older
AstraZeneca vaccine found effective in reducing COVID-19 in older adults

The AstraZeneca/Oxford vaccine can reduce severe COVID-19 in older adults by up to 70%, says a new Public Health England (PHE) study – which offers the first real-world evidence of the effectiveness of the vaccine in preventing serious disease among older adults, following its approval by UK and European regulatory agencies. 

Findings about the efficacy of the AstraZeneca/Oxford vaccine in among older people are critically important for countries not only in Europe but also in Asia and Africa – where the vaccine’s efficacy has been a matter of debate – even as it starts to be rolled out massively through the WHO co-sponsored COVAX global vaccine initiative.  

Meanwhile, an indigenous Indian COVID vaccine showed an “efficacy trend of 81%”  in a Phase 3 trial involving some 25,800 people, according to a statement Wednesday by the Indian Council of Medical Research.  The “interim analysis” involved some 6,000 participants, including mostly older people and people who had chronic diseases.

Among the 46 participants who contracted COVID, 36 had been given a placebo, said Bharat Biotech, the company that co-developed the vaccine.  

“The interim efficacy trend of 81%, analyzed as per the protocol approved by the DCGI, puts it at par with other global front-runner vaccines,” stated the ICMR press release.  It quoted ICMR’s director general as saying: “The bench-to-bedside journey of [a] completely indigenous COVID-19 vaccine in less than 8 months’ time … is a testament to India’s emergence as a global vaccine superpower.” 

UK Findings Relevant For Europe, Asia and Africa – Where AstraZeneca’s Efficacy had been Questioned 
AstraZeneca’s COVID vaccine will be the bulk of the COVAX products shipped to Africa

With regards to the AstraZeneca vaccine, preliminary findings from the Public Health England study, pre-released Monday in draft form, should provide welcome reassurance to other national health authorities rolling out the vaccine. 

“The effect of a single dose of the ChAdOx1 [AstraZeneca/Oxford] vaccine against symptomatic disease was approximately 60-75% and there was again an additional protective effect against hospitalisation, though it is too early to assess the effect and mortality,” state the study’s authors. 

Among older people aged 70 and above, who received the first dose of the AstraZeneca/Oxford vaccine, effectiveness against symptomatic disease was approximately 60-75% – although the paper did not assess the effectiveness of the full two-dose vaccine regimen. 

The study also looked at impacts from the Pfizer vaccine, finding that one vaccine dose prevented up to 70% of symptomatic disease. For two Pfizer doses, effectiveness was up to 90% among older adults. 

PHE Study Should Build AstraZeneca Vaccine Confidence – In Europe as well as Asia & Africa 
COVID-19 vaccination of elderly in India

While the Pfizer vaccine has already demonstrated its effectiveness in reducing serious illness and mortality among older adults in a number of large Israeli studies, the UK data represents the first real-world findings on the efficacy of the AstraZeneca/Oxford vaccine since the vaccine was approved by regulators in the UK as well as the European Medicines Agency. 

A number of European governments had last month recommended against using the AstraZeneca/Oxford vaccine among older age people – due to what authorities then described as a lack of evidence following approval by the European Medicines Agency. 

French President Emmanuel Macron even went so far to describe the vaccine as “quasi-ineffective for people over 65”. The Swiss regulatory agency, Swissmedic refused to approve the vaccine altogether, saying that the data so far was “not yet sufficient to permit authorization.’’ 

On 10 February, however, the World Health Organization recommended the vaccine’s use across all age groups. The WHO expert group expressed  “high confidence” efficacy among the +65 age group. The experts noted that even though the numbers of older people involved in AstraZeneca’s Phase 3 studies had been small – their immune response had been almost as good as that of younger people. 

In Africa, the Oxford/Astra Zeneca vaccine is set to be a cornerstone of the first phase rollout of COVID vaccine deliveries by the WHO co-sponsored COVAX vaccine facility initiative. The first shipments of AstraZeneca vaccines  reached Ghana and the Ivory Coast on Monday, followed by Nigeria later this week.   

In India, the AstraZeneca vaccine is a cornerstone of the national campaign – along with the Covaxin indigenous vaccine.

Study Shows Vaccines Are Effective Against so-Called British SARS-CoV2 Variants 

The PHE results also are reassuring insofar as they reflect the efficacy of both Pfizer and AstraZeneca/Oxford vaccines against the so-called British (B.117) variant that has now become dominant in the country – also spreading widely across Europe and beyond.  

The study results do not, however, provide evidence about the vaccine’s efficacy against another variant that has become a major concern due to its apparently greater ability to elude the body’s immune response – and that is the B.1351 variant first identified in South Africa. 

Earlier findings from a small South African study found that the AstraZeneca/Oxford vaccine was ineffective in preventing mild and moderate disease among younger age groups – prompting the country to rapidly shift its vaccine campaign from AstraZeneca/Oxford to Johnson & Johnson – which just received US FDA regulatory approval. 

The UK was the first country to implement a COVID-19 vaccination campaign following the approval of the Pfizer-BioNtech messenger RNA (mRNA) vaccine, BNT162b2. The UK was also the first high-income country to approve and begin rolling out the AstraZeneca adenovirus-vector vaccine, ChAdOx1 nCOV-19.  

“This adds to growing evidence showing that the vaccines are working to reduce infections and save lives. “While there remains much more data to follow, this is encouraging and we are increasingly confident that vaccines are making a real difference,” said Mary Ramsay, PHE Head of Immunisation, in a comment on the study. 

Pfizer Vaccine Also Offers High Levels of Protection Against Asymptomatic COVID  
Vaccination of the UK’s healthcare workers and elderly began in December 2020

In another UK study among healthcare workers, the Pfizer vaccine was shown to provide high levels of protection against any form of infection – preventing up to 85% of those immunized  from developing asymptomatic forms of COVID-19  as well.  

The study is important because it shows that the vaccines can also help stop the wider cycle of COVID transmission, as well as preventing symptomatic and serious disease. 

Healthcare workers in the study are regularly tested for coronavirus every 2 weeks, whether or not they have symptoms. Early data from the PHE SIREN study showed a single dose of the Pfizer vaccine had efficacy of up to 70% in preventing asymptomatic disease, rising up to 85% following the second dose. 

Even so, Ramsay cautioned: “It is important to remember that protection is not complete and we don’t yet know how much these vaccines will reduce the risk of you passing COVID-19 onto others. Even if you have been vaccinated, it is really important that you continue to act like you have the virus, practise good hand hygiene and stay at home.”

Image Credits: Gilbert Mercier/Flickr, Tim Reckman/Flickr, BNarayanpatna/Twitter, Eric Fiegl-Ding/Twitter.

Israeli Prime Minister Benjamin Netanyahu kicked off Israel’s vaccine campaign 21 December – in which more than half of the country’s population have now received at least one jab.

JERUSALEM – A three-way collaboration between Israel, Austria and Denmark to expand COVID vaccine manufacturing capacity may be taking shape – just as Moderna gears up for a major global manufacturing expansion and the Israeli-based firm, Teva Pharmaceuticals, negotiates with vaccine manufacturers about ways to support more vaccine production and distribution.  

Austria’s Chancellor Sebastian Kurz and Denmark’s Prime Minister Mette Frederiksen were reported to be planning a visit to Israel at the invitation of Prime Minister Benjamin Netanyahu – to talk about setting up “an international corporation for manufacturing vaccines” – in the words of the Israeli prime minister on Monday.  

The high-profile visits, if they come off, coincide with a quest by Moderna Therapeutics to set up some 20 new manufacturing plants around the world where “fill and finish” vaccine manufacture could start immediately, Israeli sources told Health Policy Watch. 

But rather than siting their plants in Israel, Moderna may also be eyeing Teva facilities in Europe or elsewhere, some sources suggest. Teva, while based in Israel, has a worldwide network of over 61 manufacturing plants, including Austria and Denmark as well as elsewhere in Europe. 

Riding on the jet-stream of fast-moving vaccine geopolitics, Pfizer’s CEO Albert Bourla was also reportedly set to make a visit to Israel on Sunday, 8 March. The visit could coincide with an announcement by Pfizer that it will locate a vaccine R&D facility in Israel – to come up with next-generation jabs against the ever-mutating coronavirus.

Bourla last week described Israel as “the world’s lab” for the Pfizer vaccine “ because they are using only our vaccine at this state and they have vaccinated a very big part of their population, so we can study both economy and health indices.”  

Moves Come Against Backdrop of Israeli Election Campaign 
Albert Bourla, CEO Pfizer, announces vaccine procurement deal with the WHO co-sponsored COVAX, Friday 22 January 2021

However, some leading Israeli scientists and diplomats have urged the Pfizer CEO to postpone his high profile visit –  which would come just two weeks ahead of a hotly-contested Israeli national election campaign. 

Netanyahu is trying to retain his 12-year-long grip as prime minister – despite corruption cases in the courts and political challenges from former allies on the political right. Showcasing Israel’s success in its vaccination campaign, which has seen over half of Israelis get first jabs and led to a dramatic decline in COVID cases among people over the age of 60, has been a key part of Netanyahu’s re-election strategy. 

While Netanyahu has been widely acknowledged by Israelis for his aggressive moves to acquire and roll out vaccines rapidly and efficiently – he has also been criticized for politicizing an already charged vaccine landscape at home and abroad  – including recent offers of vaccines to alliles in far-flung capitals even before Palestinians next door get access to significant COVID vaccine supplies.

“It is understandable why the chairman and CEO of Pfizer, Dr. Albert Bourla wants to visit Israel. The country – both the government and the scientific and medical communities – will enthusiastically welcome him. Many are looking forward to exploring the possibility of R&D projects and a Pfizer production line in Israel,” wrote Alon Pinkas, former Israeli Consul General in New York, in an op-ed in the Ha’aretz national daily. 

But, Pinkas added, “It defies logic why Bourla, the CEO of a world-leading biopharmaceutical company worth nearly $190 billion, would visit Israel on March 8, 15 days before the Knesset [parliamentary] election. To put it bluntly, Pfizer will become a political prop, and the visit will be politicized with high-octane intensity. Prime Minister Benjamin Netanyahu no longer has Donald Trump as some brother-in-arms campaign asset, so why not use Pfizer?”

Netanyahu Says Israel May Host Moderna Plant –  Others Say Country Lacks Immediate Manufacturing Capacity
Tal Ohana, mayor of the Negev desert town of Yeruham, Israel is actively searching for a COVID vaccine manufacturer to locate in an available facility.

In a February 15 interview with Israel’s Channel 12 news channel, Netanyahu said that he was negotiating with both Moderna and Pfizer  “to build two factories in Israel – making us a global center in the fight against COVID-19.” 

“The Moderna complex will be a center for filling vaccine vials, while Pfizer’s will work as a research and development site for the fight against future viruses,” Netanyahu said.

However, Tal Ohana, the mayor of the Israeli Negev desert town of Yeruham, which had been considered one of the leading sites in the country for a vaccine manufacturing plant, said in an interview with Health Policy Watch that she doubts that Israel can host a plant of the capacity and dimensions that Moderna is seeking at this stage. 

“We are in touch with Moderna,” said Ohana, who had been trying to attract a vaccine manufacturer to the town of 10,000 people even before the pandemic began. “They have decided to create 20 new manufacturing sites around  the world.  But they need something immediate for ‘fill and finish’, with sterile rooms.  To produce at export scale, the company is also looking for large-scale facilities – e.g. of 5,000 square meters in size and employing about 200 workers to produce 100 million vaccines a year, she said. 

While Yeruham is “the most advanced in the process among all of the options in the country… we aren’t at that stage…. we don’t have that capacity here. It takes time,” Ohana said of the facilities already available. “So Moderna is looking at establishing sites elsewhere in the region and to come back to us later.”  

Ohana said it was her understanding that Pfizer would, however, be setting up an R&D facility somewhere else in the country soon. She noted that the company has been eyeing an R&D facility in Israel for some time – “but there were disputes over the IP… then with the interventions of the prime minister, I’m pretty optimistic it will happen,” she added.    

The 36 year-old Ohana, who holds a master’s degree in government and diplomacy and has won recognition for driving COVID cases in the town down to single digits, said that she is focused on attracting a vaccine manufacturer – which would provide a larger employment base. To that end, the municipality is still in negotiations with a third pharma company – which she preferred not to name.

Teva Keen to Fill Manufacturing Niche in International Vaccine Market 
Israeli Prime Minister Benjamin Netanyahu and Health Minister Yuli Edelstein visit a Teva Pharmaceuticals ultra-cold logistics center in November 2020, just before the first deliveries of Pfizer mRNA COVID vaccines – for which Teva is managing distribution.

Meanwhile, as another piece in the jigsaw, Teva appears likely to step in soon as a manufacturing solution for capacity-strapped vaccine producers – which are struggling to fill orders now that vaccines have been approved. A spokesperson for Teva, the world’s largest generic drug manufacturing company, confirmed to Health Policy Watch on Wednesday that “there are discussions between Teva and vaccine originators about production – but we have no information to add about their identity.”

In a series of mid-February media interviews Teva CEO Kare Schultz said Teva was one of the companies best positioned to fill the current holes in the COVID-19 vaccine manufacture market: 

“We have a large, worldwide network of manufacturing capabilities,” from creating underlying drug substances to putting solutions into sterile vials, known as the fill-finish process, Schultz told Fortune Magazine. “There are a limited number of facilities that can do this kind of manufacturing, and it takes time to build them.”

While declining to comment on which vaccines Teva might produce, the company is equipped to make the messenger RNA active ingredients used in the Moderna and Pfizer-BioNTech vaccines.

Teva has already played a huge roll in Israel’s massive vaccine rollout, – the largest in the world, handling the distribution process from airport delivery to ultra cold-chain storage and transportation to hundreds of vaccination sites around the country.

“We also have distribution capability in the U.S. and would be more than happy to help there,” Schultz also said.

But significant to any upcoming talks between Israel, Austria and Denmark, Teva also has plants in Europe, including in Seborg, Denmark and  Teva Ratiopharm Austria, an Austrian firm acquired by Teva in 2010, 

Flurry of Activities Come Against Persistent European & Global Vaccine Shortages 

The flurry of activities by both countries and pharma manufacturers to rev up vaccine manufacturing production come against the stark reports of vaccine supply shortages in Europe – not to mention globally. 

Speaking at her first session of the World Trade Organization’s General Council on Monday, incoming WTO Director General Ngozi Onkonjo-Iweala noted that the world’s vaccine manufacturing capacity currently stands at only about 3.5 billion doses annually – while the needs in the COVID era are for the manufacture of some 10 billion doses a year. 

Iweala has also said she would advocate for a “third way” approach with pharma companies to expand global manufacturing, particularly in low- and middle-income settings where production could also expand access to vaccines among less developed countries.  

It remains to be seen if the vaccine scale-up envisioned by Moderna, and the moves being made by Teva, as well as Israel and its European allies will support that wider objective – or merely expand supplies to high-income countries in Europe and elsewhere.    

 

Image Credits: Youtube – Israeli PM, wikipedia , Kobi Gideon, GPO.

As a deaf child in India, Sneha Das Gupta struggled to make friends and to learn during classes at school. Fortunately, in her earliest years, she was able to do well because she had access to a hearing aid, as well as speech therapy and support from her teachers at school.  Today, she is a PhD student at the prestigious TATA Institute of Social Sciences.

Most people who are at risk of hearing loss, however, are less lucky than Sneha, struggling to communicate, study, and to earn a living, revealed the WHO’s first World Report on Hearing, published on Tuesday, ahead of World Hearing Day on 3 March. 

“Our ability to hear is precious,” said Dr Tedros Adhanom Ghebreyesus, WHO Director-General. “Untreated hearing loss can have a devastating impact on people’s ability to communicate, to study and to earn a living. It can also impact on people’s mental health and their ability to sustain relationships.”

Over 1.5 billion People Affected – Another 1 Billion At Risk 

The number of people affected is massive, found the report, with over 1.5 billion people, from all walks of life, with some degree of hearing loss. And unless hearing care is prioritized and integrated into national health systems, that number will grow to 2.5 billion people by 2050, generating losses of over US$ 1 trillion a year to economies worldwide –  especially in low- and middle-income countries which harbor 80% of the total number of people with hearing loss. 

The report, published in collaboration with the US-based Institute of Health Metrics and Evaluation, found that most countries have failed to integrate hearing care into their national health systems, and that the bulk of people who need EHC services cannot access them – largely as a result of stigma associated with hearing loss, as well as insufficient human resources and services to deliver, fit, maintain and support use of the hearing aids.

“About 1 billion people around the world are at risk of avoidable hearing loss,” said Malala Yousafzai, Nobel laureate and UN messenger of peace. “WHO estimates that over 400 million, including 34 million children, live with disabling hearing loss, affecting their health and quality of life”, added Yousafzai, who has suffered from hearing loss herself. 

Because hearing loss severely impairs the cognitive and linguistic development of children, it can have lifelong impacts on their education and employability. People with moderate to severe hearing loss were half as likely to achieve higher education and twice as likely to be unemployed as people without hearing loss, the report notes.

The causes of hearing loss are often preventable, at least in children and young adults. In children, 60% of hearing loss can be prevented through vaccinations against preventable illnesses and treatment of common ear diseases. And 50% of young people aged 12–35 years – or one billion people – are at risk of losing their hearing due to exposure to unsafe sound levels in recreational settings. 

Number of people with hearing loss, by severity

Workplaces & Public Venues Key To Reducing Risks  

The report also illustrates how practical solutions for workplaces and stricter legislation for public venues can reduce hearing loss risks. 

European countries such as France, Italy, the United Kingdom, and Czechia – have reported dwindling levels of noise-induced hearing loss (NIHL) in past years, largely as a result of hearing conservation programmes. In the US, for instance, a military hearing conservation programme found that workers were almost 30% less likely to develop hearing loss.

Meanwhile, strict legislation in Switzerland has ensured that audiences at public venues are offered free ear plugs. Together with other measures, this may explain why an impressive 40% of attendees in recreational venues in Switzerland wear hearing protection – a much higher percentage than in other countries. Such measures include: 

  1. A limit on the average hourly sound levels to 100 A-weighted decibels.
  2. Measurement and recording of sound levels.
  3. Visible information and posters on safe listening.
  4. Provision of “quiet areas” for events whose duration exceeds three hours. 

The report also calls on Member States to implement “HEARING”, a package of cost-effective interventions that include: screening and intervention; ear disease prevention and management; access to technologies; rehabilitation services; improved communication; noise reduction; greater community engagement.

Through HEARING, the WHO aims to boost the relative coverage of ear and healthcare services by 20%, building on the World Health Assembly’s resolution in 2017 to prevent deafness and hearing loss, and contributing to the Sustainable Development Goals – including SDG3 (good health and well-being), SDG4 (quality education), SDG8 (decent work and economic growth), and SDG10 (equality). 

Shortage Of Trained Specialists To Address Ear Health

The WHO’s report also found glaring disparities in the numbers of trained professionals equipped to help people with hearing issues. It found that 80% of LMICs have only 1 ear, nose and throat specialists (EAT) specialist per 1 million people – in contrast to 95% of high-income countries, which have ten times as many ENT specialists.

Similarly, the report found that 35% of countries in Africa had less than 1 teacher of the deaf per million people, in comparison to 15 teachers per million people in 50% of American and 42% of European countries, respectively. 

Using various case studies, the report also illustrates strategies to overcome the shortage of highly specialized professionals at a low-cost in a range of settings. 

On Kiribati’s island of South Tarawa, for instance, 25% of patients who presented at the island’s hospital suffered from ear problems – prompting authorities to train nurses to deliver ear health care to children in three primary schools. The strategy, which also included the set up of a specialized ear clinic on the island, contributed to a “dramatic decrease” in chronic ear problems faced by students.

Use of earplugs in noisy places can reduce the risk of hearing loss significantly

Stigma As Key Barrier To Uptake Of Hearing Services 

The report also emphasizes that stigma is a key issue that has hampered progress in EHC care. In some communities, deaf babies are regarded as a “bad omen” that could bring misfortune. As a result, families are less likely to screen their children for hearing disabilities.

“Hearing loss has often been referred to as an “invisible disability”, not just because of the lack of visible symptoms, but because it has long been stigmatized in communities and ignored by policy-makers,” said Dr. Tedros in the report. 

Stigma could also explain why adults usually stall for ten years before seeking any hearing care, and why in high-income countries, three-quarters of the people that need hearing aids do not use them, even when they are available. 

Marketing strategies that promote hearing devices do not help either, notes the report, because they emphasize discreteness of their devices, thus reinforcing the belief that hearing devices should be hidden, and contributing to public reluctance to wear these devices – even when they are accessible. 

According to the WHO, usage of a hearing aid can reduce the years lived with disability (YLDs) due to unaddressed hearing loss by almost 60% – but only 68 million out of a total 400 million people in need actually use one.

Hearing Aids Are Expensive ; Six Manufacturers Produce 98% of Hearing Aids Worldwide

Apart from stigma, hearing devices can be expensive, and earmolds, batteries, and maintenance services are not always covered by health insurance. In countries like the US, the price of hearing aids ranges between US$ 500 and US$ 3000, although low-cost devices in India can be bought for as little as US$50.

Another issue that is likely to maintain high prices is the fact that a mere 6 manufacturers produce up to 98% of the hearing devices worldwide. And they mostly tailor their products to high-income markets, further complicating access in low-resource settings. 

Initiatives like pooled procurement, usage of solar-powered batteries and locally-sourced materials, or even innovative reimbursement schemes, can bolster access to hearing aids across a range of settings, suggests the report, noting that the UK’s pooled procurement scheme has fitted 750,000 hearing aids across all age groups in recent years.

Universal Screening Is Crucial 

A child in South Africa receives screening using automated audiometry and noise cancelling headphones

Given that hearing lies at the heart of cognitive and linguistic development in children, health systems should attempt to screen children as early as possible, emphasizes the report. 

Perhaps surprisingly, many parents may be unaware of their children’s hearing difficulties, according to a Polish study of 71, 000 first-graders who were examined in over 4,000 schools. In the study, about half of parents who had children with hearing issues were unaware of their child’s condition. In total, almost 15% of all children who were screened were diagnosed with hearing loss, and referred for further care and treatment. 

Screening, however, should not be limited to children, given that 1.1 billion young people are at risk of permanent hearing loss due to exposure to unsafe sound levels in recreational settings.

Older people should also take part in screening programmes, as two thirds of people over the age of 60 experience some degree of hearing loss. 

Timely diagnosis of hearing loss in older people could also have another benefit – it could prevent up to 8% of cases of dementia in older adults, which is one of the major causes of disability in adults worldwide.

Image Credits: WHO/Otto Mejía, Eddie Linssen / WHO, Hear The World Foundation.

COVAX press conference: (from left): President of Ghana, Nana Akufo-Addo, UNICEF’s Henrietta Fore, Africa CDC Director John Nkengasong, GAVI’s Olly Cann; CEPI CEO Richard Hatchett; German Parliamentary State Secretary, Maria Flaschbarth; Gavi CEO Seth Berkley; UNICEF’s Gian Gandh; Soumya Swaminathan, WHO Chief Scientist; Kate O’Brien, WHO Vaccines & Biologicals; WHO Director General, Tedros Adhanom Ghebreyesus.

The global vaccine platform, COVAX, aims to distribute 237 million doses of the Oxford/ AstraZeneca vaccine to 142 countries by the end of May 2021, its managing partners told the media on Tuesday.

Eleven million doses will be delivered this week alone, with Angola, Cambodia, Democratic Republic of Congo and Nigeria getting their vaccines on Tuesday, according to World Health Organization (WHO) Director General Tedros Adhanom Ghebreyesus.

Tedros described COVAX as “an unprecedented partnership that will not only change the course of the pandemic but will change the way the world responds to future health emergencies,” at a media briefing hosted by the WHO, the Global Vaccine Alliance (GAVI), the Coalition for Epidemic Preparedness Innovations (CEPI) and the United Nations Children’s Fund (UNICEF). 

“We very much appreciate the support of Germany and other G7 countries who have supported COVAX with the resources it needs,” said Tedros. 

“The distribution of vaccines has not been as equitable as we would have liked, but it has been certainly more equitable than it could have been and we still have many challenges to overcome, including the local production barriers and delays to intellectual property,” he added.

COVAX, led by the WHO, GAVI and CEPI with UNICEF as the implementing partner, hopes to deliver 2 billion doses to people in 190 countries in less than a year. 

Some 1.2 million doses of the Pfizer-BioNTech COVID shot will also be delivered in the first quarter of 2021, according to the COVAX allocations.

Seth Berkley, CEO of GAVI, The Vaccine Alliance.

GAVI CEO  Seth Berkley said that it might be possible to purchase “1,8 billion doses of vaccine in 2021 for the low and lower middle income AMC countries in 2021” – 500 million more doses than anticipated last year. 

“We are also excited by the progress made by the Johnson and Johnson single-dose vaccine which just received US FDA emergency use authorisation and has agreed to provide us with a half a million doses,” said Berkely. 

Meanwhile, COVAX aimed to turn a recent memorandum of understanding with as-yet-unlicensed Novavax into a “firm advance-purchase agreement for 1.1 billion doses in the current weeks,” Berkley told the media briefing.

He also applauded the G7 countries (Canada, France, Germany, Italy, Japan, the United Kingdom and the United States) for doubling COVAX’s funding recently.

UNICEF – COVAX Making Good on Promises

UNICEF executive director Henrietta Fore said COVAX was beginning to make good on its promise to ensure that there was equitable access to vaccines. 

“Vaccine doses have arrived in West Africa and Asia, with many more countries to follow in the coming days and weeks,” said Fore, whose organization is overseeing the logistics.

“We’ve now seen Africa’s first vaccinations with COVAX doses in Ghana and Ivory Coast, in truly moving ceremonies in both countries yesterday. 

“But what took place on Monday is more than a feel-good story that speaks to our collective best natures. It is a necessary first step that speaks to our collective interests. 

“The only way out of this pandemic is to ensure that vaccination is available across the globe and that people from less wealthy countries are not left behind in the race to be protected,” said Fore.

She revealed that at least 20 countries could expect to receive hundreds of thousands of doses this week.

“Only today, we have five shipments including to Democratic Republic of Congo, Angola, Nigeria where we are delivering COVID-19 vaccines with consolidated syringes and routine vaccinations, ensuring that children are also protected among many other countries,” Fore said.

Nigeria alone received nearly four million doses. 

Fore said that the arrival of the vaccines represented hope particularly for children as “their access to education, health and protection services has been severely disrupted by the pandemic”.

Multilateralism key to fighting Covid-19
Ghaanian President Nana Akufo-Addo gets vaccinated against COVID-19 on Monday, 1 March, with the first COVAX vaccine to be distributed in the world.

Also addressing the briefing, Ghanaian president Nana Akufo-Addo, who was vaccinated on Monday, said that Africa needed to develop the capacity to produce vaccines “to facilitate easy and affordable access”.

 Maria Flaschbarth, Parliamentary State Secretary to the German Minister for Economic Cooperation and Development, described COVAX as an indication of the strength of multilateralism and working together to achieve a common goal.

“What we are witnessing here is the strength of multilateralism. We have seen what can be achieved when all actors work together. The public sector, scientific community, economic actors as well as civil society. We will defeat COVID-19 everywhere or nowhere. No one is safe until everyone is safe. The current mutations show this simple fact very clearly,” Flaschbarth said.

Flaschbarth further indicated that the current financing gap of the Access to COVID-19 Tools (ACT) Accelerator which includes COVAX, was over US$22 billion for 2021 alone. 

“To close this gap, it will be necessary to widen the donor base by further sustainable contribution of other public donors as well as the private sector,” she said. “Therefore, Germany very much welcomes the leadership of the current G7 and G20 presidencies putting equitable access to Covid-19 vaccines, therapeutics and diagnostics on the international agenda. This will be very helpful to mobilise more funding for the global medical answer to the Covid-19 pandemic.” 

Africa Centre for Disease Control (CDC) director John Nkengasong also said COVAX was beginning to show the power of global cooperation and the victory of “multilateralism versus protectionism”.

Nkengasong added that the African Union Commission will host a meeting on 12 April “to develop a roadmap and a framework that will enable Africa to begin to address with specifics, the key milestones to begin to manufacture vaccines on the continent”.

“All of this speaks to the need for our own ability to stand up and say that we as a people of 1,2 billion people will continue to invest in our health security and economic security that increasingly is being threatened by COVID-19,” Nkengasong said.

Vaccines to Address Virus Variants

CEPI chief executive officer Richard Hatchett said while the world was making progress in curbing COVID-19 through COVAX, there was a need for the more sophisticated vaccines to deal with emerging variants.

“In parallel to the global rollout of vaccines, we must now double our R&D efforts so that we have the tools we need for the emerging type of variant of Covid-19 as rapidly as possible,” Hatchett said.

“CEPI will continue to invest in R&D for vaccines that can be made available to COVAX to support the adaptation of existing vaccines and to initiate the development of new vaccines specifically targeted at the new variants” Hatchett said. 

 

Ngozi Okonjo-Iweala enters the WTO on 1 March 2021 to take over as WTO Director General.

Despite a groundswell of growing support, a South African and Indian proposal to the World Trade Organization to suspend patents and other intellectual property on vital COVID-19 vaccines and other health products was put on hold by WTO’s General Council in its session on Monday – with the next debate likely to occur in May. 

But there is growing pressure among supporters to move discussions to a draft text – to be hammered out in the interim by WTO members of the TRIPS Council, (which oversees the Trade Related Agreement on Aspects of Intellectual Property Rights).   

The proposed TRIPS Waiver, first submitted by South Africa and India on 2 October, now has the support of Kenya, eSwatini, Mozambique, Pakistan, Bolivia, Venezuela, Mongolia, Zimbabwe and Egypt – as well as WTO’s least developed group of 35 mostly African and SouthEast Asian countries.   

“I think there is a general agreement among members to continue these discussions with the aim of trying to find some sort of compromise that would help and address this urgent matter regarding the global crisis,” said a Geneva WTO official, commenting on the TRIPS waiver deliberations, just after they concluded Monday evening.  

The official said that some 31 delegations had taken the floor to comment at today’s WTO General Council meeting, the first since the election of new WTO Director General Ngozi Okonjo-Iweala. 

New WTO Director General, Ngozi Okonjo-Iweala presides over virtual meeting of WTO General Council, 1 March 2021

“The discussion was overall positive and constructive,” the official said. “Proponents underlined the urgency of addressing the matter.  Nearly all the delegations agreed on the need to ensure widespread and affordable access to vaccinations as soon as possible. 

“It was very constructive, with no animosity between the delegations, no name-calling, but a sense of urgency among many of the proponents, to ramp up manufacturing the vaccines – ensuring their widespread and affordable distribution.  And I think nearly all members agree to that goal. The difference is how that is to be achieved. Some pointed to initiatives outside of the WTO that are being undertaken on the matter.” 

According to other sources, while the majority of the 31 WTO  members who took the floor spoke on behalf of the waiver, about 10 countries remained in the middle while about six countries cautioned against relying on the waiver as the approach for this issue, [saying that] the argument is more complex and we have to look more at the exact role of IP as a problem in accessing vaccines.  

Among those more cautioning voices, Switzerland, Japan and New Zealand also stressed that pharma and industry representatives need to be drawn more deeply into the waiver discussions – in which they have so far not been involved.  

Significantly, neither the United States nor the European Union took the floor Monday on the waiver matter, sources said. 

Interventions by OECD members were “rather short” a Geneva trade official told Health Policy Watch.  Some focused on the existing TRIPS “flexibilities”, which allow countries to manufacture or export generics in health emergencies, but said they were keen to hear practical and effective ways to address bottlenecks. Others stressed existing international cooperation around the WHO co-sponsored COVAX vaccine facility as the preferred way forward to expand vaccine access.

But overall, obsevers say, countries that are supporting the waiver still haven’t yet managed to make a convincing case to high-income countries that IP is the major roadblock to expanded COVID vaccine manufacturing.

Significantly, South Africa’s  Xolelwa Mlumbi-Peter, currently chairs the TRIPS Council where waiver discussions are currently being held. But that roll will soon rotate to another country – there has been some speculation that the next candidate could be Norway, which could potentially play a bridging role between countries pro and con on the issue. 

Ngozi Says: WTO Delegates Need to ‘Walk & Chew Gum’ SImultaneously
Virtual meeting of WTO General Council, which began Monday, is likely to continue until Wednesday, 3 March.

Incoming WTO DG Iweala, meanwhile, said that WTO delegates and countries should “walk and chew gum” simultaneously – stepping up informal contacts with industry voices over the vaccines manufacturing bottleneck – while debates over the formal WTO waiver proposal continue at the WTO TRIPS Council. 

“We have a demand for a TRIPS waiver by a growing number of developing countries and the dialogue is intensifying,” declared Iweala. 

“Whilst this is happening, I propose that we “walk and chew gum” by also focusing on the immediate needs of dozens of poor countries that have yet to vaccinate a single person. 

“People are dying in poor countries. We just had our first COVAX shipment to Ghana last week and others will follow but it will not be enough. There is serious supply scarcity and some countries are out bidding COVAX and diverting supplies. 

‘Third Way’ Now Framed As ‘Interim’ Approach  

At the same time, Iweala’s comments represented a slight shift from remarks that she had made only two weeks ago, when she was elected to head the WTO. At the time, she said she would advocate for a “third way” approach based on voluntary licensing of patented vaccines to generic manufacturers in the global south.  

However, in her remarks to the WTO General Council this Monday, shared after the closed meeting, Iweala said that would only serve as an “interim solution” – until a more formal agreement were reached. 

“The world has a normal capacity of production of 3.5 billion doses of vaccines and we now seek to manufacture 10 billion doses. 

“This is just very difficult, so we must focus on working with companies to open up and license more viable manufacturing sites now in emerging markets and developing countries. We must get them to work with us on know-how and technology transfer now. 

“There will soon be a world manufacturing convention where we can seek to build this partnership. I also hope we can initiate a dialogue and information exchange between us and representatives of manufacturers associations from developing and developed countries. Excellencies, this should happen soon so we can save lives. 

“As I said at the beginning, this will be an interim solution whilst we continue the dialogue on the TRIPS waiver,” said Iweala. 

In her remarks, Iweala also called on members to “do things differently” to achieve reforms necessary to keep the WTO relevant, starting with swift action to curb harmful fisheries subsidies, as well as scaling COVID-19 vaccine production and distribution. The new head of the WTO noted that high expectations for her tenure can only be met if members are willing to compromise and reach agreements – instead of “talking past each other” as has become the norm.

Without such compromises, she warned that the WTO risks becoming irrelevant and bypassed increasingly in global trade discussions and debates. 

 

Image Credits: ©WTO/Bryan Lehmann, ©WTO/Bryan Lehmann.

Ghanaian President Nana Akufo-Addo gets vaccinated against COVID-19 with the first vaccine in the world to be distributed by the WHO co-sponsored global COVAX facility.

Ghana and Cote d’Ivoire have become the first countries in the world to start vaccinating their health workers against COVID-19 with a supply of doses from the WHO co-sponsored global COVAX facility. But it is “regrettable” that this milestone has come almost three months after vaccine campaigns already began in rich countries, World Health Organisation’s (WHO) Director General Dr Tedros Adhanom Ghebreyesus said on Monday.

“And it is regrettable that some countries continue to prioritise vaccinating younger, healthier adults at lower risk of disease in their own populations, ahead of health workers and older people elsewhere,” Tedros told the WHO bi-weekly media briefing.

However, Tedros told the briefing that, by the end of May, 237 million doses of COVID-19 vaccines will be allocated to 142 countries participating in the global COVAX facility.

Samira Bawumia, wife of the Ghanaian vice president, Mohammed Bawumia, enters her biodata into the Ghana vaccine data base just before she and her husband are vaccinated against COVID 19 in the kickoff to the Ghanaian campaign on Monday, 1 March.

Eleven million more doses will be dispatched to 15 countries this week, 14 in Africa, according to the WHO. Nigeria reported last week that it is expecting to get 4 million COVAX vaccines this week.

The WHO has been at pains to stress that, if the virus is to be eliminated, there needs to be a uniform global vaccination campaign that prioritises health workers and the elderly throughout the world.

But COVAX, the facility set up to acquire and distribute vaccines equitably, has been undermined by bilateral deals between pharmaceutical companies and wealthier countries intent on vaccinating all their citizens first. This has resulted in a worldwide shortage of doses and a situation whether 130 countries have not yet started to vaccinate citizens.

“The goal of COVAX was to bring an end to the acute phase of the pandemic by the end of 2021,” said WHO Chief Scientist Soumya Swaminathan. 

WHO Chief Scientist Soumya Swaminathan

“We cannot completely eradicate the virus by the end of the year but we can reduce hospitalizations, deaths and severe illness. But we can only do that if people at risk around the world get the vaccine. And at this point in time, they’re not. 

COVAX aims to vaccinate 20% of the world’s population by the end of the year – those who are most at risk of severe illness and death. 

“Then we can scale up as production increases and expand the vaccination campaigns to cover healthier younger adults and really start bringing down transmission,” explained Swaminathan. “But our goal really should be to protect people’s lives and do it as quickly as possible by sharing the vaccines that we have today.”

Swaminathan, who described the COVAX launch as “the start of the largest vaccine campaign the world has ever seen”, added that early data from countries who had started vaccinations showed a “very encouraging” impact on hospitalisation and deaths.

“The safety profile is also encouraging, as about 250 million doses have been given worldwide and so far there have been no major safety signals,” she added.

Mariângela Simão, WHO Assistant Director-General for Drug Access, said the order in which countries were getting COVAX doses was based on “preparedness”, as each country had to accept the vaccine liability indemnification and their medicine regulatory authorities had to authorise the vaccine for use.

Bruce Alyward, who represents the WHO at COVAX, added that “just getting so much vaccine labelled, packaged, booking shipping space and getting them shipped” was a “massive logistical operation that UNICEF and the Pan American Health Organisation are managing right now”. 

Cases Increase, Raising Threat of New Variants

Tedros reported that, for the first time in seven weeks, COVID-19 cases had increased in four WHO regions, the Americas, Europe, Southeast Asia, and the eastern the Mediterranean, apparently because of a “relaxation of public health measures”.

“This virus will rebound if we let it,” said Maria van Kerkhoven, WHO’s Technical Lead on COVID-19. “We’ve all been in a position previously, where we’ve gotten transmission down to very low numbers. We cannot allow it to take off again, especially as we have vaccines rolling out, and especially as more vaccines are coming online and as COVAX is starting to distribute the vaccine around the world.”

Van Kerkhove stressed that people must continue to “limit your contacts with others”, reduce social mixing with other families as schools open up, continue to keep a distance from others and wear masks.

Kate O’Brien, WHO’s director of immunisations, said that “anywhere where the virus is transmitting, and transmits in ever-increasing numbers, is going to increase the chance that there are changes to the virus that would also put the vaccines at threat. 

“So this is really really important that, as vaccines are rolling out, people continue to pay attention and be as vigilant as possible to ensure that transmission is as low to give the vaccines their best opportunity for impact.”

 

Image Credits: Samuel Neequaye , Samuel Neequaye .

Vials of Johnson & Johnson’s vaccine that was granted emergency use authorization by the FDA on Saturday.

The United States Food and Drug Administration (FDA) granted Johnson & Johnson’s single-dose COVID-19 vaccine emergency use authorization on Saturday, clearing the way for it to become the third COVID vaccine to be administered in the US starting on Tuesday. 

Initial supplies to the US market, however, are likely to be limited for at least the first few weeks due to issues with scaling up manufacturing, officials warned. Meanwhile, there was no clear timetable yet for the provision of the vaccine to the WHO co-sponsored global COVAX facility – which is supposed to receive some 500 million doses. 

“The authorization of this vaccine expands the availability of vaccines, the best medical prevention method for COVID-19, to help us in the fight against this pandemic, which has claimed over half a million lives in the United States,” said Janet Woodcock, Acting FDA Commissioner, in a press release.

The vaccine was 66% effective overall in preventing moderate to severe infection and 85% effective in preventing severe disease, according to results of Phase 3 trials with 43,783 participants. 

The level of protection against moderate to severe infection provided by the vaccine varied by country and region, with the US recording an efficacy rate of 72%, Latin America reporting 66%, and South Africa recording 57%. This suggests that the vaccine is slightly less effective against the B.1.351 variant, first identified in South Africa. 

Although lower than the 90%-plus efficacy ratings of the Moderna and Pfizer/BioNTech vaccines, as well as trial results obtained by Novavax and AstraZeneca, J&J’s vaccine offers dosing and handling advantages. 

Early Supply of J&J Vaccine Could Be Scarce

US hospitals are expecting to begin receiving the initial 3.9 million doses of the J&J vaccine on Tuesday, but officials from the Biden administration have warned that the supply could be uneven for the next few weeks. 

J&J signed a US$1 billion agreement with the US for 100 million doses, with the option to purchase an additional 200 million doses. The company is planning to deliver 16 million doses to US markets by the end of March and 100 million doses during the first half of 2021. 

Initially, the plan had been to deliver 37 million doses by the end of March, but the pharma company is facing difficulties scaling up its production, specifically at its manufacturing plant in Baltimore. The first round of 3.9 million doses are being delivered from the company’s factory in the Netherlands. The rest will be produced in the US. 

“We do not expect any additional deliveries next week and we expect deliveries to be uneven during the weeks of March,” said a senior Biden administration official at a press briefing on Sunday. “We’re getting doses out the door as soon as they’re available to ensure vaccines get into the arms as quickly as possible.” 

J&J Vaccine Under Review By EMA and WHO

The European Union has a purchase agreement with J&J, securing 200 million doses, with the option to order another 200 million. 

“We stand ready to begin distributing our vaccine within the European Union in the second quarter of 2021,” said Stoffels, Chief Scientific Officer of J&J, in a statement. 

Meanwhile, much to the dismay of medicines advocates, the promised distribution of J&J vaccines to the global COVAX facility may start even later.  J&J and GAVI, The Global Vaccine Alliance, recently announced an agreement to supply some 500 million doses of the vaccine to the global COVAX facility by 2022. 

“Johnson & Johnson is ready to join the fight on the ground against COVID-19 and eager to help bring this pandemic to an end – not just in the United States, but throughout the world,” said Alex Gorsky, CEO of J&J, in a statement. 

But it remains unclear how soon rollout of the vaccine through COVAX might begin,  particularly in light of the demands in the United States and Europe. And medicines advocates have already complained that poorer countries risk being pushed to the back of the bus in terms of getting access to a vaccine that is much easier for many countries to manage.  J&J’s modest temperature requirements, one-shot regimen, and demonstrated efficacy against the B.1351 variant that is spreading across southern Africa have all made it an attractive candidate to LMICs. 

J&J submitted applications in mid-February to the European Medicines Agency (EMA) for a “conditional marketing authorization” and to the WHO for an emergency use listing (EUL) – which would clear the way for distribution through COVAX. The EMA plans to meet in mid March to issue a decision.

Benefits of J&J Vaccine

The J&J vaccine only requires a single dose and can be stored for up to three months at standard refrigeration temperatures (2 to 8°C) and transported using existing cold chain technologies and standard vaccine distribution channels.

In contrast, the Moderna vaccine can only be stored at refrigeration temperatures for 30 days and Pfizer’s vaccine can be stored for two weeks. If the vaccines need to be stored longer, they have to be kept between -80ºC to -60ºC for Pfizer’s vaccine and between -25°C and -15°C for Moderna’s. 

Johnson & Johnson will ship the vaccine using existing cold chain technologies because the temperature requirements are not as strict as for Pfizer’s and Moderna’s vaccines.

J&J’s vaccine uses a more widely tested method than the Pfizer and Moderna mRNA vaccines. It uses an adenovirus to provide the cells with the genetic material to make the “spike” protein of SARS-CoV2. This triggers an immune response against the virus.

“We believe Johnson & Johnson single-shot COVID-19 vaccine is a critical tool for fighting this global pandemic, particularly as it shows protection across countries with different variants,” said Paul Stoffels, Chief Scientific Officer of J&J, in a press release. “A vaccine that protects against COVID-19, especially against the most dire outcomes of hospitalization and death, will help ease the burden on people and the strain on health systems worldwide.”

Following the FDA’s decision, the US Centers for Disease Control and Prevention (CDC) endorsed the J&J vaccine for use in people aged 18 and older, including the vaccine in the national immunisation program. 

“This vaccine is also another important tool in our toolbox to equitably vaccinate as many people as possible, as quickly as possible,” said Rochelle P. Walensky, CDC Director, in a statement released on Sunday. 

“Having different types of vaccines available for use, especially ones with different dosing recommendations and storage and handling requirements, can offer more options and flexibility for the public, jurisdictions and vaccine providers,” Walensky added.

Dr. Anthony Fauci, the Director of the National Institute of Allergy and Infectious Diseases, described the three vaccines as “highly efficacious in many ways, including, importantly, preventing severe or critical disease” in an interview with CBS News on Sunday. 

“People should take the one that’s most available to them,” said Fauci in an interview with NBC News. “If you go to a place and you have J&J and that’s the one that’s available, I would take it. I personally would do the same thing. I think people need to get vaccinated as quickly and expeditiously as possible.”

In a video release by the White House on Monday, Dr. Fauci explained the method used by the vaccine and attempted to settle fears that the J&J vaccine is less effective than the other COVID-19 vaccines available.

South Africa Removes ‘Remaining Restrictions on Economic Activity’

With COVID-19 cases – and its economy – in decline, South Africa has moved to a more relaxed COVID Alert Level 1 from Monday in the hope that this will stimulate economic activity.

South African President Cyril Ramaphosa made the announcement on national television on Sunday night but stressed that the mandatory wearing of masks in public was even more important as the country opens up.

The country’s curfew is now between midnight and 4am, alcohol sales are permitted over weekends and indoor gatherings of up to 100 people and outdoor gatherings of up to 250 people will be allowed, depending on the size of the venue. Five airports have been opened for international flights, although 33 land border posts will remain closed.

Night clubs and night vigils are still not allowed.

“The return to alert level 1 means that most of the remaining restrictions on economic activity have been removed. We expect this to lead to higher consumption spending, bolstered by the steady recovery in employment,” said Ramaphosa.

By Sunday,  67,000 health workers had been vaccinated with the Johnson & Johnson vaccine in the 10 days since the vaccine had landed in the country. A new batch of 80,000 J&J vaccines arrived in the country on Saturday. 

Ramaphosa said that the number of vaccination sites “will increase from 17 to 49 sites next week.  Of these, 32 will be in public hospitals, and 17 in private hospitals”. 

Ramaphosa also reported that a further 11million J&J vaccines had been secured along with 20 million Pfizer vaccine doses with delivery expected in the second quarter, as the country rushes to vaccinate health workers, frontline workers and the elderly before the southern hemisphere winter and an anticipated third wave of the pandemic.

South Africa recorded around 10,000 new COVID-19 cases in the past week, a quarter of the case load it recorded a month ago.

Image Credits: Johnson & Johnson, NBC News.

Angela Merkel, Chancellor of Germany, at the European Council’s virtual meeting on Thursday.

Leaders of the 27 European Union member states are moving closer to a consensus on an EU-wide system of vaccine certificates for travel between countries in the bloc. Within three months a system will be introduced, EU officials announced on Thursday, the first day of the two-day virtual summit of the European Council.

Several EU member states that rely heavily on tourism believe that a system of digital vaccine passports or certificates could revitalize air travel and ease the pressure on economies. Many, including Greece, Spain and Italy, are urging other countries to support a common European approach.

“Of course more work needs to be done on digitalization and on cooperation with the World Health Organization, but we felt tonight more and more convergence among us about this important topic,” said Charles Michel, President of the European Council, at a press conference on Thursday. “The European Council will resolve this matter.”

WHO has been reluctant to move forward on creating an international framework for vaccine passports so far, until it becomes clear that vaccination inhibits COVID-19 transmission and vaccines become more available globally – beyond the high-income countries that currently dominate in the number of doses administered. 

WHO officials have made clear, however, that requiring proof of vaccination could be a good idea in the future – and based on an existing clause allowing for countries to demand proof of yellow fever vaccination – embedded in the WHO International Health Regulations. 

Hesitancy From Some EU Leaders Won’t Stop Plans To Establish An EU-Wide System

The leaders of France, Germany, and Belgium have, however, expressed concerns that more evidence on vaccines inhibiting SARS-CoV2 transmission needs to be amassed before such a system is put in place. 

“First, it must actually be clearly resolved that vaccinated people are no longer infectious,” Angela Merkel, Chancellor of Germany, told the Frankfurter Allgemeine Zeitung. 

However, “we all agree that we need [a digital vaccination certificate],” Merkel said at a press conference Thursday following the virtual meeting. 

Angela Merkel, Chancellor of Germany, at a press conference following the meeting of the European Coucil on Thursday.

Despite concerns about the current low level of vaccinations, particularly in Germany where people have been hesitat about accepting the Oxford/AstraZeneca jab, Merkel announced that the EU member states will have developed digital vaccine certificates and the technical framework required for their introduction within three months.

“That will make travel within the European Union possible by having more information,” and could open up the opportunity for third-country nationals to enter the EU, said Merkel. 

COVID-19 tests could also be part of the new system, she added.

Both political and scientific questions remain to be answered, said Ursula von der Leyen, President of the European Commission, at a press conference on Thursday. The issue of what the certificates will be used for will ultimately be decided upon at the national level.

“But at the EU level, I believe we should use them to ensure the functioning of the single market,” Von der Leyen said. 

The content of the certificates will be uniform and will contain minimal medical information. Beyond providing proof of vaccination and specifying which vaccine was administered, the  system would also allow for the certification of immunity from a previous COVID-19 infection, or a negative PCR test.

The certificates will provide individuals with a unique identifier – similar to an IBAN code. 

Each country will need to integrate this into their health systems and the European Commission will provide a “gateway for interoperability” between nations, said Von der Leyen. 

“Member states will need to move fast with the implementation if we want such a green certificate to be in place by summer,” said Von der Leyen. “Beyond bringing on the principles and the technology, they will have to ensure a quick and complete rollout in their national health systems and in their border systems.”

Ursula von der Leyen, President of the European Commission, at a press conference on Thursday.
Some European Countries and Others Already Moving Ahead with Systems 

Some EU countries already have created systems or have advanced plans for digital systems that document individuals’ vaccination status, both for the purposes of travel as well as to facilitate entrance to crowded venues or attendance of large in-person events. Many others are likely to move forward even without an EU-wide system – such as Denmark, Greece, Iceland, Hungary, and Poland.

The African Union, in partnership with the African Centers for Disease Control and Prevention (CDC), is developing a “My COVID Pass” tool to verify vaccine certificates, COVID test records and other documents, to facilitate travel across Africa. 

Thailand plans to ease restrictions for vaccinated individuals and shorten the mandatory quarantine from two weeks to three days. Lebanon is reportedly allowing those who have received the COVID-19 vaccine to be exempt from quarantine if they also take a PCR test upon arrival. 

Bahrain incorporated vaccine certificates into its “BeAware” contact tracing app, allowing authorities to scan a QR code linking to the national vaccine register.

Israel’s  “green pass” programme was launched last week –  and is intended to provide access to gyms, theatres, hotels, concerts and synagogues. Israel has also created bilateral agreements with Greece and Cyprus – and is in talks with Seychelles and Romania to establish a similar agreement – to permit the free flow of vaccinated travellers back and forth. 

However, at the country’s Ben Gurion Airport, current reality is almost the diametric opposite of any “green passport” vision. International flights have all but halted with thousands of Israelis left stranded overseas – and those wishing to return forced to submit requests to a “Exceptions” Committee – which critics say is politically stacked. The travel bottleneck has led to widespread allegations of corruption and bias in the issuing of the precious “exceptions” permits largely for ultra-Orthodox travelers and politically well-connected individvuals. And this is happening just week’s before a national election.  More fundamentally, COVID test forgeries and inconsistent quarantine enforcement also plague the system – with bureaucrats so far unable to come up with solutions for either.

Israel’s vaccination “Green Pass” that can be used to access in-person events and gatherings.
Experts Raise Scientific & Technical Questions About Vaccine Passport Plans

The experiences illustrate just a few of the technical, scientific, and ethical dilemmas yet to be faced from a region-wide or international system of vaccine certifications. 

Others include questions such as: Will two doses of the vaccine be needed? For how long will immunity – and thus the passport – be recognized?   And which vaccines would qualify? For instance, would individuals who have been vaccinated by China’s Sinopharm and Sinovac vaccines or Russia’s Sputnik V vaccine –  that have not been approved by an internationally recognized regulatory agency or the WHO have problems travelling? 

Along with those issues, experts wonder about the ability of vaccines to actually halt the transmissibility of SARS-CoV2, and the effectiveness of vaccines against the virus variants that continue to evolve and mutate, are yet to be faced.  

“If we can still get infected but remain asymptomatic, a vaccine passport may make the situation worse if it is not supported by testing and social distancing, so it may not be a real way out,” Gian Luca Burci, Professor of International Law at the Graduate Institute of International and Development Studies, told Health Policy Watch. 

“The science doesn’t support COVID Passports b/c vaccines can’t guarantee immunity,” wrote Lawrence Gostin, Professor of Global Health Law at Georgetown University, on Twitter. “Vaccines are really good, but passports are premature.”

Validation of Vaccine Status – Requires Cooperation Across Complex Systems

Beyond the scientific considerations, there are also worries about validating the certificates, preventing forgery and hacking, protecting medical privacy and assuring digital data security.

“The ability to identify an individual and validate vaccination status requires international cooperation, orchestration across complex systems and widespread adoption of open interoperability standards to support secure data access or exchange,” said a WHO statement released in early February. 

While a WHO standard does exist for providing proof of vaccination for international travellers, with the requirement of vaccination against yellow fever for entry into countries where yellow fever is endemic, implementing such a system for SARS-CoV2 would bring countless more considerations. 

International Certificate of Vaccination or Prophylaxis (ICVP) booklet. Yellow fever is the only disease in the International Health Regulations (2005) for which proof of vaccination may be required for entry to a country.

“Disease passports have rarely been tried. The only parallel is @WHO’s Yellow Fever certificates. That program is small & doesn’t face near[ly] the same logistical, scientific, legal & ethical hurdles of #COVIDVaccine Passports,” Gostin tweeted. “COVID Passports are tempting, but too many hard problems.”

Others say that the bigger challenge may very well be how to use vaccine passports domestically – outside of the travel industry.

“Being certified for being vaccinated is not a new or recent issue. If you want to travel internationally, it is expected that you have been vaccinated against some of the major diseases,” Dr. Sridhar Venkatapuram, Senior Lecturer in Global Health and Philosophy at King’s College London, told Health Policy Watch. “This seems to be like that for international travel during this pandemic.” 

“The difficult and new thing is that vaccination is not just for travel, but to carry on with daily activities like work, socializing, sports et cetera,” said Venkatapuram. “You can’t create benefits to being vaccinated if you can’t assure everyone who wants a vaccine has access.” 

Human Rights and Ethical Questions

In line with those challenges, the prospects that a system of vaccine certificates could create new forms of discrimination, exacerbate existing inequality, and even amplifying vaccine hesitancy are another source of expert concern. 

The use of vaccine passports could “create a two-speed society with potential for marginalization and demonization of the non-vaccinated,” said Burci. 

“Another criticism is that it would make vaccination practically compulsory, which is an extremely sensitive point given the widespread vaccine hesitancy and [may] even generate pushback against vaccination programmes,” Burci added. 

COVID vaccine hesitancy is widespread in many European countries, with Italy (53.7%), Poland (56.3%), and France (58.9%) having among the lowest rates of vaccine acceptance, found a study reviewing the results from 31 peer-reviewed studies on COVID-19 vaccine acceptance. Ecuador, Malaysia, Indonesia and China had the highest rates of vaccine acceptance, among members of the public, the study found – while the lowest was in Kuwait, at only 23.6%. Meanwhile, in the Democratic Republic of Congo, another study found that less than 30% of health care workers would readily take up a COVID vaccine. 

Such low rates of vaccine acceptance also could pose a challenge for the widespread implementation of vaccine certificate programmes. 

“There is distrust of vaccines and pharma companies. So certifications will make people choose between their beliefs and distrust vs the benefits of getting vaccines,” said Venkatapuram.

In addition, vaccine certificates could lead to the gathering of “data that places marginalized and stigmatized people at risk, and could create a two-tier system that jeopardizes all our human right to work and to freedom of movement,” Dr. Sara Meg Davis, Senior Researcher at the Global Health Center at the Graduate Institute of International and Development Studies, told Health Policy Watch. 

National and Global Vaccine Equity

But one of the biggest barriers to the international rollout of a vaccine passport may be the small and disproportionate numbers of people to be vaccinated so far. Only about 8% of the adult population in Europe have received jabs: 

“Do we want to confer even more privilege on people who have so much privilege? Do we want to deny people a normal life if they can’t access vaccines?” Gostin tweeted. 

Beyond national equity, global equity is another concern, with vaccination campaigns in low- and middle-income countries only beginning recently and the first COVAX delivery of vaccines taking place on Wednesday. 

“Would we prevent travel & other joys of life primarily to rich country residents, when poorer nations can’t afford vaccines – especially when rich states hoard scarce vaccines,” Gostin tweeted. 

“One can also imagine that given extremely limited quantities of vaccines, if you add further benefits to getting vaccines, then they become even more valuable and people may start to distribute them even more unfairly or unjustly,” Venkatapuram said. 

“Despite the problems, there are policy makers and others who are interested in the big picture…The suffering of disadvantages of the few will be seen as acceptable, or will be ironed out as time goes on,” said Venkatapuram. 

Under Pressure from Travel Industry 

Whatever the the issues may be, EU politicians are also under pressure to act from the airline and travel industry. Ahead of the European Council meeting, the International Air Transport Association (IATA), a trade association representing 290 airlines globally, had urged EU leaders to implement a standardised travel solution. 

The IATA has already issued its own proposal for  a digital travel pass to verify and store details of travellers’ vaccination status and COVID-19 tests, sharing the results with government authorities before entry into the country. 

An overview of the IATA Travel Pass system presented at a media briefing this week.

According to Venkatapuram, it would be technically feasible for the EU to establish a vaccine certificate system within three months, as announced by EU officials on Thursday. 

“Policies can be made quite quickly…Different countries, or groups of countries may implement them. Like the EU,” said Venkatapuram. “The airline and travel industry is likely putting a lot of pressure on governments and summer is when people will want to travel. So yes, a policy could be put in place.” 

“The policy is easy to draft and enact. [Setting up] the actual infrastructure is a different story,” he added.

Image Credits: Twitter – EU Council Press, Press Office of the Federal Government, Deutsche Welle, Twitter, WHO, IATA.

COVID-19 vaccine administered in mid January at the Jacob K. Javits Center in New York City, which has been converted into a vaccination site.

A new COVID-19 virus variant recently detected in New York is “surging alarmingly,” according to the authors of two new pre-print studies by two teams of US researchers, from Columbia University and the California Institute of Technology. 

Even worse, the new variant, dubbed B.1.526, shares some key mutations in its “spike” protein structure with several other major variants of concern – which may enhance the SARS-CoV2 virus’ ability to evade the immune system and reduce vaccine efficacy.

The studies also predict that the variant is already on its way to becoming the predominant viral variant in New York and in the broader Northeast region of the United States. 

The most recent study – published by the Columbia University team on Thursday – which tested 1,142 samples from patients at the University’s Irving Medical Center, found that those infected with the new variant were on average six years older – and more frequently hospitalized than those infected with the original strain of SARS-CoV2. 

The B.1.526 variant first emerged in November 2020 and a steady increase in the detection rate was noted in the study – with an “alarming rise” of 12.3% in the past two weeks.

Mutations Can Give Variants ‘Evolutionary Fitness Advantage’

“As mutations develop, one of those variants may have an evolutionary fitness advantage allowing it to predominate over its ancestral virus and outcompete other variants,” Stephen Morse, Professor of Epidemiology at the Mailman School of Public Health at Columbia University, told Health Policy Watch.

Notably, the new variant identified in New York contains a key mutation in its spike protein, called the E484K mutation, which is also present in the B.1.1.7 and B1.351 variants, first detected in the United Kingdom and South Africa respectively. 

This mutation has been linked to reduced activity of neutralizing antibodies; studies have thus reported lower protective efficacy of vaccines against the variants with the E484K mutation. 

E484K has emerged in at least 59 lineages of SARS-CoV2, which is evident of convergent evolution – meaning it appeared in variants that evolved independently from each other. This may signal that the mutation is advantageous for the virus. 

According to the Columbia researchers, the B.1.526 variant “could threaten the efficacy of current antibody therapies and vaccines.”

“We find the rate of detection of this new variant is going up over the past few weeks. A concern is that it might be beginning to overtake other strains, just like the UK and South African variant,” David Ho, head of the Columbia University study, told CNN. 

“However, we don’t have enough data to firm up this point now,” he added.

Another Worrying Mutation Detected By Researchers

A separate pre-print study, led by researchers at the California Institute of Technology and published on Tuesday, used a variant database to detect the same emerging B.1.526 virus variant. The study found that as of February, the variant accounted for 25% of the COVID-19 genomes sequences in the state of New York. 

Among the other mutations identified in this B.1.526 variant, the CIT researchers detected another, the S477N mutation, which occurs near the binding site of multiple antibodies and has been associated with increased viral infectivity in previous virus lineages. 

“Given the involvement of E484K or S477N, combined with the fact that the New York region has a lot of standing immunity from the spring wave, this is definitely one to watch,” Kristian Andersen, a virologist at the Scripps Research Institute in San Diego, told the New York Times. 

Basic Public Health Measures Critical To Curb Variant Evolution 

“As long as the virus continues to circulate, variants will continue to emerge, and we don’t know what future variants may do,” said Morse. “We can reduce this risk by preventing viral transmission.”

This can be done by maintaining compliance with public health measures – masks, distancing, ventilation and hand hygiene – “at very least until everyone in the world is effectively vaccinated,” Morse said. 

Several experts, including the researchers involved with the Columbia University study, agree that systematic national and global genomic surveillance is needed to detect the variants in a more coordinated and consistent manner.

The UK, where the B.1.1.7 variant is widespread, has a program to sequence 10% of its positive SARS-CoV2 samples, which has assisted with the tracking of the variant. The United States, by contrast, is sequencing less than 1% of samples.

“There are probably far more variants already out there than we know about,” said Morse. “Luckily for us, they haven’t taken over the world yet, but we really do need systematic and meaningful global genomic surveillance.” 

Image Credits: Flickr – New York National Guard, Flickr – Metropolitan Transport Authority.

Mariângela Simão WHO Assistant Director-General on access to medicines

WHO Director General Dr Tedros Adhanom Gheyebresus on Friday issued his strongest call to date for a waiver on intellectual property related to COVID vaccines, medicines and other health products – which is due to be considered next week by the World Trade Organization’s General Council.

While welcoming a new UN Security Council resolution also approved on Friday, which calls for broader access to COVID vaccines in conflict zones and poor countries, Dr Tedros stressed that the UN resolution needed to be accompanied by concrete global actions of the kind that the WTO was positioned to take – by relaxing rules that restrict the generic manufacture and trade in patented COVID vaccines and health products. 

“I’m glad the UN Security Council has voted in favour of vaccine equity. And at the same time, if we’re going to take practical solutions, then the waiver of intellectual property should be taken seriously,” Tedros told the media at the body’s bi-weekly COVID-19 briefing.

“Voting for vaccine equity is important and we appreciate that. But concrete steps should be taken to waive intellectual property to increase production, increase coverage of immunisation and get rid of this virus as soon as possible.”

Referring to joint South African/India proposed TRIPS [Trade-Related aspects of Intellectual Property Rights] waiver to be discussed at the WTO, Tedros said that the pandemic was a “once-in-100-years occurrence”, so if the waiver “can’t be used now, when will it be used?”

The UN Security Council resolution, which was passed unanimously, calls for “the strengthening of national and multilateral approaches and international cooperation.. to facilitate equitable and affordable access to Covid-19 vaccines in armed conflict situations, post-conflict situations and complex humanitarian emergencies.”

It also calls on developed economies to donate vaccines to low- and middle-income countries and other countries in need.

Voluntary Licenses Could Also Be Tool For Increasing Manufacturing Capacity & Tech Transfer

WHO special adviser Bruce Aylward stressed that pharma should also issue more ‘voluntary licenses’ to firms in other countries for the generic manufacture of life-saving vaccines as a means of increasing vaccine manufacturing capacity and ease supplies. .

Mariângela Simão, WHO’s Assistant Director-General for Access to Medicines & Health Products, added that the WHO-managed COVID Technology Access Pool (C-TAP) offers a way to “share technology and issue voluntary licenses”.  However, so far there have been few, if any, industry takers in the COVID patent pooling plan. 

As a result, the WHO is “very interested in the outcomes ” of the upcoming WTO discussions, said Simão, saying: “Intellectual property is always a very sensitive topic in anything that’s related to access to medicines… Countries are looking for alternatives to increase production capacity and of course, this includes how to manage the intellectual property rights.

“We welcome any movement from countries to decrease and address current barriers to access as well as barriers to access that could be seen mid- and long-term. So this is quite an important discussion.”

Nigeria expects COVAX Vaccines Next Week

Also addressing the press conference were Chikwe Ihekweazu, Director General of the Nigeria Centre for Disease Control (NCDC) and Walter Kazadi Mulombo, WHO Representative in Nigeria

Chikwe Ihekweazu, Director General of the Nigeria Centre for Disease Control

Nigeria, which has a population of over 200 million, has secured close to 14 million doses of AstraZeneca vaccine through COVAX, and expects 4 million of these doses to be delivered next week, according to Mulombo.

Ihekweazu said that Nigeria had chosen not to do any bilateral deals with pharma suppliers, but rather to work only in a multilateral fashion through COVAX and the African Union.

“We will prioritise our health care workers, absolutely first,” said Ihekweazu. “We’re making some very hard decisions. I think at the end of the day, the key thing is we all recognise that we can only impact on transmission and reduce the burden in our hospitals if we target the right people, initially at the right pace, and at the right distribution.”

“Everything will come into play, not only the priority population groups but geography as well.  We have a very uneven outbreak in Nigeria. Lagos State, for instance, has 40% of all the cases in Nigeria, so it wouldn’t be a surprise if they are prioritised to a certain extent. But at the same time, we need to get some vaccines to every state in Nigeria. It’s a big country and a complex country, a lot of detailed planning is going into ensuring that the vaccines get to the right people as quickly as possible, so that we can get the outbreak under control.”