Mother practices breast feeding her baby in the hospital maternity room in Ethiopia.

One stillbirth occurs every 16 seconds worldwide with approximately 2 million stillborn babies a year, says the first UN-wide report to document the global scale of the issue.

And COVID-19 related interruptions in maternal and child care services, particularly emergency obstetric care, could lead to an additional 60,000 to 200,000 stillbirths over the next 12 months, warns the report that was jointly produced by UNICEF, the World Health Organization, the World Bank and the Population Division of the United Nations Department of Economic and Social Affairs.  

“COVID will have an increase, reversing the gains that we have made,” said Anshu Banerjee, Director of the Department of Maternal, New born, Child and Adolescent Health and Ageing at the WHO, speaking at a press briefing on the report, which was released today. “However, we have seen that it is possible to make progress,” by strengthening health systems, improving the quality of care, and increasing the skills of birth attendants.” 

The WHO defines a stillbirth as babies born with no signs of life at 28 weeks of pregnancy. Approximately 2 million babies are stillborn every year. Often, these are deaths that lead to long-lasting psychological and financial consequences for women and their families.

In the majority of cases, stillbirths could have been avoided with high-quality care antenatally and during birth. The global issue of stillbirths is largely neglected in terms of research, data collection, and funding for interventions – although there is increasing recognition of the issue as a critical global health problem. 

“Losing a child at birth or during pregnancy is a devastating tragedy for a family, one that is often endured quietly, yet all too frequently, around the world,” said Executive Director of UNICEF Henrietta Fore. 

The report finds several reasons for these preventable deaths, including: absence of or poor quality of care during pregnancy and birth, lack of investment in preventable interventions, absence of global and national leadership on the issue, and few established global targets. 

Access to Emergency Obstetric Care Could Reduce Scale Of Problem

With over 40 percent of stillbirths occurring during labour, access to emergency obstetric care and improved monitoring could reduce their scale, the report finds.  

“The tragedy of stillbirth shows how vital it is to reinforce and maintain essential health services, and how critical it is to increase investment in nurses and midwives,” said Dr. Tedros Adhanom Ghebreyesus, WHO Director-General. 

84 percent of stillbirths occur in low- and middle-income countries, with 3 in 4 stillbirths taking place in sub-Saharan Africa or Southern Asia, according to the report. In sub-Saharan Africa, 1 in 46 babies are stillborn, compared to the global average of 1 in 72 or the European and Northern American average of 1 in 321. 

Stillbirth rates globally per 1,000 births in 2019.

There are substantial disparities in stillbirths between income groups. And strikingly, one-half of all stillbirths occur across six countries – India, Pakistan, Nigeria, Democratic Republic of the Congo, China, and Ethiopia. The risk of a stillbirth is 23 times higher in the worst affected countries compared to countries with the lowest stillbirth rates. 

Access to health care, maternal education, socioeconomic status, and ethnicity are other factors that contribute to the variations in stillbirth rates. Notably, higher rates are observed in rural areas, among women without post-secondary education, in groups on the lower end of the socioeconomic spectrum, and among ethnic minorities. 

Over the past two decades there has been slow progress on preventing stillbirths. Although the global stillbirth rate declined by 35 percent since 2000, progress has lagged in comparison to achievements in reducing maternal and under-five mortality rates. 

The Every Newborn Action Plan (ENAP) was launched in 2014 to provide evidence-based solutions to prevent newborn deaths and stillbirths. It established a target rate of 12 stillbirths per 1,000 total births to be achieved by 2030 and issued guidelines for national steps to achieve this goal, which includes investing in quality antenatal and delivery care. 

Projected number of stillbirths by different scenarios from 2020 to 2030.

Currently, 56 countries are at risk of missing the ENAP target by 2030, 34 countries are at risk of missing it by 2050, and eight countries will not meet the target by the end of the century, according to the report. 

Projections for the next decade estimate that 20 million babies will be stillborn by 2030, of which 2.9 million could be prevented. In order to curtail the current trend, the new report calls for increased political will, smart policies, and targeted investment in antenatal and delivery care to accelerate progress towards the ENAP aims and Sustainable Development Goals. 

COVID-19 Exacerbates Existing Stillbirth Trends

The COVID-19 pandemic has disrupted health systems and services globally, including antenatal and labor care. The report projects that these disruptions could lead to 60,000 to 200,000 additional stillbirths over 12 months, increasing the global number of stillbirths by 3.2 to 11 percent. The impact is expected to be greatest in Armenia, the Dominican Republic, Jamaica, Egypt, Iraq, Pakistan, and South Africa, among others. 

“COVID-19 has triggered a devastating secondary health crisis for women, children and adolescents due to disruptions in life-saving health services,” said Muhammad Ali Pate, Global Health Director for Health, Nutrition and Population at the World Bank. 

The collective action plan provided by the report emphasizes the importance of reducing stigma, supporting bereaved families, strengthening health systems, nationalizing and localizing stillbirth targets, prioritizing equity through investment, and improving the measurement of stillbirth data. 

 

Image Credits: Flickr – UNICEF Ethiopia, UNICEF.

Moderna’s mRNA research and innovation centre

Moderna, Inc., developer of one of the four front-running COVID-19 vaccine candidates, announced on Thursday that the the company would “not enforce” its COVID-19-related patents against other companies making vaccines to combat the pandemic – and would also be willing to license intellectual property for their COVID-19 vaccines for the post pandemic period. 

“We feel a special obligation under the current circumstances to use our resources to bring this pandemic to an end as quickly as possible.” said the company’s statement, which raises the bar on corporate policies around patents as the world fights a pandemic. “Accordingly, while the pandemic continues, Moderna will not enforce our COVID-19 related patents against those making vaccines intended to combat the pandemic. 

“Further, to eliminate any perceived IP barriers to vaccine development during the pandemic period, upon request we are also willing to license our intellectual property for COVID-19 vaccines to others for the post-pandemic period. Moderna is proud that its mRNA technology is poised to be used to help end the current pandemic.”

Speaking at a webcast of the company’s 8 October update where the announcement was made public,  Stephen Hoge, president of Moderna told investors, “It is our responsibility to be upfront and transparent, but we’re not going to be using those patents and try to enforce them.”    

Added Tal Zaks, Moderna Chief Medical Officer at the presentation:  “It is the right thing to do, to protect the population.”  

Leading Medicine Access Advocate Applauds Moderna Announcement – Others Demand More 

The announcement was greeted with applause by one leading medicines access advocate, Jamie Love of Knowledge Ecology International, who said that the new Moderna policy offers a model that other pharma companies should follow: 

Statement by Moderna on Intellectual Property during COVID-19 Pandemic

“Moderna is the only company manufacturing a drug or vaccine that has made a pledge to openly share its COVID-19 patents,” Love, generally an outspoken critic of pharma positions, told Health Policy Watch.  “And the statement includes both the period during the pandemic, and an offer to license in the post-pandemic,”

Love added that the commitment, “should be matched by every manufacturer of a therapeutic, vaccine or diagnostic test…”  

Love contrasted the Moderna pledge with the fact that Oxford University had granted the pharma company AstraZeneca exclusive rights to the IP associated with the adenovirus vector vaccine technology that they are co-developing, with backing from the Bill and Melinda Gates Foundation.  

“This makes the deal that Oxford and Gates struck with AstraZeneca look absurd,” Love said, adding that no matter how rights are used during the pandemic, the framework of the latter also leaves AstraZeneca to “tighten the screws” when the pandemic is over while, “Moderna will provide licenses that extend post-pandemic.”    

A KEI statement, however, added that Moderna should still go further and “engage with the WHO COVID-19 Technology Access Pool (C-TAP) and the Medicines Patent Pool” – which are serving as vehicles for more systematic pooling of vaccines and their patents. “Every manufacturer of a vaccine, drug or diagnostic should follow suit and publish the patents relevant to the technology, waive or license rights in those patents, and  provide constructive transfer of manufacturing know-how and access to cell lines and data when necessary”.

Other advocates expressed skepticism about the reasons behind the moves, saying that the announcement was motivated by pending legal challenges to Moderna IP claims, as well as rising consumer and political pressures:  Moderna “should not be lionized for taking baby steps on access when we are in a race for our lives,” stated an op-ed by Asia Russell, Brook Baker and Jessica Bassett, published by HealthGap Global Access Project:

“It is no accident that Moderna’s announcement comes less than a week after South Africa and India filed a petition to the World Trade Organization calling for waiver or suspension on the granting or enforcement of any intellectual property protections on COVID-19-related medical technologies for the duration of the pandemic.

“But Moderna knows that this non-enforcement-of-patents concession is meaningless without a commitment to share not only the patents, but also all the information, know-how, data, and biologic resources needed for other qualified vaccine manufacturers to produce the vaccine economically and at scale to meet global need. Moderna should fully commit to sharing all necessary rights and knowledge through the WHO COVID-19 Technology Access Pool (C-TAP), with no artificial time limitation based on the severity of the pandemic.”

Moderna To Submit Vaccine Candidate to FDA 25 November for Approval

The Moderna announcement comes just days after Moderna’s chief executive officer Stéphane Bancel said that the company aims to submit the candidate vaccine to the FDA for emergency use authorization by 25 November 2020. The company then intends to submit the vaccine as a candidate for the general population by late January. If approved, the vaccine would be available for widespread distribution by spring 2021. 

Stéphane Bancel, CEO of Moderna

Based in Cambridge, Massachusetts, Moderna is a biotechnology company pioneering the development of messenger RNA (mRNA) vaccine and therapeutics. The mRNA-1273 technology contains the “coding” for a stabilized form of the Spike (S) protein that is characteristic of the SARS-CoV2 virus that, which was co-developed by Moderna and investigators from NIAIDS’s Vaccine Research Center.

Moderna’s vaccine candidate uses novel mRNA technology to prime and boost the immune response in regards to antibody neutralization across all age groups. Effectively, the vaccine  “teaches” human cells to induce an immune response that could build the body’s own defense against COVID-19. 

The company’s Phase 3 study of RNA-1273, the vaccine candidate against COVID-19 began in July, and is close to its target enrollment of around 30,000 US participants.

AstraZeneca and Pfizer are also in late-stage Phase 3 testing; however, AstraZeneca’s timeline has been stalled after reports of severe side effects from several trial participants administered its vaccine candidate, which is based on a different technology. Participants from both Moderna and Pfizer’s Phase 3 studies have reported symptoms of high fever, body aches, headache, and exhaustion after receiving the respective candidate vaccines. The two companies have recognized that there is potential for the recipients of their vaccines to induce “mild” side effects similar to mild COVID-19 symptoms.

Tal Zaks, chief medical officer at Moderna
Other Pharma Companies Received Billions in Public Subsidies – But Holding Patents Close

Only recently, KEI sharply criticized Moderna for failing to disclose public funding from BARDA [US Biomedical Advanced Research and Development Authority]as well DARPA, (Defense Advance Research Projects Agency), in its patent applications, and the two agencies are currently examining the alleged omissions.

But even if the company made the announcement under burgeoning consumer and government pressure, its new policy still contrasts sharply with other firms that have benefited from similar public subsidies for urgent COVID-19 research, but are retaining their patent rights close to their chest.  

Among those, BioNTechSE, partner of Pfizer Inc., have been adamant about their about complete ownership of their vaccine patents – even when they, too, benefitted from large US government subsidies. 

 “Contrasts should be drawn between Moderna and other companies, including in particularly those that have benefited from massive subsidies from governments and foundations, that are not even making patent landscapes transparent, let alone making the inventions widely available,” said Love in the KEI statement..

“Moderna is also making it clear that government agencies like the NIH [National Institutes of Health] and BARDA have been too willing to grant or enable exclusive rights when subsidizing COVID-19 research.”

 

Image Credits: Moderna, Moderna, Moderna, Moderna TX.

Punjab, India – Crop burning reduces crop yield and worsens air pollution.

With fires from crop stubble burning spreading across northern India heralding the beginning of Delhi’s winter air pollution season, Delhi’s Chief Minister Arvind Kejriwal has pledged to take pre-emptive action – announcing a ‘war on pollution,’ led from a ‘war room’ that he will personally command. His arsenal includes a seven-point action plan that will include:  tracking the city’s hotspots; launching a ‘green Delhi’ mobile app to address open air burning complaints; and repairing the city’s potholed roads to control dust.  But his most powerful weapon for now could be a cheap and simple rapid compost brew, Pusa Decomposer that he hopes will inspire farmers in surrounding rural states to turn their crop waste into valuable fertilizer rather than burning it.

If Kerjiwal’s initiative succeeds, that could mark a turning point in decades of inaction contributing to northern India’s bleak air pollution situation – as well as climate change.

If not, Delhi and neighboring areas are headed for what Indians are now calling an ‘Airpocalypse’, or toxic pollutant-laced air that is poised to exacerbate COVID-19 respiratory disease in a country that has the second highest coronavirus case toll in the world.

In particular, cases are surging in the very regions facing potential air pollution emergencies. While Punjab is about to cross one 100,000 positive cases, Haryana has reported 118,000 cases so far. Delhi, one of the worst affected states of the country, has 260,000 infections so far. And the evidence that air pollution puts people at an increased risk of COVID-19 is strong.

But the war on air pollution has only been declared. And time for Delhi is quickly running out, as the seasonal crop burning in neighbouring rural regions of Punjab, Haryana and Uttar Pradesh, which fuel Delhi’s air pollution, has aleady begun, while the city’s Air Quality Index already crossed the 200 mark yesterday after months of double digit levels. 

In addition, it’s so far unclear how much backing Kerjriwal will receive for his war from Prime Minister Narendra Modi – a political rival who has remained largely indifferent to the criticism heaped upon him nationally and globally over his failure to take action on practical matters like stubble burning – as well as the bigger picture of expanded dirty coal power production. His ruling Bharatiya Janata Party is already grappling with farmers already agitating against the passage of three agriculture bills in Parliament last month.

New Delhi, India – Toxic smog blocks out the sun.

Crop waste fires contribute to nearly half of Delhi’s Pollution in Peak Season

Due to an unfortunate convergence of weather and geography, the impact of rural crop burning on Delhi and other parts of northern India’s plains is huge. Particularly in the autumn months, preveailing winds bring the smoke emitted by crop burning into the city. Low wind speeds, dry weather, and temperature inversions combine to keep pollutants trapped in and around the metropolis and the wider region. The Himalayas form an additional barrier to the north, preventing toxic pollutants from dissipating. Past year’s have seen record air pollution events, with levels reaching hundred of times higher than the WHO’s recommended limits, and urban average are among the highest in the world. 

Altogether, it is estimated that crop burning in the States of Punjab and Haryana last winter accounted for up to 44% of Delhi’s air pollution during peak burning periods in autumn 2019, Central Pollution Control Board Member Secretary Prashant Gargava stated.  The burning of crop stubble by farmers in Punjab and Haryana cause fires so large that they can be seen from outer space.

This year, again, Nasa satellite data tracking PM2.5, the most health-harmful particulate pollutants, has already begun showing small spikes caused by farm fires, although the worst is yet to come. Fires usually peak to around 4,000 per day by late October and smoke from these add to the existing urban pollution load of vehicles, construction, road dust and other sources. So any measures to deal with crop stubble, if successful, would be significant.

True colour image and aerosol optical thickness (AOT) showing smoke depth from open agricultural burning in India in fall 2016 spreading across the northern plains, NPP VIIRS satellite data, NOAA View

At the same time, to really turn the corner on air pollution year round, the Delhi leader also needs to update plans on existing solutions like increasing electric buses for public transport; enacing stricter waste management measures; stricter enforcement and penalties for emissions from coal power plants; and better controls on upcoming government construction projects that could have a large pollution footprint. 

On the plus side, critics see it as a good sign that the Delhi Chief Minister’s initiative addresses multiple sources of pollution – instead of only focusing on the politically-charged crop residue burning by farmers from neighboring states. He has, in fact, reiterated his commitment to strengthen the newly-announced electric vehicle policy and denounced coal power plants that aren’t meeting their emission norms, while also announcing a renewed focus on transplanting mature trees rather than saplings to replace those sacrificed to new construction.

Serious implementation of a mix of these initiatives, including the composting technology, will be key to any significant reduction in air pollution, especially as the economy gears up to recover from the Covid-induced lockdown.

India had the world’s highest outdoor air pollution rate in 2017

Composting crop waste to save Delhi’s air 

In the states of Haryana, Punjab, Rajasthan and Uttar Pradesh, farmers produce almost 50 million tons of straw a year, four fifths of which are burnt, concluded a joint industry-government report in Bloomberg. CIMMYT’s more conservative estimates say farmers in northern India burn an estimated 23 million tons of straw from their rice harvests. That enormous mass of straw, if packed into 20-kilogram 38-centimeter-high bales and piled on top of each other, would reach a height of over 430,000 kilometers — about 1.1 times the distance to the moon.

Burning of crop residue not only releases toxic gases into the air, it also burns precious nutrients away from soil, reduces crop yields, and promotes excessive use of fertilizers, according to the International Wheat and Maize Improvement Center. Use of fertilizers is not only more expensive for governments, which provides massive fertilizer subsidies, it also increases costs for farmers.

In mid-September, a task force led by PK Mishra, principal secretary to Prime Minister Narendra Modi met with the states of Punjab, Haryana and Uttar Pradesh to brainstorm how farmers can limit stubble burning and reduce pollution.

Of all the measures that are being discussed, the Pusa Decomposer seems to be the most promising.  The technology includes four ‘bio-decomposer’ capsules that can be dissolved into a liquid formulation, sprayed on shredded paddy straw, turning it into manure, said Dr YV Singh, principal scientist at the Indian Agricultural Research Institute. 

“The four capsules in a pouch can be used to make 25 litre solution which can then be used on one hectare or 2.5 acres of field,” he told India Today last week. “This capsule will help in curbing the practice of crop burning. This can be used in all forms and on any farm.”

Whereas rice paddy straw from the summer’s harvest normally takes 45 days to compose even if it is shredded, the Pusa Decomposer speeds up the process to  25 days, according to Singh. Shortening the process would give farmers time needed to prepare fields for their winter wheat crop – without harming having to burn their fields.  

Delhi officials are now trying to promote the idea amore widely: ‘This will end stubble burning and pollution to a huge extent,” said Delhi State’s Environment minister Gopal Rai. “We are planning to provide all sorts of help to farmers so that Delhi is safe from stubble burning,” he added. 

Growing the wrong crop at wrong time in wrong state

Wheat field in Punjab, Pakistan – sown after the rice harvest is finished.

Crop-stubble burning isn’t new. But it has become much more common in the past decade, after a government order in 2009 compelled farmers to begin sowing their rice seeds in June at the beginning of the monsoon season, rather than in April, when the weather is still hot and dry. The new policy was intended to ensure that the first monsoon rains recharge groundwater reservoirs before the rice planting began, but it backfired.

As a result of delaying the time of the harvest to early autumn, farmers have struggled to clear their fields in time for the next planting season, leaving them no other choice but to burn their fields – the quickest option they had.

Winds also change direction by October, so if paddy fields are on fire due to the later harvest, toxic smoke from the north blows directly towards urban areas with dense populations such as Delhi, as well as satellite towns known as the National Capital Region –  choking roughly 46 million residents in the area.

More fundamentally, rice is one of the most water-hungry crops in the world, and Punjab isn’t the ideal location to grow rice at all, as its groundwater levels are chronically low; rice also requires standing water in its early stages of growth.  Traditionally the area grew wheat and other nutrient-rich legumes and grains, which were more in tune with local conditions – and also healthier diets. 

However, over the past few decades, government rice subsidies encouraged farmers to grow so much rice that India has now become one of its largest exporters, at 12 million tonnes a year. Even the government’s own stocks are now more than twice the required level. By growing so much rice, environmentalists, the country is effectively exporting its most precious resource – water – out of the country. Some have theorized that Punjab’s shifts in crop sowing and production patterns have also been encouraged by the government and industry promotion of genetically modified Bt rice seeds.  The agrochemical conglomerate Monsanto has been promoting the seeds, which include genetic material from the Bacillus thuringiensis to ward off pests across Asia, although so far China has resisted, India was more accomodating. 

Monsanto seeds are less nutritious than traditional varieties, and result in high levels of silica in soil

An analysis by the NGO Ecologise Network explains that the government subsidies, along with the industry promotion of GM seed varieties has, over time, undercut production of  more nutritious, traditional varieties of legumes, grains and seeds. These were not only less water-hungry but also easier to manage after harvests because they did not require widespread burning. Some of the new varieties of rice also leave high silica levels in paddy stalks, making them unusable for use as animal fodder.   

The network also charges that other Monsanto GMO maize and wheat products are contributing to the destruction of bee colonies that pollinate 90% of the world’s food supply, including plants vital to Indian food production, also replacing human food stocks with ones destined for animals.  

“Monsanto’s GMO maize is also not fit for human consumption and is primarily used as chicken feed. Likewise, most of Monsanto’s wheat is used to feed animals because it is unfit for human consumption,” charges the NGO.  

Getting more with less: the power of ancient grains  

Merely by shifting its subsidy policies and food support, the government could easily persuade farmers – and consumers – to switch back to traditional Indian coarse grains that are more nutritious, use less water, and don’t need to be burned at  the end of the season, critics say. These include pearl millet (bajra), finger millet (ragi), sorghum (jowar), barley, rye and maize – all of which are traditionally grown in India. These grains have a high iron content and are perfect for a country that harbors one quarter of the world’s cases of anaemia. 

These traditional crops would also give farmers a longer window of time to clear their fields so they don’t have to slash and burn so hurriedly. Furthermore, with India’s ethanol policy 2018, any ethanol produced as a by-product can help farmers augment their income. For the country as a whole, investing in ethanol would also help create new employment opportunities and to save on oil imports.  

Until recently, the government’s main alternative to crop burning involved the promotion of tractors such as the ”Happy Seeder”, that mechanically cut stubble and sow seeds, and which have become popular in Punjab. However, critics say that the diesel-run machines are not only polluting but expensive to operate.  And they have not gained widespread acceptance either. Farmers in the neighboring state of Uttar Pradesh, for instance, have instead opted for more traditional farming techniques, as well as seed varieties that produce less stubble and silica than their counterparts in Punjab.

India could halt subsidies for the Happy Seeder – a dirty diesel-run machine to cut stubble and sow seeds

Improving Appetite For Stubble – IKEA Leads Way

At the same time, whether or not stalk waste is  processed by big tractors or more traditional methods, farmers will stop burning crop stubble if they can cut it and sell it. So solutions that reuse farm waste, and preferably monetize it, also  incentivize farmers not to burn it. Some advocates have proposed that the government directly pay farmers to deposit crop waste at collection centres or link it to their support price payments. 

Still other solutions would involve subsidies to entrepreneurs that create solutions to tackle crop stubble burning, such as green refrigeration systems powered by farm waste or ecologically-based crockery or textiles, which also reduces plastic use.

The Swedish home furnishings company IKEA, for instance, recently launched its Forandring collection of home accessories like baskets and mats, textiles,  made  in collaboration with local industries, and which are using rice stubble pulp.  The collection is part of IKEA’s  Better Air Now initiative which is collaborating with the UN Environment Programme’s  Climate and Clean Air Coalition.

“No-till” farming can improve soil quality and crop yields

There is yet another way to reduce the air pollution and greenhouse gas emissions from crop burning by almost 80%  – and it can also maximize profits for farmers, according to a 2019 study published in Science.

No-till practices that leave straw on top of the soil as mulch can preserve soil moisture and improve soil quality and crop yields in the long-run, said Principal Scientist of the International Maize and Wheat Improvement Center M.L Jat, who co-authored the Science study.

Image Credits: Neil Palmer, Sumitmpsd , Our World In Data, AishaSaleemkhan100, Karen Eliott, Science Direct, Maggilautaro .

Pfizer is one of the front-runners in development of a COVID-19 vaccine.

Acting on the advice of experts, the United States Food and Drug Administration on Tuesday issued new safety-focused guidelines for approval of new COVID-19 vaccines, that would almost certainly delay their emergency approval until after the November Presidential elections.

Just hours after the rules were issued, United States President Donald Trump accused the FDA of carrying out a “political hit job” against him by releasing new standards that could delay authorization of a coronavirus vaccine until after the November election.

“But in a subsequent video issued Wednesday evening, Washington DC time,  Trump said he’d go along with the FDA vaccine timeline, and was switching his focus to accelerating rapid FDA emergency use approval of the new antibody-rich cocktail, Regeneron, that he himself had used as a treatment, while hospitalized for COVID-19 over the past week.

In his video-taped message, issued on his personal Twitter account, the president described rapid approval of the antibody treatments as “much more important than a vaccine” since it could bring immediate relief to people who are already ill with the virus, in the way that it did for him.

“We have Regeneron, we have a very similar drug from Eli Lilly and we are trying to get them on an emergency basis,” Trump said in the video. “We have to get them to the hospital where people are feeling badly, that is much more important than the vaccine….I want to get you what I got. I want to make it free,” he also said.

“On the vaccines, we have many companies that are in final stages, Johnson & Johnson, Moderna, Pfizer… and we are going to have a great vaccine very very shortly.  I think we should have it before the election. But frankly the politics gets involved, and that’s ok. They want to play their games, it’s going to be right after the election.

“The FDA has acted as quickly as ever they acted in history, and no president has pushed them like I did. And so the FDA is approving things in a matter of weeks, that used to take them years,” Trump added in a 5-minute message that also lambasted the virus as “China’s fault.”

The new FDA guidance on vaccine aprovals, posted on the Agency’s website, would require vaccine manufacturers to follow trial participants for at least two months after they completed their vaccine course, to ensure that major adverse effects did not emerge – at least immediately.

Since the two leading vaccines in the most advanced stages of clinical trials, by Moderna and Pfizer, both require two doses, it appeared increasingly unlikely that either firm would have sufficient trial candidates having cleared that two-month milestone before November.

COVID-19 vaccine research

According to news reports, the White House had earlier tried to block the FDA’s plans to formally publish the new safety guidelines including the two-month data requirement, arguing there was “no clinical or medical reason” for it. President also had openly opposed any delays when he talked about the potential offered by forthcoming COVID vaccines in the Presidential debate with former Vice President Joe Biden, the Democratic Party candidate, last week.

But on Tuesday, the FDA posted the guidance on the agency’s website anyway, pushing back against the president’s pressures.  The requirements include a review by a panel of experts and two months of safety data. The guidelines are intended to reassure the American public any vaccine is safe and effective, amid fears that the President has been trying to accelerate approvals ahead of the elections – no matter what the data shows.

FDA Commissioner Stephen Hahn said in a statement posted on the FDA’s website: “We are committed to expediting the development of COVID-19 vaccines, but not at the expense of sound science and decision making. We will not jeopardize the public’s trust in our science-based, independent review of these or any vaccines. There’s too much at stake.” Pharma companies have generally taken a prudent stand.

Pfizer’s CEO Albert Bourla even spoke out publicly last week out about his concerns over the politicization of the vaccine approval timetable, saying that it was caught in the “crucible” of the presidential elections.

Albert Bourla, CEO of Pfizer

In an FDA press release introducing the new guidance, Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research added:

“Being open and clear about the circumstances under which the issuance of an emergency use authorization for a COVID-19 vaccine would be appropriate is critical to building public confidence and ensuring the use of COVID-19 vaccines once available. The FDA’s new guidance on emergency use authorization of COVID-19 vaccines underscores that commitment by further outlining the process and recommended scientific data and information that would support an emergency use authorization decision. In addition to outlining our expectations for vaccine sponsors, we also hope the agency’s guidance on COVID-19 vaccines helps the public understand our science-based decision-making process that assures vaccine quality, safety and efficacy for any vaccine that is authorized or approved.”

The FDA said it will now convene on October 22 an open session of its Vaccines and Related Biological Products Advisory Commitee to discuss any upcoming emergency use authorization requests and processes for handling them:

“The FDA plans to convene an open session of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) prior to issuance of any EUA for a COVID-19 vaccine to discuss the EUA request and whether the available safety and effectiveness data support the authorization. The VRBPAC is currently scheduled to meet on Oct. 22 to discuss the general development, authorization and/or licensure of COVID-19 vaccines,” said the press release. “While this meeting is not intended to discuss any particular vaccine candidate, the agency is prepared to rapidly schedule additional future meetings of this committee after submission of any BLA or request for EUA to further ensure transparency.”

Trump, who is still recovering himself from a coronavirus infection, has been tweeting aggressively on a range of matters since returning from Walter Reed medical facility, where he was undergoing medical treatment, back to the White House earlier in the week.

Meanwhile over a dozen of his staff are reported to be ill with COVID-19, while unconfirmed reports put the number closer to 30.

 

Image Credits: Pfizer, Pfizer, Pfizer .

Dr Tedros Adhanom Ghebreyesus, Tuesday 6 October at Special WHO EB session.

The United States on Tuesday gave conditional praise for the “progress made” by an independent oversight committee examining the response of the WHO’s Health Emergencies Programme to the COVID-19 pandemic – asking for more updates in November and early 2021.

The report by the Independent Oversight and Advisory Committee (IOAC) to WHO’s Health Emergencies operations is was one of three reports heard by the EB at Tuesday’s meeting on various aspects of the WHO organizational and global pandemic response.

One of the key findings of the IOAC interim report, however, was that the “politicization of the pandemic response is a material impediment to defeating the virus.”

And indeed it seemed as though the member states were already taking that piece of advice to heart.

While the last Executive Board meeting in May saw significant geopolitical tensions emerge between the United States and China over who was most at fault for the expansion of the pandemic, this meeting remained sober and substantive – with both sides dialing down their remarks.

And after months of blithering White House criticism of the WHO, the conditional endorsement of the inpendent review, still underway, seemed to indicate that Washington was well along the path to remaining within the Organization, despite US President Donald Trump’s announcement in July that the US was withdrawing.

“We appreciate the progress made,” said US Deputy Secretary of Health and Human Services Brett Giroir, asking that EB members be briefed again in November and early 2021 “so we can engage in substantive discussions about how best to address the challenges and issues identified.”

Key Report Findings

Key findings of the report were that despite WHO’s declaration of a global public health emergency (PHEIC), response among member states was inconsistent and delayed.  Key gaps also emerged in national preparedness strategies, further hampering rapid mobilization. And the overall level of COVID-19 data reporting, “needs furhter improvement in terms of speed, consistency, and completeness.

Interim report of the Independent Oversight Advisory Committee (IOAC)

 

EU Bloc; Strengthen WHO’s ‘Perogative’ in Access to Information

While the committee also found that WHO acted within the legal frameworks that is currently has available, key WHO EB members suggested that those need to be strengthened.

Significantly, Germany speaking on behalf of the European Union bloc said member states need to consider “strengthening WHO’s perogative in terms of access to information” and urged the three panels that are now exploring the pandemic response from various angles: “do not to be afraid to tell uncomfortable truths.

Roles and responsibilities of the three independent committees and panels examining various aspects of the response by WHO and countries to the COVID-19 pandemic

“In your recommendations, do not be afraid to challenge all as member states to question current modes of operation and to show boldness and vision. You can count on the full support of the EU and its member states states,” said Björn Kümmel, Germany’s EB representative, to review panel members.

That EU statement, coming after months of heavy US criticism of Beijing, for allegedly withholding vital information on the emergence of a mysterious virus in Wuhan, China in late 2019, is highly significant – as it represents the diplomatic backing Washington may receive for rules changes that require  greater transparency among member states, when it comes to reporting on emerging infection threats.  Along with EU member states, Japan and Australia as well as the United Kingdom have also voiced criticism of Beijing’s handling of the pandemic in the past.

Germany also suggested that the addition of an “intermediate level” of alert that would be short of a full-fledged global public health emergency.

“We support considering the long standing idea of creating an intermediate level of alert. But we need the expertise of the Secretariat and of the evaluation groups regarding its definition, the consequences that will be attached to its activation, and the possible process for its implementation,”  Kümmel, added, also speaking on behalf of the European Union bloc.

“We look forward to discussing ideas such as increased accountability of member states on preparedness, for example, through the establishment of a periodic review mechanism, as proposed by the African Union, and all strengthening WHO’s prerogatives in terms of access to information.

“Emphasis must also be placed on development of proper and unified health data collection at all levels,” Kümmel added.  

The United Kingdom, meanwhile, said that the team leading a second review, The Independent Panel (IPPR), which is examining both national and WHO response, should add a scientific advisory panel to structure.

“Given the potentially unlimited amount of quantitative and qualitative information available to the panel, we believe a scientific advisory group will be a beneficial addition to your structure,” said the UK’s representative Chris Whitty. “It would ensure that the advice given to the Co-chairs and the panel is fully independent and impartial, capturing the best evidence available.

“It would streamline and speed up the collection and analysis of evidence enabling the development of a comprehensive pace to inform your reviews output, and it will provide the co-chairs and panel with consistent advice over the entire course of review, covering the range of necessary technical expertise, including for example, as mentioned by others, human health, animal health, behavioural science, organisational change and modelling and forecasting.”

Russia Criticizes Makeup of Review Committee – China remarks remain muted

The meeting was not without its flashpoints, however couched they were in diplomatic language.

Russia complained about geographic imbalance in the makeup of a second review committee, the Independent Panel, which was mandated by the last World Health Assembly in May to take a broad look at both the WHO and national response to the pandemic.  The 13 member Panel chaired by former New Zealand Prime Minister Helen Clark and former Liberian Prime Minister Helen Johnson Sirleaf,  includes members from all WHO regions.

However,  Minister of Health Mikhail Albertovič Murashko, Russia’s EB representative, maintained nonetheless that the reprsentation on the panel was lopsided.  “As we see it, it’s important to take a balanced approach, and sadly, within the IPPR at present we do not see a balanced situation because there is one whole geographical region that is not represented at all, and if you consider the fact that this region represents a very significant proportion of the world’s population, that is a serious imbalance.”

Yet a third review committee is examining the functioning of the International Health Regulations, which form the legally binding framework under which countries report about health emergencies and WHO’s shapes its guidance and response.

China reacted in a muted way to the reports. It said it hoped the reviews would enhance the ability of WHO and the international community to “take more targeted measures to further support countries with weak health systems.”

China’s EB representative, Zhang Yang, also called upon the review panels to “inform members states of their work in a timely manner and use their platforms to enhance direction with member states.”

WHO Provides Extensive Review of COVID-19 Pandemic Response To Date

The debate over WHO’s performance followed an extensive review by WHO of the state of the pandemic and its response to date – including everything from the direct distribution of emergency supplies to the massive WHO “Solidarity Trial” for new tests, drugs and other health products involving research in dozens of countries; laboratory capacity-building; and the creation of the COVAX vaccine pool,  which 168 countries have joined so far.

The review illustrated the volatile nature of the pandemic in terms of its geographic impacts – but also included somebright spots including strikingly lower case and death counts in the African region, and the beginnings of decline in South-East Asia.  This, as cases in WHO’s European region were seeing a significant rise.

 

At the same time, one sobering note was the striking disruptions of key health services in countries across the world. Among the services hardest hit, according to a recent WHO survey: some 77% of countries have reported pandemic-related  interruptions of dental services, 66 % of countries reported interruptions in routine immunization services; 65% NCD diagnosis, 64% in family planning and contraception, and 55% of countries reported interruptions in treatment for mental health disorders.

-Pippa Cook contributed reporting to this story

President Donald Trump, still ill with coronavirus, waves to his supporters in a drive-by outside of Walter Reed National Military Medical Center on Oct. 4.

A hail of criticism has followed US President Donald Trump’s drive-by to wave at supporters outside of the Walter Reed National Military Medical Center, including by a doctor at Walter Reed who said the president put the Secret Service at great risk.

President Trump was hospitalized on Friday, after testing positive for SARS-CoV2 hours earlier. Trump was moved to Walter Reed after the White House reported that he was experiencing “mild symptoms”, including a low-grade fever, nasal congestion and a cough. 

On Sunday, the White House physician Sean P. Conley corrected previous reports, announcing that Trump had a high fever on Friday and his blood oxygen levels dropped below 95 percent on two occasions, on Friday and again on Sunday. 

The president received an antibody cocktail from Regeneron, a biotech company that has developed a treatment to lower the level of the virus. Later on Friday Trump began taking the experimental drug Remdesivir, developed by Gilead. And the following day, he was given dexamethasone, a drug reserved for use in “severe and critical COVID-19” cases, according to WHO guidelines. He was also reportedly given oxygen on a couple of occasions. 

The White House has been widely criticized for the incomplete and sometimes contradictory information regarding Trump’s health. Infectious disease experts have begun questioning if Trump’s condition is more serious than implied by his doctors due to the combination of drugs he has been given. 

Trump has attempted to quell concerns by posting a video on Twitter, praising his doctors at Walter Reed and saying, “I learned a lot about COVID…I get it and I understand it.” Moments after releasing the video, Trump left the hospital in a vehicle with his Secret Service detail to wave to his supporters – who he referred to as “the great patriots” – gathered outside. Trump was wearing a mask and the Secret Service agents were wearing respirators and eye protection.

Trump’s actions have been harshly criticized by doctors and experts for putting the Secret Service agents at risk. James Phillips, an attending physician at Walter Reed, said Trump’s drive-by was “political theater” and “insanity.” 

“The risk of COVID-19 transmission inside [the vehicle] is as high as it gets outside of medical procedures. The irresponsibility is astounding,” said Phillips. 

According to the White House spokesperson, Judd Deere, the drive was “cleared by the medical team as safe.” However, Secret Service agents told the Washington Post that Trump’s behavior was reckless. 

“By taking a joy ride outside Walter Reed the president is placing his Secret Service detail at grave risk,” said Jonathan Reiner, professor of medicine and surgery at George Washington School of medicine and health services. 

Trump’s Medical Team Report That He Will Be Discharged
White House Physician, Sean Conley, and President Trump’s medical team hold press conference on Oct. 4.

Meanwhile, Conley announced on Monday that the president will be discharged from the hospital and return to the White House on Monday evening. Trump has received a third dose of remdesivir and continues to take dexamethasone, according to his doctors at Walter Reed. 

Trump affirmed that his health has drastically improved, saying on Twitter, “I feel better than I did 20 years ago!” These feelings, however, could be attributed to the dexamethasone that the president has been taking. The steroid dampens the body’s immune response and can cause some patients to develop “insomnia, mania, agitation and grandiosity,” said Céline Gounder, a clinical assistant professor of medicine and infectious diseases at the NYU Grossman School of Medicine. 

Several medical experts have raised concerns about the decision to discharge Trump. “I think it would be disastrous to be in a situation where he gets really sick at the White House, and you’re having to emergency transfer him,” said Gounder. 

However, in the absence of more detailed, and transparent, reports about the President’s health by his doctors, the speculation remained just that.  

As the US COVID-19 deaths reached 210,000 on Monday, President Trump tweeted ,defiantly, “Don’t be afraid of COVID. Don’t let it dominate your life.”

Image Credits: Flickr – White House, Flickr – White House.

The COVID-19 pandemic has disrupted mental health services in 93% of countries at a time when they are most needed, concludes a new WHO survey, released Monday. The survey is based on data from 130 WHO countries gathered between June and August 2020.

Despite rising awareness of the enormous strain that the pandemic has placed on the mental health of people in rich and poor countries alike – as well as mounting research evidence that the SARS-CoV-2 virus can also cause or exacerbate neurological conditions – most of the world’s countries are facing massive shortfalls in funding for mental, neurological and substance use services.

WHO’s director of the Mental Health and Substance Use department Dévora Kestel

And these are exactly the kinds of services that are most needed now – as people face huge economic losses, disruption in school and social plans, and increased isolation as a result of the measures taken to contain the virus spread.  

“We want to make sure that people in need of attention receive the care they deserve and need,” aid WHO’s director of the Mental Health and Substance Use, Dévora Kestel, at a WHO press briefing. “And so we want to make sure that there is better, [and] more investment on essential services for mental, neurological, and substance use [disorders].” 

While nine out of 10 countries surveyed have included mental health and psychosocial support within their national COVID-19 response plans, less than one-fifth have allocated enough funding to implement those plans, according to the report, published just days before World Mental Health is observed on 10 October, including WHO’s Big Event for Mental Health.

“The problem is that only 17% of countries have the funding for the implementation of [mental health and psychosocial] plans,” added Kestel.

Even though evidence-based interventions in mental health are highly cost-effective, mental health funding has stagnated at less than 2% of national health budgets, according to WHO.

The data were collected by WHO through a web-based survey completed by mental health focal points at ministries of health between June and August 2020. 

Children And Adolescents Most Affected By Mental Health Service Disruption

Children and adolescents are the most severely affected by mental health service disruptions

Children, adolescents and older people were the most severely affected groups, said the report. Disruptions in services for these groups were reported by 70% of countries, especially mental health promotion and prevention services in schools. 

Almost two-thirds of mental health services in schools or workplaces were wholly or partially disrupted, warned the report. Only 30% of mental health services for children and adolescents or for older adults were fully available without disruption.

Community-based and outpatient mental health services were also deeply affected, including the closure of, or restrictions on residential, home and day-care services.

Disruptions in mental health services are often a result of travel restrictions that have prevented patients from reaching clinics, especially in low-income countries, which have had trouble responding to COVID-19 through digital healthcare services like telemedicine, teletherapy or hotlines. 

While over 80% of high-income countries said they used digital healthcare to replace in-person consultations, only 50% of low-income countries have been able to do so, revealed the report.

Lower-income countries have found it harder to adopt digital health solutions during the pandemic

Countries Must Ramp Up Mental Health Surveillance And Research

Countries must ramp up mental health surveillance and research, especially as the coronavirus exacerbates existing mental, neurological and substance use issues and triggers new ones – including delirium, strokes or psychoses, said Kestel.  She added that only half of  130 surveyed countries have collected data on mental, neurological and substance use disorders – and fewer than one-tenth are researching how the COVID-19 virus attacks the brain.

People with pre-existing mental, neurological and substance use disorders are also more vulnerable to COVID-19 disease, according to the latest research.

In one cohort study of almost 1,700 patients with COVID-19, those with psychiatric disorders were about 1.5 times more likely to die from COVID-19, even after adjusting for differences in age, underlying conditions or hospital locations, reported researchers from Yale University’s School of Public Health less than a week ago.

Even if people with mental health disorders are safe from the coronavirus, inadequate access to services can be life-threatening. Together, suicides, alcohol and drug overdoses kill over 4 million people a year – or four times more than the coronavirus has killed thus far.

“The impact of the pandemic on people’s mental health is already extremely concerning,” said Director-General of the World Health Organization Dr Tedros Adhanom Ghebreyesus in mid-May. “Social isolation, fear of contagion, and loss of family members is compounded by the distress caused by loss of income and often employment.”

Image Credits: WHO/NOOR/Sebastian Liste, WHO, WHO.

The 5th Special Session of the WHO Executive Board – hybrid virtual and face-to-face meeting

The United States appears to be walking back on threats to withdraw from the World Health Organization – just as US President Donald Trump is reported to be recovering from a bout with COVID-19 in Washington, DC. 

Speaking at the first formal meeting of WHO’s Executive Board governing body to be convened since May, US Assistant Secretary for Health, Brett Giroir, said that the US had developed a “roadmap for WHO reform” together with other members of the Group of 7 industrialized nations, suggesting that the US would be pushing for uptake of those  measures within the global health organization – rather than pulling out altogether.    

“The United States working closely with G7 partners, developed a roadmap for WHO  reform, which I shared with my fellow executive members in August,” said Giroir in his remarks today at the meeting of the 33- WHO member states that guide key policy directions.

“The roadmap outlines opportunities to strengthen the WHO by increasing its accountability, transparency and overall effectiveness, as well as promoting our shared accountability to one another to address new and emerging threats. Germany and France jointly provided a paper also along these lines, and we understand Chile, also has recommendations.” 

In his remarks, Giroir made one pointed, albeit indirect reference to alleged Chinese “failure” to report earlier on the virus spread – but in a departure from the heated anti-China rhetoric coming from the White House, he did not call out Beijing by name.

US Deputy Secretary of Health, Brett Giroir, speaking at a special session of the WHO Executive Board, 5 October 2020.

“Despite the many advances in technology, international cooperation and instantaneous communication, and the positive steps in response outlined this morning,… we cannot overcome the failure of any member state to provide accurate, complete and timely information on outbreaks and potential health emergencies,” Giroir said. 

The balance of his remarks stressed the common goals shared with other WHO member states going forward in beating back the pandemic.

“We also all share the same goal of reforming the WHO, fighting COVID-19 and defeating future outbreaks,” said Giroir. “The US welcomes all good faith efforts to strengthen public health protections, and we hope we can use this special session. To begin, converting these many good ideas, actions. 

“Consistent with our longstanding policy, the United States will be promoting reforms that strengthen transparency and accountability at every international organization, including the WHO.”  

Austria, Brazil and Others Echo Reform Calls  

An assortment of other high-income countries also joined into the US calls for reform – with a range of statements. 

Austria praised “the good and early reaction of WHO.. whoever says different is far from the facts, and believes in fake conspiracies.” But the Austrian representative, Clemens Martin-Auer, also complained that there had been “no global leadership when it comes to the many aspects of travel regimes and restrictions that is hurting commerce and the travel industry in many respects. We have no proper guidance of this valuable organization.”

And while he praised WHO Director General, Dr Tedros Adhanom Ghebreysus for doing an “extraordinary job when it comes to information” he pointedly added that “information is not a substitute for consultation,” saying that the organization’s “governing bodies” such as the Executive Board, could have been consulted more.  

In an obvious swipe at the United States, Martin-Auer added: “In addition to the health crisis, we are also facing a weakening of the organization. This political weakening is further reinforced by the potential withdrawal of a strong WHO Member State from the organization, which means a serious loss of organizational resources.”

Maria Nazareth Farani Azevêdo, Brazilian representative to the United Nations in Geneva

In their remarks, a number of other leading countries signaled their readiness to cooperate with the US ‘reform’ initiative. Brazil, for its part, said it was ready to “engage with other interested member states in a reform process of the WHO, on the basis of the roadmap circulated by the United States in collaboration with G-7 partners.”

And yet others, sidestepped criticism of WHO altogether, preferring to focus on the importance of maintaining a strong WHO leadeship role.  

“Our duty is to demonstrate that protecting the health of the people, makes good economic sense. We need a strong WHO to lead us forward,” said Dr Päivi Sillanaukee, Finland’s representative to the Executive Board. 

Meanwhile, India and Kenya called for a stronger WHO, with more transparent decision-making and better equity in access to vaccines and medicine. “It must be our collective endeavor to make the WHO accountable, stronger, and a more vibrant organization in the interest of our future generations,” said the Indian representative. “The WHO must also put in place a robust mechanism to ensure fair, affordable, equitable access to vaccines diagnostics, and therapeutics.”

The WHO Says Just Three Countries Hold More Than Half of All COVID-19 Cases
Dr Tedros Adhanom Ghebreyesus, Director General of the WHO.

In WHO’s opening remarks Monday morning before the EB governing body, WHO Director General Tedros pointedly noted that while “all countries have been affected by the virus, this is an uneven pandemic.”

“Just 10 countries account for 70% of all reported cases and deaths, and just three countries account for half,” Dr Tedros said. Although he didn’t call out the countries by name, the United States, India, and Brazil have together have had the largest cumulative totals, racking up nearly 19 million of the 35.3 million COVID-19 cases reported to date.

He outlined what he described as the four situations that countries are facing:

“First, some countries acted decisively and quickly and have avoided large outbreaks. Second, some countries have had large outbreaks but were able to bring them under control, and continue to suppress the virus. Third, while some countries brought the virus under control, as economies and societies have eased restrictions, there has been an increase in cases. And fourth, there are still some countries that are in the intense phase of transmission.”

But the virus is highly dynamic, he emphasized, meaning that “every situation can be turned around. And hard-won gains can be easily lost.”

World map representing COVID-19 deaths per 1 million population globally.
Shock Over Sexual Abuse Allegations in Democratic Republic of Congo

While most of the all-day session, which continues tomorrow, was devoted to reviews of the progress and challenges related to pandemic response, some countries, such as the United Kingdom, also expressed their dismay over the recent allegations of sexual exploitation among members of the WHO Ebola team that had been based in the Democratic Republic of Congo. 

“Like others we were shocked to hear the recent allegations of sexual exploitation and abuse against who and other organizations fighting Ebola in DRC. We welcome to DDS commitment to investigate these allegations and to ensure who safeguarding systems are for the offenses,” said the United Kingdom’s representative, Chris Whitty.  

-Raisa Santos and Madeleine Hoecklin contributed to this story.

Image Credits: WHO.

Albert Bourla, CEO of Pfizer, speaking at the World Economic Forum

The CEO of Pfizer, one of the frontrunners in the race to develop a COVID-19 vaccine, has lambasted US President Donald Trump’s politicization of the vaccine approval timeline, declaring in an open letter that the company is “moving at the speed of science” and will not “succumb to political pressure” to prematurely rush its product to market.

The letter by Albert Bourla to “US colleagues” was issued shortly after President Donald Trump declared Tuesday in a televised US presidential campaign that a COVID-19 vaccine could be ready “a lot sooner” than timelines laid out recently by US Centers for Disease Control Robert Redfield and other scientific experts.  

Responding to a debate question about Redfield’s projection that public release of a vaccine might not be feasible until next summer, Trump said: “I’ve spoken to Pfizer, I’ve spoken to all of the people that you have to speak to, Moderna, Johnson & Johnson, and others. I’ve spoken to the companies and we can have it a lot sooner.”

Bourla retorted that “the world will be safer if we stop talking about the vaccines’ delivery in political terms and focus instead on a rigorous independent scientific evaluation and a robust independent approval process.” 

Referring explicitly to Tuesday’s debate in his letter, Bourla said that “once more I was disappointed that the prevention for a deadly disease was discussed in political terms rather than scientific facts.”

He added that the political rhetoric swirling around the vaccine approval timeline undermines public confidence, which is crucial for the acceptance of a vaccine: “People, who are understandably confused, don’t know whom or what to believe. Global health has too much at stake, and the public trust and acceptance of a vaccine is so important to me, that I’m writing to explain the principles we are using at Pfizer today.”  

Among the three pharma front-runners in late-stage trials, Pfizer is the only company that has projected that it could have “an answer by the end of October,” before the 3 November US election. President Trump had, in turn, praised Pfizer for their speed and accelerated timeline. Experts have noted that the timeline  is largely driven by the shorter interval required between Pfizer’s two-dose vaccine and another candidate, being tested by Moderna, Inc.  Trials of a third vaccine candidate, by AstraZeneca, have stalled due to safety concerns.  

While Bourla’s letter did not upend the official Pfizer projections, the CEO said the pace of approvals should be determined separately from politics: 

“In March, I declared a bold ambition: that Pfizer would create a vaccine…I further announced, after consulting with our scientists, that we could have vaccine data ready to submit to the FDA by end of the third quarter, in October, and hopefully a hundred million doses delivered by the end of the year. I knew our goal was ambitious, but it would also be critical to protect against the second wave of cases that could accompany the return of colder weather in the Fall.

“Now, we are approaching our goal and despite not having any political considerations with our pre-announced date, we find ourselves in the crucible of the U.S. Presidential election. In this hyper-partisan year, there are some who would like us to move more quickly and others who argue for delay. Neither of those options are acceptable to me. Against this backdrop, people need to know three things:

“First, we are moving at the speed of science. With a virus this ferocious, time is our enemy. This week, we will hit the grim marker of 1 million deaths globally and the number continues to climb. This danger supersedes any other timing considerations.

“Second, we would never succumb to political pressure. The only pressure we feel—and it weighs heavy—are the billions of people, millions of businesses and hundreds of government officials that are depending on us. We’ve engaged with many elected leaders around the globe through this health crisis, but Pfizer took no investment money from any government. Our independence is a precious asset.  

“Third, our priority is the development of a safe and effective vaccine to end this pandemic…The amplified political rhetoric around vaccine development, timing and political credit is undercutting public confidence. I can’t predict exactly when, or even if our vaccine will be approved by the FDA for distribution to the public. But I do know that the world will be safer if we stop talking about the vaccines’ delivery in political terms and focus instead on a rigorous independent scientific evaluation and a robust independent approval process.”   

Newly Established Global Lab Network Will Compare COVID-19 Vaccines 
The manufacturing process of Pfizer’s COVID-19 mRNA vaccine

Presuming that several vaccines, at the least, will eventually make it to marketing approval, scientists are also grappling for ways to assess what are the most effective vaccine(s) for different population groups and settings. 

As part of that effort, a new global laboratory network is being set up to examine data from major COVID-19 vaccine trials and assist with their selection, said Melanie Saville, director of vaccine R&D at CEPI, the Oslo-based Coalition for Epidemic Preparedness Innovations. Ultimately, the information would help inform the choice of vaccines for mass manufacture and procurement by the WHO co-sponsored COVAX initiative, which has brought 168 countries together in a vaccine purchasing pool. 

The non-profit coalition involving Norway as well other donor countries and health research foundations, has co-funded nine of the leading  COVID-19 vaccines in advanced Phase 3 clinical trials, including candidates from Moderna, AstraZeneca, Novavax and CureVac.

In an interview with Reuters, Saville said the aim is to establish a centralized network of labs across Europe, Asia, and North America. Six labs will analyze samples from trials of COVID-19 candidates, of which there are currently over 320 underway at different stages. The labs will try to improve comparisons by creating a centralized system to analyze them “as though [the] vaccines are all being tested under one roof,” said Saville, removing the inter-laboratory variability. 

Due to the variety of vaccine technologies used in potential COVID-19 vaccines, from viral vectors to messenger RNA, there is a high degree of complexity in the evaluation process. The network will begin by assessing early-stage human trials, later moving to Phase 3 trial data, she said. 

Gilead’s Remdesivir is Under Investigation by the European Medicines Agency 

Meanwhile, in what appeared to be a bad turn for the prospects of one key COVID-19 treatment, the European Medicines Agency announced on Friday that its safety committee was reviewing reports of acute kidney injuries in COVID-19 patients taking Gilead Sciences Inc.’s Remdesivir. 

Remdesivir was one of the first treatments found to shorten recovery time in COVID-19 patients and was approved for emergency use by the US Food and Drug Administration as well as by the European regulatory authority, where it has been given a conditional marketing authorisation as a treatment for COVID-19 for severely ill adults and adolescents.

Emer Cooke, WHO

At the time of the authorization, Remdesivir was flagged for the potential risk of renal toxicity. Subsequent reports of acute kidney injury in patients who were treated with the medication triggered action by an EMA safety committee, which has now enhanced monitoring of the drug. 

The EMA said in a press release that kidney injuries can also be caused by other factors, including diabetes and COVID-19 itself, so as of yet, there is no causal relationship between remdesivir and kidney injury. In response to the reports, WHO’s Emer Cooke, said that it would be examining the reports, but that the EMA investigation was still in the “early stage of development.”

 

Image Credits: Pfizer, World Economic Forum.

Donald Trump at a recent White House meeting – close contact among staff may have fueled COVID-19 infection spread

WHO Director General Dr Tedros Adhanom Ghebreyesus joined the chorus of world leaders wishing United States President Donald Trump and his wife a speedy recovery from COVID-19 – while the US presidential campaign entered uncharted waters, with the cancellation of campaign rallies and fears that other White House Staff and political allies who had accompanied Trump recently on the campaign trail, and to a raucous election debate with Democratic candidate Joe Biden, might also have been exposed to the virus.     

Trump revealed on his Twitter account early Friday morning that he, along with first lady Melania Trump, had tested positive for the SARS-CoV-2 virus. He said they will quarantine in the White House for an indeterminate period. 

“Tonight @FLOTUS and I tested positive for COVID-19,” tweeted President Trump at 1 a.m. EST. “We will begin our quarantine and recovery process immediately. We will get through this TOGETHER!”

“The President and First Lady are both well at this time, and they plan to remain at home within the White House during their convalescence,” said Dr. Sean P. Conley, the White House physician, in a statement.

Speaking at a WHO press briefing later the same day, Dr Tedros and other senior WHO officials avoided any reference to the hailstorm of criticism that Trump had directed for months at WHO’s performance in the pandemic. Instead, they struck a conciliatory note, stressing the leadership role the US President could still play in the battle against the pandemic.

“Overnight we heard that the president of the United States of America Donald Trump, and first Lady Melania Trump tested positive for COVID-19; I want to start today by wishing them both a full and swift recovery. Our prayers are with them,” said Dr Tedros in his opening remarks at the briefing. 

Asked whether Trump had failed to show adequate leadership in controlling infection spread  in the United States, where new infections are averaging some 40,000 cases a day, Mike Ryan, Executive Director of Health Emergencies, refrained from explicit comment.  

But Ryan suggested that the US President, who is 74 and overweight, might draw new insights into the disease from experiencing it himself, adding it was still not too late for the United States to “turn the corner” on it’s own chronically high infection rates.  

“We wish the president well. Like we would wish anyone facing this disease well. This is a nasty virus and this virus can cause severe disease. Particularly in older individuals with underlying conditions,” said Ryan. 

“We’ve all been through things in our life, health events that transform our lives whether we want them to or not. And other things that allow us to learn and absorb lessons in our lives. 

“We want all public leaders, particularly leaders of great countries to lead us and to give us hope, to give us certainty, to give us truth and to give us a chance to fight and win against this disease. So it is never, ever too late for that to be true.” 

Election Campaign In Uncharted Waters Alongside Reports Biden may have been infected   
Crowds flock to recent Trump campaign rally in Virginia

The news of Trump’s infection poses a clear challenge to the pace and tone of his re-election campaign against former Vice President Joseph Biden, the Democratic nominee. The President has already cancelled his campaign rallies scheduled over the weekend and early next week, while uncertainty surrounds plans for the next presidential debate, scheduled for October 15 in Miami. 

Disease experts also suggested that a much wider outbreak among White House staff and political allies may be underway. In the week leading up to Trump’s positive test, he interacted with staff members, donors, and supporters at a variety of events. 

It is presumed that the president and first lady tested positive for the virus following close contact with a senior advisor, Hope Hicks, whose positive test results were reported late on Thursday evening. However, according to White House officials, Hicks began exhibiting symptoms on Wednesday, when she traveled with Trump to a campaign rally in Minnesota. The White House wanted to keep the news of Hicks’ positive test result from leaking, said White House aides. 

Advisors to the president were reported as saying that they expected additional cases among those who are in close and regular contact with Trump. Ronna McDaniel, Chairwoman of the Republic National Committee, already had tested positive for the coronavirus on Wednesday, after having contact with Trump last Friday. However, Vice President Mike Pence and Secretary of State Mike Pompeo, tested negative for the virus on Friday as did Biden who had faced off against Trump on Tuesday in a raucous, nationally televised election debate that lasted more than two hours and included ample shouting from the podium.  

Asked about the potential for a wider COVID outbreak among White House staff, Biden and others, WHO’s Ryan added: “Two cases that are linked to space and time can be considered to be an epidemic or a cluster, and there is clearly a cluster of cases occurring in that scenario. And that needs to be properly investigated. And those individuals who may be at risk need to be advised, the necessary quarantines need to be put in place. This is epidemiology 101. 

“We absolutely trust the US public health authorities to make the appropriate decision and advise those individuals whether there may be a risk,” he said, adding, “There is no reason why the United States of America cannot control this disease, turn the corner. But that requires work. Corners don’t turn by themselves, they need to be turned in the case of biologic processes.  You’ve got to fight the virus, push the virus down. That costs, that costs in effort, in commitment in transparency. It costs in honesty and it costs a sustained support to get that job done. 

New Report Charges Trump With Fueling “Infodemic” On COVID-19

Trump’s positive COVID-19 test results emerge after months in which he consistently downplayed the severity of the pandemic and the threat of the virus, saying at times that it was no worse than the flu. While the pandemic advanced, killing 207,816 people in the US so far, Trump continued his appearances before large crowds of people, both indoors and outside. Those appearances had picked up in pace as he hit the campaign trail even harder, in preparation for the November 3 Presidential election, holding big rallies with little social distancing, and limited mask wearing – often in defiance of state public health guidelines and regulations. 

The news also followed the recent publication of a critical report, charging that Trump is one of the leading contributors to the current ‘infodemic’ of misinformation around COVID-19, including disinformation and conspiracy theories about a virus that he has consistently blamed China for releasing, even malevolently. 

He has also been accused of lighting false hopes of an easy resolution to the pandemic from a vaccine – which experts have said would likely only be about 50% effective, and still take a number of more months to develop and release safely. On Thursday night at a political dinner, several hours before Trump’s diagnosis, the US President remained optimistic, saying, “we are on track to develop and distribute a vaccine before the end of the year, and maybe substantially before… the end of the pandemic is in sight.” 

And at the same time, Trump’s eagerness to accelerate the vaccine clinical trial processes  – even overriding standard scientific safety protocols – has also fueled growing distrust among members of the US public that a vaccine, whenever one is released, will be safe and reliable. 

“We don’t comment on the behaviour of any specific individual,” said WHO’s Ryan, when asked about Trump’s overall attitude towards the pandemic as well as the preventive measures that the President may or may not have observed personally.

“We don’t know what risk management measures were put into place, especially around the president. What we do know is that each and every individual and each and every citizen should be guided by the national guidance in their country, and that there are a combination of different measures that reduce risk … washing your hands, staying at a safe distance, avoiding crowded spaces, wearing a mask, both to protect others and yourselves. We are a community and we need to get through this together.” 

Even so, WHO Health Emergencies technical lead, Maria Van Kerkhove, herself a US citizen, acknowledged that Trump, 74, is in an age category considered most vulnerable to the coronavirus. 

“If you have underlying conditions or are above 60, 70, 80 you have a higher risk of death,” Van Kerkhove said at the WHO briefing. She added that the infection fatality rate “increases by age.. estimates overall are around 0.6 %, … and the more infections we have, the more opportunity there is for those infections to reach people of an older age, who are at a higher risk of dying.” 

According to the US Centers for Disease Control, eight out of 10 COVID-19-related deaths in the US have been among adults aged 65 and older. Trump reportedly also has a Body Mass Index over 30, which places him in a higher risk group of overweight people.

Trump’s age has thus raised concerns about the potential incapacitation of the US president, which would have global repercussions. In the case of medical incapacitation, presidential power could temporarily be transferred to Vice President Mike Pence, according to the 25th Amendment in the US Constitution. 

Such scenarios are not far-fetched, particularly in light of the hospitalization of leaders such as Britain’s Prime Minister, Boris Johnson, 56, after contracting a serious case of COVID-19 in April. 

On the other hand, a range of other world leaders have contracted COVID-19 and recovered relatively quickly,  including Jair Bolsanaro, president of Brazil, Juan Orlando Hernandez, president of Honduras, Alexander Lukashenko, president of Belarus, Alejandro Giammattei, president of Guatemala, and Jeanine Anez, the interim president of Bolivia.  So it remains to be seen if Trump will emerge more defiant than ever from a mild bout of the virus –  or visibly humbled by a more serious case. 

 

Image Credits: WHO, White House, Twitter – Donald Trump.