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.

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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.

The White House

A White House spokesperson on Tuesday said that the United States would not be joining the COVAX Facility, an initiative led by the World Health Organization and its partners to pool global demand for a COVID-19 vaccine, and ensure its equitable distribution.

“The United States will continue to engage our international partners to ensure we defeat this virus, but we will not be constrained by multilateral organizations influenced by the corrupt World Health Organization and China,” White House spokesman Judd Deere said in a statement.

“This President will spare no expense to ensure that any new vaccine maintains our own FDA’s gold standard for safety and efficacy, is thoroughly tested, and saves lives,” Deere added. 

The US’ refusal is a blow to the COVAX Facility – led by the WHO, Oslo-based Coalition for Epidemic Preparedness Innovations (CEPI), and Gavi, the Vaccine Alliance – which is still in the process of negotiating final commitments from countries. 

If successful, the COVAX Facility could set a historic precedent and overturn a tide of “vaccine nationalism” in which rich countries have placed pre-orders for promising investigational vaccines, potentially leaving poorer countries in the dust. 

The COVAX Facility is designed to have rich countries help subsidize the cost of a vaccine for lower-income countries, and may be the best chance for poorer countries to get their hands on an effective COVID-19 vaccine as soon as possible. So far, over 170 countries, including 92 low and middle-income countries that qualify for development aid have expressed interest. The European Commission and Germany both made public commitments to join the initiative on Monday.

But since the Trump administration indicated its intent to withdraw the US from the WHO to Congress and the United Nations in July, it has distanced itself from most global COVID-19 initiatives, particularly those involving the WHO. While initially Trump praised the WHO response to the pandemic, the president began criticizing the agency for allegedly failing to act in a timely fashion and catering to China in March, shortly after the epidemic began accelerating in the US. 

United States Leans On Operation Warp Speed

Now, as the US surpasses 6 million confirmed COVID-19 cases, the Trump administration is hedging its bets on Operation Warp Speed, a government initiative to roll out an effective COVID-19 vaccine to the masses by January 2021. Under Operation Warp Speed, Moderna, AstraZeneca, and Johnson&Johnson have received massive infusions from the US Department of Health and Human Services to finance vaccine development. 

US Food and Drug Administration Commissioner Stephen Hahn even told the Financial Times on Sunday that the FDA may consider approving a vaccine for emergency use before final phase trials are concluded, if preliminary data shows that the benefits outweigh the risks. This strategy would follow closely in the footsteps of Russia, which drew both criticism and offers to collaborate when it announced it had approved a COVID-19 vaccine in early August, ahead of final phase clinical trials.

However, the World Health Organization warned against premature approval of a vaccine candidate on Monday.

“The risk of approving a vaccine prematurely for us is that first of all, it will make it very difficult to continue with randomized clinical trials,” said WHO Chief Scientist Soumya Swaminathan.
“And secondly, that there’s a risk of introducing a vaccine that’s been inadequately studied. And that might either turn out to have low efficacy, thereby not doing the job of bringing an end to this pandemic. Or even worse, it could have a [poor] safety profile, which is just not acceptable.”

“The move to use a drug or a vaccine from an emergency point of view does not take away the need to collect important information,” added WHO Executive Director for Health Emergencies Mike Ryan. “The difficulty right now is we’re moving from vaccinating tens or hundreds of people to thousands [in Phase III trials]…and certain adverse events you won’t pick up with smaller numbers. You need to maintain monitoring.”

But ultimately, said Ryan, each country has a sovereign right to define its own vaccine policy. 

The Trump administration has already  inked bilateral deals with a number of vaccine developers, including Moderna and Johnson&Johnson, to produce millions of doses of their COVID-19 vaccine candidates. Manufacturing for these doses will begin as final phase clinical trials are still being conducted for these vaccine candidates, so that doses will be ready to ship if the investigational vaccines prove safe and effective.

Image Credits: Flickr: Radek Kucharski.

Tal Zaks, chief medical officer at Moderna

Tal Zaks, chief medical officer at Moderna Therapeutics since 2015, which has become one of the front-runners in the race to develop a vaccine for COVID-19, is in fact an oncologist, not a virologist by training.

And so it’s perhaps no accident that the innovative “messenger RNA” (mRNA) technology upon which the company’s vaccine candidate is built, first got its foothold as a potential strategy for cancer treatment. Currently Moderna has nearly a dozen vaccine candidates in the pipeline, based on the same technology, including ones for long-neglected tropical diseases like Chikungunya and Ebola. But the pandemic, in fact, created a big break the tiny startup biotech company needed. Zaks sat down with Elaine from Geneva Solutions’ health stream, produced in collaboration with Health Policy Watch, to talk about the technology and why he believes in it. 

Geneva Solutions: Moderna’s vaccine candidate operates on a wholly different technology than traditional vaccine technologies. Can you explain in a nutshell what that is and why you think it is better? 

Tal Zaks: The central dogma of biology is that genetic material is stored in DNA, and the intermediary of translating the information from DNA to the cell to make a particular protein is mRNA

mRNA is a transient copy of the instructions in our genes that instructs the cell’s ribosomes to make protein. Every cell has the same DNA. But what makes every cell unique is the fact that it actually has different mRNAs that translate different proteins. Now, what our technology does is it allows us to make a protein-based vaccine; instead of making the protein outside the body, we actually just set the messenger RNA as the vaccine, and that teaches our body’s own cells to make the protein.

GS: Is this the protein that fights the virus, or is this a protein that is a part of the virus?  

TZ: The most common type of virus is an RNA virus. What we do though is we take just the information required to instruct the immune system to recognize the most important advantage of this virus – the distinctive spike protein [the crown, from which coronavirus gets its name]. 

An mRNA vaccine is not a virus, [or even a weakened virus]. It only gives the cells transit instructions to make that one piece of virus that we want to educate the immune system to recognize – [the distinctive spike protein from which coronavirus gets its name].  

It’s essentially an instruction code. I inject it into the muscle. It gets distributed to the lymph nodes where the immune system works. The messenger RNA encodes for the spike protein and our cells start to make this spike protein. 

Now the immune system sees a new protein it’s never seen before. And it goes, ‘Oh, hold on a second. This looks like a foreign threat. I’ve never seen this protein before, let me go block it.’ And so the immune system starts to generate antibodies and T cells that recognize that spike protein. It focuses the attention of the immune system, just on that one protein.

mRNA serves as a template for cells to produce the coronavirus spike protein, which then triggers the body’s immune system to produce neutralizing antibodies against the protein.

GS – To recap, you’re sending an instruction to the body to make a spike protein, which is only one part of the virus, and so it’s not really dangerous. But the body’s immune system will see that spike protein and say, hey, this is dangerous and start making antibodies and T cells, which will protect the body if the same spike protein starts to invade as part of a real virus.  

TZ: And because that spike protein is what the virus uses to attach itself to a cell, if you can generate an antibody that recognizes those [spike proteins], a good proportion of them will end up blocking the virus, and therefore neutralizing its ability to infect cells. And that’s where the concept of “neutralizing antibodies” comes from.

GS: Yes, we said that a successful vaccine must not only produce “antibodies” but it must produce “neutralizing antibodies”. What’s the difference? 

TZ: When the immune system sees the spike protein, it doesn’t know which part of that protein is actually the critical part for the virus to attach, so it starts making antibodies against all sorts of different components. What’s important is that you have enough it starts making antibodies against all sorts of different [viral] components. What’s important is that you have enough antibodies that some of them actually now combine to neutralize the virus. 

GS: So they bind with the protein and neutralize it. 

TZ: Correct. They neutralize the virus’s ability to infect cells. When you measure antibodies in the blood,  you can either measure the total amount of antibodies that can bind to anything. Or you can actually set up an assay to see the level of neutralizing activity in the blood. The more you’re able to dilute the blood, and still block the virus, the higher the level of neutralizing activity, or neutralizing antibody “titres” in that blood, which will block the virus.

Bioreactors for mRNA vaccine production are smaller and cheaper than those used for making traditional vaccines.

GS: What are the advantages of this technology, as compared to a traditional vaccine where you just inject a weakened form of the virus, or a part of the virus protein, into the body directly?

TZ: There are several. The first is this is a relatively rapid enzymatic process, which can be done more rapidly from a manufacturing standpoint. Secondly, [we are doing the process inside the body], as opposed to a [more conventional recombinant engineering] technology where we take [artificial] cells, and have those cells make the virus [spike] protein for us outside of the body. A bioreactor needed to make a batch of vaccine protein is typically a 30,000 litre affair that takes up three stories of a building and costs between half a billion and US$ 1 billion to build.  Whereas a bioreactor to make [the same quantity] of an mRNA vaccine is just 30 litres, not 30,000 litres.  That’s a huge difference.  It takes weeks, not months, to set up. And it can all be done in simple [bio]degradable plastic. And so from a production standpoint, there’s a tremendous efficiency here in time and capital to get it started.   

The second advantage is that we mimic biology in a very profound manner. So there is no way [for our body] to make the wrong protein, because our cells are the factories that make the protein and we just give it the instruction set.  Whereas when you make a vaccine from recombinant protein in artificial cells, you always worry about, have you made the right protein? So there is a tremendous advantage in terms of the biological fidelity of your vaccine.  

GS: You are also testing the same technology on many other viruses, correct? 

TZ: The COVID-19 source code is the tenth virus against which we have demonstrated the ability to generate neutralizing antibodies in the clinic. And that’s out of ten viruses that we have tried, so our hit rate has been pretty good. That being said, we are less than five years out from having dosed the first ever subject on an infectious disease vaccine. So it’s a relatively young technology.  [Before COVID-19 came along] our most advanced program was the vaccine for CMV (cytomegalovirus) one we’ve completed enrollment in Phase 2, and are on track to start a Phase 3 trial next year. So in a way, we got lucky because we had already been planning and thinking ahead of how one scales up this technology. And it’s one of the reasons that overall, we’re pretty advanced in our cold chain distribution and some of the other manufacturing components here, because we’ve been at it for a few years. But COVID-19 is going to be the first, I think, to get the market.

GS: In terms of the efficacy you’ve shown in the Phase 1 trial for the COVID-19 vaccine, you provoked a neutralizing antibody response in all 45 volunteers that participated, correct – and those were all at different dosing levels? 

TZ: In the first phase we tested at 25, 100 and 250 microgram levels – and already at the 25 microgram level we can get to levels roughly of those who have been sick.  But we wanted to be sure that we give the immune system the best chance to protect subjects. And so we were able to dose up to 100 micrograms and exceed the levels of antibodies that you see in convalescent plasma.  I think that’s important because if you can get to higher levels, your chances of protecting people are going to be higher and the duration of protection will hopefully be longer.  And the question of duration is obviously a big unknown.  Nobody knows how long you are going to be protected, either from having been sick, or from having been immunized, but I think it’s a fair assumption to say that the higher the levels you start with probably the longer protection, you’re going to have.  

Early phase clinical trial results show that volunteers who received 2 100 microgram doses of Moderna’s COVID-19 vaccine candidate produced the same levels, or higher levels, of neutralizing antibodies [blue box] compared to people who were naturally infected with the virus [red background]
GS: In terms of length of protection, we’re seeing a few reports of reinfection from other viral strains, as well as research indicating that the antibodies in people who have recovered don’t seem to stay very long in the body. So could this be like the flu where we’re going to have to get vaccinated every year unless or until we get rid of this virus? 

TZ: The answer is we don’t know, but I don’t think it’s going to be like the flu, let me tell you why. When you look at cases of reinfection, nobody has yet described a case of somebody getting sick a second time.

So what does that mean well let’s say that I’ve got antibodies to the virus and I walk down the streets and somebody sneezes on me. And there’s a lot of SARS-COV-2 in what I’ve just inhaled. Okay, so now that virus is in my nose, and my antibodies are starting to fight it. Now if somebody says, Hey, let me put a swab in your nose and do a PCR test to see if you’ve got the virus, well guess what, they’re gonna find some virus. It doesn’t mean that virus is going to make me sick. It doesn’t even mean I can shed enough of that virus to make somebody else sick. So the fact that we’ve been able to detect reinfection so far. I have no idea what it means.

Except, nobody has yet even shown one case of somebody who was sick, and got sick a second time. And that tells you that at least with the experience we’ve had to date, in 5-6 months, immunity is pretty robust. And it’d be really surprising if somebody got really sick, and six months later got really sick again – we as a species wouldn’t survive. The immune system has served us well throughout its evolution, so that when we recover from an infection, we tend not to get sick a second time. So the data today are that if you’ve been sick, you don’t get sick a second time at least after five six months. If I can achieve the same level of neutralizing antibodies with the vaccine, or in fact, if I can exceed them, which I can now do across all age groups, including the older people, [as the most recent Moderna study has shown] then I would expect the duration of protection from a vaccine to be as long as the duration of protection from having been sick, because we believe that protection is a function of the immune system recognizing the spike protein as manifest by these neutralizing antibodies. 

GS: But is it possible that two years down the road, that protection wanes and we need another dose? 

TZ: Sure it is. But in terms of what we’re trying to achieve for society, if we can get everybody immunized in the next year or so, then, we will make a big dent in this pandemic. And if we need to get booster shots to remind the immune system, well, I think that’ll be a problem for 2022-2023 and beyond.

And by the way, one of the utilities of a messenger RNA technology is that you can actually get very effective booster shots. And that’s not true of all technologies. In fact, the problem people have with adenovectors, like the Oxford/AstraZeneca candidate, CanSino and others, is that it’s very difficult to give a booster shot with an adenovector. And the reason is the immune system recognizes the entire adenovector, and so when you come in a second time, it very quickly neutralizes it.

Because the spike protein is just one small component of everything else [in the vaccine], you don’t get much of an opportunity to show that antigen a second time. With an mRNA, when we give the injection, the immune system doesn’t recognize the messenger RNA, it only wakes up when the body starts to make the protein.  And so we can boost as many times as we need. So, to summarize it – so far we’ve seen [natural] protection for at least five to six months. I anticipate that vaccination should give as much durability as [actually] being sick. And should we need booster shots in the future, I think we’re well positioned with an mRNA technology to do that.

Moderna’s clinical development manufacturing facility in MA, USA.

GS: And what about the comparison to flu? 

TZ: The reason we need a vaccine every year is not that the immunity wanes. It’s because there’s a new viral strain that has escaped. So today, in fact, our SARS-COV-2 vaccine generates antibodies that are able to neutralize the strains that are in the population. And this type of coronavirus actually has a proofreading engine so it’s less mutation prone. Now, of course, it can mutate, it’s already proven its ability to mutate, but if SARS-CoV-2 mutates to something that the immune system doesn’t recognize we’ll probably be calling it SARS-CoV-3. In which case, if we have a proven mRNA technology that can indeed prevent disease, and we will have set up a manufacturing platform to enable millions of doses to be produced quickly, we’ll just put in the new sequence into an mRNA platform and turn out a new vaccine [if we run into SARS-CoV-3].

GS: And in terms of the speed with which a vaccine could be adapted? 

TZ: I do think that this platform can do better than traditional flu technologies, which take six months between the time the WHO releases the strain [to making a vaccine]. And the problem with that long [lead] time is that every few years, we end up immunizing ourselves against something that’s less relevant or not as protective. 

So if [in the case of SARS-CoV-X], your turnaround time is 2-3 months, then your ability to actually make sure that you produce the right stuff is much higher. And so, even if if these coronaviruses start to behave like flu, and cause significant morbidity with rapid mutation rates and strains that emerge at a higher pace, hopefully we’ll be able to immunize ourselves better in the future by having established technology like an mRNA platform.

GS: You also mentioned that the mRNA vaccine sparks the creation of neutralizing antibodies against the spike protein, and isn’t the spike protein pretty  much the same in all of these SARS-CoV-2 strains? 

TZ: Exactly. There’s one mutation -the d 614g – that allows the spike protein to, to improve the infectivity of the virus, but it doesn’t change anything in the recognition domains and so the same neutralizing antibodies that worked against the original Wuhan strain are also as effective against this more infectious strain – and that’s the one that is currently circulating. 

GS: Let’s turn to the policy questions. Moderna has signed up to a long-term contract with the Swiss manufacturing firm, Lonza, which can manufacturer as much as a billion doses a year? 

TZ: Including Swiss, US and UK manufacturing, that’s the total globally. 

Moderna TX’s manufacturing partners for its COVID-19 vaccine candidate.

GS: You have more than the US, Switzerland and Israel that have signed pre-orders, can you tell us how many countries you have. 

TZ: At this point, no. 

GS: But you are part of the [WHO-led] COVAX facility?

TZ: We are in discussions with them, yes.

GS: Because you were funded by CEPI (Coalition for Epidemic Preparedness Initiative), partly, correct? 

TZ: There was a very small, initial first seed funding that just allowed for that first lot that went into Phase 1. That is the total extent of funding we’ve received from CEPI. There has not been significant funding from CEPI for scaling up or for supplies. 

GS: Having said that, are you positive about trying to make some of your amazing vaccine available through the COVAX facility to low and middle income countries? How will Moderna be playing that hand? 

TZ: Absolutely. I hope to be able to do so. I am not in a financial position where I can simply donate vaccine supplies. I think people need to recognize that I’m not an established pharmaceutical company.

And I’m hoping through that facility that the rich countries step up to the plate, and support the poor countries in ability to access vaccines. I don’t think it’s reasonable or realistic to expect the pharmaceutical company to shoulder that. So having said that, I do hope that through COVAX and other like minded bodies, we will be able to enable access to our vaccine to countries and individuals that currently are unlikely to afford it.

GS: OK,  you say that you can’t be expected to donate as a young biotech company. What about a concessionary price?  If supplies are made available to the COVAX Facility, will there be a price differential? You talked about how much cheaper and easier this is to manufacture than a regular vaccine. 

TZ: That will be in the future once we actually get there.  Remember this is the first scale up of production. Anytime you do something for the first time for a technology, it is expensive. We have a line of sight in the future, you know 10-15 years from now, this will be much cheaper. But compared to the cost of the first recombinant proteins that were made back in the 1990s, and their current cost of production today, you’ll see logs of decreasing cost. So I think we anticipate a decrease in costs but I don’t think that’s the reality today.

And I think it’s too early for me to talk about differential pricing. I think we’ve made pretty clear what our pricing strategy to date is, and that pricing strategy is fair and equitable across everybody, broadly speaking. The only concessions we’ve made are for much higher volumes, so far.

GS: And what about the Swiss connection – can you say anything about this? Will we need to ask the Swiss investors that are backing Moderna to accept a lower dividend in order to make the vaccine cheaper to low and middle-income countries?  

TZ: Moderna is now a publicly traded company on the US stock exchange. 

I have a tremendous respect for and I very much like my Swiss colleagues and investors. Obviously we’ve also been talking to Swiss Medic [the Swiss drug regulatory authority] and Swiss physicians in terms of specific interest in this vaccine for the Swiss population. And I’m happy that some of the smartest people who understand not just finance and investment, but also biology and how the two come together, are in Switzerland and I think we have benefited from their foresight.

GS: Do you think that you can credit Switzerland for having helped really leverage the funds that allowed you to do some of this? Was it the investment community or was it the IPO that really launched you?

TZ: The current investment in manufacturing specifically for COVID is the use of proceeds for the fundraising that we did earlier this year in May, right. So we raised over a billion dollars on the US public markets, specifically to invest in manufacturing ahead of time, at risk. The Swiss investors, I think, were early and long term backers of our company in the sense that they saw the potential of this company in the early days and you should recognize that. 

Whether it’s this last billion or whether it’s the close to a billion dollars that the United States has been investing or has promised to invest in supporting us, that was actually made possible – I mean, nobody could actually make those investments were it not for the billions of dollars of private investment in the last decade that public investors have made in building Moderna. So, it’s both capital and money, and time and talent of people who’ve been at this for the past 10 years almost, that enabled in 2020, additional investments on top of that, which is just a fraction of the total investments that went into making this enterprise possible. And I think the Swiss, I give a lot of credit for their role in those early investments to make all this to make 2020 possible for Moderna. 

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An oncologist by training, Zaks was previously head of Global Oncology at Sanofi and prior to that, built the oncology translational medicine team at GlaxoSmithKline’s genetics research group. 

He received his MD and PhD from Israel’s Ben Gurion University of the Negev, and then conducted post-doctoral research at the U.S. National Institutes of Health, while completing his clinical training in internal medicine at Temple University Hospital. He also is an associate professor of medicine at the University of Pennsylvania.

Image Credits: Moderna TX, Moderna TX, Miller J. (2020). ACIP COVID-19 Vaccine Presentation. Moderna TX, Moderna TX.

Dr Vinh-Kim Nguyen is accustomed to straddling two worlds – academia and front-line medical work. But those dual roles took on new meaning this year as Nguyen, new co-director of the Global Health Centre of the Geneva Graduate Institute (IHEID), travelled to Montreal during the first Covid-19 wave to treat patients and organize urgent services at Montreal’s first COVID-19 referral hospital in the city, and later in area nursing homes.

A family physician and medical anthropologist who also worked on HIV and Ebola in Africa, Nguyen talked to Geneva Solutions about the importance of treating the “whole” individual and informing health policies from the ground up.

Please tell us more about your experience in Canada as a front-line health worker – which is a pretty unique role for an academic.

I have just never been able to leave clinical practice. I am a doctor. I just love it. And in trying to understand the health issues going on with my patients, anthropology was a more useful lens than epidemiology. As a family physician, the aspect of talking, understanding through stories, and not through numbers, made a lot more sense to me. So, after I fell into an academic career, I always kept up my minimalist hospital career, working 6-8 weeks a year. I was scheduled to do a two-week stint at Jewish General Hospital in early April –  a large tertiary centre that is one of the busiest places in Canada. Its clients come from across the city, and include including many recent immigrants from Africa and Asia. Ultimately, I remained for much longer.  I spent two weeks helping set up the Covid-19 wards in the hospital, three weeks in the hospital and three weeks in long-term care homes.

And what were your first impressions?

We were the first designated Covid hospital in Montreal, because we had the most negative pressure rooms.  The week I started on the Covid ward, in early April,  was the week when the epidemic turned from one affecting younger people and travelers to older patients.  We started to get the elderly from care homes. As we saw the numbers rising, we soon saw that we would need more beds.  So I worked with the hospital to convert regular wards to isolation wards, like for Ebola.  We went to about 200 Covid beds, and worked in PPE all day.

Vinh-Kim Nguyen, co-director of the Global Health Centre of the Geneva Graduate Institute, looks out onto Montreal’s skyline from the city’s first Covid hospital ward, where he worked during the pandemic’s first wave

The Québec Ministry of Health had a plan to keep mildly ill older people from the care homes out of the hospital. The thinking was that if they went to the hospital, the hospital would be overwhelmed, which was happening in Italy.

The plan made a lot of sense at the time. Mildly ill elderly patients didn’t need an ICU, they needed good, basic supportive care, and so it made sense to try and provide that care in their homes.  And yet, as it turned out, the care homes didn’t have the capacity to provide these basic services. I started working on our first Covid hospital ward on a Monday; by Thursday, doctors working in care homes were rebelling. That night 12 ambulances came just from one care home, bringing in elderly patients with Covid.

Soon became very clear to me that the care homes, with hundreds of residents and only 1 or 2 staff physicians, were collapsing.  Particularly as the staff all became sick. So, after my stint in the hospital, I went to work at a care home. One place I worked, almost 100 percent of the residents and 90% of the staff got Covid.

What I pieced together was that we had made a terrible miscalculation. We had tried to put into place measures to maintain elderly in care homes, but the homes couldn’t give them the care they needed. In normal times, with 200-300 residents maybe 5 would be ill and require extra care; with Covid that number would go up to maybe 100 people sick. People had to be fed, given oxygen, and put on IVs – and these were not services a care home was set up to provide to so many people. In some homes, up to 90%  of residents became infected, and as many as 40% died.

Trying to keep the elderly out of hospital was a terrible, terrible miscalculation, which amounts to a kind of genocide of the elderly, to be frank. Some of these people had survived the Holocaust and now they were going to die of thirst. In the care home where I worked, the staff was just so overwhelmed and burnt out.  There has now been a human rights complaint filed against the Quebec Ministry of Health. There was a pretty deliberate sacrificing of the elderly, dependent population to protect our hospitals for the younger and healthier.

Suited up for COVID-19 ward duty

So, what lesson can we learn from the care home tragedies that can help us do better next time around?

There was a kind of top-down message about what we should do.  Eventually instructions were defied or ignored, and that was good. My care home colleagues started sending patients to the hospital, and the hospital CEO said ‘we will take everyone’.  The policy shifted from the ground up. But it didn’t happen fast enough.  We remained in a remarkable situation where we had to triage, who in the care homes would get IVs – because we could only do so many at a time. The hospital ICU was not overwhelmed, but tragically, triage still happened by keeping old people out of hospitals, and many died.

The lesson is that a highly centralized  Ministry of Health, even in a strong public health system like Canada’s, doesn’t always understand what is going on in the field. The networks ended up adapting their responses based on the evolving situation on the ground. My hospital eventually put together SWAT teams and we would send out teams to the care homes. Some of them were really abandoned. There was a scandal where people were found lying in their feces, not having been fed or cared for days.

What about treating the “whole person” you stressed this is part of your training – but how do you do this while battling a highly contagious infection?

The hardest experience that I have had as a physician was Covid.  People were dying alone.

I had to talk to families who were  distraught and angry. It was wrenching. What we have learned is that we really have to pay more attention to the whole patient.  Patients were eating, but they weren’t walking around. So, they needed more physical therapy upon recovery. We really shot ourselves in the foot.

One of the things I learned from Ebola is that concerns over infection prevention and control can also impair our ability to deliver holistic and humane care.

Hopefully with the second wave [of Covid], we will be much, much more proactive about letting people in to see patients, getting people out and around the ward. In my hospital, they eventually set up a Covid ward for the elderly, where people could walk around.

Looking towards the fall and autumn, what do you expect? From the clinician’s perspective, is the virus becoming any less deadly, as some doctors now claim?

There is a tendency for viruses to become much less virulent over time. Although it is not clear, in the case of Covid, if there is less illness, less death among the elderly, right now.  The other grounds for optimism is the behavioural changes that we have seen. Small behavioural changes, if taken up by enough of the population most of the time, can have a huge effect.

But pandemics teach you humility. In the winter, if it’s a bad flu year, then we can already be close to the limits of hospital capacity just with flu cases.  And, fortunately or unfortunately, we have this ongoing experiment called the United States – which is showing us what to do – or what not to do.

What lessons do you bring from Canada back to Geneva about coping with this pandemic?

The policymaking needs to be very close to the ground. You need to do things differently, depending on where your epidemic is, as epidemics move quickly.

In Switzerland, there were concerns that there was quite a bit of muddle at the federal level, and squabbles between federal and cantonal level. So initially, the measures put into place were not the most draconian. But that didn’t matter because local responses appear to have been sufficiently robust.  Switzerland is a small decentralized country, which makes it exquisitely responsive at the local level. The entire Canton of Geneva is only 400,000 people. That is the size of one neighbourhood in Montreal. In Québec decisions were made 300 km away in the provincial capital.

The second asset here is what you might call Swiss discipline. I don’t see it as a cultural trait as much as it is a reflection of the history of trust in public authority. Trust isn’t moral authority, it is earned.  Strong democracies lead to populations that can enact necessary discipline because they have trust in their institutions.

As you have recently taken over as  co-director of the GHC – how would you like to shape or strengthen the Global Health Centre’s role in public health education and research?

My Global Health Centre co-director, Suerie Moon and I feel increasingly the urgency of opening global health to new voices and perspectives. I had not realized until really the last six months, how bizarrely parochial and even “white supremacist” the global health arena can be.  The way in which the playing field and the rules are set up to make the default choice the white person. I have seen this up close and personal, how people who are not from a certain pedigree are not valued. And if we don’t change this very soon, we will have more major, major trust problems, as we go forward to battle the pandemic and other critical diseases. Ebola in DRC was a wake-up call where communities protested the corruption and the disconnect between global health policy leaders, foreign aid workers and reality on the ground.  If it keeps going on this way, we won’t have a “herd immunity” level of trust that allows us to have any kind of traction for global health programmes.

Vinh-Kim Nguyen with an Ebola response team in North Kivu, Democratic Republic of Congo, where he worked with Médecins sans Frontières during the 2018-19 Ebola epidemic.

What can the Global Health Centre do about this?

It boils down to very practical things. When we organize events, to ensure that a diversity of views is included. We need to think about the way we frame issues, and the kind of knowledge that is valued in academia.  That knowledge is often a male white, universalist perspective; there is a privileging of numbers.  But how do we bring in an approach that is more particularistic? As we are not in a school of public health or faculty of medicine, we are in a good position to do this.

We are a school that stresses the social sciences and humanities.  Global health is about power, it is about governance.  It’s understanding power and politics that make you more effective.

Bottom-line lessons for global health?

I can have a vaccine, but I need to gain the trust of people and to mobilize resources in order to have the vaccine work in the world. We have to be able to work synergistically in the messy world of politics and with the biomedical world. The political, affective and emotional dimensions of public health policies need to be looked at quite seriously

In a sense, Covid has made things very, very easy for us. The health literacy of the world’s population has expanded enormously.  Many more people understand issues in basic epidemiology, such as  herd immunity.  And most of all, in terms of issues ranging from access to PPE and vaccines to access to treatment among different populations, people are really seeing concretely, the links between politics and medicine.

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

Image Credits: Vinh-Kim Nguyen.

Colorized electron microscope photograph of SARS-CoV-2 (yellow) heavily infecting a dying cell (blue)

The United States Defense Advanced Research Projects Agency (DARPA) is investigating Moderna, a company developing a much hyped COVID-19 vaccine candidate, for allegedly failing to disclose federal funding on its US patent applications.

A Moderna spokesperson on Monday told Health Policy Watch that “the Company believes it has complied with applicable patent reporting requirements regarding patent filings.”

The spokesperson additionally referred to a patent application Moderna submitted to the World Intellectual Property Organization (WIPO), which did reference DARPA funding.

The comment was made in response to a letter and 25-page report from pharma watchdog Knowledge Ecology International urging the federal government to investigate the company for allegedly failing to disclose federal funding from US DARPA, a branch of the Department of Defense, in patent applications for investigational vaccines and treatments built on its messenger RNA platform.

DARPA spokesperson Jared Adams told the Financial Times that the department was “actively researching agency rewards to Moderna to identify which patents and pending patents, if any at all, may be associated with DARPA support,” following the publication of KEI’s letter.

“We are pleased that DARPA is now taking this seriously,” James Love, director of KEI told Health Policy Watch.

“Despite the evidence that multiple inventions were conceived in the course of research supported by the DARPA awards, not a single one of the patents or applications assigned to Moderna disclose U.S. federal government funding,” KEI analyst Luis Gil Abinader writes in the research note, referring to patents granted by the US Patents and Trademark Office (US PTO).

It is likely that two DARPA grants, totaling around US $25 million, supported early development of Moderna’s mRNA platform, according to KEI’s letter to DARPA and the Secretary of Defense. Under the Bayh-Dole Act, the company should be required to disclose DARPA funding in patents for new vaccine or treatment candidates using the company’s proprietary messenger RNA (mRNA) platform, such as their investigational COVID-19 vaccine.

But none of 126 patents granted by the US PTO to Moderna have referenced the initial funding provided by DARPA, according to the KEI report. Published academic papers and disclosures filed to the US Securities and Exchange Commission (SEC) refer to the DARPA grants, but patents granted to Moderna for the same technologies do not mention DARPA funding. KEI highlighted 11 patents that they say should have referenced the DARPA funding, including patents for chikungunya and Zika vaccine candidates and patents related to the mRNA platform.

Moderna Disclosed DARPA Funding in a WIPO Patent Application, But Did Not List DARPA Funding Elsewhere

Moderna does disclose federal funding in one patent application filed with WIPO. The company references a DARPA grant in an application jointly filed with Vanderbilt University for an antibody treatment producing platform for the viral disease chikungunya.

Moderna spokesperson Ray Jordan noted that since 2013, Moderna had also publicly acknowledged the DARPA funding in contexts such as its October 2013 announcement that stated:

“This $24.6 million grant could support research for up to 5 years to advance promising antibody- producing drug candidates into preclinical testing and human clinical trials. The company also received a $0.7 million “seedling” grant from DARPA in March to begin work on the project.”

However, in contrast to the $25+M DARPA funding, private investors have supported the development of Moderna’s mRNA platform with approximately $5.1 billion in funding, Jordan said.

Still, regardless of the amount of DARPA funding that the company received, Moderna should still be required to disclose federal funding in it’s US patent applications, in line with requirements by the US PTO and the Bayh-Dole Act, according to KEI.

“The requirement to disclose DARPA funding on DARPA funded inventions has nothing to do with the investor funding or other grants, such as the US$2.45 billion in BARDA contracts,” said Love.

Furthermore, two inventors who are listed in US PTO patents that did not disclose DARPA funding are also listed in the WIPO patent application that did disclose federal funding, and these two inventors have acknowledged being funded by DARPA in academic papers, according to Love.

If the company is found to have failed to disclose DARPA funding, KEI recommended that the funding agency, DARPA, should at least request a correction to the patent. At most, it could be grounds for the agency to claim the patents themselves, as a sanction for the failure to disclose public funding, according to the KEI letter.

Image Credits: NIAID.

Many self-care products have been recommended to treat COVID-19 symptoms

Healthcare systems were not ready for COVID-19, which has been declared as ‘the defining global health crisis of our time’. The extended practice of self-care among individuals has helped to ease the strain on healthcare systems and improve the delivery of treatment in communities, providing vulnerable patients with the care they need. Personalized health and medicine have become priorities during the pandemic as people care from home.

Increasingly, people are accessing healthcare through new means, such as pharmacies, stores, and even the internet. The COVID-19 pandemic has only accelerated this trend. Science-based self-care interventions help to improve health outcomes and healthcare delivery while ensuring that health systems around the world are sustainable.

But this shift towards self-care comes with the necessity to introduce sound regulation to enable people to make the right decisions about their health, and protect those who are vulnerable to fraud or misinformation.

What is Self-Care?

Self-care is the practice of individuals looking after their health using the knowledge and information available to them. It involves empowering individuals to care for themselves, in collaboration with health practitioners as needed.

The World Health Organization (WHO) defines self-care as: “the ability of individuals, families and communities to promote health, prevent disease, maintain health, and to cope with illness and disability with or without the support of a healthcare provider.”

Concretely, self-care products include over-the-counter medicines (OTCs), vitamins and dietary supplements, medical and diagnostic devices, and other items available for purchase without a prescription at a local pharmacy. Medical devices, such as blood pressure monitors, insulin pumps, inhalers, and thermometers, can be used autonomously by people. Throughout the pandemic, many self-care products, such as pain medications or fever reducers, have been recommended to help treat the symptoms of COVID-19.

The novel coronavirus has disrupted healthcare systems in several ways. Many healthcare systems have been unable to cope with the unprecedented number of patients requiring urgent care in addition to usual healthcare demands. Hospitals have been forced to suspend non-essential procedures in order to anticipate an influx of coronavirus patients, resulting in disparities in care and consideration, particularly for patients suffering from non-communicable diseases (NCDs).

Pharmacists and pharmacies have been on the frontlines of the COVID-19 pandemic (Photo credit: SteFou!)

Pharmacies and pharmacists have played an increasingly crucial role in the promotion and practice of self-care interventions. Typically, the first point of contact with healthcare systems, pharmacies have provided an indispensable service throughout the pandemic, adapting their practices to overcome restrictions imposed during the lockdown period. In addition to stocking appropriate products and promoting disease prevention, certain pharmacies have offered drive-through services, telemedicine and medication deliveries to ensure the continuation of patient treatment.

Consequently, COVID-19 has led to more public awareness about self-care, promoting positive change in the day-to-day habits of individuals. New research shared by GlaxoSmithKline Consumer Healthcare and IPSOS finds that consumers are more involved in their healthcare journeys and show a willingness to change behaviour in favour of greater health practices. The study also shows that Europeans are taking extra precautions to avoid illness transmission and are taking their health into their own hands to relieve pressure on healthcare systems.

Combatting an ‘Infodemic’

In the climate of fast-paced information, the need to consult reputable sources for matters concerning medical care cannot be emphasised enough.

WHO identified the dangerous consequences of misinformation and misleading or false healthcare information early on in the pandemic, calling it an ‘infodemic’. There have been reports of unproven and unsafe practices to prevent the transmission of COVID-19, such as ingesting bleach solutions, hand sanitizer or essential oils as a means of ‘internal disinfection‘- methods that are not only ineffective, but also dangerous. Poison centres have also noted an increase in the number of cases related to use of bleach and other disinfectant solutions.

The quantity of misinformation concerning the COVID-19 virus has urged many health agencies to set up information hubs to combat false information and curb widespread confusion.

As the Global Self-Care Federation, we launched a COVID-19 portal on our website to share and centralise credible news updates and official statements within the self-care industry and highlight the numerous initiatives led by our members in the COVID-19 response. We are continuing to develop a hub for self-care resources from our members and other recognised bodies.

It is crucial that people exercise self-care responsibly. Health practitioners have a duty to provide reliable and timely information to consumers to support self-care and ensure the safe use of medical products.

Consumers and practitioners of self-care also have a responsibility to ensure they are well-informed on the proper use of medicines, medical devices, and, crucially, when to seek professional guidance.

Self-care should not be understood as a replacement for traditional medical care. It is primarily a means of promoting good health and general well-being while preventing illness and injury. Any doubts related to the correct or appropriate use of self-care products should be addressed to a registered healthcare professional.

Consumer education and enhancing health literacy remains a critical factor in the success of self-care interventions and greater healthcare delivery. This is especially true in lower-income countries, where healthcare systems have been hit more severely by the adverse effects of the COVID-19 disruption, and where populations can benefit from a wider adoption of self-care practices.

Alcohol-based hand sanitizers are used to prevent the transmissions of the virus
Regulation of the Self-Care Industry Builds Trust – And Better Interactions Between Providers and Patients 

Trust is a principal component of any system where people are the common denominator.

This year, GSCF conducted a trust audit to understand the impact of trust on the self-care industry for both consumers and stakeholders, and we found that trust in the self-care industry is lower in countries with weaker regulation. The weaker regulation can reflect quality of care and the ability of people to make the right decisions about their health. The audit also showed that safety is the primary driver of trust among healthcare consumers. Europe, for example, scores high in trust as a result of its focus on policy, testing and regulatory control of self-care products and services.

There is a clear relationship between quality healthcare and a well-regulated healthcare system. Regulation is used to protect consumers, but beyond ensuring safe healthcare treatments, an appropriate regulatory framework can be used to provide greater access to healthcare.

Policymakers should provide pharmacies and pharmacists with a greater capacity to deliver responsible self-care. Evidence suggests that further integration of self-care in healthcare stands to support the healthcare industry by creating more efficient choices for consumers, while generating better health outcomes for greater value.

Positive changes in legislation during the pandemic have allowed pharmacies to remain operational for longer, modify prescriptions and dispense alternative medicines without consulting a doctor. This has allowed for the continuity of treatment among vulnerable persons. Other regulatory flexibilities have occurred to ensure the continuity of supply amid increased demand for self-care products including nonsteroidal anti-inflammatory drugs (NSAIDs) such as paracetamol. These flexibilities have translated into welcome efficiencies, and I hope they form a basis for improved policy and regulations beyond the coronavirus pandemic.

Furthermore, advancements in technology are rapidly changing the way individuals interact with healthcare providers and access self-care products, such as remote medical consultations and diagnoses or portable life-saving medical devices. As healthcare systems adopt innovations, a robust regulatory framework is not only advisable, but necessary.

The delicate balance between regulating access to medicines and empowering individuals to take charge of their healthcare journeys is one to approach cautiously. Nevertheless, the increased role of self-care amidst the global health crisis has set a hopeful precedent for future self-care policy decisions.

Self-care has the potential to become an integral part of healthcare systems around the world. Through ensuring the correct adoption of self-care interventions, supported by a robust regulatory framework, we can ensure that self-care continues to play a role beyond the pandemic, providing better choice, value and improved health outcomes for all.

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Judy Stenmark is Director General at The Global Self-Care Federation (GSCF). GSCF represents associations and manufacturers in the self-care industry, promoting sustainable and better global health outcomes for all. The Global Self-Care Federation is the go-to source of information for the self-care industry. We work closely with our members and relevant stakeholder groups to deliver better choice, better care and better value. By placing the benefits of self-care at the heart of what we do, promoting industry transparency, and supporting the regulated use of health data, we ensure that self-care continues to play its increasingly vital role in sustainable healthcare, worldwide. For more information please visit: www.selfcarefederation.org 

Image Credits: Shutterstock, Flickr: SteFou!, Shutterstock (from GSCF), GSCF.