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Commissioner Stephen Hahn said that the FDA had notified the officials handling vaccine distribution logistics for the US’ ‘Operation Warp Speed’ so they can begin timely execution of their plans.

United States Food and Drug Agency Commissioner Stephen Hahn Friday said that the agency will “rapidly work toward the finalization and issuance of an emergency use authorization” for the cutting edge Pfizer/BioNTech COVID-19 vaccine – following a vote by an independent FDA expert panel on Thursday recommending that the vaccine be approved.

Hahn said that the FDA had notified the US Centers for Disease Control and Prevention and officials handling vaccine distribution logistics for the US’ ‘Operation Warp Speed’ “so they can execute their plans for timely distribution” of the vaccine across the country. Currently, the US has more than 6 million active cases of COVID-19 and is seeing new cases reported at a rate of 200,000 a day.

The daily confirmed cases in the current 10 most affected countries.
US FDA Approval – Signal For WHO & The World

US FDA approval will not only open the floodgates of vaccine distribution in the United States. As the world’s flagship regulatory agency, it will send a strong signal to the rest of the world that the vaccine is effective and safe. The European Medicines Agency is next set to review the Pfizer request on 12 January.

To speed up regulatory approvals elsewhere in the world, WHO will also be issuing its own “Emergency Use Licenses (EUL)” for quality-assured vaccines, WHO Chief Scientist Soumya Swaminathan said at WHO’s Friday press conference.

She noted that the WHO assessments would be done with a number of other national regulatory agencies – and could then provide a  “stamp of efficacy and manufacturing quality”, upon which other countries could rely. The approvals would also support more rapid distribution of vaccines through the WHO co-sponsored COVAX vaccine facility.

Soumya Swaminathan, WHO Chief Scientist.

“We have asked countries to either accept the WHO EUL or another stringent regulatory agency approval,” said Swaminathan. “What we don’t want is for every country to start their own national assessment because that will take a lot of time.”

She said that WHO will review vaccines submitted to the agency for approval on a rolling basis as Phase III trials are completed.

“We expect in the coming weeks we will be reviewing the Pfizer-BioNTech vaccine and coming out with something,” Swaminathan said, adding that she expected the Moderna and AstraZeneca vaccines to be next in line.

“Products issued by a stringent regulatory authority can also be used by the COVAX facility so there will be no barrier to speedy use,” added WHO’s Bruce Aylward, a senior advisor to the WHO Director General.

FDA Recommendation Is Not Without Reservations – Concerns About Vaccine Allergy & Hesitancy

Thursday’s 17 to 4 vote, with 1 abstention, by the Vaccines and Related Biological Products Advisory Committee (VRBPAC) reflected the overall high level of confidence that the vaccine had earned – but also some reservations.

Those centered largely around the safety of vaccines in young people and other vulnerable populations, as well as how vaccination centres would cope with potential allergic reactions – following two instances in the United Kingdom, which began rolling out the vaccine on Tuesday.

Reports of UK healthcare workers experiencing allergic reactions to Pfizer’s vaccine may have a negative impact on vaccine uptake in the US, the panel noted.

Two healthcare workers in the UK experienced allergic reactions after their injection on Tuesday, leading the British Medicines and Healthcare products Regulatory Agency (MHRA) to issue a warning that anyone with a history of severe allergies should refrain from getting the jab.

The two workers – who are believed to have suffered anaphylactoid reactions (less severe than anaphylaxis) – had a history of allergies, and are recovering well.

While there is currently not enough data to suggest how likely or severe a reaction could be, the FDA experts expressed concerns about how public concerns around allergic reactions could also impact vaccine uptake.

Tens of millions of Americans with a history of severe allergic reactions could now be hesitant to receive an injection, Paul Offit, vaccinologist from the Children’s Hospital of Philadelphia, said during the FDA panel meeting, which was broadcast live.

The FDA expert review group was already aware of the possibility that the Pfizer vaccine could cause an allergic reaction, prior to the occurrences in the UK when it launched its vaccination campaign on Tuesday.

This could have a significant impact on attempts to reach high levels of overall immunity, even as the most recent surveys show that the number of Americans willing to be vaccinated has risen to 6 in 10.

However, the FDA expert review group was already aware of the possibility that the Pfizer vaccine could cause an allergic reaction, prior to the occurrences in the UK.

Pfizer’s draft EUA had been updated several weeks ago warning that anyone with an allergy to a component of the vaccines should not get it, said Marion Gruber, director of the office of vaccines research and review at the FDA.

Equipment for dealing with severe allergic reactions should therefore be available on vaccine sites, the EUA draft request stated.

Questions Remain: Can Pregnant Women and 16 Year Olds Get the Vaccine?

A lack of sufficient data on the vaccine’s safety in pregnant and lactating women as well as adolescents aged 16-17 were the other key issues of debate among the expert panelists.

Pfizer’s EUA submission only included data on 153 participants aged 16-17. The overall lack of data appeared to be the main source of the concern, with no clear negatives or side effects specific to this age group reported.

As Offit noted: “We have clear evidence of a benefit. All we have on the other side is theoretical risk.”

Arnold Monto, an epidemiologist who chaired the panel, said: “We will get more data as we start using the vaccine more extensively. “With rare outcomes, you have to start using the vaccine in order to see them.”

It is highly unlikely the FDA will authorise a vaccine for these groups until a reproductive toxicity study is complete.

The experts also were undecided about whether pregnant and lactating women should receive the vaccine – due to a similar lack of evidence in the Phase III study trials. Pregnant women are often excluded from such trials, at least at the initial phases, in order to avoid unknown long-term effects on their fetus.

Manufacturers have been told to conduct developmental and reproductive toxicity (DART) studies, which indicate if a vaccine presents any risk to a fetus. Pfizer has reported that its preliminary results will be ready within days.

Until these studies are complete, it is highly unlikely the FDA will authorise a vaccine for these groups.

Image Credits: BioNTech, US Senate, Johns Hopkins University & Medicine, WHO.

COVID-19 has revealed disproportionate spending in health systems between low- and middle-income countries and high-income countries.

The combined health and economic shocks triggered by COVID-19 have revealed profound weaknesses in health systems, with direct consequences on the future of healthcare, says a new World Health Organisation report on global health financing systems. 

“COVID-19 has revealed [the] underlying weakness of country and global health financing systems. There needs to be a proactive policy response. The year 2020 is the ultimate proof that investing in health is good for people and good for the economy,” said Agnes Soucat, one of the head writers on the new WHO report, Global Spending on Health: Weathering the storm. 

The global health expenditure report highlights COVID-19’s devastating impact worldwide – describing global patterns and trends prior to the pandemic, the changes in allocation levels in 2020 arising from country responses, and the challenges raised by future health spending and equitable access to healthcare. 

All countries have responded to the health and related economic crisis of COVID-19 with exceptional budget allocations, and yet there have been stark differences in response depending on a country’s income level, the report reveals.

Low-Income Countries Allocated the Least Per Capita – but Most of Their Budgets Channeled Into COVID Response

Per capita, high-income countries spent far more on the COVID-19 response, averaging US$205, as compared to middle-income countries US$20 and low-income countries US$3. But low-income countries allocated the largest proportion of their health budgets to the response. 

Per capita budget allocations for the COVID-19 health response and per capita pre-COVID-19 public spending on health, by income group, constant US$ 2018. Low-income countries allocated the highest proportion of health budgets to the response.

And at the same time, those proportionately higher allocations may not have been used to their full potential due to pre-existing financial management issues that hinder budget implementation – spending authorization delays and difficulty in channelling resources towards service providers are some examples. 

“Health spending has an impact on unmet health needs. During COVID-19, unmet health needs have implications for health equity. Poor and vulnerable populations suffer disproportionately,” said Dr Soonman Kwon, Professor at the School of Public Health at Seoul National University, who also spoke at the launch of the report.

Almost all countries will see economic contraction in 2020, with the rest experiencing a major slowdown in growth. Stringent lockdowns reduce countries’ ability to cope with COVID-19’s economic impact, but other factors include constrained trade, tourism, and remittances, and ongoing fiscal challenges such as low tax revenues, high debt servicing and large deficits. Declining economic activity has increased unemployment and reduced working hours, and unemployment rates are expected to increase. This has the potential to decrease revenues from employment-based contributions, while both economic and health needs rise. 

Low-Income Countries Continue to Spend Far Less, Per Capita On Health – and Much More On Infectious Diseases 

Before the COVID-19 pandemic, global spending on health was rising, albeit at a slower rate in recent years, peaking at $8.3 million in 2018. 

But there have been deep-seated disparities in where and how money was spent. More than 75% of global spending on health in the WHO regions of the Americas and Europe, while WHO’s Western Pacific Region accounted for 19% of global spending, South-East Asia and Eastern Mediterranean regions accounted for only 2%, and the African region only 1%. The differences have continued to grow over time. 

Health spending by World Health Organisation region and country, 2018. Most health spending took place in the WHO Americas and European regions in 2018.

Low-income countries also continue to depend heavily on donor funding. Aid for health per capita more than doubled in real terms from 2000 to 2018, accounting for a quarter of lower income countries’ health spending in 2018. Two-thirds of external aid for health addressed infectious diseases in both low- and middle-income countries (LMICs). In middle-income countries, HIV alone accounted for nearly half the aid for health.

Other key trends in lower income countries include: 

  • Average domestic spending on health was only about about 4.4% of GDP, or US$ 34 per capita in 2018, of which nearly 60% was out-of-pocket. 
  • Average government spending on health was only US$ 9 per capita in 2018, about 1.2% of GDP, and the priority given to health in public spending has been declining between 2000 and 2018.
  • In low-income countries, infectious diseases accounted for half of overall health spending, while in middle income countries, they accounted for one-third. Noncommunicable diseases accounted for about 30% of health spending in middle-income countries and about 13% in low-income countries – even though NCD rates are soaring in LMICs.
Spending disaggregated by disease or programme, by country income group, 2018. Low-income countries spent half their overall health spending on infectious diseases, while middle-income countries spent one-third. Noncommunicable diseases accounted for about 30% of the health spending in middle-income countries and about 13% in low-income countries.

“Equitable allocation of resources needs to remain font and center of any decision-making. Civil society plays a crucial role to demand that spending is geared to community needs,” said Lenio Capsaskis, Head of Health Policy, Advocacy and Research at Save the Children UK.

Opportunity for Financial “Reset” in a Post-COVID World  
The health sector must work closely with finance authorities in public spending especially in the health sector’s role in delivering the COVID-19 vaccine and other common goods for health.

The health sector must work more closely with finance authorities to raise health care spending as a higher priority in government budgets, the report underlines. There is an opportunity for economic ‘reset’ in countries with weak health financing systems following the pandemic, the report advises. Health policy leaders can aim to raise awareness among other government sectors – using COVID vaccines as an example of a “common good” important to health and restarting economies. 

The report puts forward six recommendations that call for a new “health financing compact” for a post-COVID world. 

Secure domestic public spending on health as both a societal and an economic priority – The global GDP loss due to the pandemic is estimated to be approximately US $4 trillion , while needed funding for Common Goods for Health to ensure epidemic preparedness is estimated to be approximately US $150 billion per year. Investing in Common Goods for health should incorporate the implementation of International Health Regulations, epidemic preparedness, essential public health functions, animal health and environmental health. 

Fund Common Goods for Health as step zero of equitable access to healthcare at a country level – The Common Goods for health are core, top-priority public health functions focused on population-based health that require collective action. They can be grouped into five categories: policy coordination; laws and regulations; information (including surveillance); taxes and subsidies; and public health programs. 

Invest in global Common Goods for Health to enable global health security – The global international architecture is not well suited to the current health challenges and has no sustained revenue for the common goods of health. Unified guidance is lacking on using funds for preparedness and on making trade-offs between research and development, regulation, and surveillance and information. A tracking mechanism is needed to identify spending beyond that of any one country. 

Prioritise public funding to ensure equity of access and financial protection through a primarily health care approach – Clear priorities in spending need to ensure access for everyone to essential health services. Public subsidies are needed to ensure universal equitable access. How much governments fund, what health functions and systems they support, and how effective systems are in using public funds will define the role of private health spending. 

Increase the level of aid to lower income countries, but adjust aid modalities  – Lower income countries face severe fiscal constraints that include increasing debts that may limit social sector spending in the future. This is occurring concurrently with the decrease in external aid. Sustained aid in the form of grants, concessional lending and debt relief will be needed to strengthen health systems so countries build preparedness and strengthen public health systems that deliver equitable access to health. 

Fund national institutions for transparent and inclusive tracking of health spending at both country and global levels – Timely monitoring of spending is essential for monitoring health system performance and ensuring transparency and accountability. Given the vast effort and resources devoted to COVID-19 control, real time monitoring is needed to assess how actual spending supports health system performance. This can help governments gain the trust of their population, a proven factor for the effective control of the COVID-19 pandemic. 

Said Dr Michael Borotwitz, Chief Economist at Global Fund, on the report recommendations: “We need to figure out how to fund global public goods, and come together and support WHO in this area. We need to link health security and national health accounts.” 

Image Credits: elycefeliz/Flickr, WHO, Marco Verch/Flickr.

2019 Asia Pacific Patients Congress in Taipei, Taiwan; IAPO’s Asia Pacific Patients Congress hopes to bring patients and patient groups together in the Western Asia and Southeast Asia region

Raising a conversation about patients rights and patient care over the din of the COVID-19 pandemic is not easy. But hundreds of patient groups and thousands of attendees drew together virtually last week at the 2nd Asia-Pacific Patients Congress to talk about how to reclaim a voice and space for patient rights in the wake of the COVID-19 pandemic – where patients have been more disempowered than ever before. 

COVID-19 has greatly altered the patient experience, shifting people more than ever from an active to a passive role in their health care, especially in the initial stages of the pandemic, said Dr Sanjiv Kumar, Chair of the India Alliance of Patient Groups.

“[Patients] were picked up from homes and placed in hospitals. They were not allowed initially to even make phone calls to their friends and relatives; no visitors were allowed. It was more like putting somebody in a jail,” he said.

Speaking at the keynote event, ‘Patients’ co-creation in future proofing health systems: preparedness for the next phase of the pandemic’, Sanjiv reflected on how COVID-19 has been “treated not as a health problem, but as a law and order situation” in India and many other countries.

The stigma has been reinforced by measures created by the government and police authorities, where the implementation of restricted areas and red zones prevented people and patients from entering and leaving areas.  

According to Dr Sanjiv, healthcare must shift to a people-centered approach that allows patient participation and respects their needs and preferences – if goals for equity, quality and universal access are ever to be achieved..

“The patient community underscored the reality that for sustainable universal health coverage, there needs to be active patient engagement at all levels of the health system decision-making process,” said Karen Alparce-Villanueva, Secretary of the International Alliance of Patients’ Organisations (IAPO), speaking at the event. 

IAPO 2nd Asia Pacific Patients Congress – inaugural launch, featuring, clockwise, Karen Alparce-Villanueva, Dr Neda Milevska, and Dr Ratna Devi
Patients As Experts in Healthcare 

The Congress – which ran  3 – 4 December and drew in 298 patient groups and 3046 attendees from 66 countries – included presentations on topics such as digital literacy, patient registries, clinical trials and increased participation, patient safety, reducing harm, patients led research, patient co-authorship, regulatory reliance and harmonisation, and building back better healthcare systems post COVID-19.

“COVID-19, took a lot of the attention and resources globally, but we wanted to leave no one behind,” said Dr Neda Milevska Kostova, Vice-Chair at IAPO, who spoke on initiatives created by IAPO, such as the Congress, that have been organized to “make patient voices heard.” The Congress is one of several regional conferences organized by IAPO that occur annually in order to fulfill the vision of seeing patients and patient groups at the center of healthcare. 

Speakers flagged that patients’ right to choice and their role as experts in healthcare should be acknowledged and given appropriate space and environment to contribute meaningfully. 

Said Dr Ratna Devi, Chair at IAPO. “This is a huge opportunity for patient groups to come together to lend their voices.” 

She stressed that healthcare is “not one size fit all,” since providers are working with diverse patients from diverse backgrounds. “Healthcare needs to be customized, messaging needs to be customized, and how you ask people to change their behaviors needs to be customized.”

At the same time, to become more empowered, patients need to be more aware of the need to act pre-emptively when accessing health care, she said, adding: “If patient groups integrate themselves and understand that early diagnosis, and early seeking of treatment, could be a better option, things could change for them.”

Health Authorities Need to Build Patient Trust & Engagement  – COVID Vaccine Rollouts Will be a Litmus Test 
Health systems must work together with populations, communities, and patients in addressing the COVID-19 response and other health risks

Health authorities need to implement strategies that engage and empower people and communities. Patient leaders must become active participants in the implementation of health policies that ensure they are at the center of equitable health access. 

“Every one of us is a potential patient, and everyone one of us has the motivation to be involved in combating the pandemic,” said Dr Martin Taylor, Director of Health Systems and Services in the WHO’s Western Pacific Regional Office. He addressed the role played by patients, their families, and communities in shaping the collective and societal response to COVID-19. 

Dr Martin Taylor, Director of Health Systems and Services at the WHO Western Pacific Region

Community engagement has become a key strategy in a successful COVID response, Taylor noted.  “Trust is central to this in the Asia Pacific region,” he added. An effective response to COVID-19, said Dr Martin, requires that governance, health systems, populations, communities, patients, all work together. Community health leaders who have succeeded in curbing transmission trends and assuring quality care have done so by building trust and engagement in solutions that worked for health workers, patients and their families, as well as the broader populoation.  

Looking ahead, the development and rollout of COVID-19 vaccines will be the next great opportunity for new models of patient engagement. A successful rollout is dependent on extremely effective engagement with groups, making sure that instead of misinformation, there is trust, and that vaccine supplies and delivery are carefully managed.  

Added Taylor: “Our vision [for the future] will only be possible if patient and patient groups, and communities, engage, and are engaged, both in shaping and advocating for a vision in which health is at the core of society’s values.” 

Image Credits: Flickr: Rumi Consultancy/World Bank, APPC, APPC.

COVID-19 Pandemic Relief Services, New Delhi. India experts say Delhi’s air pollution peaks is also causing more  COVID mortality. The government’s suggested mitigation strategies have included wearing a mask and eating carrots.

As COVID-cases rose rapidly in Delhi this November, the strong correlation to increasingly dangerous levels of air pollution in the state has brought more attention to the political pressure to address the health emergency.

Delhi saw its highest number of COVID-19 cases in November, totalling more than 175,000. The city administration also recorded more than 2,000 deaths, the highest so far in the city. The death rate  – 1.6% – was also higher than the national average of 1.45%.

In the same period, Delhi also had 9 days with air quality that was categorised “severe”, with an air quality index (AQI) between 400-500. This corresponds to hazardous levels of small and fine particulate matter: PM 10 and PM 2.5. While PM 10 are particulate matters that can be inhaled, PM 2.5 particles are the ones that carry the highest health risks.

The tiniest particles penetrate deep into the lungs, causing or exacerbating chronic lung disease as well as acute respiratory illnesses like pneumonia. Entering the bloodstream, they are also a factor in increasing risks of hypertension, strokes, and heart attack.

In the wake of the COVID pandemic a growing number of  Indian politicians, including Delhi chief minister Arvind Kejriwal, and government-based scientists have stated that mounting air pollution levels in Delhi and surrounding states this winter has been one of the drivers behind the recent increases seen in COVID-positive cases and mortality.

The air pollution crisis has become an annual occurrence of the early winter across northern India – caused by human factors and exacerbated by winds, drier weather, and temperature inversions.

The seasonal burning of rice stubble by farmers in neighbouring states to clear fields for the winter sowing of crops has become one key factor. Others include road and construction dust, traffic and power plant emissions and the lighting of fireworks during the Hindu festival of Diwali, which was celebrated this year in mid-November.

Kejriwal told Hindustan Times last month: “While I do not discount other factors that may have contributed to [an] increase in COVID-19 cases, experts say that pollution has hugely contributed to the rise of COVID-19 cases in the city, the intensity of the wave of cases, and increasing the number of deaths.”

He added that “we can’t play politics with this problem”, referring to what he alleges is apathy toward pollution on behalf of political parties, and lack of initiative to work towards cleaner air.

Law makers in India’s central government have traditionally denied the extent of the impact of pollution on health. In 2017, the Indian Health Minister told news channel NDTV it was “too much” to attribute “any death to a cause like pollution”.

Dr Balram Bhargava, the director-general of the respected Indian Council of Medical Research also linked air pollution to rising COVID-19 mortality.

“It is well-known that pollution is one of the most important aspects of death,” said Bhargava at a virtual briefing in October. “First being malnutrition, then tobacco, high blood pressure, and pollution.

“On pollution related to COVID-19 mortality, there have been some studies in Europe and the United States. They have looked at polluted areas, and have compared the mortality during lockdown and correlation with pollution, and have found clearly that pollution is contributing to the morality in COVID-19. That is well established by these studies.”

Bhragava’s only strategy for mitigating the problem, however, was to advocate more wearing of masks, as the “most inexpensive treatment”.

Strong Correlation Between Air Pollution and COVID-19 Mortality

A growing number of recent studies have reinforced the links between air pollution and COVID-related mortality.

A recent China-based study published in BMJ Public Health, which concluded that along with travel patterns, airborne particulate matter may be associated with an increased risk of COVID-19 transmission.

Other studies have also reinforced the links between chronic exposure to air pollution and higher COVID-19 mortality rates. A study published in October in the journal Cardiovascular Research estimated that 15% of deaths worldwide from COVID-19 could be attributed to prior patterns of long-term exposure to air pollution.

India has noted more than 9.5 million cumulative COVID-19 cases, as of the morning of 10 December 2020.

The researchers used epidemiological data from previous US and Chinese studies of air pollution and the 2003 SARS outbreak, supported by additional data from Italy.

An earlier study by researchers from Harvard TH Chan School of Public Health, Boston, concluded that higher historical PM 2.5 exposure is positively associated with higher COVID-19 mortality rates in the US.

In a recent World Health Organization (WHO) presentation, Dr Maria Neira, WHO’s Director of Public Health and Environment concluded: “We know that in case of patients with COVID-19, those who will be more at risk of developing severe illness are those with underlying conditions like high blood pressure or heart diseases.

“We see that air pollution might exacerbate those diseases making the population more vulnerable to the disease plus to the severity of developing a more serious illness.”

Indian Government Historically Denied Air Pollution’s Health Impacts

In India, 1 in 8 deaths were attributable to air pollution in 2017, making it a leading risk factor for death in India, a study published in The Lancet reported.

More than 75% of the population in India is chronically exposed to average ambient PM2.5 levels above 40 μg/m3, the recommended limit by National Ambient Air Quality Standards. The highest PM2.5 exposure levels are in Delhi, followed by the other north Indian states of Uttar Pradesh, Bihar and Haryana.

However, lawmakers in the central government, which can help coordinate between different agencies and state governments to reduce pollution, have traditionally denied the extent of the impact of pollution on health.

In 2017, the Indian Health Minister, Dr Harsh Vardhan said that the hazardous pollution level was not a public health emergency and told news channel NDTV “to attribute any death to a cause like pollution may be too much”.

Last year, he advised people on Twitter to eat carrots to mitigate pollution-related harm.

Even more puzzling was the advice of the Minister of Environment, Forest & Climate Change, Prakash Javadekar, who simply tweeted an encouragement for citizens to “start your day with music”, in a week in November 2019 that saw peak levels of air pollution last year.

Later, as Delhi’s air pollution levels rose further to some of the highest levels ever recorded, India’s Environment Minister Prakash Javadekar declared before the Indian parliament: “No Indian study has shown pollution shortens life. Let us not create fear psychosis among people.”

He was contradicted, however, by his own Environment Secretary, CK Mishra, who told Health Policy Watch during an exclusive interview at the Madrid COP25 Climate Conference: “Nobody denies that poor air quality causes morbidity and may also cause mortality. Certainly … it must be causing mortality.”

“It may not be 7.5 [million deaths],” Mishra added. “But the fact remains that there are numbers to be attended to. As far as the ministry is concerned, we are very conscious of the fact that it is leading to loss of human life and we need to correct this situation.”

Signs of Action This Year – But No Results So Far

In October this year, with COVID sweeping across India as well, Delhi’s Kejriwal declared a “war on pollution”, forming a team to monitor the sources of pollution including open air burning complaints, and repairing the city’s potholed roads to control dust.

Kejriwal also began promoting an inexpensive biological formulation that can be sprayed on rice stalks, accelerating their decomposition, eliminating the need to burn them. He has said that the ‘Pusa decomposer’ is already being used by farmers in Delhi State to convert their stubble into fertilizer.

The innovation has not, however, reached the surrounding states of Punjab, Haryana and Uttar Pradesh, from which most of the stubble pollution originates.

The current subsidy structure incentivizes excessive rice yields. These rigid stalks are the most difficult to manage and so are often burnt.

“This should be the last year of pollution,” Kejriwal affirmed at a recent leadership summit. “We have petitioned the air quality commission formally to order Punjab, Haryana and Uttar Pradesh governments to ensure this bio-decomposer is used in all the farms there.”

But expert observers are less sure.  They note that the Delhi government so far failed to even curb the use of firecrackers during the week long festival of Diwali.  Despite a ban on their sale, firecrackers were heard across the city during the festival.

Under pressure from the country’s Supreme Court, the Central Government also constituted a permanent Commission for Air Quality Management in the region, which has the power to coordinate action among states. Headed by a former top official in the Petroleum Ministry, the Commission has so far done almost nothing.

Following Diwali and past the peak of the crop burning season, pollution rates in Delhi have subsided somewhat, with an AQI averaging 300-400, but experts are asking how and where more systemic changes could be made to reduce levels year-round as well as avoid future emergencies.

 

Meanwhile, the city has been blockaded for several weeks by farmers from around the northern Indian region, who are protesting a government plan to remove subsidies. Through a ‘minimum support price’ the government sets to procure produce from the rice and wheat crops that farmers grow, forcing them to sell on the open market.

Farmers have demanded that fines and penalties for stubble burning be withdrawn. In order to appease the protesters, the government might refrain from fining farmers who violate existing laws by burning their crop stubble. While the fines have never been very effective, it’s still a measure that could also create a setback in the air pollution battle.

Indian farmers protest outside of Delhi in early December

So far, the dispute over the crop subsidies has failed to get to the root of the air pollution issue, experts also say. This lies in the fact that the current subsidy structure incentivizes farmers to grow excessive amounts of rice, whose rigid stalks are the most difficult to manage – and so are often burnt. The rice cultivation also consumes excessive water in the water-scarce Punjab region.

Environmentalists have said that the crop subsidy structure should support farmers’ cultivation of nutrition rich grains and legumes indigenous to the region, like millet or lentils, which are also less polluting, in how the stubble can be managed.

But neither nutrition content or air pollution seem to be key factors right now in the debate over farm subsidies that is occurring right now. It is unlikely that, if subsidies were removed along the lines of the government plans, farmers would grow more nutritious crops either: they are not big candidates for large multinational purchases on the private market.

Despite the inertia, there are growing public pressures on the government to act, said Arvind Kumar, a chest surgeon from Delhi who is internationally known for his outspoken criticism of India’s air pollution and its health impacts.

And so the tide of political apathy towards pollution may be turning, said Kumar, who is the founder of the Lung Care Foundation, a non-profit that spreads awareness about pollution and its effects.

“In the heart of hearts, the politicians know that pollution is a problem and that it damages health. The challenge is admitting that to the public,” said Kumar. “But with every passing year, with the problem becoming more acute and more intense, there will be more outcry.”

-Jyot Pande Lavakare contributed to this story.

Image Credits: Rashed Shumon, Belur Math, Howrah, Johns Hopkins University & Medicine, Neil Palmer, @DevinderBenipa2 , Dāvis Kļaviņš .

Pfizer’s mRNA vaccine is being rolled out in the United Kingdom, to be followed by the United States and Europe. 

While some of the world’s richest countries have now stockpiled more COVID vaccines than they have people to inject, the world’s 67 poorest countries may only be able to vaccinate 1 in 10 people against COVID-19 next year, unless urgent action is taken by governments and the pharmaceutical industry to make sure enough doses are produced.

This was the warning in a report published on Wednesday by Oxfam, Amnesty International and other advocacy groups

The report notes that the massive pre-purchase of leading vaccine candidates by rich countries means that some of the world’s wealthiest nations have bought up enough doses to vaccinate their entire populations nearly three times over by the end of 2021 – supposing the vaccines in clinical trials are all approved for use.

The same data suggests that countries representing just 14% of the world’s population have bought up some 53% of all the most promising vaccines so far. Canada tops the chart with enough vaccines to vaccinate each Canadian 5 times over.

The organizations analyzed data on publicly reported vaccine deals done between countries and the eight leading vaccine candidates. They found that 67 low and lower middle-income countries risk being left behind. Five of those countries – Kenya, Myanmar, Nigeria, Pakistan and Ukraine – have reported nearly 1.5 million COVID cases between them.

The Republic of Korea has vaccines to cover 88% of its population of more than 50 million people. But nearby, the low-income Philippines, has so far secured only 2.6 million doses for next year covering only 1.3 million people out of its total 106 million population, according to the report.

Report Comes Amidst Flurry of Upcoming Vaccine Regulatory Approvals
the total number of confirmed vaccine doses procured, displayed by income level. (Duke Global Health Innovation Centre)

The report comes on the heels of the inaugural jab in the United Kingdom of 90 year-old Margaret Keenan on Tuesday with the first commercially available COVID-19 vaccine.  The UK became the first country to approve Pfizer’s high-tech mRNA vaccine candidate for widespread use last week.

On Thursday, the United States Food and Drug Administration is expected to approve the Pfizer vaccine for emergency use among Americans, after already issuing a positive review of the vaccine’s clinical trial results. That is likely to be followed by FDA approval of a similarly designed mRNA vaccine by Moderna on 17 December, and the European Medicines Agency will review the same vaccines in early January.

The third vaccine-in-waiting is likely to be AstraZeneca’s cheaper and simpler adenovirus vaccine, based on a more common delivery mechanism, that uses a weakened form of a common cold virus to deliver a fragment of the trademark SARS-CoV-2 spike protein into the body, and prompt an immune reaction.

Results of the AstraZeneca vaccine trial involving some 24,000 people and published Tuesday in The Lancet, found that the vaccine was 70% effective on average – with efficacy rising to 90% among trial participants who accidentally received only a half first dose.

In the wake of the serendipitous discovery, a larger trial with the amended dosing regime will be undertaken, AstraZeneca has said. But it said that with average efficacy rates still above the 60% benchmark set by regulatory agencies, it would also seek regulatory approval simultaneously.

A number of low- and middle-income countries (LMICs) like India, Mexico and Brazil have managed to secure large vaccine procurement commitments through manufacturing deals with AstraZeneca, a Swedish firm that undertook its vaccine development effort in collaboration with the UK’s Oxford University.

That joint initiative has championed the development of a low-cost vaccine, which the company has committed to producing on a non-profit basis during the pandemic – leaving an estimated cost of about US$3, per dose, as compared to $20-$30 for the more high-tech Pfizer and Moderna alternatives.

But since a large portion of AstraZeneca’s planned production of nearly 3 billion doses will be directly taken up by India, Brazil and Mexico – also among the LMICs hardest hit by the virus – that will still leave comparatively little to distribute more broadly.

WHO Aims to Get 20% Coverage Worldwide Next Year
Soumya Swaminathan, WHO Chief Scientist

Speaking at last Friday’s WHO briefing, WHO Chief Scientist, Soumya Swaminathan, stated that the WHO co-sponsored COVAX vaccine pool has so far secured deals for 700 million doses of a COVID-19 vaccine.

“That’s not sufficient,” said Swaminathan. “The goal is to get at least two billion doses by the end of 2021, which would be enough to vaccinate approximately 20% of the populations of the countries that are part of COVAX.”

The WHO co-sponsored COVAX vaccine facility, a global collaboration to accelerate development, production, and equitable vaccine access, includes some 187 countries, covering 90% of the global population. WHO officials have held out hope that LMICs could also begin vaccinating the highest-risk groups, like health workers and older people “in the first quarter of 2021,” with the support of vaccines procured through the facility.

Both rich and poor countries have joined the initiative, which aims to offer reduced prices for vaccines to most countries, and use donor funds to supply vaccines to some 92 countries that cannot afford to purchase them on their own.

However, despite repeated pleas to donors for support, the facility remains some US$28 billion short on the funding needed for next year to fully fund the vaccine drive, as well as drugs, tests and health system support services in the world’s poorest 92 countries.

The COVAX programme “urgently needs another US$5 billion in order to meet that goal of two billion doses”, stressed Swaminathan on Friday.

World Trade Organization Debates IP “Waiver” for COVID Medicines and Vaccines

On Thursday, the World Trade Organization (WTO) will resume its review of a proposal by South Africa and India to extend a broad WTO “waiver” over COVID-related patents, copyrights, and trade secrets for vaccines, medicines and health equipment, as part of another access initiative.

The initiative has picked up considerable support among African, Asian and Latin American member states. But it is stiffly opposed by a wall of G-20 countries with huge pharma interests at stake.

Thursday’s debate comes ahead of a full, formal review of the waiver proposal by the WTO’s General Council on 17 December. Leaders of the initiative have also threatened to put it to a vote, if it is not taken seriously.

Medicines access groups are stepping up pressure on governments and organizations to consider the waiver concept, saying that sharing trade secrets and technologies is the only way to ensure fair distribution of brand-new medical technologies such as the COVID vaccines.

On Wednesday, a petition organized by the online campaign organization AVAAZ and signed by some 900,000 people, was delivered to WTO members. The petition called on all governments, WTO members and pharmaceutical companies to “ensure access to lifesaving COVID-19 vaccines, treatments and equipment for everyone in the world”.

“While the world waits with bated breath for the possible approval of these COVID-19 vaccines, it’s not time to celebrate yet,” said Dr Sidney Wong, Executive Co-Director of Médecins Sans Frontières Access Campaign in a press release on Tuesday.

“Right now, we’re in a situation where a lion’s share of the limited number of first doses have already been snatched up by a handful of countries like the US and UK, as well as the EU, leaving very little for other countries in the short term. What we really want to see is a rapid expansion of the overall global supply, so there are more vaccines to go around and doses can be allocated according to WHO’s public health criteria, not a country’s ability to pay.”

Image Credits: Pfizer, Duke Global Health Innovation Center.

Deaths by diabetes more than doubled in the Eastern Mediterranean, with a global increase of 70%, between 2000 and 2019.

The NCD Alliance has called the millions of avoidable deaths due to noncommunicable disease (NCDs) a “collective failure”, as new WHO data shows NCDs now constitute 7 of the top 10 causes of death globally, up from 4 of 10 top causes of death in 2000.

According to WHO’s new Global Health Estimates released Wednesday, the top 10 causes of death amounted to half of the total 55 million deaths worldwide last year. But deaths from NCDs are increasing the most rapidly and dramatically, according to the report, which also looks at trends over the past twenty years, from 2000 to 2019.

More and more low- and middle-income countries (LMICs) are suffering from rising NCD rates, associated with poor diets, environmental conditions and unhealthy lifestyles.

In the past 20 years, for instance, deaths from diabetes more than doubled in WHO’s Eastern Mediterranean region, which has been beset by an epidemic of obesity, while diabetes deaths rose globally by 70%.

Heart disease retained its position as the leading cause of death, causing some 9 million deaths last year – up by 2 million since the turn of the millennium. Alzheimer’s and other forms of dementia ranked as the 3rd highest cause of death in the Americas and Europe.

The data highlights the need to focus much more intensely on the prevention and treatment of cardiovascular diseases, cancer and chronic respiratory diseases, among others, WHO said.

“These new estimates are another reminder that we need to rapidly step up prevention, diagnosis and treatment of noncommunicable diseases,” said Dr Tedros Adhanom Ghebreyesus, Director General of WHO.

“The WHO report depicts a devastating toll on human life that could have and should have been prevented,” said Katie Dain, CEO of the NCD Alliance.

“If governments are serious about preventing both avoidable death on a massive scale and better preparing the world for future pandemics, then they have to invest in the health of their citizens and promote healthy environments by tackling the common risk factors.”

The “collective failure to” address alcohol, tobacco and substance abuse, unhealthy diets and lifestyles, and air pollution, she said, “has got us to an unsustainable position”.

LMICs Still Struggling with Communicable Disease Despite Global Decline

Even as the number of NCDs in the top 10 causes of death globally increased by 3, and WHO noted a global decline in deaths caused by communicable diseases like HIV/AIDS and tuberculosis (TB), LMICs are still strapped by both.

For example, TB left the global top 10, falling from 7th place 13th and seeing a 30% reduction in deaths worldwide. But in low-income countries, TB remains at a much higher 8th place. Similarly, HIV/AIDS dropped from 8th to 19th globally, but sits at 9th place in low-income countries.  Groups in countries where undernutrition is still prevalent also now are seeing pockets of obesity and malnutrition, as a result of increasingly unhealthy diets, including too many fat-rich fast foods and processed foods.

Dr Samira Asma, WHO Assistant Director-General, Division of Data, Analytics and Delivery for Impact.

Speaking at a press conference on Wednesday as the report was published, Dr Samira Asma, WHO Assistant Director-General, Division of Data, Analytics and Delivery for Impact, said: “It is important to acknowledge the progress we have made in addressing communicable diseases, such as HIV/AIDS and TB.

“This reflects sustained investments made to bring down the burden of these diseases. It is, however, very important to underscore the need to stay vigilant and to avoid backsliding.”

In recent years, WHO has cited a plateauing of progress against infectious diseases like HIV and TB. Available resources for HIV dropped by US$1 billion in 2018, marking the first time global HIV funding declined since 2000.

While the global AIDS response was off track before the COVID-19 pandemic, the onset of lockdowns and travel restrictions created additional setbacks, WHO and UNAIDS said on World AIDS Day in December.

26 million people living with HIV/AIDS today are now regularly using antiretroviral therapies, falling short of the 30 million target for 2020, that was set before the COVID pandemic began.

UNAIDS warned that the world may still see up to 293,000 more HIV infections and up to 148,000 AIDS-related deaths by 2022, despite treatment services having successfully “rebounded” from the pandemic, as WHO stated.

“There are many chronic conditions which commonly occur together, such as HIV and cervical cancer, TB and diabetes, or hypertension, diabetes and chronic kidney disease – and now COVID-19,” NCD Alliance’s Director of Policy and Advocacy Nina Renshaw told Health Policy Watch.

“But because of the imbalance in global health funding and programmes, someone living with HIV is likely to have access to affordable antiretrovirals – which is great – but they might die very young because of lack of access to insulin or to screening for cervical cancer or early treatment for heart disease.  We are hearing more and more stories like this.”

100 Million More Healthy Life-Years Lost in 2019 Than 2000

The WHO report also found that although people were living on average 6 years longer than in 2000, only 5 of those years were lived in good health.

Dr Bente Mikkelsen, WHO Director for NCDs.

Heart disease, diabetes, stroke, lung cancer and chronic obstructive pulmonary disease contributed to a total of nearly 100 million additional healthy-life years lost globally in 2019, compared to 2 decades earlier: the same diseases that are also causing the most deaths.

“We have seen that it is the people living with NCDs that have been most impacted from the pandemic,” Dr Bente Mikkelsen, director of WHO’s Department of Noncommunicable Diseases, said at a press conference. “Many have become severely ill and, of course, they have been untreated, undiagnosed and, to some extent, unprotected.”

The Americas region experienced a threefold increase in deaths from drug use: the only region to note this in its top 10 contributors to healthy life-years lost. In all other regions, drug use lies outside the top 25.

NCDs Are Now Diseases of Poverty

Mikkelsen said that the data counters the common “misconception” that NCDs are “the diseases of the wealthy and the high-income countries, given bigger risk appetites” related to tobacco, alcohol and diet.

“I think we see from this data that … health systems are not prepared to respond to [increasing cases of] heart disease, diabetes, cancer and lung disease,” she said. “The leading causes of death are draining resources.”

In a factsheet published alongside the new report, WHO notes that in most low-income countries “policy-makers still do not know with confidence how many people die and of what causes” – a data gap worsened by excess COVID deaths, also going unrecorded in some cases.

In a statement, Dr Tedros said that the report highlights “the urgency of drastically improving primary health care equitably and holistically. Strong primary health care is clearly the foundation on which everything rests, from combating noncommunicable diseases to managing a global pandemic”.

As one response, this week saw the launch of a new NCD Poverty Network, Alliance to improve NCD interventions and treatments in low – and middle income countries.

The new network includes some 20 low- and lower-middle-income countries (LLMICs) with large populations of people living in extreme poverty. The network will collaborate with the Lancet NCDI Poverty Commission to identify and advocate for effective evidence-based policies and services to combat NCDs in poor countries.

A map indicating which countries will belong to which phase. The majority fall into Phase 1: prioritising conditions and interventions.

Collaborating countries will pass through a 4-phase system designed to introduce and expand the delivery of care that can be offered to people doubly affected by extreme poverty and NCDs.

  • Phase 1: prioritize conditions and interventions.
  • Phase 2: develop models for integrated delivery of priority interventions.
  • Phase 3: establish training sites and national operational plans.
  • Phase 4: build financial and technical partnerships to support scale-up.

Factors associated with both NCDs and poverty often include unhealthy housing and living environments, including excessive exposures to air pollution; unhealthy workplaces including exposures to chemicals or toxics in workplaces; unhealthy foods including an over-reliance on cheap starches, fast foods and processed foods; and a lack of physical activity associated with increased urbanization and a lack of safe outdoor spaces for leisure and exercise.

Treatment Can Cost One-Third of Household Income

NCDs are also extremely expensive to treat, and in countries like Jamaica, they can eat up one third of household income, said Jamaica’s Minister of Health and Wellness Christopher Tufton on Tuesday, at a press conference hosted by the NCD Alliance.

NCDs also lead to disability, which can mean joblessness and a loss of income, particularly said Tufton. These hit hardest at households in LMICs which may not have large disability and unemployment benefits in the first place.

In Caribbean countries like Jamaica where the brunt of chronic diseases is among the highest in the world, the NCD crisis accounts for 56% of total deaths every year, Tufton added. In 2015, 7 out of 10 Jamaicans died from four major NCDs, including cancers, cardiovascular disease, diabetes and chronic lower respiratory disease, he added.

He emphasized that access to healthcare must go beyond the “bare minimum”, and ensure that healthcare systems offer high-quality medicines that do not perish several months after they are purchased. He quoted surprising results from a Rwandan study that found that up to a fifth of antihypertensive formulations were of substandard quality at their time of purchase, and that 70% became substandard after six months in tropical conditions.

“Improving integration of NCD care and prevention into universal health coverage is an important step towards upscaling cost-effective solutions and implementing policies that ensure that those who cannot afford to pay the associated costs have access to care without suffering financial hardships,” warned Tufton on Tuesday.

Image Credits: WHO/INADI, The Lancet NCDI Poverty Commission.


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Prime Minister Boris Johnson on the day of the COVID vaccine roll-out
UK Prime Minister Boris Johnson at the COVID-19 Vaccine Centre, Guy’s Hospital in central London today.

London. The cameras were focused on the face of 90 year-old Margaret Keenan, the first UK citizen to receive the newly approved Pfizer/BioNTech COVID-19 vaccine on Tuesday at University Hospital in the city of Coventry.  After her jab, she passed through a corridor of applauding nurses. Behind her mask was the glint of a smile as she described the experience as an “early birthday present”. She turns 91 next week.

But underneath the hopeful photo-ops, staged in England’s north, one of the areas hardest hit by the coronavirus, a technically complex “V-Day” operation was getting underway across the hospitals, and primary health care centers of the UK’s National Health Service (NHS).

Famed for its octopus-like bureaucracy, the vaccine rollout could still be a model for other countries if it goes off smoothly as 800,000 vaccines are rolled out this month, to be followed by up to 4 million more vaccines in January 2021.

Some 50 hospital hubs around the country, with cold chain capacity to manage the -70C ultra-cold conditions required for the Pfizer vaccine, were the first to begin administering vaccines on Tuesday, according to a detailed NHS plan, that is to be executed with military-style precision.

In line with the recommendations of an independent expert group published just last week, the campaign will focus first on vaccinating people over the age of 80, as well as some of the most vulnerable health and care staff – particularly people working in care homes.

UK Health Secretary Matt Hancock.

Health Secretary Matt Hancock dubbed Tuesday “V-day”. The term, hearkening back to the legacy of Britain’s World War II’s D-Day landing at Normandy, illustrated both the drama of the moment as well as the complex logistics required to successfully execute the vaccination operation.

“Today marks the start of the fight back against our common enemy, the coronavirus,” said Prime Minister Boris Johnson, on a visit to a London hospital where others were lining up to receive their first vaccine doses. He summoned national pride as well, declaring that getting vaccinated was “good for you and good for the whole country”.

Initiative Begins at Hospitals – Moving Next Week To Primary Care Networks

While the initiative was beginning at 50 hospital hubs across the country, there were also plans to distribute about one-fifth of the vaccines through about 280 pre-selected NHS ‘primary care networks’ (PCNs).

These PCNs are local health care centres that house clusters of NHS general practitioners who are the first point of care for patients’ routine healthcare needs in the state-sponsored NHS system. The PCNs will be expected to deliver around 945 vaccines in the 3 days after receiving a vaccine batch; they would also executive “roving vaccine” services to nearby care homes.

An exhaustive NHS circular on Monday outlined the steps that would be required for the vaccine campaign, in nitty-gritty detail, to those local practitioner centres

These steps ranged from details of the protocols for selecting and booking the first patients, to instructions about the drop-off of portable refrigerators to ensure adequate cold-chain storage for the sensitive Pfizer vaccines.

The PCNs must also perform a battery of assessments, reviewing the readiness of their site, supplies, workforce, IT systems and medical records, and how they plan to dispose of vaccine waste. Training webinars, a hotline and a process to request more vaccine supplies have also been set up.

The NHS document outlined how doctors’ offices should prepare to store the Pfizer vaccine at sub-zero temperatures.

The circular illustrated the special measures being put into place to handle the ultra-cold conditions required for the vaccines – and ensure their use rapidly after delivery. It read:

“A separate delivery of an under-counter sized refrigerator will be made to every site between Tuesday 8 th – Saturday 12th December. You will be given 24 hours’ notice before your delivery is made. Deliveries will be made between 08:00 and 18:30 on weekdays and between 09:00 and 16:00 on Saturdays,” the circular told primary care networks.

“We expect the remaining vaccine shelf life once delivered and stored at 2-8°C to be in the range of 86 hours (3 days 14 hours) to 99 hours (4 days 3 hours).”

On storing the vaccine, it said: “Shelf life will be clearly marked on the vaccine box label. Further guidance on the appropriate cold chain procedure can be found in the SOP. Note that it is essential that sites have sufficient vaccine storage space at 2-8 °C for up to 5 days.

“Sites that receive the initial vaccine delivery on 14 December will receive their corresponding vaccine delivery for dose 2 on Monday 4 January 2021. Sites that receive their initial vaccine delivery on 15 December will receive their corresponding vaccine delivery for dose 2 on Tuesday 5 January 2021.”

Ethnicity Also A Recommended Factor in First Vaccine Selections

The recommendations to GPs also include advice to consider placing older people who are members of an ethnic minority to go first in line.

“GP practices know their local populations and are responsible for generating patient lists based on the priority cohort definition, which for sites going live next week is ‘All those 80 years of age and over’ (excluding the housebound),” the circular clarified.

“If your site potentially has more than 975 patients over 80 years who may wish to be vaccinated, and you need to prioritise which patients should have access to the first supply of vaccine to your designated site, then you could consider the following: i. Age 80 or over; ii. Co-morbidities; iii. Ethnicity.”

That last recommendation is based on the Department of Health and Social Care expert group  findings that “certain black, Asian and minority ethnic groups” should also receive preferential vaccine treatment because they are at higher risk for serious disease. This risk is due largely to socio-economic inequalities, inequalities in access to health services, and related health conditions.

“There is clear evidence that certain black, Asian and minority ethnic (BAME) groups have higher rates of infection, and higher rates of serious disease, morbidity and mortality,” the expert group report, published last week, stated.

“There is no strong evidence that ethnicity by itself (or genetics) is the sole explanation for observed differences in rates of severe illness and deaths.”

“What is clear is that certain health conditions are associated with increased risk of serious disease, and these health conditions are often overrepresented in certain BAME groups. It is also clear that societal factors, such as occupation, household size, deprivation, and access to healthcare can increase susceptibility to COVID-19 and worsen outcomes following infection. These factors are playing a large role in the inequalities being seen with COVID-19.”

Roll-Out Logistics Aside – The Public ‘Hearts-and-Mind Challenge’ Remains

Precise, considered actions – like those outlined above – coupled with close monitoring of vaccinated populations, are vital in ensuring the NHS gives a strong performance on the global stage this December, but the true challenge lies in public uptake, a professor of general practice in south west England told Health Policy Watch.

“The supply, the manufacturing, the distribution – these are all going to be very stretched,” said Professor John Campbell, Professor of General Practice and Primary Care at the University of Exeter Medical School. He said that despite the government’s assurance “that Brexit is not going to affect any of that, you can imagine getting this into the UK is going to be quite a challenge”.

The first batch of the Pfizer coronavirus vaccine left the manufacturing facility in Belgium on Thursday 4 December and was ready for use by Tuesday morning with no delays.

But the UK’s Brexit deadline of 31 January has also raised concern as to how quick and easy deliveries can remain after that date.

Even more pressing concerns, Campbell said, are not strictly logistical. While complications in the distribution and administering of a vaccine can be ironed out, “the bigger issues are related to the public perception and understanding of a new type of vaccine”, referring to the relatively novel mRNA technology used by Pfizer.

“There is a hearts-and-mind challenge for the wider public that we have to be sure to overcome,” he warned. “While people are desperate to get back to some sort of normality, people are still questioning [getting vaccinated].”

Increasingly positive vaccine news has caused concern among health leaders that the public will throw precautionary measures to the wind.

Both the UK and WHO have acknowledged the threat posed by a limited vaccine uptake by the public. WHO has published guidance for improving acceptance – and the UK’s Department of Health is also making patient engagement a key part of its package for primary care networks.

But there could be an equal threat growing in the opposite camp, Campbell underlined: among those who are willing to be vaccinated as soon as possible.

The other concern is that increasingly positive news of an imminent vaccine roll-out could urge the public to throw precautionary measures to the wind, despite the fact that most people will remain unprotected until a critical level of herd immunity is reached in vaccine coverage.

“People are now thinking that the new vaccine is around the corner,” Campbell noted. “Realistically, for the majority of the population, it’s going to be many months off.”

This was a fear that was shared by WHO last week, with WHO Director General Dr Tedros Adhanom Ghebreyesus warning last Friday: “There is a growing perception that the pandemic is over. The truth is, at present, many places are witnessing a very high transmission of the virus, which is putting enormous pressure on hospitals, intensive care units and health workers.”

Campbell said: “People have this sense that the vaccines are here so we don’t need anything else, and that’s very much not the case … It’s in this 6 to 9 month gap that there are important opportunities for other interventions.”

A Vaccine Can’t Come Too Soon

For most countries, weary of economic lockdowns, social strains, pressured hospitals, not to mention the human tragedies of serious illness, death and “long COVID” after effects, the introduction of vaccines cannot be too soon.

Over 1.5 million people have died since the pandemic began nearly a year ago, including more than 61,000 in the UK, the fifth hardest hit in terms of mortality, after only the United States, Brazil, India and Mexico – and just ahead of Italy, France, Iran, Spain and Russia. Many of those same countries are now in the thralls of a second or third wave of virus infections and deaths.

At a press conference on Friday, WHO officials held out hope that low- and middle-income countries, and more affluent ones, could begin vaccinating the highest-risk groups, like health workers and older people in the first quarter of 2021, with the support of the WHO co-sponsored Act Accelerator’s COVAX vaccine facility initiative.

Most of the world’s countries, rich and poor, have joined the initiative – which also aims to raise donor funds to supply 2 billion vaccines to countries that cannot afford to purchase them on their own.

However, despite repeated pleas to donors for support, the facility remains some US$28 billion short on the funding needed for next year to fully fund the vaccine drive, as well as drugs, tests and health system support services in the world’s poorest 92 countries.

Meanwhile, a parallel initiative by India and South Africa in the World Trade Organization to extend a “waiver” on COVID-related patents, copyrights, and trade secrets for vaccines, medicines and health equipment has picked up considerable support among African, Asian and Latin American member states. But it is stiffly opposed by a wall of G-20 countries with huge pharma interests at stake.

WTO members are due to meet again on Thursday to debate the waiver proposal – ahead of a full hearing by the WTO’s General Council on 17 December. While a number of high- and middle-income countries, including Canada and Australia, have tried to mediate a highly polarized debate, leaders of the initiative have also threatened to put it to a vote, if it’s not taken seriously.

Medicines access groups are now stepping up their campaign for approval of the WTO waiver – saying it’s the only way to ensure fair distribution of the brand-new technologies.

“While the world waits with bated breath for the possible approval of these COVID-19 vaccines, it’s not time to celebrate yet,” said Dr Sidney Wong, Executive Co-Director of Médecins Sans Frontières Access Campaign in a press release on Tuesday.

“Right now, we’re in a situation where a lion’s share of the limited number of first doses have already been snatched up by a handful of countries like the US and UK, as well as the EU, leaving very little for other countries in the short term. What we really want to see is a rapid expansion of the overall global supply, so there are more vaccines to go around and doses can be allocated according to WHO’s public health criteria, not a country’s ability to pay.”

Image Credits: Pfizer, BioNTech.

The first peer-reviewed clinical trial results for a coronavirus vaccine were published Wednesday

Just hours after the UK jabbed its first citizen against the coronavirus, researchers have confirmed that Oxford’s vaccine is safe and effective in the first peer-reviewed publication of a Phase III coronavirus vaccine trial yet. 

“The results for me are very compelling,” said AstraZeneca’s executive vice president Mene Pangalos on Wednesday at a press conference. “They clearly show that we have an effective vaccine that meets the regulatory standard for approval around the world.”

He added that there were no cases of death, severe COVID-19 or hospitalization in the vaccine arm of the trial; in contrast, the control arm recorded 10 hospitalised COVID-19 cases, two of which were severe, including one death.

The pooled analysis, which was published in The Lancet, was pre-specified and was designed in collaboration with regulatory bodies in the UK, Brazil and Europe. It includes data from four ongoing randomised trials across the UK, Brazil, and South Africa involving almost 24,000 adults, said the head of the Oxford Vaccine Group Andrew Pollard on Wednesday.

“The vaccine is safe, it’s highly effective, and we also know it can be manufactured in large quantities, and at a low price and can feed into existing supply and distribution networks,” Pollard said, speaking at a press conference on Wednesday.

This is probably the best day we’ve had in 2020,” added the Oxford vaccine’s architect Sarah Gilbert on Wednesday, who co-authored the peer-reviewed Lancet report. “It’s a study that’s taken place in three different countries and that’s important.”

Sarah Gilbert, Professor of Vaccinology at Oxford University

Oxford Vaccine Is Safe, But Dosage Regimen Still Unclear 

The interim analysis found that the Oxford vaccine was safe, based on a three and a half month long assessment of 23,745 adults. While 175 severe adverse events were recorded in total, 172 were deemed unlikely to be related to the COVID-19 vaccine – or the placebo  given to the control group. 

There were, however, three events that experts concede may be related to the trials including: one case of haemolytic anaemia in the control group; one case of transverse myelitis in the vaccine group; and one case of severe fever in South Africa in a participant who is still masked to group allocation. On the upside, all three participants are recovering or have already recovered, and are still part of the Oxford vaccine trial.

Nonetheless, the efficacy of the Oxford vaccine is less clear-cut than its safety results, and depends on the vaccine dose that was received. While the “general” pooled efficacy was at 70%, the “minimum” efficacy was at 62% in those that received two standard doses of the vaccine. 

Intriguingly, efficacy rose to 90% in a group that accidentally received half a dose followed by a standard dose – due to an error in the preparation of one large vaccine batch that was used for one group of trial participants. 

In response to a question on the ideal dosage regimen, the vaccine-makers refrained from drafting any recommendations, and have left it in the hands of regulatory agencies to decide for themselves based on the Lancet report. AstraZeneca’s CEO has previously said, however, that a new trial of the lower dose regimen would be undertaken to unequivocally confirm the results and the best dosing protocol. 

Andrew Pollard, head of Oxford’s Vaccine Group

“It is entirely up to the regulators to look at the data and decide exactly what they think their label should say [efficacy and dosage regimen] at the end and so that’s sort of in their hands,” said Pollard. 

Even if the minimum efficacy were to be only 62% – almost thirty percentage points lower than Pfizer’s and Moderna’s mRNA vaccines – the Oxford vaccine will still meet the threshold set by major regulators in the UK, Europe and the United States for efficacy, and have a “very important” impact on healthcare systems around the world, emphasized Pangalos. 

At only about US$ 3 per dose, as compared to US$20-US$25, the Oxford vaccine is much cheaper than its mRNA counterparts, and also can be stored at normal refrigeration temperatures, making it particularly suitable for distribution in low- and middle-income countries. 

“It is hard not to be excited about these findings and now the existence of three safe and efficacious COVID-19 vaccines, with 57 more in clinical trials,“ emphasized Maria Deloria Knoll and Chizoba Wonodi from Johns Hopkins Bloomberg School of Public Health in a  joint comment, referring to the results of the Pfizer, Moderna and AstraZeneca trials. 

However, further studies of the AstraZeneca vaccine are needed in more diverse groups – out of the 11,636 people enrolled in ongoing Phase III trials in Brazil and the UK, only 12% were older than 55, and over 80% were white. In addition, all of those volunteers who accidentally received the half-dose regime that appears more effective were under the age of 55.

Image Credits: John Cairns, UK Science Media Centre:.

Dr Tedros admitted there “could be a conflict of interest” as money would come from areas where WHO cannot mobilise directly.

The WHO Foundation has appointed a senior pharma executive as CEO of the flagship WHO Foundation, suggesting it will make a big push to secure donations from the broader private sector as the curtain closes on a precarious budget year.

But speaking at a press briefing on Monday, the WHO DG commented on the recruitment of an industry figure, Anil Soni of the US-based Viatris, to the WHO Foundation would create a whole new set of headaches in the form of potential conflict of interests with industry donors whose money WHO Foundation is soliciting – at the same time that the Organization must also act as a neutral broker for the worldwide endorsement of new pharma products.

“The money will come from areas where WHO cannot mobilise directly … and where there could be a conflict of interest,” Tedros admitted. But since the relationships fostered with industry would be “indirect”, they wouldn’t pose a conflict of interest for WHO, as such.

“So, the relationship between WHO and WHO Foundation is not direct,” he said. “So one thing I would like to assure you is that we have done all the assessments.”

The WHO Foundation, which was launched in May 2020, operates as a separate legal entity, allowing it to recruit funds from the private sector and private individuals and use that money to invest in research and science-based initiatives for which WHO lacks adequate budget.

Soni will be joining the WHO Foundation in January 2021 from the Pennsylvania-based company Viatris, formed in November 2020 as a combination Mylan N.V. and Pfizer’s Upjohn business, where he has worked as Head of Global Infectious Diseases for nearly 10 years.

US President Donald Trump’s announcement in April to suspend the US funding to WHO, followed by his July announcement of a US withdrawal from the global health body, highlighted the delicate nature of the Organization’s resource base, which relies heavily on voluntary donations from member states as well as from other charities.

Until April, the US was the biggest single donor to WHO, providing US$400 million in 2019, accounting for around 15% of its annual budget. Although the subsequent election of a new US president, Joe Biden, will see another US about-face, since Biden has declared his intention to rejoin WHO, the events of the summer, in the midst of a pandemic, underlined the precarious state of WHO’s budget: its programme budget for 2020-21 amounts to about US$5 billion a year.

“If any of [our] donors withdrew their funding, WHO would experience a shock which it cannot absorb,” Dr Tedros said at Monday’s briefing, adding that since his election to head WHO in 2017, his “strategy solution … was for WHO to broaden its base of donors”.

Soni has a two-decade career in the public, private and nonprofit sectors. He also served as CEO of the Clinton Health Access Initiative. Prior that he also worked for the Global Fund to Fight AIDS, Tuberculosis and Malaria between 2002-04 as the Advisor to the Executive Director, and he has been an advisor to the Bill & Melinda Gates Foundation: the second largest contributor to WHO’s annual budget this year, after Germany.

The COVID-19 outbreak has sparked new trends in counterfeit medical products, including masks, medicines, hand sanitizers, and vaccines.

The approval of the world’s first COVID-19 vaccine candidate last week in the United Kingdom is stoking fears that the global rollout of vaccines to fight the pandemic could also stimulate a counter-pandemic of fake online cures as well as criminal attempts to sabotage or interrupt vaccine supply chains. 

To counter the growing threat, a new industry-backed alliance to fight fake COVID-19 medicines and vaccines was launched on Monday. Building on the informal Fight the Fakes advocacy campaign and week (7-13 December), the new Fight the Fake Alliance aims to muster more government, civil society and private sector awareness and support about the risks posed by the attempts of organized crime, individual profiteers and hackers to interfere with the COVID-19 vaccine and medicines supply chain, as well as profit from fake products. 

The Alliance was formed just a few days after Interpol, the international criminal police organization, issued a sharp warning to law enforcement agencies in its 194 member states that criminal networks were laying plans to target COVID-19 vaccine supply chains, physically and online, disrupting distribution of legitimate products and sowing confusion. 

“As governments are preparing to roll out vaccines, criminal organizations are planning to infiltrate or disrupt supply chains,” said Jürgen Stock, Interpol Secretary General, in a statement released last Wednesday (2 December). “Criminal networks will also be targeting unsuspecting members of the public via fake websites and false cures, which could pose a significant risk to their health, even their lives.” 

Interpol Infographic on the dangers of fake medicines and medical supplies
Interpol infographic warning about the dangers of counterfeit medical supplies.

The Alliance is composed of 15 groups involved in various aspects of the medical supply chain and representing health care professionals, manufacturers, wholesalers, researchers and patients. Its members include the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), International Alliance of Patients’ Organizations (IAPO), and International Council of Nurses (ICN).

“In the current environment of misinformation – the so-called ‘infodemic’ by the World Health Organization (WHO) – it is particularly important to prevent the manufacture and trade of falsified COVID-19 vaccines as they have the potential to undermine trust in modern medicine, health care professional and health care systems as a whole,” the Alliance’s new Vice Chair and Director of Partnerships & Programmes at the World Heart Federation, Andrea Vassalotti told Health Policy Watch.  

“With the on-going COVID-19 pandemic and the rise in falsified medicines now and in the future, our combined efforts to mitigate, control and ultimately eradicate the damage they cause to patient health and lives are more crucial than ever,” said Adam Aspinall, Chair of the new Fight the Fakes Alliance and Senior Director of Access and Product Management at Medicines for Malaria Venture, in a press release. 

“The threat of fake medicines knows no borders,” said Miriam Holm, co-head of the Secretariat for Fight the Fakes, in a podcast Monday hosted by King’s College London lecturer, Bahijja Raimi-Abraham. “I think it’s only a matter of a few weeks until we have fake COVID vaccines circulating.” 

“We have joined forces with the Fight the Fakes Campaign to raise awareness of the dangers of fake medicines,” said the International Council of Nurses (ICN), one member of the new alliance, in a statement. “ICN supports international initiatives to combat counterfeiting and urges nurses and national nurses associations to collaborate with pharmacists, physicians and others to disseminate accurate information on detection and elimination of counterfeit medicines.”

High Income Countries not Immune to Attacks 

While low- and middle-income countries with weaker regulatory systems have been the most typical targets for the trade in fake medicines, high-income countries are not immune either.

That was evident as news emerged last week about cyberattacks targeting the vaccine distribution networks in the United States that are being prepared to roll out new COVID-19 vaccines, following expected approval of a Pfizer vaccine later this week. 

According to the Cybersecurity and Infrastructure Security Agency, which operates under the Department of Homeland Security, cyber actors were impersonating a biomedical company in phishing emails, which aimed to steal log-in credentials of executives and officials at companies and government organizations involved in distributing vaccines. One aim of the hackers was the disruption of sensitive vaccine cold chain processes. 

The cold chain process is the refrigeration system critical for the storage, transportation, and distribution of vaccines, especially mRNA vaccines, such as the ones developed by Pfizer and Moderna, which require sub-zero storage temperatures. Interference with this system could affect the quality or effectiveness of the vaccine and compromise the infrastructure to deliver vaccines to billions of people globally. 

Organizations in Taiwan, South Korea, Germany, and Italy, involved in development of solar-powered vaccine cooling systems, as well as UNICEF, which has been part of the WHO co-sponsored vaccine planning in low-income countries, were targeted in similar cyberattacks, the New York Times reported. 

Rise In Falsified COVID-19 Diagnostic Kits Heralded New Threat 

The launch of the new Fight the Fakes Alliance coincides with the third annual Fight the Fakes week, designed to raise awareness about the dangers of falsified and substandard medicines among governments, industry and civil society. 

“Fight the Fakes Week 2020 is appropriately timed to inform the general public of the importance of consulting health care professionals for legitimate advice on COVID-19 vaccines,” Vassalotti told Health Policy Watch. 

“While we saw a rise in falsified diagnostic testing kits and substandard personal protective equipment during the initial stages of the pandemic, falsified COVID-19 vaccines will likely emerge sooner rather than later,” she added.

Early on in the pandemic, when numerous countries were experiencing shortages of personal protective equipment for healthcare workers, there was a surge in the circulation of poor quality and fake masks, gloves, and diagnostic testing kits. Additionally, with the speculation of hydroxychloroquine as a treatment for COVID-19 came reports of falsified versions, particularly in the African region.

An Interpol operation in March in Mozambique seized dangerous falsified pharmaceuticals related to COVID-19 worth USD 14 million.

WHO’s Global Surveillance and Monitoring System for Substandard and Falsified Medical Products issued a medical product alert in late March to warn consumers, healthcare professionals, and health authorities against a range of falsified products claiming to prevent, treat, or cure COVID-19

The convergence of falsified medical products with the infodemic, characterized by the overabundance of misinformation and falsified information, is highly damaging. Together, these crises have the potential to undermine the already shaky trust of the public in the reliability of vaccines and health institutions. The existing hesitancy of accepting a COVID-19 vaccine could be further fueled by the circulation of falsified products and misinformation.

Substandard and Falsified Medicines

Substandard medical products are authorized products that nonetheless fail to meet quality standards, perhaps due to incorrect storage or damage during transportation. Falsified products, on the other hand, deliberately misrepresent their identity, composition and source and do not meet regulatory requirements. 

One in 10 medical products in low- and middle-income countries is either substandard or falsified, according to a study by the WHO. These medicines not only fail to treat or prevent diseases, but can also cause serious illness or death. 

The higher burden in developing countries is due in part to less rigorous regulatory requirements and more porous borders, which allows for illegal trade between countries. While fake medicines have posed a danger in all disease areas for decades, COVID-19 has amplified the threat of fake medicines to public health.

The lack of access to necessary medicines and vaccines creates a vacuum often filled by falsified and substandard medical products.
Fake Medicines Also Can Fuel Antimicrobial Resistance

Along with the immediate issues of the COVID-19 pandemic, falsified and substandard antibiotics, anti-viral and anti-parasitic medications can also contribute to another major global health threat, antimicrobial resistance (AMR). 

The administration of weakened drugs may foster the development of drug-resistant microbes that will then be resistant to full drug course as well. While a great deal of research has documented how the overuse of antibiotics is stimulating the rise of antimicrobial resistance, there is, however, relatively little work examining the role of poor drug quality in fostering resistance of bacteria, fungi, viruses and parasites to drugs. 

Antibiotics are, however, among the most frequently reported falsified medical products. One study found that antimicrobials with low doses of active ingredients lead to low levels of the drug in the patient. Exposing drug-resistant microbes to subtherapeutic doses of medicines, through falsified or substandard drugs, enables the survival and spread of resistance.

Falsified medical products also cause very immediate and direct damage because they compromise the treatment of potentially deadly chronic and infectious diseases, causing disease progression and even death. 

For instance, falsified pneumonia medicines cause an estimated 170,000 children to die each year, according to the Alliance. 

Image Credits: Interpol, Interpol, Interpol, Interpol, WHO.