Ngozi Okonjo-Iweala speaking at her first press conference after being appointed as the new WTO Director General on Monday.

IBADAN, NIGERIA – She is happy to be breaking World Health Organization (WTO) ceilings for women and Africans – but has always been a disrupter and technocrat who is used to making changes that stand the test of time and put those in need at the center — even when it is unpopular. 

Beginning on 1 March 2021, Ngozi Okonjo-Iweala will become the first woman and African to take the helm as Director General of the WTO. While this feat is resonating across the world, it is not the first time the Nigeria-born and US-educated development economist has broken global records. She also did so whilst holding senior positions as Finance and later Economics Minister in the Nigerian government. Iweala was widely regarded and even revered as one of the country’s most able technocrats – sustaining major achievements like the renegotiation of Nigeria’s crippling foreign debt – while suffering personal tragedies of her own.

Young Iweala with her now husband while in college.

Iweala was just six years old when her country gained independence from its British colonial masters. Just 60 years later, she has become one of Nigeria’s—and indeed one of Africa’s—frontline technocrats working with national governments and politicians while remaining relevant on the global scene. 

Princess in Nigeria’s Southern Delta Region   

Born in Ogwashi Ukwu in southern Nigeria’s Delta region, Iweala is an indigene of a town that has  produced several notable Africans, including Olympics medalists and the phenomenal football legend, JJ Okocha. But Iweala is not just an indigene of the town, she is also known to Nigerians as a princess of the city considering that her father, Professor Chukwuka Okonjo, was the Obi (King) from the Obahai Royal Family of Ogwashi-Ukwu.

Her early years were spent modestly; she lived with her grandmother in her hometown while her parents studied abroad. But education was always a family priority; she attended a series of top-notch schools that flourished in this period, including Queen’s School, in Enugu State, followed by St. Anne’s School, Molete, in the city of Ibadan, and then the International School of Ibadan. 

In 1973, she moved to the United States to study economics at Harvard University, graduating in 1976. She loved the education she had at Harvard – later ensuring that all four of her children would also have a Harvard education.  

5 Harvard graduates in one family. Iweala with her husband Dr.Ikemba Iweala, a neurosurgeon, and their four children.

Five years after leaving Harvard, Iweala finished her PhD in regional economics and development from the Massachusetts Institute of Technology (MIT) in 1981 – her thesis focusing on credit policy, rural financial markets, and Nigeria’s agricultural development.

Twenty-five Year World Bank Career

Throughout her travails in the face of opposition from President Donald Trump-led US government, supporters of Iweala spoke glowingly of her credentials, both in her national government roles and her World Bank career that spanned 25-years – and where she rose to the position of Managing Director, overseeing the financial institution’s $US 81 billion operational portfolio in Africa, South Asia, Europe and Central Asia.

During her term as Nigeria’s finance minister, from 2003-2006 Iweala led discussions and negotiations that resulted in the Paris Club wiping out US$30 billion of Nigeria’s debt. She was also instrumental in the creation of the Nigerian government’s excess crude oil account — in which revenues accruing above a reference benchmark oil price are saved in the special account for use to stabilize the country’s economy and smooth out the impact of price volatility in oil exports. 

Ngozi Okonjo-Iweala at the 2004 Spring Meetings of the International Monetary Fund and the World Bank Group when she was the Finance Minister of Nigeria.

Over 18 years later, the policy is still being implemented, and it has helped Nigeria in protecting itself from today’s volatile oil market. In February 2014, the account had a balance of about US $3.6 billion – although over the past few years of global oil price decreases, the account has been drawn down dramatically by the current government to its current balance of just  $72.4 million in January 2021.

In a later term, as Minister of Economics, she tackled corruption frontally – instituting a practice whereby the national government began to publish the monthly financial allocation that each state received from the federal government in the national dailies with the aim of improving transparency in governance. This is still being done to date.

Her policies met a challenge of the most personal nature. 

On 9 December 2012, Iweala’s mother, Prof Kamene Okonjo, was kidnapped from the family home in Ogwashi-Uku, with the kidnappers demanding Iweala’s resignation. After three days her mother was freed, and Iweala went public. 

“My mother, a retired professor, was held without food or water. The kidnappers spent much of the time harassing her. They told her that I must get on the radio and television and announce my resignation,” Iweala later said.

The kidnappers, she said, were most likely driven by her intervention to address a US$ 6.8 billion oil subsidy scam.

Within Nigeria, Iweala has been a rallying force driving public attention to previously ignored ministries, agencies and issues – including issues where health, well-being and economics converge. 

This same drive has already been evident in her rise to the leadership of the WTO—an organisation that many Nigerians did not know much about – before the US opposition to her candidacy drew vast attention from different quarters to the election process.

In another term at the World Bank, between her stints in the Nigerian national government, she led the organization’s initiatives to assist low-income countries during the 2008-09 food crisis that coincided with the US stock market crash and global recession – rising to the position of managing director. 

Ngozi Okonjo-Iweala as Managing Director of the World Bank at a World Bank/IMF Spring Meetings Water and Sanitation Event in Washington, DC in 2010.
Iweala’s Critics and Targeted Attacks

Inasmuch as Iweala’s rise to the top of the WTO is being celebrated, it has also not been void of controversies.  Iweala’s years of experience at the World Bank means that she is also closely associated with an institution that many progressive critics say can use economic policies to reinforce global inequalities.

In its publication on the criticisms of the World Bank, the Bretton Woods Project noted that power imbalance in the World Bank meant there is structural under-representation of the Global South.

From a policy point of view, some critics will no doubt say that Iweala’s long sojourn at the World Bank means she is well aligned with its more regressive side – including policies that can favor government reductions in social services, protections and subsides; support labour “flexibilities” and lowering of public sector wages; or increase value added taxes and other regressive tax measures- as a means of containing inflation and keeping corporate tax rates low. 

Leading on a Broader Path – Including Health, Gender & Climate

Still in terms of the WTO, which has become deeply mired in the more legalistic and tactical aspects of trade policies and disputes over the past few years, Iweala now sees herself leading the trade organization on a potentially broader path, which looks more deeply at the bigger picture issues.

She also wants the Organization to regain its stature, telling WTO members shortly after her election that: “A strong WTO is vital if we are to recover fully and rapidly from the devastation wrought by the COVID-19 pandemic.”

In June 2020, a few weeks after the first case of COVID-19 was confirmed in Nigeria, Iweala was on a World Economic Forum podcast where, among other things, she revealed that while globalisation is good, COVID-19 has shown that individual countries would need to reassess their supply chain, and ensure that a certain basic minimum of the supply chain is either locally available or accessible when the needs arise – to avoid the rush for gloves and surgical masks seen then.  

“If we are rebuilding and creating jobs through infrastructure, do we build them back in the old way or do we look for low carbon emission more climate friendly ways to do it?” she asked.

And the gender agenda can also be integrated into that, by putting women and youth more at the center of decision making.

“Very often they [women] are not consulted in the way they should and this pandemic has affected them differently. Take women, for example, they’re the bulk of frontline workers in terms of nurses, community, health workers, and so on. But are they really consulted in the way decisions are made? The answer is no,” Iweala has said.

The Critical Moment for WTO – in the Post Trump Era 

WTO may have been sigficantly weakened by the bigger geopolitical and economic battles at play – between the United States and China as well as global haves and have nots. But those also were sharply exacerbated over the past four years by the administration of former US President Donald Trump. 

The Trump administration not only blocked Iweala’s election as WTO DG, it also effectively blocked one of WTO’s most important functions, that of of resolving trade disputes between countries – by blocking the appointment of new judges to the trade dispute mechanism – thus paralyzing the global organisation.

Along with unlocking Iweala’s stalled appointment, it is now hoped that new US administration of President Joe Biden will also help facilitate the appointment of judges to the WTO appellate body, so that the organisation can resume its adjudication responsibilities in trade disputes between countries. 

In a press conference Monday, just after her election, Iweala recalled the moment at which she learned of the Biden administration’s decision to support her candidacy as “absolutely wonderful…. when the Biden-Harris administration came in and broke that logjam joined the consensus and and gave me such a strong endorsement.

But she said that she hasn’t taken much time to celebrate, adding that as the first African and woman to assume the helm of the WTO “I absolutely do feel an additional burden” as well.

“Being the first woman and the first African means that one really has to perform,” she said. “It’s groundbreaking, and all credit members for electing me and making that history. But the bottom line is that if I want to really make Africa, and women proud I have to produce results, and that’s where my mind is at. Now, how do we work together with members to get results.”

Image Credits: WTO, Facebook, Wikimedia Commons, Flickr – World Bank Photo Collection.

The AstraZeneca/Oxford COVID-19 vaccines being produced by the Serum Institute of India and SK Bio in South Korea were listed for emergency use by the World Health Organization (WHO) on Monday.

Emergency use listing (EUL), which involves experts assessing their safety, efficacy and quality, is a prerequisite for vaccines before they can be distributed by the global vaccine facility, COVAX. 

“Although the companies are producing the same vaccine, because there are many different production plants they require separate reviews and approvals,” WHO Director General, Dr Tedros Adhanom Ghebreyesus told the body’s biweekly pandemic media briefing.

“This listing was completed in just under four weeks from the time WHO received the full dossier from the manufacturers,” said Dr Tedros, adding that it was the second vaccine to get the WHO’s EUL after the Pfizer-BioNTech vaccine.

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

Dr Mariângela Simão, WHO Assistant-Director General for Access to Medicines, said there was now no need for countries to do bilateral deals with vaccine manufacturers as COVAX had already secured two billion vaccine doses and worked out their distribution, and the listing would “trigger a lot of purchase orders”.

“Countries with no access to vaccines to date will finally be able to start vaccinating their health workers and populations at risk, contributing to the COVAX Facility’s goal of equitable vaccine distribution,” added Simão, who described the vaccine as easy to use as it can be kept in a normal fridge.

The Pfizer/BioNTech vaccine, which was giving EUL in December, needs to be kept in very cold storage of minus 70C.

China Team Summary Report Will be Based on Consensus

In response to news reports that indicated differences of opinion among the WHO expert group on the origin of the virus, which returned from China recently, WHO technical lead on COVID-19, Dr Maria van Kerkhove stressed that the team had not yet issued its report.

“The mission team from have recently returned from China and they are working on two reports. The first is a summary report just highlighting the work that has been done and some initial findings and recommendations, and then there will be a longer report. The idea would be that they would issue the summary report and then have a full press briefing themselves,” said Van Kerkhove.

Dr Peter Ben Embarek

Team leader Dr Peter Ben Embarek said that the summary report, expected in a matter of days, would be a “consensus report” reflecting  joint activities.

“The international teams and its Chinese counterparts have already agreed on the summary report when we were in Wuhan on the last day of mission, in particular, in terms of key conclusions, key findings, and key recommendations,” said Ben Embarek, adding that they were currently finalising the technical, background and methodological parts.

“The report will make recommendations for future long-term studies to explore some of the hypotheses and advance our understanding of the origin of the virus,” he added.

“Of course, the fact that we have different scientists with different backgrounds and different fields of experience, means that everybody has their specific views, specific recommendations, specific interest in moving some studies forward,” he said.

His comments came after Dominic Dwyer, an Australian infectious disease expert who was part of the international expert team, said the team had requested raw patient data from the Chinese but were only given a summary.

Dwyer told Reuters on Saturday that sharing anonymised raw data is “standard practice” for an outbreak investigation. He said raw data was particularly important in efforts to understand Covid-19 as only half of 174 initial cases had exposure to the now-shuttered market where the virus was initially detected. “That’s why we’ve persisted to ask for that,” Dwyer said. “Why that doesn’t happen, I couldn’t comment. Whether it’s political or time or it’s difficult.”

Dwyer also told the New York Times that the lack of access to detailed patient records from early confirmed cases, and possible ones before that, had prevented the team from nailing down when the first clusters of cases really emerged from Wuhan.

“We asked for that on a number of occasions and they gave us some of that, but not necessarily enough to do the sorts of analyses you would do,” said Dwyer.  The black spots are all the more troublesome because Chinese scientists have acknowledged that nearly 100 people were hospitalized in Wuhan as early as October 2019 with symptoms such as fever and coughing. Other international reports have also provided evidence of an uptake in hospitalizations overall in the autumn months – before the usual start of the flu season. Although the Chinese experts claims that these patients were not COVID cases – without detailed records that would be impossible to confirm.

The battle over the early cases is critical because it would be evidence that the virus originated in China. China has tried to promote a theory that the virus first infected people in Wuhan via imported frozen foods – something the WHO team agreed to investigate – even though key members are skeptical: “I think it started in China,” Dr. Dwyer said. “There is some evidence of circulation outside China, but it’s actually pretty light.”

A Danish epidemiologist on the team was also highly critical of the lack of Chinese transparency regarding the data, saying that the trip was. “If you are data focused, and if you are a professional,” said Thea Kølsen Fischer told the New York Times, then obtaining data is “like for a clinical doctor looking at the patient and seeing them by your own eyes.”  She added, “It was my take on the entire mission that it was highly geopolitical….Everybody knows how much pressure there is on China to be open to an investigation and also how much blame there might be associated with this.”

WHO Does Not Support Vaccine Passports at Present

Dr Michael Ryan, WHO executive director of emergencies, said that the emergency committee “does not advise the use of immunity certification as a prerequisite of travel” at this stage.

This was because “the vaccine is not widely available would actually tend to restrict travel more than permit travel” and there was not enough data to understand “to what extent vaccination will interrupt transmission”, particularly whether a vaccinated person can continue transmitting disease, said Ryan.

Once the vaccine is widely available and there is clarity about transmission dynamics, “disease vaccination passports can form part of a long term strategy for disease control and for the prevention of the disease potentially moving from one place to another, as we’ve seen with yellow fever vaccination requirements, which have been in place for a large number of decades now”, said Ryan. 

Ryan also cautioned that, although the global COVID-19 cases had decreased for the fifth consecutive week and were now at their lowest since last October, this could be the result of the natural patterns of the virus.

“I do think a good portion of that has been done to the huge efforts made by communities. There have been very stringent lockdowns and stay-at-home orders and other things, but also serum prevalence is rising. We need to understand what is driving those transmission dynamics. Is it natural seasonality and wave-like pattern of the disease? Are we building up a level of immunity in the population that’s preventing the disease from finding the next case? Are our control measures having an impact on that?’ asked Ryan.

He said that while all these factors were likely to hold some truth, the virus also had “a high force of infection” and it could “re-ignite and re-accelerate”. 

“It’s the accelerations in these in this disease that have been the most worrying,” said Ryan. “The disease can move along at fairly low levels and then you see this really fast acceleration and spread.

“We need to avoid that the next time, and we do believe that vaccines offer an opportunity to reduce the hospitalizations and deaths. ”

  • Updated 16 February, 2021

Image Credits: AstraZeneca.

Ngozi Okonjo-Iweala, next WTO Director General, speaking at a press conference Monday, just after her election.

Nigeria’s former finance minister, Dr Ngozi Okonjo-Iweala has become the first woman and first African to be elected as Director-General of the World Trade Organisation (WTO).

In a press conference just hours after her historic election, she signalled that she would reboot the WTO’s mission, making both health and climate twin cornerstones of global trade – including sustainable oceans and fisheries. She said that she would look for ways to make existing WTO intellectual property flexbilities (TRIPS) s work to stimulate the manufacture of vaccines and other health products in low-income countries – as well as removing trade restrictions impeding the free flow of health products between countries.

On the climate and environment, Dr Ngozi, as she said she would prefer to be called, said an unfinisheries fisheries treaty was “low-hanging fruit” that could he harnessed to promoting more sustainable fisheries and oceans.  She also said she would introduce the climate agenda into the WTO chambers – where it has rarely been discussed – with initiatives to support of low-carbon trade whilst discouraging trade in high-carbon emitting products.  And she said she would look for ways to support countries implementation of carbon taxes. 

The incoming WTO DG also said that she would seek to get quick agreement for an exemption of the World Food Programme from national food restrictions – which impede the humanitarian work of the Nobel prize-winning organization among communities locked in crisis and conflict.

And as critical facilitator for all of the WTO’s policies and rules, the Organization’s moribund trade dispute settlement system urgently needs a reboot, she added.  Calling the issue of the dispute system “the jewel in the crown of the WTO.  But there is no point in agreeing to more rules, where the only pleace in the world where countries can bring trade disputes does not work – it’s paralyzed. SO it’s a priority to really reform that and take account of the inputs of our members to make sure that we come up with a dispute settlement system that works for all.”

President Buhari – Today the United States Stands With Nigeria & Africa 

Iweala’s electon was greeted with enthusiasm in Nigeria where she served twice as the finance minister: between 2003 and 2006 under under President Olusegun Obasanjo and between 2011 and 2015 President Goodluck Jonathan respectively. She has also had a 25-year career at the World Bank.

Nigerian president, Muhammadu Buhari said his country “certainly welcome the decision of the new US administration to remove the last obstacle in the path of Dr. Okonjo-Iweala to becoming the first female and the first person of African descent to lead the organisation.

“Today, we see that the United States stands with Nigeria and Africa, with the acceptance of our widely respected citizen, Okonjo-Iweala to lead the WTO. We look forward to working very closely with the new U.S administration on this and all issues of common interests, especially in such areas as accelerated economic growth, fight against terrorism and deepening progress on development issues,” Buhari stated.

Pandemic, Pandemic, Pandemic

“The priorities will be one- working on solutions to the COVID-19 pandemic,” said Dr Ngozi, in the press briefing, framing it as the number one global humanitarian and economic problem – “I think this is an issue of lives.  We are losing lives in all countries all over the world, but in poor countries, if we don’t act, more lives will be lost,” she said. .

But she also stressed that pandemic relief would help rich countries as well as poorer ones – insofar as poor countries will continue to be fertile ground for new and dangerous variants of the SARS-CoV2 virus if vaccination coverage remains inadequate.

“When this kind of thing happens, is very natural for leaders and politicians to want to take care of their own population,” she said, but. “Taking care of your population, and being nationalistic with respect to vaccines won’t work this time, because even if you get everyone vaccinated and there’s a country down the road that hasn’t done that, it’ll come back in the way of variants.

So one of the things that we would like to do is to see what the WTO can do under the TRIPS agreement to use all of the flexibilities opossible to allow countries to manufacture the available vaccines so that there can be more for poor countries quickly.”

In tackling the pandemic, Dr Ngozi also said she would tackle export restrictions on COVID-related health products – which some 100 WTO members maintain – to facilitate a freer flow of COVID-19 tests, treatments and other medical supplies. “It’s very important if we are also to come out of this pandemic, both in terms of helping make sure there’s a freer flow of medical goods and supplies to deal with the public health emergency,” she said.

The WTO will also work closely with the WHO and other multilateral co-sponsors of the global COVID-19 Tools “ACT Accelerator”, including the COVAX Vaccine facility – “which are trying to accelerate supplies and vacines to poor countries.”

A “Third Way” Out of Impasse Over WTO IP Waiver on COVID Health Products.

As an alternative to wrangling over the deadlocked proposal in the WTO TRIPS Council for a blanket “waiver” on patents and other IP rights over available tests, treatments and vaccines, Dr Ngozi said her efforts would be focused upon etching a “Third Way” – that did not entirely upend global patent regimes

She said that “Third Way” would be centered around using existing IP flexibilities, available through the existing WTO TRIPS agreement more creatively.  She said that she intended to work personally to encourage more pharma manufacturers to sign voluntary licensing deals for manufacture of their vaccines by third parties – as per the example set by AstraZeneca – which has signed agreements in India, the Republic of Korea and Brazil, among others.

“The Third Way would be one in which vaccines can be manufactured in many more countries – whilst taking care that we don’t discourager research and innovation, which is linked to intellectual property rights,” she said.

Noting that “90% of health products used on the [African] continent are imported, she also called for the expansion of pharma manufacturing in low- and middle-income countries more generally.

Beyond the immediate heatlh crisis, however, she said a system needs to be put into place for a faster and more effective global trade and economic response to similar future threats.

” I would also like to see a longer-term framework set up for response to pandemics – so we are not just solving the immediate problem, but ….we are going to have more pandemics in the future. I think the WTO should get with other international organizations like the WHO, GAVI, and the World Bank and the IMF, all of those multilaterals, to try to set the rules so that next time we don’t spend time trying to figure out how to respond,” she said.

New US Administration of Biden-Harris Ended Months of Uncertainty Over DG Election  

Okonjo-Iweala faced months of uncertainty after the administration of former United States President Donald Trump refused to “join the consensus” around her candidacy, supporting South Korea’s Trade Minister, Yoo Myung-hee of the Republic of Korea, according to a statement from the WTO released late on Monday. But shortly after the inauguration of President Joe Biden, the United States signalled a change in its position – and Korea’s candidate withdrew her candidacy. 

“Following Ms Yoo’s decision on 5 February to withdraw her candidacy, the administration of newly elected US President Joseph R. Biden dropped the US objection and announced instead that Washington extends its ‘strong support’ to the candidacy of Dr Okonjo-Iweala,” the statement added. Okonjo-Iweala, in fact holds dual US and Nigerian citizenship. 

General Council Chair David Walker of New Zealand who, together with co-facilitators Dacio Castillo (Honduras) and Harald Aspelund (Iceland) led the nine-month Director-General selection process, described her election as “a very significant moment for the WTO”. 

“Dr Ngozi, on behalf of all members I wish to sincerely thank you for your graciousness in these exceptional months, and for your patience,” he added.

Speaking to WTO members, just after her election, she said:  “A strong WTO is vital if we are to recover fully and rapidly from the devastation wrought by the COVID-19 pandemic. I look forward to working with members to shape and implement the policy responses we need to get the global economy going again. Our organization faces a great many challenges but working together we can collectively make the WTO stronger, more agile and better adapted to the realities of today.”

Her tenure starts on 1 March and lasts until 31 August 2025.

The leadership position has been vacant since late August 2020 when Roberto Azevedo stepped down a year earlier than planned. 

Iweala is also a COVID-19 special envoy for the World Health Organization (WHO) and the African Union (AU), with the AU appointing her to mobilise international economic support for the continent’s fight against the pandemic. 

South African president and recent AU Chair, Cyril Ramaphosa, described Iweala as “an internationally respected economist and development expert”.

While shying away from full public altercations with the US government regarding its earlier opposition to Iweala’s emergence, stakeholders and several eminent personalities on the continent publicly pledged their support for Iweala.

The WHO’s Regional Director for Africa, Dr Matshidiso Moeti, told Health Policy Watch that she is confident about Iweala’s capacity — and hopeful that the majority choice of WTO’s 164 member governments will ultimately prevail.

“We believe in her competence and capacity for this position and we wish for an outcome, and resolution that will be based on the outcome of the election, which was an open process as we understand,” Moeti said at a press briefing.

Along with holding degrees from Harvard and the Massachusetts Institute of Technology (MIT), Iweala also sits on a number of boards including Standard Chartered Bank, the Global Vaccine Alliance (GAVI), Twitter and the African Risk Capacity.

Image Credits: WTO.

Pfizer’s COVID-19 vaccine during the manufacturing process.

The contribution COVID-19 vaccines can make to beating the pandemic will depend on the extent to which they are produced at scale, priced affordably, and deployed globally, says the first peer reviewed study on equitable access to vaccines, published in The Lancet on Friday. 

The Lancet article comes in the wake of a joint appeal by WHO and UNICEF for governments to share vaccines through the WHO co-sponsored COVAX facility, and for vaccine manufacturers to maximise production and transfer technology to help scale up the global supply of vaccines. 

In The Lancet study, researchers from universities and research centres in the United Kingdom, the United States, Thailand and Singapore evaluated the potential global contributions of each of the 26 leading vaccine candidates, scoring them based on their potential role in achieving global herd immunity.

“Several manufacturers have successfully developed COVID-19 vaccines in under 12 months, an extraordinary achievement. But the stark reality is that the world now needs more doses of COVID-19 vaccines than any other vaccine in history in order to immunise enough people to achieve global vaccine immunity,” said Olivier Wouters, lead author of the study and assistant professor at the London School of Economics and Political Science, in a press release.

“Unless vaccines are distributed more equitably, it could be years before the coronavirus is brought under control at a global level. The questions now are when these vaccines will become available, and at what price,” he added. 

The 26 vaccine candidates, several of which are still in development, were scored using a traffic light system. Some 13 of the 26 vaccine candidates got a green light across at least one of the categories of development and production, affordability, allocation and deployment, including vaccine’s produced or in late stage development by Oxford/AstraZeneca, Novavax, Sinopharm/Beijing Institute, and Gamaleya, which is developing Russia’s Sputnik V vaccine. 

Key characteristics of leading vaccine candidates with traffic-light system signalling potential for achieving global vaccine immunity.

Only five of the vaccines reviewed have already been authorised by a stringent regulatory agency. Just five of the vaccines have a supply agreement with COVAX, the WHO-supported a global initiative to procure and equitably distribute vaccines, and only one vaccine, China’s Sinovac vaccine, was assigned a green light for its ease of cold-storage in low-resourced settings.  

Pricing and Accessibility of Vaccines

The pricing of the 26 vaccine candidates varies from US$5 to US$62 per vaccine course. Advanced deals between pharma companies and high-income countries have limited supplies available to low- and middle-income countries, and potentially caused the prices to rise, the study’s authors found. 

“Securing large quantities of vaccines in this way amounts to countries placing widespread vaccination of their own populations ahead of the vaccination of health-care workers and high-risk populations in poorer countries,” said Mark Jit, co-author and professor at the London School of Hygiene & Tropical Medicine. 

“Based on known deals, governments in high-income countries representing 16% of the global population have secured at least 70% of doses available in 2021 from five leading vaccine candidates,” said Jit. 

The COVAX facility is attempting to combat this uneven access to vaccines by securing low prices to vaccines and developing a diversified portfolio for the 190 participating countries, particularly for the 92 low- and middle-income countries eligible for donor-supported vaccine supplies through the Advanced Market Commitment of GAVI, The Vaccine Alliance, which is a key COVAX partner along with WHO and UNICEF. 

“With additional funding, COVAX could compete better in the global scramble for vaccines,” said Wouters, but the global initiative is facing a US$6.8 billion funding gap that needs to be closed to fulfil the goal of delivering two billion doses by the end of 2021.  There is a total US$ 27 bilion funding gap for all arms of the global Act Accelerator Initiative – including tests, treatments and health systems strengthening as well as vaccine rollout. 

In addition to the challenges of basic vaccine affordability and access, many low- and middle-income countries lack the infrastructure needed for vaccination registries and for the storage, delivery and waste management of the vials and syringes, the study notes. 

This is particularly an issue for COVID-19 vaccines that require ultra-cold chain storage and have multiple doses. Single-dose vaccines that only require regular refrigeration temperatures, such as AstraZeneca/Oxford and Novavax vaccines, will likely be preferable in resource-constrained countries – while the Sinovac vaccine, which can be stored at room temperature, has the most modest requirements of all.

The cold chain storage for the Pfizer/BioNTech vaccine at Pfizer’s warehouse in Kalamazoo, Michigan.

“Both globally and nationally, the availability of diversified sets of vaccine options is likely to be needed to bring the global pandemic under control,” stated the study.

A select few vaccine developers have committed to maintain a low price globally for their vaccines during the pandemic, including Oxford/AstraZeneca, Gamaleya, J&J, Novavax, and Bharat/BioNTech, whose vaccine is still in development. 

However, AstraZeneca’s licensees as well as other vaccine developers in India and elsewhere are also making arrangements to sell a portion of their vaccines production on the private market in countries such as India, Bangladesh, and Brazil, raising concerns that private sales in poor countries could further undermine the aim of equitable access.

According to Wouters, “vaccines developed by Chinese, Indian, and Russian manufacturers may…offer a lifeline for the lowest-income nations if they show good results in phase 3 trials, allowing them to procure abundant doses of vaccines that have not yet been authorised in most high-income countries. Once authorised by WHO, these vaccines could also potentially contribute to the COVAX portfolio.”

The vaccines developed by Chinese manufacturers, however, are among the most expensive, with Sinopharm charging US$62 and Sinovac charging US$21 for both doses. It is currently unclear if the companies intend to reduce their prices for low- and middle-income countries.

Challenge of Scaling up Production

Expanding production capacity is a “monumental challenge” at the moment and disruptions in manufacturing have been announced by AstraZeneca, Pfizer, Moderna, and Johnson & Johnson, all of which have delayed initial deliveries of promised doses in Europe, the United States and elsewhere due to production kinks in the initial rollout phases. 

According to the authors of the study, the more widespread transfer of technology, knowledge and data would provide a solution to the production bottleneck. So far, vaccine knowledge sharing efforts, including through WHO’s COVID-19 Technology Access Pool (C-TAP), which calls on member states and manufacturers to share intellectual property on vaccines, have been limited. 

The significant amount of public funding that has gone towards the development of COVID-19 vaccines enables governments to “insist that, as a condition of getting public funding, companies engage in sufficient licensing to enable widespread global production, and they must set affordable prices,” said Kenneth Shadlen, co-author of the Lancet study, and a professor at the London School of Economics and Political Science. 

WHO/UNICEF Call on Countries to Share Excess Doses and For Pharma To Rapidly Scale Up Production – Pharma Warns Against Unrealistic Expectations

The study follows on the heels of last week’s joint statement UNICEF’s Executive Director, Henrietta Fore and Dr Tedros Adhanom Ghebreyesus, WHO Director General, which criticised the “vaccine nationalism” that has dominated the first phases of global vaccine rollout, with 75% of the total doses administered so far taking place in 10 countries. 

“COVAX participating countries are prepared to receive and use vaccines. Health care workers have been trained, cold chain systems primed. What’s missing is the equitable supply of vaccines,” said the statement. 

In order to achieve the goal of beginning vaccinations in all countries in the first 100 days of 2021 – among which 57 countries have not launched vaccine campaigns at all – Tedros and Fore called on governments and pharma leaders to do the following: 

  • Governments to share vaccine doses obtained through bilateral deals so that healthcare workers and high risk individuals in low- and middle-income countries can get vaccinated; 
  • Donor countries to fill the US$27.2 billion funding gap for the Access to COVID-19 Tools (ACT) Accelerator, the global initiative to ensure equitable access to COVID-19 health products and technology, and its vaccine pillar COVAX; and
  • Vaccine manufacturers to allocate their limited vaccine supplies equitably, step up production, and transfer technology and knowledge to other manufacturers to expand the global supply of vaccines.

In response to the WHO/UNICEF statement, the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) warned against setting unrealistic goals for vaccine rollout. The IFPMA also said IP rules were enabling innovation that also expands access.  

“Having condensed four or more years of vaccine development into less than a year, through unparalleled partnerships, underpinned by IP, we now have one vaccine that the WHO has approved and others hopefully will be approved shortly,” said Thomas Cueni, Director General of IFPMA. 

Thomas Cueni, Director General of the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA), speaking at the World Health Summit in October.

In response to the calls by UN agencies and civil society for greater technology sharing, IFPMA stated that, “most collaborations – if not all – involved some sort of licensing and transfer of technology, which would not be possible in the absence of a robust global IP system.”

IFPMA noted that there are already 234 manufacturing and production deals arranged for COVID-19 vaccines, representing partnerships that are scaling up to meet the global demands. Examples of deals include those between Johnson & Johnson and Aspen in South Africa; AstraZeneca and the Serum Institute in India; BioNTech and Fosun Pharma in China; and the US-based Novavax and Takeda in Japan. 

“We will continue to do all we can to support [COVAX] delivering the 2 billion doses target for 2021…But understanding the urge for early and equitable vaccine rollout, we warn against setting unrealistic expectations given the inherent risk of vaccine development and the complexity of scaling up manufacturing from scratch,” said Cueni. 

Behind the scenes, there are also some voices in pharma noting that the first port-of-call for WHO and its partners should be at those developed countries that have monpolized markets by purchasing 2-3 times more vaccines than needed to vaccinate everybody – and which could turn the surplus over to COVAX.

IP Waiver Described As Effort to “Erode Intellectual Property Policies”

Meanwhile, the US-based Pharmaceutical Research and Manufacturers of America (PhRMA), called upon the Office of United States Trade Representative (USTR) to oppose a proposal submitted by South Africa and India for a World Trade Organization waiver of IP rules on essential COVID health products – saying that it would undermine the global intellectual property system that fosters pharma innovation. 

The South African and Indian proposal, requesting that the WTO Trade-Related Aspects of Intellectual Property Rights (TRIPS) Council temporarily waive certain IP obligations on COVID-19 tests, treatments and vaccines, has become another big bone of contention between developed and developing countries – which see it as a means of gaining faster access to manufacturing capacity.  

The IP waiver proposal by South Africa and India to suspend the protection of IP related to COVID-19 health products is due to be debated again this month in the TRIPS Council, after being shelved late last year, and then being debated again in January – meeting stiff oppositiong from G-20 countries.

In a submission presented on 28 January to the USTR for its “Special 301” report for 2021, which reviews the global state of IP, the US-based PhRMA group also heaped  blame on WHO, the UN Development Programme (UNDP), the UN Conference on Trade and Development (UNCTAD), and Unitaid for supporting the waiver moves behind the scenes and thus – “seeking to undermine and even eliminate intellectual property protections that drive and sustain biopharmaceutical innovation….

“The WHO Director-General even publicly supported an extreme and unnecessary proposal at the WTO TRIPS Council to waive entirely certain international obligations with respect to COVID-19 technologies, even as Member States were still debating this proposal,” said PhRMA’s statement. 

The South African and Indian IP waiver prposal “marks a significant escalation in anti-IP global activism” the PhRMA group added, saying, “Some countries are using the COVID-19 pandemic opportunistically to advance longstanding industrial policies to further erode intellectual property policies.”

But it warned that “The proposal will do nothing to address the production and distribution challenges for making COVID-19 vaccine globally available. If anything the proposal [will] threaten to undermine the ability to respond to another pandemic.”

 

At the most recent WTO meeting in mid-January, opponents to the waiver, which include the US, Australia, Brazil, Canada, the EU, Japan, Norway, Switzerland, and the UK, showed no signs of changing their position on the proposal – which typically would require a consensus agreement by the TRIPS Council, in order to go before the entire membership body of the WTO General Council’s 164 member representatives for approval. 

In a document published on 15 January, proponents of the WTO waiver provided evidence of the disparity in access to COVID-19 health products. The document was supported by Bolivia, India, Kenya, Mongolia, South Africa, and Zimbabwe, among others. 

“Per capita imports of the medical goods essential to mitigate the COVID-19 pandemic have been about 100 times larger in high-income countries in comparison to low-income countries,” stated the document, submitted to the TRIPS Council to respond to questions from several of the waiver’s critics. 

“A solution to this challenge is to diversify and increase production and supply. This requires addressing the legal barrier of IP that prevents diversification and production,” specifically the relevant categories of IP that are implicated are patents, trade secrets, industrial designs, and copyright, said the document. 

The next meeting of the TRIPS Council, on 23 February, will come right on the heels of Monday’s expected election of a new WTO Director General Okonjo Ngozi-Iweala – after the new administration of President Joe Biden removed the US opposition to the candidacy of Iweala which had blocked her election under the tenure of former President Donald Trump.  Iweala, a former high-ranking World Bank official and dual US citizen, was nominated by Nigeria where she both served as a finance minister and economic minister over the past two decades, helping rescue the debt-ridden country from financial ruin.   

As chair of GAVI, and a special WHO envoy on the COVID-19 pandemic, she has spoken up frequently on global health issues, expressing her own deep commitment to ensuring vaccine equity for low- and middle-income countries. In her new WTO role, she will have to steer a delicate course between LMIC’s demands and those of the WTO’s powerful G-20 member states. 

Image Credits: Johnson & Johnson, Pfizer, The Lancet, World Health Summit.

President Joe Biden speaking at the National Institutes of Health on Thursday.

The United States government has now secured enough COVID-19 vaccines to vaccinate every American adult after purchasing an additional 100 million doses each from Pfizer and Moderna, President Joe Biden said Thursday However, currently vaccines are in short supply across the country and logistic challenges abound. 

Biden used the option in the contracts negotiated last year to seek additional doses, which will bring the total number of doses to be supplied by each company to the US to 300 million, meaning that there will be sufficient doses for 300 million people. 

“We’ve now purchased enough vaccine supply to vaccinate all Americans. And now we’re working to get those vaccines into the arms of millions of people,” said President Biden during an appearance at the National Institutes of Health. 

According to the US Centers for Disease Control and Prevention (CDC), over 24 million individuals have received the Pfizer/BioNTech jab and over 22 million have received the Moderna vaccine since they were both granted emergency use authorization in mid-December by the US Food and Drug Administration (FDA).

Both companies have agreed to expedite the delivery of vaccines for the summer. 

Moderna has supplied the government with 41 million doses so far and is reportedly on track to deliver the first 100 million doses by March, the second order of 100 million doses in May, and the new order of 100 million doses by the end of July. 

“We appreciate the confidence that the U.S. government has demonstrated in our COVID-19 vaccine,” said Stéphane Bancel, CEO of Moderna, in a press release. “We continue to scale up our manufacturing capability, both in and outside of the United States. Our goal is to bring our vaccine to as many people as possible around the world to help end this pandemic.”

Similarly, Pfizer’s CEO, Albert Bourla, expressed his support for the new administration’s plan to vaccinate as many people as quickly as possible and said, “we are pleased to work with the administration to provide these additional vaccines, so that more Americans receive their first and second doses as soon as possible.”

Earlier on Thursday, Dr Anthony Fauci, Director of the National Institute of Allergy and Infectious Diseases and President Biden’s chief medical adviser, predicted that any American could get a vaccine as early as April. 

Dr Anthony Fauci, Director of the National Institute of Allergy and Infectious Diseases, in an interview with NBC’s Today Show on Thursday.

“I would image by the time we get to April, that will be what I would call, for better wording, ‘open season,’” said Dr Fauci in an interview with NBC’s Today show. 

Logistical and Operational Challenges Remain

However, the country is still facing numerous challenges and the government is attempting to do “everything that’s needed to get vaccines into people’s arms,” including investing more in testing, tracing, the manufacturing and distribution of vaccines, and setting up vaccination sites, said Biden.

“We remain in the teeth of this pandemic. January of 2021 was the deadliest month we’ve had. We lost over 100,000 of our fellow citizens. We’re on track to cross 500,000 dead Americans this next month,” said President Biden.

Many areas have reported vaccine shortages, with Los Angeles’ Mayor Eric Garcetti announcing on Wednesday the temporarily closure of five mass vaccination sites and describing the vaccine supply as uneven and unpredictable. 

Los Angeles’ supply of COVID-19 vaccines is “exhausted,” leading five mass vaccination sites to temporarily close.

Staffing issues are expected to arise as the new vaccines become available in the coming months. In an attempt to solve this challenge, retired doctors and nurses will be allowed to administer the jabs. 

In addition, drugstores and grocery store pharmacies will play an increasing role in national vaccination efforts, with a plan to include 40,000 sites for inoculations. Vaccines will be delivered directly to approximately 6,500 retail pharmacies beginning on Friday. 

In the face of the logistic challenges and the spread of the SARS-CoV2 variants, Biden pushed for continued compliance with existing public health measures. 

“Masking is still the easiest thing to do to save lives,” said President Biden. “I know it’s a pain in the neck, but it’s a patriotic responsibility. We’re in the middle of a war with this virus…We need everyone to do their part for themselves, their loved ones, and yes, for their country.”

“Mask up, America. Mask up,” he urged.

Biden’s emphasis on the importance of mask wearing followed the release of the CDC’s new guidance on masks, recommending the use of double masks or tightly fitting masks, which it says can filter out over 90% of SARS-CoV2 viruses.

On Friday, the CDC also provided new guidelines on the reopening of K-12 schools, laying out the mitigation measures that should be put in place to reduce the risk of transmission. The issue of reopening schools is highly debated among parents, teachers, and public health officials.

The five key mitigation measures are: universal and correct use of masks, physical distancing, handwashing, cleaning of surfaces, and contact tracing, in combination with isolation and quarantine.

The “CDC’s operational strategy is grounded in science and the best available evidence,” Dr Rochelle Walensky, Director of the CDC, told reporters on Friday.

Image Credits: ABC7 News, ABC27 News, NBC.

3D rendering of San Francisco based earth imaging company Planet Labs released images of the incident that shows movement of ice before the flash floods in Uttarakhand’s Chamoli district. Image vetted by Climate Data Concierge Project of the Brown Institute for Media and Innovation.

PUNE, INDIA – For Anjal Prakash, a climate scientist based in India, the flash floods in the Himalayan state of Uttarakhand this past week did not come as a surprise. 

“The writing was on the wall,” said Prakash, a research director at the Indian School of Business, Hyderabad, of the 7 February rockslide and avalanche that killed over 32 people with nearly 204 still missing.

The resulting downstream flood washed away a 13.2 MW hydro-electric project on the Rishiganga River and another larger project by the NTPC – India’s largest power utility company that is run by the government. 

The uncertainty about the exact cause of the incident shows the “total lack in the monitoring of these glaciers”, said Prakash.

“We need to have more high-altitude meteorological monitoring to generate data,” said Mohd Farooq Azam, assistant professor of glaciology and hydrology at Indian Institute of Technology (IIT) in Indore. “Currently we have only 12 to 15 glaciers under monitoring.” 

Image released by India’s Indian Space Research Organisation (ISRO) that shows the damage caused downstream due to the flash floods.

The Hindu-Kush Himalayan region is the third largest reservoir of frozen water outside the two poles. Ten of Asia’s largest rivers originate there, providing an estimated 1.3 billion people with water. 

But local and international studies have pointed out that nearly 75% of the glaciers are retreating at an alarming pace due to climate change. 

While scientists are still unpacking the intricate links between glaciers, groundwater and spring systems here, the regional conflicts between India, Pakistan and China also stand in the way of research, data-sharing and mitigation. 

In 2015, Prakash and his colleagues waded through over 7,000 research papers and concluded that climate change was causing drastic changes in the Himalayan region and warned of more extreme events. 

The findings were a part of the special report by the Intergovernmental Panel on Climate Change (IPCC), a UN body formed to assess science related to climate change. 

Infrastructure Projects in a Fragile Ecosystem

As the Indian Himalayas are densely populated, it has been necessary to put in infrastructure for the mountain communities here, including hydropower dams.

“One of the most unfortunate outcomes of the climate policy discourses globally has been a reacceptance of large dams by governments as a viable non-fossil fuel source of energy,” said Manju Menon, senior fellow at the Centre for Policy Research (CPR), a policy think tank.

“This reacceptance is ironic because climate change has also made hydrological flows in the Himalayas erratic and unpredictable, in terms of the impacts on glaciers and monsoon patterns.” 

Menon added that experts have been warning about the impact of engineering on Himalayan rivers for decades; now more than ever, development and environment policies need to be designed so as not to put people at a greater risk than they already are in due to climate change.

“The construction of the dams generates local pollution and black carbon [tiny particles of soot] which settles on the glaciers. But in the long run they reduce carbon emissions and are helping save the environment at the global scale,” said Azam.

But black carbon also is a climate-changer, speeding up the rate of melting of ice, and Azam said it was time to reconsider the siting of such dams to minimize the damage. 

India was ranked as the seventh most vulnerable country in the world for extreme weather events in 2019 by Bonn-based think tank Climate Watch.

The country urgently needs more investment in primary healthcare including at address the health impact of climate change. But India’s health sector has seen little real increase this year, according to the data journalism initiative IndiaSpend. 

Following the flash floods India’s Prime Minister Narendra Modi spoke to the authorities in the state and promised all possible support to the affected in Uttarakhand. The United Nations has offered to contribute to the ongoing rescue and assistance efforts if necessary. A team of scientists from India’s defence research organisation DRDO-SASE were flown in to survey the area.

It will be another few days – or even weeks -before the government scientists present their official assessment of the incident.

Image Credits: Planet Labs.

Mother and daughter leaving a Tel Aviv, Israel vaccine centre after they both received their second jab. Some 80% or more of Israelis over the age of 70 have been vaccinated – but demand is slumping now that the campaign has been opened to all ages.

TEL AVIV- New data on over 500,000 Israelis who have been fully vaccinated with two Pfizer jabs shows the vaccine is 93% effective – with no deaths and only 4 severe cases for people who are a week or more after receiving the second dose. 

Out of the 523,000 fully vaccinated people studied, 544 were still infected with COVID, but only 15 of those people actually needed hospitalization. 

The data, released by the country’s Maccabi Health Fund provider, which has been out front analyzing and releasing trending data, is an encouraging sign for other countries – particularly considering the rapid expansion of the highly infectious “British” variant B.1.1.7 – which has driven record high rates of new infections and severe cases. 

Belatedly, new COVID cases as well as serious COVID cases were now finally in slow decline as the impacts of vaccination kicked in on a wide scale. After weeks of hovering at 1,200 cases, the number of people in critical care has finally dropped, albeit slowly, below 1,000 – in the country of 9.3 million people. 

“We can say with caution, the magic has started,” tweeted Eran Segal, a scientist at the Weizmann Institute, in early February, when the turnaround first began.  

His latest analysis, published Thursday, noted a decrease of 58% in new COVID cases, 44% in hospitalizations, 38% in the number of ill and 40% in mortality, among people over the age of 60 – since the latest wave of the pandemic peaked in mid-January. 

But that encouraging news has also come only after some 40% of Israelis have gotten two jabs, including 80-90% of people 70 years and older, and 75% of people aged 60 years and older. About 80% of people over 50 years of age have received their first dose.  

As such, it’s a rough indicator for other countries of the proportions of people that will need to be vaccinated to just relieve pressure of overburdened health services.  

Trends Still Reflects Uphill Battle Countries Face To Beat Virus With Vaccines  

A preprint study, published this week by Segal and a group of other colleagues on the server Medrxiv.org confirms the same trends and challenges. 

Among Israelis 60 years and older, new positive COVID cases and new moderate or severe hospitalized cases both began to decline about three weeks after Israel officially kicked off its massive vaccination campaign in late December. And those declines among older people have continued. 

However, among people 0-59, where vaccination rates are much lower, serious cases have climbed steadily in that same period – even after new infections initially dropped a bit and then remained stable. The increase seen in hospitalizations among younger people has been attributed to the more infectious B.1.1.7 variant – which has also been associated with a sharp increase in serious cases in the UK as well as in Israel and the United States. 

“For the first time in the pandemic, there were fewer COVID-19 hospitalizations this week in the 60 year old and older age group than in the 60 year old and younger age group. The 60 years and older were first to vaccinate and 91% of them have been infected or vaccinated to date,” tweeted Segal. 

But that very crossing of the lines also suggests the next challenge that will have to be faced – and that is to confront vaccine hesitancy so as to curb the risks of runaway infections in younger age groups. 

Confronting Vaccine Hesitancy 

Tel Aviv vaccine – Israel’s massive campaign now open to all ages but seeing a slump in customers.

The issue of vaccine hesitancy has surfaced in Israel almost unexpectedly –  given the eager rush first seen after the vaccines.

While Israel has been primed to vaccinate some 200,000 people a day, demand has slumped around 120,000 vaccines daily. As compared to the long lines seen at the beginning of the campaign, waiting rooms are now standing empty.  

That could leave the country falling short of having 60% or more of the countries’ citizens and residents vaccinated by late March. 

While authorities are still preaching masking and social distancing, vaccinating the way out of the pandemic is still seen as the major solution – given Israel’s overall high infection rates, large families, and intensity of social contacts, and the failure of lockdowns to restrain mass gatherings for prayer, weddings, funerals and other ritual celebrations. 

And so experts worry that such hesitancy could derail the gains now being made – slowing the climb towards real herd immunity.  

The hesitant groups have included ultra-orthodox Jews, Arab citizens of Israel, and younger Israelis generally, who may not feel that they are at risk from the virus. 

Among the ultra-Orthodox population, which comprises some 10% of Israelis, only 17.5% of people have received their first dose of vaccine and only 9.5% their second dose – as compared with 40% of the general population who have received at least one dose – and 25% their second dose. 

Teachers, who were prioritized to get the vaccine right after people over the age of 60 have not turned out to be vaccinated in the numbers hoped. Health Minister Yuli Edelstein has now begun talking about sanctioning teachers who refuse to get vaccinated – requiring a COVID test every time they enter a classroom. And some other ministers and municipal leaders are talking about barring them altogether. 

Two post-high school students, doing volunteer service, getting their COVID-19 vaccines in Tel Aviv – shortly after Israel’s campaign opened to all ages – but turnout has since languished.

Cholent and Green Passports 

But authorities are also trying to roll out incentives to get more people immunized. 

Those range from organizing Thursday evening “cholent” nights in ultra-Orthodox Bnai Brak – where people can get a free hot meal of the traditional Jewish meat stew if they also take the jab – to “green passports” for travel-hungry secular Israelis to attend sports and cultural events and travel abroad. 

Already Israel is building tourism agreements with Greece and Cyprus, based on the free flow of citizens who have been vaccinated. Paradoxically, the airport is currently shut altogether, with only a few “rescue” flights available for returning Israelis – who were never vaccinated, may be infected, and could even return without undergoing a basic COVID test if they can document the reason to an “Exceptions” Committee. 

But in the Israeli incarnation, “green passports” would not only be a passport to international travel – but a much broader incentive used domestically. Only people who have been vaccinated – or recovered from COVID – would be able to gain ready entry to crowded sports and cultural events. Despite all of the hype, however, no concrete plan has yet been rolled out. And it remains to be seen how effectively something so complex can be implemented whilst Israel is also in the midst of a national election campaign that will take place in late March. 

Of course, civil libertarians have also raised the question of how such preferential treatment of vaccinated groups would work legally – and the extent to which it’s permissible to compel people to undertake an invasive procedure like a vaccine. 

However, initial legal opinions have held that while vaccination may not be compelled – there are basic laws as well as legal precedents for incentivizing those who get vaccines – and penalizing those who do not – when not doing so jeopardizes public health. 

“Legal experts are rightly concerned about individual liberty when making health-related decisions, but it may not be possible to avoid measures that incentivize young people to be vaccinated. This dilemma will also preoccupy countries that have fewer vaccine doses at their disposal than Israel,” opined Amos Harel in the liberal mass circulation daily Ha’aretz.

Image Credits: Health Policy Watch .

Dr Peter Ben Embarek, head of the WHO investigative team and food safety expert.

None of the hypotheses about the origins of the SARS-CoV2 virus have been discarded and the World Health Organization (WHO) origins mission might be expanded to include other experts to take forward new areas of research, WHO Director General Dr Tedros Adhanom Ghebreyesus told the body’s bi-weekly media briefing on Friday.

“I wish to confirm that all hypotheses remain open and require further analysis and studies, some of that work may lie outside the remit and scope of this mission,” said Tedros about the mission which returned earlier this week from a month-long investigation in China.  

Before leaving China on Tuesday, the expert team told a media briefing that it had identified four hypotheses about the origin of SARS-CoV2, including that it originated in a laboratory, which they deemed “unlikely.”

The most likely cause was that the virus was transmitted from bats by an intermediary animal source, while bats as the direct source of the virus or it being transmitted by frozen food were the two other theories.

Team leader and WHO food safety expert Dr Peter Ben Embarek told the briefing that he regarded the mission as a success as it “came to a better understanding of the early days of the pandemic in Wuhan and identified areas for further analysis and research.”

Reacting sharply to a question about whether it could have found more evidence had it gone to Wuhan earlier, Ben Embarek said it was “not a mission to go and chase an animal in the market or chase a patient somewhere.”

“In February, it would have been impossible to be in Wuhan because Wuhan was in total lockdown in the middle of fighting the disease, and that took a few months before the city was reopened and the business returned to normal,” said Ben Embarek.

“Many of these studies have involved thousands of people and researchers in China to conduct. And if we had gone much much earlier we wouldn’t have had the same material to look at,” he added.

Over 97,000 Patient Records Assessed

The team found no evidence of the virus in Wuhan before December. Elaborating on this, Professor Marion Koopmans, team member and head of the department of Viroscience at the University of Rotterdam, said that the team had examined mortality statistics to see whether they could identify any unusual death patterns, as well as reports of influenza.

They assessed 97,000 patients’ records and narrowed down 92 cases of COVID-like symptoms in Hubei Hospital – but none of the patients that they could trace tested positive for the virus, although a few could not be traced or had died.

“All the potential cases were tested for COVID-19 and were negative, the one question that is out there is, can you still rule that out, a year after an infection, the serology is negative then,” said Koopmans, who added that there were ongoing discussions with China about the team getting access to blood banks to test samples.

Ben Embarek said that the mission had been “successful in many ways,” and had provided evidence that there was “no widespread and no large cluster of the disease in Wuhan, or elsewhere, around Wuhan, in the months prior to December 2019.”

Professor Marion Koopmans, member of the WHO investigative team and Head of the Department of Viroscience at the University of Rotterdam. 

“We have been able to demonstrate that there was substantial circulation of the virus in Wuhan in December 2019, we’ve been able to link genetic sequences of different patients across the city in December with their physical location in and outside the market across the time, from early December to end of December,” said Ben Embarek.

“We have a much better understanding of what happened in the market, the role of the market, we have also been able to trace back all the suppliers of different wild animal products into the market as a potential clue for further studies,” he added.

The team’s findings from their mission and the studies that were conducted will be written in a summary report, due to be published next week, with the full report following in the coming weeks, said Tedros.

Vaccines Likely to Protect Against Severe Disease – Even With Variants

In response to a question about whether the AstraZeneca vaccine would still be effective against variants in the light of the small South African study that showed it had little effect against the 501.V2 variant, WHO Chief Scientist, Dr Soumya Swaminathan, said the body still had hope that the vaccine could prevent “severe infection and death.”

“The trials that have been done so far in South Africa, as well as in Brazil with different candidates have shown complete protection against severe disease and hospitalisation,” said Swaminathan. 

“Our goal in the first wave of vaccinating people is to protect those at highest risk from severe disease, hospitalisation and death. So vaccines are protecting against getting severely ill, even though they may not protect completely against getting infected or mild disease,” she added.

She also urged people who have been vaccinated to “take precautions, to wear a mask, to wash hands, to maintain the physical distancing, to really reduce the risk” as it is still unclear whether they can pass on the virus to others.

However, Dr Bruce Aylward, WHO Expert Adviser, said confirmatory studies would have to come from countries that had these variants.

Vaccines to be Airlifted to Ebola Outbreak in DRC 

Two of the three people infected with Ebola in the Democratic Republic of Congo died, but the source of the outbreak has not been identified, Dr Michael Ryan, WHO Executive Director of the Health Emergencies Programme, said. 

Extensive contact tracing of the three has already taken place, and “over half of those contacts were vaccinated in the previous Ebola outbreak, most of those are actually health workers who were previously vaccinated,” said Ryan, who added that 16,000 vaccines would be airlifted to the affected area from Kinshasha over the weekend and there were 400 doses of monoclonal antibodies to treat those who might get infected.

Image Credits: CGTN.

Director of the Africa CDC, Dr John Nkengasong

In the next two weeks, distribution of millions of doses of the Oxford/AstraZeneca SARS-COV2 to health workers across Africa will get underway, said the director of the Africa Centers for Disease Control in a joint press briefing with the WHO Regional Office for Africa on Thursday. 

CDC Director John Nkengasong told Health Policy Watch that at least 20 African countries have so far ordered for over 200 million doses of COVID-19 vaccines, including AstraZeneca’s,  through the African Union’s African Vaccine Acquisition Task Team (AVATT)  – the first such vaccine pre-order arrangement by the AU, similar to ones brokered by the European Union. 

The AU purchasing channel comes in addition to the rollout of some 90 million doses of the AstraZeneca vaccine, which are set to be distributed to countries on the continent through the WHO co-sponsored global COVAX facility, beginning this month.   

However, striking a different note from WHO recommendations issued only yesterday, Nkengasong said that Africa CDC was not recommending use of the AstraZeneca vaccine, at this stage, in countries where the B-1351 variant, first identified in South Africa, has become dominant.

“We should encourage countries actually to use that [AstraZeneca] vaccine, where they do not have evidence of that South African variant,” said Nkengasong, adding, “having reported one or two cases in the country doesn’t mean that the variant has dominated; we only have to be cautious in areas that have an extensive takeover of the pandemic by the variant. 

“So, our recommendation for the use of the AstraZeneca vaccine is very clear – if you have evidence that the variant is predominant in your country, then we recommend that the [AstraZeneca] vaccine should not be issued for the obvious reason that it will have reduced activity in neutralizing antibodies,” Nkengasong said.

Active cases of COVID-19 in Africa as of 1:00AM EST 12 February 2021. (Johns Hopkins University & Medicine)

On Sunday, South Africa announced that it was pausing a massive public rollout of the AstraZeneca vaccine, pending more research – after a small local trial showed that it performed poorly in controlling mild and moderate cases of the virus caused by the B-1351 variant of the SARS CoV2 virus that has become dominant there.  

However, in a press briefing on Wednesday, WHO’s Strategic Advisory Group of Experts (SAGE) said it was still recommending that African countries begin immunizing with the AstraZeneca vaccine – even if the variant is present – because it’s still likely to be effective against more serious COVID cases. 

South Africa has, meanwhile, decided to roll out to its public a one-shot Johnson and Johnson vaccine – while undertaking a larger controlled trial among health workers to examine the performance of  AstraZeneca – particularly for controlling severe COVID cases. 

African CDC Statement Recommends Targeted AstraZeneca Use 

In the formal Africa CDC statement, the recommendation was two-fold stating:

  1. For countries that have NOT reported the circulation of the SARS-CoV-2 N501Y.V2 (or B.1.351), we recommend proceeding with the rollout of the AstraZeneca vaccine.
  2. For countries that HAVE reported the circulation of the SARS-CoV-2 N501Y.V2 (or B.1.351), we recommend the acceleration of their preparedness to introduce all COVID-19 vaccines that have received emergency use authorization or approval by regulatory authorities. Consideration should be given to the effectiveness of the vaccine against SARS-CoV-2 N501Y.V2 or any other circulating SARS-CoV-2 variant in the country.

The CDC also called on countries to expand their genomics testing capacity – so that it could identify and track the expansion of new virus variants.

Vaccines Can’t Come Too Soon 

Dr Matshidiso Moeti, WHO Regional Director for Africa

Altogether, the vaccines cannot arrive fast enough as African health facilities have been overwhelmed by the pandemic’s second wave, said WHO’s Regional Director Matshidiso Moeti, also speaking at the joint briefing.  

According to a recent WHO survey of 21 countries,  66% reported inadequate critical care capacity; 71% were reporting shortages of vital oxygen supplies, and 24% reported health worker burnout, she said.  

According to WHO, the B-1351 variant has now spread to eight African countries including not only South Africa but — Botswana, Ghana, Kenya, Comoros, Mozambique, Zambia and Tanzania. The Tanzanian variant cases, identified among travelers arriving in the United Kingdom, are significant as it suggests the steady creep of the variant northward.  

The report about Tanzania also is significant insofar as the country is widely believed to be underreporting its COVID case numbers – with doctors and health workers under government pressure to avoid COVID diagnoses whenever possible. Only 509 COVID cases have been reported in the country, to date, as compared to 102,000 cases in Kenya, which lie on Tanzania’s northern border,  and 65,000 in Zambia, to the south.  In light of the weak overall surveillance of the disease – new variants that migrate in are likely to escape notice as well.

South Africa, meanwhile, continues to lead in the number of cases on the continent, with more than 14 million cases and over 45,000 deaths, Africa CDC said.

Over 200 Million Vaccine Orders Through African Union Platform – Long-Term Local Manufacturing Capacity Needed 
South Africa receiving first consignment of coronavirus vaccine in February 2021

There have been worries that the slow spread of the South African variant, which is more effective than others in evading antibody immune responses,, has dampened some of the enthusiasm over the use of AstraZeneca’s vaccine in Africa.   

But despite the concerns about variant creep, no country so far has requested that its AstraZeneca vaccine order be swapped for other vaccines on the platform, Nkengasong said at the briefing. 

And the vaccine is still available for preorder by African countries until February 15 on the Africa Medical Supplies Platform (AMSP) that was created by the African Union , to facilitate countries’ vaccine purchases after the AU negotiated a series of bilateral pre-order deals with pharma manufacturers to ensure higher volumes than the WHO’s COVAX facility could provide.   

While the AU arrangements, supported by Africa CDC, have been a milestone, going forward, Nkengasong stressed that Africa CDC supports a long-term plan to enable the manufacturing of COVID-19 vaccines in more countries on the continent – particularly in light of the fact that periodic vaccine boosters will likely be needed. 

 CDC is thereby backing calls by African heads of governments for more effective transfer of COVID health technologies, especially in the area of vaccine production.

“We truly are dealing with a new virus, we don’t know for how long, when people receive vaccines, their protection will last,” Nkengasong said.

“And if, it so happens….that we do periodic vaccinations, we also require that Africa is well-positioned and equipped to be able to manufacture vaccines locally so that the continent can at least meet the demand for 1.2 billion people.” 

The ‘Predominant’ Variant Criteria
A pharmacist wears a face mask while helping a customer in a pharmacy in Yeoville, Johannesburg.

In contrast to Nkengasong’s recommendation that countries where the B1351 virus variant is ‘predominant’ should try to procure other vaccines, Moeti’s comments adhered more closely to the WHO global guidance advising use of the AstraZeneca vaccine irregardless. 

That guidance, issued by WHO’s SAGE expert group on Wednesday, holds that the AstraZeneca vaccine is still likely to reduce more serious COVID disease – despite the findings of the small South African study in which it failed to reduce mild and moderate cases.  

Although a vaccine that protects against all forms of COVID-19 illness is the aspiration, preventing severe cases and hospitalizations which overwhelm hospitals and health systems is the first priority, Moeti stressed. And the AstraZeneca vaccine can still perform that task, she affirmed. 

“If cases remain mostly mild and moderate, and don’t require critical care, then we can save many lives,” she said. 

She encouraged Africans to go out and get vaccinated whenever a vaccine becomes available in their country, adding that ensuring equitable access to COVID-19 vaccines and sustaining other preventive public health measures, such as masking, hygeine and social distancing, are all critical priorities to overcome the pandemic.  

According to the AMSP site, the AstraZeneca vaccine uses “a replication-deficient chimpanzee viral vector based on a weakened version of a common cold virus (adenovirus) that causes infections in chimpanzees and contains the genetic material of the SARS-CoV-2 virus spike protein. 

“After vaccination, the surface spike protein is produced, priming the immune system to attack the SARS-CoV-2 virus if it later infects the body”.

While the SARS-CoV2 virus has spawned multiple variants, the B-1351 virus variant is particularly significant because of a spike protein mutation (called 501Y-V2), which has been better at eluding some of the vaccines that target the virus spike, in particular, to prime immunity. 

According to the recent study of the AstraZeneca vaccine, conducted by a team of researchers at the South African University of Wits in collaboration with Oxford University and involved nearly 2000 study participants, the vaccine’s displayed only a 21.9% efficacy, in terms of prevent mild and moderate disease. This was well below the levels demonstrated in the company’s Phase 3 trials, which yielded an average vaccine efficacy of 66.7% among volunteers aged 18-55.  

More Genomic Tracking In Africa Critical To Successful Vaccine Rollout

Increasing genomic tracking of virus variants on the continent is also critical, Nkengasong stressed – if the challenges posed by virus variants are to be met. So far, only South Africa has adequate genomic surveillance data on variants to identify not only which variants are present but also those that are predominant.

Developing such data will require countries to begin sequencing many more COVID test samples – and yet many countries lack any genomic sequencing capacity at all. Through the Africa CDC Pathogen Genomic Initiative,  CDC is leveraging its network of laboratories to support countries to build their capacity to conduct genomic sequencing for the purposes of widespread tracking and surveillance. 

“Our target is to generate about 50,000 genomic sequences in the next coming months, so that we better understand the layout with respect to the new variant,” Nkengasong said.

In addition, as African countries begin to roll out vaccines, health authorities need to do so in a way that they can also generate data on the safety and efficacy of vaccine candidates, particularly in regions where variants may be present.  

“It is important that we generate, very quickly, data that will inform us on the rollout,” he said.

 

Image Credits: GovernmentZA/Flickr, Paul Adepoju, Johns Hopkins University & Medicine, Flickr: IMF Photo/James Oatway.

(DoD photo by Lisa Ferdinando, Flickr)
  • Weak medicine regulators in Africa mean the continent is vulnerable to falsified COVID vaccines being circulated.
  • Sources at international anti-crime agencies argue that Africa’s strong trade routes with China and India are going to allow criminals to introduce shipments of falsified vaccines into supply chains.
  • The World Health Organisation says the global market for substandard or falsified medicines could be worth up to 15% of the total pharmaceutical market.
  • In November 2020, two people were arrested after a consignment of falsified COVID vaccines were discovered in a warehouse in Germiston, South Africa. 

JOHANNESBURG, – On Friday, 6 March 2020, a day after South Africa recorded its first-confirmed case of COVID-19, and a few weeks after Egypt had on 14 February become the first African country to register an infection, Ugandan police arrested a traditional healer and his daughter in a village 120km east of Kampala.

Police spokesperson, Fred Enanga, told Uganda’s New Vision newspaper: “They visited a number of families … telling them that they had discovered a vaccine for the coronavirus disease … The unknowing subjects purchased the said vaccine at a fee that was negotiated with the seller before it would be administered.”

On 19 November, 2020, a far more sinister incident unfolded in a warehouse in Germiston, according to Mlungisi Wondo, acting manager of the South African Health Products Regulatory Authority’s (Sahpra) regulatory compliance unit.

The police, he says, tracked “suspicious freight” from Johannesburg’s OR Tambo Airport to the building east of the city. After opening a “lot of boxes”, an officer called Sahpra for assistance.

“Our inspectors got there and then they saw prefilled syringes, and they [had labels that] were written in Chinese … The two people who were at the site, the owner of the warehouse and the Chinese owner of the consignment were arrested,” says Wondo.

“There were clear indications that the contents of the boxes were going to be sold as genuine COVID-19 vaccines.”

According to Interpol, the “vaccines” had been advertised for sale on a Chinese social media app, WeChat, and had been imported from Singapore as “cosmetic injections”.

Wondo says the police, in cooperation with Sahpra, are “still trying to trace if there were units released into the country. The risk now is, if people are injected with those [fake] vaccines; we don’t know what is in them because we are still doing the tests at the National Control Laboratory in Bloemfontein.”  

Nigeria’s Food & Drug Administration Also Spots Fake Vaccines in Country

On 15 January, Nigeria’s National Agency for Food and Drug Administration and Control (Nafdac) said it was aware of fake vaccines circulating in the country. The agency’s director-general, Mojisola Adeyeye, told a press conference: “Nafdac is pleading with the public to beware. No COVID vaccines have been approved by Nafdac. Fake vaccines … could kill.” 

And on 31 January, a “Dr H. Losho from Lagos”, who also advertises sex toys, clothes and shoes, posted the following tweet: “If you’re interested in 2 shots of Covid Vaccine at 50k each, contact @ad_de_moles. AstraZeneca. Arrives in 2 weeks. You get a card.”

Africa Is Fertile Ground For Distribution Of Falsified Medicines & Stolen Vaccines

These cases show that Africa is fertile ground for distribution of falsified and stolen vaccines. And with the emergence of new SARS-CoV-2 virus variants, such as the  B.1.351. variant (carrying a mutation called 501Y.V2) that was first identified in South Africa, COVID vaccines will become an even more sought-after commodity — because, at least so far, those variants have proven to be more infectious than the original form of the virus. Some are also able to escape the immunity that current vaccines induce, leading to more fear — and desperation — to be protected from such variants by adjusted, newly developed vaccines specific to those variants.

The statistics also show the continent is extremely vulnerable to vaccine crime: A 2018 report by the World Health Organisation  said between 2013 and 2017, almost half of all substandard and falsified medicines found were in sub-Saharan Africa, where regulations are weak, borders porous and the distribution of fake pharmaceutical products is often not even considered a crime, despite the harm they do.

“We’ve found very toxic substances in falsified medicines. First, you are not cured, and then you have seen cases of people who are dying because of the product they were taking,” says Cyntia Genolet, the associate director of Africa engagement at the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA). The organisation represents the world’s major pharmaceutical firms, including most of those making COVID-19 vaccines.

The WHO report estimates that fake malaria drugs alone cause up to 158 000 deaths every year in sub-Saharan Africa, and that the global market for substandard or falsified medicines could be worth $US 200 billion, or 10-15% of the total pharmaceutical market.

Most African countries are unprepared for the potential onslaught of vaccine theft and falsification

In South Africa, one of the African countries worst-affected by the pandemic, the Health Department says at least 67% of the population of about 60-million must be vaccinated to achieve the herd immunity that would effectively end its epidemic.

South Africa’s vaccine roll-out, that would have started with the AstraZeneca vaccine, was temporarily suspended this week, after new, early data showed that the jab only provides 10% protection against mild to severe COVID-19 caused by the new 501Y.V2 variant.

The Health Department announced that the country will now, instead, launch an implementation study that will compare how well three jabs — Johnson & Johnson, Pfizer and possibly AstraZeneca — protect against severe COVID-19 disease caused by the new variant. Severe COVID leads to hospitalisations and death, and protection against it is therefore an important function of vaccines during pandemics.

And, once the country’s roll-out finally takes off, it will be massive and fraught with challenges.

“This roll-out will be unprecedented in scale, importance and complexity. Will there be crime around that? Probably. But I think we have bigger problems, like how are we going to get the vaccine into the arms of millions of people?” says Salim Abdool Karim, an epidemiologist and co-chair of South Africa’s scientific ministerial advisory committee on COVID-19.

Abdool Karim, who also heads up the HIV research organisation, the Centre for the Aids Programme of Research, Caprisa, adds: “The system that’s going to regulate the vaccines seems pretty strong; they say security around the vaccines will be strong.”

But nowhere close to as strong as in Europe and the United States, where almost every entity involved in distributing the jabs, from airports to transport firms to manufacturers, has formed task teams to keep them safe.

New York National Guard troops support state efforts to administer COVID-19 vaccines. (U.S. Army National Guard photo by Sgt. Sebastian Rothwyn, Flickr)

In high income countries, companies have done background checks on staff; GPS trackers are inside every box of vaccines, which are being stored in secret locations; some vials contain black light verification technology (markings that are only visible using equipment that emits ultraviolet rays) to prevent falsification; some firms are using bogus shipments to throw criminals off-track.

But most African authorities, entangled in negotiations to secure vaccines and preparing for the logistical nightmare of getting them to people across vast territories where transport routes are poor and sometimes non-existent, are nowhere near ready to safeguard the vaccines, according to numerous sources interviewed by Bhekisisa, including law enforcement, crime intelligence, customs and border officials, government representatives and crime analysts.

Africa has almost 1.4-billion inhabitants, according to the latest Worldometers population recording mechanism.

In an analysis in late November last year, the WHO warned that “Africa is far from ready for what will be the continent’s largest ever immunisation drive”.

The analysis found that, based on self-reports by all countries, Africa had an average score of 33% readiness for a COVID-19 vaccine roll-out, far below the WHO’s desired benchmark of 80%.

The organisation said less than half of Africa had identified “priority populations” for vaccination, and had plans in place to reach them; only 44% had “coordination structures” in place.

According to the WHO report, only 24% had “adequate plans for resources and funding”; a mere 17% had data collection and monitoring tools ready; and just 12% had plans to communicate with communities “to build trust and drive demand for immunisation.”

Maurice Ogbonnaya, a crime analyst and former security analyst at the National Institute for Legislative and Democratic Studies at Nigeria’s National Assembly in Abuja, says it’s precisely such inadequacies, “gaps” and disorganisation that could allow organised crime groups (OCGs) to insert falsified vaccines into supply chains, and to steal vaccines.

Why is Africa ripe for a COVID vaccine black market?

Inspired by a brother addicted to illegally trafficked codeine in Nigeria, Ruona Meyer spent more than a year infiltrating gangs dealing in illicit pharmaceuticals in West Africa.

She went undercover as a buyer, her contribution to a Emmy Award-winning documentary in 2018, Sweet Codeine, resulting in several arrests and convictions, including that of a pharmaceutical company executive.

[WATCH] Sweet Codeine

“In Africa, you have all the elements necessary to allow a black market in vaccines to flourish,” says Meyer. “Lack of resources, logistics and technical capacity means it’s going to take incredibly long for the roll-outs to happen. That gives organised crime the time and space needed to strategise, adapt to security measures and to insert their products into supply chains. The poverty and official corruption that’s unfortunately prevalent throughout Africa makes their job much easier.”

In its July 2020 research brief analysing the impact of the COVID-19 pandemic on organised crime infiltration in the legal economy and illegal governance, the United Nations Office on Drugs and Crimes (UNODC) says: “Although no country is completely immune from fraud, countries with a high level of corruption are at a much greater risk of being affected.”

Meyer adds: “It also doesn’t help that healthcare workers in Africa, many who are going to be in charge of vaccine supplies, are very poorly paid … Of course criminals will take advantage of this.”

Organized Crime Groups “Ideally Placed” For Trade in Fake or Stolen Vaccines

Interpol East Africa crime intelligence analyst, John-Patrick Broome, says OCGs are “ideally placed”, having “well-developed networks and methodologies” to smuggle falsified, substandard and stolen vaccines.

“Illicit medications are primarily entering the market in eastern Africa through three key areas. There’s the avoidance of regulations, there’s violence-based criminality and there’s corruption … at a number of different levels,” explains the former British Isles border policing officer.

“The organisations in eastern Africa that have responsibility for regulating the legislation and enforcement activities around this form of criminality have been seen to lack some of the autonomy and powers that they require to deal with the illegal trade.”

Meyer says rising infections and deaths and third and even fourth waves of COVID-19, could cause increasing fear, thus driving demand for vaccines up even further.

“At certain stages supplies will be low. This is the gap that the criminals will fill. We’ve seen it happen already with personal protective equipment (PPE) and chloroquine, when the crime groups got their fakes into global supply chains quite easily.”

Chloroquine & PPE Provide Sorry Precedents

Demand for chloroquine, a medication used to treat rheumatoid arthritis, the autoimmune disease lupus erythematosus, and also malaria, rocketed after a French microbiologist claimed in March 2020 it was “efficient” at combating COVID-19.

Former US President Donald Trump also began touting a form of chloroquine, hydroxychloroquine, as a potential cure, even though there was no evidence to prove that the drug could either treat or prevent COVID-19.

[WATCH] Should doctors prescribe chloroquine to COVID-19 patients?

In the months that followed, Voice of America reports, authorities throughout West and Central Africa seized large quantities of falsified and substandard chloroquine. Many of the tablets were compressed chalk. Police in Cameroon raided and shut down several pharmaceutical manufacturers who were producing fake chloroquine.

There’s currently also immense international demand for the anti-parasitic drug, Ivermectin, which is being promoted by some voices in the medical community as prevention of and treatment for COVID-19, although there remains a dearth of clinical trial evidence. Nevertheless, seizures of illicit Ivermectin are occurring around the world, including in South Africa.

Mafia groups are moving illicit vaccines throughout Europe — and cooperate with criminal enterprises in Africa

Lawyers Marius Schneider and Nora Ho Tu Nam, who advise some of the world’s major pharmaceutical companies on intellectual property issues, warned of the probability of the distribution of fake COVID-19 vaccines on the continent in a report published in the Journal of Intellectual Property Law & Practice in May 2020.

“Why are we going to have an issue with the vaccines? Well, it’s very easy: Because the demand will be high, access will be limited, everybody will want to have his shot, and in that kind of situation this vaccine is liquid gold, as it has been called by some, for these criminal syndicates. They will exploit the situation by either stealing the vaccine, or by counterfeiting it,” argues Schneider, a former chairman of the anti-counterfeiting committee of the European Community Trademark Association.

The advocate, originally from Belgium, founded the IPVocate Africa law firm in Mauritius in 2012 to focus on the “severely neglected” areas of protection, management and enforcement of intellectual property rights in Africa.

Schneider’s practice sometimes coordinates anti-counterfeiting raids with law enforcement agencies and represents pharmaceutical multinationals in legal cases.

“We have seen instances where non-governmental organisations (NGOs) have been engaged in the distribution of these [falsified] vaccines. These NGOs had as a mission to distribute real vaccines to the people. Employees on the ground in African countries were implicated in vaccine trafficking,” he says.

The IQVIA Institute for Human Data Science calculates global spending on pharmaceuticals in 2019 at $1.25-trillion (almost R18.7-trillion). It projects that the global pharmaceutical market will exceed $1.5-trillion (almost R22.4-trillion) by 2023.

Big Money Equals Big Crime

Big money equals big crime, says Ho Tu Nam.

In September 2015, a UK court jailed two former United Nations (UN) consultants for rigging a contract for life-saving drugs between a Danish pharmaceutical firm and government officials in the Democratic Republic of Congo. Guido Bakker and Sijbrandus Scheffer took a bribe of £650 000 (about R13.2-million) to secure a £66-million (about R1.3-billion) tender.

“OCGs have always been interested in pharmaceuticals because of the high profit margins and low risks involved,” says Mark Micallef, North Africa and the Sahel Observatory director of the Global Initiative against Transnational Organised Crime. “They move wherever the greatest profits are to be made at a specific time, therefore it is quite obvious they will get involved in whatever ways they can in the vaccine supply.”

Much of Schneider’s career has focused on organised crime. He participated in the famous “Gomorra” investigation in the 2000s that exposed the sale of counterfeit power tools in Europe, which resulted in the downfall of several figures in the Naples-based Camorra mafia.

“The Camorra had set up production of the tools in China,” Schneider recalls.

Three-Quarters Of Falsified & Substandard Medicines Originate in China  -Africa’s Biggest Trading Partner – and India

The UN estimates in a 2019 report that 75% of falsified and substandard medicines in the world originate from China, Africa’s biggest trade partner, and India, with which the continent also has close relations. The world’s largest vaccine producer, the Serum Institute of India, is already manufacturing COVID vaccines for the drug company AstraZeneca and China has at least three vaccine candidates, two of which are already in distribution.

The UNODC says Italian and Sicilian mafia have for decades trafficked in falsified, substandard and stolen pharmaceutical products, mostly sourced in Asia. 

A senior police investigator in the UK, who asked not to be named because he’s not authorised to give information to the media, told Bhekisisa in early December: “The mafia are moving illicit vaccines in locations throughout Europe.”

He confirmed links had been established between these mafia groups and “criminal gangs in Nigeria, Morocco, Egypt and Ivory Coast”. The Camorra mafia, for example, have also been active in South Africa. In 2014, five Italian nationals linked to it were arrested near Port Elizabeth and charged with trying to sell counterfeit power tools worth millions of rands, IOL reports.

Well-established Routes for Trade in The Opoid, Tramadol, “Waiting to be Fuelled” with Fake Vaccines

Sources at international anti-crime agencies argue that Africa’s strong trade routes with China and India are going to allow criminals to introduce shipments of falsified vaccines into supply chains.

The 1-million AstraZeneca vaccines that arrived in South Africa on 1 February, came via India from the country’s Serum Institute.

On Sunday, the health department also announced that South Africa is in talks with a Chinese company, Sinopharm, with regards to their COVID jab.

Bhekisisa has spoken with a former trafficker of illegal pharmaceuticals in West Africa, who now assists authorities there with investigations.

He says OCGs are “simply waiting for chaos, desperation and no organisation” in vaccine roll-outs before distributing falsified vaccines, or stealing the genuine product.

“Their networks are activated. They will use the same networks, the same corrupt officials that they are using (for other illegal products). They have the printers and the packaging they need.”

Says Meyer: “There have been cases in which employees of pharmaceutical manufacturers sell genuine medicine packaging to criminal groups.”

The ex-trafficker speaks of a “well-established route for [illegal] tramadol [an opioid pain reliever]” between Nigeria and India “that is waiting to be fueled with (fake) vaccine”.

He says links exist between “front companies in Nigeria and their partners in India so they will try to replace tramadol with COVID vaccines because the money to be made is much more. We talk here of one 1000% plus profit on a vaccine”.

Doing the ‘tramadol dance’: What this latest music craze says about Africa’s pill addiction.
(Pic credit: Nyani Quarmyne, Mosaic)

He scoffs: “I’m sure in some cases the police and soldiers are going to be protecting bad [falsified or stolen] vaccines.”

Micallef collects his information about trafficking of falsified medicines in North Africa from a network of 160 field monitors in Algeria, Chad, Libya, Morocco, Niger, Sudan and Tunisia.

“Fake vaccines; I think there’s a big danger of that,” says the analyst. “In the Maghreb itself, so unregulated territories in Libya, definitely. But also in Tunisia and maybe border areas of Egypt, less so in Algeria, perhaps, but especially in the northern Sahel.”

Micallef says OCGs dealing in falsified vaccines exploit gaps in health services and this will be especially true of COVID-19 shots, which is going to make the crime very difficult to control.

“This form of trafficking … is tapping an actual health sector need. And the fear is that in the case of the vaccines a similar scenario might unfold where there are shortages, especially in the (Sahel) border areas, that are preyed upon by criminal enterprise trying to fill that gap.”

In West Africa, vaccine roll-out is set to happen at a time when regional governments, especially Nigeria’s, have been cracking down on tramadol trafficking. Between 1 and 19 June last year, the Nigerian Drug Law Enforcement Agency and the National Agency for Food and Drug Administration and Control seized illegally imported containers of the drug worth more than 300-million naira ($US 786,988), reports Enact, an organisation that works to combat organised crime in Africa.

According to the former trafficker, the tramadol crackdown is providing an additional incentive to OCGs in the region to turn their attention to dealing in falsified COVID-19 vaccines.

A senior security official in Nigeria, who requested anonymity, says criminals in India have been “rebranding and renaming” tramadol to import into the country “as something harmless … The concern is they will do similarly with COVID vaccines”.

Ogbonnaya says many parallels can be drawn between tramadol trafficking in West Africa and the “likely” illicit trade in falsified and stolen coronavirus vaccines.

“It boils down to weak regulation by state regulatory agencies; it boils down to corruption by those who are saddled with the responsibility of ensuring that the regulations are put in place. It also boils down to a complete absence of a continent-wide regulatory framework.”

Many African countries don’t have medicine regulators, making it easier for criminals to operate

The IFPMA supports “regulatory harmonisation” in Africa, in particular via the Africa Medicines Agency (AMA). According to a press release issued by the African Union in February last year, the AMA is “a proposed specialised agency of the African Union intended to facilitate the harmonisation of medical regulation throughout the African Union”.

The treaty establishing the AMA was unanimously adopted by the assembly of the African Union in 2019, but only a minority of nations have so far ratified it.

“There are so many elements that will make Africa more vulnerable during this time of the vaccines being distributed,” says Genolet. “The weak regulatory system is also something that’s been identified by the WHO.”

In the Battle against Fake COVID Vaccines & Medicines – Africa Isn’t Alone

Africa isn’t alone in this.

According to a 2017 WHO global report on medicines surveillance and monitoring systems, only three out of ten countries worldwide have medicine regulators that function “according to acceptable standards.”

On the African continent, there are 54 national regulatory authorities for medical products (NMRAs) on the African continent, but there are “varying degrees of capacity among them” according to a WHO fact file.

However, many African countries don’t have well-functioning regulatory systems, such as South Africa’s SAHPRA (South African Health Products Regulatory Agency) at all. Says one expert: “That’s very important to make sure that medicine that enters a country is safe, and that you can also control what happens after the medicines enter a country.”

Only one NMRA in sub-Saharan Africa — Tanzania’s — has been formally assessed by the WHO. In 2018 it gave the East African country’s regulator a maturity level 3, the second highest on the WHO’s scale.

Andy Gray, senior lecturer in pharmacological discipline at the University of KwaZulu-Natal’s school of health sciences, says previous WHO reports have not identified which African NMRAs “were acceptable and which were not, due to political sensitivity, and the assessment has not been updated. The more mature are certainly the South African, Zimbabwean, Kenyan, Tanzanian, Ghanaian, and Nigerian agencies”.

Gray, who’s also part of the WHO Collaborating Centre on Pharmaceutical Policy and Evidence Based Practice, adds: “There is some capacity in Uganda, Botswana, Namibia and Zambia. I’m less sure of the Francophone countries, but would expect some capacity in Senegal and Morocco, and perhaps Cameroon; but the ties with France are tighter, and so is reliance on their approved products.”

Gray says it “does not sound far from the mark” to say that only 10% of African medicine regulators have “moderately developed capacity”, with 90% having “little to no capacity”.

Void in Medicine Regulation Leaves the African Continent Exposed

This void in medicine regulation, says the WHO, leaves most of the continent exposed to unsafe medical products and “facilitates the proliferation of substandard, spurious, falsely labelled, falsified and counterfeit medical products.”

Genolet says the frequent absence of regulation means medicine supply chains in Africa are “very porous. This means there’s limited control of the supply chain. When you have a lot of middlemen involved, and borders that don’t always have controls, it makes it easy to move counterfeit medicines into and out of countries.

“South Africa has one of the better [medicine] regulatory systems in Africa, but even it has thousands of kilometres of unregulated borders.”

But Sahpra’s Mlungisi Wondo emphasises: “Vaccines that are substandard or falsified will be blocked by our processes at the points of entry. Our controls are very strong.”

He says inoculations could come into the country through four points of entry, depending on their origins: Durban, Cape Town, Port Elizabeth (all by sea and air) and Johannesburg (air).

“Medicines can’t come into the country [legally] without going through one of those points. At those points we have customs and port health officials that have been trained to assess medicines coming in,” Wondo explains.

This assessment is, however, based on the particular consignment’s appearance, in terms of labeling, relevant registration numbers and attached documentation.

“If the registration certificate of the product is in order, it is released to the pharmaceutical company for eventual release onto the market. Those that do not fulfill registration requirements, the officials refer to Sahpra for further investigation,” says Wondo.

He acknowledges that fake and substandard pharmaceutical products do sometimes “slip through” the checks.

“It will be your smuggling, where people are false declaring, saying it’s clothes, then maybe in the middle of the container they’ll put those boxes of medicines. Those then may go through, because of the false declaration.

“But, with the help of the regulatory compliance inspectors and the South Africa Police Services, we do pick the fakes up inside the country, eventually.”

Vaccine Theft, Rather than Falsified Jabs, could be South Africa’s Challenge

Gray says South Africa’s reputation is one of having a secure medicine supply chain.

But he adds that because Sahpra doesn’t proactively sample the market, relying on good manufacturing practices by pharmaceutical companies and the “vigilance” of their forensic units, it could be missing “problems”.

“If our medicines go across into neighbouring countries, is somebody slipping falsified versions into those countries? We don’t know. Are some of the importers’ medicines that are arriving on our shelves not the ones that we expect to find? We haven’t detected any, but it’s not impossible that they are happening,” says Gray.

Many of South Africa’s vaccines are expected to be made at the Serum Institute of India (SII), which is contracted by the COVAX facility to manufacture vaccines for developing countries.

“The Serum Institute is approved by the WHO to manufacture the vaccines, so we know it will manufacture good quality products,” says Wondo.

The SII is acknowledged around the world as a safe and secure pharmaceutical production facility. But, as Ho Tu Nam points out: “Medicines emerging from every manufacturer in the world have been falsified; no one’s immune.”

Wondo responds: “Each batch of vaccines that comes into South Africa will be tested. Either by us, or by our trusted partner countries. [Falsified] vaccines will not get past our systems. We will keep our people safe.”

Although Gray believes South Africa’s “vulnerable in some ways” to falsified vaccines, and “bypassing of normal actors” in the supply chain represents a “very ripe opportunity to bring a totally falsified product into the market”, like Abdool Karim he’s convinced the country will have “much bigger problems” to deal with, such as the transportation and distribution of shots.

He does, however, think that vaccines are at risk of being stolen in South Africa.

“I think we are far more vulnerable than we even know,” says Gray. “We’ve certainly had theft from the provincial depots and we have a lot of theft happening from hospitals. In fact, we’ve had problems with theft on demand, where people just phone in to a member of staff and a box gets packed up for them.”

Vaccine Distribution Sites May Be The Most Vulnerable Points For  Vaccine Theft 

In South Africa, like in many other countries on the continent, inoculations will happen at public and private hospitals and clinics, pharmacies, mobile centres and places of work. There might also be larger venues where a big number of people can be vaccinated in a relatively short space of time.

Gray believes these vaccine administration sites will be the most vulnerable points along the distribution chain, because they’ll be under much less scrutiny than vaccine shipments.

Meyer says this will be true continent-wide, but he adds:

“I’ve got confidence in the African Union getting verified, real vaccines into Africa. After a few initial issues with fake PPE, it did a great job coordinating PPE supplies.

“Where we’re going to have the problem in Africa is with the distributors; in this case, the ministries of health, the little primary healthcare centres that get it from the ministry of health, and further down the line.

“That’s where we are going to have problems with secure storage; there are not these super-secure storage facilities in most of Africa. That’s where we might have people who steal vaccines, or who might break the content of the vaccine. The same way somebody would take pure kilos of cocaine and they’ll mix it with all sorts of things so they can make more profit.”

In East Africa, Interpol’s Broome says the pandemic has already led to an increase in criminal attacks on medical professionals: “due to the perception that they have access to medications of which there’s a large demand of across the region. Doctors have been robbed at gunpoint in the belief that they have this access. Organised crime groups have sought to exploit corrupt medical professionals also.”

Abdool Karim is sure there will be “some” theft related to the vaccine roll-out in South Africa. But he adds: “I can’t see how people are going to really steal vaccines and sell them in the black market. If they do, it’ll be a very small, niche population of the very wealthy who will want to jump the queue. Because everybody’s going to get the vaccine; the government is giving it to everybody for free.”

To Stop Vaccine Crime – We’re Going To Have To Boost Supply 

But free or not, says Meyer, if vaccines are in short supply and infections and deaths are continuing, demand will “skyrocket” and “the door will be open” to theft and the insertion of falsified and substandard vaccines into the supply chain.

“To stop narcotics crime, you cut the supply. It’s going to be the opposite way with vaccines: to stop vaccine crime we are going to have to boost supply. The more legitimate vaccines on the market, the less space that criminals are going to have, the less demand there will be for their fake or stolen products.”

Gray agrees, referring to the beginning of the pandemic when South Africans were encouraged to get flu vaccinations. The state had, however, bought most of the jabs to give to “high-risk” employees in the public sector.

“The private sector was battling to get hold of stock; many patients were phoning around pharmacies; there were allegations that some of the chains tended to get preferential access and independent pharmacies couldn’t get access; everyone was trying to buy something somewhere.”

It’s not hard to imagine this scenario being repeated at some stage during the vaccine roll-out, he says.

“That is a perfect breeding ground for a criminal to step in and say, ‘I’ve got some stock which I can get you, which fell off the back of a truck.’”

This article was produced by the  Bhekisisa Centre for Health Journalism, as part of a series on Covid-19 and organised crime. This investigation was made possible with a grant from the Global Initiative Against Transnational Organised Crime (GI-TOC). Sign up for Bhekisisa’s newsletter here.

Image Credits: Lisa Ferdinando/Flickr, Bhekisisa, Sgt. Sebastian Rothwyn/Flickr, Nyani Quarmyne/Mosaic.