A new partnership between Coalition for Epidemic Preparedness Innovations(CEPI), Africa CDC and the African Union Commission to enhance vaccine research, development and manufacturing in Africa has been hailed as “critical” to enable countries to take ownership of their national health security.

Following a two day African Vaccine Manufacturing Virtual Conference held earlier this week, the CEPI and AUC announced an agreement that will ultimately see the strengthening of the COVID-19 pandemic and outbreak preparedness on the continent, build on key lessons from the COVID-19 pandemic and leverage the successes recorded by the procurement and distribution of vaccines through COVAX and African Vaccine Acquisition Task Team (AVATT).

The agreement was one of the major highlights of the conference that featured deliberations on various key aspects of vaccine manufacturing in Africa. It was concretised with a memorandum of understanding that was signed by all three institutions.

The partners said they would also invest in vaccine R&D innovations to enable faster and easier production of vaccines in Africa; invest in capacity building and training to foster the development of local expertise needed to boost vaccine R&D and manufacturing in Africa; strengthen institutions that enhance enabling science needed for vaccine development – for example, through investments in regional laboratory and research hubs across Africa – and build partnerships that enable the sustainable expansion of vaccine manufacturing in Africa.

Dr John Nkengasong, Director of the Africa CDC, said the partnership was critical for Africa to achieve its lofty local vaccine manufacturing goals. “Trusted partnership will be critical in advancing the vaccine manufacturing agenda on the continent. The partnership with CEPI symbolises cooperation and collaboration to help respond to infectious disease threats and ensure Africa’s health security,” Nkengasong said.

Importantly, the initiative will help strengthen Africa’s capacity to prevent, detect, and respond to emerging and re-emerging infectious threats, according to Richard Hatchett, CEO of CEPI. “By building regional resilience and strengthening health security on the continent, we can mitigate the disproportionate health and economic impacts that epidemic infectious diseases can have on populations in low and middle-income countries,” Hatchett said.

Health Policy Watch on Monday reported a number of speakers including Abderrahmane Maaroufi, Director of Morocco’s National Public Health Institute, recommending that Africa prioritise the development of vaccines for emerging diseases including Ebola, Lassa fever and Rift Valley Fever (RVF). This approach is in line with CEPI’s vaccine pipelines as it has candidate vaccines for these three diseases.

Early this year, a CEPI-funded vaccine programme kicked off the first clinical trial of a Lassa fever vaccine candidate to be conducted in West Africa, where the virus is endemic. CEPI also has two RVF vaccine candidates in its portfolio.

Trusted Partnerships are Critical in Building Africa’s Vaccine Manufacturing Agenda

Throughout the conference, African leaders and experts provided indications that lessons learnt from Africans countries having to look on as the developed countries immunise their citizens, should spur actions that will ensure that the continent is better prepared for the next pandemics.

South Africa’s President Cyril Ramaphosa said that despite Africa’s delayed access to COVID-19 vaccines, the continent has shown that its capabilities cannot be overlooked, even as its leaders are demonstrating greater political commitments towards prioritising people’s wellbeing on the continent.

“Throughout this pandemic, Africa has demonstrated it has substantial and extensive capabilities as well as resources and skills to address the challenges that have given rise to the pandemic. Africa’s response has shown the depth of scientific expertise on the continent and has provided opportunities for unprecedented scientific collaborations,” Ramaphosa said.

South African President Cyril Ramaphosa

Ramaphosa said Africa, in the medium term, needed to expand available capabilities into regional hubs that serve the entire continent.
“We also need to forge sustainable partnerships with entities in both developed and developed worlds. Partners in various countries could offer technological expertise, financing and investments. Countries such as India and Brazil could provide guidance on how they developed their own generic pharmaceutical industries,” President Ramaphosa added.

The pandemic has however shown that vaccine equity cannot be guaranteed by goodwill alone, said Rwanda’s President Paul Kagame, further urging the continent to expand production capacity for vaccines and other essential medical products.

“Vaccine production goes hand-in-hand with increased investment in health systems as well as building an efficient and autonomous African CDC. Rwanda is ready to play a role in the effort together with other member states and partners,” he said.

President Paul Kagame of Rwanda

For Felix Tshiseked, President of the Democratic Republic of Congo, the emphasis was on the need for Africa to achieve vaccine, diagnostic and therapeutic security.

In his closing remarks, Nkengasong urged African governments and its partners to” act now, act collectively but act differently”. “Trusted partnerships will be critical in building Africa’s vaccine manufacturing agenda,” he said, adding that it would take greater collaboration for Africa to overcome its challenge of currently only meeting only 1% of its vaccine needs to 60% by 2040.

“We are fully aware that this will be a challenge but we are also aware that a journey of 1,000 miles begins with a single step,” he said.

He warned that if Africa does not plan to address its vaccine security needs today, the continent is setting itself up for failure.

He then announced a partnership with Afreximbank and the Africa Finance Corporation to support the development of vaccine manufacturing in Africa by focusing on four areas of support — identifying and engaging partners, co-financing transactions and projects, providing preparatory support to project developers and promoters, and providing policy and advocacy support to unlock major market barriers.

This past few weeks has seen a flurry of open letters from academics, politicians and NGOs dispatched to British Prime Minister Boris Johnson, US President Joe Biden and other heads of state, urging their governments to support a proposal to the World Trade Organization to for a proposed “waiver” suspending intellectual property (IP) rights, and the enforcement of patents, on COVID-19 health products during the pandemic. 

The conflict about patents and medicines is long-standing.  But in the light of reports that Washington may indeed support the temporary waiver of IP, it is time to call out why the proposal is at best useless, and at worst,  would seriously undermine the kinds of medical innovation so long supported by the US. 

Pro IP Waiver is Strong on Beliefs, Thin on Facts
Professor Mariana Mazzucato (UCL Institute for Innovation & Public Purpose), chair of the  new World Health Organisation (WHO) Council on the Economics of Health for All, criticizes patents for vaccines and medicines

The critics, who include Professor Mariana Mazzucato (UCL Institute for Innovation & Public Purpose), chair of the  new World Health Organisation (WHO) Council on the Economics of Health for All, believe that patents for medicines and vaccines are fundamentally a bad thing.  

Amongst other bad things, patents are blamed for keeping prices high; restricting access to medicines (particularly in the developing world); and making big pharma companies very profitable.  Critics further claim that medicines are often based on inventions made by public bodies (such as universities or research institutes) but then hijacked by big pharma; which drives the direction of research to profit, not public good.

The critics say the best remedy for these ills would be to dismantle the patent system for medicines and vaccines altogether. Or, if not that, then such patents should be the subject to compulsory licences, which countries could issue easily and at will to produce generic or biosimilar versions of patented innovations. 

To take control of innovation, critics believe the direction of research should be dictated by a state-appointed body. It should not be aimed at finding new medicines that generate profit; instead it should be “mission oriented.”  Moreover universities and research institutes should either dedicate their medical inventions to the public or at least licence all-comers.

IP Supports an Innovation System That Puts the Risk of Failure with Innovators
patent
Those defending patents argue that it is has been the basis of pharmological innovation for over a century

The defenders of patents for medicines and vaccines contend that the prospect of obtaining a patent, and indeed making a profit, has been the major foundation upon which successful pharmaceutical innovation has been based for over a century. Those defending patents do not start with theories, beliefs, or assumptions but with facts.

Fact: It takes a long time, normally 12-15 years ,from patent filing to take a putative new medicine to market – because that is how long it commonly takes to prove that it is effective and safe. Vaccines can be done more quickly. But until the vast pressures exerted by the COVID pandemic, aided by big government investments, the typical R&D period was still on the order of 8 years.

Fact: The patent will expire at the end of twenty years from filing, with the possibility of a few more years (maximum 5) of extra protection. The cost of getting a wholly new drug to market is on the order of $US 1.5 billion.  If you have to build a new production line, which you would for any new vaccines, it would typically take you up to 5 years, and $US 500 million of investment.   Most putative medicines fail to reach the market at all – sometimes after the failure of Phase III trials and expenditures on the wrong side of $US 1 billion.  The odds are low for vaccines too.  Experience is no guarantee of success.  In January, for instance, one of the world’s leading vaccine makers, MSD, threw in the towel for its two COVID-19 vaccine candidates.

The business model of big pharma depends on finding new successful medicines.  The CEO of a big pharma company knows that all of the company’s products will lose protection within around 10  years or less , and many much sooner. In rough figures, worldwide the big innovative pharma companies still spend four times more than the combined spend of governments and charities on R&D.  

Academics, Generic Producers, All Need Strong IP to Thrive
Most of the medicines on the WHO Essential Medicines List are no longer patented

Fact; Most important medicines are no longer protected by patents.  Around 95% of the products on the WHO List of Essential Medicines, are no longer patented.  Without the innovation in the first place, we would not have had many of the now generic medicines on that list. The cost of patented medicines is but a minor aspect of costs to health systems as a whole.

Fact: Neither universities nor research institutes have the resources or expertise to bring their basic research for a potential medicine to market.  What works is cooperation between an research institute that found a product with potential and a big pharma company. A good recent example is the cooperation between the Japanese research institute Ono and Bristol-Myers-Squibb to bring Professor Tasuku Honjo’s Nobel prize winning invention of cancer curing anti-PD antibodies to market.  But it is obvious big pharma will not (and cannot afford to) take on a nascent medicine that, if (and when) proven to be successful, can immediately be copied. It is naive to believe that Governments could or would do it – no new medicine has been brought to market by a government.

Final fact: there is no evidence that compulsory licensing has provided significant access to medicines or vaccines.  It has in some cases reduced prices a little (not a large) amount and it has made some people who took no risk and contributed nothing by way of pharma research very rich.   

Defenders Do Not Say That the System is Perfect 
Neglected Tropical Diseases go largely unnoticed, as there is little incentive to investigate new medicines with no chance of profits

The IP system has its limitations. For instance there is little incentive to investigate new medicines for neglected diseases, where there are no prospects of profits.  But even here, the private sector is the second largest funder after the USA’s National Institutes of Health (NIH). 

COVID-19 has intensified the arguments between critics and defenders of the current IP system.  Much of the debate has been largely irrational, both about medicines and vaccines. 

It is largely a trumped-up cause.  There cannot be any existing patents for medicines or vaccines specifically directed at COVID 19: because the patenting process takes a long time – a few years even in the fastest Patent Offices. There are or may be patents for some re-purposed known medicines (though most will probably be out of patent) and maybe some on more general vaccine production.  But no-one has identified any specific patent relevant to vaccines which is being used to stop production – nor identified any patented re-purposed medicine in short supply.

Waiving IP Won’t Help Scale Up Manufacturing of COVID-19 Vaccines
The real challenge is manufacturing the vaccines, not the patents for them

Anyway, patents for vaccines are rare. The challenge is manufacturing. Vaccines are not like small molecule medicines where a single factory can readily make enough active ingredient for a country or even a continent. Vaccines require elaborate, dedicated facilities and a huge amount of know-how. Even then, things can and do go wrong because the processes are biological – witness the recent production problems seen in Pfizer and AstraZeneca facilities in the United States as well as in Europe.   

And, as far as I know, no-one has ever applied for a compulsory licence under a patent relating to a vaccine. Even if a company got a licence, where would it get the investment to build a factory and the skills to run it? The bottleneck for vaccines is not patents or IP but simply investment in production capacity. 

Patent System, Even in Extraordinary Circumstances, Stands the Test of Time

Fortunately, there are now a number of COVID-19 vaccines that have received emergency use authorizations from the US Food and Drug Administration, the United Kingdom’s Medicines and Healthcare products Regulatory Agency and the European Medicines Agency, among other regulatory authorities. We have to thank big pharma for this. If those companies had been diminished, as the critics have long wanted, where would we be now?  Does anyone realistically expect governments to pay for risky long-term research? The truth is that the patented medicines of today pay for the medicines of tomorrow.

It is time for the critics to understand the patent system: that it really does advance innovation and lead to new medicines. The English philosopher, jurist, and social reformer, the founder of modern utilitarianism, Jeremy Bentham, said it all back in 1792:

“So long as men are governed by unexamined prejudices and led away by sounds, it is natural for them to regard Patents as unfavourable to the encrease of wealth. So soon as they obtain clear ideas to annex to these sounds, it is impossible for them to do otherwise than recognize them to be favourable to that encrease: and that in so essential a degree, that the security given to property can not be said to be compleat without it.”

The critics should put aside their “unexamined prejudices” and cease to be “led away by sounds”.  

___________________

Professor Sir Robin Jacob, University College London

The Rt. Hon. Professor Sir Robin Jacob, holds the Hugh Laddie Chair as Professor of Intellectual Property Law, University College London, for the past 10 years. He practised at the Intellectual Property Bar since 1967, was made a Queen’s Counsel in 1981 and served as a High Court Judge (Chancery Division) from 1993 to 2003. He was appointed a Lord Justice of Appeal in October 2003 where he was in charge of the Court of Appeal’s Intellectual Property List.  He has written extensively on all forms of intellectual property, including “IP and Other Things”, published by Bloomsbury.

 

Image Credits: Open Source/Flickr, Marco Verch/Flickr, MissionInnovation/Flickr, Marco Verch/Flickr, Marco Verch/Flickr, Naiad Productions.

The variant of SARS-CoV-2 2, B.1.1.7 is now the most common COVID-19 strain in the United States and has been reported in 125 countries, according to the WHO Weekly Epidemiological Update. 

Two studies published by The Lancet Infectious Disease and The Lancet Public Health report that the United Kingdom’s dominant strain of the virus is not linked to more severe disease or death, and that there was no apparent increase in reinfection rate from the variant. 

The variant of SARS-CoV-2 2, B.1.1.7, emerged as the dominant cause of COVID-19 infection in the UK in November 2020, with its high transmissibility when compared to other strains. 

B.1.1.7 has since been reported in 125 countries, according to the WHO Weekly Epidemiological Update.  The variant is now the most common COVID-19 strain in the United States. 

In the study published in The Lancet Public Health, researchers used data collected from 36,000 participants of the COVID Symptom Study App, and investigated whether the appearance of the B.1.1.7 variant was connected with differences in symptoms, duration of disease, hospital admission, asymptomatic infection, risk of reinfection, and transmissibility for users reporting a positive test result from 28 September and 27 December 2020.

The data was used in combination with surveillance data from the COVID-19 Genomics UK Consortium, which randly sequences viruses from positive test samples in the UK, to determine what proportion of positive tests included the B.1.1.7 variant. 

Overall, researchers found no association between the B.1.1.7 variant and type of symptoms, disease duration, asymptomatic infection, and hospital admission, and a low prevalence of possible reinfection.

This data suggests that vaccines developed against previous variants will be effective against B.1.1.7, said Mark Graham, research associate at King’s College London and lead author of the study. 

Graham also adds that the data “suggests that B.1.1.7 doesn’t really have a substantial effect on reinfection, and immunity developed from previous infections with COVID should sufficiently protect against B.1.1.7. “

Researchers from the study published in The Lancet Infectious Diseases further investigated reports of increased transmissibility by sequencing the virus obtained from samples in 341 patients who had tested positive for COVID-19 in two London, UK hospitals between November and December 2020. 

58% of the 341 patients had the B.1.1.7 infection and 42% had non-B.1.1.7 infection. Researchers found no association between the variant and disease severity. Those infected with B.1.1.7 were also no more likely to die compared to those infected with another SARS-CoV-2 strain.  

“We didn’t find an association between severity of disease with the variant after adjusting for other factors [like age, ethnicity and other health conditions],” said Dr Eleni Nastouli, associate professor of infection, immunity, and inflammation at the University College of London and study lead.

Patents are not the main roadblock to producing enough coronavirus vaccines for the world – rather the challenge is technology transfer with manufacturers, said a top official at the Bill and Melinda Gates Foundation (BMGF) on Wednesday. 

His comments joined those of pharma voices in what seems to be a growing counter-trend to that of civil society advocates who say that intellectual property (IP) monopolies are blocking the rapid scale-up of manufacturing. 

Speaking at an event sponsored by the Geneva Graduate Institute’s Global Health Center, Chris Elias also said that the Foundation is presently working on a number of new tech transfer agreements to expand vaccine manufacturing in low- and middle-income countries – which have not yet been made public. 

“I don’t want to say patents are never the problem, but I think the bigger problem in vaccines is how do we get as many of these tech transfers so that we can get high quality, low cost vaccine at scale as soon as possible,” said Elias, President of the Foundation’s Global Development Division. 

“As we’ve been working with the vaccine companies, now, the challenge seems to be more about the tech transfer, the rapid scale-up, the capacity for producing vaccines,” he said at the webinar on “Public and private responsibilities in COVID-19”. 

“We are actually supporting a range of different tech transfer efforts,” said Elias. “We are working on other tech transfer agreements that are just not ready to be announced yet.”

The Foundation played an important role in mediating the successful licensing deal for the AstraZeneca vaccine with one of the world’s vaccine manufacturing powerhouses – India’s Serum Institute – which has enabled hundreds of millions of doses of the AstraZeneca vaccine to be produced for the world. 

“We were able [with] Gavi to move quickly with Serum Institute of India because it is such a large scale and well established partner of COVAX, but it’s not exclusive in any regard,” Elias noted. 

Gates Was Not Part Of Oxford-AstraZeneca Decision To Exclusively License Vaccine Technology

Chris Elias, President of the Foundation’s Global Development Division.

But Elias denied that Gates had played a role in Oxford University’s decision to exclusively license its vaccine technology to AstraZeneca, instead of sharing the vaccine recipe openly – a  decision that has come under intense fire from vaccine access advocates.

“We were not part of the individual licensing agreements, I’d have to defer to Oxford. We weren’t a part of those negotiations between them and AstraZeneca,” he said.

Rather, he said that the Gates Foundation tried to help Oxford University “align” with pharma  companies that could ensure its technology could be brought to scale.  

“No university is positioned to start making billions of doses of vaccine,” said Elias. “In my experience of 20 plus years, every case where a university has found a new innovation they have to have a partnership with pharma to get to scale.”

“There were a number of organizations including the Gates Foundation that had discussions with Oxford. And they discussed the importance of aligning with a multinational company in order to ensure that they could bring their innovation to scale and benefit humanity.”

Waiving Intellectual Property Is Not Way Forward, Says Elias

With regards to the proposed World Trade Organization waiver of IP rules under the WTO’s  Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement, Elias expressed skepticism, noting that the Foundation “hasn’t been very involved” in those discussions.   

“It could be debated whether waiving TRIPS is going to get you there faster so I think we really want to focus on what can we do now to secure as much supply for the the advanced market commitment and COVAX for vaccines,” he said, referring to the WHO co-sponsored global vaccine facility. “I’m not aware that we’ve used our voice to try and influence people’s position on that [the WTO waiver].”

And although he acknowledged that mechanisms like the WHO’s proposed COVID-19 Technology Access Pool (C-TAP), to share intellectual property for COVID-19 health technologies, may be “useful” at some point, he argued that it is not needed at this moment. 

“It’s not correct to say that we’re not in favor of it [CTAP],” he said. “I think it’s a useful mechanism…If a patent proved to be the obstacle, C-TAP or some other mechanism could be part of the solution….In our experience, patents haven’t been so much the problem,” Elias  said. 

“The real issue is to “build more manufacturing capacity”, he said, “that’s a different kind of problem that’s not going to be solved by C-TAP, so we’re not opposed to C-TAP [but] it’s just not in our experience the solution we need at this moment.”

Beyond IP and even vaccine technology know-how, there are many other bottlenecks to expanding manufacturing capacity, like high-quality medical glass, which is currently in shortage, Elias stressed. 

WHO DG Asserts That IP Waiver Is Relevant  

Meanwhile, in a parallel forum underway Wednesday at the WTO, the WHO Director General Dr. Tedros Adhanom Ghebreyesus outlined a countervailing view that a proposed WTO waiver of COVID-related IP could expedite the sharing of know-how and technologies – stating that the WHO’s C-TAP IP pool may be immediately relevant.

The closed door WTO meeting brought together leading pharma manufacturers, banking officials and health ministers to discuss WTO Director General Ngozi Okonjo-Iweala’s proposed “Third Way” to expand access through more voluntary licensing to manufacturing companies in LMICs. 

“This is an unprecedented emergency that demands unprecedented measures,” Tedros said at the high-level forum, including representatives from Pfizer, Moderna and AstraZeneca, as well as the International Federation of Pharmaceutical Manufacturers (IFPMA) and the Developing Countries Vaccine Manufacturers Network.

“We must leave no stone unturned. We must explore every option for increasing production, including voluntary licenses, technology pools, the use of TRIPS flexibilities and the waiver of certain intellectual property provisions,” he said. 

Tedros also defended the COVID-19 Technology Access Pool (C-TAP), which has failed to generate interest from big pharma, even though it has been backed by 40 countries so far. 

“Like COVAX, it [C-TAP] holds enormous potential, but like COVAX, that potential has not been fulfilled,” he said. “WHO is also calling for expressions of interest to establish technology transfer hubs to assist countries acquire vaccine technology and know-how as rapidly as possible.”

“The current company-controlled production sharing agreements are not coming close to meeting the overwhelming public health and socio-economic needs for effective, affordable and equitable access to vaccines, as well as therapeutics and other critical health technologies.“

IFPMA Comments At WTO

Thomas Cueni, director general of the IFPMA

In an IFPMA statement at the WTO event, Director-General Thomas Cueni offered a pharma counterpoint that echoed the Gates official, saying: 

“We tend to forget the daunting task of scaling up manufacturing. Vaccine manufacturing is a complex biological process. Vaccine development is not granted for success. We have seen problems with scarcity of raw materials ingredients, and we have problems with export restrictions. 

“We are on track with this target of 10 billion doses, because industry is doing what society and all of you would have expected it to be doing, namely: engaged in unprecedented partnerships, in unprecedented technology transfers. I’ve counted 272 partnerships, which the industry has signed on COVID-19. More than 200 of them involving technology transfer.  I expect that we will see more also in terms of partnership, building capacity.  

“We are willing to sit down with our partners in COVAX to see what can be done in terms of supply chain visibility, in export restrictions to accelerate trade – WTO will play an important role there. We truly know that no one is safe until everyone is safe.”

Civil Society Calls on United States To Play A Bigger Leadership Role 

Meanwhile in Washington DC, some 66 health and development organisations called on US President Joe Biden to launch a global vaccine manufacturing program to end the pandemic.

The open letter, published by Public Citizen on Tuesday, called upon the United States to invest US$ 25 billion to establish in collaboration with the WHO hubs for vaccine production in Africa, Asia and Latin America; and to ensure open sharing of technology via WHO’s C-TAP access pool. 

The group called on President Biden to “announce and implement a global vaccine manufacturing program to end the pandemic and build a globally-distributed vaccine infrastructure for future pandemics.

“Much more ambitious U.S. leadership is needed to end the global pandemic,” said Peter Maybarduk, director of Public Citizen’s Access to Medicines program. “The U.S. government should establish, urgently, a manufacturing operation for the world, that would share vaccine recipes and work with the World Health Organization to alleviate suffering and bring billions of additional vaccine doses to humanity.”

Image Credits: IFPMA .

It is “unacceptable” that millions of people diagnosed with diabetes do not have access to insulin because of financial hardship – 100 years after the lifesaving medication was discovered.

World Health Organization Director General Dr Tedros Adhanom Ghebreyesus was speaking at a Global Diabetes Summit that saw the launch of a new Global Diabetes Compact between governments, care providers, and patient advocates. 

The WHO DG said a key aim of the new compact, first announced last November on World Diabetes Day, is to improve access to comprehensive affordable and quality care, including insulin – as well as supporting diabetes prevention and other health sector measures to reduce the burden of diabetes-related illness and mortality. 

“Through this ambitious and much needed collaboration, we can prevent diabetes, save lives and move one step closer to the healthier, safer, fairer world,” said Dr Tedros, noting that diabetes is on the “rise globally and rising faster in low-income countries”.

“It is a failure of society and the global community that people who need insulin should encounter financial hardship to buy it or go without it and risk their life. This year has been a wake-up call. People living with diabetes are at an increased risk of severe illness and death from COVID-19, while diabetes care has been severely disrupted due to the pandemic. We must and can do better.” said Dr Tedros.

About 422 million people worldwide have diabetes, the majority living in low-and middle-income countries, and 1.6 million deaths are directly attributed to diabetes each year. Both the number of cases and the prevalence of diabetes have been steadily increasing over the past few decades

Launch of the Compact was led by a range of high- middle-  and lower-income countries, including Canada, Fiji, Norway, Singapore and Kenya.

More Needs to be Done to Protect and Save Lives

Canadian Health Minister Patty Hajdu

Patty Hajdu, Canadian Health Minister, said not enough was being done to deal with the diabetes pandemic and urged countries to share knowledge and foster international collaboration to help people with diabetes live longer and healthier lives. 

Her government is currently debating a bill in parliament  to provide a national framework to prevent diabetes and to support people living with the condition. The Canadian Institute for Health Research also continues to invest in ongoing research and innovation to break through barriers for people living with diabetes, and to understand the role that the social determinants of health play in both acquiring the illness and living and managing it. 

Canada has instituted measures that will directly and indirectly impact the incidence of diabetes, said Hadju. “Together we will make a difference. We will reduce the cases of diabetes and we will help people who are living with diabetes, live longer, healthier and save lives.”

The new Compact, said Ren Minghui, WHO Assistant Director-General, offers the world a second chance to change the course of diabetes management.

Current models of diabetes prevention and management have failed to provide equitable diabetes care to those in need, especially in poorer countries because of lack of reliable and affordable access to diabetes medicines, glucose testing and monitoring, he said adding: “We can and we must change this.”

Minghui said the COVID-19  pandemic is “shocking” reminder to protect people living with or at risk of diabetes. He urged the private sector to step up and provide “ immediate concrete solutions” to governments to help lower the price and improve the availability of diabetes medicine and essential technology.

Areas that needed urgent attention include access to diabetes diagnostic tools and medicines, particularly insulin, in low- and middle-income countries.

Global Diabetes Compact

Innovation is to be one of the core components of the Compact, with a focus on developing and evaluating low-cost technologies and digital solutions for diabetes care.

Minghui highlighted six imperatives of the Compact, including: 

  • Calling on everyone working in the field of diabetes to unite around inclusive and action-oriented narratives on diabetes prevention and treatment with ambitious yet realistic targets;
  •  Bringing together all the top tools and resources available for prevention and management of diabetes, both existing and new into one seamless package;
  • Accelerating prevention to help promote healthy living with a focus on reducing childhood obesity;
  • Working towards improving access to diabetes medicines and technologies in the poorest countries and humanitarian setting;
  • Ensuring that people living with diabetes have a seat at the decision making table and;
  • Aiming to close knowledge gaps and stimulate innovations related to technology.

Singapore’s Battle To Prevent and Treat ‘Invisible Disease’   

Speaking at the session, Prime Minister of Singapore Lee Hsien Loong said diabetes is an “invisible disease” and  major priority for his country with one in three Singaporeans expected to develop diabetes in their lifetime.

Singapore has launched a range of  programmes that seek to deal with the scourge of diabetes. These include grading and labeling of ready- to- drink beverages; banning advertising of beverages with high sugar and saturated fat content and promoting regular physical activity to maintain fitness and reduce obesity.

“We’ve built parks and fitness corners all over our island, and are happy to see them well used by joggers, cyclists and exercise groups, old and young. A national health screening program encourages Singaporeans to go for regular health checkups, in order to earlier detect the onset of disease, said Loon, adding that the island has optimised disease management, emphasizing prevention of complications for those living with diabetes.

“We’ve set up a Diabetes Center to bring together different specialists and allied health professionals. The center organizes care around the needs of diabetic patients and aims to raise standards of care, education, and research centers,” said Loong.

Kenya’s Recognizes Diabetes Dilemma 

Approximately 3% of the adult population in Africa is already living with diabetes.

A recent survey revealed that 18.3% of COVID-19 deaths in the African region were among people living with diabetes. Approximately 3% of the adult population in Africa is already living with diabetes. The prevalence is projected to rise to 4.4% by 2025, health experts say.

Kenyan President Uhuru Kenyatta said he is pleased that one of the key objectives of the Compact is to enhance the capacity of health systems in lower-income countries to detect, diagnose, and manage diabetes. 

“We are realigning diabetes and other non communicable diseases, service delivery to make it easier for our people to access, quality health care based on need – and not the ability to pay,” said Kenyatta.

Image Credits: The Canadian Press/Adrian Wyld.

COVID-19 cases in India have skyrocketed by 70% in the past week

India has greenlighted Russia’s Sputnik V vaccine for emergency use following a severe shortage of vaccines against the coronavirus and a massive spike in cases, and is now poised to become one of the world’s largest manufacturing hubs for the vaccine with 50 million doses produced by July. 

India’s aproval of a third COVID vaccine comes as the country recorded over 185,000 new cases of COVID-19 on Tuesday – which is almost double that at the height of the first wave seen last September – and represents a 70% increase in cases over just the past week. 

So far, India has administered 100 million vaccine doses to its population of 1.4 billion people. These include Covishield, the lstraZeneca-Oxford vaccine being manufactured locally by the Serum Institute, as well as the indigenous Covaxin, developed by India’s Council for Medical Research, and manufactured by Hyderabad-based Bharat Biotech.

Sputnik V, produced by Moscow’s Gamaleya Institute and marketed abroad by the Russian Direct Investment Fund (RDIF), is a two-dose adenovirus vaccine that has boasted an efficacy of 91.6% in clinical trials  – nearly on par with the highest-performing mRNA vaccines produced by Moderna and Pfizer/BioNTech. It is priced at only $10 per dose, which is only a third of the cost of its mRNA counterparts, and rather requiring ultra-deep freeze, can be stored in conventional refrigerators for months.

Sputnik V costs $10 per dose and can be stored in conventional refrigerators, making it ideal for low-income settings

India Plans To Produce 50 Million Doses of Sputnik By July

Through new partnerships and “working capital” investments with five vaccine manufacturers, India should have the capacity to produce over 50 million doses of Sputnik by July, announced the CEO of the RDIF on Tuesday.

“We have announced partnerships with five of the largest production companies in India,” said Kirill Dmitriev, noting that improved manufacturing capacity will help speed up India’s vaccination drive. “We will be announcing a few more.”

The new partnerships, sealed with Gland Pharma, Hetero Biopharma, Panacea Biotec, Stelis Biopharma, and Virchow Biotech, will help India become the world’s “largest production hub” of Sputnik, said Dmitriev, who called it a “Russian-Indian” vaccine.

“We believe Russia and India will be the largest production hubs [of Sputnik V] in the world,” said Dmitriev. “We actually think of this [Sputnik-V] as Russian-Indian vaccine because lots of production will be done in India,” said Dmitriev at a virtual press conference.

In recent months, the RDIF has partnered with a dozen countries to manufacture Sputnik, including China, Kazakhstan and South Korea. In total, it aims to produce 850 million doses of the vaccine a year.

Meanwhile, as India begins to ramp up domestic production of Sputnik V, the country may see its first deliveries of the vaccine from other RDIF production centers abroad within the next three weeks, Dmitriev told India Today. 

Dmitriev also said that RDIF is in negotiations with the Indian government to set a differential price for Sputnik V for the private and public health sectors.

India Will Fast-Track Approval of Foreign Vaccines 

In another effort to expedite the country’s massive vaccination drive, the Indian government also announced that it will fast-track foreign vaccines that have been approved by “credible” regulatory authorities – such as the US Food and Drug Administration, the European Medicines Agency, or the WHO’s Emergency Use Listing.

India’s health secretary Rajesh Bhushan said this will speed up India’s vaccination drive by overcoming the need for local clinical trials, the so-called “bridging trials”, which serve to ensure that foreign vaccines cater to the Indian context. 

“The pre-condition of having bridging clinical trials for a foreign vaccine before emergency use authorisation has been done away with and has been replaced with a parallel bridging trial post-approval,” he said in a press release.

“This decision will facilitate quicker access to such foreign vaccines by India & would encourage imports including import of bulk drug material, optimal utilization of domestic fill and finish capacity etc., which will in turn provide a fillip to vaccine manufacturing capacity and total vaccine availability for domestic use,” said the press release.

Image Credits: RDIF, WHO.

The USA can do better to protect emerging global health threats for hundreds of millions of Americans and for billions of people around the world.

The Joe Biden-Kamala Harris administration and its allies in Congress have already posted an impressive track record of early efforts to revive and champion U.S. leadership in global health. The American Rescue Plan, proposed by President Biden in January and passed in March, includes significant emergency funding to support the international COVID-19 response through initiatives like the Global Fund to Fight AIDS, Tuberculosis and Malaria; a multilateral vaccine development partnership; the President’s Emergency Plan for AIDS Relief; and global health programs at the US Agency for International Development (USAID). 

America’s shift to tackle COVID-19 beyond our borders cannot happen fast enough. 

Every day, this depressingly unyielding pandemic serves up reminders of not only the power of biomedical research and development (R&D) to deliver amazing innovations—several vaccines developed and deployed in just over a year—but also of the shocking disparities in gaining access to them. Low- and middle-income countries, despite being home to 85% of the global adult population, account for only 49% of COVID-19 vaccine doses administered worldwide.

With awareness of the importance of global health R&D at an all-time high—and global health champions now aligning to pull levers of power at both ends of Pennsylvania Avenue—policymakers have an opportunity to provide investments and reforms that can help us emerge from the pandemic primed to conquer a number of stubborn global health foes. Seizing this moment will involve building on the successes of the last year and learning from the failures.

As Congress and the administration get to work on the FY2022 federal budget, here are six things they can do to provide much better protection from enduring and emerging global health threats for hundreds of millions of Americans and for billions of people around the world.

US Aid need to increase its funding for Research and Development.

1. Double Funding for Global Health Programs at USAID. From these increases, USAID should set minimum funding targets for the agency’s R&D work, establish a new chief science and product development officer position and create a $200 million USAID Grand Challenge for health security. USAID is the only U.S. agency with a mandate to focus on global health and development. Yet despite its track record of delivering high-impact health innovations, funding for global health R&D has waned in recent years and the agency’s unique capabilities have been underutilized and underfunded as part of the US government’s COVID-19 response. The American Rescue Plan includes funding that recognises USAID’s importance in combating COVID-19 and advancing global health. We need to build on this progress.

2. Increase Support for the Centre for Disease Control and Prevention – especially for its Centre for Global Health, the National Centre for Emerging and Zoonotic Infectious Diseases, and the Division of Tuberculosis Elimination and its Tuberculosis Trial Consortium. These programs have been operating on tight and relatively stagnant budgets even before COVID-19 diverted critical resources and expertise.

3. Provide Targeted Funding for Product Development and Translational Research Lacking Commercial Interest.

There is also a need for steady funding increases at the Fogarty International Center and sustained growth for the National Institute of Allergy and Infectious Diseases and the Office of AIDS Research. The National Institutes of Health’s high-profile work in confronting COVID-19 has highlighted the importance of past investments. But the pandemic also drained dollars and diverted talent from non-COVID priorities.

4. Establish a Permanent Funding Line at the Biomedical Advanced Research and Development Authority (BARDA) of at least $300 million annually to support work on emerging infectious diseases—a category of which COVID-19 is a high-profile, but not singular, example. Despite its proven value in dealing with a range of threats, BARDA has been overly reliant on “one-off” emergency supplemental appropriations for threats like Ebola and Zika, leading to dangerous gaps in its portfolio when limited funding runs dry. BARDA should also expand its research on antimicrobial resistance (AMR) to include drug-resistant tuberculosis (TB), which is a major health security threat to the United States. 

5. Protect Department of Defence Programs Focused on Malaria and Other Parasitic Diseases, TB and AMR. There have been internal proposals to potentially eliminate DoD’s malaria research programs, which would scuttle decades of progress achieved via research at the Walter Reed Army Institute of Research and the Naval Medical Research Center—despite malaria remaining a leading threat to U.S. troops deployed abroad. DoD’s efforts to develop new treatments for drug-resistant pathogens, which include dangerous strains of TB, are also essential to achieving global health security.

6. Increasing Support for Key Multilateral Initiatives, like the Coalition for Epidemic Preparedness Innovations (CEPI). Formalizing U.S. support for CEPI and committing at least $200 million annually would provide a much-needed boost to an initiative dedicated to developing vaccines against epidemic threats and making them globally accessible—but first, the U.S. should provide CEPI with $300 million of the global health funding just passed in the American Rescue Plan to boost its work on COVID-19. Also, Congress can support efforts at the Food and Drug Administration to provide technical support to under-resourced regulatory authorities around the world, which could accelerate access to a range of biomedical advances.

Together, these six recommendations can form the core of a broader effort to supercharge America’s global health R&D capabilities. Whether the motivation is to protect Americans from threats that have no respect for geography, to advance health equity around the world, or somewhere in between, the United States must take decisive action to resume its leadership in global health R&D.

Jamie Bay Nishi

Jamie Bay Nishi is director of the Global Health Technologies Coalition (GHTC), a coalition of more than 30 nonprofit organizations, academic institutions, and aligned businesses advancing policies to accelerate the creation of new drugs, vaccines, diagnostics and other tools that bring healthy lives within reach for all people. For more information, read GHTC’s agency-by-agency blueprint for supercharging global health R&D: Meeting the moment, fueling the future: Policy recommendations for a new era of US leadership in global health R&D

 

Image Credits: Global Health Technologies Coalition.

Transparency in medicine pricing is a key theme of the Fair Pricing Forum that started this week.

The World Health Organization (WHO) and the World Trade Organization (WTO) both are hosting key global meetings aimed at improving global access to COVID-19 vaccines and fair medicine prices this week behind closed doors.

The WHO Fair Pricing Forum started on Tuesday and its stated aim is to activate “additional support for countries to achieve more affordable and fairer access to pharmaceutical products during the COVID-19 pandemic and beyond”.

Meanwhile, on Wednesday, the WTO Director General, Ngozi Okonjo-Iweala, will host a meeting on “COVID-19 and Vaccine Equity: What can the WTO Contribute”.

The Fair Pricing Forum (FPF), supported by the Ministry of Health of Argentina and running virtually until 22 April, is likely to focus on transparency of medicine prices and production as well “upstream innovation” aimed at widening the manufacturers’ pool. 

This is according to Suerie Moon, co-director of the Global Health Center of the Graduate Institute of Geneva and a member of the FPF expert advisory group, who describes the forum as an “important space for governments to connect and co-operate”.

Transparency and the Innovation System

“There’s a lot of focus on transparency in the agenda. COVID-19 raised public awareness of the problem of confidentiality. But there is a lot governments can do on transparency that they haven’t yet done – there also needs to be a strengthening of backbones,” she said. 

Moon added that linking high prices to the underlying innovation system “has never been so front and centre of discussion as it is now”.

“There is an entire strand of the conference on innovation, looking at how governments can change innovation incentives, how they can rewrite the rules that structure innovation and pricing of medicines,” said Moon, of the meeting, which paradoxically is taking place away from the media and public eye..

She added that while the discussion in the WTO’s TRIPS Council over the IP waiver is split along predictable North-South lines, more informal alliances are easier to build at the Forum where there are “challenges common to countries in the North and South and shared concerns vis-à-vis the medicine pricing practices of the pharmaceutical industry”.

Health Policy Watch has seen two discussion papers to be discussed at the Forum, which look at how medicines pricing could be made more “sensitive to health systems’ ability to pay”, and “incentives for pharmaceutical innovation to achieve fair pricing” respectively. These were developed by two technical working groups formed at the last FPF meeting in South Africa in 2019.

Global Framework to Address Pricing

The first paper suggests a global framework to tackle the “unaffordability of medicines and vaccines”. It also flags that the lack of transparency relating to prices and contracts undermines good governance ‘especially when the public expects full accountability for public spending’. 

It highlights the success of cross-border collaborative initiatives in ensuring more affordable medicines, including global initiatives such as Stop TB Partnership’s Global Drug Facility; the Medicines Patent Pool; Gavi, the Vaccine Alliance; and the WHO co-sponsored COVAX global vaccine facility; as well as regional efforts including the Pan American Health Orgqanization’s “Revolving Fund for Vaccine Procurement” and the Beneluxa initiative of smaller European countries, including Belgium, the Netherlands, Luxembourg, Austria and Ireland, to coordinate policies on pharma purchases and pricing.

The second paper argues that ‘“pharmaceutical innovation is a hybrid public and private effort”, with the public sector paying for about 30% of the upfront total investment in pharmaceutical R&D and the private sector paying for about 60% of upfront investment in the later, relatively lower-risk stages, with the remaining 10% coming from sources such donors.

It also flagged the need for “frameworks for global governance”, noting that “the bilateral agreements for COVID-19 vaccines are a sober reminder that public sector stewardship at the national level sometimes may serve narrower national interests at the risk of disregarding larger issues of global health equity”. 

WTO Invites Wide Range of Pharmaceutical Companies 

WTO Director-General Ngozi Okonjo-Iweala

Meanwhile, the WTO’s Wednesday meeting includes various trade ministers, including those from the European Union and the United States, as well as India and South Africa, which are co-sponsors of the WTO proposal to waive intellectual property rights on COVID-19 health products for the duration of the pandemic.

A wide range of pharmaceutical companies are also invited, including representatives from Pfizer, Moderna and Astra Zeneca, the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA); the Developing Countries Vaccine Manufacturers Network,  the European Federation of Pharmaceutical Industries and Associations (EFPIA), the Pharmaceutical Research and Manufacturers of America (PhRMA) and the Japan Pharmaceutical Manufacturers Association (JPMA).

Speaking at meetings in the US last week, Okonjo-Iweala said that equitable worldwide access to COVID-19 vaccines “is necessary for economic growth and trade to bounce back from the pandemic and that a reinvigorated multilateral trading system would strengthen both the health response and the economic recovery”.

The first session of the  WTO meeting focuses on challenges to “equitable vaccine distribution”, including a focus on export restrictions and trade barriers.

Thomas Cueni, IFPMA Director General, confirmed to Health Policy Watch that his association and a number of its member company experts “have accepted the Director General’s invitation to speak at the WTO event”.

‘“We believe this is an important opportunity to contribute to the DG’s expressed desire to find pragmatic outcomes to increase vaccine production.  We hope to be able to share our experience of the complexities in researching, developing, registering, manufacturing and distributing COVID-19 vaccines,” said Cueni

However, over 240 civil society organisations wrote an open letter to Okonjo-Iweala on Tuesday expressing concern “over the emphasis on industry-controlled bilateral agreements as the primary approach to addressing global production constraints and supply shortages”.

Referring to her “Third Way” approach, which they described as “appealing to pharmaceutical corporations to take voluntary actions”, the organizations said this had “proven to be insufficient in this pandemic”.  

Instead, they proposed that WTO member states approve the initiative to remove “barriers towards the development, production and approval of vaccines, therapeutics and other medical technologies necessary for the prevention, containment and treatment of the COVID-19 pandemic” by supporting the temporary waiver on intellectual property rules.

 

 

Image Credits: WHO, ©WTO/Bryan Lehmann.

Pangolin, Manis javanica – a mammal that can harbor coronavirus infections; huting for its meat and scales have made it one of the world’s most endangered species.

In an unusually bold step for the cautious global health agency, the World Health Organization has called upon countries to suspend the sale of captured live wild mammals in food markets as an emergency measure.

The appeal follows on the publication of a report by a WHO-convened international team examining the origins of the SARS-CoV2 virus – which found that one of the most likely routes by which the virus may have first infected people was via wild food markets. Such markets are a well entrenched tradition in parts of Southeast Asia and China, including cities such as Wuhan, where the first novel coronavirus case clusters visibly appeared in December 2019.

In the closed and contained surroundings of such markets, scientists have long maintained that it’s highly possible a wild mammal such as a pangolin, itself an endangered species, could have conveyed the SARS-CoV2 virus to humans – either directly or indirectly from another infected animal source such as horseshoe bats. Horsehoe bats, which are indigenous to southwestern China’s Yunnan Province, have been found to harbor coronaviruses that are among those most genetically similar to the SARS-CoV2.

The call by WHO is only for an “emergency” suspension of wild animal trade and slaughter at food markets – and it is limited to mammals – rarther than including reptiles and other species that can also harbor and carry dangerous viruses. But it is still unprecedented.

Live animal markets in China have been the source of previous coronavirus outbreaks, including the 2003 SARS,  In that case, Asian Palm Civets, infected by horseshoe bats, reportedly carried the virus to humans working or shopping in the markets.
WHO Traditionally Avoided Strong Policy Advice on Upstream Causes of Foodborne Diseases

WHO has traditionally steered clear of definitivie policy advice to ban or curb activities related to the upstream causes of foodborne disease – and which touch heavily on local economies, food sources, cultural sensitivities and traditions.

For instance, it has taken years for the agency to gingerly take up even a few cautious statements that support less meat consumption in diets overall – despite the overwhelming evidence that diets heavy in red meat, in particular, are bad for both health, and climate/environment.

And in the case of the much more widely discussed issue of air pollution, which still killed more people annually than COVID-19, WHO has avoided direct calls for similar restrictions or bans on the production or sale of pollution sources, such as highly polluting second hand vehicles – which are among the leading sources of air pollution in fast-growing low- and middle-income cities today.

Equally noteworthy is the fact that the WHO statement on the wild mammal trade and slaughter was issued jointly with the World Organization for Animal Health (OIE) and the United Nations Environment Programme.  It is one of the more immediate signs that the agencies are indeed taking up a “One Health” approach to the pandemic that they have talked about so much – and thereby also tackling other upstream causes of foodborne diseases in the food production and supply chain.

While the WHO appeal, and the companion guidance it has issued on reducing public health risks from live animal markets, is hardly likely to make an immediate dent in the very widespread practice in Asia and Africa of wild mammal capture and sales – it is still a modest starting point.

It signals  the growing recognition of zoonoses from wildlife as a key cause of new and emerging pathogens – which have bequeathed the world HIV/AIDS, Ebola, SARS and now COVID19 in recent decades, to name only a few diseases.  And while many wild animals can harbor dangerous diseases, it is mammals, the closest relatives to homo sapiens, that generally harbor the viruses of greatest danger to people, the guidance notes.

“To reduce the public health risks associated with the sale of live wild animals for food in traditional food markets, WHO, OIE and UNEP have issued guidance on actions that national governments should consider adopting urgently with the aim of making traditional markets safer and recognizing their central role in providing food and livelihoods for large populations,” the guidance states.

“In particular, WHO, OIE and UNEP call on national competent authorities to suspend the trade in live caught wild animals of mammalian species for food or breeding purposes and close sections of food markets selling live caught wild animals of mammalian species as an emergency measure,” the guidance further adds.

“Although this document focuses on the risk of disease emergence in traditional food markets where live animals are sold for food, it is also relevant for other utilizations of wild animals. All these uses of wild animals require an approach that is characterized by conservation of biodiversity, animal welfare and national and international regulations regarding threatened and endangered species.”

Nod to Traditional Cultures – Stops Short of Calling For Permanent Bans on Trade and Market Slaughter of Wild Mammals
Seafood and fresh food market in Wuhan, Hubei, China. Most confirmed cases of 2019-nCoV were traced back to Huanan Wholesale Seafood Market, although at some of the early cases never visited the market.

The guidance notes that traditional food markets are an important part of “the social fabric of communities and are a main source of affordable fresh foods for many low-income groups,” as well as being an important source of livelihoods for millions of people.

“Significant problems can arise when these markets allow the sale and slaughter of live animals, especially wild animals, which cannot be properly assessed for potential risks – in areas open to the public. When wild animalsii are kept in cages or pens, slaughtered and dressed in open market areas, these areas become contaminated with body fluids, faeces and other waste, increasing the risk of transmission of pathogens to workers and customers and potentially resultingin spill over of pathogens to other animals in the market.”

While the exact pathway by which the SARS-CoV2 infection entered the human population has not yet been identified – and some scientists believe that the virus may have even escapted from a laboratory research facility where coronaviruses were being studied – rather than first being spread through the food chain, the legacy of foodborne transmission of other coronaviruses in Asia’s traditional food markets is an established fact that WHO highlights.

“Such environments provide the opportunity for animal viruses, including coronaviruses, to amplify themselves and transmit to new hosts, including humans. Most emerging infectious diseases – such as Lassa fever, Marburg haemorrhagic fever, Nipah viral infections and other viral diseases – have wildlife origins. Within the coronavirus family, zoonotic viruses were linked to the severe acute respiratory syndrome (SARS) epidemic in 2003 and the Middle East respiratory syndrome (MERS), which was first detected in 2012,” the guidance further notes.

Freshly slaughtered animals in a market in Wuhan, Hubei, China,hanging above conventional produce

Not only that, but “animals, particularly wild animals, are reported to be the source of more than 70% of all emerging infectious diseases in humans, many of which are caused by novel viruses. Traditional markets, where live animals are held, slaughtered and dressed, pose a particular risk for pathogen transmission to workers and customers alike.

“To mitigate this risk, an immediate emergency measure for regulatory authorities would be to introduce regulations to close these markets or those parts of the markets where live caught wild animals of mammalian species are kept or sold to reduce the potential for transmission of zoonotic pathogens,” the guidance states.

However, the guidance stops far short of calling for a permanent ban on the sales of wild mammals in traditional markets.

Rather it states that the “emergency measures should be of a temporary nature while responsible competent authorities conduct a risk assessment of each market, to identify critical areas and practices that contribute to the transmission of zoonotic pathogens.

“Competent authorities should work with market managers to introduce measures to mitigate identified risks. Markets or section of markets should be allowed to reopen only on condition that they meet rquired food safety, hygiene and environmental standards.”

The guidance also stops far short of suggesting that wlidlife farms, which may have been an upstream source of the first SARS-CoV2 infections, be closed, stating only that authorities need to ensure that live, caught wild animals “are not illegally introduced to wildlife farms, thus increasing the risk of transmission of zoonotic pathogens circulating in wild populations.”

Live chickens await slaughter at a traditional market in Xining, Lanzhou, China. Along with mammals, live poultry also harbor pathogens that have lept to humans, in episodes such as the H5N1 outbreak of avian influenza of the late 1990s.

Rather it sugggests that “farms that produce wild animals need to be registered, approved and inspected for animal health and welfare standards by relevant competent authorities.”

However the guidance does suggest that there should be a phasing out of the slaughter of live wild animals in market areas that are frequented by shoppers and members of the public.

“Such strategies envisage phasing out live animal marketing and slaughter in proximity to the public or physically separating such activities to reduce the risks of transmission of zoonotic diseases. Slaughter and dressing should be carried out in suitable facilities under control of the official veterinary service for ante- and post-mortem inspections,” the guidance states. “Key areas needed for inclusion in plans to upgrade hygiene and sanitation standards are sanitary facilities (toilets, hand washing), pest control, waste management and disposal (solid and liquid wastes), drains and sewage disposal. Food handling and marketing activities should be moved to wellmaintained stalls where surfaces can be easily washed and disinfected.”

Link here for the complete guidance document. 

 

Image Credits: Piekfrosch/wikipedia, lihkg.com, Arend Kuester/Flickr, Arend Kuester/Flickr, Flickr/M M.

united states
Vials of Johnson & Johnson’s vaccine.

The United States’ Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) have recommended a “pause” in administration of Johnson & Johnson’s (J&J) single-dose COVID-19 vaccine out of an “abundance of caution” following six cases of a rare type of blood clotting among the 6.8 million US recipients of the vaccine. 

The six reported cases had a rare and severe type of blood clot, called cerebral venous sinus thrombosis (CVST), in addition to low levels of blood platelets (thrombocytopenia). 

The same kind of adverse effect has been noted in Europe among recipients of the AstraZeneca vaccine in Europe – where some 62 cases of the rare disorder have been seen among the 34 million people vaccinated as of 4 April. So far, however, the AstraZeneca vaccine has not been approved in the United States – while the J&J vaccine is only just starting to be rolled out in Europe, following regulatory authorization there in mid-March.   

While an anticoagulant drug called heparin is typically used to treat blood clots, alternative treatments are needed for CVST – which combines clotting with low platelet levels. 

In the case of the J&J jabs, all six cases occurred in women between the ages of 18 and 48, with symptoms occurring 6 – 13 days following vaccination.  That, too, follows a pattern similar to that seen in the AstraZeneca vaccine – where most of the CVST cases were also seen in women under the age of 60 – prompting some countries, like Germany, to halt administration of the vaccine to younger people generally. 

“Right now, these adverse events appear to be extremely rare. COVID-19 vaccine safety is a top priority for the federal government, and we take all reports of health problems following COVID-19 vaccination very seriously,” Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, and Dr. Anne Schuchat, principal deputy director of the CDC, said. 

The pause is important to ensure that the health provider community is aware of the potential for these adverse events and can plan for proper recognition and management due to the unique treatment needed for CVST, the agencies’ statement said. 

The European Medicines Agency was the first to announce a review of cases linked to the J&J vaccine on 9 April following four reports of blood clots.  Following a similar review of the AstraZeneca vaccine, the EMA last week reaffirmed that the vaccine was safe for use by all groups – but said that a label should be affixed to the vaccine warning of the rare blood clot potential. 

The White House said in response that the FDA/CDC announcement will not have “significant impact” on US vaccination plans. 

“We are working now with our state and federal partners to get anyone scheduled for a J&J vaccine quickly rescheduled for a Pfizer or Moderna vaccine,” said Jeff Zients, White House COVID-19 Response Coordinator on Johnson & Johnson’s vaccine. 

As of 12 April, more than 6.8 million doses of the Johnson and Johnson vaccine have been administered in the US, making up less than 5% of recorded doses in the country. The US currently has secured Pfizer and Moderna vaccines for 300 million Americans. 

The CDC will convene in a meeting on Wednesday to further review the cases. The FDA will then review the analysis while also investigating cases. 

In a company statement,  Johnson & Johnson said that it is  “aware“ of the adverse events that occur from administration of the vaccine, and is working with medical experts and health authorities in both Europe and the US through the investigation. 

“We have been working closely with medical experts and health authorities, and we strongly support the open communication of this information to healthcare professionals and the public,” the company said in its statement.

Image Credits: Johnson & Johnson, NBC News.