiology in children by WHO Region since 1 October 2021, as of 8 July 2022

Pathogens such as adenovirus and SARS-COV-2 have been detected by PCR testing in a number of cases, with the adenovirus the most frequently detected pathogen among cases with available data. 

In the European region, adenovirus was detected by PCR in 52% of cases (193/368). In Japan, adenovirus was detected in 9% of cases (5/58) with known results.

SARS-COV-2 has also been detected in 16% (54/335) cases in the European region, and 8% of cases in the US (15/197). In Japan, 8% (5/59) of cases also had SARS-COV-2.

Most cases did not appear to be epidemiologically linked, although there have been epidemiologically linked cases reported in Scotland and the Netherlands.  

Launch of global online survey 

The WHO has also launched a global online survey with an aim to estimate the incidence of severe acute hepatitis of unknown aetiology in 2022 compared to the previous five years, in order to understand where cases and liver transplants are occurring at higher-than-expected rates. 

Until more is known about the aetiology of these cases, WHO advises implementation of general infection prevention and control practices, including frequent hand washing, avoiding crowded spaces and ensuring good ventilation when indoors. 

“Efforts to communicate with empathy in a timely and transparent way, acknowledging what is known and unknown and what is being done to investigate will help to reassure parents and caregivers, maintaining trust in health authorities and interventions,” according to the WHO.

Image Credits: F1000research.com, WHO.

Sputnik V vaccine

Two leading researchers who have raised questions about the reliability of Sputnik V’s vaccine efficacy ratings across age groups shared their concerns with Health Policy Watch. One called the results “impossible” and “very concerning”.

More than 70 countries have approved the use of Sputnik V, Russia’s COVID-19 vaccine, based on the reported 91.6% efficacy across nearly all age groups in the first part of its Phase III trial published by The Lancet in 2021. 

But a number of scientists have since raised a red flag about the reliability of the published data. 

In exclusive interviews, two of the leading critics told Health Policy Watch that such consistent efficacy is not only nearly impossible but also unmatched by any other vaccines. 

These findings “may have substantial implications for the utility of the vaccine and thus regulatory approval and the ongoing use to prevent COVID-19,” wrote Dr Kyle Sheldrick, author of the most recent report, published in  American Therapeutics.

In a recent interview with Health Policy Watch, Sheldrick said that data on the Sputnik vaccine as reviewed in independent analyses, such as one published by the Mexican Ministry of Health, is “very reassuring that this is a vaccine that works.” 

Another vocal critic, the Italian researcher Enrico M. Bucci, echoed that, telling Health Policy Watch in an interview that Sputnik is essentially a combination of two proven vaccine delivery platforms, the Chinese CanSino vaccine and Johnson & Johnson dose.    

But the question still remains, the researchers said: does the Sputnik vaccine work as well as its developers have claimed? 

Concerns about transparency and homogeneity of results 

Concerns about a lack of transparency with regards to aspects of the clinical trials for Sputnik V, as well as the unusual homogeneity of results among different age groups, have been raised about Sputnik since Russia first approved the jab back in August 2020. At that time, it was the first vaccine to receive a green light from any country’s regulatory agency. 

To date, the World Health Organization, European Medicines Agency and the US Food and Drug Administration have not authorized the vaccine, despite repeated statements by Russian officials and representatives of the Russian Direct Investment Fund (RDIF) that funds and sells it that all necessary data has been submitted to those bodies. 

In Sheldrick’s recent paper, he asserts that “the results contained with the phase-III RCT of Sputnik by Logunov et al showed a distribution [among age groups] inconsistent with what would be expected from genuine experimental data.” 

He was referring to the fact that the reported Sputnik results showed equal efficacy amongst all age groups. 

“It is our opinion that it is not possible for a journal or reader to have confidence in the results, and the article should be thoroughly investigated, including immediate release of anonymized individual patient data to an unbiased statistical expert. If the authors are not willing to do this, the paper should be retracted.”

Sputnik results ‘too perfect’

Using data from the Ministry of Health of the Republic of San Marino, the Russian Direct Investment Fund (RDIF) announced in 2021 that Sputnik V efficacy is significantly higher than Pfizer vaccine after 6-8 months

Specifically, Sheldrick and his team performed a simulation study that assessed the statistical probability that the results for different age subgroups participating would fall in the results ranges reported for the Sputnik vaccine in The Lancet article. They compared their findings for Sputnik with those of other US and Australia-approved vaccines, including AstraZeneca, Johnson and Johnson, Moderna and Pfizer. 

To do this, they ran statistical simulations for all of the vaccines 1,000 and then 50,000 times – so as to yield probability factors for the likelihood that results by age subgroup would line up exactly as they did in the real, reported results of the trials. 

“We used study-wide efficacy and infection rate for all age groups,” the paper explained. “We recorded the observed vaccine efficacies in each age group and summated how many simulations had all observed efficacies fall within the range of efficacies described in the relevant article.

“We calculated how many times, on average, a trial would need to be repeated to obtain results that fell within the range of efficacies from the relevant published article,” the authors reported. 

Their findings: The simulations showed that each of the vaccines except Sputnik has a range of efficacy results, by age subgroup, which is not unexpected, when considering the prevailing infection rates in the country at the time,  number of participants, and reported study-wise efficacy.  

“You would only have to repeat the studies two or three times to get a similar result for these other vaccines,” Sheldrick explained. “For Sputnik, you would have to repeat it 3,800 times to get results as perfect as they claimed.”

For instance, in the 1,000-trial simulation for the AstraZeneca vaccine, in 23.8% of simulated trials, the observed efficacies of all age subgroups fell within the efficacy bounds for age subgroups in the published article, according to the report. For J&J: 44.7%, Moderna 51.1%, Pfizer 30.5%. For Sputnik, the result was 0.0%. 

“In 50,000 simulated trials of the Sputnik vaccine, 0.026% had all age subgroups fall within the limits of the efficacy estimates described by the published article, whereas 99.974% did not,” it said in the report. 

Australian scientist: ‘Very uncommon to raise accusations against Lancet’

Sheldrick said that it is improbable that the Russian researchers “just got very lucky,” a notion that has been seconded by a number of other scientists in the US, Italy, Europe and Australia. 

“It is very uncommon to have accusations such as this raised against papers in journals as big as The Lancet,” Sheldrick told Health Policy Watch, “maybe because concerns are rare or because we don’t have a culture of double-checking. At first I thought I was just being suspicious.”

But after completing his study: The combination of the rapid approval timeline, the lack of availability of the data and the unexpected results “are very concerning to me.” Although he said he still believes that the Russian vaccine is likely to be at least somewhat effective against fighting COVID.

“Just because the data is not genuine, does not mean the vaccine does not work at all,” he stressed. 

Time and political pressures could have led to shortcuts 

Russia, which only offered its citizens Sputnik, is experiencing a slight increase in cases like the rest of the world, but at a much slower pace, according to official data.

The Reuters COVID-19 tracker, for instance, reported only 15 infections per 100K people in the last seven days. That as compared to 385.23 infections and 324.38 infections per one million people in nearby European countries of Estonia and Latvia.

But Sheldrick said that given the lack of transparency seen in other areas, he is unsure whether one can trust the daily cases as reported by the Russian government.  

He also stressed that he and his colleagues had been attempting to raise its concerns about the Russian researcher in private long before the country’s invasion of Ukraine, so the recent paper has nothing to do with the war.

“We raised these concerns with The Lancet before the invasion occurred,” he told Health Policy Watch. Some people like to link the two. I try to stay out of the political side.”

So why does he think that the Russian scientists would have fudged the data, assuming that they did? Time, Sheldrick said. 

“There was internal pressure to produce results before other vaccines,” he said. “Also, the vaccine was already being given to the general public. If you had by random chance found low results in one group, this would have looked particularly bad.”

Not the first to raise concerns

Sheldrick is not the first to raise concerns over Sputnik’s Phase III data. 

Within days of  Sputnik publishing its Phase I/II data in The Lancet, Italian researcher Enrico M. Bucci published a “note of concern” on his website about the data. 

Bucci and his team also were concerned that the homogeneity of results for different age groups, as reported in the Sputnik V trials was improbably high. They estimated that  the probability of results falling within the ranges reported in The Lancet study was less than 0.1%. But they had concerns beyond that as well. 

“We noted several gross inconsistencies, including several data points from different experiments which look identical, as well as inconsistencies in the number of enrolled patients and some more problematic data,” Bucci explained to Health Policy Watch. 

“With 15 other colleagues from several international institutions, we signed a letter asking for access to the full data set documenting the results purportedly obtained in the Phase I/II study,” Bucci recounted to Health Policy Watch. 

“In disregard of our and others’ requests, access to the data set used for the study publication was never granted.”

A version of that letter was ultimately published by The Lancet in September 2020 under the title “Safety and efficacy of the Russian COVID-19 vaccine: more information needed.” 

In it, Bucci stressed that “while the research described in this study is potentially significant, the presentation of the data raises several concerns which require access to the original data to fully investigate.”

Sputnik: All has data been double-checked

A Gamaleya National Center’s Employee, where Sputnik V was developed

Sputnik immediately responded to Bucci’s points, stressing in a formal letter that the data had all been “double-checked.”

“Some data that repeated itself was what elicited the greatest number of questions from Bucci and his colleagues: nine of the volunteers from day 21 to 28 in the vaccination process registered antibody indicators that were completely identical,” Sputnik wrote on its website. “Logunov stated that in small-sized groups of test subjects this possibility ‘cannot be ruled out.’

“‘It is possible that immune system indicators could reach the kind of plateau that we observed during the research,’ the letter states. Logunov also stated that all of the data obtained by scientists during the experiment was double-checked.”

But Bucci said that it was not only the Phase I/II study that raised eyebrows. 

There have now been three Lancet articles on Sputnik, all of which were problematic and subjected to several partial corrections after the errors were flagged, including the most recent Phase III study. 

Errata were published by The Lancet on 22 September 2020; 7 January 7 2021, 9 January 2021, 20 February, 2022 and finally on 11 June, 2022 – the latter in response to an Argentinian paper on Sputnik.  

‘Doubts about the reliability of data

“The published corrections did not address most of the flagged problems,” Bucci contended. “This is why several criticisms were raised in several scientific journals by researchers from all over the world.”

In May 2021, for instance, Vasiliy Vlassov, vice president of the Society for Evidence-Based Medicine in Moscow, published a piece on the BMJ blog in which he stated that “the quality of the reports and secrecy over trial data raise deep concerns about research integrity.”

Another paper titled, “Controversy surrounding the Sputnik V vaccine,” was published in October 2021 by independent researchers in the journal Respiratory Medicine in which they, too, stated there are “doubts about the reliability of the [Phase III] study and that while “Sputnik V could meet the need to provide equitable access to COVID-19 vaccines for people living in low- and middle-income countries …there are still many concerns regarding the use of this vaccine.”

Still… Sputnik V vaccine should work 

Because The Lancet left the paper online and no action was taken, Bucci ultimately put out yet another assessment, this time in March 2022. In this report, he stressed once again his belief that the vaccine works, but that the data was incorrect. 

From the early days of vaccine roll-outs, the Sputnik vaccine has received considerable uptake in many low- as well as middle and even upper-middle income countries, particularly in Latin America – where it was more widely available and affordable than mRNA options. 

“The Russian Sputnik V vaccine should work much like any others,” Bucci wrote. “I am convinced of this because Sputnik V basically can be seen as a combination of a Chinese adenoviral vaccine and a Johnson & Johnson dose. Such vaccines use disabled adenoviruses (cold viruses) to deliver an inactive fragment of the SARS-CoV2 spike protein into the body, prompting an immune reaction.   

“The [Sputnik] production problems are linked precisely to the fact of combining two different vaccines in one, with what follows for the simplicity of the process and the quality control; but this does not mean that the idea, from a scientific point of view, is not valid, or that once the vials are obtained, they should not be useful.”

Bucci also said he had observed instances of sloppiness in data reporting, which nonetheless made it to press. For instance in the original online version of an article on Sputnik’s rollout in Argentina, published in The Lancet on 15 March, 2022, one chart showed that in the 60-69 age group,  49.7% of vaccine recipients were women and 80.7% were men – obviously impossible. The currently available version online shows the data as 49.7% women and 50.3% men -although it acknowledges that a correction version was posted on 9 June. 

Sputnik’s rollout in Argentina, published in The Lancet

The final results of Sputnik’s Phase III trials have not yet been published by the Russian Direct Investment Fund (RDIF), which developed the vaccine together with the Gamaleya Institute – although their completion was announced by the Russian Health Ministry in September 2021. 

At the time, the Health Ministry explained to the Russian media agency Kommersant that the results would not be published at all, since “the results of clinical trials are a trade secret.”

RDIF: ‘Best vaccine in the world’

This has not stopped RDIF from continually stressing how good the vaccine is. 

The Gamaleya Institute told Health Policy Watch in an email that “the efficacy of the Sputnik V vaccine has been documented  in more than 50 real-world and scientific studies in 10 countries, involving more than 12 million people.” 

It highlighted studies in the United Arab Emirates, Bahrain, San Marino, Argentina, Iran, Belarus and Paraguay. 

 “A computer simulation is not the way to check the quality of clinical trials, as opposed to the multiple independent studies in different countries,” the Gamaleya Institute added in its reply to Health Policy Watch. 

“In international science, computer modeling is not a recognized method to cast doubt over outcomes of clinical trials and real-world studies whose peer reviewed results were published in respected medical journals.” 

In his own interviews, RDIF CEO Kirill Dmitriev has stated boldly that “Sputnik is the best vaccine in the world, we have proven it.” He said any challenges were “bureaucratic obstacles.”

Kirill Dmitriev, CEO of the Russian Direct Investment Fund
Kirill Dmitriev, CEO of the Russian Direct Investment Fund

In November 2021, RDIF also disclosed real world data of the Health Ministry of the Republic of San Marino on the Russian Sputnik V vaccine – which it said demonstrated that Sputnik V was 80% effective against COVID-19 infection up to eight months after receiving the second dose – a much higher percentage of efficacy more months after receipt than Pfizer or Moderna.

“Sputnik team believes that adenoviral vaccines provide for longer efficacy than mRNA vaccines due to longer antibody and T-cell response,” a release by Sputnik stated.

Ultimately, the vaccine received approval for use in 71 countries, RDIF reported, and more than 100 million people outside of Russia have received a Sputnik vaccine.

As of 31 January, “over 400 million Sputnik vaccine doses have been supplied worldwide including Russia to date to fight COVID-19 pandemic,” Sputnik tweeted less than a month before the war. “Over 800,000 doses of 1-shot Sputnik Light, standalone vaccine & universal booster effective against #Omicron & other mutations arrived in Turkmenistan.”

‘Science is based on trust’

Bucci said that the most important point at this stage is to address the potential shortcomings in  proper data checking and editorial controls by The Lancet, as well as its failure to press harder for more detailed data clarifications from the authors of the Sputnik studies when questions arose.  

“Science is based on trust stemming from the possibility of checking and reproducing published results,” he told Health Policy Watch. “When the scientific community is denied access to the data needed to reproduce the findings from a specific research group, we are no longer dealing with science but with unsubstantiated claims.”

In response to queries from Health Policy Watch, The Lancet Group said that it “takes issues relating to scientific misconduct extremely seriously and follows best practice guidelines set by the Committee on Publication Ethics (COPE)”. 

“We acknowledge the questions raised about the validity of Sputnik vaccine data published in The Lancet and we have invited the authors of the Lancet paper to respond to these latest questions,” it added.

Image Credits: RDIF, Sputnikvaccine/Twitter, The Lancet.

Scenes like this at Puerto Rico’s airport, January 2022, are now rare as countries drop COVID measures – but WHO says the pandemic remains a public health emergency says WHO.

With a surge in cases and the rapid rise of new subvariants, the COVID-19 pandemic continues to be a global health emergency posing significant risks to public health, a WHO committee of public health experts has concluded.

The statement by the COVID-19 Emergency Committee, was published Tuesday, four days after experts gathered for their 12th meeting since a COVID-19 global health emergency was first declared on 30 January 2020 under the terms of the WHO International Health Regulations.

“This is in no way over,” WHO’s Director General Dr Tedros Adhanom Ghebreyesus told a media briefing. He and his team pointed to the worldwide surge in cases driven by the Omicron BA.5 subvariant in particular.

“As the virus pushed at us, we must push back — we are in a much better position than at the beginning of the pandemic,” he said. “We have safe and effective tools that prevent infections, hospitalization and deaths. However, we should not take them for granted.” 

COVID Cases increased by 30% in last two weeks

The WHO committee cited the 30% global  increase in COVID cases over the last two weeks and the still-unpredictable evolution of key SARS-COv2 variants driving infections as key to its decision to maintaining the current level of emergency alert.

Dr Michael Ryan

It noted that “both the trajectory of viral evolution and the characteristics of emerging variants of the virus remain uncertain and unpredictable,” according to the statement.

“The resulting selective pressure on the virus increases the probability of new, fitter variants emerging, with different degrees of virulence, transmissibility, and immune escape potential,“ the committee added.

Other concerns, it said, are the “steep reductions in testing, resulting in reduced coverage and quality of surveillance as fewer cases are being detected and reported to WHO, and fewer genomic sequences being submitted to open access platforms.”

The decline in testing, the committee noted, also could “hinder the detection of cases and the monitoring of virus evolution,” citing remarks by Dr Mike Ryan, WHO’s Executive Director of Health Emergencies.

Along with that,  “inequities in access to testing, sequencing, vaccines and therapeutics, including new antivirals; waning of natural and vaccine-derived protection; and the global burden of post COVID-19 condition,” were other factors considered. 

Dr Maria Van Kerkhove

Speaking at the press briefing, Maria Von Kerkhove, WHO’s health emergency technical lead, said the BA.5 subvariant of Omicron is spreading “at a very intense rate at a global level” that far outpaces the other subvariants.

“We are seeing countries become concerned about this, but we feel that countries should be concerned about SARS COV-2 overall,” she said. 

Monkeypox Emergency Committee to reconvene next week

The statement on the continuing COVID emergency comes just ahead of a critical meeting of a WHO Emergency Committee on Monkeypox scheduled for the week of 18 July to determine if that outbreak should also be categorized under the IHR as a Public Health Emergency of International Concern (PHEIC).

As of today, there were some 9,200 Monkeypox cases in 63 countries, Tedros told the briefing.  

That means cases have increased by 50% in the week since WHO issued its last report on 6 July, which confirmed 6,027 cases in 59 countries. 

Those numbers represent cases reported largely outside of the the central and western African areas where the disease is endemic.  Altogether some 1,597 suspected cases were reported in WHO’s Africa Region as of mid-June, but most were unconfirmed due to a lack of testing capacity. 

Criteria for determining a monkeypox global emergency 

Tedros said the Monkeypox emergency committee will convene against next week to look at trends, counter-measures and recommendations on what countries can do. If it decides Monkeypox also constitutes a global health emergency, it would be a rare instance of WHO simulatenously confronting three global health emergencies, including Polio, designated a global health emergency since 2014. 

Key to their deliberations will be an assessment of the evolving situation in light of nine criteria, said Dr Sylvie Briand, who heads WHO’s Global Infectious Hazard Preparedness department. 

Dr Sylvie Briand

Those include questions of “increasing cases, deaths, diseases spreading outside of the initially affected community, changes in the virus and so on,” she said, noting the situation has evolved since the committee last met on June 25. “We see an increasing number of cases, we have also seen new geographies affected. So it’s worth looking at it again and see if we need to reinforce the advice.”

At the same time, Ryan said, it appears that “sexual contact is what is driving the outbreak” of Monkeypox infections in Europe and elsewhere that have occurred in circles of men who have sex with men.

He also cited evidence that transmission can occur as a result of contact with the virus on infected surfaces, particularly in health care settings.

Wild animals hunted for food are an infection risk – not supermarket purchases

Contact with virus-contaminated wild animals, hunted and killed for food, also is an important source of Monkeypox infection in central and western Africa which frequently experiences such  “zoonotic spillover” events. But food-based contamination is not an issue elsewhere, Ryan and others stressed. 

“You are not going to get the virus from food you buy in a supermarket,” Ryan stressed. 

Dr Rosamund Lewis, WHO’s Monkeypox lead, said the virus circulates in rodent populations, but also in primate populations in central Africa. “So there is potential of being exposed in the course of hunting and preparing wild game involving an infected animal,” she said.

Dr Rosamund Lewis

Von Kerkhove added there are many known pathogens that are zoonotic that spill over from animals to humans, and that have epidemic and pandemic potential. Identifying and targeting such risks, she said, requires “improved surveillance in communities and on farms, and improved laboratory capacity.”

WHO recently launched a 10-year strategy for improving the genomic sequencing of pathogens with epidemic and pandemic potential. That included bringing together veterinary and public health teams in countries to figure out what Ryan described as “how can we make these two systems work better together.”

Accelerating access to genomics – first ever WHO report

The statements about the importance of genomic tracking of both COVID and Monkeypox coincided with the release of a first-ever WHO report on “Accelerating Access to Genomics for Global Health” by the new WHO Science Council.

The report, also released Tuesday, calls for less-developed countries to gain better access to genomics technologies, which not only are critical to disease surveillance but also drives much of the groundbreaking research into health treatments today.

The field of genomics uses methods from biochemistry, genetics, and molecular biology to understand and use biological information in DNA and RNA, with benefits for medicine and public health. That has especially proven relevant during the COVID-19 pandemic and with agriculture, biological research and other such uses. 

While the costs of establishing and expanding genomic technologies are declining, making them increasingly feasible for all countries to pursue, those costs can and should be further lowered, the report finds.

Dr Harold Varmus

The report suggests using making genomic technologies more affordable for LMICs through tiered pricing; sharing of intellectual property rights for low-cost versions; and cross-subsidization, which involves using profits in one area to fund another.

“Genomic technologies are driving some of the most groundbreaking research happening today. Yet the benefits of these tools will not be fully realized unless they are deployed worldwide.” said WHO’s Chief Scientist Dr Soumya Swaminathan in a press release on the report.  

Harold Varmos, head of WHO’s Science Council., said the benefits of genomics have been illustrated in the COVID pandemic, namely, in the development of vaccines and tests and the identification of variants that continue to pose serious problems for the world.

“Genomics has been adopted in many poor countries” as costs decline, said Varmos. Nevertheless, he said, “we are concerned that the already widespread use of genomics in advanced countries should not leave low- and middle-income countries behind. WHO and member states can do more to promote the adoption of genomics.” 

Image Credits: Kevin Torres Figueroa/ US Army National Guard/ Flickr.