Health care workers sensitize a Kenyan community to COVID-19 precautions.

In early January 2020, as our Health Policy Watch team returned to work just after the New Year’s break, our production editor who had returned from a visit to her mother in China, called me to say in a mildly worried tone: “Hi Elaine, there is a strange virus circulating in Wuhan. I thought you should know.”

Within just several weeks, we watched and wrote, and probed and wrote, as the first cases of the “novel coronavirus” spread like wildfire in the city of ten million people, to other parts of China, and then hip-hopping to Thailand, Singapore, the French Alps, an office in Germany, small communities in northern Italy, cruise ships, and beyond.

Journalists crowded into the press room at Geneva’s WHO headquarters to get briefings on the spreading virus – until we understood that it was no longer safe to do so because the virus had also arrived at our doorstep.

As COVID-19 captured headlines in media around the world, there has been new recognition of how important health is to social and economic development. But while a single virus came to dominate almost every aspect of our lives – from how we work, order food or do drug discovery – we realized that, as a media outlet specializing in health policy reporting, we need to constantly be getting “under the hood” of this fast-moving story.

This includes examining the diverse ways in which the pandemic has manifested itself in different parts of the world. And through the lens of COVID-19, we can gain new insights into a range of other thorny health issues that haven’t gone away – including HIV/AIDS, tuberculosis, non-communicable diseases, drug-resistant pathogens, air pollution, climate change, and more.

Health Policy Watch’s Kerry Cullinan interviewed Professor Kelly Chibale,, founder and director of the Holistic Drug Discovery and Development (H3D) Centre at the University of Cape Town (UCT), who is studying how African populations metabolize drugs – an issue that goes beyond COVID-19.

In the same way that polaroid glasses allow you to see beneath the sunlight’s glare over water to appreciate the fish, the coral reefs – and also the plastic debris otherwise concealed – COVID-19 has given us a new lens through which we can see much better.

We can see how well health systems are functioning – or not; the racial and socio-economic inequalities that can hinder public health crisis response – and the importance of evidence-based political leadership.

We can appreciate how climate change and ecosystem degradation are increasing pandemic risks and threatening decades of hard-won health gains. Armed with greater awareness, we can strengthen the debate about how to clear away the systemic, long-term threats we face – along with the pandemic.

New Support from The Wellcome Trust

In line with that vision and mission, we are pleased to announce new support from the Wellcome Trust. This will enable us to redouble efforts to report on all aspects of the pandemic by bringing on new reporters from the Global South, in turn fostering a more balanced health policy dialogue.

Social distancing and mask measures at a KFC outlet in Ibadan – Health Policy Watch’s Paul Adepoju looked at how Nigerians are coming to terms with COVID.

As we head into 2021, we expect that COVID-19 will continue to dominate the news for some time. And we will continue writing about pandemic trends and responses, new drug innovations, and the rollout of long-awaited COVID vaccines.

But we will also explore the broader health issues, through the “COVID-19 lens” that has sharpened our insights into the challenges we face, and how we can rebound and recover – in even better shape.

One key to this is a more balanced dialogue between policymakers and the public as well as between voices in the north and south. The new support we gain from the Wellcome Trust will help us to  build  out our “network approach” to journalism – to link global and regional health policy debates, bridge ideological divides and bring more developing country media voices into the circuit of our coverage.

As Will Hall, Wellcome’s Global Policy and Advocacy Manager told us: “New digital platforms, such as Health Policy Watch, bring fresh perspectives to debates, including from low- and middle-income countries.

“We are pleased to support them in this effort to amplify the voices of journalists in the global south across interconnected health challenges.”

COVID-19 Pandemic Relief Services, New Delhi. Health Policy Watch’s Menaka Rao and Jyoti Pande Lavakare explored how COVID-19 cases rose this autumn, along with air pollution levels.
About our Team

Our small and nimble team is based in Geneva, a global health hub that is home to the World Health Organization and dozens of global health organizations. We operate under the auspices of the non-profit, Global Policy Reporting Association – which has been providing media services for over 15 years.

We already have reporters corresponding from Nairobi, Ibadan, Delhi and Cape Town, as well as from New York City and London. And in 2021, we will be building out our team further into English-speaking parts of Africa; southeast Asia, western Pacific and Latin America and the Caribbean.

Menaka Rao, Delhi
Jyoti Pande Lavakare, environmental health
Kerry Cullinan, Cape Town
Paul Adepoju, Ibadan

 

 

 

 

 

 

Says Kerry Cullinan, our Africa editor: “Health Policy Watch ensures that the voices and experiences of African policy-makers, health workers and patients are heard by global decision-makers in Geneva, providing a unique platform for an exchange of views and news.”

We will be boosting our columnists to provide “Inside Views” from a diversity of regions, disciplines and perspectives.   We urge you to get in touch with us by email or @HealthPolicyW with your ideas for stories and op-eds.

Wellcome Trust – a new supporter of Health Policy Watch reporting in the Global South

Finally, we retain as a core value that of accurate, evidence-based and independent reporting. With regards to the latter, we appreciate the complete editorial freedom accorded to us under the terms of the Wellcome Trust support.

After the dark days of 2020, we sincerely hope that the New Year may indeed see further milestones in strengthening health systems, supporting health workers, and reducing the terrible burden of the pandemic on peoples, societies and economies. Sincere wishes for a brighter, and COVID-free, 2021!

Elaine Ruth Fletcher
Editor-in-Chief

Image Credits: WHO African Region, Photo : Victoria Nthenge/Trocaire, Kerry Cullinan, P Adepoju/HP-Watch, Belur Math, Howrah, Jyoti Pande Lavakare, Courtesy of Kerry Cullinan.

The US COVID-relief package confirmed a US $4 billion investment in Gavi, the Vaccine Alliance.

Just 2 weeks ago, the World Health Organization (WHO) issued a plea to countries to honor their donor pledges to support its COVAX vaccine procurement scheme to equitably distribute at least a portion of forthcoming COVID-19 vaccines to countries around the world. Without donor support, the globall vaccine procurement facility that over 180 countries have joined, risked “becoming no more than a noble gesture”, the WHO warned.

Shortly after the warnings, commitments of some US$ 2.4 billion by eight high-income countries ended the immediate crisis. 

And now, after a vote by the United States Congress, the funding prospects for COVAX in 2021 are looking even brighter. The US COVID-19 relief package – agreed upon on Sunday night, after a near-five-month-long gridlock – has earmarked a US$ 4 billion investment for Gavi, The Vaccine Alliance, which along with WHO, is a co-sponsor of the COVAX initiative.

GAVI launched the COVAX Facility in collaboration with WHO – with the aim of immunizing at least 20% of peple in all countries, prioritizing those at highest risk, regardless of income or development levels. It aims to distribute 2 billion doses by the end of 2021, including to 92 low- and middle-income countries (LMICs) that cannot afford to pay on their own.

While donor commitments made in recent weeks led to last week’s announcement of procurement deals for nearly 2 billion vaccine doses – enough to vaccinate about 1 billion people, the new US aid should help the campaign go further yet.  It will provide much needed support to health systems to actually carry out the vaccine campaigns – as well as enabling the purchase of further doses required to meet the 20% vaccination goal.

The US investment also represents a domestic about-face after months of almost exclusively “America First” rhetoric and policies on the pandemic from lame duck President Donald Trump; the move by Congress acknowledges that, in fact, a global vaccine drive also will help hasten the end of the pandemic. 

USGLC President & CEO Liz Schrayer

As Liz Schrayer, President and CEO of the US Global leadership Coalition (USGLC), said in a statement: “As the virus is spreading anywhere in the world, Americans are not safe, and that means our current global response is simply not enough.

“There’s no denying this year-end agreement was difficult and hard-fought to address many critical domestic needs. At the same time, hundreds of lawmakers from both sides of the aisle have spoken out in recent months that failing to invest in a global response comes at our own peril.”

“More must still be done to address the indirect impacts of the pandemic, particularly the damage its done to stabilization efforts in fragile states and on the food security of vulnerable populations around the world,” said House Foreign Affairs Committee Lead Republican Michael McCaul.

Schrayer also said that this “critical step in the right direction” would “directly impact America’s health and economic recovery”.

COVAX: A Tough Funding Year

The COVAX facility was launched to ensure equitable distribution of the COVID-19 vaccine.

Despite remaining largely uninvolved in the drafting of the Congressional bill, Trump told reporters Wednesday morning that Congress’ coronavirus relief bill “really is a disgrace” – for reasons including the several billion dollars in foreign aid.

He said: “Congress found plenty of money for foreign countries, lobbyists and special interests, while sending the bare minimum to the American people who need it. It wasn’t their fault. It was China’s fault.”

He capped his remarks with a call to raise the one-off payment to be made to most Americans from US$600 to US$2,000.

Whether Trump’s remarks were merely rhetorical, or not, they followed in line with his previous announcements in April to suspend US funding to the World Health Organization, followed by his July announcement of a US withdrawal from the global health body, altogether. The US moves highlighted the delicate nature of the Organization’s resource base, which relies heavily on voluntary donations from member states as well as other charities. Until April, the US was the biggest single donor to WHO, providing about US$400 million in 2019, and accounting for around 15% of its annual budget. WHO’s programme budget for the two-year 2020-21 period amounts to about US$5.84 billion a year.

While the monies are being directed to Gavi, and not WHO, the bi-partisan approval by Congress of the COVID global vaccine aid, as part of domestic COVID bailout measures, suggests the winds of change that are blowing, ahead of the inauguration of US president-elect, Joe Biden. And while Biden will still have to win the approval of the Republican-controlled Senate for other domestic and global public health spending initiatives, some things can also be done by executive order. For instance, Biden has declared his intention to rejoin the Paris Climate Agreement as well as halting the process of withdrawl from the WHO, which was only supposed to take effect in July, 2021.

Image Credits: Ennoti/Flickr, USGLC/Flickr, CIO Look/Flickr.

Wuhan residents lining up outside a drugstore to buy masks in January. From the beginning of the outbreak, masks were required by Chinese authorities to reduce person-to-person transmission – WHO only issued a recommendation months later.

The redacted WHO report on Italy’s pandemic response, “An Unprecedented Challenge” contained a brief timeline of events in the early days of the SARS-CoV-2 outbreak in China, which a number of WHO officials sought to amend or suppress even before the entire report was recalled.

In fact, the so-called “China box” on the outbreak’s early days, which had been vetted by several experts, contained a narrative of sensitive key events – including the fact the genome sequence was posted publicly by scientists the week before the official report by Beijing of the genome sequence to WHO – which have either been omitted or muted in the official WHO timeline of the COVID-19 pandemic, which was updated just last week.

Straightforward Narrative – With  Bombshell Implications – Ruffling Feathers In Beijing or Washington?  

The intent of the “China box” – the name gaven to a box-out in the report – of no more than 300 words, was straightforward: to present a terse, factual narrative of the pandemic’s onset in Wuhan and beyond. 

However, just ahead of the report’s publication, a controversy over the fine print of the “China box” text erupted among WHO officials, Health Policy Watch has learned. And it was in fact concerns over that box, which directly led to the report’s withdrawal from the WHO website on 14 May, a day after it had been published online. 

The chain of events raises further questions over whether the entire document’s recall may not only have been linked to the feathers it might ruffle in Rome, but also those in Beijing.  

China Box Timeline Drawn From Original WHO Reports – Which Were Later ‘Amended’   
The China box: excerpted from the suppressed WHO report, “An unprecedented challenge”

The report’s “China box” provided a cursory, but unvarnished narrative of the early days of the SARS-Cov-2 virus spread, which was based on initial WHO epidemiological reports from January 2020 and other expert sources. But that WHO narrative has since seen several major revisions – including on 27 April, 29 June, and again on 15 December.  As a result, some of the facts to which the “China box” briefly refers – and verified by outside sources – have since been muted or even removed from the official WHO record.  

Examples include: the circumstances around the initial SARS-Cov2 genome sequencing; WHO statements downplaying the possibility of human-to-human virus transmission in connection with the first reported cases in Wuhan; and the first case reported outside of China in Thailand on 13 January- in someone with no link to the Wuhan seafood market – providing evidence of human to human transmission. Here below are the details of the “China box” account of events – and the revisions the record has since undergone: 

First Case Reports  & WHO Statement on “No Evidence” Of Human to Human Transmission 

The China box states that “As of 3 January, 2020 China had reached 44 cases, including 11 with severe systems; the Wuhan City Health Committee confirmed that 121 close contacts were under observation. WHO was told that there was no evidence of human to human transmission.” 

Indeed, WHO repeatedly referred to the lack of any evidence, or any clear evidence, of human-to-human transmission in the first three weeks of January, at WHO press conferences as well as in tweets, such as one on January 12. Only in the latter part of January, shortly before declaring a public health emergency of international concern, did WHO finally begin to concede that human to human transmission was occurring. The “China Box” narrative refers bluntly to this “inconvenient” fact of WHO’s earlier communications which downplayed transmission risks – communications that are now muted in the official WHO account. 

WHO Timeline Revisions: WHO “updates” of the pandemic timeline, in April, June and December, omit reference to WHO’s initial dismissals of human to human transmission risks. The latest WHO timeline, updated on 15 December 2020, begins the narrative on the transmission risks with a tweet from 19 January 2020, by WHO’s Western Pacific Regional Office, stating; “According to the latest information received and @WHO analysis, there is evidence of limited human-to-human transmission of #nCOV.”  

A little more than a week later, on 30 January, WHO declared the new coronavirus a public health emergency of international concern. The initial number of cases that had been reported in Wuhan as of 3 January 2020 (44 ill, 11 seriously)-  are not explicitly mentioned in the most recent 15 December timeline update either; the timeline refers simply to a “cluster of cases”. The case numbers are, however, still available online in the 5 January 2020 WHO Disease outbreak news.  

Publication Of the SARS-CoV-2 Genome Sequence

The China Box states: “On 7 January, the causative agent was identified by China as a novel strain of coronavirus and the genetic sequence was quickly made available.”

Early WHO accounts acknowledge that the virus had been isolated in the week of 7 January. A WHO disease outbreak report from 12 January stated: “The Chinese authorities identified a new type of coronavirus (novel coronavirus, nCoV), which was isolated on 7 January 2020.”

A 10 December post on virological.org, by an Australian researcher from the University of Sydney “on behalf of the consortium led by Professor Yong-Zhen Zhang, Fudan University, Shanghai” note that the sequence was available on an open-source data base called GenBank. This is echoed by direct postings from the University of Minnesota’s prestigious Center for Infectious Disease Research and Policy.

However, the fact that the virus sequence had first been posted independently online by a  group of Chinese researchers before it was shared by China officially with WHO on Saturday, 11 January became a subsequent point of political embarrassment. It is among the issues that has been raised by WHO critics, who say that there was intense backroom coordination between WHO and Beijing over the course of the pandemic narrative. 

Either way, the updated WHO timelines contain no reference to any independent sharing of the sequence by researchers in the week of 7 January – and the fact that the virus sequence was already available on an open source database by Friday, 10 January.  

Rather, the official WHO timeline begins with 11 January in one tweet, headlined “Breaking” noting that the virus had been made available to WHO. An earlier WHO report in “Disease Outbreak News, which has since been removed from the record, cites 12 January as the date in which the genetic sequence was officially shared by Chinese government officials.

The fact that the “China box” suggests that the virus was sequenced and publicly available earlier in that week – resurrects a politically sensitive issue that WHO and Beijing would both rather forget. That is the fact that China may have dallied in sharing the vital information with the global body – possibly doing so only after it had been made available ad-hoc by a group of Chinese researchers.   

First Case Report Outside China – Growing Evidence of Human-to-Human Transmission 

The China box states: “The first case outside of China was reported on 13 January in Thailand. There was a link to Wuhan, but not to the market in question, suggesting human-to-human transmission.”

The fact that the Thai case was the first abroad, and it also had no apparent link to the Wuhan seafood market, were both facts widely reported in the media as mounting evidence of the virus spread, and likely human-to-human transmission – including in this paper, which led a story on Wednesday, 15 January, stating “Human Transmission of New Coronavirus May be Occuring.”

Further evidence of human-to human transmission was indeed evident by Wednesday, as second case was reported in Thailand, as well as another infection in Japan – the latter in a man who had never visited the Wuhan seafood market thought to be the center of the outbreak. In addition, a commission of technical experts from Hong Kong, Macao and Taiwan, visited Wuhan on 13-14 January, confirming that they had found two family clusters of the virus, including a spouse who had not visited the market recently. Chinese links to the original Wuhan government report about the experts’ visit, as well as the statement by Wuhan authorities about the woman who may have been infected by her husband, which were linked to the Health Policy Watch story of 15 January, have since been deleted.  

In a WHO press briefing on 14 January, WHO’s Maria Van Kerkhove, admitted that “from the limited information that we have, it is possible that there is limited human-to-human transmission, especially among families who have close contact with one another.

However, the official, updated, WHO timeline account remains silent about the ways in which the Japanese and Thai cases had heightened concerns over human-to-human transmission – and ambivalent about those risks overall. A 14 January tweet by WHO continued to maintain that “Chinese authorities have found no clear evidence of human-to-human transmission of the novel #coronavirus (2019-nCoV) identified in #Wuhan, #China.” 

WHO’s official Disease Outbreak Report, posted 14 January. also maintained that: “To date, China has not reported any cases of infection among healthcare workers or contacts of the cases. Based on the available information there is no clear evidence of human-to-human transmission.” 

That same disease outbreak report also sounded another note of false reassurance, stating that: “No additional cases have been detected since 3 January 2020 in China.” 

Cases Increasing Exponentially & Health Workers Dying 

WHO statements to the contrary – cases were increasing exponentially in Wuhan in that period – but under the international health radar.  

And health workers were falling ill – including the Chinese whistleblower, Li Wenliang, who had alerted colleagues to the new infectious virus in a medical chat group on 30 December 2019, was hospitalized on 13 January, and died February 7.  At the same time in mid-January when WHO Director General was repeatedly praising China for its fast and efficient response, Wenliang and other Chinese doctors trying to get a grip on the emerging virus were being reprimanded and detained by authorities.  

Li Wenliang, doctor at Central Hospital of Wuhan, was one of the 8 people detained by police for spreading “rumors” about the new viral disease – from which he died on 7 February.

Even so, WHO resisted acknowledging the human to human transmission was occurring until a WHO mission visited China in the last part of January. 

On 19 January, WHO’s Western Pacific Regional Office (WPRO), which is responsible for China, tweeted that “there was evidence of limited human to human transmission”

On 21st January WHO/WPRO tweeted that “it is now clear that there is at least some human to human transmission”.

It wasn’t until 22 January that the WHO mission which had rushed to China issued a statement saying that “Data collected through detailed epidemiological investigation and through the deployment of the new test kit nationally suggests that human-to-human transmission is taking place in Wuhan” The WHO Mission added, however, that “more investigation was needed to understand the full extent of transmission of human-to-human transmission.” 

On the same day, WHO’s Second Situation Report on the novel coronavirus, reported a total of 314 cases, of which 270 were in Wuhan, 39 elsewhere in China, and four abroad in Thailand, Japan and South Korea. WHO’s Emergency Committee met and on 23 January failed to agree on declaring a public health emergency of international concern (PHEIC).  

Just one week later on 30 January, the number of confirmed cases globally had increased 25 fold to 7818, including 82 cases in 18 countries outside of China; no one could doubt that human-to-human transmission was occuring. And WHO would finally declare a Public Health Emergency of International Concern, this critical point of human transmission was still up for debate.

China Box Became a Lightning Rod For WHO Political Concerns 

Ultimately, insiders say, the China box became a lightning rod for the full set of WHO political concerns that were weighing down on the document. 

Key WHO China experts also were afraid that geopolitical sensitivities would be aroused by the facts that it cited – which were in the process of being buried by WHO official records, sources say. 

“Kindly pull the document off the web immediately. Consider this an emergency,“ said one internal email, seen by Health Policy Watch. 

One key correction was needed, in fact: unlike the narrative implied by WHO’s initial alert about the outbreak, in its 5 January 2020 “Disease Outbreak News” account, the Chinese authorities had not directly “informed” WHO’s China Country Office on 31 December 2019 about the outbreak; rather WHO learned about it from a Wuhan Municipal Health Commission press release. After the exact circumstances of the first alert were aired widely by media, WHO amended the account in its official timeline. 

But there were yet other, more politically-tinged objections to the text – including objections to a reference that the 13 January report of the infected person in Thailand was “suggesting human-to-human transmission.” While this, too, was widely reported in the media as one of the first examples of human-to-human transmission (the person in question had not been at the Wuhan Seafood Market), the text was perceived as “contradicting” 14 January statements by Director General Dr Tedros Adhanom Ghebreyesus downplaying the risks, the team was told.   

The fact that official WHO statements downplayed the human-to-human transmission risk in that period is very clear, as described in the official outbreak news reports and Twitter chains cited here. The record of Dr Tedros’s own statements is more elusive. A google search turned up a single tweet by @DrTedros on 5 January acknowledging the outbreak and noting WHO was in contact with Chinese authorities; another tweet 20 January announces the IHR Emergency Committee’s meeting. Dr Tedros’ first official statement on the WHO record about the novel coronavirus dates to 22 January, 2020, when he convened the IHR Emergency Committee. 

Text Revisions lead to Report Suppression 

Whether the issues raised by the China box touched on facts, political sensitivities – or a combination of both – the report’s lead coordinator, Francesco Zambon, based in WHO’s Venice Office, was asked to make textual revisions – and told he should also talk to the WHO Legal Department. In fact, it is WHO Legal – and not only the scientists – who have a final word on the elements of the coronavirus narrative that are published in WHO’s name – and those that are muted or ignored.  

Rather than see the objections proliferate further, the report’s lead author, Wim Van Lerberghe, who was focused on portraying the account in Italy and not in China, quickly offered to remove the sensitive box from the document altogether. Zambon and the writing team, at the WHO Venice Office, which was in charge of the publication, agreed. 

The team was particularly eager to resolve the issues over China – insofar as these were coming on top of objections raised by WHO’s Assistant Director General Ranieri Guerra, a former Italian Ministry of Health official, to the detailed Italy narrative that was the heart of the report.

Guerra, according to the emails and testimonies reported by Health Policy Watch on 15 December, wanted to remove or tone down phrases in the report that he perceived as shedding negative light on the Italian government response or even, as insiders say, on him personally. Notably, the record shows that Guerra wanted to amend a reference in the report to Italy’s national pandemic preparedness plan, so as to suggest that the 2006 plan had been updated in 2016 – when in fact it had not been. In this same period he was in charge of the Ministry’s   prevention initiatives  -which should have included updating the decade-old plan.  

On 14 May, the day after the report’s publication, it was removed from the WHO website – so that an amended version without the China box could be uploaded again – a process that was supposed to happen the same day. 

But the report on Italy’s pandemic response – An Unprecedented Challenge – never was republished.  

WHO’s official response 14 December states that: “Following publication, factual inaccuracies were found in the text and the WHO Regional Office for Europe removed the document from the website, with the intent to correct errors and republish it. 

“By the time corrections were made, WHO had established a new global mechanism – called the “Intra-action Review” – as a standard tool for countries to evaluate their responses and share lessons learned. The original document (“An unprecedented challenge”) was therefore never republished.”

In fact, the corrections to the China box were only supposed to take a couple of hours; the WHO Intra-action review process guidance to countries for conducting their own pandemic response reviews, was published over two months later – on 23 July, 2020.  

Asked on by Health Policy Watch to explain what factual inaccuracies at stake, a WHO spokesperson declined to comment, saying, “We are not going to discuss factual inaccuracies.” 

WHO Responds To China Box Story

In a response following the publication of this article, a WHO spokesperson provided Health Policy Watch with the following clarifications about the issues surrounding the China box controversy, and the WHO narrative around the early days of the outbreak:

“Regarding the issue itself of China box: The Italy report was removed to address concerns expressed by WHO’s China country office about ‘Box 1: How it started.’

“The report was never re-published, however, upon the decision of the WHO Regional Office for Europe for reasons unrelated to the China box. There are several inaccuracies in the China box in relation to the reporting of the outbreak and the characterization of human to human transmission:

“Having made a request to the authorities on 1 January 2020, WHO’s China country office received information on the cluster of cases of ‘viral pneumonia of unknown cause’ identified in Wuhan directly from Chinese officials on 3 January 2020 – not 31 December 2019 as the ‘How it started’ box says.

“WHO did learn of the outbreak on 31 December 2019 through its monitoring in two ways. Its Country Office in China picked up a media statement by the Wuhan Municipal Health Commission. WHO’s Epidemic Intelligence from Open Sources (EIOS) platform also picked up a media report on ProMED (a programme of the International Society for Infectious Diseases).

“The box says that “WHO was told that there was no evidence of human-to-human transmission” but our Disease Outbreak News from 5 January importantly nuances this statement with the word ‘significant’: ‘Based on the preliminary information from the Chinese investigation team, no evidence of significant human-to-human transmission and no health care worker infections have been reported.’

The box surfaces human-to-human transmission (H2H) as an issue but does not reference relevant and important WHO documents and statements from January, including:

  • 10 January: Guidance on infection prevention and control
  • 14 January: Press conference, which recognised H2H as a possibility; WHO tweet that preliminary investigations by the Chinese authorities had found “no clear evidence of human-to-human transmission”; WHO’s own risk assessment saying that additional investigation was needed into H2H.
  • 19 Jan: WHO Western Pacific Regional Office tweet that there was evidence of limited H2H.

WHO continues to refine the timeline of its activities from Day 1 of the outbreak. The interactive and text timelines are regularly updated to add recent activities and also amend earlier listings. We aim to state clearly when we have made a material change in a timeline.

The interactive timeline remains our main reference piece.”

________________________________________________

-Updated 29 December 2020

Third in a series. First two stories include: 

World Health Organization’s Censorship Of Report On Italy’s Pandemic Response Sets Dangerous International Precedent – Critics Say  

WHO Playbook For Responses To Media Queries On Suppressed Italian COVID-19 Report – Raises More Questions than Answers 

 

Image Credits: Flickr/Nicolò Lazzati, China News Service／中国新闻网, An unprecedented challenge, WHO 2020, Nandu News.

 

Kelly Chibale in the H3D laboratory in Cape Town

CAPE TOWN – A new antiretroviral drug was supposed to be a game-changer for South Africa, which has one of the largest HIV-positive populations in the world. The drug, dolutegravir, was cheap, had few side effects, and – most importantly – it suppressed the virus quickly.

But after a few months on the treatment, many African women began experiencing significant weight gain. A clinical study published in The Lancet in October this year showed that one in five were clinically obese after 96 weeks of treatment, running the risk of cardiovascular problems and diabetes.

These unexpected side effects were in patients that had been excluded from the initial clinical trials, as historically, medicines have been optimised for people in the Global North.

To address this bias and improve the treatment outcomes for millions of African people, Professor Kelly Chibale, founder and director of the Holistic Drug Discovery and Development (H3D) Centre at the University of Cape Town (UCT) in South Africa, is turning his attention to how African populations metabolize drugs.

Dosing regimens are optimised for Caucasians

One of the things Chibale is doing is ‘collecting’ livers. Specifically, he is assessing the livers of African patients for the African Liver Project, which is investigating the African microbiome – the microorganisms in various parts of the body or the combined genetic material of all the microbes, including bacteria and viruses, that live inside people on his continent.

“Africans account for 15% of the world’s population, and 25% of the global disease burden,” he says. “But they are involved in less than 2% of clinical trials that happen here.”

Dosing regimens – meaning the dosage and the frequency a medicine is taken – are optimized for the populations involved in the trial: typically caucasians.

This is a trend that exists across nearly all medical sciences, from treatment design to vaccine development. Although the COVID-19 crisis that has gripped the whole world has highlighted the need for diversity in clinical trial research, the conversation goes beyond COVID-19 and it is only just beginning. And even as awareness grows, three-quarters of COVID-19 treatment trials still exclude pregnant women.

“African patient responses to the medicines are varied and accompanied by suboptimal treatment outcomes in some instances,” adds Chibale, who is also the Neville Isdell Chair in African-centric Drug Discovery and Development and a professor of organic chemistry at UCT.

One of the reasons for such variable responses is down to genetic polymorphism: genetic differences in the activity of enzymes that metabolize drugs in the liver.

For example, for one of the five drug-metabolizing enzymes there is a variation between Africans and Caucasians in its gene coding. The liver is the major organ where metabolism occurs, and five drug-metabolizing enzymes in the liver are responsible for metabolizing 90% of all medicines.

People are either slow, normal or fast metabolizers. Slow metabolizers have too much of the drug in their system which leads to adverse effects, and likely poor patient adherence.

Ultra-fast metabolizers have suboptimal levels of the drug in their system, which leads to poor efficacy and disease-related morbidity.

In a number of cases where African patients have experienced unexpected side effects, the participants in the drug trials had normal or fast metabolisms, whereas the Africans were slower metabolizers. They experienced more drug toxicity because they were unable to process the drug fast enough.

Look at the drug efavirenz, a first-line treatment for HIV/AIDS, for example. Its main route of metabolism involves the cytochrome P450 2B6 (CYP2B6) enzyme. Mutations of this enzyme may lead to reduced metabolism leading to higher efavirenz exposures. These CYP2B6 mutations are more common in patients with African heritage.

“One way to address these variations is to have more clinical trials in Africa. Our people have to understand that taking part in clinical trials will help them,” Chibale rationalises. “It is a necessary sacrifice to be part of the solution. The safety of the medicines we take has been established because someone else sacrificed and took part in a clinical trial.”

Creating a liver ‘bank’

Kelly Chibale in the H3D laboratory in Cape Town

Chibale’s solution is to do more pre-clinical work even before getting to the clinical trials.

“In the past, 40% of the failures in clinical trials were due to suboptimal drug metabolism and pharmacokinetics, which is basically what the body does to the medicine,” he says.

“This was until the pharmaceutical industry realised that we needed to front-load drug metabolism and pharmacokinetics pre-clinical studies much earlier on, to gain an understanding of what the human body is likely to do to a drug,” says Chibale.

‘Front-loading’ involves incubating potential drugs with liver fractions that contain drug-metabolising enzymes. Researchers are then able to examine how human livers process the drugs. By the time drugs get to human trials, scientists are able to make much better predictions about what doses to use.

This is done in conjunction with laboratory test-tube testing the drug, then ethically on animals like rodents and non-human primates to understand its efficacy and safety.

Chibale aims to refine this further, developing tools that will help to identify which drugs are more likely to perform well in African patients, predict what the optimal human dose is likely to be in specific African populations, provide useful data for targeted clinical trial design and eventually for the establishment of better-directed dosing regimens.

The African Liver Project objectives include creating a unique and novel biobank of well-characterised African human liver tissue, generating liver cells (known as hepatocytes) and subcellular liver fractions, and investigating the metabolism of study drugs across different tissue in matching African populations in the same way as has been done for the Caucasian derived human livers and tissue.

This would create a platform for hypothesis testing before clinical trials are carried out.

The proposed in vitro (test tube) experiments would be cheaper to design and perform to get data that can be extrapolated to pharmacokinetics in humans using mathematical models.

To do this, the H3D team needs to get access to diverse African livers to see how their drug-metabolising enzymes work – but most of the liver fractions available have been donated by Caucasians in the Global North and need to be bought for large amounts of money from Western companies.

To address the lack of African liver fractions, the H3D Centre has formed a partnership with the UCT Liver Transplant Centre and has ethical approval to process African human liver tissue from discarded or diseased livers, and examine how the drug-metabolising enzymes present in the liver fractions process drugs.

But Chibale would love to have similar arrangements with liver transplant centres throughout the continent to increase the samples from which to derive robust data and because there are many genetic differences between populations on the continent.

“To do this at scale, we need more transplant hospitals in South Africa and other regions of Africa to collect enough samples. Then, with enough African-derived human liver tissue samples collected, we want to then start generating metabolism data, starting with existing medicines for any disease, whether it’s diabetes or cancer,” says Chibale.

“You know why? Because then this data can help any company really look at their own medicine that they’ve been giving out to African patients, and reformulate it in terms of the right dose,” says Chibale.

Studying the effects of antibiotics 

But drug-metabolising enzymes aren’t the only factors in determining how patients process drugs. Research has shown that the microorganisms that live in the body, including bacteria, viruses and fungi – known as the microbiome – are also important.

“Literally in the last decade, there has been an accumulation of evidence of the involvement of the gut microbiome in the metabolism of medicines, including having an impact on what happens in the liver,” says Chibale. “This means if we just optimise medicine for liver metabolism, we will not necessarily get it right. Why the microbiome is so important is, first of all, clearly genetic differences and there is overwhelming evidence of this.”

H3D’s more recent initiative, the African Gut Microbiome project, is aimed at investigating the impact of microorganisms found in various parts of the body on the metabolising of drugs. It is also aimed at studying the effect of antibiotics on the gut microbiome and the resultant changes in drug metabolism of a range of commonly used medicines.

The idea is that these initial in vivo (human) studies will inform subsequent studies around the African gut microbiome, with the goal of establishing relevant preclinical research tools that mimic those aspects of Africa-specific microbiomes that are involved in variable drug responses.

But socio-economic and physical environments in which patients live also affect how a patient can process drugs. The diet of a person has a major role to play in how the body functions, while the physical environment affects a person’s resilience.

Chibale’s centre is unique in that it is based at a university rather than being a stand-alone company or being part of a drug company. He hopes it can become an example for other parts of the world, such as South America.

Funding comes from a variety of sources from the South African government to philanthropic organisations and innovative pharmaceutical companies.

H3D has the strategic advantage for developing Africa-specific pharmaceutical research tools because of its location on the African continent providing easy access to African patients and researchers who are interested in addressing global health and health inequality issues.

Chibale has built a network of collaboration involving the chemistry, biology and pharmacology departments at the university, and has an 80-person staff, that includes post-doctoral scientists and students from all over the world.

It’s been a long journey for Chibale from a village in northern Zambia and townships in the Zambian Copperbelt, to a PhD at Cambridge University, then research positions at Liverpool University and the Scripps Research Institute in San Diego. For the past 24 years, he has been in Cape Town with his wife and three sons.

Always up for new lessons, Chibale confides that he has recently joined Twitter and realised that he needs to be part of the push-back against misinformation.

“Life is about taking risks and sacrifice. We can never achieve anything if we live in fear. Look what the world has been able to achieve in the face of COVID-19, a vaccine in an unprecedented time,” he says.

Image Credits: Kerry Cullinan.

Health workers in full protective gear do a COVID-19 throat swab in a Addis Ababa isolation centre.

Cape Town – As South Africa records over 930,000 COVID-19 cases and its scientists race to understand whether a new variant is driving the country’s second wave of infections, countries across the African continent are reporting an increase in cases.

But there is widespread anecdotal evidence that many African countries are massively  under-reporting their COVID-19 caseloads, primarily because not enough tests are being performed. The threat is that this is giving citizens a false sense of complacency.

According to the latest report from Africa Centers for Disease Control and Prevention (CDC), the countries with the highest caseloads on the continent are South Africa, Morocco, Egypt, Tunisia and Ethiopia, with Libya and Kenya not far behind. Nigeria, Zambia and the Democratic Republic of Congo are also reporting rising infections.

Since late October, the Africa CDC has been warning the continent to prepare for this scenario. And In the light of the new, potentially more infectious variant identified in South Africa, the CDC urged African countries “not to relent in their efforts to step up testing, contact tracing and early treatment of cases”.

Denial Across the Continent

But few countries have ramped up testing. In fact, many have even seen non-clinical prevention measures flaunted.

Large election rallies in Ghana, Tanzania and Uganda have seen large crowds of people in very close proximity without masks.

People fail to wear masks at election rallies in Uganda.

Tanzania is perhaps the most extreme example of COVID-denialism. President John Magafuli replaced 3 of the country’s top health officials in April and simply stopped reporting cases to the World Health Organisation (WHO) from 29 April.

In May, he said that imported coronavirus tests were faulty after claiming several non-human samples – including from goats and papayas – tested positive.

“We should not accept that every aid is meant to be good for this nation,” he said at the time.

The following month, he declared the country COVID-free thanks to the prayers of citizens, praising them for not wearing masks.

Tanzania stopped reporting its COVID-19 cases to the WHO in April.

 

Since this declaration Tanzanian truck drivers, who are required to provide negative tests before entering neighbouring countries, have tested positive.

Health sources inside the country claim that it is impossible for anyone to receive a positive coronavirus test result as the government has taken control of testing at all private laboratories: only negative test results are being released to patients.

“Even travellers who need a test only get it back if it is negative, otherwise their test never comes back,” a source told Health Policy Watch.

In July, Kwanza TV was taken off air for 11 months for an “unpatriotic” post on Instagram: a message from the US embassy in Tanzania warning of “elevated risk” of community transmission in the country.

East Africa – Limited Capacities and Public Complacency

Meanwhile, in Kampala, Uganda, a doctor working in a busy hospital told Health Policy Watch that “all the hospitals are full and there are many respiratory-related cases” but that COVID-19 surveillance was low, in large part due to difficulties with the tests.

“The results come back late, and the patient might have already passed away, or the lab doesn’t send the results at all,” he said, adding that people were only able to get COVID-19 tests in Kampala or at major regional hospitals. “We are also under pressure not to put COVID-19 on the death certificate.”

Ghanaian President Nana Akufo-Addo has closed the country’s land and sea borders, and confirmed that beaches and pubs will remain closed during the festive period.

Last week, Zambia’s President Edgar Lunga raised concern about “a generalised spread of COVID-19” in North-Western, Muchinga, Copperbelt, Central, Lusaka and Southern provinces.

Zambian Ministry of Health Permanent Secretary Kennedy Malama has cautioned that the country is still at risk of a second wave. Cases in Zambia continue rising, especially in patients with HIV and other non-communicable diseases such as diabetes.  

But Zambia’s National Director for Infectious Diseases, Dr Lloyd Mulenga, said that his country has managed the pandemic  “pretty well” with the help of cooperating partners like the Africa CDC, which had helped to address shortages of health workers and in Personal Protection Equipment (PPE) for health workers.

Zambia closed four of its isolation centers in various parts of the country in October because not enough patients required the services.

However, a medical doctor at Levy Mwanawasa Teaching Hospital, one of the 12 isolation centers, warns of a likelihood of a spike in infections as people relax their adherence to safety measures.

Zambia’s official COVID-19 cases.

He is also wary of the health ministry’s weekly COVID-19 statistics, claiming that these  under-represent the number of people infected with the virus and deaths due to COVID-19, which is making people complacent.

He believes that the recorded number of infections is small – 18,716 cases by 21 December – because the testing sample size is small. Usually, there are around 5,000 to 6,000 tests performed daily in Zambia.

“And yet in July, we were told the country could test up to 12,000 people a day. Why are we not doing it? We do not have sufficient test kits,” he said.

He worries that untested and unconfirmed infections could raise the rate of disease and fatalities in a susceptible population. That wards and health facilities have not been oversubscribed is not an indication that there are few COVID-19 infections, he says.

“Going by [government] statistics, there are 366 deaths recorded. Of those, 283 were brought in dead. This figure tells you that there are uncaptured infections in the community.” 

While there are several reasons people do not seek medical attention in health facilities, there is insufficient testing conducted in communities, he says. The government cannot reasonably say it is managing the crisis.

Another medical officer who worked in an isolation center and was part of the public testing campaign in the initial phase of the pandemic, told Health Policy Watch that  said the Ministry of Health was advised to stop random testing in communities because of a shortage of test kits. 

“Now we only test people coming to health posts presenting with one or more of COVID -19 symptoms, and those who are travelling abroad. This leaves out the huge segment of the population who do not, as a matter of course, seek medical attention when they are sick and are not going out of the country,” he said.

West Africa – Test Shortages and High Positivity Rates Among Youth

While Nigeria is the most populous country on the continent, it has the ninth highest number of cases of COVID-19 on the continent and has only conducted the sixth-highest number of COVID tests in Africa.

Nigeria’s daily new confirmed COVID-19 cases per million people have been rising steadily since 2 December but there are indications that there are more cases than are being reported. 

By 19 September, Oyo state had the third-highest number of confirmed cases of COVID-19 in Nigeria, but health officials attribute this to a community testing exercise. 

Kemi Ayoola, a medical scientist with the Oyo state ministry of health, said that during this time, she and her team were involved in community testing exercises in densely concentrated areas of the state.

“We would go to a community, announce that there was free testing and people would show up. During the period, we were seeing lots of cases. But when we stopped, the number of cases drastically dropped,” Ayoola told Health Policy Watch.

COVID-19 cases also emerged when young men were tested before being admitted to camps for the mandatory National Youth Service Corps (NYSC) service.

The Director of the Nigeria Center for Disease Control (NCDC), Dr Chikwe Ihekweazu, said that 138 out of a total of 34,785 corps members tested positive, representing a prevalence of 0.4%.

“It means one out of 200 people,” Ihekweazu said. For a population of 200 million, that could mean about 800,000 cases.

Officials at the NCDC told Health Policy Watch that testing with the recently approved antigen-based rapid diagnostic testing kit for SARS-CoV-2 would improve access to testing and is likely to further increase the number of confirmed cases.

The NCDC reported a “sharp increase” in cases between 30 November and 6 December, with almost three-quarters of those new infections found in Lagos, Kaduna and the Federal Capital Territory. Lagos has closed schools and banned large gatherings including concerts and carnivals over the festive season.

Boss Mustapha, chairperson of the Nigerian Presidential Task Force (PTF) on COVID-19, warned last Thursday that these indications seemed to spell a second wave.

“We are in a potentially difficult phase of the COVID-19 resurgence. Accessing the hope offered by the arrival of the vaccine is still some time ahead,” Mustapha said.​​​​​​​ 

Nigerian Health Minister Osagie Ehanire had earlier announced that the government would receive 20 million doses of a COVID-19 vaccine by January 2021.

PPE Shortages

After an 8-month stand-off with the government, the 7,000-strong Kenya Medical Practitioners, Pharmacists and Dentists Union (KMPDU) began striking from Monday in protest against pay problems and a shortage of PPE for health workers.

After months of negotiating, Kenyan health workers went on strike this week.

Health workers in Uganda have also reported chronic shortages of PPE in hospitals receiving COVID-19 patients – with doctors and nurses having to purchase their own masks and gloves. 

While teams undertaking the testing may be specially equipped with PPE, other doctors and health workers treating suspected COVID-19 patients often only have masks and gloves, and suspected COVID-19 patients remain in regular wards until their tests are confirmed.   

In Nigeria,  frontline health workers also embarked on a strike action to protest shortages in PPE, but this has been addressed by the local production of PPE.

In North Africa – Egypt To Be First Country Rolling Out Vaccines

Meanwhile, cases in Tunisia and Morocco peaked in November and are starting to reduce but Egypt’s caseload is rising again. However, Egypt has received a batch of doses of a Chinese COVID-19 vaccine, clinical trials for which were conducted in Egypt, and the country is now due to roll out vaccinations in early January, starting with health workers and people with chronic conditions.

Many other African countries are likely to have to wait a lot longer to get access to a vaccine and face increasing sickness and economic hardship as they do.

Image Credits: WHO, © WHO/Otto B..

Development workers hand over relief aid to a woman amid the COVID-19 pandemic at Madartek area in Bashabo of Dhaka.

Nearly all countries’ development rankings have been shaken up, following the addition of new climate and environmental metrics in a UN global index designed to measure human progress, with the greatest decline in ranking position occurring among high income and developed countries.

The 2020 Human Development Report, published by the United Nations Development Programme (UNDP), details the myriad of challenges posed by climate change and poverty, which have been exacerbated by the ongoing pandemic.

But it also includes a new generation of human development metrics to reflect countries’ progress in lowering climate emissions and making more efficient use of natural resources, in what UNDP describes as an attempt to better visualise and measure the effectiveness of countries’ climate and environmental policies.

The two new metrics – measuring national carbon dioxide emissions and material footprint, per capita – have been added to UNDP’s Human Development Index (HDI), as part of its ‘planetary pressures’ adjustments.

The HDI is a system used to assess the multiple dimensions of the development of a country, including health, education, and standard of living. The Index ranks countries by how they expand people’s freedoms and opportunities.

With the HDI’s adjustments in place, more than 50 developed countries fall from a very high human development ranking to much lower ones due to their high dependence on fossil fuels and their raw material consumption.

The adjustment to standard Human Development Index values by the Planetary pressures–adjusted Human Development Index widens as human development levels increase.

The top ten countries that fared poorly under the adjusted index are: Luxembourg (falling the furthest, dropping 131 places), Singapore, the United Arab Emirates, Qatar, Kuwait, Australia, Brunei Darussalam, Kazakhstan, the United States, and Canada. 

Luxembourg, the country with the highest energy consumption per capita and lowest share of renewable energy consumption in Europe, has an enormous ecological footprint, causing it to fall from position 23 to 154. The economies of the Gulf states rely heavily on hydrocarbon revenues and environmentally unsustainable industries, prompting many of them to drop over 70 places. The United States dropped 45 places on the ranking, from position 17 to 62, which reflects its outsized environmental impact. Additionally, Norway, which has led the HDI rankings for 3 decades, fell 15 places to position 16 due to its oil-fueled economy. 

In contrast, several countries – including Costa Rica, Moldova, and Panama – rose on the ranking by at least 30 places. Countries that crossed the threshold from the high to very high development category, included Sri Lanka, Cuba, Albania, Armenia, and Colombia.

Among countries with very high development levels, Argentina rose 20 places, France’s ranking inceased by 16, the UK rose 10 places, and New Zealand moved upwards by 6 places.

The rise in temperatures, sea levels, epidemics, extreme weather events, and forest fires are expected to result from anthropogenic climate change.

“This is the reality of the Anthropocene, the age of humans, as we refer to it. And in it, humanity is, in a way, waging a war against itself,” said Achim Steiner, UNDP Administrator, at a WHO press briefing on Monday.

The report also found that global emissions and material footprint per capita have been increasing consistently for the last 30 years: the amount of time since the first Human Development Report was published. No country has achieved very high human development without placing a heavy toll on the planet’s health.

Environmental damage is highly correlated with wealth and power, as the world’s 10 largest emitters account for 45% of total global emissions, while the bottom 50% account for only 13%. The wealthiest 1% of individuals worldwide emit 100 times as much carbon dioxide annually as the poorest 50%.

“Inequality is both a cause and a consequence of planetary imbalances and it stands in the way of solutions,” said Steiner.

Redefining the Anthropocene

“As the Human Development Report makes clear, COVID-19 is the latest in a string of consequences resulting from the ever growing pressures we put on the planet in the name of progress,” Steiner warned on Monday.

The COVID-19 pandemic has triggered a social and economic development crisis, destroying livelihoods, disrupting health systems, and barring millions of children from classrooms, indicating that – for the first time in 30 years – global human development progress is going backwards.

The COVID-19 pandemic’s unprecedented shock to human development.

By UNDP’s estimate, 1 billion people could be living in extreme poverty by the end of the decade, with potentially a quarter of them pushed into poverty as a consequence of the pandemic.

The COVID-19 pandemic is linked to anthropogenic environmental changes and rising temperatures, which contribute to increasing zoonotic diseases, caused by pathogens that jump from animals to humans.

Additionally, changes in the number of extreme temperature days, which result from climate change, will worsen inequalities in human development and social vulnerability, the report says.

Projections estimate that by the turn of the century, the poorest countries in the world could experience up to 100 more days of extreme weather each year.

Achim Steiner, Administrator of UNDP, at the WHO press briefing on Monday.

“Humans wield more power over the planet than ever before. In the wake of COVID-19, record-breaking temperatures and spiralling inequality, it is time to use that power to redefine what we mean by progress, where our carbon and consumption footprints are no longer hidden,” said Steiner in a press release.

Redesigning the path to human progress begins with ensuring the equitable, efficient, and trusted delivery of COVID-19 vaccines to all countries regardless of income or development levels, the report stated.

Change Requires Incentive

The Human Development Report called for transformations in the way individuals, governments, and organizations live, work, and cooperate by influencing social norms, improving incentives for change.

For example, cumulative global investment in low-carbon power is estimated to total about US$16 trillion between 2020 and 2040. To reach net-zero emissions by 2050 would require at least an additional US$11 trillion, however.

“Such shifts call for a wide range of changes in incentives, with governments playing a key role,” the report noted. “But [these shifts] can also emerge as a result of pressure from the investors who entrust their savings to financial firms.”

Steiner said: “This is the ultimate stress for planetary health: delivering the largest public health intervention of a lifetime and driving in a concurrent way the recovery in an inclusive and green direction.”

“The next frontier for human development is not about choosing between people or trees; it’s about recognizing, today, that human progress driven by unequal, carbon-intensive growth has run its course,” said Pedro Conceição, Director of UNDP’s Human Development Report Office.

“By tackling inequality, capitalizing on innovation and working with nature, human development could take a transformational step forward to support societies and the planet together,” he added.

Image Credits: Flickr – UN Women Asia and the Pacific, UNDP, UNDP, WHO.

The Pfizer-BioNTech COVID-19 vaccine during the manufacturing process.

The European Medicines Agency (EMA) announced on Monday that it would recommend conditional marketing authorization for the Pfizer/BioNTech COVID-19 vaccine – positioning Europe to finally begin rolling out vaccines across the continent – albeit after the United States, Canada, the United Kingdom and Israel have already moved into high gear vaccine campaigns.  

Mass vaccinations were set to begin next week in a number of countries across Europe – following the expected European Commission approval of the EMA recommendation later this week. Germany, France, Austria and Italy all said that they planned to start vaccination programmes for their most vulnerable groups beginning on Sunday 27 December.

The EMA move was preceded by Swiss approval of the Pfizer vaccine on Saturday; like the EMA, the Swiss approval came earlier than previously expected. Mass vaccine campaigns of vulnerable, priority groups, will begin in Swizerland on 4 January, 2021, Swiss health authorities said. However, a spokesperson declined to provide details on the planned pace of vaccinations – saying only that Swiss authorities hope to immunize most of those who want the vaccine “by summer.” 

Emer Cooke, Executive Director of the European Medicines Agency.

Originally set to meet on vaccine approvals in January, the high rates of infection coupled by the fast pace of rollouts occurring elsewhere – apparently inspired both the EMA and the independent Swissmedic regulatory agency to act earlier – although not with undue haste, an EMA official was careful to point out.  

“Our thorough evaluation means that we can confidently assure EU citizens of the safety and efficacy of this vaccine and that it meets necessary quality standards,” said Emer Cooke, the newly appointed Executive Director of EMA – who only recently left the World Health Organization to assume the post. 

The Swiss approval also marked the first time that a COVID-19 vaccine had received a standard regulatory authorization.  Since Switzerland has no emergency use or conditional approval process the normal process was the only one that could be followed – observers explained. 

Vaccine Rollouts – Race Against Mounting Infections  

The authorizations and vaccine rollouts coincide with mounting levels of infections and death rates in many parts of Europe, despite successful infection control campaigns over the spring and summer.  Concerns have now risen further with the discovery of a new, and more contagious variant of SARS-CoV2 in Britain, South Africa, leading to travel bans and flight cancellations  (See related story).  

It is still too soon to know if the vaccines being rolled out now will be as effective against the new coronavirus variant as they have proven to be against those prevalent until now.  But experts are hopeful that the recently-approved vaccines will meet the test.  

“We don’t yet have evidence with respect to the new strain, whether it is susceptible to the antibodies generated by the vaccine,” said Cooke at the EMA press briefing. 

“However, we have quite broad knowledge around the fact that this vaccine is capable of generating neutralizing antibodies that can neutralize the different variants with mutation within the receptor binding domain, which is the key area for attachment to the cells in the human body. 

“So we think that, even if we don’t yet have full confirmation, it is very likely that the vaccine will retain protection, also against this new variant.”

“In principle, what would scare us would be if we see multiple mutations, particularly on this spike protein and on the receptor binding domain that will really alter the antigenic profile of the virus with respect to these vaccines and render them incapable of neutralizing the virus,” said Marco Cavaleri, Head of Anti-infectives and Vaccines, Scientific and Regulatory Management Department at EMA. 

3D print of a spike protein on the surface of SARS-CoV-2, enabling the virus to enter and infect human cells.

“We will need to see the virus changing quite substantially before we can really be in a situation to see…think [about] whether the vaccine has to be somehow rebuilt, incorporating new emerging strains. So, for the time being, we are not too worried.”

Next In Line – Moderna Vaccine  

The EMA is planning on announce its recommendations on a second vaccine, produced by Moderna, on January 6. 

Meanwhile, in the United States,  transportation and delivery of the Moderna vaccine to hospitals and health centres had already begun following its emergency use authorization by the US Food and Drug Administration (FDA) on Friday. 

“With the availability of two vaccines now for the prevention of COVID-19, the FDA has taken another crucial step in the fight against this global pandemic that is causing vast numbers of hospitalizations and deaths in the United States each day,” said Stephen Hahn, US FDA Commissioner, in a press release.

The US Department of Health and Human Services has purchased 200 million doses of the Moderna COVID-19 vaccine, which will provide for continuous delivery of the vaccine through the end of June 2021.  The vaccine, based on the same mRNA delivery technology as the Pfizer vaccine is less temperature sensitive – it can remain stable for long periods at temperatures of -2 -8 C as compared to Pfizer’s -70 C storage requirement. 

Israel’s Prime Minister – First Head of State Immunized in COVID-19 Vaccine Rollout

Meanwhile, while the United States has seen Vice President Mike Pence immunized as well as President-elect Joe Biden, Israeli Prime Minister Benjamin Netanyahu was likely the first serving head of state to publicly receive an approved Pfizer-BioNTech vaccine jab in a televised broadcast Saturday night.

Israeli Prime Minister Benjamin Netanyahu receiving the Pfizer-BioNTech vaccine on Saturday.

“I asked to be vaccinated first, together with Health Minister Yuli Edelstein [Minister of Health], to serve as personal examples and encourage you to be vaccinated,” said Netanyahu. “It’s one small shot for a person and one big step for everyone’s health.”

Netanyahu – with his government crumbling and personally under assault from both the left as well as the right –  has sought to take credit for procuring enough doses of the Pfizer and Moderna vaccines to immunize almost all of Israel’s 9 million citizens.  

The Ministry of Health announced that the vaccine operation would rollout in stages, beginning with health care workers, high risk populations, and those of 60 years of age. According to preliminary reports, approximately 10,000 medical staff members were vaccinated on Sunday. 

“I am pleased to announce that on the first day of Operation ‘Latet Katef [to give a shoulder]’ there is an excellent response by medical staff throughout the country and that starting yesterday afternoon, public pressure to get vaccinated was sensed,” said Hezi Levy, Director General of the Ministry of Health. “We will vaccinate everyone…the Operation progresses on the move.”

The campaign received immediate uptake with appointment hotlines crashing as Israelis clamored to set appointments to be vaccinated. While limited right now to health workers and people over the age of 60, the gates will be opened to everyone over the age of 16 within a couple of weeks.  The rapid timetable set by the government should see some 60,000 Israelis vaccinated a day for coming months – with the hopes of reaching herd immunity of 60% immunized by spring. 

What was less clear, however, was the timetable for vaccinating some 3.5 million Palestinians in the West Bank and Gaza – who are not members of the Israeli health funds that are running the vaccine campaigns. 

In addition, the nearly 2 million Palestinians living in the Hamas-controlled Gaza Strip have  been subject to a longstanding Israeli boycott, making the transport of temperature sensitive vaccines in and out of the Gaza strip even more challenging than usual. 

And even in the more affluent Palestinian West Bank – home to some 3 million Palestinians – there is reportedly only one vaccine refrigerator capable of managing the ultra-cold storage required for the Pfizer vaccine.  

Dr. Ali Abed Rabbo, a senior Palestinian health official, told media that Palestinian Authority will rely largely upon the WHO- supported COVAX global procurement initiative to eventually get vaccines to their communities – which are currently under lockdown due to high COVID-19  infection rates.   Through COVAX, WHO hopes to distribute vaccines to some 10-20% of people in low- and middle-income countries, beginning in the first quarter of 2021.  

At the same time, Israeli Deputy Health Minister Yoav Kisch told the local Kan Radio station that Israel might consider allocating some of its vaccine supply to the Palestinian areas – if sufficient quantities are available after most of Israel’s nine million citizens are vaccinated – a population that includes some 20% Arab Muslim, Christian and Druse minorities.

“Should we see that Israel’s demands have been met and we have additional capability, we will certainly consider helping the Palestinian Authority,” he told Israel’s Kan Radio station. 

Like many other things in the Israeli-Palestinian conflict, the vaccine issue casts into sharp  relief the broader and more global distributional divide between high income and lower or middle income countries vis a vis vaccines – in a particularly up-close way. 

It also illustrates, however, how vaccine sharing may also be, ultimately, in self- interest of higher-income countries – including communities in conflict zones. Since Israeli settlers are scattered across the occupied West Bank, while tens of thousands of Palestinians work in settler-owned enterprises or in Israel proper – in the absence of vaccine sharing with the Palestinians, the goal of herd immunity will be that much harder for Israel to attain.   

 

Image Credits: European Commission, Pfizer, European Medicines Agency, Flickr – NIAID, Youtube – Israeli PM.


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The UK has backtracked on its easing of holiday restrictions, joining a number of European countries spending the season in near-lockdowns. Travel restrictions imposed so close to Christmas are likely to cause upset.

European countries rushed to impose travel bans on UK and South African travellers after both countries reported individual new variants of SARS-CoV-2, thought to be much more infectious than the ones already circulating worldwide.

In the past few days, there have been reports of new variants of the COVID-19 virus in South Africa and the UK, particularly around London. While these variants have developed independently of each other, they are both similar in that they appear to be more transmissible. WHO has reported that the UK’s new variant’s transmissibility is up an estimated increase of between 40% and 70%.

Even so, WHO officials have stressed that there was no evidence that these variants would result in more severe illness or have an impact on vaccine efficacy, during a media briefing on Monday 21 December. The UK reported its variant on 14 December, with South Africa confirming a notable variant was in circulation 4 days later, on 18 December.

Speaking at a press briefing Monday, Dr Maria Van Kerkhove, WHO’s Clinical Lead on COVID-19, said that although the UK had reported in an increase in transmission of this variant from 1.1 to 1.5, scientists “are trying to determine how much of that is associated with the variants itself and how much was related to the behavioural differences in individuals that this variant test affected”.

She added: “The information that we have so far is that there isn’t a change in the clinical presentation or severity from this variant, but again the work is still underway, and they’re looking at a number of factors, including patients who are hospitalised with this variant, as opposed to the wild type.”

The variant identified in South Africa “has one of the same mutations, this 501Y mutation, but it’s a different variant”, she clarified.

“They’ve arisen at the same time so it sounds like they’re linked but this is actually a separate variant,” she said. She confirmed that South Africa is working with WHO ‘s virus evolution group.

Yesterday, WHO Director-General Dr Tedros Adhanom Ghebreyesus said that it is natural for viruses to mutate over time and that the WHO is “working with scientists to understand how these genetic changes affect how the virus behaves”.

“The UK has reported that this new variant transmits more easily but there is no evidence so far that it is more likely to cause severe disease or mortality,” said Dr Tedros. “The bottom line is that we need to suppress transmission of all SARS-COV-2 viruses as quickly as we can. The more we allow it to spread, the more opportunity it has to change.

“I can’t stress enough – to all governments and all people – how important it is to take the necessary precautions to limit transmission right now.”

Dr Tedros Adhanom Ghebreyesus, WHO Director General, at the WHO press briefing on Monday.
New Wave Of Travel Bans Hit Holiday Season

Throughout Europe, countries slapped travel bans on both South Africa and the UK in an effort to head off the spread of the more infectious viral strains – just ahead of the Christmas holidays as well as the pending initiation of mass vaccination campaign.

Ireland, Italy, Switzerland and Belgium banned arrivals from the UK, with France suspending travel for 48 hours. In the latter’s case, this resulted in the closure of the Eurotunnel, which is used by freight lorries. The UK Transport Secretary stated, however, that this would not impact vaccine distribution. Switzerland  has banned arrivals from South Africa while Germany is considering such a ban.

Outside of Europe, Israel was one of the first countries to react to the new virus variant by closing its borders to all foreign nationals who are non-residents, another blow to already muted celebrations of the upcoming holidays in the holy land.

Facing a rapid domestic rise in infections, Israel already had closed its skies to travelers from Britain, Denmark and South Africa yesterday. Now, returning Israelis will also be forced to go into quarantine in designated coronavirus hotels once they arrive.

This mutation could be coronavirus two,” Prime Minister Benjamin Netanyahu told reporters on Monday. “Therefore, I decided last night – and we implemented today – to close the skies of the State of Israel. Foreign nationals will not enter the country, other than exceptions such as diplomats.”

The new orders, coming into effect on the day before Christmas Eve, could have a particular severe impact on Christian communities in Israel and in the Palestinian Authority.

Extended family members living abroad often return to the region via Israel’s Ben Gurion Airport for the holiday season, but many lack the Israeli residency or citizenship documents guaranteeing them entry under the new policies.  It was unclear if returning Palestinians could still enter from Jordan via the West Bank’s Allenby Bridge. The Palestinian Authority has currently placed areas in its jurisdiction under a strict lockdown as a result of soaring Palestinian infection rates.

UK government U-Turns

U-Turns in domestic policies in the UK and other countries were also evidence of the deepening COVID-crisis sweeping Europe.

In the weeks building to Christmas, the UK government, like many of its counterparts on the continent,  had announced an easing of COVID restrictions almost unheard of since March 2020: for a five-day period, up to three households would be able to meet indoors, with permitted travel across the country.

UK Health Secretary Matt Hancock.

On Wednesday 16 December, however – 48 hours after Health Secretary Matt Hancock confirmed the appearance of a more transmissible viral variant in the capital – Prime Minister Boris Johnson was forced to backtrack. But it took him another four days before he  cancelled Christmas easings, by which point cases had risen significantly.

Named ‘VUI (Virus Under Investigation) – 202012/01’, the UK variant had infected more than 1,000 people when Hancock first confirmed the investigation was underway.

Similar lockdowns, restrictions and curfews were introduced across Europe last week, in Germany, France and Greece respectively.

Meanwhile, South Africa – already under curfew with restrictions on beaches, in restaurants and on alcohol sales – announced no new measures.

“It is still very early, but at this stage, the preliminary data suggests that the virus that is now dominating in the second wave is spreading faster than the first wave,” said Professor Salim Abdool Karim, co-chair of South Africa’s Ministerial Advisory Committee on COVID-19.

“We would expect it to be a less severe virus, but we do not have clear evidence at this point. We have not seen any red flags looking at our current death information,” he said. It is not clear if the second wave will have “more or less deaths”.

Karim confirmed that in South Africa, this variation accounts for around 80-90% of cases.

South Africa’s Health Minister Zweli Mhize appealed  to the media and medical and scientific community to “focus on the facts and avoid entering into speculation or issue unproven statements and generate panic and disinformation”.

He provided a stark reminder: “Many countries experienced a second wave that was more severe than the first – even where no mutations were reported.”

Behind the Variants: How Do The Two Differ?

Both virus variations are believed to be similar in that they appear to be transmitting far more rapidly than previous strains, with Karim noting scientists had been surprised by how “this variant has become dominant” in South Africa’s second wave.

The appearance of both at the same time in separate countries, has caused some confusion, however. Despite those similarities, and very similar mutations to the key proteins in the virus, there is little doubt that the two are unique in origin.

The COVID-19 Genomics UK Consortium (COG-UK) identified that the virus contains a substantial number of mutations, including an N501Y mutation existing in the spike protein’s receptor-binding domain. This is also true of the South African strain.

This mutation has created a change at the point at which the spike first contacts our bodies’ cells. A mutation here means the virus is more easily able to enter cells, allowing it to spread more quickly.

A more recent UK study has identified up to 16 additional potential mutations. The most notable here is a “H69-70” spike deletion. The study notes it has “been described in the context of evasion to the human immune response”, noting that it has also occurred a number of times in other variants, like the one discovered in mink populations in November.

WHO: PCR Tests Reportedly Less Effective

Given the relative novelty of the variants, advice provided by WHO is somewhat limited, with the Organization urging countries to be transparent, to share epidemiological, virological and full genome sequence information, to assess levels of local transmission, and to continue taking a risk-based approach.

It did flag a reported loss of performance in PCR assays that target the spike protein, however. If this is the case, a country’s detection capacity could become limited, with potentially severe consequences: all the more concerning as the variant appears to be quickly becoming the dominant strain in regional epidemics.

Laboratories using commercial kits for which the targeted viral genese are not labelled or identified should contact the manufacturer, WHO advised in a statement on Tuesday.

“Laboratories using in-house PCR assays that target the S gene of the virus should also be aware of this potential issue,” it said. “In order to limit the impact on the detection capacities in the countries, an approach using different assays in parallel or multiplex assays targeting different viral genes is also recommended to allow the detection of potential arising variants.”

Image Credits: Nathan Rupert, WHO.

Migrants, who constitute a significant proportion of the global health workforce, struggle to access appropriate healthcare in the midst of the pandemic. Of those surveyed who did not seek healthcare, 35% cited financial constraints and 22% reported fear of deportation.

Despite the “enormous” contributions that migrants have made to society, they still face discrimination, social exclusion, and struggle to access health services even years after migrating, especially during the current pandemic, the first survey ever of migrant health during COVID-19 has found.

The report, which was led by Ghent University and the University of Copenhagen in collaboration with WHO, highlights an urgent need to include refugees and migrants in countries’ COVID-19 response plans, especially in upcoming vaccination campaigns.

WHO director general Dr. Tedros Adhanom Ghebreyesus.

These preliminary findings, based on self-reports of 30,000 refugees and migrants around the world, were published on International Migrants Day, just a week after May Parsons, a Filipina nurse in the UK, was the first to administer a coronavirus vaccine developed by a Turkish couple in Germany: the mRNA-based Pfizer/BioNTech vaccine.

“It is indeed critical that we join forces to ensure that migrants, refugees and asylum seekers internally displaced persons, and in general, people on the move, are not left out of our global efforts to fight back against the COVID-19,” said António Vitorino, director general of International Organization for Migration, at a press conference on Friday.

“I want to take this opportunity to call on governments to count and include all migrants present in their territory, no matter their legal status in their national vaccination plans.”

WHO’s director general Dr. Tedros Adhanom Ghebreyesus added: “Investing in the health of migrants is not just the right thing to do – it also has long term benefits for social cohesion and economic development. Exclusion is costly in the long run, but inclusion pays off for everyone.”

Migrants Contribute To Innovation & Lifesaving Work, But They Lack Access To Basic Services Despite High Need

Despite the innovation that migrants can bring, and the lifesaving work they undertake in a range of sectors – particularly in healthcare – they remain outsiders in their adopted communities, especially undocumented migrants, said Dr. Tedros.

In countries like the US, migrants account for almost a fifth of the health workforce, with numbers rising rapidly. In the last decade, the number of migrant doctors and nurses working in Organisation for Economic Co-operation and Development (OECD) countries has increased by a stunning 60%, according to WHO.

“To be honest, what I have found particularly intolerable in this current crisis is that while being so often left behind, migrants have also been on the front line of the response to the pandemic, taking personal risks for everyone’s well being,” added Vitorino. “And this is across many critical sectors, not just the healthcare sector, but also transport, food, retail, research.”

Half Of Migrants Surveyed Struggle With Depression, Worry, Anxiety And Loneliness

The new survey also found that migrant health was most affected in the European, American, Southeast Asian and Western Pacific WHO regions, triggering depression, worry, anxiety, and loneliness in more than half of migrants and asylum seekers surveyed. The report also found that one in five migrants had increased their intake of drugs and alcohol compared to the start of the pandemic.

12% of those surveyed lacked access to healthcare and 10% were not entitled to healthcare.

Migrants are also generally less likely to access high-quality healthcare, found the report, despite their worse health outcomes. Of those who did not seek healthcare, 35% cited financial constraints and 22% reported fear of deportation. Additionally, 12% lacked access to healthcare and 10% were not entitled to healthcare, among other barriers.

“One of the crucial issues is that migrants sometimes are suspicious to look for health care because they are afraid of contacting health services,” said Vitorinio. “They [fear being] detained or even deported.”

The survey, which closed on 31 October, was based on around 30 self-reported questions in almost 40 languages. However, given the online nature of the report, it is likely that these trends underestimate the struggles faced by migrants, as it could not account for participants without access to technology.

Health Policies Must Be Inclusive To The Diverse Needs Of Migrants And Refugees 

Countries can take several measures to include refugees and migrants in their COVID-19 response plans, noted Dr Tedros on Friday.

They should de-link access to care from a migrant’s legal status, remove financial barriers to access, improve internet access for migrants, offer health information in multiple languages, and foster mutual trust between public health services and migrants, he said.  This is especially important as the world gears up for what is likely to be the largest vaccination campaign in history.

Before the pandemic, only 40% of all countries offered universal health coverage to all migrants, irrespective of their legal status, Vitorino flagged. On the upside, several countries have introduced new policies or relaxed requirements to bolster access to healthcare ever since the pandemic struck.

“Health for all means, all, including migrants,” said Dr Tedros. “That means increasing investments in health, especially in primary healthcare to create health systems that are sensitive to migrants needs, their language and their health problems.”

 

Image Credits: Flickr – EU Civil Protection and Humanitarian Aid, MSF/ Sophia Apostolia.

At least 1.3 billion of the 2 billion donor-funded vaccine doses secured will be distributed in the poorest economies.

The WHO-led COVAX Facility announced Friday that it has now secured some 2 billion vaccine doses and distribution of vaccines will begin in the first quarter of 2021 – ensuring that at least some vaccines will begin to reach the 92 low-income countries that are largely dependent on global philanthropy to access sufficient vaccine supplies.

That would be roughly enough vaccines to immunize a little more than one-eighth of the global population: most of the vaccines procured so far require two doses.

At least 1.3 billion of the 2 billion donor-funded doses secured will be distributed in the poorest economies, said the heads of Gavi, the Vaccine Alliance and the World Health Organization (WHO) at a press conference on Friday.

They said that the COVAX facility – co-sponsored by WHO and GAVI – would push ahead to acquire more doses, so that all countries worldwide could reach 20% population coverage of the highest risk groups by the end of next year.

“We have secured access to the first 2 billion vaccines and these will be delivered in the first quarter of next year,” said Seth Berkley, head of Gavi, The Vaccine Alliance, at the press conference on Friday.

“This is fantastic news and a milestone in global health,” WHO’s Dr Tedros Adhanom Ghebreyesus, at the event. “Images of people receiving vaccines are giving us hope, but it must be hope for all, not hope for some.”

The announcement was made jointly with leading pharma companies that had just sealed deals with COVAX.

Paul Stoffels, head of Johnson & Johnson, said the firm had signed a memorandum of understanding (MOU) to market some 500 million courses of its one-dose vaccine candidate through the facility, if the vaccine wins regulatory approval.

“We are reaching the end point in a large clinical trial, likely by the end of January,” Stoffels said in the briefing. “Following regulatory approvals, we hope to be delivering vaccines in the course of the next year.”

Dr Paul Stoffels, head of Johnson & Johnson.

In addition, Pascal Soriot of AstraZeneca, announced a deal with the COVAX facility for some 170 million doses of the AstraZeneca/Oxford vaccine.

The new deals come in addition to previously announced pre-purchase agreements with India’s Serum Institute, which has signed agreements with COVAX to provide at least 200 million doses – with options for up to 900 million doses more – of either the AstraZeneca/Oxford or Novavax candidates. This is as well as an agreement, in principle, for 200 million doses of another vaccine candidate by Sanofi/GSK.

AstraZeneca’s Soriot said that the company hopes to be geared up to produce up to 3 billion doses of its vaccine, following approval. As one of the cheapest and most durable, it is expected to play a major role in immunization drives in lower-income countries.

US$ 2.4 Million More in Donations – Vaccine Sharing Plans Also Unveiled

The purchases will be funded by US$2.4 billion in donor funds made available over the past two weeks, WHO said in a press release. This includes new pledges from Norway, Canada, Kuwait, Denmark, New Zealand, the Netherlands, Singapore and Estonia.

But the biggest influx of funds has been in the form of a combined European Commission grant and European Investment bank loan totaling €500 million.

At the press conference, Canada’s Minister of International Development, Karina Gould, and France’s Stephanie Seydoux, also said that their countries would consider making donations from their pre-reserved vaccine stockpiles to the COVAX facility, for use in low- and middle-income countries (LMICs).

With pre-orders for around 10 vaccine doses per capita, Canada has one of the largest stockpiles of pre-orders: far more than it can use domestically.

Karina Gould, Canada’s Minister of International Development.

“The idea [is] to be ready to start sharing vaccines as early as possible, that is what we are considering … in conformity with the sharing principles that COVAX and WHO issued today,” said Seydoux.

Their announcement coincided with the release of a WHO paper on Principles for Dose-Sharing. Under this, higher-income economies could donate surplus doses they have procured through direct deals with manufacturers to the COVAX facility’s low-income countries. The framework “opens another potential source of vaccines – supporting the overall goal of equitable access”, WHO said in a press release.

“France will rely on this framework to consider sharing doses, as early as possible to enable vaccination against COVID-19 low priority populations,” said Seydoux, encouraging countries belonging to the G7 and G20 to follow suit.

It remains to be seen if other countries will indeed choose to donate surpluses to the global COVAX initiative – or share directly with other close neighbors and allies.

For instance, New Zealand, an ostensibly strong supporter of the COVAX initiative, announced a plan this week to share its vaccines with its Pacific region partners using any surplus that it acquires.

At the same time, it also committed NZD 10 million this week to the COVAX global scheme this week.

Pfizer and Moderna Vaccines Noticeably Absent on Stage

The Pfizer and Moderna vaccines – which have been the first to secure regulatory approvals in the United Kingdom and by the United States Food and Drug Administration (US FDA) – do not appear in the COVAX vaccine portfolio.

Moderna’s absence is even more striking, since it received funding for Phase 3 of its clinical trials from the Oslo-based Coalition for Epidemic Preparedness Initiative (CEPI), which is funded by a number of governments as well as philanthropies and other public partners.

Moderna’s mRNA vaccine received overwhelming approval from an advisory panel to the US FDA, on the same day as the COVAX announcement.

Since these vaccines are also going to be the first to reach markets – it also means that high income countries in North America, Europe and elsewhere, will inevitably be the first to have their high-risk populations immunized en masse. This process has already begun in the UK and US. Other countries, such as Israel, begin next week with immunizations.

While there are some objective reasons why the Pfizer vaccine would be difficult to deploy – namely, its ultra-cold -70 C temperatures required for storage – Moderna’s vaccine, with its -2C to -8C storage, is much easier to handle.

CEPI’s CEO Richard Hatchet made no mention of the absence, saying only at the briefing: “Science has given us the tools to fight the pandemic. But equitable access is what will enable us to win in the pandemic” 

COVAX Dose Distribution To Be Pro-rated by Population

In terms of the COVAX organized rollout, WHO’s Chief Scientist Soumya Swaminathan said that a pro-rated number of doses would be distributed to countries based on their population.

It would remain up to the countries to prioritize the distribution, but she said that she expected most to go along with WHO guidelines calling for health workers, older people and other high-risk groups to be vaccinated first.

“In the first year, when we have limited supplies, we would distribute them by tranches, based on the country’s population, understanding that most countries are prioritizing their health care workers and vulnerable workers,” said Swaminathan.

Dr Soumya Swaminathan, WHO’s Chief Scientist, WHO.

Executing the initiative will still be a massive logistical task, however, and global health leaders at the briefing said that helping health systems prepare to receive the vaccines would be the next step. To support its plan to transport 850 tonnes of vaccines a month, UNICEF’s Henrietta Fore said that the organization is aiming to install 70,000 cold chains fridges fridges in lower-income countries by the end of 2021, almost half of which will be solar powered.

“As we’ve learned with routine immunisation vaccines don’t save lives, vaccination does,“ said Dr Kwaku Agyeman Manu, Minister of Health for Ghana said in a statement. “This means we need the health infrastructure in place – from supply chain and logistics to well- trained health workers – to ensure the effective and streamlined distribution of vaccines.

“For this we call on governments, manufacturers and the private sector to make urgent and necessary investments in COVAX so that no one is left behind.“

While COVAX was designed as a vaccine pool for countries at all income levels, with a self-financing arm as well as an arm for donations, as more and more high- and middle-income countries make bilateral deals, the focus of the facility has shifted to supplying shots to the world’s 92 LMICs that traditionally rely on donor aid for other vaccine campaigns.

That has left COVAX heavily reliant on voluntary donations to make the system work. Currently, 86 of the 92 LMICs eligible for COVAX have submitted vaccine requests.

On Friday 11 December, WHO director-general Dr Tedros Adhanom Ghebreyesus issued a plea to world leaders to “honour their pledges” to fund the scheme.

Regulations and Readiness: Plans for a 2021 Rollout With Health Workers In Mind

A press release by GAVI said that the first wave of doses, expected to be delivered in the first half of 2021, should be enough to protect health and social care workers.

Prioritising health workers should help these countries keep infection rates low and health systems functioning in the interim period between production waves. Healthcare staff have constituted about 15% of the global COVID-19 case toll: they account for only 3% of the world’s population.

As the rollout continues beyond this initial group, COVAX will aim to support the immunization of up to 20% of a given country’s population.

But a successful global campaign such as this is also dependent upon national regulatory approvals, cautioned Swaminathan. She said that WHO has been working with LMICs to ease the process in countries outside of the European Union and other developed regions.

World Trade Organization IP Waiver For COVID Health Products – Opponents Ask Countries To Explore What Are the Barriers In Use Of Current Rules

Meanwhile, WTO spokesperson Keith Rockwell said that the debate over a South African and Indian proposal to issue a WTO “waiver” for IP related to COVID medicines, vaccines and other tools would be continued in January 2021, following the impasse reached in the meetings held over the past two months.

He spoke at a press briefing just as the WTO’s General Council was wrapping up two days of meetings in Geneva on Friday that had examined the issue – after the WTO TRIPS Council (Agreement on Trade-Related Aspects of Intellectual Property Rights) had failed to come to any agreement over the far-reaching proposal.

WTO spokesperson Keith Rockwell said the discussion surrounding the WTO IP waiver will resume in January.

“There was no decision in the offing. This conversation is going to continue,” said Rockwell, speaking after the discussion in the General Council. “I would say it was a very important conversation, and it was not a conversation that was vitriolic or acerbic.

“The conversation will continue in January. In the TRIPS Council … there was support for continuing the conversation,” he said.

He said that while all WTO members agreed that it was important for low- and middle-income countries to be able to acquire essential health technologies, opponents of the waiver say that existing TRIPS flexibilities for health emergencies already allow governments to take unilateral measures to produce essential drugs and other health products – through measures such as “compulsory licensing” to domestic producers for the manufacture of patented products.

Rockwell suggested that among the countries that oppose the waiver, “there was a strong view expressed by many of them to try to use these discussions to identify where there may be imperfections in the TRIPS agreement that do not make it easy for the members to access these flexibilities, particularly as they pertain to compulsory licensing”.

In the General Council discussions, the UK’s WTO Ambassador Julian Braithwaite, along with Singapore’s Tan Hung San, both said that the recent agreements between India’s Serum Institute and AstraZeneca and South Africa’s Aspen Corporation had indicated and existing flexibilities are working, in terms of vaccine distribution.

On the other hand, proponents of the waiver say that “the flexibilities that are available are cumbersome and difficult to implement.”

Rockwell said progress on this and other health related WTO disputes have suffered from the lack of a new WTO Director General. This follows the impasse over the final appointment of the leading candidate, Nigeria’s Ngozi Okonjo-Iweala, which was opposed in October by one sole WTO member, the United States.

So far “a consensus remains elusive” on the new DG appointment, said Rockwell. While there is now a possibility that the incoming US administration of Joe Biden may withdraw its opposition to Iweala clearing the way for her appointment early next year, Walker made no reference to the pending change in the US administration in Washington, saying only:

“It has not been an easy year. We need to do all we can to get a director general here. This is something that really has to be taken care of, hopefully soon. At the end of a long and difficult year for everyone around the planet, we will use the break to pause and reflect and see what the best way forward will be when we come back.”

Image Credits: CDC Global/Flickr, World Economic Forum, UNICEF Ethiopia, Moderna, World Health Summit, APEC 2013.