pandemic

Conquering the COVID-19 pandemic will inevitably be the main topic for discussion at the impending 74th session of the World Health Assembly, which begins Monday, 24 May. Global health experts weighed in this week at a series of briefings on what to expect from at the upcoming event. Geneva Solution’s Pokuaa Oduro Bonsrah reports:

The annual World Health Assembly will open online on Monday, with ministers of health from the World Health Organization’s 194 member states tasked with wading through a heavy agenda dominated by how to fix the COVID-ridden global health system and step up global response to future crises. 

“It is time to elevate the threat of pandemics at the level of other existential threats such as nuclear accidents,” Dr Joanne Liu, former International president of Médecins Sans Frontières (MSF) and a member of the Independent Panel for Pandemic and Preparedness Response (IPPR), said in an interview with Geneva Solutions. 

“This is why we call it a “Chernobyl moment in the 21st century”. If we want to move fast and in a sustainable way this scale up is necessary.” The findings of the independent review panel, set up by the WHO to examine the international COVID-19 response and published last week, will be at centre of discussions next week. 

What is the WHA and Why is it Important?

WHO Director-General Dr Tedros Adhanom Ghebreyesus delivers the closing speech for the World Health Assembly, 2019

As the decision-making body of the World Health Organization (WHO), the annual WHA meet-up gives member states the opportunity to chime in on WHO’s policy direction, governance, budget spending and health priorities.

The eight-day assembly, while officially hosted in Geneva, will take place online for the second year in a row, with over 2,750 people already registered to the event including civil society organisations. While COVID-focused, the Assembly will also tackle a range of health issues from antimicrobial resistance to non-communicable diseases. Exhibiting the largest agenda ever, with over 72 items, global health experts shed light on areas that they expect will dominate this 74th session.

Pushing for Legally Binding Instruments to Fight Pandemics

Charles Michel, President of the European Council

Hot on the agenda are talks for a “pandemic treaty” or convention to better prevent, prepare and respond to infectious disease outbreaks. First floated by the European Council’s president Charles Michel in November, the idea has so far been backed by 25 countries, including the WHO. However some of the world’s major powers, including the US and China, have yet to commit. 

The organisation’s treaty-making powers have only been used once in its history to create the Framework Convention on Tobacco Control (FCTC); it is one of three decision-making tools the WHA has at its disposal, including its recommendation powers used the majority of the time, and its regulation tool that formed the basis of the International Health Regulations.

Speaking at a press briefing on Wednesday, Steven Solomon, principal legal officer at the WHO said: “What’s so interesting about this upcoming World Health Assembly is that all three tools will be considered for possible needs in response to the pandemic,” Solomon noted.

Antoine Flahault, director of the Institute of Global Health at the University of Geneva

Although the intricacies of the treaty are yet to be discussed, Dr Antoine Flahault, director of the University of Geneva’s Institute for global health, said a pandemic treaty should guarantee the power of investigation from an early stage.

“With COVID, it would have been useful to have a pandemic preparedness treaty to allow full, independent, rapid investigation into the inception of the pandemic. As we have seen in the China example and the investigation in Wuhan, we missed the chance to scrutinise the origins of the pandemic early on, which has potentially devastating effects” said Flahault, also speaking at the briefing.

Bearing this in mind, when convening a Public Health Emergency of International Concern (PHEIC), the formal declaration by WHO of “an extraordinary event which is determined to constitute a public health risk to other states through the international spread of disease”, the pandemic should be treated in a similar way to the treaty on the non-proliferation of nuclear weapons or World Trade Organizations directives, “giving it the same level of power and impact, so that when violated sanctions are imposed,” he added.

In Liu’s opinion this should go beyond agreeing on rules, and would instead like to see more “action and accountability.”

Cementing the Power of the WHO to Fight Off Future Health Crises and Eradicate the Current Pandemic

The Independent Panel Team

At a more informal level, countries have been working amongst themselves to agree on how to strengthen WHO preparedness and response to health emergencies, and it is hoped recommendations emerging out of these discussions will be made at the WHA, according to Solomon.

In the recent report by The Independent Panel, co-chaired by the former prime minister of New Zealand, Helen Clark, and president of Liberia, Ellen Johnson Sirleaf,  weak links were found in both preparedness and response – including a broken global emergency alert system, a hesistant WHO and patchy country responses.  Lessons from previous pandemics were not incorporated either, the panel found, citing, for example, the 2009 H1N1 influenza response. 

Along with supporting a Pandemic Treaty, as a way to make pandemic response a higher political priority back by an stronger legal mandate, the Independent Panel also urged that WHA member states push for the creation of a Global Health Threats Council, with plans to put the idea forward at the United Nations General Assembly (UNGA) in September.

“By having this at the highest level it gives it the attention it deserves. We want it at the UNGA after discussion at the WHA, giving heads of states and governments the opportunity to take up ownership it needs,” said Liu.

WHO’s Political Independence

Current WHO Director General Dr Tedros Adhanom Ghebreyusus

In order for the WHO to flourish and have the appropriate means to address the current and future pandemics, the global health experts also believe the political independence of the WHO also needs to be frankly  discussed as  a top priority at the WHA.

This includes a recommendation by the Independent Panel that member states limit the WHO director general’s tenure to just one term of no more than seven years – as compared to the system today, whereby he can hold office for up to two, five year terms. 

The hope is this would shield the WHO chief from political pressures during his tenure – and from pressures to collude  with certain member states in order to secure re-election for a second term.

Instead of a seven-year non-renewable-term, Flahault, however, advocates for a five-year non-renewable term. Still, the main message of independence and autonomy  remains the same.

Governance and Funding Without Strings Attached

Bill Gates, chair of the Bill and Melinda Gates Foundation

When it comes to coughing up cash, member states have stalled on increasing their contributions. Philanthropic actors such as the Bill and Melinda Gates Foundation have filled the void by becoming major funders of global health and the WHO; but this has in turn been met with criticism from civil society as well as some member states for giving external actors too much influence over the organization.

Both Flahault and Liu say the blame should be shifted from philanthropies – to that of countries that are not playing their role. “The total WHO budget for example is hardly above the budget of most teaching hospitals in high income countries, such as University of Geneva Hospital,” explained Flahault.

Read also: Bill Gates is ready to spend more on global health – governments should too, says foundation official

The WHO should be robust and agile enough to anticipate, and respond to, health crises. As such the question of reform, including of its governance structures, also is a looming issue at WHA meetings.   

But for Flahault institutional reform can suck up a lot of energy and time – without yielding enough results. Instead, he says that the focus should be on giving the WHO the mandate to coordinate and lead on health matters.

The Question of Vaccine Equity

Civil society groups demonstrate outside embassies of the United States, United Kingdom, Australia, Canada, Brazil, and other countries which oppose a temporary WTO patent waiver on COVID-19 health products.

“One of the priorities of the WHA to be discussed with urgency is the production of vaccines, technology transfer and patent waivers”  Flahault also said.

While the final decisions around a proposed intellectual property waiver on Covid vaccines and other health products will be made in the World Trade Organization, WHA statements and discussions will also have an influence. 

The WHA debate will also come on the heels of a critical Global Health Summit of the Group of 20 (G-20). Outcomes of Friday’s G-20 meeting, hosted by the Italian government and the European Commission, will also set the texture of high-income country positions in the WHA proceedings.  

A draft G-20 “Rome Declaration” seen by Health Policy Watch,  makes no mention of the proposed IP waiver – referring only to the potential for “voluntary… technology transfer and licensing partnerships.”  And although the leaders of the G20 will also affirm their support for the WHO and Gavi co-sponsored ACT Accelerator initiative, which aims to hasten the distribution of Covid-19 vaccines, drugs and tests across the world, they fall short of clearly committing desperately needed new funding to it. 

A weak G-20 commitment would be a blow to the WHO-backed scheme, Flauhault said, adding that if there was sufficient political will, the US and its allies could potentially vaccinate the whole planet.

“It would cost about 27 billions of dollars to immunize the world population, which is affordable. A country like the US, which I am not saying should vaccinate the world, could however do so if it wanted to. If not high income countries should invest in doing so as soon as possible,” Flahault said.  

At the same time, this year’s WHA will see solid support from the United States, following the change in the administration – and Washington is expected to be a big player in the proceedings. 

Read also: Fauci signals new chapter in US relations with the WHO

“The US body-language is quite important because they have recently been a big defender for multilateralism,” said Liu.

“These are good signals for global health and particularly during the pandemic.  They are pushing back on the waivers of patents, and should also really consider funding the Covax equitable vaccine sharing scheme,”  Flahault added. 

COVID Will Become a Pandemic of the Poor if Neglected Now

The pandemic may become a disease of the poor if nothing is done; coronavirus lockdown in a Roma community in Romania. Makeshift barracks leaves it difficult to follow social distancing and basic hygiene rules.

In the absence of strong action by wealthy donor countries at the G-20 and the WHA, the trajectory of COVID risks the disease becoming a “pandemic of the poor”, Liu warns.

For Liu, if the opportunity is not seized at this year’s WHA to adequately address the WHA, by taking bold decisions and committing to actions then she believes COVID will become an endemic disease, mostly but will be limited to low and middle income countries, whilst high income countries leave the rest of the world behind.  

 “My biggest worry is that high income countries will pull themselves out of the grip of COVID-19 because they will vaccinate the population, and have herd immunity. Low and middle income countries will then be stuck, just like what happened with  HIV and Tuberculosis,” she said. 

The Question of Taiwan

Former Taiwan Vice President Chen Chien-jen in an interview in 2017 discussing the absence of an invitation for Taiwan to attend the World Health Assembly.

In 2008, Taiwan was invited every year to the WHA as an “observer” but since 2016, this invitation – issued at the discretion of the WHO Director General – ceased. This was after Taiwanese elections brought a new government into power with a more hard-line stance toward China – leading Beijing to oppose the seat for Taiwan in the Assembly – even as an observer.  

In the wake of the pandemic, which saw allegations of a Chinese cover-up of the SARS-CoV2 virus origins, as well as a refusal then and now to share critical data around the outbreak’s early days,  there have  been growing  calls to renew the invitation to Taipei – beginning already last year.  

For this year’s 74th WHA, some 13 WHO member states have called for Taiwan to be allowed to participate, with the issue set to be discussed on Monday.  This includes the G-7 (Group of Seven most industrialized countries), which have formally  endorsed Taiwan’s attendance. 

The participation of Taiwan is critical for scientific reasons,  says Flahault. “In global health and security terms, there is absolutely no doubt that Taiwan should be one of the full members of the WHA. The way the country has managed the pandemic offers great tools and lessons which will be important knowledge to share at the WHA and it is a pity if we do not get this,” he said. 

From Taiwan to vaccine equity, the challenge throughout all of the WHA debates will be for individual member states to rise above their own narrow set of national or geopolitical interests – recognising that the pandemic is a threat to all.  

“What I expect from the WHA is that member states show exemplary leadership. This year has to be a game changer in terms of response and preparedness to pandemic,” said Liu.

Republished from Geneva Solutions. Health Policy Watch Watch is collaborating with Geneva Solutions, a new non-profit Geneva platform for constructive journalism covering International Geneva

Image Credits: WHO / Antoine Tardy, Antoine Flahault, IPPR, UNGA, Tadeau Andre/MSF , Thomas Hackl/Flickr, Flickr – Taiwan Presidential Office.

ip
A network analysis of COVID-19 mRNA vaccine patents

Governments and pharmaceutical companies alike must work together in combating the ‘virus of intellectual property (IP) monopolies over COVID-19 vaccines – which  further exacerbates inequality and lack of access to vaccines for vulnerable groups. 

That was the uptake of a group of experts speaking at a webinar Wednesday on “The Virus of IP Monopoly Capitalism”’ hosted by the Society for International Development (SID). 

“What we need is collective intelligence, not the segmentation of different actors, allowing each person possible to participate in the production process,” said Ugo Pagano of the Italy-based Siena University, during a webinar 

The symposium discussed current global tensions between proponents of the proposed World Trade Organization (WTO) TRIPS waiver to accelerate access to COVID-19 vaccines – and its pharma industry opponents who support a system that they say stimulates innovation – even if the benefits may be unevenly distributed.  

Intangibles Controlling Global Economy

The smiling curve of intangibles – Investor state dispute settlements shift power to private actors and increases value of intangibles

IP, or ‘intangibles’, are “‘considered a lion’s share of powers concentrated in the global economy”, said Susan Sell of the Australian National University.

Intangibles are IP trademarks and patents that play an outsized role in the global economy, with the political and economic powers that own those goods controlling the value of oft-essential products and services. 

In terms of the COVID-19 pandemic, that can include patents governing tests, Personal Protective Equipment (PPE), vaccines, and medicines. 

“It’s a winner-takes-most system right now – and those who own the intangibles are the winners in this system,” said Sell. 

This means that developed countries and pharmaceutical companies are the “winners” of this system, said Sell, with developing countries and vulnerable groups struggling to access essential equipment and treatment, worsening inequality and poverty, and leading to many unnecessary COVID deaths. 

IP Regulation is Not Sustainable 

IP

Experts argued that protecting IP so as to stimulate innovation is not a sustainable model. The COVID crisis has forced the world to rethink issues around the efficiency and efficacy of IP regulation moving forward.

“[It is now the time] to start raising some questions about the sustainability of [IP regulations],” said Mohammed El Said, of the University of Central Lancashire, United Kingdom.

“The COVID-19 pandemic is not the first pandemic and it won’t be the last. However, our ability in dealing with and actually having the correct and right mechanisms in limiting its impact will, [in turn] impact how we’re actually going to deal with future occurrences of this nature.” 

Although more and more of the world’s population are now able to access COVID vaccines, which El Said called a ‘turning point in the fight against the pandemic’, sufficient supplies have yet to reach developing countries. 

Vaccine nationalism is ‘counterproductive’ to the vaccine supply problem, because while most developed countries have access to vaccines, the pandemic will still persist in other countries and regions that are now labeled hotspots, such as India and Latin America and the Caribbean, prompting all the hard work in fighting the vaccine to be undone. 

Future of Global Economy – Innovation Towards Delivering Global Public Goods 

Susan Sell, School of Regulation and Global Governance, Australian National University

The future of the global health economy must shift towards a model where innovation, which is now left to the markets, would instead be the basis for a model that can deliver global public goods.  

There’s a ‘reduced commitment to social policy in the face of imperatives of finance capitalism’, said Sell.  “It’s really about profits, it’s really about shareholder value.”

This, according to her, causes economic powers to block social and reform initiatives if they have the potential to threaten either profits or shareholder value. 

Evidence of this can be seen in the resistance by countries with large pharma interests, such as Germany, to waiving patent protections. German officials believe that the United States’ support of the TRIPS waiver would create ‘severe complications’ for the production of vaccines, a German government spokeswoman told Bloomberg recently. 

The spokeswoman argued that the limiting factor for the production of vaccines is manufacturing capacities and high quality standards, not the patents, countering the point made by experts during the webinar to shift  market innovation towards increased accessibility of global public goods.

Monopoly on Knowledge Impacts Vaccine Production and Supply

Els Torreele, Institute for Innovation and Public Purpose; University College London

However, Els Torreele of the University College London asserted at the webinar that the protection of IP through monopolies, also impacts production capabilities and technologies, leading to vaccine hoarding and the buying up of available stock. 

“[These monopolies] have led us to the situation that we’re in,” said Torreele, noting that the public ends up on the ‘losing end’ of this situation. 

“We’re confronted with this highly unequal and inequitable situation”, she added.

As a way forward, Torreele cited the recommendations contained in the recent report of The Independent Panel to transform the Access to COVID-19 Tools Accelerator (ACT-Accelerator) into a truly global end-to-end platform for development and rollout of vaccines, diagnostics, therapeutics, and essential supplies. 

“We need to make sure all our efforts result in equitable access.” 

Image Credits: Nature Biotechnology, OECD, Open Source/Flickr.

Malawi Health Minister Khumbize Chipondo places a bag of COVID-19 vaccines in an incinerator in Lilongwe. The country burned nearly 20 000 expired AstraZeneca vaccines on Wednesday.

Malawi on Wednesday burned nearly 20,000 doses of expired AstraZeneca COVID-19 vaccines. The government move happened shortly after the Serum Institute of India (SII) announced that it would only resume its export of the precious vaccines to the rest of the world at the end of 2021 – due to the still burning pandemic crisis on the Indian subcontinent. 

Malawian health authorities said that they had incinerated 19, 610 doses of the vaccines, produced by the SII, at the Kamuza Central Hospital in the capital Lilongwe – which the country had been unable to administer prior to expiration.

The vaccines were the remainder of a batch of 102, 000 doses that arrived in Malawi on 26 March – with some doses marked with an expiration date that was just 18 days later, or 13 April, said health secretary Charles Mwansambo in a statement.

Decision Goes Against Pleas by WHO and Africa CDC to Use the Vaccines

The decision to destroy the vaccines goes against early pleas by the Africa CDC and the World Health Organization. Last month the two organisations urged African countries not to destroy COVID-19 vaccines that had passed their expiration dates, saying they were still safe to use.

Africa CDC director, John Nkengasong, citing the example of the Democratic Republic of Congo, said that instead of destroying vaccines, countries should redistribute vaccines that they cannot use to other Member States.

“During a time where access to COVID-19 vaccines is particularly difficult for Africa, utilising an entire vaccine consignment could have been accomplished without much challenge,” said director Africa CDC, John Nkengasong said on 6 May during a weekly briefing.

If, for example, governments set a goal of administering a minimum of 5, 000 vaccine doses per day for just 10 days, an entire consignment of vaccines would be fully utilised well before the listed manufacturer expiration date, said Nkengasong.

Malawi’s destruction of the vaccine should be a lesson to other countries to better plan their vaccination programmes, said Professor Pontiano Kaleebu of the Uganda Virus Research Institute and London School of Hygiene and Tropical Medicine

“What happened in Malawi is a learning experience and should be used to encourage people to get vaccinated so that the vaccines do not expire elsewhere. Many people in Africa have not come to get the vaccine, which is not what we expected. It is a big problem that needs to be addressed,” Kaleebu added.  

Said Nkengasong: “Given the urgent need to save as many lives as possible, countries were informed by the Africa CDC to vaccinate quickly. It is indeed, critical to use such donations in a timely fashion in order to save lives and bring the pandemic to an end on the continent”.

Message To Not Destroy Came Too Late

The Malawian government however contends that the communication from the WHO and Africa CDC came too late.

Health Ministry spokesperson Joshua Malango telling Health Policy Watch that by the time they received communication they had already removed the vaccines from the cold storage systems and it was deemed unfit for use. 

“By the 14th of April we had already removed the unused COVID-19 vaccines from the refrigerators,” said Malango, adding that the communication from WHO came in after Malawi had sought clarity from the SII, from which the vaccines were procured. The SII, said Malango, had formally responded , indicating an approved “shelf-life extension” for an additional three months, through 13 July 2021.

Out of a population of about 18 million people, the country has recorded 34,232 confirmed coronavirus cases and 1,153 deaths. To date,  the country has vaccinated 330,336 people.

The country received  360,000 AstraZeneca doses from the COVAX facility in March and received another batch of 50,000 of the same dose from the Indian government.  The expired doses were part of a donation from the African Union. 

At a media briefing, Mwansambo assured Malawians that “we still have adequate stocks of COVID-19 vaccines”, and that a second dose of AstraZeneca would be administered  to high-risk groups that had received their first dose, beginning on 3 June. Mwansambo also told reporters that health officials had been concerned that using expired vaccines could scare off people from getting vaccinated.

WHO and partners released guidance on COVID-19 vaccination planning and deployment for national governments, with the aim to help them design strategies for the deployment, implementation, and monitoring of COVID-19 vaccines and better integrate their strategies and financing to boost efficiency.

The global health body advised countries that prior to receiving the vaccines they should thoroughly prepare and ensure the logistics including cold chain maintenance, training of health workers, a system to manage the demands of injections devices-syringes and needles, and to follow adverse events. Countries also have to pre-register and create databases for vaccine uptake.

Exports of AstraZeneca from SII by End of 2021

Meanwhile, in a statement on Tuesday, Serum Institute of India chief Adar Poonawalla said that SII is scaling up its manufacture of vaccines, but would be prioritising India for the remainder of 2021.

“We also hope to start delivering to COVAX and other countries by the end of this year,” he said in the statement.

Poonawalla said there has been intense discussion between SII, the Indian government and other vaccine manufacturers in the past few days on the export of vaccines.

Although SII had commitments to the COVAX facility, he said that the domestic needs still take precedence and the vaccination drive in India “cannot be completed within two to three months, as there are several factors and challenges involved”.

 

Image Credits: Joshua Malango.

Dust off your passports: The European Union (EU) has agreed to open up its borders to COVID-19 vaccinated travellers after more than a year of restrictions which virtually banned the entry of tourists from outside the bloc.

The European Union Council (EU) on Wednesday agreed to relax travel restrictions on entry by foreign tourists – clearing the way for countries in the bloc to open up their borders to COVID-19 vaccinated travellers after more than a year in which visits by most non-EU passport holders were refused. 

With the summer tourism season approaching, ambassadors of the 27 countries approved the recommendation which was proposed by the European Commission, its spokesman Christian Wigand told reporters.

Wigand said the agreement still needed to be formally adopted by the European Council, but that it is something “which we understand will happen very soon”.

Travellers who received EU-approved COVID-19 vaccines will be allowed entry into the bloc. COVID-19 vaccines authorised by the European Medicines Agency (EMA), the bloc’s drug regulator, include those by Pfizer, Moderna, AstraZeneca and Johnson and Johnson.The EMA hasn’t approved any vaccines from Russia or China as of yet but is looking at data on Russia’s Sputnik V jab.

The EU also agreed to ease the criteria for nations to be considered a safe country, from which all tourists can travel. Up to now, that list included only seven nations – Australia, Israel, New Zealand, Rwanda, Singapore, South Korea, Thailand and China.

Wigand said the EU’s European Centre for Disease Prevention and Control is to give advice on the list of non-EU countries with a “good epidemiological situation” from where travel is permitted.

“What will be adopted are the criteria for revising the list and also for the other recommendation on making it possible for vaccinated travellers to come to Europe,” said Wigand.

EU Council Will Expedite Proposal 

Earlier this month the EU Commission president Ursula von der Leyen revealed the bloc’s plan “to revive the tourism industry and rekindle cross-border friendships”.

“We propose to welcome again vaccinated visitors and those from countries with a good health situation. But if variants emerge we have to act fast: we propose an EU emergency brake mechanism,” Von der Leyen said at the time.

Wigand did not give a timeline on when travellers could start making bookings to visit the EU, but said: “We have seen in the past the Council moving very quickly on this”.  Wigand also made no reference to whether people who have recovered from COVID would also be included in the plans. 

Individual EU member nations will in any case, continue to exercise discretion over whether to require proof of a negative coronavirus test, a quarantine period after arrival, and other control measures. In March the European Commission released a proposal establishing a framework for a “Digital Green Certificate”, clearing the way for a vaccine certificate system to be set up by the summer. 

The EU imposed strict measures, including closing its external borders, in March 2020 to contain COVID-19 outbreaks, but the 27 ambassadors now say many of those restrictions on non-essential travel should be eased.

Member States have also agreed to set up a coordinated emergency mechanism to rapidly suspend third country arrivals in the event of deterioration in the health situation due to the appearance of coronavirus variants.

Dust Off Your Passports: Borders Are Opening Up

EU nations have been struggling throughout the pandemic to prop up their vital tourism industry, and now hope to recover some income over this year’s peak summer season.

There was building pressure to open up borders – with some countries such as Greece and Spain, which depend heavily on tourism, already making moves.

On May 14, Greece lifted travel restrictions for tourists who have proof of vaccination, proof of recovery from COVID, or a negative COVID-19 PCR test.

Germany has eased quarantine requirements after travel for fully vaccinated people – although there are still restrictions upon the entry to the country by non-EU citizens. 

On Monday, the UK lifted a ban on non-essential travel, saying that Brits could now go on holiday to the other 12 countries on a UK green light list of low-risk locations.

Image Credits: Wikimedia Commons: Nemo.

Major global vaccine manufacturers and biotech companies have committed to a five-point plan to “advance COVID-19 vaccine equity”, focusing on “responsible dose-sharing” and “maximizing production”. 

They pointed out that, within a few months, vaccine doses had gone from “zero to 2.2 billion” and were predicted to reach 11 billion doses by the end of 2021 – “enough to vaccinate the world’s adult population”. 

“Critically, however, COVID-19 vaccines currently are not equally reaching all priority populations worldwide,” said a media statement issued by the Association of the British Pharmaceutical Industry (ABPI), Biotechnology Innovation Organization (BIO), European Federation of Pharmaceutical Industries and Associations (EFPIA), International Council of Biotechnology Associations (ICBA), International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), Pharmaceutical Research and Manufacturers of America (PhRMA) and Vaccines Europe. 

Dose-Sharing and Optimising Production

To enable more equitable distribution, the vaccine manufacturers and biotech companies committed to stepping up dose-sharing by working with governments with enough supply to “share a meaningful proportion of their doses with low- and lower-middle-income countries in a responsible and timely way through COVAX or other efficient established mechanisms”.

Second, they committed to optimising production, “including through additional collaborations with partners that can produce significant quantities”.

Third, they said they would identify trade barriers that needed to be eliminated. To do this, they aim to work with the new COVAX Supply Chain and Manufacturing Task Force that is identifying production gaps and facilitating “voluntary matchmaking for fill and finish capacity”.

They would also urge governments to work with the World Trade Organization (WTO) to “eliminate all trade and regulatory barriers to export” and to “adopt policies that facilitate and expedite the cross-border supply of key raw materials, essential manufacturing materials, vaccines”.

They also committed to supporting country readiness, “particularly in low- and lower-middle income countries, to ensure that they are ready and able to deploy available doses within their shelf life”.

More Innovation

Finally, they committed to driving “further innovation”, and “prioritise the development of new COVID-19 vaccines, including vaccines effective against variants of concern”.

At the World Health Organization’s (WHO) bi-weekly media briefing on Monday, WHO Director Dr Tedros Adhanom Ghebreyesus appealed to wealthy countries to urgently donate vaccines to COVAX, which has a 190-million shortfall.

Tedros also called on various major pharmaceutical companies to either increase their COVAX commitments, speed up delivery or reach agreements with the vaccine platform.

Meanwhile, UNICEF Executive Director Henrietta Fore quoted research which showed that G7 and European countries could make 153 million vaccine doses available if they shared 20% of their supply for June, July and August.

Tedros added that manufacturers needed to give the right of first refusal to COVAX for any additional dose capacity and also enter into their deals with companies like Teva, Incepta, Biolyse and others that are willing to use their facilities to produce COVID-19 vaccines.

This follows a report by Politico that large vaccine manufacturers had so far failed to take up offers by smaller manufacturers – Bangladesh’s Incepta, Canada’s Biolyse, Israel’s Teva, and Bavarian Nordic in Denmark – to assist with vaccine manufacturing.

Bruce Aylward, WHO’s lead at COVAX, stressed that the vaccine platform’s aim to vaccinate 20% of the world’s people by the end of the year was “at risk” because of supply shortages.

 

Image Credits: NBC, NBC News.

COVID-19 vaccination in Lima, Peru.

Sanofi and GSK will test their two-dose SARS-CoV2 vaccine candidate as a booster for other vaccines during its phase 3 trial, following a phase 2 trial that showed that it triggered a strong neutralizing antibody response in people previously vaccinated.

Those who had already been vaccinated showed a strong response after one jab, indicating that that the candidate vaccine could be used as a “booster” shot against variants, according to a press statement from Sanofi on Monday.

The as-yet-unpublished results showed “95% to 100% seroconversion following a second injection in all age groups (18 to 95 years old) and across all doses, with acceptable tolerability and with no safety concerns,” according to Sanofi.

The phase 2 trial, which started in February in the US and Honduras, consisted of 722 volunteers split equally between those aged 18 to 59 year-olds and those 60 years and above.

The adjuvanted recombinant vaccine is based on one of Sanofi’s seasonal influenza vaccines in combination with GSK’s pandemic adjuvant, and it targets the SARS-CoV2 virus spike protein.

“Our phase 2 data confirm the potential of this vaccine to play a role in addressing this ongoing global public health crisis, as we know multiple vaccines will be needed, especially as variants continue to emerge and the need for effective and booster vaccines, which can be stored at normal temperatures, increases”, said Thomas Triomphe, Executive Vice President and Global Head of Sanofi Pasteur on Monday. 

‘Shows Potential to Address Variants’

GSK president Roger Connor added that the data showed “the potential of this protein-based adjuvanted vaccine candidate in the broader context of the pandemic, including the need to address variants and to provide for booster doses”. 

The companies intend to start a phase 3 trial “as soon as possible to meet our goal of making it available before the end of the year”, added Connor.

Around 35,000 people will be enrolled in the phase 3 trial, which will include “booster studies with various variant formulations in order to assess the ability of a lower dose of the vaccine to generate a strong booster response regardless of the initial vaccine platform received,” according to the media release.

Booster shots may be necessary to address new virus variants that are able to escape the neutralising antibodies of earlier vaccines.

Results of the Novavax vaccine, published in Nature in March, support this concern. The vaccine was 90% effective against the UK-identified B1.17 variant but only 49.4% effective against the B1.351 variant first identified in South Africa. Newer variants identified in Brazil and India have not yet been tested against vaccines.

But Columbia University Professor David Ho, the Novavax study’s lead author, said that his study and other data showed that “the virus is traveling in a direction that is causing it to escape from our current vaccines”. 

“If the rampant spread of the virus continues and more critical mutations accumulate, then we may be condemned to chasing after the evolving SARS-CoV-2 continually, as we have long done for influenza virus,” Ho said in an interview. 

 

Image Credits: International Monetary Fund/Ernesto Benavides.

Pictorial warnings on cigarette packs are one of the measures required by signatories to the Framework Convention on Tobacco Control.

ISLAMABAD – Pakistan health authorities are struggling to fully implement a World Health Organization (WHO) treaty to help reduce tobacco-related diseases in the country – some 17 years after they ratified it.

Furthermore, the country’s health ministry recently announced the termination of the services of a number of staff members in its Tobacco Control Cell (TCC), the only government body addressing tobacco consumption, by the end of May.

When challenged, government officials claimed that its tobacco control work would not be affected, but tobacco control activists fear that they have given in to industry pressure to close down the TCC.

Pakistan signed the Framework Convention of Tobacco Control (FCTC) in 2004, and in terms of its guidelines, signatories are duty-bound to increase excise duty on cigarettes by up to 70% and impose pictorial health warnings covering up to 85% of cigarette packs.

Countries also undertake to monitor tobacco use, protect passive smokers, provide facilities to help people to quit tobacco and enforce bans on tobacco advertising, promotion and sponsorship.

Not Enough Taxes or Pictorial Warnings

But activists believe that the country’s Ministry of National Health Services Regulations and Coordination (NHSR&C) has failed to achieve a significant increase in federal excise duty (FED) or place sufficient pictorial health warnings on cigarette packs. 

“So far, Pakistan has increased the FED to 45% and pictorial warning to 50% only,” says Sanaullah Ghuman, Secretary General of the Pakistan National Heart Association (PANAH).

Despite vowing to impose a “health levy” on tobacco and sugary drinks back in 2018 and to spend the proceeds on the health sector, this levy has never been adopted  – and some believe it is being deliberately delayed. 

Ghuman believes that the future of the levy hangs in the balance as it has been in line for three years to become a law. He also believes that Pakistan should increase taxation on tobacco products, but said this issue was given very low priority in the current budget.

Despite a recommendation from the Ombudsman Court and Law Department that the Federal Board of Revenue (FBR) should “immediately” implement the health levy, the matter is on backburner in FBR, added Ghuman.

In 2014, the health ministry announced that it would introduce health pictorial warnings to cover 85% of cigarette packs but this has never been implemented and warnings currently only cover 60% of packs.

“India, Sri Lanka, Bangladesh and Iran all have comparatively higher pictorial size warnings on cigarette packs and high prices when compared to Pakistan,” said Ghuman.

Huge Cost of Tobacco Use

The senator’s cigarettes were distributed to MPs branded as ‘Senate House’.

Pakistan has an estimated 22 million smokers and is one of 15 countries with a high burden of tobacco-related diseases. Over 30% of men and almost  6% of women smoke and, according to the TCC website, 163,360 people died in 2017 due to tobacco use in the country. 

Between 30-40% of Pakistanis die of cardiovascular diseases and tobacco-induced heart attacks are one of the major reasons for this, according to a study by Center for Global and Strategic Studies (CGSS) published in January.

In addition, 1.5 million cases of oral cancer and almost half of tobacco users contracted tuberculosis, according to the study.

Discouraging tobacco consumption in public remains a tough task for the Pakistan government as its own ministers have been found violating smoking in public places.

The current Minister for Interior smoked during a press conference in his previous portfolio as minister for railways.

Meanwhile, a senator who is also a cigarette manufacturer was exposed in the media for distributing cigarettes branded ‘Senate House’ in the parliament.

However, Prime Minister Imran Khan, who also established the first cancer hospital in the country, is in favour of taxing tobacco products.

According to a document obtained by Health Policy Watch, Dr Faisal Sultan, the Special Assistant on health to the Prime Minister (SAPM), urged the then advisor to finance, Dr Abdul Hafeez Shaikh, to impose the proposed health tax on tobacco and sugary drinks.

According to the letter: “Health tax on tobacco @Rs10/per pack of 20 cigarettes and on carbonated drinks @Rs1/250 ml bottle through Finance Bill 2019-20 shall be imposed”.

“The revenue generated through this health tax will be earmarked for the health sector development over and above its routine budgetary allocation. The Finance Bill will also include measures to check illegal manufacturing and illicit trade of cigarettes and other tobacco products,” the letter added.

Malik Imran, head of Tobacco Free KidsPakistan, told Health Policy Watch that the national exchequer had lost PKR 615 billion (around $4.3 billion) by not increasing tobacco taxes.

“It’s about 1.6% loss in GDP,” Imran said, adding that, due to inflation, the tax on cigarettes was effectively at the 2016 level of 33% instead of the framework-recommended 70%.

According to a study conducted by a semi-government department Pakistan Institute of Development Economics (PIDE), the cost of treating smoking-realted cancer, cardiovascular and respiratory diseases was estimated to be Rs437.8 billion ($6 billion) in 2018–2019.

In comparison, the total revenue collected from the tobacco sector covered only around 20 percent of the total cost of smoking.

Health Levy is Still on Track, Says Official

A senior official of the federal health ministry, who requested not to be named, said that one project of the TCC is going to be closed at the end of May and staff contracts terminated.

The official said that “it does not affect FCTC work”.

The official added that the health ministry had followed up on the health levy bill with the  law division and the Federal Board of Revenue was expected to submit it as an ordinary bill in the parliament after the budget, because it is not a money bill.

The official also said that, at present pictorial health warnings were at 60% of packs as the decision to increase this to 85% was being challenged in court.

The official claims that “we are working on raising FED on cigarettes in this budget”.

The Prime Minister’s Aide on Health, Dr Faisal Sultan, said that the TCC had not been dissolved, the health levy was being worked upon and the health ministry was pushing for it and that the pictorial warnings were likely be enhanced.

The WHO’s country office did not respond to a number of requests for comment although its communication officer ,Maryam Yunus, acknowledged receiving the queries. 

The letter informing the Tobacco Control Cell that its pictorial warnings project was being closed.
Intestinal worm infection can increase the likelihood of genital herpes, according to a new study

NAIROBI – New research has found that intestinal worm infections may put women at increased risk of sexually transmitted viral infections (STIs) – a discovery that researchers hope will help health workers to explain why STIs can be more virulent in areas such as sub-Saharan Africa, where worm infections are common.

The study, published in Cell Host and Microbe, discovered that intestinal worm infection can change and increase the likelihood of Herpes simplex virus type 2 (HSV-2) infection, which is the main cause of genital herpes.

The study was conducted by an international team led by researchers from the University of Cape Town (UCT) and in collaboration with the University of Birmingham, University of Bonn, Norwegian University of Science and Technology, University of Liege and the French National Centre for Scientific Research

“We have found that intestinal worm infection can change female reproductive tract (FRT) immunity by causing a worm associated immune response in the FRT, even though the worms never reside there,” said Dr William Horsnell from UCT’s Institute of Infectious Disease and Molecular Medicine, the lead author.

“In particular, we found that worms induced eosinophils in the vagina. These are immune cells associated with anti-worm immunity and can cause allergic disease. Their role in the FRT is not known.”

Horsnell added that if the eosinophils immune cells were “targetted with molecules that can deplete them, we can prevent the increase in pathology”.

“This suggests that this pathology can be targeted and may be prevented or reduced by using existing drugs. The research also shows that eosinophils can have a very important role to play in vaginal immunity. This has never been so strongly demonstrated before,” he added.

More Research Needed

Dr William Horsnell from UCT’s Institute of Infectious Disease and Molecular Medicine

The correlation between STIs and intestinal worm infections is an area of research that has not been given much attention in the past, said Horsnell, despite the fact that the rates of intestinal worm infections in sub-Saharan Africa are “huge,” especially since worm infections in the intestine can change immunity in other parts of the body.

For example, even though researchers would expect 10-20% of study participants to have an active ascaris or hookworm infection, evidence of infection was well over 50%, explained Dr Horsnell.

While UCT has an active vaginal mucosal (mucous membranes of the vagina) immunity unit that looks at microorganisms that influence vaginal immunity, researchers had “never looked at [whether] worm infection may also indirectly influence the vagina,” Horsnell noted in an interview with Health Policy Watch.

Research Benefits

According to the researchers, these findings were very unexpected. “We show that worm infections that never colonise the vagina cause a strong change in the vaginal immunity,” he explained.

Until now, Horsnell maintains, research into STIs has largely neglected the role of worm infections.

“Based on my other work looking at the effect of these infections on tissues not infected, I thought it was time we looked at the effect on STIs,” he said.

Horsnell was hopeful that the discovery would boost efforts to understand how parasitic worm infection indirectly influences the control of sexually transmitted infections.

Intestinal Worm Infections Have Declined, But Still a Concern

Soil-transmitted helminth (worm) infections are among the most common intestinal worm infections worldwide, and affect the poorest and most deprived communities with compromised sanitation, according to Professor Charles Mwandawiro , senior principal research scientist at the Kenya Medical Research Institute (KEMRI).

They are found in all sub-Saharan African countries. Countries with huge worm burdens include Nigeria, Ethiopia, DR Congo and Tanzania.

“These worms are regarded as the main cause of intellectual and physical setbacks, especially in children,” said Mwandawiro, adding that they are associated with reduced cognitive ability, consequently denying children their full potential in life.

Since 2009, KEMRI has been monitoring and evaluating the impact of deworming in 16 countries in Africa, and Mwandawiro maintains that the rates of infections have declined significantly in the last five years from 35% to 12%.

The Institute has been working with the Japan International Cooperation Agency to coordinate de-worming exercises in nine countries in eastern and southern Africa.

“The findings from such activities have achieved wider application on the African continent through the close working relationship with the World Health Organization,” Mwandawiro told Health Policy Watch in an interview.

These intestinal worms include hookworms (Necator americanus and Ancylostoma duodenale), whipworms (trichuris) and roundworms (ascaris ).

Disease resulting from intestinal worms is insidious, says Mwandawiro: “Worms compete with their victims for nutrients and vitamins, thereby causing general ill-health, anaemia and diarrhoea, which can lead to death,” he observes.

Image Credits: UCT.

COVAX
COVAX vaccine deliveries have stopped because of supply shortages.

COVAX has a shortfall of 190 million COVID-19 vaccine doses, and the few manufacturers that have reached agreements with the facility will only deliver later in the year or even in 2022, World Health Organization (WHO) Director Dr Tedros Adhanom Ghebreyesus said on Monday.

“Pfizer has committed to providing 40 million doses of vaccines to COVAX this year, but the majority of these would be [delivered] in the second half of 2021. We need those right now and call on them to bring forward deliveries, as soon as possible,” Tedros told the body’s biweekly pandemic briefing.

“Moderna has signed a deal for 500 million doses with COVAX but the majority has been promised only for 2022. We need Moderna to bring hundreds of millions of this forward into 2021 due to the acute moment of this pandemic.”

Meanwhile, COVAX discussions with Johnson & Johnson about getting its vaccine had not been finalised, he added.

“While we appreciate the work of AstraZeneca, who have been steadily increasing the speed and volume of their deliveries, we need other manufacturers to follow suit,” stressed Tedros.

Shortly after the WHO press conference, US President Joe Biden announced a major donation of 80 million vaccine doses that he said will be sent immediately overseas.

G7 Could Donate 153 Million Doses, Says UNICEF

UNICEF Executive Director Henrietta Fore

UNICEF Executive Director Henrietta Fore also drew attention to the COVAX shortfall in a statement on Monday, urging wealthy countries to donate doses to the facility.

“G7 leaders will be meeting next month with a potential emergency stop-gap measure readily available,” said Fore, referring to research by Airfinity that showed that G7 nations and the ‘Team Europe’ group of European Union member states could donate around 153 million vaccine doses if they shared 20% of their supplies for June, July and August. 

Fore said that soaring domestic demand for vaccines in India meant that 140 million doses intended for distribution to low- and middle-income countries by the end of May could not be accessed by COVAX. 

“Another 50 million doses are likely to be missed in June,” said Fore. “This, added to vaccine nationalism, limited production capacity and lack of funding, is why the roll-out of COVID vaccines is so behind schedule.”

She warned that the “deadly spike” in India could be a precursor to what might happen in other low- and middle-income countries “without equitable access to vaccines, diagnostics and therapeutics”. 

“While the situation in India is tragic, it is not unique. Cases are exploding and health systems are struggling in countries near – like Nepal, Sri Lanka and Maldives – and far, like Argentina and Brazil,” stressed Fore. “Sharing immediately available excess doses is a minimum, essential and emergency stop-gap measure, and it is needed right now.”

Tedros added that manufacturers needed to give the right of first refusal to COVAX for any additional dose capacity and also enter into their deals with manufacturers such as Inceptor, Biolyse, Teva and others that are willing to use their facilities to produce COVID-19 vaccines.

This follows a report by Politico that large vaccine manufacturers had so far failed to take up offers by smaller manufacturers – Bangladesh’s Incepta, Canada’s Biolyse, Israel’s Teva, and Bavarian Nordic in Denmark – to assist with vaccine manufacturing.

Bruce Aylward, WHO’s lead at COVAX, stressed that the vaccine platform’s aim to ensure that  20% of the world’s population was vaccinated by the end of the year was “at risk” because of supply shortages.

However, he said that COVAX was in talks with a number of countries and was hopeful about “the possibility of larger-scale donations over the coming days, hopefully weeks at the longest”.

“I’d like to emphasise that, in speaking to everyone, no one has surplus doses”, but would be donating from what they had,” said Aylward.

Norway and Sweden have already made donations, while France, New Zealand, Belgium, the United Arab Emirates (UAE), Spain, Portugal and US have all indicated that they want to donate. 

“What we’re hoping now that these pledges of donations can rapidly change into actual shipments of vaccines to countries that need them,” said Aylward.

He added that the WHO and UNICEF were concerned that the gap between rich and poor countries was widening, as wealthier countries vaccinated “younger populations, non-risk populations in terms of severe disease” while many countries still did not have access to vaccines to cover healthcare workers and older people.

Call for Low-Speed Cities

Road safety advocate Zoleka Mandela

This week UN Global Road Safety week and road safety advocate Zoleka Mandela joined the briefing to make an appeal for “low-speed cities”.

“Throughout the pandemic, as cities around the world locked down and the traffic dropped, we’ve seen a different reality where road traffic injury have been briefly lowered, where our air was made cleaner, and our communities, in some ways, became more livable,” said Mandela, the granddaughter of iconic South African leader Nelson Mandela.

“Now of course we need our cities to be fully functioning again. But what our campaigning has been focused on is how we can take some of these temporary benefits, and make them more permanent,” said Mandela.

“I lost my daughter, Zenani Mandela, to road traffic injury. She was killed on a Johannesburg road and had just celebrated her 13th birthday. I have never recovered from this. And my family has never recovered from this. No family ever does,” said Mandela.

“Every day, 3000 children and young people are killed or injured on the world’s roads. This is a crisis which is manmade, and one that is entirely preventable.”

“Our call to action launch today is for low-speed streets in every community all around the world,”  said Mandela, who called for urban streets where children and elderly mix with traffic to have 30km per hour speed limits.

“Spain has committed to 30km an hour in its cities, the whole of the Brussels City region has been going at 30, and there’s work for low-speed streets all around the world from Bogota, and Mexico City,” she said.

 

Image Credits: WHO, UNICEF.

South Africa’s Health Minister Zweli Mkhize announced the official start of the country’s vaccine programme when people over the age of 60 will get vaccinated.

CAPE TOWN- South Africa finally started to vaccinate people over the age of 60 on Monday, but it’s roll-out is being severely hampered by a hold-up in the verification of millions of Johnson & Johnson (J&J) vaccines by the US Food and Drug Administration (FDA).

Although Monday marks the official start of the country’s vaccination programme, in the preceding weeks it had vaccinated 478,000 of its approximately 1.2 million health workers as part of a programme dubbed the Sisonke “implementation study” to get around the fact that the J&J vaccine was not registered when vaccinations started.

Initially, South Africa had planned to use AstraZeneca vaccines it had purchased from the Serum Institute of India but changed its mind and opted to use only the Pfizer and J&J vaccines after the publication of a small study that showed AstraZeneca’s vaccine had markedly lower efficacy in protecting people against mild and moderate infection with the B1.351 variant dominant in the country.  

“The worst thing would have been to start a vaccination programme with vaccines and then say to the population, ‘we are sorry but the vaccine that you had is not going to protect you because our variant is able to escape that’. So we’re taking that cautious approach and that’s the reason for the pace that we’ve moved at,” Anban Pillay, Deputy Director General of Health, told a meeting of the Government Employees Medical Scheme (GEMS) last week.

Only Pfizer Doses Currently Available in South Africa

A healthcare worker receives his COVID-19 vaccine jab during the implementation phase of South Africa’s vaccination drive.

Currently, the country only has 975,780 of the two-dose Pfizer vaccines for its adult population of 40 million. This phase, consisting first of those over the age of 60 then later essential workers and those working in congregate setting is targeting 16.6 million people.

At this stage, though, give the dire shortage, urban health workers and residents of old age homes are likely to be the only ones who will get vaccinated during the first few weeks. 

Meanwhile, 1.1 million J&J vaccines are sitting inside the country at the warehouse of Aspen Pharmacare, a local pharmaceutical manufacturer which has been contracted to “fill and finish” millions of J&J vaccines globally.

In an address on national television on Sunday evening, Health Minister Zweli Mkhize said that he was waiting for the US FDA to release these. The hold on J&J vaccine stems from problems at the Bayview manufacturing plant of Emergent BioSolutions in the US, which was also manufacturing AstraZeneca vaccines. 

The FDA requested the plant to halt production on 16 April after it identified a number of problems including the cross-contamination of the two vaccines. This has led to the destruction of 15 million vaccine doses.

According to an agreement filed three days later, “at the request of the FDA, Emergent agreed not to initiate the manufacturing of any new material at its Bayview facility and to quarantine existing material manufactured at the Bayview facility pending completion of the inspection and remediation of any resulting findings”.

Vaccine Nationalism ‘Unravels’ Equitable Access

Stavrou Nicolaou, Aspen’s head of Strategic Trade, told the GEMS meeting that the country was hoping for “good news” about the release of the J&J vaccines during the course of the week.

“J&J has committed to an initial 1.1 million with another 900,000 doses at the end of this month (May),” said Nicolaou, who also chairs Business for South Africa (B4SA), a huge private sector initiative to assist the public roll-out.

The pause on J&J vaccine deliveries means that vaccinations in rural areas will not get off the ground as the Pfizer vaccines need to be stored at temperatures of minus 20C, meaning and only urban areas have such storage facilities.

During May, Pfizer is delivering 325,260 doses every week and this will increase to 636,480 in June, while another 1.4m doses are expected from COVAX. “By the end of June, we should have 4.5m Pfizer doses and 2 million J&J,” Mkhize said on Sunday.

According to Nicolaou, the country has secured enough vaccines to cover 45 million people by the end of the first quarter of 2022. “This is very complex and, in terms of scale, the largest public initiative that our country has ever embarked on,” said Nicolaou.

“We’ve analysed the [vaccine] delivery schedule against the vaccination capacity, understanding that it will be slow initially, and we believe we will be able to start peaking at that 260,000 vaccines a day from July,” he said.

However, Nicolaou added that “vaccine nationalism” had “unravelled” concepts such as equal distribution and placed “a particularly sharp focus on building local capacities and local capabilities – basically becoming self-dependent”. 

In order to get the vaccines, people aged over 60 have been asked to register on an online electronic vaccination data system (EVDS) and wait for an SMS to notify them about when and where they will be vaccinated. But by Sunday night less than a quarter of the 5 million eligible people had registered, and no one had yet been sent SMS notifications of their appointments. 

The government has since set up a helpline to enable people to register by phone, but Pillay said he envisaged that, as the vaccine supplies picked up, facilities would allow “walk-ins”.“The first few days will start slowly as vaccinators get used to the process. It will take a few days to iron out teething problems,” warned Mkhize. 

However, the country’s biggest teething problem is a dire shortage of vaccines.

Image Credits: GCIS, WHO African Region .