Countries (in blue) where the Delta variant has been verified (US CDC)

Countries as diverse as Russia, Portugal, South Africa and Sydney have imposed new lockdown regulations as they attempt to control the spread of Delta, the SARS-CoV-2 variant that is more deadly and infectious than any other variant.

By last Friday, the World Health Organization (WHO) reported that the Delta (B.1.617.2) variant had been detected in at least 85 countries, describing it as the “fastest and fittest” variant, likely to dominate all others in time.

The WHO also urged everyone – including those who are fully vaccinated – to continue to wear masks in the face of Delta, which was responsible for the devastating wave of COVID-19 cases in India in early May where the country recorded over 400,000 cases per day.  The WHO advice has prompted renewed debate over mask policies in countries like the United States, where the US Centres for Disease Control had recently stated that fully vaccinated people no longer needed to wear masks indoors or outside.  Even Israel, which had driven COVID cases down to nearly zero with one of the highest vaccination rates in the world, has now reinstated mask requirements for indoors spaces and mass gatherings – in the face of a Delta-driven virus resurgence.  

In Russia’s capital, meanwhile, unvaccinated Muscovites have been told to work from home and observe tighter restrictions on movement and social gatherings, as the city’s mayor told the public that Delta now accounts for over 90% of the city’s new COVID-19 cases.

South Africa moved to a Level Four lockdown on Monday, bringing a tighter curfew, the closure of sit-down restaurants, and a ban on alcohol sales for two weeks. The country has been battling a third wave, which is surging in its economic heartland – Gauteng province – which by Sunday accounted for over half the country’s 158,998 active cases. Leisure travel in and out of the province has also been restricted for two weeks.

Over the past weekend, only those who had been vaccinated or could show a negative COVID-19 test were allowed to enter or leave Portugal’s capital, Lisbon. Last Thursday, the city recorded its highest case number since February – 1556 new cases – and authorities said that 70% of these were from the new variant.

Sydney residents have been ordered to stay at home for two weeks since last Saturday (26 June) and entering or leaving the city is prohibited except for a few exceptions. New South Wales reported 130 active cases by Sunday.

Taiwan tightened border controls from 27 June, making a 14-day quarantine mandatory for all travellers. Those from seven high-risk countries – Brazil, India, the UK, Peru, Israel, Indonesia, and Bangladesh – face free quarantine in government facilities while all other travellers need to quarantine in group quarantine facilities at their own expense, according to the Taiwanese Ministry of Foreign Affairs.

The proportion of Delta cases in the US has risen exponentially in the past month and now account for almost 10% of cases, with the highest prevalence in Missouri where almost 30% of cases are due to Delta, according to the US Centers for Disease Control (CDC).

In May, 4,7% of California’s cases were from the Delta variant but this had jumped to 14.5% of cases by 21 June, according to the California Department of Public Health.

Delta Variant Associated With Higher Risk of Hospitalisation

A report on COVID-19 hospitalisations in Scotland published in The Lancet, reported that there had been twice as many hospitalisations in people infected with the Delta variant in comparison to the Alpha variant.

“Based on the available evidence, the SARS-CoV-2 Delta (B.1.617.2) variant of concern (VOC) is 40-60% more transmissible than the Alpha (Β.1.1.7) VOC and may be associated with higher risk of hospitalisation,” according to a risk assessment published by the European Centre for Disease Prevention and Control last week.

“Furthermore, there is evidence that those who have only received the first dose of a two-dose vaccination course are less well protected against infection with the Delta variant than against other variants, regardless of the vaccine type. However, full vaccination provides nearly equivalent protection against the Delta variant,” it added.

A risk assessment for Delta published last Friday by the UK government noted that  

“there are now analyses from England and Scotland supporting a reduction in vaccine effectiveness for Delta compared to Alpha against symptomatic infection” which were “more pronounced after one dose”. 

“Iterated analysis continues to show vaccine effectiveness against Delta is high after 2 doses. Current evidence suggests that [vaccine efficacy] against hospitalisation is maintained,” it added.

Europe CDC Warns Against Summer Relaxation as Africa Scrambles for Vaccines

Delta is the predominant variant in the UK and is driving a surge in cases there, and the European Centre for Disease Prevention and Control predicted that Delta would account for 90% of cases in the European Union by the end of August.

“Modelling scenarios indicate that any relaxation over the summer months of the stringency of non-pharmaceutical measures that were in place in the EU/EEA in early June could lead to a fast and significant increase in daily cases in all age groups, with an associated increase in hospitalisations, and deaths, potentially reaching the same levels of the autumn of 2020 if no additional measure are taken,” it warned, urging faster vaccination of vulnerable groups.

However, mass vaccinations are still out of the reach of many African countries that are dependent on the WHO-lead global vaccine access platform, COVAX, which has run out of vaccines for distribution.

Cases continue to surge in southern and East Africa, with Delta suspected to be driving cases in Uganda, Zimbabwe and Zambia, as well as South Africa which confirmed last Sunday that Delta was driving its third wave.

Spread of the Delta variant in South Africa

Meanwhile, a more dangerous mutation of the variant,  Delta Plus,  is driving cases in the Indian state of Maharashtra, causing the state to tighten up on restrictions there. All malls and auditoriums were closed from Monday.

Delta Plus is more transmissible than Delta, according to the Indian health ministry. Public Health England issued a briefing on Delta Plus last Friday noting that 41 cases had been detected in the UK.

Image Credits: US CDC, Department of Health, University of KwaZulu-Natal.

Dr Tedros Adhanom Ghebreyesus, WHO Director-General.

Artificial intelligence (AI) has the potential to strengthen the delivery of healthcare and move the world closer towards universal health coverage, but ethical considerations and human rights must be central to the design, development, and deployment of AI technologies, according to a new report released on Monday.

The World Health Organization’s (WHO) Ethics and Governance of Artificial Intelligence for Health report, the world’s first global report on the use of AI in health, is the result of two years of consultations conducted by a panel of 20 international interdisciplinary experts in ethics, digital technology, law, human rights, and health.

“Like many new technologies, artificial intelligence holds enormous potential for improving health,” said Dr Tedros Adhanom Ghebreyesus, WHO Director-General, at the launch of the report on Monday. “This important new report provides a valuable guide for countries on how to maximize the benefits of AI, while minimizing its risks and avoiding its pitfalls.” 

“I hope this report will help countries to harness the power of artificial intelligence while minimizing the risk for a healthier, safer, and fairer future,” Tedros added. 

AI refers to the ability of algorithms encoded in technology to learn from data to perform automated tasks and is an exploding area of science that is being used in numerous disciplines. 

AI is “poised to strengthen healthcare, health research, drug development, improved diagnosis of infectious diseases, including COVID, as we are now seeing, and public health surveillance,” said Professor Partha Majumder, co-chair of the WHO Expert Group on Ethics and Governance of AI for Health and founder of the National Institute of Biomedical Genomics in India.

Professor Partha Majumder, co-chair of the WHO Expert Group on Ethics and Governance of AI for Health and founder of the National Institute of Biomedical Genomics in India.

The COVID-19 pandemic accelerated the willingness to use and invest in innovations, including AI, to address disease outbreaks and curb the spread of pandemics. 

“The key lesson from the pandemic is the important role technology plays in surveillance, disease detection, and treatment,” said Dr E. Osagie Ehanire, Nigeria’s Minister of Health. “[The pandemic] also highlights the potentially enormous value of digital health in improving care and outcomes.”

As innovation and development of AI continues, it could allow medical providers to make faster and more accurate diagnoses, enhancing the capabilities of health systems. 

The future of public health will increasingly become digital, with the development of technologies that “bring both promise and opportunities, but also challenges and ethical questions,” said Dr Soumya Swaminathan, WHO Chief Scientist. 

Applications of AI in Health 

In high-income countries, the use of AI has already begun to transform health systems through the prevention, diagnosis, and treatment of diseases.

Currently, AI is being used for radiological diagnosis in oncology, such as colonoscopy, mammography, and brain imaging. In addition, AI algorithms based on RNA and DNA sequence data are used to guide immunotherapy cancer treatment.

AI technologies are also being piloted for the detection, management, treatment, and care of patients with tuberculosis (TB) and those living in areas with rampant TB. 

Predictive AI systems were able to identify the risk of birth asphyxia, a condition where a newborn doesn’t get enough oxygen before or during birth, with the use of imaging technology during the labor process, according to the report. 

In Singapore, a national programme was established in 2017 to develop and support the country’s AI ecosystem, focusing on healthcare innovation. AI-driven solutions are being used to address high cholesterol, high blood pressure, and diabetes, which are prevalent in Singapore. 

Predictive modelling is used to identify those at the highest risk of developing chronic diseases for early intervention programs. The goal in using AI is to slow the progression of diseases, reduce complications in patients, and lower healthcare costs. 

Low- and middle-income countries (LMICs) have the most to gain from the transformation to health systems brought by AI, as it could fill gaps in health care delivery and services. 

Numerous LMICs face chronic shortages of health workers, a high burden of diseases, and large underserved populations. AI could provide healthcare workers with assistance in diagnostics and speed up the analysis of X-rays and pathology slides, if there is a lack of health specialists. 

A pilot programme of AI-based tools is underway in India, Kenya, Malawi, Rwanda, South Africa and Zambia to screen for cervical cancer. LMICs could also use AI to manage HIC antiretroviral therapy by predicting resistance to the drugs and helping health workers to optimize the therapy, according to WHO’s report.

Ethical Challenges of Using AI in Health Systems

While AI tools and technologies will likely play an important role in improving patient outcomes, strengthening health systems, and driving progress towards universal health coverage, several ethical challenges could emerge. 

“In as much as AI offers enormous advantages to healthcare delivery systems, there remain significant challenges and gaps in the adoption, scale up and integration into health systems,” said Dr Ehanire. 

Dr E. Osagie Ehanire, Nigeria’s Minister of Health.

“Like all new technology, artificial intelligence holds enormous potential for improving the health of millions of people around the world, but like all technology, it can also be misused and cause harm,” said Dr Tedros. 

“Artificial intelligence raises potential ethical concerns, including equitable access to technologies, data protection, and liability,” he added. 

The use of limited, low-quality, or non-representative data in AI could deepen disparities in health as predictive algorithms based on inadequate data could result in racial or ethnic bias. 

Biases based on race, ethnicity, age, or gender that are encoded into AI algorithms can be detrimental to the equitable provision of and access to healthcare services. Many data sets used to train AI models exclude women, ethnic minorities, older people, rural communities, and disadvantaged groups. 

Discrimination in health systems will be captured by machine-learning models, making their recommendations inaccurate for populations excluded from the data. 

“Machine learning technologies have been shown to harm our right to equality and non-discrimination,” said Agnès Callamard, Secretary General of Amnesty International. “There is a substantive and growing body of evidence showing that these machine learning systems have discriminatory impacts and contribute to discriminatory practices.”

Potential to exacerbate disparities

The quality and availability of data may not be adequate in LMICs, resulting in algorithms with inaccurate performances. 

In addition, it is unclear whether AI trained for use in one context can be used accurately and safely in another geographical region. 

Investments will be needed to improve the collection of data in resource-poor settings and to ensure sufficient data on vulnerable and marginalized populations. 

If AI technologies are not deployed carefully, they could exacerbate disparities in health care, cause the over-medicalization of individuals, and cause stress and stigmatization of individuals or communities, according to the report. 

Issues of equity and access could be raised through the exacerbation of the existing digital divide, which refers to the uneven distribution of access to or use of information and communication technologies, such as broadband or smartphones. 

Some 1.2 billion women in LMICs don’t use or have access to mobile internet services and the infrastructure to operate digital technologies may be limited in many countries. 

Employing AI could further marginalize those who lack access to health services and they could be left behind by healthcare systems. 

Another major ethical issue is cybersecurity and data protection. AI technologies, which hold patient health data, could be the target of malicious attacks, putting individuals’ privacy at risk.

With the involvement of the private sector in designing AI systems, concerns are raised over where data is coming from, how it is being stored, how it is being used, and who has access to it. 

To combat the ethical issues that emerge through the use of AI, transparency must be prioritized, with independent oversight and public participation in the design and use of AI in healthcare, said experts at a WHO briefing on Monday.  

AI systems have to be designed to reflect the socio-economic and racial diversity in the relevant health care setting and must be accompanied by training of healthcare workers in digital literacy. 

Principles and Recommendations for use of AI

In an effort to limit the risks and maximize the benefits of AI systems, the expert group developed six principles as a basis for AI governance in the domain of health:

  • Protecting human autonomy;
  • Promoting human wellbeing and safety and the public interest;
  • Ensuring transparency, explainability, and intelligibility;
  • Fostering responsibility and accountability;
  • Ensuring inclusiveness and equity; and
  • Promoting AI that is responsive and sustainable.

The report detailed 47 recommendations to a range of stakeholders to encourage the ethical and transparent design of AI technologies to enhance clinical decision making, mitigate workforce shortages, and increase efficiencies in health service delivery. 

“The need for international comprehensive guidance on the use of artificial intelligence for health, in accordance with ethical norms, cannot be overstated,” said Callamard. 

“There needs to be a framework that addresses some of the ethical issues, the legal issues, as well as other societal challenges, including not creating another digital divide,” said Swaminathan.

Dr Soumya Swaminathan, WHO Chief Scientist.

The recommendations called on the private sector to design AI systems with the accuracy to improve the capacity of health systems; governments to require the use of impact assessments of AI technologies; companies to adhere to national and international regulations on the development and use of AI for health systems; and governments to support the global governance of AI for health. 

“To harness the promise of artificial intelligence for health, human rights cannot be an afterthought,” said Callamard.

“Success is only possible if we collectively and deliberately place ethics and human rights at the center of the design, deployment, and use of AI technologies for health,” said Dr John Reeder, Director of WHO’s TDR, the Special Programme for Research and Training in Tropical Diseases. 

The report was created as a living document, with the opportunity to update it as research emerges on AI and as the field evolves. 

In the coming weeks and months, WHO will focus on developing an implementation plan for the report, holding mission briefings for member states to advise them on the enactment of the recommendations. 

“We should all work together so that artificial intelligence for health becomes a panacea for most of the world and…[it] can be used to meaningfully make universal health coverage a reality,” said Majumder. 

Image Credits: WHO.

Pakistani workers protest against being given Chinese vaccines.

ISLAMABAD – Thousands of Pakistani migrant labourers fear that they might lose their jobs after the governments of Saudi Arabia and the United Arab Emirates (UAE) banned entry for Pakistanis vaccinated with COVID-19 vaccines produced in China.

Meanwhile, Europe’s digital ‘Green Pass’ is not available to those vaccinated by the AstraZeneca vaccine made by the Serum Institute of India – all the COVAX recipients – as the European Medicines Agency (EMA) has only approved the Vaxzevria version of the AstraZeneca vaccine that was produced and manufactured in the United Kingdom or other sites around Europe, Health Policy Watch reported last Friday.

In the past two weeks, dozens of Pakistanis have held protests outside a mass vaccination center in Islamabad,  demanding that health authorities vaccinate them only with vaccines approved by the two countries and not any of those produced by the Chinese.

The UAE has authorised Sinopharm but Saudi Arabia has not authorised any of the Chinese COVID-19 vaccines, while most Pakistanis are vaccinated with Sinovac.

The protestors say that if they are not vaccinated with the UAE and Saudi-approved vaccines, they will not be able to return to their jobs in those countries. Those who have not been vaccinated with vaccines approved by the Gulf states either face exclusion or have to undergo a 10-day quarantine at their own expense, which is unaffordable to ordinary workers.

Last month, Saudi Arabia updated its travel restrictions to enable travellers vaccinated with the Pfizer, AstraZeneca, Moderna and Johnson & Johnson vaccines to enter the country – excluding the five vaccines produced by China, including Sinovac and Sinopharm which have been widely used in Pakistan.

Last week, the UAE lifted its ban on passengers from India, requiring them to be fully vaccinated and to undergo a PCR test on entry and remain in quarantine until the test results were known. Passengers from South Africa and Nigeria will also no longer be banned from the UAE.

Pakistan’s foreign office spokesperson, Zahid Hafeez Chaudhri, told a press briefing on 17 June that the UAE government had suspended the entry of passengers from Pakistan and some other South Asian countries in mid-May based on COVID-19 numbers.

“We hope that the UAE will review its COVID-related advisory for all Pakistanis soon. Currently, Pakistanis having diplomatic and official visas and UAE Golden visas can travel to the UAE,” he said.

“We have proposed inclusion of some of the Chinese vaccines used in Pakistan in the list of vaccines approved by the Saudi authorities. The Ministry of Foreign Affairs is actively pursuing this matter,” Chaudhri added. 

AstraZeneca to be Offered to Workers

A few days earlier, the government had buckled under the pressure from the protesting workers and amended the criteria for those eligible for the AstraZeneca vaccine from 40 years and over to anyone above 18. 

However, a spokesperson for Pakistan’s Ministry of National Health Services Regulations and Coordination (NHSR&C), Sajid Hussain Shah, told Health Policy Watch that those under 40 would only be given the AstraZeneca jab after submitting a consent form. This decision had been taken after analysing the scientific data by the authorities and considering the situation of expats working in other countries. 

“Labour class and students would have to show work and study visas to get AstraZeneca jab. The vaccine will also be administered to work permit holders in Saudi Arabia,” Shah said.

When asked about sudden change in the health guidelines of the AstraZeneca vaccine and its side effects,  NHSR&C Director General Dr Rana Muhammad Safdar said that “there is no harm at all” in administering AstraZeneca to people below age 40.

“Consent was required only as the expert committee recommended it under 40 due to limited availability of data,” said Safdar.

However, the country faces a shortage of AstraZeneca vaccines, which are no longer being exported by its main manufacturer, the Serum Institute of India.

Pervaiz Khan, one of the protesters from the north-western city of Mardan, works in a construction company in Saudi Arabia. Khan has prepared a ‘consent form’ declaring that he “has viewed the information related to adverse effects of the AstraZeneca vaccine and requests to get this vaccine”.

“Our visas are getting expired, and we will lose our jobs if we don’t get Kingdom of Saudi Arabia (KSA) approved vaccine jabs,” said Khan.

Pakistan Reneged on its Pfizer Announcement

Pakistan had announced that it would administer the Pfizer vaccine to migrant workers returning to Gulf countries, but later reneged on this due to a lack of sufficient Pfizer vaccines, Khan said.  

Workers staged their first protest on 14 June when authorities changed the vaccines to be administered back to AstraZeneca due to a lack of Pfizer supplies, but now, even AstraZeneca is said to be in short supply.

“This is a disappointing situation for low-income laborers struggling for their bread and butter in gulf countries, where Saudi Arabia does not approve Chinese vaccines, and the Pakistan government is not smoothly administering Pfizer and AstraZeneca to them,” a frustrated Khan said.

Saudi Arabia has refused to recognize any Chinese-made vaccines for visitors and migrant workers; the UAE has only allowed SinoPharm vaccine for travelers entering the Gulf states. 

Pakistan has mostly administered Chinese vaccines including Sinopharm, SinoVac and CanSino to its citizens.

Although Saudi Arabia and the UAE have imposed strict travel restrictions for Pakistani nationals, those visiting the United Kingdom (UK), European Union (EU) and the United States (US) have not faced such hurdles. The US, UK and EU made it compulsory for passengers from Pakistan to have a negative PCR COVID-19 test, but have not raised concerns about which vaccines travellers have received. 

Lower efficacy of Sinopharm and Sinovac

China has sold and donated millions of Sinopharm and Sinovac doses to low-income countries in Asia, Latin America and Africa.

However, there are concerns that the two vaccines are less efficacious than Pfizer, AstraZeneca Moderna and Sputnik-V vaccines following COVID-19 outbreaks in countries with high vaccination rates with these vaccines.

However, the World Health Organization’s (WHO) Chief Scientist, Soumya Swaminathan, told a recent press briefing that more data was needed “from well-designed studies on the efficacy of the different vaccines that are in use in different countries against the different variants.” 

Latin America and the Asia-Pacific region have bought up around 80% of the 759 million doses of Chinese vaccines sold to date. About 511 million of these are from Sinovac, and the rest from  Sinopharm. 

The WHO recently granted both vaccines Emergency Use Listing. Sinovac’s vaccine efficacy stands at 51% against symptomatic disease and 100% against severe disease, while Sinopharm showed an efficacy rate of 79% protection against mild and hospitalized disease.

Health Policy Watch recently reported a surge in COVID-19 cases in a number of African and Latin American countries that had vaccinated fairly extensively with the Chinese vaccines. This has added to concerns about the lack of follow-up surveillance of the vaccine’s  real-life impacts. 

Pakistan Reliance on Chinese Vaccines

According to the NHSR&C, the country has procured about 14 million doses of five different COVID-19 vaccines. Of these, 12 million were from China, with one million doses each of AstraZeneca and Pfizer vaccines procured through COVAX, the global vaccine-sharing facility, 

Special Assistant to Prime Minister on Health Dr Faisal Sultan said that 76% of the vaccines had been bought and the remainder were donations. A total of 10 million doses of vaccine have been administered so far this month, according to the health ministry.

Director General Safdar told Health Policy Watch that another Chinese vaccine, CanSino, was being produced in the country under the name of PakVac, with 3 million doses being produced per month.

Meanwhile Pfizer Pakistan and BioNTech SE announced an agreement last week with the Pakistan government to supply 13 million doses of their COVID-19 Vaccine (BNT162b2). Deliveries are expected during the course of 2021.

Pakistan Depends on Remittances From Labour Force in Gulf

Pakistan is considered a strategic partner to Saudi Arabia and the UAE. It provides a huge labor force to the Gulf countries, and they provide financial assistance to Pakistan’s unstable economy.

Around 2.6 million Pakistanis are working in Saudi Arabia, while 1.5 million are in the UAE, according to the International Labor Organization (ILO). 

An August 2020 report by the State Bank of Pakistan states that in  the 2019/2020 financial year, Pakistan workers’ remittances received from Saudi Arabia was US $ 821.6 million and UAE US $ 538.2 million). 

 

WHO representative in Ghana, Francis Kasolo, on left, with UNICEF’s representative, Anne-Claire Dufay as first COVAX vaccine doses arrive on 24 February in Accra, Ghana,  Most vaccine recipients won’t be eligible for an EU “Green Passport.”

The much-trumpeted European Union COVID Digital Green Pass, which launches 1 July and is meant to vastly ease travel to Europe for vaccinated and recovered passengers is being rolled out with one important hitch.

Anyone vaccinated with an AstraZeneca vaccine produced by the Serum Institute of India would not be qualified to get the pass – and that includes most citizens of low- and middle-income countries who were immunised with vaccines distributed by the WHO co-sponsored COVAX initiative. 

That’s because the EU green pass will only recognise the Vaxzevria version of the AstraZeneca vaccine that was produced and manufactured in the United Kingdom or other sites around Europe, and thus approved by the European Medicines Agency (EMA). 

In contrast, most of the COVAX facility’s global procurement and distribution was built around the “Covishield” AstraZeneca vaccine, produced by the Serum Institute of India.  

Rude Shock

Proportion of different vaccines distributed by the COVAX initiative – Africa CDC

As of 25 June, more than 89 million vaccines have been distributed by the COVAX initiative to some 133 mostly low- and middle-income countries of Africa, Asia and Latin America, according to Gavi, the Vaccine Alliance, which is administering the massive programme. 

That’s a drop in the ocean of the more than 2.6 billion doses of COVID vaccines administered so far globally, according to WHO. But, it constitutes the majority of vaccines received in many of the world’s poorest countries. 

According to the COVID-19 vaccination dashboard of the Africa CDC, over 90% of vaccine doses administered so far,  are Covishield.

Only Four EU-Approved Vaccines 

EU digital green passport

Under the EU Digital COVID Certificate system, freedom will be restored to the region for individuals that have been fully vaccinated with one of the vaccines approved by EMA, in addition to individuals that have recently recovered from the virus, and those who tested negative.

While WHO has opposed issuing COVID passports at all, a key practical bone of contention emerging is the non-inclusion of Covishield and other WHO-approved vaccines on the list of EMA-approved products that can be considered for the EU digital green pass. 

When Health Policy Watch searched for Covishield on EMA’s website, there was no record of the vaccine even though Vaxzevria, the version produced in Europe, is listed.

Traveller information issued by the authorities of the “Schenghen Zone” which includes EU countries plus several other non-EU European states like Norway and Switzerland,  also clearly states: “As the Member States reopen the borders for travel from non-EU countries for non-essential purposes, they also intend to issue EU COVID travel certificates to travellers from third countries intending to enter their territory. The Commission also intends to accept certificates issued in third countries, which are issued under the same conditions as the ones by the EU….In order for the traveller to be able to get the vaccine, he/she should be vaccinated with one of the EU-approved vaccines.” 

The advice adds, however, a caveat stating that individual: “Member States, can, however, issue the certificate even to those who have been vaccinated with other vaccines if they are willing to do so.”

In all, only four vaccines have been authorised by the EMA, and they are ComirnatyⓇ (BioNTech, Pfizer), ModernaⓇ, Vaxzevria Ⓡ (previously COVID-19 Vaccine AstraZeneca) and JanssenⓇ (Johnson & Johnson).

Covishield is not even listed among the vaccines that are under review by the agency which has listed CVnCoVⓇ (CureVac), NVX-CoV2373Ⓡ (Novavax), Sputnik V Ⓡ(Gam-COVID-Vac), COVID-19 VaccineⓇ (Vero Cell) and CoronaVac Ⓡ(Sinovac).

Even though the passport regime is expected to go into effect next week, more than ten countries in the region, including Germany, Greece and Spain are already issuing the green digital pass.  

Second Class COVID Travellers 

The double standard of EU recognition for identical AstraZeneca vaccines is beginning to send ripples across the African continent and African media – stimulating anger as well as stoking vaccine hesitancy, as reported by the French media channel, RFI.fr this week.

“When the [AstraZeneca] vaccine was received, representatives of the international community were present at Ivato airport in Antananarivo, including representatives of the European Union, to encourage people to be vaccinated,” said Emée Ratsimbazafy, vice-president of a Madagascar civil society association, told RFI.

“And then, all of a sudden, we learn that this vaccine is not recognised by the European health authorities. Why not? Many people are now wondering if this vaccine is really harmless and effective. Some people are now reluctant to be vaccinated,” he said, noting that the dual standard has raised fears that the COVAX vaccines are of inferior quality. 

Madagascar’s Minister of Health, Professor Jean-Louis Rakotovao-Hanitrala, said he was “surprised and shocked” to learn that the vaccines being distributed wouldn’t be accepted in Europe.

“This vaccine was given to us by the WHO and welcomed by the European Union and all the UN agencies,” he was quoted as saying.  That , he said “makes us wonder if there is not one vaccine for Africans and another for Europeans”.

On the other side of the continent, Nigerian health experts are also worried that the EU policy may stimulate more vaccine hesitancy – threatening the delicately built trust in the vaccine that is most widely available.

“Something is definitely fishy somewhere. We need these people to come clean and tell us what is happening. My parents received this vaccine. Should we be worried?” one Nigerian woman, who asked to remain anonymous, told Health Policy Watch. 

African countries do not have luxury of choices like European countries have and as such they need to continue to build acceptance around Covishield, stressed Oyewale Tomori, a Nigerian professor of virology and chairman of Nigeria’s Ministerial Expert Advisory committee on COVID-19. 

“This is the vaccine that we have and we will continue to encourage our people to take while ensuring that we do not find ourselves again at the mercy of the rest of the world in future pandemics,” Tomori told Health Policy Watch.

WHO Officials – Protest in Africa, Silent In Geneva 

WHO Regional Director for Africa Dr Matshidiso Moeti speaking about the EU COVID Green Pass at Thursday’s Regional press briefing,

At Thursday’s Africa Regional press briefing, WHO’s Regional Director for Africa, Dr Matshidiso Moeti, protested the double standard, telling reporters that the European green pass programme should recognize all eight vaccines that have been approved by the WHO, which include the AstraZeneca vaccines produced in India, as well as two Chinese-made vaccines, rather than only those that are EU approved. 

“Increasingly proof of vaccination permits the removal of travel restrictions, and even if it is important to secure the frontiers and prevent the propagation of the virus, African’s shouldn’t be subject to any more restrictions because they can’t access a particular vaccine,” she noted.   

“Only four of the eight vaccines recognised by the WHO are recognised by the European Medicines Agency for the digital passport system put in place by the European Union.  We hope that all countries will respect the principles of the International Health Regulations, and see to it that all vaccines are approved by the WHO and are accessible to everyone, before they can become a prerequisite for travel,” she sai.

Moeti said the WHO and EMA  use the same standards in assessing vaccines. “The safety and efficacy of all WHO emergency use listed vaccines has been proven globally in preventing severe COVID-19 illness and death.” 

Added Richard Mihigo, African regional director for immunisation and vaccines development:  “Actually, WHO is in the process of working with the European Union so that there can be a harmonisation and a recognition by all of the EU members, for all of the products that were approved by the WHO, in a general manner.”   

“What people have to understand is that the EMA only approves  products that are being used in the EU. For those [vaccines] not being used by the EU, they are not even submitted for approval to the EMA, and that is the case for AstraZeneca CoviShield, being produced by the Serum Institute of India, which was from the beginning intended to fulfil the needs for a segment of the market – the COVAX countries.

Mihigo stressed that there was “no ambiguity about the quality of this vaccine produced in India”.

“It’s strictly an administrative process, which has nothing to do with the quality of the AZ vaccine, which is being produced in several countries in Europe, the United States, India, and  South Korea.”

At Geneva’s headquarters, however, WHO officials speaking at a Friday press conference made no reference to the EU conundrum – despite protesting, in principle, the fact that COVID passports are being used at all in travel – when access remains so limited in many countries.

“WHO should not be recommending a requirement for vaccination as a condition of travel,” declared Michael Ryan, executive director of health emergencies, “and that is particularly related to the scarcity of vaccines and the fact that there is such an inequity of distribution of those vaccines –  plus uncertainties regarding the extent to which vaccination prevents infection, or transmission of the disease”.

“Any imposition of such a requirement for vaccination, around the world does, in effect, deliver a double inequality as individuals from countries who have no access to vaccines will then have no access to travel, and therefore it is very important that if we’re going to impose restrictions on the travel of individuals, we must at least attempt to do that from a level playing field of having access to vaccine,” Ryan added.

A Health Policy Watch request to WHO/HQ for comment regarding the exclusion of the Serum Institute version of the AZ vaccine from the EU green pass received no response, as of press time.

Image Credits: UNICEF, African CDC , Tourism Watch.

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An estimated 20 million Americans were infected with COVID-19 in mid-July 2020 – 17 million more than the three milion officially recorded, a new study has found.

The United States may have experienced nearly 17 million additional COVID-19 cases in the first six months of the COVID-19 pandemic, according to a new study by the National Institutes of Health (NIH).

The NIH study,  published this week in Science Translational Medicine, suggests that for every coronavirus infection recorded until mid-2020, nearly 4.8 more asymptomatic cases went undetected.  In the United States alone, a total of 16.8 million infections with SARS-CoV2 were undected, as of mid-July 2020 – meaning that as many as 20 million Americans were infected with COVID-19 by mid-July 2020 – in comparison to the the three million cases officially recorded in that period.

“This study helps account for how quickly the virus spread to all corners of the country and the globe,” said Bruce Tromberg,  director of the National Institute of Biomedical Imaging and Bioengineering (NIBIB), one of the NIH institutes that runs the NIH SARS-CoV-2 Seroprevalence Project, in a statement on Tuesday.

Blood samples were collected from 8,058 volunteer participants between 10 May and  31 July 2020, among people who were not previously diagnosed with COVID-19. Of the sampled blood, approximate 304 contained antibodies against COVID-19.

Based on the analysis of the data , NIH researchers estimated that for every diagnosed COVID-19 case during the spring and summer of 2020, there were 4.8 undiagnosed cases – representing an additional 16.8 million cases.

The research team observed that Black participants had the highest estimated rate of positive COVID-19 antibody tests (14.2%), followed by Native American/Alaska Native (6.8%), Hispanic (6.1%), white (2.5%) and Asian (2%) respondents. When comparing age groups, the youngest participants – those between the ages of 18 and 44 –  had the highest estimated rate, at 5.9%, the study found.  Women (5.5%) had a higher positivity rate than men (3.5%); and numbers for those living in urban areas (5.3%) were higher compared with rural participants (1.1%).

Pandemic Hallmark – Many People Infected with Few or No Symptoms

“A hallmark of the coronavirus pandemic is that there are people infected with the virus that causes COVID-19 who have few or no symptoms,” Dr Matthew Memoli, director of the Laboratory of Infectious Diseases Clinical Studies Unit at the National Institute of Allergy and Infectious Diseases, which participated in the research team, said in a statement. 

“While counting the numbers of symptomatic people in the United States is essential to contend with the impact of the pandemic and public health response, gaining a full appreciation of the COVID-19 prevalence requires counting the people who are undiagnosed.”

The research team also included scientists from the National Institute of Allergy and Infectious Diseases (NIAID), the National Center for Advancing Translational Sciences (NCATS); and the Frederick National Laboratory for Cancer Research, sponsored by the National Cancer Institute (NCI). 

The team argues that the USA’s official COVID-19 numbers should be revised upwards from the three million cases reported in mid-July 2020 to almost 20 million, once the proportion of asymptomatic positive results are included.

Said senior co-author Kaitlyn Sadtler, chief of the NIBIB Section on Immunoengineering: “This wide gap between the known cases at the time and these asymptomatic infections has implications not only for retrospectively understanding this pandemic, but future pandemic preparedness.”

The research team said they are currently following up with the study participants to evaluate the presence of antibodies after six and 12 months, as well as antibody reactivity to variants of concern, the medical research agency said

“The information will be invaluable as we assess the best public health measures needed to keep people safe, as new – and even more transmissible – variants emerge and vaccine antibody response changes over time,”  said Tromberg.

healthcare workers
Nurses celebrate Nurses Appreciation Week in New York City, 2020, at the height of the COVID pandemic.

Healthcare professionals, and particularly community health workers who have been the backbone of local and national health systems during the COVID crisis, are also unsung ‘first responders’ to the massive mental health fallout from the pandemic, now and going forward.  

That is the central theme of a webinar panel on ‘COVID-19 and Frontline Workers’, Wednesday, 30th June, 13:00 – 15:00 CET, which featuring COVID response and mental health experts from the World Health Organization, the International Council of Nurses and consumer groups.

The panel is sponsored by the Geneva-based Global Self-Care Federation with Health Policy Watch serving as media partners for the event.    

Protecting Healthcare Workers’ Wellbeing Through Inclusive Mental Health Care

While the tireless work of nurses and healthcare professionals has been championed and celebrated throughout the pandemic, those workers have, for the most part, been ‘largely absent from the mental health discourse’, said Judy Stenmark, Director-General of GSCF, in a recent blog post on mental health. 

Stenmark calls for a more ‘more inclusive approach that brings all stakeholders into the equation’ to both consider the mental health needs of health workers during the pandemic period – as well as optimising their contribution to community-based mental health response.

“Without healthcare workers, there’s no chance we will see this pandemic through. Therefore, a greater consideration of self-care for healthcare workers is essential as we learn more about the consequences of the pandemic on healthcare systems,” she said in her blog, adding: “Unless we take proactive measures to ensure staff are safe at work and have sustainable working conditions – we’re at risk of losing the means that make healthcare possible.”

WHO Action Plan Extension Receives Wide Support During WHA

The Maldives’ delegate at the 74th World Health Assembly on Monday.

Those messages also echo ones heard during last month’s 74th World Health Assembly, in which WHO Director General Dr Tedros Adhanom Ghebreyesus called for a rethinking of mental health treatment and delivery: 

“One day this pandemic will be over – but many of the psychological scars linked to the pandemic will stay with us for a long, long time,” he stated, at the Assembly, in which a special session saw WHO officials and member states acknowledging how the ‘mass trauma’ of COVID-19 has worsened mental health worldwide. 

A draft decision endorsing an updated version of WHO’s Mental Health Action Plan also was adopted during the 74th WHA. 

The updated WHO Action Plan will include a greater forums on suicide prevention, workplace mental health, universal health coverage, mental health of children, mental health across the life course, and the involvement of people with lived experience of mental health conditions. 

“It is crucial to prioritize the actions to minimize mental health consequences of the pandemic and incorporate these actions into emergency and disaster risk management strategies,” said Asim Ahmed, Permanent Representative at the Permanent Mission of the Maldives to the UN in Geneva, during the 74th WHA. 

Incorporating Mental Health into COVID-19 Response Plans 

Mental health services for children and adolescents have been disrupted due to COVID-19

During the pandemic, WHO and its Member States have also worked to incorporate mental health and psychosocial support into COVID-19 response plans.   That has included WHO’s development of a wide range of resources in collaboration with partners, including: a stress management guide for the general public; a guide for COVID-19 responders on basic psychosocial skills; and a toolkit to help older adults maintain mental well-being.

  • “Doing What Matters in Times of Stress: An Illustrated Guide” is a stress management guide aimed at equipping people with practical skills to help cope with stress, especially in the early stages of the pandemic. 
  • The Inter-Agency Standing Committee Reference Group on Mental Health and Psychosocial Support in Emergency Settings, co-chaired by the WHO and the International Federation of Red Cross and Red Crescent Societies, has created an illustrated guide aimed at building basic psychosocial skills among all essential workers responding to COVID-19. 
  • The group has also produced a storybook for children, “My Hero is You, how kids can fight COVID-19”, to help children of 6-11 years learn how to protect themselves, their families and friends from coronavirus, and how to manage difficult emotions during the pandemic. 
  • A sequel that addresses the concerns of children during the current stage of the pandemic is planned for the third quarter of 2021. 

New WHO Guidance on Community-Based Mental Health Alternatives

A lay counsellor on the Friendship Bench in Zimbabwe – part of an innovative community-based mental health programme rolled out in the country.

With community-based services the backbone of better mental health services, WHO has recently highlighted successful examples of person-centered and rights-based community mental health services from across the world in a new report, released on 10 June.  

The report, ‘Guidance on community mental health service: promoting person-centered and rights-based approaches’, offers over two-dozen peer-reviewed examples of mental health services around the world that demonstrated good practices that are non-coercive, incorporate the community, and respect people’s agency, or their right to make decisions about their treatment and life.  

These include examples of cost-effective initiatives in low- and middle-income countries that promote frontline health workers, social workers, trained lay experts, and guided self-care networks as a backbone of service delivery to people in need. Examples include initiatives such as the Friendship Bench in Zimbabwe, Atmiyata in India, as well as self-help groups, such as Kenya’s Users and Survivors of Psychiatry (USP-Kenya).  

These services also feature alternative methods of treatment that ireduce compulsory hospitalization, over-prescription of anti-psychotic drugs – and critically, incorporate the voices of those with their own experiences with mental health conditions and psychosocial disabilities through peer-support groups. 

“[The value of peer-support groups] has been about restoring power, voice, and choice to persons with psychosocial disabilities,” said USP-Kenya CEO Michael Njenga.

Nurses and healthcare workers are the frontline of the health workforce

 

 

Image Credits: R Santos, Raisa Santos , WHO, WHO/NOOR/Sebastian Liste, Tim Kubacki/Flick.

Directors-General of WIPO (far left) WHO (back center) and WTO (far right) discuss stepped up cooperation on combatting COVID-19 pandemic

 

In a first-ever tripartite meeting this year, the heads of the World Health Organization, the World Trade Organization (WTO) and the World Intellectual Property Organization (WIPO),  have agreed to step up their collaboration on tools and resources for fighting the COVID-19 pandemic.   The meeting was the first formal tripartite meeting since Ngozi Okonjo-Iweala was elected as head of WTO earlier this spring, following the election of Daren Tang as the new head of WIPO late last year.

In a joint statement issued after the meeting the three heads of agencies, including WHO’s Director General Dr Tedros Adhanom Ghebreyesus, pledged to collaborate more closely on a joint platform for tripartite technical assistance to member governments relating to their needs for medical technologies as well as a series of workshops – to augment capacity and information flow.

In a joint statement issued following their meeting 15 June, the three agency heads stated that they would ramp up cooperation focusing first on “the organization of practical, capacity-building workshops to enhance the flow of updated information on current developments in the pandemic and responses to achieve equitable access to COVID-19 health technologies.

“The aim of these workshops is to strengthen the capacity of policymakers and experts in member governments to address the pandemic accordingly.

“The first workshop in the series will be a workshop on technology transfer and licensing, scheduled for September. The workshop will help our members update their knowledge and understanding of how intellectual property, know-how and technology transfer work in actuality. This would be in the context of medical technologies and related products and services. This first workshop will be followed by others on related practical themes.”

A second prong of the joint initiative, will be the joint platform for technical assistance, that aims to provide “a one-stop shop that will makae available the full range of expertise on access, IP and trade matters provided by our organizations, and other partners, in a coordinated and systematic manner.”  The platform will focus, in particular, on:

  • supporting countries to assess and prioritize unmet needs for COVID-19 vaccines, medicines and related technologies, and;
  • providing “timely and tailored technical assistance in making full use of all available options to access vaccines, medicines and technologies, including through coordination between members facing similar challenges to facilitate collective responses.”

The effort would also include “periodical update” of baseline resources maintained by the three organizations, mapped in the joint publication:  “Promoting Access to Medical Technologies and Innovation: Intersections between public health, intellectual property and trade”, the statemnt said.

The initiative appears to bring WIPO closer into the circle that has already been established by WTO and WHO on pandemic response – following last year’s change of administration in the agency that maintains a critical repository of data on intellectual property on health products for manufacturers worldwide – but has been too often accused of remaining outside of the loop of practical advice on IP use to low- and middle-income countries.

 

 

Image Credits: World Trade Organization .

Dr Rifaat Safadi, director of the Liver Unit at Hadassah Hebrew University Medical Center, in Jerusalem, Israel.

Patients who had liver transplants or those with advanced liver fibrosis may not be adequately protected against COVID-19 after two doses of the Pfizer-BioNTech vaccine, in light of the findings of a new study presented Wednesday on the opening day of the International Liver Congress(ILC) 2021.

Presenting abstracts from the soon-to-be-released study on Wednesday, Dr Rifaat Safadi, director of the Liver Unit at Hadassah Hebrew University Medical Center, in Jerusalem, Israel, said the study suggests that such patients with low levels of antibodies to the SARS-CoV-2 virus should get a third booster Pfizer shot to increase their chances of protection against the virus.

The global virtual conference, convened by the European Association for the Study of the Liver (EASL), is taking place Wednesday – Saturday.  This year’s conference brings together leading liver disease researchers from around the world to explore new science around the prevention and treatment of liver disease caused by Hepatitis C, alcohol abuse and other risk factors, as well as the  impact of the COVID-19 pandemic on people living with liver diseases and on liver disease medications.

This year’s conference proceedings are highlighting the extreme vulnerability of people with liver disease to COVID – with one new study finding the chronic liver disease increased the odds of COVID-19 death by  80%.

On the more positive side, another study however, found that the antiretroviral drug, tenofovir, prevented serious COVID-19 illness amongst people living with chronic Hepatitis B.

Research on the impact of COVID-19 on alcohol-related liver disease is also being showcased at this year’s conference session, along with new or improved treatments for people suffering from HCV. 

“We are beginning to understand  more clearly just how disproportionately COVID-19 is impacting on people living with liver-related diseases and the studies presented at  ILC 2021 advance  our knowledge on multiple fronts, knowledge that can potentially help inform policy responses to the  pandemic going forward,” said Philip Newsome, General  Secretary of EASL and Director of the Centre for Liver Research at the University of Birmingham in the UK, at Wednesday’s opening session. 

Pfizer-BioNTech Vaccine Offers Low Immunity for People with Advanced Liver Disease

Data from an Israeli study found that patients with advanced liver fibrosis may not be adequately protected against COVID-19 after two doses of the Pfizer-BioNTech vaccine.

With regards to the Pfizer vaccine on patients with liver disease, Safadi, who will present the full results of the Israeli study on Saturday, explained that “older age”, advanced fibrosis and decreased steatosis appear to be risk factors for lower vaccine response among people with related forms of liver disease.

The study analysed data from 88 patients living with hepatic fibrosis who had tested positive for COVID-19  and who had received both doses of Pfizer’s-BioNTech vaccine.

It found that elderly patients with advanced liver fibrosis had a lower response to Pfizer’s vaccine, with Safadi suggesting that those patients may need a third booster shot.

“Therefore, we have to think about the booster vaccination… we are thinking now about boosting the third shot, especially those with high risk for non responsiveness or lower response,” said Safadi.

The study’s recommendation, however, goes beyond current US Food and Drug Administration (FDA) recommendations.  The FDA has so far not recommended the use of  antibody tests to check the effectiveness of vaccination against the virus, nor has it  approved a three-dose regimen or booster of any SARS-CoV-2 vaccine.

Tenofovir Reduces Severity of COVID-19 in Patients with Chronic Hepatitis B  

Encouraging data from another new study found that antiretroviral drug, tenofovir, prevented serious COVID-19 illness amongst people living with chronic Hepatitis B.

A study conducted in Spain found that antiretrovira drug tenofovir reduced the severity of COVID-19 in patients with chronic Hepatitis B.

Beatriz Mateos Muñoz, PhD Specialist in Gastroenterology and Hepatology at the Hospital Universitario Ramón in Spain, said the study analysed data from 4736 patients from 28 Spanish hospitals. 

Of the 117 COVID-19 positive patients who were identified, 67  were taking  tenofovir  and 50 were on entecavir, an antiviral drug in the treatment of hepatitis B virus infection.  Muñoz said the incidence of COVID-19 in patients on tenofovir or entecavir were similar, but that patients on entecavir “more often had severe COVID-19, required ICU, ventilatory support, had longer hospitalization or died”.

The study found that tenofovir seemed to offer some protection in patients with chronic  hepatitis B infected by COVID-19.

“In multivariate logistic regression adjusted by age, sex, obesity, comorbidities and fibrosis stage, tenofovir reduced by 6-fold the risk of severe COVID-19. Patients with chronic  hepatitis B on tenofovir have a lower risk of severe COVID-19 infection than those on entecavir.”

COVID-19 Related Alcohol Sales May Have Increased Alcohol-related Liver Disease

Abdel-Aziz Shaheen, assistant professor at the Gastroenterology and Hepatology at the University of Calgary in Canada, said a large population-based study found a significant increase in the number of patients with alcoholic hepatitis who were hospitalised last year in Alberta, Canada  last year, with the highest admission rate recorded in April 2020.

Shaheen said a significant increase in alcohol sales across Europe and North America during the early months of the pandemic had alarming consequences for patients with alcoholic hepatitis. He said most of the newer patients with alcoholic hepatitis were younger and mainly from rural areas.

“There was a significant 9% increase in alcoholic hepatitis admissions per month between March and September and the average rate of alcoholic hepatitis hospitalizations compared to overall hospitalizations rate doubled from 11.6/ 10,000 general hospitalizations to 22.1/ 10,000 general hospitalizations for the same period,” said Shaheen.

More worrying, said Shaheen was that: “Our results show that the increase in alcohol sales post pandemic will significantly impact the natural history of alcoholic liver disease in Canada”. 

Chronic Liver Disease Increased the Odds of Covid-19 Death by 80%

Vincent Mallet, Managing Senior Physician and Professor, Hepatology Unit, Cochin University

Another study that used the French National Hospital Discharge database for patients who were hospitalised for COVID-19 found that chronic liver disease increased the odds of COVID-19 death by  80%.

Vincent Mallet, Managing Senior Physician and Professor, Hepatology Unit, Cochin University said the hospital records showed that  3, 943 of the 16,338 patients diagnosed with chronic liver disease who were admitted for Covid-19 in France in 2020 died, including 2518 after liver-related complications.

He said liver complications and alcohol use disorders may have contributed to the COVID-19 deaths of patients with chronic liver disease.

People with Obesity & Diabetes Related Fatty Liver Disease Also at Higher Risk from COVID-19

Similarly, a small study in Mexico of 348 patients found that people living with Metabolic Associated  Fatty Liver Disease (MAFLD) were five times more likely to die during hospitalization for COVID-19 than people without these factors.  

The patients studied were admitted with the SARS-COV-2 infection to a number of  tertiary referral hospitals between 4 April and 24 June 2020, said Martin Uriel Vázquez Medina, Researcher at the Laboratory of Biomathematical and Biostatistical Modelling for Health Escuela Superior de Medicina, México. 

Major risk factors for the chronic conditions are obesity and type-2 diabetes, common conditions in many parts of Latin America, also closely associated with unhealthy diets, including high sugar consumption, and lack of physical activity. 

Medina added: “We also want to show with this result that [patients in] Latin American countries that have this overhead problem of obesity, diabetes, and pre-diabetes, could also be associated with increased risk from COVID-19”.

The ILC continues until Saturday.

The African Medicines Agency’s framework would help combat falsified products and by ensuring harmonized drug standards and approvals, ease access to more affordable medicines and vaccines for people throughout the continent.

Michel Sidibé, Special Envoy of the African Union and Minister of Health of Mali has high hopes that 15 African countries will have finally ratified the African Medicines Agency (AMA) Treaty in time for the 35th African Union (AU) Summit, scheduled for early 2022.

Fifteen is the magic number of countries that must ratify the treaty creating the AMA – in order to birth the agency into operational existence.

By the time of the summit, Sidibé also predicts that 30 or more countries will also have signed the framework agreement on the creation of the agency – an agreement that was first approved by the African Union in February 2019. He was speaking at a virtual session on Tuesday,

From civil society to the pharma industry, establishment of the continent-wide AMA is regarded as an important step forward that would help improve the functioning of national medicines regulatory agencies – combating fake medicines and streamlining approval of new medicines and vaccines. That, in turn, should also help reduce prices and boost access for people throughout the continent, observers predict.  

Snail Speed Pace of Ratification So Far

However, snail-speed ratification of the treaty by the legislatures and parliaments of the AU’s 54 member states has become a major hurdle to actually opening the doors of the new agency. This is despite the strong support displayed by global health actors actors ranging from the World Health Organization, Africa Centres for Disease Control, as well as other regional drug regulatory agencies such as the European Medicines Authority.  

However, Sidibé said he is confident the new agency, once it finally begins operations, can build upon the continent’s existing  expertise in pharmacovigilance – developed by  national agencies  such as the Moroccan agency for medicines and the Nigerian Agency for Foods, Drugs Administration and Control (NAFDAC).

As for concerns regarding the slow pace of country approvals of the framework agreement and formal ratification, Sidibé said the plan has been to first target a balance of countries in diverse African regions as “low-hanging fruit” – followed by others. In fact, so far most of the countries signing and then ratifying the agreemeht have been West African and/or Francophone.  But as the critical mass of ratifications is approached, momentum elsewhere is also building.   

“Our strategy was to go for different regional balances… , to make sure that we can have a low hanging fruit so we can get quickly the 15 countries,” he said. “Now we are almost there. I am sure by the next meeting of the African Union, we can come and present to the leaders that we managed to have 15 countries,” he said, adding that the priority is to ensure that all African countries are soon on board.

Getting buy-in from all African countries will involve actively engaging with governments that are yet to sign and/or ratify the treaty, one by one. Top countries earmarked now for the next stage include north and west African regional leaders such as Ethiopia and Nigeria, as well as the Democratic Republic of Congo.

“We are learning from different experiences and ensuring that we are not losing time. We are making sure we bring different partners together to implement the agenda quickly,” Sidibé  added.

The Long Road to Ratification

In October 2020  Health Policy Watch reported that only 18 of Africa’s 55 countries had signed the framework agreement to establish the agency, while only 5 countries – Rwanda, Mali, Burkina Faso, Ghana and Seychelles –  had actually ratified the agreement.

At the time, Africa CDC Director John Nkengasong,  told Health Policy Watch the delay in the treaty ratification was due to the COVID-19 pandemic.

“I don’t think it is because countries do not want to sign on. I think it is because of the process that is required to make them sign that treaty, and the countries are currently focusing more on COVID-19,” said Nkengasong. “I think it’s a much needed institution. If we had the AMA, it would be working very closely with the WHO and other bodies to facilitate regulatory issues on drugs to help control the COVID-19 pandemic.”

Since then,  Zimbabwe and the Seychelles have signed the AMA framework treaty, raising the total number of signatories to 20.  Guinea, Namibia and Sierra Leone have ratified the treaty, followed by Algeria this month, raising the number of countries that have fully completed the two-step approval process to nine.

In order to get across the finish line, a new  African Medicines Agency Treaty Alliance (AMATA) has also recently been created, said Kawaldip Sehmi of the International Alliance of Patients Organizations (IAPO), at Tuesday’s session.  The Alliance, led by IAPO and including patient groups, researchers and academics, and industry, will advocate for rapid AMA ratification continent wide. It will also work to establish meaningful engagement with patients, industry and other relevant parties once the Agency becomes operational.

The WHO is also actively supporting the emergence of the AMA, with its Director-General, Dr Tedros Adhanom Ghebreyesus describing the lack of strong national regulatory systems as “one of the biggest obstacles to improving access to medical products in Africa”.

WHO Regional Director in Africa, Dr Matshidiso Moeti, has also reiterated the importance of the agency, telling Health Policy Watch: “AMA is a very important platform for medicines to be available and affordable equitably, and to be of good quality so that we have both good outcomes for the money that people and countries are spending, and that we prevent problems.” 

Other Benefits – International Partnerships and Support for Local Production

The AMA will also help strengthen global collaborations, including participation of African researchers and patients in clinical research trials of new medicines, especially in the area of cancer, said Emer Cooke, Executive Director of the European Medicines Agency, speaking at Tuesday’s event. 

“We’re already collaborating with a number of initiatives on clinical trials with African regulators, particularly in the context of the African Vaccines Regulatory Forum. We can use forums such as this to build on the collaborative activities that take place to share our experiences and to help us to work on training and capacity building initiatives,” Cooke said.

“I think we should be heartened by the fact that there’s already good discussion and collaboration in the context of clinical trials.”

Fighting Fake Medicines

Meanwhile, Lotfi Benbahmed, minister of the pharmaceutical industry of Algeria, said the AMA can help improve the reliability of Africa’s medicines — a feat that he said requires the existence of a regional framework to fight fake drugs.

“So what we need to do is to harmonise rules and regulations, and enable countries to fight the illegal markets, and the informal markets,” Benbahmed said, who spoke alongside other African ministers of health from Algeria, the Democratic Republic of Congo, Egypt and Cape Verde. .

According to him, a similar framework can be deployed to tackle the challenge of low quality drugs on the continent from the point of production, including setting up measures to inspect and control equipment in laboratories. 

At the same time, delays being encountered in the finalisation of the agency are “understandable”, said Dr Margareth Ndomondo-Sigonda, African Union Development Agency-New Partnership for Africa’s Development (AUDA-NEPAD), who highlighted the  extensive harmonisation processes that needs to be undertaken between national governments to birth the new agency.

“It takes time to get to the point where you’ve achieved regulatory harmonisation of African medicines and harmonization of regulatory standards. You have to make sure that through harmonization of these technical requirements, you know the quality standards and practice and  you build trust,”  Ndomondo-Sigonda said.

She was however hopeful that once AMA comes into force,  it will be able to deal with many outstanding issues regarding the harmonisation of Africa’s medicines landscape.

Image Credits: Marco Verch/Flickr.

Launch of the AMR Preparedness Index Panel – left to right – James Anderson, Susan Schwarz, Neil Clancy, Anand Anandkumar, Christine Ardal, Mike Hodin, Norio Ohmagari, Tiemo Wolken

Government action against the threat of “superbugs” in most of the world’s leading economies gets a score of less than 50%, according to a new AMR Preparedness Index, released today by a global coalition committed to fighting current trends. 

Great Britain, the United States, Germany and France rated highest on a score of 1-100 in an assessment of responses in 11 of the world’s leading economies to antimicrobial resistance (AMR) threats.  

Meanwhile, emerging economies such as Brazil, China, and India scored the worst in the assessment that looked at national strategy; awareness and prevention; innovation; access; appropriate and responsible use; AMR and the environment; and collaborative engagement. 

The index was launched today by the Global Coalition on Aging (GCOA) and the Infectious Diseases Society of America (IDSA), to shine more light on how the governments are living up to their commitments to address antimicrobial resistance (AMR). 

“We need health systems and policymakers to really step up and advocate that federal, state, and local governments prioritize AMR,” said Neil Clancy of the AMR Committee, Infectious Disease Society of America, during an event Wednesday launching the Index.

“Without significant national and global coordination and multi-party interventions in this area, our efforts are not going to succeed.”

action
The AMR Preparedness Index ranked 11 countries across 7 categories in a 1-100 point scale.

UN Report Warns That AMR Could Cause As Many as 10 Million Deaths/ Year 

Livestock applications of antibiotics in metric tons/year, among countries reporting use. (The Antibiotic Footprint)

An estimated 700,000 people already die each year from drug-resistant infections and the lack of antimicrobials to treat them. A 2019 UN report warned that if trends are ignored, AMR could  cause as many as 10 million deaths per year, and GDP losses of more than US $100 trillion by 2050. 

The report assigns scores to each of the 11 countries across seven categories for needed and achievable policy action. 

Although the assessment considered national policies on “AMR and the Environment” it was unclear how heavily weighted that issue was in the overall index.  Per capita, the US agricultural industry is one of the heaviest users of antibiotics in the world. 

COVID-19 Is a Warning Light to Act Preemptively on AMR  

The cost of AMR action pales in comparison to the future costs of inaction, participants underlined, drawing comparisons with the COVID-19 pandemic. Delays in responding to urgent public health crises have deadly consequences.  

“If the pandemic has taught us one thing, it is that we are not well-prepared to combat the serious threat that emerging infectious diseases can pose to human health and our economies,” said Tiemo Wölken, member of the European Parliament, Germany. 

In Europe, AMR causes the annual death of 33,000 people and costs 1.5 billion Euros in regards to healthcare costs and productivity losses. 

COVID-19 has highlighted the need for increased monitoring tools, more improved detection, prevention, and control practices, said Wölken. 

“The time to act is now. COVID already put our healthcare systems under extreme pressure, and this could only be a foretaste of what we could expect from a world where antibiotic microbials are no longer effective.” 

All Countries Fail in Awareness & Prevention of AMR  

Testing for antimicrobial resistance at the Liverpool School of Tropical Science.

The analysis identified critical opportunities for all governments to act upon to slow the growth of drug resistant bugs. 

“Despite the progress that’s being made and despite the good work being done in countries throughout the world, we need to do more,” said Clancy. 

Several trends have emerged from an analysis of the different indices that went into the combined score. 

All countries performed insufficiently with regards to awareness and prevention of AMR, with India lagging furthest behind. 

More developed countries tended to fare better in the appropriate and responsible use of existing antibiotics and other antimicrobial agents – as compared to developing country counterparts.  

Outside of the UK and US, most other countries performed poorly in assessments of the quality of national strategies, innovations, and collaboration.  

Innovation Important  

Training on standardized and harmonized surveillance methods for antimicrobial resistance in food animals in Southeast Asia

Innovation is another area that requires more significant action going forward, said James Anderson, Executive Director of Global Health at the International Federation of Pharmaceutical  Manufacturers and Associations (IFPMA).

“We do need to really drive pipelines. We do need investments in AMR.” 

In the fight against the borderless threat of drug resistance, the Index included key insights and guidance for governments to immediately prioritize in order to fulfill their commitments on AMR. 

Overall, the top-level priorities identified in the Index were to: Strengthen and fully implement national AMR strategies; and raise awareness of AMR and its consequences. 

Along with that, other key priorities were to: 

  • Bolster surveillance and leverage data across AMR efforts;
  • Enable a restructured antimicrobial marketplace to stimulate innovation;
  • Promote responsible and appropriate use of antibiotics;
  • Enable reliable and consistent access to needed and novel antimicrobials;
  • More effectively integrate the One Health Approach, including environmental concerns, into national strategies;
  • Better engage with other governments, third-party organizations, and advocacy groups 

Despite AMR being one of the top five global health challenges, as cited by the WHO, a large majority of the public remains unaware of their role. Local, national, and international efforts are needed in raising awareness and investment in AMR. 

“All of us have a stake in preserving antibiotics and assuring the development of new antibiotics,” said Clancy. 

Vaccinating Older Groups Against COVID – Can Help Fight AMR 

93-year-old Lebanese actor Salah Tizani, who falls into the elderly priority group, receives his first vaccine dose against COVID-19 in Beirut on Feb. 14, 2021.

In terms of the battle against COVID and AMR, the report underlines how vaccinating older adults can help fight overuse of antibiotics during the pandemic. 

That is because people who become seriously ill with COVID, are often given antibiotics preventively in order to ward off secondary infections.  Adequately vaccinating older populations against other infections such as pneumococcal pneumonia and tuberculosis, and even infections like influenza is also critical step to combatting AMR. 

In other ways, too, older adults have a key stake in fighting AMR, because they tend to be major consumers of health services, and also may be more vulnerable to drug resistant bacteria and viruses overall. 

“We are at a time now when the megatrend of aging is at the top of our agenda, not just the public health agenda but the economic and social agenda as well,” said GCOA CEO Michael Hodin. 

As the UN Decade of Healthy Aging was launched in January, AMR needs to be a central part of this initiative, applied not only to older people but to all of us for a healthy and active aging, Hodin added. 

Coordination and Collaboration Across Low- and Middle-income Countries and High-Income Countries  

Most countries examined in the report are not making adequate investments to combat the AMR threat, with the lack of commitment felt globally. Huge disparities in total public AMR research funding remains an issue across high, middle, and low-income countries.  

“We cannot afford to be only US-centric, or only LMIC centric. It takes a very globalized approach,” said Anand Anandkumar, Founder and CEO of Bugworks Research, India. 

Greater support and collaboration is necessary to increase capacity for AMR initiatives, such as monitoring and surveillance in many low and middle-income countries (LMICs). 

Consequently, high income countries must collect and provide more complete data to increase the robustness of international, regional, and domestic efforts.  

“Access and equity are global challenges and the central tilt to competitive AMR,” said Clancy. 

“[We need to ensure] that we get antibiotics and access to these drugs in an equitable fashion. We’re all at risk from AMR.” 

 

Image Credits: USAID Asia/Flickr, GC, antibioticfootprint.net, Flickr – UK Department for International Development, World Bank: Mohamed Azakir.