Within a week of overturning the constitutional right to an abortion, the United States Supreme Court has now dealt a severe blow to the nation’s ability to strictly regulate and reduce carbon dioxide emissions from power plants that contribute to global warming, with escalating impacts on health and well-being.

US President Joe Biden described Thursday’s ruling as “devastating”, while China questioned the United States’ sincerity in tackling international carbon emission targets.

Voting along ideological lines, the court ruled 6-3 in favour of an appeal brought by 19 states and coal companies against the U.S. Environmental Protection Agency (EPA) that contended it only had narrow authority to regulate carbon emissions generated by power production. 

According to the ruling, the US Congress did not explicitly grant EPA the authority to cap greenhouse gas emissions across the sector in the Clean Air Act, but only to regulate actions at individual power plants.

Chief Justice Roberts, supported by five other conservative judges, stated in the judgement that “it is not plausible that Congress gave EPA the authority to adopt on its own such a regulatory scheme”.

“A decision of such magnitude and consequence rests with Congress itself, or an agency acting pursuant to a clear delegation from that representative body,” he added.

Dissenting opinion – emissions also contribute to air pollution that endanger public health

Health-harmful pollution emissions have declined sharply since 1990, but ozone emissions stalled a decade ago and some PM indicators slightly increased recently.

However, in her dissenting statement, Justice Elena Kagan wrote that “Section 111 of the Clean Air Act directs EPA to regulate stationary sources of any substance that ’causes, or contributes significantly to, air pollution’ and that ‘may reasonably be anticipated to endanger public health or welfare.’ “

Dirty coal and oil-fired power plants that emit the highest levels of CO2 also emit other pollutants harmful to health, including fine particulates (PM10 and PM2.5) , volatile organic compounds (VOCs) and nitrogen dioxide (NO2), which contribute to the formation of ozone. While there has been a decline in such emissions over the past 20 years, ozone emissions have plateaued in the past decade, and PM2.5 emissions even increased recently – and are above new WHO guideline standards of 5 µg/m3. New EPA rules to prompt broader, sector-wide shifts to cleaner power and more renewables would have also helped address those nagging pollution issues.

Higher levels of PM 2.5 and PM10, for instance, lead to more premature deaths from heart attack, stroke, cancers and lung disease, while ozone is closely associated with increased asthma, including childhood asthma cases. There are still an estimated 100,000-200,000 deaths annually from air pollution in the United States, according to a 2020 paper by a leading group of researchers. And one-half of those deaths can be attributed to just five activities, including heat and power production.

In addition to deaths directly attributed to power plant pollution emissions, there is a growing toll in the United States  in terms of deaths and injuries related to wildfires and other extreme weather events, also being exacerbated by climate change.

Power plants are one of the five core sources of health-harmful air pollution in the United States (Thakrar et al, 2020)

Green economy threatened

One of the cornerstones of US President Joe Biden’s administration is boosting the so-called ‘green economy’ of low carbon and low polluting energy technologies, and this ruling could undermine multibillion-dollar efforts underway to phase out fossil fuels and replace them with cleaner energy sources. 

“I have directed my legal team to work with the Department of Justice and affected agencies to review this decision carefully and find ways that we can, under federal law, continue protecting Americans from harmful pollution, including pollution that causes climate change,” Biden said in a statement.

“Since the Clean Air Act was passed by a bipartisan majority in Congress in 1970, the landmark law has enabled both Democratic and Republican administrations to protect and improve the air we breathe, cutting air pollution by 78% even as our economy quadrupled in size,” he said. “Yet today’s decision sides with special interests that have waged a long-term campaign to strip away our right to breathe clean air.”

China’s foreign ministry spokesman Zhao Lijian told a regular media briefing on Friday that his nation took note of the ruling and the international community’s “fair criticism” of it.

“As we always say, to address climate change, it is not enough to just chant slogans. It is about everyone doing their own part,” said Zhao.

“We urge developed countries, including the US, to earnestly abide by the principle of common but differentiated responsibilities, own up to their historical responsibilities and show greater ambition and actions,” he said. “At the same time, developed countries should effectively help developing countries enhance their capacity to cope with climate change in terms of funding, technology and capacity building.”

The main source of greenhouse gas emissions in the US is from electricity, which accounted for a quarter of the emissions in 2020. 

‘Disappointing and disheartening’

EPA Administrator Michael Regan said he was “deeply disappointed” by the decision but emphasised that EPA remains committed to protecting communities and cutting emissions that drive climate change.

“EPA’s number one priority is to protect people’s health, especially those who are on the front lines of environmental pollution. Make no mistake: we will never waiver from that responsibility,” Regan said in a statement. “We will move forward to provide certainty and transparency for the energy sector, which will support the industry’s ongoing efforts to grow our clean energy economy,” he added.

Regan said addressing climate change means putting the US economy on a more competitive footing by creating jobs in the clean energy sector, lowering costs for families and protecting people’s health and well-being.

“EPA will move forward,” he added, “with lawfully setting and implementing environmental standards that meet our obligation to protect all people and all communities from environmental harm.”

More court challenges by polluters? 

The global public health organisation Vital Strategies condemned the Supreme Court ruling, which it described as “an assault on the nature of government as much as nature itself, stripping agencies of their ability to act with scientific authority”. 

The organisation’s senior vice-president, Daniel Kass, warned the ruling would “accelerate our very real climate crisis, leading to more preventable illness and death”, and was likely to result in new challenges by “polluters” in state courts.

“Just this March, the EPA, under its authority from the Clean Air Act, re-enabled California and other states to regulate greenhouse gas emissions from [vehicle] tailpipes. We can now expect polluter-financed challenges to all state-level efforts to regulate CO2 emissions,” Kass said.

“Public health officials must pressure policymakers to join amica briefs to defend state regulations and to align with the overwhelming majority of the public that want to see CO2 regulated,” he said. “The urgency of climate change demands it. There is no time to wait for a generational swing back to centre.”

John Noel, a senior climate campaigner for Greenpeace USA, noted in a statement that air pollution from fossil fuel burning caused about one-in-five deaths worldwide in 2018. 

“Radicals in robes are severely restricting the federal government’s ability to protect people and the ecosystems that support life,” he said. “It is unconscionable that six Supreme Court Justices have ruled in favour of sacrificing more lives to enrich millionaire coal and oil barons.”

Image Credits: Ella Ivanescu/ Unsplash, US EPA, (Environ. Sci. Technol. Lett. 2020, 7, 9, 639-645), Us Environmental Protection Agency.

Dr Ahmed Ogwell Ouma, Africa CDC’s acting director, asserts the continent should be top priority for vaccine doses for monkeypox.

WHO and Africa CDC are trying to close a huge testing gap for monkeypox that has left some health workers reliant on symptomatic diagnosis.

The World Health Organization (WHO) and African Centres for Disease Control and Prevention (Africa CDC) acknowledge they will not be able to gain a clear understanding of the monkeypox outbreak in Africa until the continent improves its ability to test better and close the gap between confirmed and suspected cases.

Just 104 new cases of monkeypox have been confirmed compared with 1,678 suspected cases in Africa since the beginning of 2022, Africa CDC’s acting director, Ahmed Ogwell Ouma, announced during a press briefing on Thursday.

He told Health Policy Watch the gap is due to limited capacity at labs and lack of enough test kits.

“This usually means appropriate training is not yet widespread and the test kits are also not available,” he said, adding that health workers in Africa are resorting to “clinical acumen and high levels of high index of suspicion” to identify monkeypox cases “because of capacity issues.”

This will hopefully change soon, he said, as Africa CDC acquires and provides more training and test kits. In Europe, the Americas and elsewhere some 3414 cases had been confirmed as of 22 June, WHO reported on Tuesday.  

Monkeypox rash

WHO is also procuring test kits for Africa

Along with Africa CDC, the UN health agency is working on building up testing capacity on the continent.

All African countries have the polymerase chain reaction (PCR) equipment needed to test for monkeypox.  But many lack essential reagents and training in specimen collection, handling and test administration, Dr Matshidiso Moeti, WHO AFRO’s regional director, told a press briefing on Thursday.

WHO is working to procure 60,000 tests, she announced, including 2,000 that will be dispatched to the countries at highest risk.

“Over the past month, five African cities have received donations of reagents from partners, bringing to 12 the number with enhanced monkeypox diagnostic capacity, and another group of countries in West Africa receiving agents just after participating in the necessary training,” Moeti said.

Monkeypox virus genome sequencing in Africa

Seven African countries are sequencing the monkeypox virus genome and using an improved genomic sequencing capacity acquired during the COVID-19 pandemic, according to Moeti. That should improve understanding of how the monkeypox virus is spreading across countries and continents.

Some 300 samples have been sequenced since the beginning of the year, with most of the published sequences showing the West African clade of the virus.

WHO says it is working to accelerate capacity through training in monkeypox genome sequencing that it is offering to lab experts from 20 countries in coming weeks.

Image Credits: US Centers for Disease Control.

Rush hour traffic in Ho Chi Minh City, one of the cities supported by Bloomberg Philanthropy’s Global Road Safety Partnership

The world’s transport ministers pledged to cut road traffic deaths and injuries by 50% by 2030, as part of a political declaration adopted at the first-ever United Nations High Level Meeting on Global Road Safety, which opened Thursday in New York City.  

The debate came as a new Lancet series suggested that some half a million lives could be saved by  targeting just four key risk factors for road injuries – speeding, drunk driving, lack of helmet, and seatbelt use –  in 185 countries could save up to half a million lives a year.

Worldwide, road crashes currently kill around 1.3 million people each year – more than 2 every minute, and more than 90% occur in low- and middle-income countries, according to the Lancet study. Road injuries are the leading killer of children and young people globally. 

Despite years of lip service to the issue, the burden of adolescent deaths in poor countries has only grown.  Almost half of adolescents killed by road injuries in 2019 lived in low-income countries, up from around a quarter in 1990, according to the Lancet study.  The study estimates that routinely wearing helmets and seat-belts, obeying speed limits and avoiding drunk-driving could save between 347,000 and 540,000 lives worldwide every year.

Low and middle-income countries experience  disproportionate deaths, due in part to the preponderance of unsafe vehicles on the road as well as lack of safety belts, helmets and speed controls. But there is also a dearth of safe cycling and walking infrastructures for non-motorized users who are often the victims of a crash.

UN Secretary-General António Guterres

Vital opportunity 

“Today’s meeting is a vital opportunity to tackle this silent epidemic,” said UN Secretary General  Antonio Guterres,” speaking at the opening of the UN high level meeting. “We need to address this leading killer of young people.”

Gutteres added that traffic accidents also are a key obstacle to sustainable development, costing 2-5% of GDP in developing countries every year and pushing “entire families into poverty due to the loss of a breadwinner or the costs associated with lost income and prolonged medical care.”

Along with technological and regulatory approaches, Guterres called upon transport ministries to adopt “a more holistic approach to road safety,” with increased financing for more sustainable mobility and greener urban planning, which can advance both safety as well as climate mitigation goals. 

“Traffic crashes caused nearly 1.3 million preventable deaths and an estimated 50 million injuries each year, making it the leading killer of children and young people worldwide. And Jamaica has not been spared,” declared the country’s Minister of Transport, Audley Shaw, as over a dozen countries took to the podium in the opening session of the UN debate.  “We have observed a steady increase in fatality rates since 2012. Fatalities have increased on average by 10%. 

“It has been generally accepted that developing nations despite, having fewer vehicles than developed countries have a larger portion of fatalities globally. The socio- economic impact on developing states is devastating,” he said, calling for those norms to change.

Unsafe road infrastructure

Historically, road safety measures have focused on safer vehicles and users.  

Particularly in developing countries, transport development has focused overwhelmingly on roads for vehicles, ignoring even the presence of pedestrians and other users on roads, experts say.

Road safety programmes have also tended to focus on private vehicles – neglecting the importance of public transport, including the creation of public transport lanes that can ease private vehicle congestion and promote safety. 

Increasingly, evidence points to the importance of urban design as a critical part of the mix, including safe spaces for pedestrians and cyclists. Measures such as footpaths, cycling lanes, safe crossing points, as well as “traffic calming” tactics like speed bumps and stricter limits in cities are therefore critical to reducing the risk of injury among these road users, says WHO. 

Decade of Road Safety 

In September 2020, the UN General Assembly adopted a resolution to proclaim the Decade of Action for Road Safety 2021–2030. WHO and the UN regional commissions, in cooperation with other partners in the UN Road Safety Collaboration, have developed a Global Plan for the Decade of Action, which was released in October 2021.  

The plan calls for continued improvements in the design of roads and vehicles, enhancement of laws and law enforcement, and provision of timely, life-saving emergency care for the injured. In addition, it sought to promote more actively “healthy and environmentally sound modes of transport” that can positively impact child health, gender, poverty and the environment. 

Image Credits: Flickr/ M M.

A Somalian mother with her baby who is being treated for malnutrition.

In the face of growing malnutrition and related diseases of pneumonia, diarrhoea and measles, the World Health Organization (WHO) has announced that it is setting up a hub in Kenya to help fight the “major physical and mental health repercussions” of the food crisis in the Eastern Africa region.

More than 80 million people, or one-in-four people who live in East Africa are food insecure and resorting to desperate measures to feed themselves and their families, according to WHO. And the Horn of Africa, which includes Ethiopia, Kenya and Somalia, is in the midst of a four-year drought.

WHO Director-General Dr Tedros Adhanom Ghebreyusus says the hub will coordinate deliveries of medical supplies to where they are needed most in the region, which is hard hit by the global price spikes of food, fuel and other commodities caused by pandemic-hit supply chains, Russia’s war in Ukraine and inflation.

“People need access to affordable and nutritious food, as well as support through these difficult times. Some regions like the Horn of Africa are facing extremely serious food insecurity issues that could lead to famine,” he told a press briefing on Wednesday. “Over 80 million people, one in four, in the Eastern Africa region are food insecure and resorting to desperate measures in order to feed themselves and their families. Lack of food and nutrition weakens people’s immune system and puts them more at risk of disease.”

Lack of food and nutrition weakens people’s immune system, putting them more at risk of disease. Children who are undernourished are at higher risk of death from pneumonia, diarrhoeal disease and measles, Tedros noted.

WHO says it is working with partners on the ground to deliver essential health services, treat sick children with severe malnutrition, and prevent, detect and respond to infectious disease outbreaks. As part of that effort, Tedros said, WHO is “setting up a hub in Nairobi, from where it will coordinate the response and organize the delivery of live-saving medical supplies to where they are needed most. These supplies include medicines, vaccines, as well the products and equipment to treat children who are severely malnourished.”

The U.N. health agency also is working with the health ministries in Djibouti, Ethiopia, Kenya, Somalia, South Sudan, Sudan and Uganda to build what Tedros described as a “robust disease surveillance system to be able to quickly detect and respond to disease outbreaks.”

Unprecedented drought

Some 146,000 Somalian children with severe acute malnutrition have already been admitted into therapeutic care this year, and more than 640,000 people have been given emergency water supplies, according to the UN Office for the Coordination of Humanitarian Affairs (OCHA). Almost half the population – 7.7 million people – face starvation.

“The current extreme, widespread, and persistent multi-season drought is unprecedented,” said OCHA. “Four consecutive rainy seasons have failed, a climatic event not seen in at least 40 years. The 2022 March-May rainy season has not materialized and is likely to be the driest on record, devastating livelihoods and driving sharp increases in food, water, and nutrition insecurity.” 

Earlier this month, UNICEF reported that the severe water shortages have led to a severe acute watery diarrhoea and cholera outbreak. “Over 18 million people – one in four – in the eastern Africa region are food insecure and resorting to desperate measures in order to feed themselves and their families,” Tedros told a media briefing on Wednesday.

“Lack of food and nutrition weakens a person’s immune system and puts them all at risk of disease. Children that are malnourished are at higher risk of death from pneumonia, diarrhoeal disease and measles.”

Over 9,500 suspected cases of measles have been reported in Somalia alone between January and 30 May, according to UNICEF.

Tedros blamed spiking prices of food, fuel and other commodities, which is “having major physical and mental health repercussions”, warning that the Horn of Africa was facing famine.

“The cost of inaction is high,” said Dr Ibrahima Socé Fall, WHO Assistant Director-General for Emergency Response.  “While the clear priority is to prevent people from starving, we must simultaneously strengthen our health response to prevent disease and save lives. Even one life lost from a vaccine-preventable disease, diarrhoea, or medical complications from malnutrition in today’s world is one life too many.”

Fall was speaking in Nairobi where WHO convened a two-day meeting [26-27 June 2022] to plan its response across the seven countries affected by the health emergency – Djibouti, Ethiopia, Kenya, Somalia, South Sudan, Sudan and Uganda – and coordinate with other UN agencies and partners.

Image Credits: UNICEF.

WHO Director-General Dr Tedros Adhanom Ghebreyesus.

Monkeypox appears to be establishing itself as a prominent danger to high-risk populations such as children, immune-compromised people and pregnant women, World Health Organization (WHO) Director-General Dr Tedros Adhanom Ghebreyesus warned.

Already, WHO said authorities confirmed cases involving two children in the UK and a child each in Spain, France and the Netherlands.

Tedros, however, defended last week’s decision by a WHO emergency committee not to declare monkeypox as a public health emergency of international concern (PHEIC). Only three of the 14-person emergency committee felt the outbreak should be declared an emergency, Tedros told a media briefing Wednesday. 

“While the emergency committee did not advise that the current outbreak represents a Public Health Emergency of International Concern, they acknowledged the emergency nature of the event and that controlling the further spread requires intense response efforts,” he said. “They advised that I should reconvene them quickly based on the evolving situation, which I will do.”

In contrast, the US Center for Disease Control and Prevention (CDC) activated its Emergency Operations Center (EOC) on Tuesday to ensure “an aggressive public health response” to the outbreak.

As of one week ago, the WHO reported there were 3,413 laboratory-confirmed cases of monkeypox and one death from the virus reported from among 50 countries, with 86% of the new cases occurring in Europe. The highest numbers of cases were reported in Germany, Spain and the UK.

In Africa, one death was reported in Nigeria. Though it has been hit with an outbreak since 2017, the nation reported more cases than usual this year.  

Vaccine shortage

Amid the public health crisis, the world has been grappling with a global shortage of vaccines that are effective against monkeypox. The nations that have them generally have limited supplies to fight a smallpox outbreak.

The only one that is licensed for use by adults against both monkeypox and smallpox –  Bavarian Nordic’s Jynneos vaccine – is in particularly short supply, and there is limited clinical data about its efficacy as the only evidence is from animal studies.

While more supply of Emergent BioSolutions’ ACAM2000 vaccine is available, it is only licensed for smallpox, has more side effects and cannot be used by immunocompromised people – including people with uncontrolled HIV.

Another vaccine called LC16m8 is licensed for smallpox – but only in Japan.

The US and Canada have made doses of the Jynneos vaccine available to health clinics for people with known exposures to the virus and those who are considered to be at “high risk,” which is currently defined as men who have sex with men with multiple recent sexual partners living in areas where there has been high transmission among this particular population.

The US CDC announced on Tuesday it had 56,000 doses available immediately, but that a further 240,000 would be available in coming weeks and 750,000 more by the end of August.

There remains some concern, however, just as there has been with COVID-19 vaccines, that the monkeypox vaccines will be monopolised by wealthy countries that can afford them and corner the market.

Even Spain, which is facing the biggest outbreak in the world at present, has only been able to give 71 vaccines to close contacts, according to La Vanguardia. These were made available to Spain from the European Union’s smallpox response stockpile.

However, Dr Mike Ryan, WHO’s executive director of health emergencies, told the media briefing that countries such as the US that have vaccine stockpiles in case of smallpox have agreed to share these with other countries in need.

“But again, we must remember that these products have been licenced in the main for the use of smallpox,” Ryan cautioned. “In one case, they’ve been licenced for monkeypox but based on animal models, and, I believe, immuno-bridging data from the smallpox side of things.”

He called for more clinical data to be collected at the same time that vaccine use is expanded, as has been the case during the Ebola outbreaks. In particular, he says, there has been no evidence of the vaccine’s effectiveness in treating high-risk groups.

Four-step approach

Tedros also called on all countries facing monkeypox outbreaks to take a series of public health steps.

First, he said, surveillance of the virus must be increased through much more testing. The next step, he said, is to follow WHO best-practice guidance in managing their responses.

Third is to actively engage communities such as LGBTQI groups to educate people about how to protect themselves, he said. And the fourth step, he said, is “to provide equitable access to countermeasures, like vaccines and antivirals.”

Dr Ibrahima Soce-Fall, WHO’s assistant director-general for emergencies response, said monkeypox already is a “multi-country, multi-regional emergency,” with Europeans facing the high risk. He said WHO regions can activate emergency measures to address it.

JYNNEOS smallpox vaccine produced by Bavarian Nordic, approved by the FDA for use against monkeypox.

The European Medicines Agency is considering the extension of the use of the smallpox vaccine Imvanex to include people at risk of Monkeypox disease, the agency said on Tuesday. 

Imvanex is a modified form of the vaccinia virus, which is related to smallpox and currently authorised in the European Union (EU) for the prevention of smallpox in adults. But it is also considered a potential vaccine for monkeypox because of the similarity between the viruses, both of the Orthopoxvirus genus. 

Supplies of Imvanex limited in the European Union    

Supplies of Imvanex are currently very limited in the EU. However, the same vaccine is marketed as JYNNEOS in the US where it is authorised for the prevention of both monkeypox and smallpox. Full EMA authorization also would clear the way for broader use of the US vaccine brand in Europe.

The EMA review follows a recent recommendation by EMA’s Emergency Task Force (ETF) that JYNNEOS, produced by the Danish firm Bavarian Nordic, be used by European national authorities for at risk groups, in view of the rising rates of Monkeypox infection across the EU.

The US Food and Drug Administration has already concluded that the efficacy of JYNNEOS in the prevention of monkeypox disease can be inferred from antibody responses against the vaccinia virus in clinical studies.  In addition, animal studies showed that the vaccine protected those exposed to the monkeypox virus and boosted pre-existing immunity induced by earlier generations of smallpox vaccines.

3413 confirmed cases outside of endemic region

As of 22 June 2022, 3413 laboratory confirmed cases of Monkeypox and one death have been reported to WHO from 50 countries/territories in five WHO Regions, WHO reported in its latest Disease Outbreak News, on Monday 27 June.     

Another 1310 cases in eight new countries have been reported over the past ten days since the previous WHO update on 17 June. 

Even so, a WHO Emergency Committee that met last week last week deferred a decision on whether to declare Monkeypox a public health emergency of international concern (PHEIC), saying it would review the matter again in another three weeks. 

The Emergency Committee said its evaluation would be based on whether there had been further “significant spread” of the infection, particularly among vulnerable groups such as people with HIV, pregnant women and children.

The concerns over the spread of monkeypox in Europe and other developed countries, followed by moves like those of the EMA to prepare for the vaccination for at risk groups, have triggered fresh allegations of inequitable treatment amongst health officials in Africa’s Region, which has lived with the virus for years with no vaccine initiatives ever proposed or considered until the virus began to expand its boundaries.

New patterns of skin-borne transmission increases risks to other groups

Since the beginning of 2022, some 1597 cases – 1488 suspected and 109 laboratory-confirmed- of monkeypox have been reported in the nine central and west African countries where the disease circulates.  That data likely reflects significant under-reporting insofar as the disease is prevalent in remote rural areas where contact with infected wild animals such as rodents and squirrles is a major source of transmission.  A total of 66 deaths have been reported by Africa CDC – although WHO recently put the death toll at 72.

Either way, that is a case fatality ratio (CFR) of  4.1% or more on the continent, including all suspected cases. Some studies have shown Monkeypox mortality rates as high as 10% in the Democratic Republic of Congo – where the most virulent clade of the virus circulates.  

Monkeypox: Africa CDC Demands Equal Treatment in Global Allocation of Limited Vaccine Doses

Traditionally, monkeypox virus outbreaks in Africa, the result of zoonotic spillover events, saw limited person-to-person transmission.  In contrast, the outbreak in Europe and other non-endemic countries has been characterised by significant community transmission, often among men having sex with men. It is the increased pattern of skin-borne transmission of the virus that also increases risks to other vulnerable groups. 

WHO had pledged to come up with a plan for equitable distribution of monkeypox vaccines between at risk groups in endemic and non-endemic areas where the recent outbreak is being experienced.  However it remains to be seen if vaccine rollout is really feasible in conflict-ridden areas like the DRC and Central African Republic, where the disease is historically most prevalent, and deadly.  It’s equally unclear if and how developed countries, such as the United States, which controls much of the world’s limited smallpox vaccine supply, will heed WHO’s appeals.

Image Credits: Barda .

Pfizer and BioNTech have announced positive safety, tolerability and immunogenicity data for two Omicron-adapted COVID-19 mRNA candidate vaccines – but for an earlier strain of Omicron than those that are currently globally dominant. 

The two Omicron-adapted vaccine candidates were given to 1,234 participants aged 56 years and older as boosters, and “elicited substantially higher neutralizing antibody responses against Omicron BA.1 when compared to the companies’ current COVID-19 vaccine,” according to the announcement. 

The monovalent vaccine candidate, which was designed to immunize against a single antigen, elicited a 13.5- and 19.6-fold increase in neutralizing titers against Omicron BA.1, Pfizer said in its release. 

The bivalent candidate, which is a combination of the traditional Pfizer vaccine and a vaccine targeting the spike protein of BA.1, exhibited a 9.1- and a 10.9-fold increase against Omicron.

However, the dominant strains of Omicron worldwide are currently BA.4 and BA.5. Preliminary laboratory studies show that the candidates neutralize BA.4 and BA.5, but to a lesser extent.

“Omicron has newly evolving sublineages that have outcompeted BA.1 and exhibit a trend of increasing potential for immune escape,” explained Prof Ugur Sahin, CEO of BioNTech. “We will therefore remain vigilant and are prepared to rapidly adapt our Omicron-adapted vaccine candidates to emerging sublineages if epidemiological and laboratory data suggest.”

Meeting with FDA

The companies will submit the results and discuss them with the US Food and Drug Administration (FDA) Vaccines and Related Biological Products Advisory Committee on 28 June and with the International Coalition of Medicines Regulatory Authorities on 30 June.

“Based on these data, we believe we have two very strong Omicron-adapted candidates that elicit a substantially higher immune response against Omicron than we’ve seen to date,” said Pfizer CEO Albert Bourla. “We look forward to discussing these data with the scientific community and health authorities so we may rapidly introduce an Omicron-adapted booster as soon as possible if authorized by regulators.”

The vaccines were also shown to be safe and have no additional side effects than the original vaccine.

Moderna Omicron vaccine also shown effective

Earlier this month, Moderna announced that it too had an updated COVID-19 booster shot that is more effective against stopping Omicron infection than its original jab. 

“We are thrilled to share the preliminary data analysis on mRNA-1273.214, which is the second demonstration of superiority of our bivalent booster platform against variants of concern and represents an innovation in the fight against COVID,” Moderna CEO Stéphane Bancel said in a company news release.

“Looking at these data alongside the durability we saw with our first bivalent booster candidate, mRNA-1273.211, we anticipate more durable protection against variants of concern with mRNA-1273.214, making it our lead candidate for a fall 2022 booster,” Bancel continued. “We are submitting our preliminary data and analysis to regulators with the hope that the omicron-containing bivalent booster will be available in the late summer.”

Like Pfizer, the company did not yet have any firm data on the vaccine’s effectiveness against BA.4 and BA.5.

Cases on the rise 

The Omicron variant was first spotted in Botswana and labeled as a variant of concern in April. BA.4 and BA.5 are its newest mutations and have been spotted in dozens of countries worldwide, causing a surge in cases because they can spread faster than other circulating variants.

On some days, more than 730,000 new daily COVID-19 cases are being reported daily, according to World O Meters – with more than 4.2 million reported in the last seven days.

The country with the highest number of new daily cases is the United States, followed by Germany and Brazil.

 

Monkeypox rash

Although the World Health Organization (WHO) has decided not to declare monkeypox a public health emergency of international concern (PHEIC), it could change its mind if there is evidence of “significant spread” in the next 21 days.   

This was announced over the weekend following the meeting of the WHO’s International Health Regulations (IHR) Emergency Committee. The Committee also recommended more aid to the 9-12 central and west African countries where the disease has long circulated, often as a result of contact with infected rodents, squirrels and other wild animals.  

According to the IHR, a public health emergency is “an extraordinary event, which constitutes a public health risk to other States through international transmission, and which potentially requires a coordinated international response”.

While the WHO conceded in its official statement that the outbreak was “unusual” in many aspects and that “a few” committee members felt it should be declared a PHEIC, it listed a number of requirements that might lead to a change in position in three weeks time. 

These would include: more cases both among and beyond the population groups currently affected; cases among sex workers; evidence of significant spread to and within additional countries; and an increase of cases in vulnerable groups, such people with poorly controlled HIV, pregnant women, and children.

Between 1 January and 22 June 2022, some 3413 laboratory confirmed cases and one death have been reported to WHO from 50 countries/territories in five WHO Regions, WHO reported on Monday, 27 June.     

‘Equitable access to lifesaving tools’

Reacting to the WHO announcement, Wellcome Trust’s Director of Infectious Diseases, Professor Gordon Dougan, urged all affected countries to “integrate their preparations and help those with limited capability”. 

“Governments do not need to wait for an official declaration to begin acting in a coordinated and measured way. Where cases have been identified, rapid public health responses such as enhanced disease surveillance, contact tracing and self-isolation will be crucial,” said Dougan.

However, he also called out the rush by some countries to acquire scarce vaccines despite mass vaccination not being recommended, urging the global community not to repeat mistakes made during the COVID-19 response.

“But while high-income countries are now paying attention to this virus, monkeypox has been affecting people in West and Central Africa for decades. And with new cases now being reported in other low- and middle-income countries, we must ensure that these lifesaving tools are equitably distributed to where they are needed most,” Dougan urged.

The response also required “establishing clinical trials of the required scale and design” to ensure improved  monkeypox vaccines and treatments, he added.

The WHO emergency committee also noted that monkeypox has been endemic in parts of Africa “for decades”, and that responding to the current outbreak should “serve as a catalyst to increase efforts to address monkeypox in the longer term and access to essential supplies worldwide”.

Cases plateauing?

Some of the issues influencing the WHO’s decision included “current observations of plateauing or potential downward trends in case numbers in some of the countries experiencing outbreak early on” as well as “the need for further understanding of transmission dynamics”.

“However, the committee unanimously acknowledged the emergency nature of the event and that controlling the further spread of outbreak requires intense response efforts,” added the WHO.

“The committee advised that the event should be closely monitored and reviewed after a few weeks, once more information about the current unknowns becomes available, to determine if significant changes have occurred that may warrant a reconsideration of their advice.”

Image Credits: US Centers for Disease Control.

The Prince of Wales and Rwanda’s President Paul Kagame meet at the Kigali Summit on Malaria and Neglected Tropical Diseases

As the Kigali Summit unfolds, Adrian Hill, director of Oxford University’s Jenner Institute, describes the great strides made in malaria control, and the contribution new malaria vaccines can make, including one designed at the Jenner Institute. He spoke to Health Policy Watch just ahead of this week’s meeting by heads of Commonwealth nations, which galvanized support for the fight against malaria and neglected tropical diseases.

Leaders of Commonwealth nations meeting in Rwanda’s capital have pledged more than US$4 billion towards global efforts to accelerate the fight against malaria and other neglected tropical diseases.

The heads of state also committed to redouble efforts on climate change and the COVID-19 pandemic, which continue to affect the lives of the 2.5 billion people in the 54 nations belonging to the Commonwealth association of one-time territories of the British Empire.

Thursday’s Summit on Malaria and NTDs, taking place on the sidelines of the broader Commonwealth meeting, also saw the signing the Kigali Declaration on neglected tropical diseases (NTDs), a political statement meant to galvanize support for some of the UN’s top health goals by 2030.

“Only through continued country ownership, political commitment, accountability and great partnership can we ensure progress is accelerated over the coming months,” the leaders concluded in their outcome statement.

Forty nations were certified malaria-free between 1955 and 2021, the World Health Organization (WHO) says. And while global efforts to fight malaria prevented an estimated 10.6 million deaths and 1.7 billion cases from 2000 to 2020, the disease still resulted in as many as 627,000 deaths and 241 million cases in 2020.

Ahead of the summit hosted by Rwanda’s President Paul Kagame, Health Policy Watch interviewed Adrian Hill, a professor of vaccinology and director of Oxford University’s Jenner Institute, which works on designing and developing vaccines for infectious diseases prevalent in developing countries. His answers have been edited for brevity and clarity.

Professor Adrian Hill.

Health Policy Watch: How will the Kigali Summit boost malaria control?

Adrian Hill:This key meeting could not have come at a better time for boosting the state of malaria control in Africa. The power of vaccines has been demonstrated strikingly by the response to the COVID-19 pandemic ─ well-illustrated by the Oxford-AstraZeneca-Serum Institute vaccine. And now vaccines for malaria that could have a huge impact on malaria control and save hundreds of thousands of lives a year will be available from next year. The challenge for the summit is to ensure that more lives are not lost because the world has failed to support the purchase and distribution of new malaria vaccines.

HPW: Why is it important to focus on the development of a malaria vaccine?

AH. Malaria is the biggest infectious killer of children from six months to five years of age in Africa. There are over 620,000 deaths from malaria a year, according to the latest WHO figures and this has been increasing. New interventions are crucial to reduce this unacceptable death rate and now malaria vaccination is at hand for the first time.

This map shows an approximation of the parts of the world where malaria transmission occurs.

HPW: What progress is being made to develop an effective, affordable and accessible malaria vaccine?

AH: There are two malaria vaccines that are close to licensure and should be available for use next year (2023). The older one is RTS,S/AS01, from GSK, that will be available at a scale of maybe 9-10 million doses. The other is the newer R21/MM that will be available, also next year, and was designed and developed by Oxford University with the Serum Institute of India. Importantly, this can be provided next year at a scale of 200 million doses a year, enough to vaccinate the 40 million children born each year in areas of Africa with high transmission of malaria and a high risk of death.

HPW: What progress has been made in the fight against malaria and NTDs in the last two decades?

AH: In 2000, there were about 1 million deaths each year globally from malaria. But with the improved use of bed nets, insecticides and chemoprevention drugs, deaths fell to about 500,000 people by 2015. Death rates are rising again, however, as these older types of interventions appear to be losing effectiveness. Fortunately, new malaria vaccines are becoming available from 2023 and one of these vaccines (R21/MM) appears more effective than any of these older interventions. However, the best approach will be to use all these interventions in parallel.

Malaria prevention tools (WHO).

HPW: Why is it important to scale up tools to eliminate malaria?

AH: The cost of malaria controls each year is now about US$3 billion. Adding the R21 vaccine will add about half a billion dollars to this cost, but this should be very cost effective. Importantly, adding new vaccines to other interventions should allow malaria to be eliminated in some countries very soon and eventually eradicated globally. Elimination and then eradication of malaria will reduce and then remove the costs of malaria control.

HPW: Why has it been so difficult to come up with a malaria vaccine?

AH: The RTS,S vaccine has not received regulatory approval as yet. It is just a WHO policy recommendation, but this should happen soon. And importantly, R21/MM should provide about 10-20-fold more doses and a less expensive vaccine. These two vaccines have emerged from over 140 candidates tested in clinical trials as the most effective to date. This reflects the great technical difficulty of making a vaccine against protozoan parasites, like malaria, which have thousands of genes, suppress natural immunity, and require exceptionally potent vaccines to provide protective efficacy. There are no licensed vaccines today against any parasite disease.

The Prince of Wales and Rwanda’s President Paul Kagame at the Kigali Summit on Malaria and Neglected Tropical Diseases.

HPW: What about the successful malaria vaccine trial with which you have been involved?

AH: The WHO has specified that a malaria vaccine should aim to show high efficacy of at least 75% over two years of follow-up. R21/MM, designed at Oxford University’ s Jenner Institute as part of a 30-year programme of vaccine research, is the only vaccine to demonstrate that level of efficacy in African children, the most important population to protect and the most vulnerable to malaria disease and death.

Image Credits: US Centers for Disease Control and Prevention, World Health Organization .

Pro-abortion protests have erupted in the US in the aftermath of the court decision.

Women’s rights activists and political opponents reacted with fury to the US Supreme Court’s stunning reversal of the fundamental right to abortion established almost 50 years ago in the landmark 1973 ruling of Roe v. Wade.

US President Joe Biden called it a “tragic error,” saying this is the first time the US Supreme Court has removed “a constitution right that is so fundamental to so many Americans.” He vowed his administration would defend a woman’s right to travel across state lines to seek an abortion.

“Now with Roe gone, let’s be very clear, the health and life of women across this nation are now at risk,” he said. “Let me be very clear and unambiguous. The only way we can secure a woman’s right to choose that exists is for Congress to restore the protections of Roe v. Wade as federal law. No executive action from the president can do that.”

Biden called on voters to elect more senators and representatives who support reproductive rights, and pointed out that the Supreme Court decision does not prevent women from crossing state lines to receive an abortion.

“My administration will defend that bedrock right,” he promised. “If any state or local official, high or low, tries to interfere with a woman’s exercising her basic right to travel, I will do everything in my power to fight that deeply un-American attack.”

Biden added his administration would also back the right of access to medication for medical abortions, which some anti-abortion states want to ban.

Trigger bans in 13 states

The Supreme Court decision triggered automatic abortion bans in 13 states that had such laws in place. This means that women living in Arkansas, Idaho, Kentucky, Louisiana, Mississippi, Missouri, North Dakota, Oklahoma, South Dakota, Tennessee, Texas, Utah, and Wyoming will no longer be able to get access to abortions. 

Some states like Mississippi make no exceptions for rape, incest or health considerations, and women and girls and doctors face jail sentences for induced abortions.

Another 13 states are also poised to curtail abortion rights, while only 16 states and the District of Columbia have laws that protect the right to abortion, according to the Guttmacher Institute, an NGO that advocates for sexual and reproductive health rights.

Abortion bans don’t work

Dr. Herminia Palacio, the institute’s president and CEO, said decades of research consistently show that abortion bans and restrictions don’t reduce unintended pregnancy or demand for abortion.

“And they certainly do not help people improve their health,” said Palacio. “Rather, they impose significant hurdles to obtaining care, causing stress for people in need of abortion and leading some to experience forced pregnancy and all its troubling consequences.”

Rep. Tim Ryan, Democrat of Ohio, said the ruling was “the largest overreach in history” as it removed a constitutional right for the first time, essentially introducing “government-mandated pregnancies.”

A tearful Rep. Cori Bush, Democrat of Missouri, who had an abortion after being raped as a 17-year-old, described the court as “far-right, racist and supremacist.”

Planned Parenthood’s CEO Alexis McGill Johnson said the decision amounts to “the removal of women’s rights to bodily autonomy” but her organization will continue fighting to ensure women can take care of themselves as best as possible.

“This is about power and control,” she said. “Abortion is still legal in some states, and Planned Parenthood will do whatever we can to ensure people have services.”

“This horrifying decision will have devastating consequences, and it must be a wake-up call, especially to young people who will bear the burden,” said former US First Lady Michelle Obama.

Friday’s Supreme Court ruling on the appeal of a case brought by the Mississippi Department of Health, Dobbs v. Jackson Women’s Health Organization, overturned the 1973 Roe v Wade decision, which held that the 14th Amendment of the US Constitution provides a “fundamental right to privacy” that protects women’s rights to seek an abortion “without undue restrictive interference from the government.” De facto, the decision also upended the Supreme Court’s 1992 decision in Planned Parenthood v. Casey, which barred states from enacting abortion restrictions expressly for “the purpose or effect of placing a substantial obstacle in the path of a woman seeking an abortion of a nonviable fetus.” 

Justice Samuel Alito Jr.’s opinion overruling Roe and Justice Brett M. Kavanaugh’s concurrence said the decision ending a woman’s constitutional right to abortion shouldn’t endanger other sexual and reproductive rights that the court has recognized such as contraception, interracial marriage and same-sex marriage.

But the concurrence by Justice Clarence Thomas calls for not just revisiting but “overruling” all of the court’s substantive due process precedents including Obergefell v. Hodges, which deals with same-sex marriage, Griswold v. Connecticut, a landmark contraception case, and Lawrence v. Texas, a major case that invalidated anti-sodomy laws.

“After overruling these demonstrably erroneous decisions, the question would remain whether other constitutional provisions guarantee the myriad rights that our substantive due process cases have generated,” he wrote – although he omitted reconsideration of interracial marriage — which would make his own marriage illegal.

States prepare for patient influx

Some states where abortion is legal are already preparing for an influx of people seeking abortion, as previously reported by Health Policy Watch.

Last month, New York State Governor Kathy Hochul announced a $35 million investment to directly support abortion providers in anticipation of Roe v. Wade being overturned.

“New York has always been at the forefront of the fight for abortion rights, and as the first female governor of New York, I will not let us go backwards,” said Hochul. “This landmark funding will get resources into the hands of clinics who need our help, safeguarding access to abortion in our state and setting an example for the rest of the nation to follow.”

Image Credits: Gayatri Malhotra / Unsplash.