A new report recommends that governments prioritise funding and support for midwifery amid a global shortfall of 900,000 midwives.

Two in every three deaths in childbirth could be prevented by 2035 if the world starts recruiting and training more midwives, a new report on the “State of World’s Midwifery 2021” has found.

The report, launched by the UN Population Fund (UNFPA) on Wednesday found a  global shortfall of 900,000 midwives – and said that the global midwifery workforce needs to be expanded by some 30% to close that gap.

Compiled by the UNFPA, the UN’s sexual and reproductive health agency (UNFPA), WHO (World Health Organization), the International Confederation of Midwives (ICM) and other partners, the report evaluates the midwifery workforce and related health resources in 194 countries.

It states that for “midwives to achieve their life-saving and life-changing potential, greater investment is needed in their education and training, midwife-led service delivery, and midwifery leadership”.

Governments must prioritise funding and support for midwifery and take concrete steps to include midwives in determining health policies.

“Midwives play a vital role in reducing the risks of childbirth for women all over the world,” said WHO director general Dr Tedros Adhanom Ghebreyesus.

Increasing their numbers will “deliver a triple dividend in contributing to better health, gender equality and inclusive economic growth,” he said.

The last State of the World’s Midwifery report, published in 2014, also raised the alarm over shortages and provided a roadmap on how to remedy this deficit. But progress over the past eight years has been too slow, the report found. The analysis in this year’s report shows that, at current rates of progress, the situation will have improved only slightly by 2030.

ICM president Franka Cadee said “midwives are continually overlooked and ignored” and called on “governments to acknowledge the evidence surrounding the life-promoting, life-saving impact of midwife-led care, and take action on the report’s recommendations”.

Almost one in five women give birth without a skilled health provider, exposing both mothers and babies to risk,  the report  further found.

It gives the latest stillbirths estimates at about two million a year, along with an estimated 2.4 million new-born deaths and some 295,000 maternal deaths, either during or soon after pregnancy.

Describing the report’s findings as “alarming”, UNFPA executive director Dr Natalia Kanem  said 1.1million more essential health workers are needed  to deliver sexual, reproductive, maternal, newborn and adolescent health care, and 80 per cent of these missing essential health workers are midwives.

“A capable, well-trained midwife can have an enormous impact on childbearing women and their families – an impact often passed on from one generation to the next,” Kanem said.

The lack of midwives, the report states,  is driven by gender inequality, with countries overlooking sexual and reproductive health and under-estimating the value of a female-dominated workforce.

Fixing the gaps in provision could save an estimated 4.3 million mothers and babies a year, cutting two in three needless deaths by 2035, said analysis conducted for the report published in The Lancet medical journal last December.

The report urged governments to put money into boosting midwife numbers, improving training and offering midwives a greater role in health policy and maternal healthcare.

Image Credits: WHO, WHO SEARO.

German Chancellor Angela Merkel

The World Health Organization and the German government on Wednesday announced the launch of a new Global Hub for Pandemic and Epidemic Intelligence that aims to harness the world of big data, media and epidemiological reports to more rapidly identify and respond to emerging disease risks.  

The hub, to be launched in Berlin later this year, would bring together scientists, data experts and other know-how from governments, international organizations and the private sector, in new, and more flexible forms of collaboration, WHO’s Director of Health Emergencies, Mike Ryan, said at a press briefing on Wednesday. 

Launch of the hub is being supported by €30 million in seed funds from the German government, said officials at the briefing, addressed by German Chancellor Angela Merkel and Health Minister Jens Spahn.

“The WHO Hub for Pandemic and Epidemic Intelligence can make a difference for a safer future…(we should focus on) the development of a global data ecosystem to produce timely insights and tools for policymakers, before and after an epidemic and pandemic events,” Spahn said.

The hub would help gather data more efficiently to predict, prevent and respond to future pandemics and epidemic risks worldwide, said WHO Director General Dr Tedros Adhanom Ghebreyesus.

“One of the lessons of the Covid-19 pandemic is that the world needs a significant leap forward in data analysis to help leaders make informed public health decisions,” Tedros said. 

“This requires harnessing the potential of advanced technologies such as artificial intelligence, combining diverse data sources, and collaborating across multiple disciplines. Better data and better analytics will lead to better decisions,” he said.

Faster Identification of Threats and Responses

Some of the first SARS-COV-2 cases emerged around Wuhan’s “wet markets” selling wild animals for slaughter and meat consumption; such markets can be a flashpoint for pathogen transmission to humans.

The initiative responds to a key issue raised by WHO member states and independent reviewers regarding the initial stages of  COVID-19 pandemic response – and the belated recognition of the SARS-CoV2 outbreak that was now obviously simmering in Wuhan throughout the fall of 2019 – and possibly even spreading then to other countries, such as Italy, where COVID-positive serum samples from the period were later identified.

Even so, the first Chinese government and media reports of the mysterious pneumonia-like outbreak in Wuhan were only picked up on 31 December, 2019 – by WHO’s China country office as well as by the WHO EIOS (Epidemic Intelligence Open Sources) platform – which noted a report from ProMED, the International Society for Infectious Diseases.  

Following that, criticism has also been leveraged against the quality of data collection by WHO, China and other member states reflecting the early days of the pandemic spread  – which may have contributed to WHO’s delays in declaring an international public health emergency over the virus – which so far has killed over 3.2 million people worldwide. 

Although not “new”, the idea of a hub, according to Tedros, coalesced during discussions with Merkel in October 2020 about the creation of a centre that would serve as a global nerve centre to enhance global capacity for pandemic and epidemic intelligence.

Merkel, in a video message, said that the COVID-19 pandemic “has taught us that we can only fight pandemics and epidemics together”.

“The new WHO Hub will be a global platform for pandemic prevention, bringing together various governmental, academic and private sector institutions,” Merkel said, further welcoming WHO’s decision to base the hub in Berlin.

The hub will bring together governmental, academic and private sector institutions to harness global data, surveillance and analytics and will involve a global collaboration of countries and partners to look for pre-signals that go beyond current systems that monitor publicly available information for signs of emerging outbreaks.

Build Upon EIOS – CERN-like Model For Cooperation 

WHO’s Director of Health Emergencies, Mike Ryan

Ryan said that the hub would not be about creating another “big bureaucratic WHO institution” but rather a transformed and engaging centre.

He said that WHO envisages the platform as functioning similar to CERN, the European Organization for Nuclear Research – an iconic Geneva-area institution that brings together research fellows, visiting scholars and other experts for brief stints,  where they can share and apply their knowledge and skills. 

“It’s about creating a platform with Germany, where everyone can come and contribute. And this becomes a facilitating environment. We bring the best minds, we bring the best ideas and we facilitate that with the infrastructure and the tools and all of the things that we need…(to) allow others to take the real innovative steps to move us forward in this regard,” Ryan added. 

He said that the hub would build upon the networks created by EIOS – in a more sophisticated model – to become operational from September. 

Germany has offered a seed fund of €30 million annually as a startup for the hub, with WHO still working on further details of the budget, he added. .

Appeals for further funding are being discussed with various potential donors at the G7 level, said Ryan.

Berlin “Ideal Location” for Global Hub

German Health Minister Jens Spahn

Merkel said Berlin was an ideal location for the hub as it already had leading players in the digital and health fields, such as the Robert Koch Institute, the German federal government’s scientific research institution.

“If that expertise is now supplemented by the WHO Hub, we will create a unique environment for pandemic and health research here in Berlin — an environment from which important action-oriented insights will emerge for governments and leaders around the world,” she said.

Emphasising that the new hub would still fall under WHO’s governance, Spahn said Germany was offering an “enabling environment for the inter linkages between public health and digital players”.

“We are very confident that this local environment will provide numerous opportunities for synergies with a new double edge  for the hub,” Spahn said, echoing Tedros’ sentiments that there was a clear need for stronger early local warning alerts and emergency response system  to help improve public health intelligence and risk analysis.

Transparent Data is Imperative

WHO affirmed that data from the new global hub will be held openly and transparently.

While affirming that data, in principle, should be held openly and transparently, Ryan acknowledged that it will still be up to the member states and the rules of the International Health Regulations to decide how, and with whom, to share verified information. 

“The aim is to bring together partners from around the world to develop better access to data and to develop tools we need to generate the insights we need before, during and after pandemics. But, also to build  trust between partners in sharing that data in sharing those insights. We aim to bring that whole process together,” Ryan said.

He acknowledged, however, that access to data as well as tools for generating insight from such data is not evenly distributed across the member states.  And the hub would try to address those inequalities, as well. 

“I can assure you that that’s the point of the centre… to democratize that process, bring more parameters and create facilities, translate trends and transformative technologies on the capabilities to our member states.”

However, issues around transparency and accountability will not be solved by new technologies, but by building trust between partners in sharing data and insights, Ryan added.

Three independent panels are due to report at the upcoming World Health Assembly (WHA)on how the WHO and member states reacted to the pandemic, and propose reforms in rules and procedures.

Effectively the creation of the hub leapfrogs over what is likely to be highly politicized deliberations on those reforms at the WHA – to create at least one fait accompli that would support earlier warnings.   

Image Credits: Breaking Asia, UCT.

High-level panel on TRIPS waiver

CAPE TOWN – The “circular discussion” at the World Trade Organization (WTO) on the TRIPS waiver needs to move to “text-based” negotiations, Ambassador Xolelwa Mlumbi-Peter, South Africa’s Permanent Representative to the WTO said on Tuesday.

Her Indian counterpart, Brajendra Navnit, added that opponents of the waiver had been using “delaying tactics” since the beginning of the year, “changing goalposts” to raise new problems once their earlier concerns had been addressed.

Mlumbi-Peter and Navnit were addressing a high-level panel on Tuesday organised by a range of civil society organisations, on the eve of yet another meeting of the TRIPS Council on the waiver issue, set for Wednesday and Thursday. 

A waiver in the enforcement of patents, copyright, industrial designs, and trade secrets, under WTO’s Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), was proposed in October 2020 by India and South Africa, for all COVID-related health products for the duration of the pandemic. 

This proposal has been supported by over 60 member states, but opposed by mostly high-income nations. During the ensuing six months of negotiations, a further two million people have died from the SARS-CoV2 virus, participants at Tuesday’s panel pointed out. 

A revised version of the TRIPS waiver proposal is to be presented at Wednesday’s TRIPS General Council “in a bid to reconcile positions”, according to the WTO.

‘Hopeful Signs” on US Position 

Ambassador Xolelwa Mlumbi-Peter, South Africa’s Permanent Representative to the WTO

Until recently, Mlumbi-Peters had chaired the WTO TRIPS Council, on behalf of South Africa, and had thus been unable to speak publicly in support of the waiver proposal. 

Another panelist, United States Congresswoman Jan Schakowsky, who has been championing the waiver in her country, said that it was still unclear if the US administration would support the waiver – but there were some hopeful signs of “dramatic change”.

“The United States position is evolving. There are divisions even within the administration – and [within] the Members of Congress, a majority of the Democrats have weighed in, in favour of a TRIPS waiver,” said Schakowsky.

“When Big Pharma talks about its priorities and that intellectual property rights rule everything, they are forgetting that the American people, the taxpayers, have spent billions and billions of dollars in research and development and distribution, have a huge stake in this,” she added.

No ‘Good Examples’ of Voluntary Licensing 

Schakowsky supported text-based negotiations on the waiver “to make the changes that are necessary that are going to allow all countries to have access”.

“We really don’t have the time to argue with the pharmaceutical industry,” said added.

Kathleen Van Brempt, Belgian Member of the European Parliament and the trade coordinator for the Parliament’s Progressive Alliance of Socialists and Democrats Group, proposed “a coalition of the willing” involving European and US politicians in particular.

Van Brempt said that opponents of the waiver claimed that it was an “ideological” proposal that would not facilitate the technology transfer needed to speed up vaccine production, and that this could be achieved with voluntary licensing of COVID-19 treatments and medicines.

“The facts and figures prove them wrong,” said Van Brempt. “I don’t know any good examples of voluntary licensing, or even of compulsory licensing, that would ramp up production. That is not the case today, and that’s why we have to move on.” 

Kathleen Van Brempt, Belgian Member of the European Parliament

Van Brempt added: “I’m very happy to see my colleague of the US Congress [Schakowsky]. I think we should work much more closely together  because I hear that the Biden Administration might move.”

She also suggested engaging with the pharmaceutical industry as a first step to inform them about “how unacceptable it is that they decide on the price, and they decide who can produce”, when these decisions “should be steered by governments”. 

She also suggested opening up the discussion on the TRIPS waiver with the aim of “ramping up [vaccine] production”. 

More Pragmatic Than Ideological

Ruth Dreifuss, former President of Switzerland, said that “unilateral, bilateral tools, like voluntary licenses, compulsory licenses, parallel imports have not adapted to the current situation”. 

“We urgently need a more global approach as proposed by India and South Africa,” added Dreifuss, who chairs WHO’s Commission on Intellectual Property Rights, Innovation and Public Health (CIPIH) and was co-chair of the UN Secretary General’s High-Level Panel on Access to Medicines.

Neither voluntary licenses (issued by pharma companies) nor compulsory licenses (which may be issued by countries in health emergencies) are tools “that would allow us to go as swiftly as we should”, as they have always involved bilateral arrangements or decisions by individual states, which do not address the broader global situation.

“With more than $100 billion of public money invested in R&D and supply of vaccines and therapeutics, the risk taken by the pharmaceutical industry has been largely overtaken by the taxpayers,” Dreifuss added. “It is, therefore, an obligation for the states to guarantee fair access, and therefore the means to control the pandemic worldwide.” 

Dreifuss added that Switzerland “doesn’t share this idea, but I think it is a victim of a vision that is more ideological – not really pragmatic and adapted to the challenge we are facing now.” 

“Making the rights of intellectual property something very sacred is not a political position I can share,” she added.

 Van Brempt, meanwhile, said she had been encouraged that the ambassadors of India and South Africa are “not locked into their own truth” but open to negotiations.

“I might be wrong but I think I can establish a majority of the European Parliamentarians, but it will involve compromises, and maybe it will not say that we fully support the waiver, as requested by India and South Africa. Maybe it will need another wording, but what I want is a shift in how the Commission looks at it.” 

 

Image Credits: Tadeau Andre/MSF .

India has received emergency COVID-19 supplies from several countries.

PUNE – For two weeks now Sijo Raju, along with a group of 20 young men and women, have been fielding calls from family members looking for oxygen cylinders, ventilator beds and ambulances. Finding a match can take a few hours as India’s overwhelmed health system and front-line healthcare workers try desperately to provide a semblance of care to the massive number of COVID patients.  

In the absence of a centrally coordinated response, citizens like Raju have stepped up. They verify messages posted online, guide family members to facilities with resources, and do their best to step in place of a government machinery that has effectively abandoned its citizens. 

“There is just too much information on the internet,” Raju told Health Policy Watch. While the group members, most of them in their 20s and 30s, are based in the Mumbai metropolitan area, they are now trying to help verify requests coming from across India and are among many such citizen groups that have banded together in the past few weeks.   

On 1 May, India reported over 400,000 cases – a record-high figure in the history of the COVID-19 pandemic so far. It was also the day the country officially lowered the age for those eligible for vaccines from 45 and above to 18 and above.

The government had placed orders for the additional vaccines that would be needed just two days before vaccination was to be expanded, and not surprisingly most young people aren’t able to find slots as they try to register for vaccines.  But Adar Poonawalla, whose company Serum Institute of India (SII) is responsible for supplying the bulk of the vaccines, said given that the orders were recently received, ramping up production would take still time.

Cases continue to rise in India overwhelming the country’s already fragile health infrastructure

Promoting Alternative Medicines
Meanwhile, India’s government is promoting a poly herbal drug named Ayush-64, calling it a “ray of hope”. The drug is being promoted by the Ministry of  Ayurvedic Medicines, Yoga, Unani, Siddha and Homeopathy (AYUSH). Alternative therapies are widely popular albeit not without controversy as mainstream treatments in the pandemic. 

The government said the drug has been found to be useful in mild to moderate cases. It is also promoting yoga as a way to “strengthen natural immunity”. Most COVID-19 cases are mild to moderate that require little to no treatment under normal circumstances.

“The claims made about certain AYUSH interventions in the absence of quality clinical studies and data being presented is unfortunate,” said Anant Bhan, a bioethicist and global health policy expert based in India.

“It could lead to reliance on interventions which could not be working, and take the focus away from interventions which do. As is the requirement with allopathic medicines, any claims about AYUSH interventions and utility in COVID-19 needs to be backed by data.”

Indian government’s push for alternative medicines comes at a time when Indians are in need of a planned COVID-19 response and urgent ramping up of health facilities. 

The country’s cases have been on an upward trajectory since March when Prime Minister Narendra Modi held massive election rallies in the state of West Bengal and allowed the Hindu religious event Kumbh Mela to go on that saw gathering of thousands of devotees to perform rituals by the holy river Ganges. Both these events ended up being super spreader ones and worsened the pandemic.

Restrictions continue in many high burden states in India and the popular cricket tournament Indian Premier League has also been postponed. The tournament had come under heavy criticism for continuing despite rising COVID-19 deaths. The secretary of the Board of Cricket Administration is Jay Shah, the son of India’s home minister Amit Shah, a key figure in the Modi Administration.

Aid Distribution and Vaccine Rollout

After India’s pandemic made headlines around the world, the country started receiving aid. Ireland became the most recent country to send aid and US aid has also arrived. Despite this, ordinary citizens continue to struggle for basics based on messages on social media. 

The government issued a statement saying that the aid will be distributed based on the number of cases and the need in the states – after questions were raised in the Indian media about the plans for distribution. 

This while the public waits for the Serum Institute to ramp up its production further.

India’s Supreme Court has also pulled up the Modi administration for failing to regulate the prices of the vaccines. Currently vaccine manufacturers are offering different prices to the centre and state governments, as well as private players, as Health Policy Watch reported in an earlier story.

Health experts have said this would set a dangerous precedent while policy experts have criticized the government for its handling of the vaccine distribution.  

Disha Shetty is an independent journalist based in Pune, India

Image Credits: @MEAIndia -Ministry of External Affairs, Spokesman's office , Our World In Data .

East African truck drivers will get access to one common COVID-19 testing system by mid-May.

KAMPALA – Uganda, Kenya and Rwanda have suspended passenger flights from India amid that country’s surge in COVID-19 cases and  fears that a number of African countries are on the brink of their own surges.

“All flights from India and all passengers originating from India are suspended from 1 May,” the Uganda Ministry of Health said in a statement. “All passenger flights are suspended until further notice. No travellers from India shall be allowed into Uganda regardless of the route of travel.”

Meanwhile, Kenya has suspended flights from India for 14 days, according to the Kenya Ministry of Health. Kenya Airways and Rwandair have also suspended flights from and to India.  

However, East African residents will be allowed to return home. India is a top medical tourism destination for residents in East Africa. 

The three countries are demanding that travellers who have been to India or travelled through India in the last 14 days, be in possession of a negative PCR COVID-19 test certificate that is digitally verifiable and has been conducted within 120 hours of travel. They will also undergo a PCR test upon arrival.

Uganda will allow cargo flights from India where the crew do not disembark and technical stops where travelers do not disembark. It is also allowing aircraft in a state of emergency, operations related to humanitarian aid, medical evacuation, diplomatic flights approved by the appropriate Authority.

Uganda has also advised travellers from the USA, United Kingdom, United Arab Emirates, Turkey, South Africa, and Tanzania to consider postponing non-essential travel to Uganda.

Travellers from these countries, including Ugandans, will be subjected to a PCR test upon arrival at the points of entry into the country said Dr Jane Ruth Aceng, Uganda’s Minister of Health, during a weekly briefing.  

“We should make a difference between people and the virus. The virus is the enemy, not the people. If someone has an authentic negative PCR test, they do not cause a problem,” said Dr John Nkengasong, director for Africa Centres for Disease Control and Prevention (CDC).  

Truck Drivers’ Testing is Tightened

The East African Community (EAC) is tightening up on the COVID-19 testing requirements  of interstate truck drivers, identified as vectors of the virus, amid numerous problems including forged tests 

At a recent EAC meeting, Uganda, Kenya, Tanzania, Burundi and South Sudan agreed to submit the names of accredited national laboratories for COVID-19 testing so that these could be linked to the upgraded Regional Electronic Cargo and Driver Tracking System (RECDTS), which recognises digital COVID-19 certificates for truck drivers.

The deadline for uploading all accredited COVID-19 testing laboratories in the RECDTS is 15 May. This will ensure that interstate truck drivers and other travellers test for COVID-19 in only through accredited laboratories and that all partner states take up and implement the RECDTS system.

Digital certificates are uploaded on the drivers’ smartphones through an app and are valid for 14 days. The App, which was launched in September 2020, was developed with donor funding. It provides a surveillance system to monitor long-distance truckers’ health and enables contact tracing. It also allows partner states to electronically share truck drivers’ COVID-19 test results.

The new system is aimed at resolving some of the challenges that were being experienced in the execution of health protocols including multiple testing of truck drivers at the border crossing as there lacked a framework of mutual recognition, document fraud and conflicting test results.

The interstate truck drivers also are the single largest group of people who have been identified to be carrying the variants of concern – the  B.1.351 variant from South Africa and the B.1.1.7 from the UK. From 399 samples sequenced by the Uganda Virus Research Institute (UVRI) these two variants were detected in 30 truck drivers.The Indian variant has been identified in one patient who was admitted to Mulago Hospital.

By Wednesday, the EAC Secretariat expects to have shared a detailed concept note on the development of a common regional health pass to be linked to the upgraded surveillance.

Uganda and Kenya Cases Increase

By Monday, the Ministry of Health in Kenya had reported that 369 people had tested positive for the disease, from a sample of 4,469 tested in the last 24 hours – a positivity rate of 8.3% compared to the world average of 2.2%. 

A total of 1,298 patients are in various health facilities countrywide, while 6,652 patients are in isolation at their homes and 19 had died in the 24 hours before Monday. Total confirmed positive cases are now 160,422 and cumulative tests so far conducted are 1,679,779.

Some 190 patients are in the ICU, 29 of whom are on ventilatory support and 118 on supplemental oxygen – 43 patients are on observation. 

Aceng said that Uganda was “experiencing a gradual increase in the COVID-19 cases and it is the beginning of a resurgence”. 

“This surge is already showing in districts that have remained on high alert and have been carrying out active surveillance,” said Aceng, adding that “this second wave will be worse than the first one”.

Uganda has already organised a resurgence plan which is projected to cost over $290 million and is organised around three thresholds: control, alert, and action. The alert threshold is reached when there is a 10% increase in cases while the action threshold begins when there is a 20% increase in the cases observed from the baseline in any geographical location.

“The main objective of the resurgence plan is to mitigate transmission and minimise the public health and social economic impact,” said Aceng. The resurgence plan will include enhanced surveillance, active case search, contact tracing, procurement of test kits, Personal Protective Equipment, critical care support, strengthening community engagement and risk communications, and supporting the vaccination teams but it does not include procurement of vaccines.

By 30 April, Uganda’s cumulative COVID-19 cases stood at 41,866 with 342 deaths. There are currently 444 active cases.

WHO Warns of African Resurgence

Dr Matshidiso Moeti, WHO Regional Director for Africa.

The World Health Organisation (WHO) predicts a high risk of COVID-19 resurgence in several African countries due to poor adherence to public health measures, mass gatherings, low testing and vaccination rates.

“We cannot be lulled into a false sense of security. The devastating surge of cases and deaths in India, and increases in other regions of the world, are clear signs that the pandemic is not yet over in African countries,” said Dr Matshidiso Moeti, WHO Regional Director for Africa. 

“ A new upsurge of COVID-19 infections is a real risk in many countries even if the region’s case count in recent weeks appears to be stable,” she added. “Combatting COVID-19 fatigue appears to be the key battle in our collective response to the pandemic.”

According to the WHO analysis of 46 African countries, Kenya, Egypt, Ethiopia face a very high risk of resurgence, while a further 20 countries face a high risk and 22, moderate risk, and only one country faces low risk. 

The risk was calculated using seven indicators with data from the past four weeks, including COVID-19 cases per million people; the percentage of change in new cases; the percentage of change in new deaths; the reproductive number (the rate at which an infection spreads); the pandemic trend; the average weekly number of tests per 10 000 people; and the percentage of the population that has received at least one vaccine dose.

With more than 4.5 million confirmed cases and over 120 000 deaths to date, the continent has not experienced a surge in cases since January and the epidemic curve has plateaued for six weeks. 

But the relatively low number of cases has encouraged complacency and reduced adherence to behavioural measures to prevent the spread of the virus.

In addition, recent political rallies in Benin, Cote d’Ivoire, Guinea and Kenya caused a spike in new cases. Upcoming elections in Cape Verde, Ethiopia, Gambia, Sao Tome and Principe and Zambia could also trigger cases due to mass gatherings, said Moeti.

Of the 46 countries analysed, 31 performed fewer than 10 tests per 10,000 people per week in the past four weeks.

“Most new cases are still not being detected among known contacts. Investigation of clusters of cases and contact tracing are worryingly low in most countries in the region,” Moeti said. “We must scale up testing including through rapid diagnostic tests to enhance response to the pandemic.”

 

 

Image Credits: EAC.

A shipment of the Chinese Sinopharm vaccine reaches Peru

The World Health Organization (WHO) appears to be inching towards the approval of the Chinese Sinopharm and Sinovac vaccines as it struggles to fill a looming vaccine vacuum left by India’s Serum Institute – which has halted exports as the country continues to reel from a tragic coronavirus outbreak. 

Meanwhile, the WHO declared the latest Ebola outbreak in the Democratic Republic of Congo to be over, just three months after the first case was reported in North Kivu.

Chinese Sinopharm & Sinovac May be Approved By End of Week

Mariângela Simão, WHO Assistant-Director General for Access to Medicines

The Chinese vaccines from Sinopharm and Sinovac could be approved by the end of this week, noted the WHO Assistant Director-General for Drug Access, Vaccines and Pharmaceuticals Mariangela Simao, speaking at a WHO press conference on Monday.

“We are finalizing the assessment of Sinopharm [but] there’s still some documentation that needs to be added,” she said. “We will start the final assessment for the listing of Sinovac on the fifth [of May], so we expect both the Chinese vaccines [to] be finalized by the end of this week.”

If both vaccines receive the WHO’s green light, China could could become the world’s largest vaccine supplier, assuming that Sinovac and Sinopharm will honor their commitment to produce two billion vaccine doses this year.

Despite the lack of published data for the two vaccines, as well as their hefty price, both seem to have met the WHO’s minimum efficacy requirement of 50%, the WHO’s chairperson of Strategic Advisory Group of Experts (SAGE) said late last month.

With regards to the WHO’s approval of another vaccine frontrunner that seems to be significantly more potent and cheaper than its Chinese counterparts, Russia’s Sputnik V, the WHO expects a final decision by June or even July, said Simao. 

“WHO still does not have the entire dossier [for Sputnik], it’s not complete yet,” she said, noting that the WHO is in the process of assessing good clinical practices for Sputnik V and is set to begin evaluating manufacturing practices next Monday until early June. 

“We expect that as soon as we have the entire dossier, plus the compliance to both good manufacturing practices and the good clinical practice, the vaccine can be assessed then by the technical expert group [SAGE] and we expect that this is likely to happen [by the] end of June or probably in July.”

Ebola Outbreak in DRC Declared Over by WHO

Meanwhile, the WHO’s Director General, Dr Tedros Adhanom Ghebreyesus, hailed the DRC’s milestone in bringing an end to the twelfth Ebola outbreak in the country – a deadly disease that kills about half of the people it infects. 

“Earlier today, the government of the Democratic Republic of the Congo, announced the end of the most recent Ebola outbreak three months after the first case was reported in North Kivu,” said Dr. Tedros on Monday, emphasizing that a comprehensive public health approach was crucial in ending the latest outbreak of Ebola.

“Huge credit must be given to the local health workers and the national authorities for their prompt response, tenacity, experience and hard work that brought this outbreak under control,” added Dr Matshidiso Moeti, WHO Regional Director for Africa. She was referring to the country’s swift move to vaccinate almost 2,000 people at high-risk of contracting the virus and providing treatment as soon as the outbreak was declared in February.

However, she stressed that going forward, strong surveillance systems will be crucial to swiftly detect potential flare-ups and to fight parallel epidemics of measles, cholera and COVID-19.

“Although the outbreak has ended, we must stay alert for possible resurgence and at the same time use the growing expertise on emergency response to address other health threats the country faces.”

Image Credits: Sinopharm, Peruvian Ministry of External Affairs.

JOHANNESBURG – South Africa received its first batch of 325,260 Pfizer vaccine doses late on Sunday night, Health Minister Zweli Mkhize announced.

This follows lengthy negotiations between the South African government and Pfizer, during which the company made “difficult and sometimes unreasonable” terms including at one stage that the country put up sovereign assets as potential collateral, according to a report by the Bureau of Investigative Journalism.

South Africa’s Health Minister Zweli Mkhize

Mkhize sent a briefing letter to parliamentarians last month, saying that the government had been “relieved” when Pfizer eventually removed the “problematic term” which had put the government in the “precarious position of having to choose between saving our citizens’ lives and risking putting the country’s assets into private companies’ hands”, according to the bureau.

Samples of the Pfizer vaccines are currently undergoing quality checks by the National Control Laboratory, and will then be sent to urban vaccination centres where they will be administered to healthcare workers.

The country expects approximately the same number of doses – 325 260 – to arrive each week during May and 636 480 doses per week in June, with close to 4,5 million doses having been delivered by the end of next month.

Each person needs two doses of the vaccine, which also needs ultra-cold storage which makes it unsuitable for rural distribution.

Johnson & Johnson Vaccines Also Being Checked

South Africa has only vaccinated slightly more than 320,000 of its estimated 1.2 million health workers so far. The country opted not to use the AstraZeneca vaccine following research that showed that it had limited efficacy against the B.1.351 variant dominant in the country.

Until now, it has been vaccinating health workers with a very limited supply of the Johnson & Johnson (J&J) vaccines. However, 1.1 million more J&J vaccines are in the country undergoing safety checks that are likely to be completed in mid-May. 

“This is due to a protracted safety verification process with international regulatory agencies,” said Mkhize in a statement on Sunday. 

“This is a precautionary measure following the adverse findings during inspection of Emergent BioSolutions Bayview facility in the United States, one of the manufacturing partners of Johnson and Johnson, which prompted the authorities to extend their assessments of all Johnson and Johnson stock worldwide.”

Once through the safety checks, the J&J vaccines will be used in rural settings as they don’t require ultra-cold storage and people only need one dose.

The country plans to start vaccinating all citizens over the age of 60 from 17 May.

Meanwhile, South Africa’s National Institute for Communicable Diseases (NICD) has released modeling data last week which predicts that the country can expect a “third wave” of the pandemic in two to three months – but that this is not likely to be as severe as the second wave as long as there are no new variants.

“The most likely drivers of a third wave are behaviour change after the end of the last wave;  ongoing viral mutation; seasonal factors; and reinfection due to the waning of immunity conveyed by previous infection,” according to the NICD.

Image Credits: US Centers for Disease Control, GCIS.

Gavi will receive 500 million doses of the Moderna vaccine to help expand vaccine coverage around the world

Gavi, The Vaccine Alliance, has secured half a billion doses of Moderna’s mRNA vaccine for the COVAX global vaccine facility in a landmark agreement that will deepen vaccination coverage in poor countries around the world, Gavi said on Monday.

Meanwhile, Sweden announced that it will donate one million doses of the AstraZeneca vaccine to the global COVAX facility to help fill an urgent shortfall of 20 million doses as the world’s vaccine powerhouse, the Serum Institute of India, has diverted most of its vaccine supply to fend off a devastating outbreak in the country. The announcement came as WHO’s Director General Dr Tedros Adhanom Ghebreyesus said in a press conference that COVAX and related medicines access initiatives face an immediate funding gap of US$19 billion, along with “further needs” of US $35-$US40 billion over the coming year. 

“We will only solve the vaccine crisis with the leadership of G7 countries,” Tedros said, speaking at a WHO press conference that featured an appeal by former British Prime Minister Gordon Brown to rich countries to immediately donate more excess vaccines.

Brown, now the UN Envoy for Global Eradication, also joined WHO in an appeal to G7 nations to dedicate some US$ 20 billion a year from their combined resources to a more robust pipeline of COVID vaccines and medicines – at an upcoming G7 meeting 11 June.

“Mass vaccination is not just an epidemiological and ethical imperative. It’s an economic imperative,” stressed Brown. “But if the cost of vaccines is in billions the overall savings is in trillions of additional economic output, made possible when trade resumes in a COVID free world.”

“In the next few months we do not expect the Serum Institute of India to be able to supply the kind of [vaccine] volumes that were originally predicted. And so it would be really helpful to get [additional] doses from other countries,” said WHO Chief Scientist Soumya Swaminathan, speaking at the briefing.

Senior WHO advisor Bruce Aylward, meanwhile, said that the immediate donation of 20 million doses is needed to ensure that vulnerable populations who have already received their first dose would get a second jab as soon as possible.

Moderna Will Supply COVAX With 34 Million Doses In 2021 and 466 Million In 2022

Moderna’s latest agreement will allow COVAX to receive 34 million doses in the fourth quarter of 2021 and 466 million doses in 2022, with an option to access a vaccine jab that is adapted to emerging variants, said Gavi in its press release. 

The announcement comes a week after Moderna pledged to expand its production capacity to three billion doses by 2022 and received the WHO’s stamp of approval – making it the fifth vaccine to be approved by the global health body to date. 

“This is an important milestone as we work to ensure that people around the world have access to our COVID-19 vaccine,” said Moderna’s CEO Stéphane Bancel in a press release.

“We recognize that many countries have limited resources to access COVID-19 vaccines. We support COVAX’s mission to ensure broad, affordable and equitable access to COVID-19 vaccines and we remain committed to doing everything that we can to ending this ongoing pandemic with our mRNA COVID-19 vaccine.”

“Expanding and having a diverse portfolio has always been a core goal for COVAX, and to remain adaptable in the face of this continually evolving pandemic – including the rising threat posed by new variants,” added Gavi CEO Seth Berkley in a press release. “This agreement is a further step in that direction.”

Moderna’s latest agreement represents the largest commitment of mRNA vaccines to COVAX yet, given that Pfizer/BioNTech, another mRNA vaccine frontrunner, has committed a mere 40 million doses to the global vaccine facility. 

Unlike the vaccine from Pfizer/BioNTech which needs to be stored at temperatures as cold as -60ºC, Moderna’s vaccine can be stored in a standard fridge at 2-8 °C for one month, and potentially for up to three months, said Moderna’s CEO last week; those looser storage requirements for Moderna’s vaccine are likely to ease its distribution to low- and middle-income countries that lack the cold-chain infrastructure to store vaccines at sub-zero temperatures. 

Sweden’s Vaccine Donation Hailed as ‘Superb’ Gesture by Tedros 
WHO director-general Dr. Tedros Adhanom Ghebreyesus and Per Olsson Fridh, Sweden’s Minister for Development Cooperation, met at WHO’s headquarters on Monday.

Meanwhile, WHO’s Director-General Dr Tedros Adhanom Ghebreyesus hailed Sweden’s donation of one million vaccine doses to COVAX as a “superb gesture” and urged the rest of the world to follow suit. So far, only a handful of countries have donated doses to COVAX, including New Zealand and France, which donated 13 million and 1.6 million doses to the global vaccine facility, respectively.

“Sweden’s announcement that it will share 1 million doses of COVID-19 vaccines with COVAX is a superb gesture that must be replicated urgently, and repeatedly, by governments around the world to accelerate the equitable rollout of vaccines globally,” said Dr Tedros in a press release Monday, shortly after his meeting with Per Olsson Fridh, Sweden’s Minister for Development Cooperation.

“Such support will ensure that people in vulnerable countries, especially, in Africa, will be able to receive their second doses through the COVAX initiative,” he added.

Gordon Brown Makes US$30 Billion Year Pitch To G7 For COVID Medicines & Vaccine Finance
Gordon Brown UN Envoy for Eradication at WHO press briefing 3 May 2021

Meanwhile, in the leadup to the next G-7 meeting on 11 June, Brown said that he was joining WHO in an appeal to the Group of 7 most industrialized nations to finance some US$ 30 billion in mass vaccination, affordable tests and treatments for lower- and middle-income countries.

“The bill for mass vaccinating the world and ensuring access also to tests and treatments is affordable: a total of around US$30billions a year,” he asserted. “If spread across the richest countries – its just 25 cents a week per citizen – and it is money we cannot afford not to spend. ”

“In total over 2 years we need to raise an estimated US$60 billion, which is not only to cover vaccines, research, production and distribution to 92 lower income countries, but help pay for vital medical supplies including diagnostics and medical oxygen currently and shamefully in short supply in India and elsewhere.

“Based on ability to pay – a formula that takes into account national income, current wealth and benefits from the resumption of trade, America would pay 27% of the costs Europe 23%, the UK 5%, Japan 6%, Korea Canada and Australia 2% (each), he said,” noting that those G7 contributions alone would cover about 67% of the US$ 30 billion needed – or about US$ 20 billion.

” I say to the G7, the forum that on June 11, six weeks from now, brings together the world’s seven richest countries: you have the power and the ability to pay for nearly two thirds (of the total costs)  and secure a historic breakthrough by agreeing an equitable burden sharing formula for global health provision.”

He said the proposed measures would also include expansion of international finance for grants for low income countries, and creation of a guarantee-based finance facility for middle income countries.

“I say to the G20: with your leadership, we can cover over 80% of the costs, and you have the means to urgently donate vaccine doses to cover the gap in supply.

“I say to the richest 30 countries in the world: you can cover almost 90% of the costs. And the same burden-sharing formula can also be applied – so that instead of the familiar pandemic cycle of ‘panic now’ and neglect later, the world invests now now, when there is a shortfall, and for the future in pandemic preparedness…to ensure that even if future outbreaks happen pandemics become preventable.”

Image Credits: Gavi , WHO .

moderna

Moderna has announced new investments from Europe and the US to increase global vaccine supply, expecting to increase 2022 capacity to up to 3 billion doses of its COVID-19 vaccine. The announcement was followed by the World Health Organization’s (WHO) decision to list the Moderna vaccine for emergency use, making it the fifth vaccine to receive emergency validation from WHO. 

“As we follow the rapid spread of SARS-CoV-2 variants of concern, we believe that there will continue to be significant need for our mRNA COVID-19 vaccine and our variant booster candidates into 2022 and  2023,” said Stéphane Bancel, Chief  Executive Officer of Moderna.

The vaccine manufacturer highlighted studies that predicted waning immunity will impact vaccine efficacy within 12 months, compounding the need for variant boosters in the coming years. 

Though many agreed that variant boosters will be necessary in the future, governments were concerned about the ability to scale up production. “We are hearing from governments that there is no technology that provides the high efficacy of mRNA vaccines and the speed necessary to adapt to variants while allowing reliable scalability of manufacturing.”

But with these investments, Moderna now has the capability to scale up drug manufacturing at the company’s Switzerland and Spain-based facilities. There will also be a 50% increase of drug substances at Moderna’s facilities in the US. 

Increased Shelf-Life for Vaccines

Moderna also announced that ongoing development data related to its current COVID-19 vaccine formula could support a three-month refrigerated (2-8 degrees Celsius) shelf life in alternate formats that make it easier to distribute, such as the doctor’s office or other small settings. 

Current vaccine supply is approved for storage up to one month at refrigerated temperatures (2-8 degrees Celsius) and up to seven months in a standard freezer (-20 degrees Celsius). Moderna’s vaccine is the only authorized mRNA vaccine that does not require on-site dilution. 

The company is also working on new formulas of its COVID mRNA-1273 vaccine and a next generation of the vaccine that will extend refrigerated shelf life longer. 

Variant and Vaccine Booster Tests Underway

Stéphane Bancel, Chief Executive Officer, Moderna.

The company is raising its 2021 supply forecast to between 800 million to 1 billion doses, with production from investments expected to ramp up in later this year early 2022. 

Earlier this year it announced that it is already testing the SARS-CoV-2 variant vaccine and multivalent vaccine boosters in humans. 

Results from its ongoing variant clinical trials and develops its booster shot strategy will place Moderna in a position to better estimate the supply ranges for 2022, which will be based on product mix across single-dose boosters, primary (two-dose) vaccinations for adults, and primary (two-doses) shots for children, which may be at lower dose levels. 

The scaled-up production and manufacturing capabilities come after last week’s forum sponsored by the International Pharmaceutical Manufacturers and Associations (IFPMA).  

Bancel, at the press briefing, had said that the company is “in the final stretch to get an agreement with COVAX” for its vaccine. 

Pfizer CEO Announces COVID-19 Oral Drug Could Be Available at the End of 2021

Pfizer CEO Albert Bourla

Pfizer’s experimental oral drug for treating COVID-19 could be available at the end of 2021,  CEO Albert Bourla told CNBC on Tuesday.  

“If clinical trials go well and the Food and Drug Administration approves it, the drug could be distributed across the U.S. by the end of the year,” Bourla told CNBC. 

Pfizer, which developed the first authorized COVID-19 vaccine in the US with German drugmaker BioNTech, began an early-stage clinical trial in March testing new antiviral therapy for coronavirus. In addition to the drug, Pfizer is testing its vaccine in 6-month to 11-year-old children. 

Earlier this month, the company asked the Food and Drug Administration (FDA) to expand its vaccine authorization to adolescents ages 12 to 15 after the shot was found to be 100% in a study, with no serious side effects. 

Bourla also told CNBC that the company is ‘comfortable’ in producing at least 2.5 billion vaccine doses for 2021, noting how Pfizer had overcome the original ‘forecasted losses’. 

“We made tremendous progress in improving processes, in building the infrastructure at the speed of light and in resolving issues with third-party supplies,” he added.

Bourla noted that the ‘horrible situation’ in India and the rest of the world, where the rate of vaccinations and availability of vaccines is lower, needed to be addressed, and saw this as an ‘ethically unacceptable issue’.

“If we are not able to provide services for India or Africa, they will become a pool where the virus will replicate and generate variants.” 

India is currently facing a catastrophic second wave that accounts for 38% of global cases reported in the past week, according to the WHO. 

 

Image Credits: Jernej Furman/Flickr, WEF, CNBC.

GHC Webinar – ‘What Lessons from COVID-19 For Advancing Antibiotic R&D?
Clockwise, moderator Suerie Moon, Manica Balasegaram (GARDP), Michelle Childs (DNDi)

In the midst of the COVID-19 pandemic, a “silent pandemic” of drug resistance to mutated bacteria, viruses and parasites is gaining ground and requires major government investments in antibiotic research and development (R&D), a group of experts has warned.

“People are dying across the world from drug-resistant infections. This is a problem of today, and it’s a problem that’s getting worse,” said Manica Balasegaram, Executive Director of the Global Antibiotic Research Development and Partnership (GARDP), during a webinar on antimicrobial resistance (AMR) hosted by the Geneva Graduate Institute Global Health Centre. 

The Geneva symposium, held on Thursday, highlighted key lessons learned from COVID-19 when looking towards the future of AMR and preparing for the next public health emergency. 

Increased Investment In AMR as a Global Health Priority 

amr pandemic
An antimicrobial is an agent that kills microorganisms or stops their growth. Antimicrobial medicines can be grouped according to the microorganism they act primarily against.

Advancing antibiotic R&D requires global health to invest in AMR as a public health issue in its own right, as antibiotics are going to be a critical tool in pandemic preparedness.

One of the benefits of AMR is that, due to its extensive R&D, researchers know the pathogens behind it, which makes it a global issue that can be prepared for, Balasegaram added. 

“We have to ensure access, particularly diagnostics, treatments, vaccines, and other tools – for infection, prevention, and control. We need to see this not just in terms of AMR but as a cornerstone for pandemic preparedness,” he added.

Although there has been a lot of progress in relation to vaccines, Michelle Childs, Director of Policy Advocacy at Drugs for Neglected Diseases Initiative (DNDi), spoke of the “acute need” to invest in COVID-19 effective treatments.

Childs addressed the need to have “well-powered, adaptive, clinical trials” to see if these treatments can be successful in repurposed and novel technologies, as well as a need to hone in on specific COVID-19 treatments, especially for those with mild to moderate symptoms of the virus.

“Potentially, those treatments could not just stop progression but could offer some hope for post-COVID symptoms,” she said. “We need to invest in virus-agnostic types of treatment in the early stages and discovery, not just for COVID but also for future pandemics.” 

Innovation in Global Health Needed, Shift Away from Traditional Sources 

The World Bank only releases funds to products qualified by the FDA

Global health actors also need to set their priorities towards innovation, as they reframe the way AMR is viewed, said Childs. She added that the level of innovation demonstrated during the COVID-19 pandemic should be applied to the future. 

“We need to ensure that when we’re looking for innovations, we don’t just look in the traditional sources in high-income countries.”

Childs also addressed the need to shift away from a “dependence on stringent regulatory agencies”, citing the negative effects on funding and access with the World Bank, for example, which only releases funds to buy products qualified by the FDA. 

“We need to strengthen further and respect the growing regulatory capacity worldwide. We have to move away from just a reliance solely on the EMA and the FDA,” said Childs, raising the African Vaccine Regulatory Forum as an example.  

Inequitable Global Response Prolongs the Pandemic

A health worker wearing personal protective equipment (PPE) carries a patient suffering from COVID-19 outside the casualty ward at Guru Teg Bahadur Hospital, in New Delhi, India.

Many of the lessons of COVID-19 are still ongoing, the most prominent being lessons on inequitable global response. The US was experiencing a drop in coronavirus cases with increasing vaccinations, while countries such as India are facing their worst outbreaks of COVID-19.

“We can’t really lift ourselves out of this situation unless we have a global response and that means global access. Inequitable access to medical countermeasures will have devastating consequences, and will prolong the pandemic,” said Balasegaram.

“If we don’t fix this now, then we’re going to face this again in AMR, and every other health issue that follows.” 

Intellectual Property Restrictions – Inequitable Access

IP

 

“We can’t really talk about lessons for COVID for the innovation system without addressing the real issues that we’re facing with COVID now,” said Childs. 

One of these issues concerns intellectual property, which comes days after nearly 400 members of the European Parliament (MEPs) and national parliaments across the European Union issued a joint appeal calling for the European Commission to drop its opposition to a proposed WTO waiver on IP related to COVID-19 health technologies for the duration of the pandemic. 

“[Lifting the restrictions allows] the vaccine recipe to be shared for countries [so they are able] to support themselves, [sharing] the know-how of technologies using some of the processes that are already available. We can’t rely on business as usual, or just rely on private licensing deals, which are inadequate.”

Image Credits: Staicon Life/Flickr, GHC, Felton Davis/Flickr, Adnan Abidi/Flickr, Open Source/Flickr.