(left-right, top-down) Clemens Martin-Auer, Frederik Kristensen, Thomas Cueni, Kate Elder, Ilona Kickbusch

COVID-19 has the potential to change how vaccines are sold and distributed, but industry leaders, academics, policymakers, and advocates are still struggling to decide the direction those changes should take.

A successful COVID-19 vaccine should only be sold by companies to countries if it fits within an equitable distribution platform made by a neutral third party, such as the World Health Organization, said Kate Elder, senior Vaccines Policy Advisor at the Médecins sans Frontières Access Campaign, at a webinar hosted by the European Health Forum Gastein. This year’s European Health Forum Gastein will be hosted virtually from 30 September – 2 October.

“Equitable allocation needs to be done based upon public health criteria,” Elder said. “All countries need to agree that that might mean that they’re not first in line for a certain number of doses, and pharmaceutical corporations most certainly also need to cooperate with that and not sell in a priority manner those future doses to any one country or bloc of countries.”

But Thomas Cueni, director-general of the International Association of Pharmaceutical Manufacturers and Associations, said that it is unlikely that a successful COVID-19 vaccine will follow only one global distribution method.

“The notion of a global public good means that if you can get it, I can get it. But it’s simply not the case when you have limited doses,” said Cueni. “Ideally you would have one global allocation mechanism, but unfortunately that is not likely to happen…Of course, vaccine manufacturers have to respond to where do they get the support, where they get the orders from.”

The debate around allocation of a COVID-19 vaccine comes just a day after the first meeting of the Facilitation Council for the Access to COVID-19 Tools (ACT) Accelerator, which includes a key pillar working on COVID-19 vaccines access. The COVAX Facility, an initiative within the ACT Accelerator, aims to pool global demand for a vaccine from rich and poor countries alike, pooling the risk of investing in the wrong vaccine candidate for rich countries, and providing poorer countries more negotiating power and financing.

Supply Will Definitely Not Meet Demand – Proposed COVAX Facility Design May Introduce ‘Inequity’

There will certainly be a shortage of COVID-19 vaccine in 2021, even after it receives regulatory approval, according to Cueni.

“We talk about the need for 12 to 16 billion doses of COVID-19 vaccine based on the phase 1 clinical trials,” said Cueni. “[Within the COVAX Facility], somebody told me that he is optimistic that 3 billion doses should be possible by the end of next year.

“We’re delighted to [be able to] vaccinate the health professional frontline workers. That’s 1% of the global population.”

But expanding vaccination to include all people over 65 years old, a high risk group for COVID-19 severe disease and death, then proportion of the global population that requires the vaccine increases to 8%. And vaccinating all people with comorbidities and pre-eixisting conditions, such as diabetes, which predispose them to severe COVID-19 will increase the proportion of the world population in need to 20%.

However, Cueni added that he was “optimistic” that many rich countries would join the COVAX Facility, even after signing bilateral deals outside the Facility guaranteeing millions of doses of vaccine. Compromises had to be made to attract more donors to the Facility, said Cueni.

Japan is one example so far – the country has preordered vaccines directly from Moderna and AstraZeneca, and has pledged to participate in the COVAX Facility.

But medicines access advocates say that the terms of the COVAX Facility still lean in favor of rich countries, who can pay more to choose which of the dozen vaccines in the Facility’s portfolio that they want to back, and opt out of purchases of vaccines they may not want or need.

“We now have a new option that was pushed by high-income countries for how self -financing countries can join the COVAX facility,” said Elder. “By the terms of that new option, if they pay more money up front, they get to opt out of certain deals. They get to pick and choose which deals they want to benefit from now.

“I think we do need to honestly acknowledge that by giving the initial opportunity to countries to pay more upfront and give only them the choice to pick and choose which doses they’re going to benefit from, it is introduces inequity by definition.

“If you cannot afford that upfront, then you don’t get those choices.”

Still, the COVAX Facility may be the largest ever multilateral effort to coalesce global demand for any vaccine. And the pooled procurement mechanism can be a powerful strategy to negotiate lower prices, with the European Union already negotiating deals outside of the COVAX facility as a bloc of 27 countries, according to Clemens Martin-Auer, lead negotiator for COVID-19 deals for the European Union.

Commitment Made To Mobilize Political Interest for the ACT Accelerator, but Finer Details Around Distribution Are Still Unclear

South Africa and Norway co-chaired the meeting, pledging to both galvanize political leadership to support the Accelerator and motivate countries to mobilize funds. However, details such as the governance structure of the COVAX Facility, or the exact distribution plan of a successful vaccine candidate, have not yet been hammered out.

The deadline for countries to make a binding financial commitment to the COVAX Facility is fast approaching on September 18th. So far, some 170 countries have expressed interest in joining the facility, including 92 lower-income countries that qualify for development assistance. Some large traditional global health donors, including the European Union, Germany, and Japan, have also made commitments to the COVAX Facility to help fund procurement of vaccine doses for poorer countries.

However, the United States, historically the world’s largest global health donor, has said that it will not join the COVAX Facility because it it is in part led by the World Health Organization. The Trump Administration in March began criticising the agency for allegedly bowing to pressure from China and moving slowly in the early days of the pandemic. Since then, Trump has suspended funding to the Organization, and has notified Congress and the United Nations of the US’ intent to withdraw from the WHO by July 2021. The US currently has the world’s highest coronavirus caseload, and the highest number of coronavirus deaths.

Locally fabricated plastic water containers with taps are making it easier for establishments and public spaces to set up handwashing stations.

Ibadan, Nigeria – The pandemic has brought to the fore Africa’s reliance on international support for its health sector – and it is also challenging the continent’s ability to build up its resilience when donors fall through. 

“There is a new public health order that is coming because of COVID-19. COVID-19 has opened our eyes to resetting lots of activities, relationships, strategies and actions,” Dr. Ahmed Ogwell Ouma, Africa Centres for Disease Control (CDC) Deputy Director, told Health Policy Watch, in an exclusive interview.  “What we are doing with COVID-19 is exactly what we need to do for all the other disease conditions and across the whole of healthcare. 

“We will own our space – Africans thinking for Africa and delivering for fellow Africans. This is the new public health order that is coming and COVID-19 is a way of delivering that public health order.”

WHO said the pandemic is not ending anytime soon. In Africa, the messaging has changed from describing the virus as one that needs to be eradicated quickly to one that the people can safely live with by following specific guidelines – including ones guiding the resumption of air travel. 

On 1 September 2020, the number of confirmed cases of COVID-19 in Africa exceeded 1.2 million, just two months after the WHO African Region announced that COVID-19 pandemic in sub-Saharan Africa had reached the major milestone of over 500,000 cases confirmed. 

While South Africa remains the epicenter of the pandemic in Africa with about 630,000 confirmed cases, there are also indications that cases are climbing elsewhere but obscured by limited testing capabilities. 

Africa’s COVID-19 Numbers Are Lower Than Expected – But Will Continue To Climb

At the outset of COVID-19, Microsoft founder, Bill Gates of the Bill & Melinda Gates Foundation, projected that the pandemic could claim as many as  10 million lives in Africa. But Africa has yet to become the pandemic’s epicentre, and governments across the continent have already reopened their countries extensively. While the global case fatality ratio is about 4.4%, it hovers around 2% in Africa.  

Ahmed Ogwell Ouma, Africa CDC’s Deputy Director

“The predictions were based on very wrong assumptions that Africa has no capacity or ability to look after itself. We’ve proven this assumption wrong as Africa has the commitment and capacity to be able to look after itself,” Ouma said. 

Ouma noted that African countries are “doing really great work keeping the virus under control”. While the numbers are rising, Ouma said the disease outlook would have been worse if the interventions did not come early. 

“The rising numbers are not an indication of failure. In fact, it is an indication that in Africa, we are seeking out those who have the virus and containing it. Africa is doing okay and much better than earlier predicted,” he said. 

Ouma said he is not worried that Africa’s COVID-19 numbers may continue to rise further, noting that the continent is not yet at the peak of the pandemic. 

“As long as we keep the number at a manageable level as we seek therapeutics and vaccines, then we are alright. I’m not worried that the numbers are going up. Indeed it’s our expectation,” he told Health Policy Watch. “But I will be worried if the graph is steep. We want the graph to stay gentle which means the numbers are not overwhelming.”

Absence of Global Leadership & The US’ Staunch Nationalism Have Pushed Africa To Be Proactive

With the entire world combatting COVID-19 at the same time, countries that had historically been supporting Africa understandably decided to prioritise their national interests. Moreover, the existence of a gap in global health leadership  is forcing a moment of reckoning that experts believe could compel African governments to begin taking more proactive roles. 

Africa countries historically been known for their weak health systems, but efforts to control COVID-19 have also been impacted by external factors. In Nigeria, for instance, the US.-based Abbott Laboratories, a major supplier of COVID-19 test kits, was accused of improper delays in filling orders from African governments, even when they were filed in a timely manner. 

The retreat from multilateralism by the United States, historically one of the continent’s biggest health donors, has signaled to African governments that they cannot afford to wait for traditional donors to step up in the COVID-19 pandemic response.

The Trump administration’s decision to withdraw the US from the World Health Organization has also distanced the continent, especially at a time when an African was leading the WHO for the first time.

“We are all very empathetic about the way Tedros (WHO Director Genera Tedros Adhanom Ghebreyesus) has been treated. We know Americans are being bullies. We don’t want that to happen anymore. What they are doing to him, they will do to Chikwe (Nigeria CDC’s Director General), and they will do to anybody,” Professor Moses John Bockarie, EDCTP’s Head of Africa Office told Health Policy Watch. 

The United States, along with other rich countries and regions such as the European Union, the United Kingdom, and Japan, have also been engaging in “vaccine nationalism” – preordering investigational COVID-19 vaccines, potentially buying up the world’s supply ahead of lower income countries. Along a similar vein, most of the world’s remdesivir, a drug that has been shown to speed up the recovery of some patients with severe COVID-19, had been bought up by the United States, leaving less than 15,000 treatment courses for countries that cannot buy generic remdesivir. 

Ouma thus described COVID-19 as a rallying moment where Africa needs to come first, African solutions should lead, and be propagated across the continent. He said Africa CDC is engaging programme officers across Africa, urging them to prioritise supply chain and capacity building on the continent. He added that COVID-19 has demonstrated why African countries should be sharing resources, particularly facilities for testing. By doing this, he said the continent will start achieving the integration and growth that is the aspiration of Agenda 2063 -The Africa We Want. 

Eswatini Builds On HIV/AIDS Capacity for Coronavirus Response
Ambrose Dlamini, prime minister of Eswatini

African countries are building on the extensive networks created for other diseases for the COVID-19 response. Ambrose Dlamini, prime minister of the Kingdom of Eswatini, told Health Policy Watch that while Eswatini is not currently fully ready nor fully-equipped to deal with pandemics, it has leveraged its HIV/AIDS response to expand capacity. 

“We’ve developed some capacity that we think we are going to leverage going forward. We are going to use the national response framework which has really done well, providing us with capacity over the years, we want to develop it to equip the country to deal with future pandemics,” said Dlamini. “That is the strategy going forward.

“Right now, it is responsible for HIV, malaria, and TB. Those are the diseases that are being managed by the framework. It is really doing quite well in all of these diseases and we hope future pandemics will be managed through that structure.”

Building on Local Capacities for Contact Tracing & Producing Equipment for Africa’s COVID-19 Response

Technology is also being deployed, to aid contact tracing in some countries – although this remains a controversial solution. Even though digital innovations have also been developed and deployed for the COVID-19 response in several African countries, Ouma said the core of Africa CDC’s strategy for contact tracing is not mobile apps.

“In developed countries they are using apps and technologies for contact tracing. In our own case, our technology is community health workers who will also educate the people on what they need to do to protect themselves,” he told Health Policy Watch. 

Handmade fabric facemasks

One very low-tech solution is the wearing face masks in public, as now recommended by the World Health Organization.

When the scarcity of PPEs hit the global market, local face masks and shield production systems soon emerged as African cities began to introduce and enforce mask policies, creating job opportunities for local tailors and entrepreneurs such as Abass Akinyemi.

“Before COVID-19, I was selling bread along the Lagos-Ibadan expressway (one of Nigeria’s busiest highways) but when COVID-19 hit Nigeria and the government introduced lockdown, I had to think of something else to do,” Akinyemi told Health Policy Watch.

He read about the state government’s plan to engage local tailors to produce one million face masks. Although he did not apply for the government project, he learnt how to make face masks, and began to sell them.

“The cost of production is very low, the profit margin is very wide and the demand for the face masks is high. Business has been good,” Akinyemi told Health Policy Watch in Ibadan, southwest Nigeria.

Different Contexts Require Different Solutions –  Some That Still Need To Be Found
Winnie Byanyima

But in many settings in Africa, some of the basic measures such as handwashing and lockdowns are difficult to successfully implement without backlash. Winnie Byanyima, Executive Director of the Joint United Nations Programme on HIV/AIDS (UNAIDS), told Health Policy Watch that the measures considered most basic, globally, are difficult to implement in many settings in Africa.

“Every day in Africa, a woman walks an average of 6 kilometer to fetch water. Now you’re saying wash hands every five/ten minutes. Who is going to fetch that water? It’s women and girls. Social protection came in so little and too late,” she said.

She noted that COVID-19 containment measures also increased vulnerability to other infectious diseases such as HIV, since people couldn’t get as easy access to prevention and treatment. But beyond the immediate impacts of COVID-19 measures on vulnerable Africans, Byanyima added that long-term impacts on relevant African programmes, which heavily rely on international donor funding. 

“For the low income countries in Africa, we have reasons to worry very much. They are funded, almost 90%, by aid money. This is disturbing because those aid countries (donors) have been hit very hard [and] they have to recover their economy and the revenue they will raise will not be what they expected. So even if we say we are going to keep the level of official development assistance (ODA) where it is – say 0.3 or 0.7%, or whatever the country has been giving, in terms of real volume of money, it will be less money,” Byanyima said. 

Next Priority Is Scaling Up Testing, Tracing & Treatment

With the pandemic not ending anytime soon, Dr. Nkengasong, Director of the Africa CDC said the priority for the response in Africa is to accelerate testing, tracing and treatment. On the continent, this is being driven through the PACT initiative (Partnership to Accelerate Covid-19 Testing). He described the initiative as the roadmap to safely unlock Africa’s economy.

“Africa is scaling up testing very rapidly. As a continent of 12 billion people we should have tested 1% of our people which is about 12 million tests. So, we have tested 2.7 million people, clearly there is a gap of 10 million that we should have tested to be ahead of the pandemic,” Nkengassong said at a recent press conference. A signature aim of the initiative is to conduct 10 million COVID-19 tests by October 2020.

But beyond testing, tracing and treatment, Ouma underlined that the COVID-19 response in Africa would still clearly benefit from the availability of new vaccines and more therapeutics. Early in July 2020, the Consortium for COVID-19 Vaccine Clinical Trial (CONCVACT) was launched to support the contributions of African scientists and healthcare professionals to the development and provision of safe vaccines. 

Ouma added that COVID-19 has also seen African countries working together to collaboratively overcome the challenges posed by the pandemic. Regarding treatment, he said African governments are being encouraged to ensure COVID-19 does not interrupt with the provision of other health services including maternal health, HIV/AIDS and malaria.

“Our intention is to ensure that Africa has local R&D, local field testing, clinical trials and production – not only vaccines but also therapies and any other supplies we may need, including equipment. It’s time for Africa to take its rightful position. A continent of 1.3 billion people must look after itself. This is our intention,” Ouma told Health Policy Watch. 

Image Credits: Paul Adepoju/Health Policy Watch.

Transmission electron micrograph of SARS-CoV-2 (red), the virus that causes COVID-19

AstraZeneca on Tuesday night suspended the Phase 3 trial of their experimental COVID-19 vaccine in order to investigate a a suspected severe adverse reaction in a volunteer reported in the United Kingdom.

The trial suspension follows just on the heels of AstraZeneca’s chief executive officer’s pledge to seek regulatory approval for a COVID-19 vaccine only after it has been proven to be safe and effective in large, randomized Phase 3 clinical trials. AstraZeneca’s CEO, along with the CEOs of eight other companies at the forefront of coronavirus vaccine development, signed the pledge on Tuesday.

“At AstraZeneca we put science, safety and the interests of society at the heart of our work. This temporary pause is living proof that we follow those principles while a single event at one of our trial sites is assessed by a committee of independent experts,” CEO Pascal Soriot said in press release. “We will be guided by this committee as to when the trials could restart, so that we can continue our work at the earliest opportunity to provide this vaccine broadly, equitably and at no profit during this pandemic.”

The pause is a sign that pharmaceutical companies are taking seriously routine clinical trial protocols to stop trials in the case of severe adverse reactions, even as pressure builds to get a safe and effective vaccine to market as soon as possible. Russia and China have already approved investigational COVID-19 vaccines for limited use, ahead of the completion of Phase 3 trials.

The Trump administration has indicated it’s looking to roll out a COVID-19 vaccine for wider use in late October, just ahead of the US presidential election on November 3rd. On Wednesday, the Administration issued new guidance to allow pharmacists and pharmacists in training to administer the vaccine, in preparation for a successful vaccine’s roll-out.

The World Health Organization and independent health experts have cautioned against prioritizing speed over safety; and are concerned that political pressure will lead to wider deployment of an investigational vaccine before large, final-phase trials have proven the vaccine to be safe and efficacious. It is unlikely that Phase 3 trial results will be available before early 2021.

Participant Who Experienced Suspected Adverse Reaction Is Doing Well

The trial was suspended because one participant was diagnosed with transverse myelitis – an inflammatory condition of the spinal cord that can be brought on by viral infections – according to the New York Times. However, it’s still unknown whether the condition was related to the investigational COVID-19 vaccine, although Soriot confirmed in a private call with investors that the patient had been enrolled in the arm that received the COVID-19 vaccine. However, he also told investors that the patient is doing well and will likely be released from the hospital as early as today, according to STAT News.

Such pauses are not uncommon, according to the director of the US National Institutes of Health Francis Collins.

“To have a clinical hold, as has been placed on AstraZeneca as of yesterday, because of a single serious adverse event is not at all unprecedented,” Collins told a Senate panel on Wednesday. “This certainly happens in any large-scale trial where you have tens of thousands of people invested in taking part, some of them may get ill and you always have to try to figure out: Is that because of the vaccine, or were they going to get that illness anyway?”

However, Collins added that should the review of the safety data find that the adverse event was related to the vaccine, all doses already manufactured would be disposed. The Trump administration signed a deal in May with AstraZeneca to produce 300 million doses of their investigational vaccine by January 2021, to be ready for mass rollout should the vaccine prove to be safe and effective.

“This ought to be reassuring to everybody listening when we say we are going to focus first on safety and make no compromises,” said Collins.

The massive trial – which has enrolled participants in dozens of study sites across the United Kingdom, Brazil, South Africa, and the United States – is one of the largest Phase 3 trials currently underway in the COVID-19 vaccine race, and the length of the trial’s suspension has not been confirmed. However, sources familiar with the trial told the Financial Times that the trial may resume in the next week.

Novel Technology Put To The Test In COVID-19 Vaccine Trials

In the private call with investors on Wednesday, Soriot also confirmed that the trial had been paused once in July due to a suspected adverse reaction. It resumed shortly after the suspected case was cleared to not be related to the vaccine candidate.

The vaccine, AZD1222, was co-developed by the University of Oxford, and uses a weakened version of a chimpanzee adenovirus – a common cold causing virus – to carry the genetic material of the SARS-CoV-2 spike protein. Once injected, cells inside the body produce the spike protein, a harmless but discrete marker of the SARS-CoV-2 virus, priming the immune system to recognize the virus and attack if the body is later infected.

There is no licensed vaccine with an adenovirus backbone on the market yet. However, this is in large part due to the novelty of the technology, according to Barry Bloom, an infectious disease epidemiologist and former dean of Harvard School of Public Health.

“No one had the genetic tools to be able to make them and make them quickly. So, the revolution in molecular biology and genetics and the ability to replace one gene with another rapidly easily and effectively, and has really speeded things up tremendously,” Bloom told Health Policy Watch. 

So far, results from a Phase 1/2 trial of the AstraZeneca/Oxford vaccine candidate published in July found that in 1,000 people, about 60% experienced “mild or moderate” symptoms after vaccination. These symptoms included pain at the injection site, feeling feverish, chills, muscle aches, and malaise. In that trial, no serious adverse reactions were reported.

Image Credits: NIAID.

Electron microscope image of SARS-CoV-2, the virus that causes COVID-19

The chief executive officers of nine biopharmaceutical companies at the forefront of the COVID-19 vaccine development race have signed a pledge to fully test the safety and efficacy of an investigational vaccine before rolling it out for mass use.

The top executives of AstraZeneca, BioNTech, GlaxoKlineSmith, Johnson&Johnson, Merck, Moderna, Novavax, Sanofi, and Pfizer signed the safety pledge on Tuesday, following reports that the CEOs were preparing such a safety pledge on Saturday.

News of the safety pledge coincided with reports Tuesday evening that AstraZeneca, which is one of the leading pharma companies in the race to develop a COVID-19 vaccine, was suspending it’s Phase III trials underway in four countries in collaboration with Oxford University, to investigate a report of a possible severe adverse reaction in one UK participant.

The AstraZeneca move was made out of “an abundance of caution,” a person familiar with the trials told STAT News – noting that such pauses are not uncommon. The trial may be resumed once the cause of the reported reaction is investigated, and if the vaccine is still deemed to be safe. However, it’s unclear how long the suspension will last.

“We voluntarily paused vaccination to allow review of safety data by an independent committee. This is a routine action which has to happen whenever there is a potentially unexplained illness in one of the trials, while it is investigated, ensuring we maintain the integrity of the trials,” an AstraZeneca spokesperson said in a statement to STAT News.

Amidst pressure from the Trump administration to begin wider roll-out of a vaccine before the US presidential election in November, pharma companies have taken the initiative to reassure the public that any potential COVID-19 vaccine will be properly tested before it receives regulatory approval.

“We, the undersigned biopharmaceutical companies, want to make clear our on-going commitment to developing and testing potential vaccines for COVID-19 in accordance with high ethical standards and sound scientific principles,” the companies wrote in the pledge.

Pharma Pledge Comes Amidst Pressure to Speed Up Approval

The pledge comes as countries’ regulatory authorities have faced pressure to release an investigational vaccine for wider use, even as large final phase clinical trials are still ongoing. Phase 3 clinical trials for the coronavirus vaccine candidates, which closely monitor the safety and efficacy of an investigational product in thousands of people, will not be complete before the end of the year.

However, the United States CDC notified US state officials in late August that a vaccine could be available for wider use by late October, just in time for the US presidential election on November 3rd, according to the New York Times.

And Russia approved a vaccine, aptly named “Sputnik 5,” before Phase 3 trials had concluded in mid-August. The move has drawn criticism and offers to collaborate by governments seeking new ways to combat the pandemic.

China in July approved a SinoVac’s vaccine candidate for emergency use, and media reports have found that nearly all of SinoVac’s employees and many of the employees’ family members have received the experimental vaccine.

The Gamaleya Institute, the developer of Russia’s approved vaccine, and SinoVac are not among the companies who have signed the pledge. However, Phase 3 trials for both companies’ vaccine candidates are currently underway.

The rapid approval of COVID-19 vaccines has drawn criticism from a number of researchers and public health specialists, who have warned governments against prioritizing speed over safety in releasing a vaccine. The World Health Organization has also recommended that countries wait for results from Phase 3 clinical trials before attempting to roll out a COVID-19 vaccine en masse.

Companies Pledge To Seek Regulatory Approval Only After Phase 3 Studies Show Safety And Efficacy

Key to the nine companies’ pledges is the promise to seek any regulatory approval, even emergency use approval, only after the vaccine demonstrates safety and efficacy in large scale, final phase clinical trials. The trials used to test the vaccine must also be designed to the highest clinical research standards, and ensure the vaccine is safe and effective in a large and diverse group of people.

“Following guidance from expert regulatory authorities such as FDA regarding the development of COVID-19 vaccines, consistent with existing standards and practices, and in the interest of public health, we pledge to..only submit for approval or emergency use authorization after demonstrating safety and efficacy through a Phase 3 clinical study that is designed and conducted to meet requirements of expert regulatory authorities such as FDA,” the companies wrote in the pledge.

Additionally, the companies made three further promises:

  • Always make the safety and well-being of vaccinated individuals their top priority.
  • Continue to adhere to high scientific and ethical standards regarding the conduct of clinical trials and the rigor of manufacturing processes.
  • Work to ensure a sufficient supply and range of vaccine options, including those suitable for global access.

Together, these nine companies represent some of the biggest vaccine developers in the world, and some of the most promising biotech firms. All companies are invested in investigational COVID-19 vaccines that are currently in Phase 3 trials.

Image Credits: National Institute of Allergy and Infectious Diseases, NIH.

Kenyan banker Peter Karagu ,alias Kanyenyaini Kangema, in his hospital bed in Nairobi. He spent 22 days under COVID-19 treatment and openly spoke about his illness with the hope of fighting stigma associated with the illness.

Nairobi, Kenya – While banker Peter Karagu is one of the over 35,000 people who have contracted COVID-19 disease in Kenya over the past 6 months, he cannot in any way be described as an ordinary victim of the respiratory illness.

Throughout his 22 days confined at an isolation ward at Kenyatta University Teaching Research and Referral Hospital in the capital Nairobi, he would update his social media followers with hilarious experiences at the hospital. You would think being hospitalised with COVID-19 was fun, had it not for days pushed him to the brink.

Sadly his rib-tickling posts on his Facebook page, where he uses the name Kanyenyaini Kangema, did little to fight stigma associated with the illness, one of the things he intended the updates to achieve, as he came to discover only a day after he left the treatment facility. 

He had developed a problem of high blood sugar during the course of treatment, just like many fellow patients at the hospital, making it necessary for him to visit a neighbourhood pharmacy to have his sugar levels checked.

However, as soon as he stepped into the shop, the terrified and panicky owner declined to attend to him, and hurriedly shut the doors before embarking on the process of spray-fumigating the pharmacy.

“The reaction surprised me, the pharmacy owner knew me, so he had heard that I had been diagnosed with the disease. What really shocked me more is the fact that he and his workers were not just ordinary Kenyans, but medical professionals who should have known better,” Karagu told Health Policy Watch.

Peter Karagu recuperates at home

Stigma Leaves Patients Alone & Fearful

Stigma associated with the disease is often leaving patients and their families more traumatised than disease itself. As a result Kenya’s Health Ministry is appealing to citizens to help fight the trend, realising that the race to conquer COVID-19 won’t be won unless the vice is tamed.

“It will not be easy winning this war if we do not all fight stigma, we must learn to accept that anybody can fall victim to this disease as it does not discriminate, so do not discriminate against those who get it,” said Director General Patrick Amoth.

Stigma was hindering efforts against the disease as community transmissions accelerated, he observed. The problem was pronounced in rural areas and making some people refuse to submit for testing, in some cases nearly derailing Kenya’s targeted testing strategy.

Stigma could also be blamed for the recorded low number of patients turning up in hospital for treatment of other diseases since the outbreak hit Kenya in March, added Dr Amoth.

“We are worried over the low numbers of patients seeking treatment in our health facilities, we think the reason for this is that people fear being tested for COVID-19 due the kind of stigmatisation those diagnosed with the disease and their kin have been subjected to,” the official noted in an August 27 press briefing.

The World Health Organisation (WHO) protocols for burying victims have not helped matters, according to Amoth. Burials are hurried compared to usual burials. Only a few people attend, and bodies are handled by health workers in very brief ceremonies. In normal times, burials are huge, elaborate affairs attended by hundreds of mourners.

In fact, it is out of the fear of his young family being treated as outcasts by neighbours that made Karagu ask his wife to drive him to hospital when results came out that he had the disease. He was afraid that ‘screaming’ ambulances sent to pick him from home, with medics “dressed like astronauts” would also traumatise the children. 

Stigma Slows Efforts To Contain The Pandemic

Ngoy Nsenga, WHO Africa COVID-19 Incident Manager

The WHO acknowledges that stigma is a major problem and has been slowing efforts to contain the pandemic in Kenya and across Africa.

“Stigma in the community is a distracting factor hindering interventions to contain the spread. People might hide for fear or refuse seeking treatment even when they have coronavirus-like symptoms, endangering themselves and others,” said Ngoy Nsenga, WHO-Africa COVID -19 incident manager.

One way of fighting the problem he says is by bringing in the community as allies, educating them and making them partners in ending it.

Acknowledging that stigma is normal at the beginning of any pandemic, Dr Nsenga says that no outbreak can be fought without community engagement, hence their importance.

“We have to make communities partners in order to win against this disease, we have to work and with and within communities to tame and stem the stigma”, he asserts.

While daily cases in Kenya seem to be dropping since the end of August, particularly in the major cities of Nairobi and Mombasa, which have been the disease epicentres, cases seem to be rising in rural areas. 

Coronavirus Cases and Fatalities as of 8 September 2020, according to the Kenyan Ministry of Health

Kenya’s Contact Tracing System Under Pressure – Community Health Workers Recruited 

And as transmission trends shift to the countryside, the strained health system has all but abandoned tracing of contacts.

Instead Kenya is undertaking targeted contact-tracing, Nsenga told Health Policy Watch in an interview.  This is advised by WHO in such scenarios, so as to trace and quarantine those who are at higher risk of contracting the disease, or at becoming seriously ill. 

“This should include those in the same household as the victim, vulnerable people such as the elderly and the sick, and health workers should they have been in contact with the case,” the official said.

“As the numbers overwhelm, we also advise authorities to consider deploying technologies including phone apps which is easy where internet coverage is good”, he added.

Some eight out of ten of the infected are turning out to be asymptomatic, or only showing mild symptoms. As a result, Kenya has also enlisted its network of Community Health Workers (CHWs) to help monitor and actualise home-based care and isolation of the patients.

Monitoring such cases for at least ten days is recommended, according to Dr Nsenga. It’s important so that they can quickly be given treatment should they develop severe disease, something he says happens to about five percent of those in this category.

“Being able to detect and net many asymptomatic patients is not necessarily a bad thing; it is actually a sign that testing is wide enough for it to be able to net those with no symptoms,” he noted. “It helped in preventing the cases from developing into severe disease.”

Many of the CHWs so far deployed by county governments in rural areas have not been received any form of compensation, according to a health official based in Kirinyaga County of Central Kenya. Yet their support has proven invaluable. 

The CHWs have been helpful in enforcing protocols for  home-based care, despite not “being facilitated to perform the tasks, and are being an important part of community participation” in fighting the epidemic, said a Public Health Officer who spoke on condition of anonymity.

CHWs and health promotion officers help educate the community about the coronavirus.

Deploying the CHWs was a good thing in home-based care situations as long the volunteers are properly trained, notes Dr Nsenga. And of course, he added, so long as they are given proper protective clothing so that they do not get infected or infect others.

Kenya’s Current Coronavirus Testing Situation

Over the past 3 weeks Kenya’s testing capacity has gone down from a high of 4,500 tests a day in July to a low of under 3,000 tests a day in September. Health Minister Mutahi Kagwe blames the low testing capacity on a shortage of reagents. 

However, while numbers of tests administered have declined, so have numbers of positive cases, suggest data provided by the volunteer tracking website, CoronaTracker.  From a high of 688 daily cases confirmed by 4,522 tests on 18 July – a positivity rate of 15 percent, numbers have fallen to 102 confirmed cases out of 2,668 tests on 7 September –a positivity rate of under four percent. As a result, there could be a further easing of restrictions in the coming few weeks.

Overall total deaths stood at 599 as at Monday this week, while a total of 35,205 of positive cases had been recorded since March. Some 21,310 people had recovered from the disease and according to the Health ministry Kenya’s death rate was at 1.7 percent.

Kenya’s Coronavirus Cases and Fatalities, 8 Sept 2020. Numbers change rapidly.

Part of a series of stories about how the coronavirus response is playing out in different parts of Africa. For more on this, see our stories on South Africa, Ibadan, Nigeria, and Kampala, Uganda. 

Image Credits: WHO Africa, Peter Karagu, WHO Africa, Twitter: MOH_Kenya, CoronaTracker.

Some Greenpeace volunteer holds sign at the Suralaya coal power plant in Cilegon city, Banten Province, Indonesia.

September 7 is the first International Day of Clean Air for blue skies launched by the United Nations’ General Assembly.

It aims to build a global community of action that calls on countries to work together to tackle air pollution and provide clean air for all. As the COVID-19 lockdowns reminded us of from Wuhan to Los Angeles to New Delhi, air pollution does not have to lead to fatality, and can drop dramatically when sources of emissions cease as a result of political decisions. In many places around the world, people rediscovered for the first time in decades what clean air looks like.

In his keynote address, the secretary-general of the United Nations António Guterres urges, “We need dramatic and systemic change. Reinforced environmental standards, policies and laws that prevent emissions of air pollutants are needed more than ever.

“Countries also need to end subsidies for fossil fuels. And, at the international level, countries need to cooperate to help each other transition to clean technologies.

“I call on governments still providing finance for fossil fuel-related projects in developing countries to shift that support towards clean energy and sustainable transport.”

Air Pollution Is The Single Greatest Environmental Risk To Human Health

Air pollution is identified since long as the single greatest environmental risk to human health and one of the main avoidable causes of death and disease globally, with 7 million premature deaths across the world attributed to indoor and outdoor air pollution, more than from Malaria, Tuberculosis and AIDS combined.

Also, all major air pollutants have an impact on the climate and most share common sources with greenhouse gases (GHGs), especially related to the combustion of fossil fuels. As citizens mobilize for cleaner air and greater protection of their health, effective sanitary regulations by city or district authorities have proven one of the most powerful instruments to both rein in toxic emissions and address the climate emergency. But countries must quick get their act together and lead the systemic change needed through greater international cooperation.

Air pollution is caused by gases and particles emitted in the atmosphere by a variety of human activities, such as the inefficient combustion of fuels, agriculture, and farming. There are also natural sources contributing to air pollution, including particles of soil dust, which greatly affects desert regions and salt in sea spray.

Tiny, invisible particles of pollution penetrate deep into our lungs, bloodstream and bodies.

These pollutants are responsible for about one-third of deaths from stroke, chronic respiratory disease, and lung cancer, as well as one-quarter of deaths from heart attack. Ground-level ozone, produced from the interaction of many different pollutants in sunlight, is also a cause of asthma and chronic respiratory illnesses.

While indoor pollution has fallen steadily, due to people accessing cleaner cooking fuels, progress on outdoor pollution remains dismal.

The Most Affected Areas 

Visiting an interactive live map created by UNEP is a real eye-opener. In the case of particulate matter, the large majority of countries are far beyond WHO’s recommended threshold, but populations in Northern Africa, the Middle East, South Asia and China are disproportionately exposed.

There have been remarkable decreases in emissions and pollutant concentrations in many European countries, as well as the USA, Canada and Japan, where strong policies, regulations and regular monitoring systems were put into place.

One of the most famous examples is London, which historically had some of the worst levels of pollution. Since then, air quality in the UK has improved remarkably. Particulate air pollution levels fell by over 97% between 1900 and 2016.

Air Pollution And Greenhouse Gases Build Upon Each Other

Air pollutants and greenhouse gases (GHGs) not only share many common sources, they also aggravate each other in multiple ways. For example, GHGs, such as methane, contribute to the formation of ground-level-ozone, and levels of ground-level ozone increase with rising temperatures. Rising temperatures increase the frequency of wildfires, which in turn further elevate levels of particulate air pollution.

A group of pollutants, called ‘ Short-Lived Climate Pollutants ’ (SLCPs) which include black carbon , ozone, methane , and hydrofluorocarbons (HFCs) , are highly potent climate forcers and – in the case of ozone and black carbon – dangerous air pollutants. Many SLCP reduction measures also reduce other air pollutants, like nitrogen oxides.

From the Macro To The Micro: Regional to City-level Cooperation Lead The Fight Against Air Pollution

A good example of the positive achievements of a multi-national air pollution reduction approach is the UNECE Convention on Long-range Transboundary Air Pollution, which was the first coordinated approach between countries to address their common and shared air pollution problems. Under the Convention, 51 countries in Europe – including all EU Member States – and North America are cooperating to reduce deadly air pollution. Achievements are significant:

  • Emissions of harmful substances including particulate matter and sulphur have been cut by 30-80% since 1990 in Europe and 30-40% in North America.
  • Soil acidification has been halted in most parts of Europe.
  • Decoupling of economic growth and air pollution.
  • Strengthened climate action thanks to the Convention’s binding emission reduction commitments for “short-lived climate forcers”. The amended Gothenburg Protocol specifically includes black carbon (or soot) – which is 680 times more heat trapping than CO2 – as a component of fine particulate matter.

Several of the world’s largest cities have peaked their greenhouse gas emissions and actually reduced them by 22% in average, according to C40, the international network of cities supporting them on climate action. In a similar way, many are adopting strong measures to curb air pollution by regulating which vehicles can access their urban centres and have signed the Clean Air Cities Declaration in 2019.

Without waiting for national policies to be in place, they are sending the advanced signals to power suppliers, manufacturers and food producers that their practices will now have to adapt radically within the next decade.

Through their action, citizens, cities, national authorities and multilateral cooperation have the potential to trigger social tipping points towards better health for people, sustainable human development and climate stability. To that effect, clean air strategies prove to be instrumental in reaching the Paris climate goals alongside parallel efforts on food systems.

__________________________________________________

Health Policy Watch is partnering with Geneva Solutions, a new non-profit journalistic platform dedicated to covering International Geneva, for a health news stream. Sign up for the daily brief, and follow Geneva Solutions at @GenevaSolutions on Twitter and Facebook. 

Image Credits: Rendra Hernawan / Greenpeace, IHME Global Burden of Disease, World Bank.

WHO Chief Scientist Soumya Swaminathan

Countries would be better off waiting until Phase 3 clinical trials, which test the safety and efficacy of an experimental vaccine in tens of thousands of people, are completed before rolling out the vaccine for wider use, World Health Organization Chief Scientist Soumya Swaminathan said on Monday.

Although some countries, including China, Russia and the United States, have approved or are considering COVID-19 vaccine candidates for emergency use, Swaminathan underlined that emergency use regulation is only a “temporary solution,” and countries needed more data before deciding to roll out the vaccine to the public.

“It is only a temporary solution, and the longer term solution is really completing those Phase 3 trials, which will provide the confidence for those vaccine candidates to be actually used in the millions of doses,” said Swaminathan. 

“We’d like to see data on both safety and efficacy in significant numbers of people,” she added. “So the phase one and two studies are usually done in a few dozen individuals. And while these give you some idea about safety and… the immunogenicity of the vaccine, what we are really looking for is signals for efficacy and safety during longer follow-up [in a larger group].” 

She was responding to a query about reports of SinoVac, a Chinese company at the forefront of COVID-19 vaccine development, allowing  its employees and their families to use the investigational vaccine before Phase 3 trials have concluded. China had already in July approved the SinoVac vaccine candidate for emergency use, although few details about the regulation are available. 

The comments also follow the publication of an op-ed by Jeremy Farrar, head of the research foundation the Wellcome Trust, that warned governments to “temper their optimism” about a “magic bullet” COVID-19 vaccine. Farrar further warned that governments must avoid compromising safety in favor of speed in vaccine development. 

Still, Swaminathan said that national authorities still have the right to decide what to do, but they should be monitoring use of the vaccine closely, and doing it under a clear emergency use authorization. 

“National regulatory authorities have the mandate and the power to allow use of medical products within their own jurisdictions under certain conditions in an emergency, and a pandemic is one of those conditions,” she said. “Hopefully this is done under monitored conditions, it’s done under what we call the emergency use of products – under research settings where people who are given the vaccine are followed regularly are assessed at periodic intervals.” 

A WHO team in China is working directly with regulatory authorities to share data on the vaccine, and to make sure the vaccine meets WHO’s standards before moving forward to ensure international access, added Mariangela Simao, WHO assistant general for Access to Medicines, Vaccines and Pharmaceuticals.

Most countries in the world are not on track to reduce premature deaths from non-communicable diseases (NCD) by a third by 2030, according to a new NCD 2030 Countdown report published by The Lancet.

“An estimated 150 million people will lose their lives too early from a noncommunicable disease over the next decade and right now NCDs are intensifying the impact of COVID-19,” said Bente Mikkelsen, director of NCDs at the World Health Organization in a press release.

But it’s not too late to turn the tide, says Geneva-based NCD Alliance, a partner in the NCD Countdown Consortium that authored the report. Imperial College London and the World Health Organization are also a part of the Consortium.

“The positive message from the study is that all countries still have options to reach SDG3.4 (the NCD target) by 2030 and in doing so save millions of lives,” Nina Renshaw, director of Policy & Advocacy at the NCD Alliance told Health Policy Watch.

“”The target can only be reached by putting in place a package of preventative and treatment measures to reduce premature deaths from multiple NCDs. No country could hit the target by focusing on just one disease, and both prevention and treatment measures are needed,” she added.

Only Six Countries On Track To Meet 2030 Targets – And Rich Countries Aren’t Necessarily Doing Better

Red indicates that the likelihood of dying prematurely from that NCD increased in the country, while green indicates the likelihood of dying prematurely from an NCD decreased. Some high-income countries such as the United States (red box) saw increasing risk in premature mortality across many NCDs, while middle-income countries like Ukraine [green box] saw a decrease in NCD mortality.
Only Norway, Denmark, Luxembourg, New Zealand, Singapore, and South Korea are on track to meet the 2030 goals for reducing mortality by preventable and treatable NCDs such as stroke, heart disease, and cancer.

And high-income countries aren’t necessarily making the most gains in NCDs overall, according to Renshaw.

“There are some LMICs who are doing well at reducing NCDs,” ” she said. ” These include Jamaica, Jordan, Maldives, South Africa, Turkey, Vietnam and many in eastern Europe, including Montenegro and Ukraine.

“On the other hand, some rich countries, most notably the USA, are going backwards, meaning people are dying younger from a number of major NCDs. This shows that success is about more smart policies first and foremost.”

The pandemic has also exposed a ‘syndemic’ – the deadly infectious disease targets those already living with NCDs such as heart disease and diabetes. Those with diabetes are 2 to 4 times more likely to experience severe COVID-19 or death by the virus, according to WHO director-general Dr Tedros Adhanom Ghebreyesus.

“COVID-19 has exposed how a failure to invest in effective public health to prevent NCDs and provide health care for people living with NCDs can come back to bite us,” said Katie Dain, CEO of the NCD Alliance. “NCD prevention and treatment can no longer be seen a ‘nice to have’, it must be considered as part of pandemic preparedness.”

With many essential health services disrupted during the COVID-19 pandemic, the risk of walking back gains on NCDs increases.

Smart Policies Can Turn The Tide On NCDs

The top NCD killers – diabetes, cardiovascular disease (CVD), chronic respiratory disorders, and cancers – can be combatted with a basic package of interventions, tailored to fit countries’ budgets and needs, according to the study.

All countries should implement tobacco and alcohol control policies, added Renshaw. Tobacco and the harmful use of alcohol are major risk factors for cardiovascular and respiratory diseases, and a number of different cancers.

“The necessary policy packages vary for different countries, depending on local disease burden and risk factors, but all countries need to implement tobacco and alcohol control policies, as well as a package of treatment interventions,” she said. “We recognize cost constraints in different countries.

“But the study shows that a basic essential package should include at least hypertension and diabetes treatment, primary and secondary prevention of cardiovascular disease (CVD), and treatment for CVD, diabetes complications, asthma and COPD, cancer screening and treatment.”

While the current report highlights the NCDs that should be prioritized by country, the NCD Countdown 2030 Consortium will be releasing a follow-up paper to look at the costs of implementing recommended interventions and policies by country and by region.

Bente Mikkelsen

And as governments build back from COVID-19, NCD’s must be addressed in recovery plans, said Mikkelsen.

“We must ensure that all NCDs are addressed in COVID-19 recovery plans so that we can turn this deadly tide,” said Mikkelsen. “Young people must lead the fight against NCDs. We cannot allow NCDs to become a generational catastrophe, where human potential is wasted, and inequality is exacerbated.”

Image Credits: WHO/A. Loke, NCD Countdown 2030: pathways to achieving Sustainable Development Goal target 3.4, WHO.

Vial of remdesivir, one of the only approved drugs to treat COVID-19

As global stocks of remdesivir, one of the few promising therapeutics for COVID-19, run low, the drug’s maker Gilead Sciences says that voluntary licensing to enable more manufacturers to produce the drug will not help expand access, countering advocates’ calls. 

Rather, the lack of a “coordinated global supply chain” is to blame for worldwide shortages of remdesivir, says the pharmaceutical giant.

“We understand we are not yet in a position to meet real-time demand of [remdesivir] in every corner of the world,” said Gilead’s CEO Daniel O’Day, at a virtual press conference hosted by the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) on Thursday. “We will do everything we can to make sure that we can produce as much remdesivir as possible.”

“What we need in order for that to happen is a coordinated global supply chain…starting material [for remdesivir] must be appropriately managed…in a way that meets the standards of patients regardless of where they are in the world,” he added, although he did not specify the exact bottlenecks the supply chain was experiencing. 

However, “the concept of just licensing [remdesivir] to everybody is not going to get more at the end of the day,” said O’Day.

Currently, Gilead has licensed remdesivir to nine generic manufacturers at a ‘no-cost basis’, and supported technology transfer for those select producers.

“Generic manufacturers have everything they need to be able to produce [remdesivir],” said O’ Day. “Nothing is getting in the way of generic manufacturers [producing remdesivir].”

Medicines Access Advocates Argue That Wider Licensing Could Improve Access

But some critics have said that more voluntary licenses are needed, arguing that increasing the number of manufacturers will further expand access. Gilead has not made the voluntary license agreements for remdesivir publicly available, despite its willingness to do so in the past. When asked about this on Thursday, Gilead did not respond.

Peter Maybarduk, access to medicines director at Public Citizen, told Health Policy Watch that Gilead’s hold on remdesivir patents “appears to be a significant problem that limits incentives and generic market access.”

Some of the countries with the largest coronavirus caseloads in the world, such as Brazil and Mexico, are not covered under Gilead’s generics licenses.

“The countries that are not covered by Gilead’s license would have to buy from Gilead, but they can’t buy from Gilead because the United States and Europe have bought up the entirety of Gilead’s supply,” said Maybarduk. Gilead will have only 15,300 treatment courses available for countries outside the EU and United States to access from August to September, according to a new report from Public Citizen. 

And the supply of one of the only drugs approved for emergency use to treat COVID-19 has even been running low in high-income countries like Spain. Demand for the treatment shot up after remdesivir was shown to significantly reduce the length of a hospital stay from an average of 15 days to 11 days for COVID-19 patients, according to a trial funded by the US National Institute of Allergies and Infectious Diseases (NIAID) in May.

With the recent expansion of the emergency use authorization for remdesivir in the United States, the country with the highest number of active coronavirus cases in the world, demand could again shoot up. The drug can now be used to treat all hospitalized COVID-19 patients in the US, rather than just severe cases. 

And despite Gilead’s view that remdesivir’s existing price is ‘well below ” its market value, civil society advocates, as well as health ministers, note that it’s priced out of reach for many people. Advocates have claimed that remdesivir could be priced even lower, given that the current market price is five times that of production, according to The Journal of Virus Eradication’s estimates. 

“Some critical drugs like remdesivir…can be significantly expensive for some in our countries,” said Honorable Mitoha Ondo’O Ayekaba, Vice Minister for Health and Social Welfare, Equatorial Guinea, at a virtual press conference on Thursday. 

Honorable Mitoha Ondo’O Ayekaba, Vice Minister for Health and Social Welfare, Equatorial Guinea

-Grace Ren contributed to this story.

Image Credits: European Medicines Agency, IFPMA, WHO/APO.

Artist’s rendition of SARS-CoV-2, the virus that causes COVID-19

The US Biomedical Advanced Research and Development Agency (BARDA) is investigating Moderna’s patents for allegedly failing to disclose federal funding, making it the second US agency to review the company’s patents.

The BARDA probe comes just days after the US Defense Advanced Research Projects Agency (DARPA) began an investigation into Moderna’s patents, after pharma watchdog Knowledge Ecology International (KEI) sent DARPA a letter alleging that Moderna had failed to disclose DARPA funding in its US patent applications.

In a public letter to acting head of BARDA Gary Disbrow on Wednesday, KEI wrote that Moderna, the biotech company behind a promising COVID-19 vaccine candidate, has failed to disclose millions of dollars of federal funding on patents granted by the US Patents and Trademarks Office (PTO). Disclosure of federal funding in patent applications is required under the Bayh-Dole Act.

“The contracting officers responsible for the BARDA contracts with Moderna are reviewing the requirements to report the role of government funding of inventions and identifying any Moderna patents or patent applications that may be associated with BARDA support,” said Disbrow, in a letter responding to the KEI request. “Following this review, BARDA Contracting Officers will be in touch with the company and will ensure Moderna’s compliance with its contractual requirements.”

So far, BARDA has provided nearly US$ 1 billion to the biotech firm to fund development of it’s COVID-19 vaccine candidate. The agency had also supported early development of the company’s investigational Zika vaccine.

Moderna Discloses Funding In One WIPO Application, But Fails To Disclose Funding In US Patent Applications

“Moderna has not been disclosing federal funding on its inventions [for patents filed with the US PTO],” James Love, director of KEI, told Health Policy Watch. “It is important for BARDA and DARPA to enforce the obligation to disclose.”

A Moderna spokesperson told Health Policy Watch that the company believed it had complied with all patent disclosure laws, in regards to the DARPA probe. Moderna does disclose DARPA funding on one patent application submitted to the World Intellectual Property Organization (WIPO).

However, KEI claims that out of 127 US PTO-granted patents and 154 USPTO patent applications, not one has disclosed federal funding.

Moderna received a modest US $25 million in funding from DARPA in the early 2010s to kickstart development on their Zika and chikungunya vaccine candidates.

However, “The US Biomedical Advanced Research and Development Agency has given roughly 100 times the money to Moderna than Moderna has received from the Defense Advanced Research Projects Agency,”  said Love.

BARDA has granted the biotech firm nearly US $1 billion in funding to accelerate development of a COVID-19 vaccine candidate, built on the company’s proprietary messenger RNA platform.

However, the agency also supported development of Moderna’s Zika vaccine with a US $125 million grant, according to the company’s Securities and Exchange Commission (SEC) filings from 2018. But USPTO-granted patents related to Moderna’s Zika vaccine do not list the BARDA funding.

“The patents are not just for a specific disease, they are for inventions that have applications across different diseases. Moderna’s work on Zika and Chikungunya were both relevant to the COVID 19 vaccine work,” explained Love.

In order to enforce the mandatory disclosure laws, agencies could take title to patents that fail to list federal funding, rather than simply requesting a correction to the patent, suggested Love.
“It will send a signal to everyone receiving federal funding that the disclosure obligation is not a joke,” said Love.
This story was updated on September 4 2020 with BARDA’s response to the KEI letter.

Image Credits: NIAID.