WHA special session in Geneva in November 2021 meets in a hybrid form to approve negotiations on a new global Pandemic Accord.

China wants to delete language supporting rapid World Health Organization (WHO) access to outbreak sites in future pandemics from a critical document that maps out a way forward in future pandemics, a diplomatic source has told Health Policy Watch.

This emerged at Monday’s start of a three-day meeting in Geneva of the global body’s Working Group on Strengthening WHO Preparedness and Response to Health Emergencies (WGPR).

The WHO working group is negotiating over an  interim draft report summing up 131 proposals from member states, four panels and various committees on how to improve global pandemic preparedness and response.

The draft report, which also zeroes in on vaccine and medicines equity, pathogen sharing, stronger “One-Health” approaches, and “adequate and sustainable financing” for WHO, is to go before the WHO Executive Board’s 150th session, 24-59 January, for “guidance”.  Further rounds of talks are then planned for February, March and April before a final version is submitted to the 75th World Health Assembly (WHA), set for 22-28 May. 

The final report, presuming it is approved by the WHA, would then form the backbone for future intergovernmental negotiations on a new global pandemic accord. A special November session of the World Health Assembly agreed to move ahead on intergovernmental negotiations over a new legal instrument to govern preparedness and response to future pandemic threats.  

Along with China veto, other parts of draft riddled with additions and deletions 

Colin McIff, USA co-chair, along with Indonesia, of the Working Group on Strengthening WHO Preparedness and Response to Health Emergencies (WGPR)

However, in the first day of discussions, China took exception to the suggestion that the WHO should have rapid access to “relevant sites during an outbreak to facilitate public health investigations”, particularly ”explicit power to investigate”, according to diplomatic sources.

China requested Paragraph 11 (d) be deleted altogether from the report, so as to wipe out any reference at all to the issue, the diplomatic source told Health Policy Watch. It was backed by Syria, sources said.

The paragraph states in full: “The four panels and committees came to the same conclusions regarding the need for WHO access to relevant sites during an outbreak to facilitate public health investigations.  However, there was divergence over the means by which this should be implemented: some advocated that WHO should be given explicit power to investigate, while others suggested that WHO be limited to offering immediate technical support to the concerned Member State(s).

“On this topic, there has been some discussion within WGPR on this as a critical gap that needs to be addressed, while several Member States have also cautioned the need to move forward in a way that fully respects national sovereignty.”

The draft text published Monday appeared sure to undergo further significant revisions – as member states entered dozens of other proposed additions and deletions in bracketed texts, color-coded in green, sources said. 

Since WHA decisions are customarily approved by consensus, opposition by just one or two countries to a concrete measure – like onsite inspections of outbreaks – can thwart approval altogether.  

Other key recommendations in the draft report include stronger action to ensure: 

  • Timely sharing of pathogens and genomic sequencing data;
  • Sustainable financing for pandemic preparedness; 
  • A “One Health” approach to preparedness that recognizes how environmental degradation, animal health and zoonotic diseases can feed outbreaks; 
  • “Equitable and timely access to countermeasures, including personal protective equipment, diagnostics, therapeutics and vaccines;”
  • More investments in R&D along with “effective and scalable supply chains”;
  • “Timely technology transfer”, including knowledge sharing. 

The recommendations were drawn from a series of external reviews of pandemic responses conducted over the last year. These include reports by: the Independent Panel for Pandemic Preparedness and Response, the Review Committee on the International Health Regulations (IHR) during the COVID-19 Response, and the Independent Oversight and Advisory Committee for the WHO Health Emergencies Programme.

China also standing fast on its refusal to allow further investigation of SARS-CoV2

Zeng Yixin, Vice Minister of the National Health Commission, at a press conference on 23 July 2021, slamming proposals for another WHO mission to China to investigate the origins of SARS-CoV2.

China has long been at odds with the WHO and member states, and particularly the United States, over its refusal to allow a second phase of on-site investigation into the origins of the SARS-CoV2 – in Wuhan and elsewhere. 

It also has refused a panel of scientists convened by the WHO access to Chinese medical and other records related to the outbreak in Wuhan.

In July, Zeng Yixin, China’s Vice Minister of the National Health Commission, described the WHO’s proposal for a more rigorous Phase II investigation of the origins of the SARS-CoV2 virus, including renewed consideration that the virus may have escaped from a laboratory, as “impossible” at a press conference.   

“We will not accept such an origin-tracing plan as it, in some aspects, disregards common sense and defies science,” said Zeng at the press conference organized by the Chinese State Council Information Office. 

Pandemic ‘instrument’ agreement

The working group of WHO member states, co-chaired by Indonesia’s Ambassador Grata Endah Werdaningtyas and the USA’s Colin McIff, deputy director of Global Affairs in the US Department of Health and Human Services, was widely credited with brokering last year’s historic agreement on the need for a global instrument to improve the world’s response to future pandemics.

Virtually all 194 member states committed to negotiating a new global accord to guide the response to future global pandemics at the WHO’s World Health Assembly Special Session (WHASS).

Equity recommendations also a lightning rod

The reference to on-site investigations was not the only clause in dispute in the report today. 

Most other paragraphs in the draft report were also being red-marked extensively, with proposed additions and deletions by various member states. 

Section 12 (d) addresses equity, for instance, and the draft Working Group report states that “Member States agree that equity is critically important for global health both as a principle and as an outcome”.

“Member States emphasized that equity is essential in particular in prevention, preparedness and response to health emergencies, including with respect to capacity-building, equitable and timely access to and distribution of medical countermeasures and addressing barriers to timely access to and distribution of medical countermeasures,” the report notes.

It also noted that “related issues such as research and development, intellectual property, technology transfer and empowering/scaling up local and regional manufacturing capacity during emergencies to discover, develop and deliver effective medical countermeasures and other tools and technologies,” were important.

A civil society representative monitoring the session indicated that the United States wanted to add the word “voluntary” sharing of licenses “on mutually agreed terms” to that text. Low-income countries such as Ghana, meanwhile, stressed that “equity is a priority” as member states ploughed word by word through the language. 

The equity language is additionally charged in light of the ongoing push by over 100 countries, led by India and South Africa, to approve a waiver of intellectual property rules in the World Trade Organization that would also facilitate more compulsory forms of tech transfer during the pandemic.  

In addition, Argentina pointed out that there needs to be stronger equity rules around the sharing of pathogens, from which new vaccines and medicines are typically developed. 

It proposed that the text on equity include reference to “the fair, and just participation in the derived benefits of the use of the exchange of pathogens”. 

Image Credits: China Daily.

president duterte
Philippine President Rodrigo Duterte addresses the nation

Philippine President Rodrigo Duterte has threatened to order the arrest of Filipinos who refuse to receive COVID-19 vaccinations – in one of the most extreme vaccine mandate edicts to be made by any government worldwide.  

“Because it is a national emergency, it is my position that we can restrain [unvaccinated people],” said Duterte in a televised Thursday address last week to the nation, in reference to a recent surge in infections.  

“I’m now giving orders to barangay captains (village leaders) to look for those persons who are not vaccinated and request them to stay put [in their house].”

If these individuals refuse to vaccinate, or continue to leave their home, the barangay captain, being a person of authority, is empowered now to arrest the recalcitrant persons, he added. 

The Philippines has administered at least 111,908,830 doses of COVID vaccines as of 10 January, with about 51.8% of the country’s population vaccinated with at least one dose. However, according to the World Bank Vaccine Deployment Tracker, only 34% of the population is fully vaccinated. 

The Philippines lags behind in vaccines in comparison to its neighbors in the WHO Western Pacific region, which have high vaccine coverage even in lower- and middle income countries like China, Malaysia and Thailand, along with high income Singapore, Taiwan and Australia, which Duterte has lamented. 

“Those who are not vaccinated, they will put everybody in jeopardy,” he said.

While other Wester Pacific region countries such as Australia, New Zealand, and Japan have become famous for their crackdowns on COVID-19 – with Australia most recently barring men’s tennis star Novak Djokovic from entering the country despite his vaccination exemption, the Philippines has gotten less attention globally, despite Duterte’s stringent policies.

Duterte brushes away legal concerns  

While Duterte acknowledged that some lawyers “are saying that we cannot restrain” unvaccinated people, he argued against this.

“I said that the ministrant function of the government is to come up with measures to protect public health, public interest, public order, and public safety.” 

“In the absence of a law, a President is called upon to act,” Duterte said, adding that those who disagree with this order “can file cases.”

“I already have a case at the International Criminal Court (ICC). File it on top of that, so I’ll just answer them simultaneously when the time comes,” Duterte said in Tagalog.  

The ICC had called for a formal investigation into Duterte’s so-called “war on drugs”, in which thousands of people have been killed. However, the Philippines has filed a deferral request in November, with the prosecution temporarily suspending its investigation for the time being.

Duterte has previously threatened people who refused to get vaccinated with jail time or an injection of Ivermectin, an anti-parasite drug widely used to treat animals. 

Arresting unvaccinated people violates Constitution 

The Commission of Human Rights (CHR) has also said that the President’s directive “violates” the Philippine 1987 constitution and human rights. 

“Presently, there is no law that makes being unvaccinated a crime, nor is there any law that would satisfy the Constitutional provision on curtailing freedom of movement. Any arrest made on these grounds may be illegal; thus, violative of the Constitution and our guaranteed human rights,” said CHR spokesperson Jacqueline Ann de Guia. 

While the 1987 Constitution does state that liberty of movement can be restricted in the interest of national security, public safety, or public health, there needs to be a law to make such restrictions legal. 

Vice President suggests incentives to encourage vaccinations

vice president robredo
Philippine Vice President Leni Robredo

Countering the president’s punitive measures, Vice President Leni Robredo took a different route, considering “positive reinforcement” as a method to address the low vaccination rates. 

“I hope the encouragement for vaccination can be more of positive reinforcement, not the fear of getting arrested for not getting vaccinated,” Robredo said in Tagalog during her weekly radio program BISErbisyong Leni over dzXL, on Monday. 

She added that refusing to get vaccinated is not a crime, and that there is no law criminalizing being unvaccinated, but COVID-19 vaccinations save lives, protect people, and prevent the spread of the virus. 

“There’s no such law, because I’ve heard there’s an order to arrest. But I will go back to my previous belief that we should be giving incentives to encourage a person to get vaccinated.”

“It should be thought of, and not be easily punitive – if you’re not vaccinated, you will be arrested or this or that. It’s more positive if it’s like this: if you get vaccinated, here are the privileges you will enjoy,” she said.

Omicron strain may soon overtake Delta as dominant strain 

The Delta strain remains the dominant variant in the Philippines, although Omicron may take over in the next three to four weeks, Philippine Department of Health (DOH) Undersecretary and country’s treatment czar Leopoldo Vega said in an interview with ABS-CBN News Channel last week.

“I think we still have the Delta around, but since we reported our first Omicron case way back 5 December, and there has been a continuously increase in the sequencing of this Omicron virus, it looks like we will presume that the Omicron is here, but it’s still not dominant.” 

As of 9 January, 28,707 new cases of COVID have been reported, nine times the number of cases reported on 1 January (3,617). 

Restrictive measures ramped up once more to stop COVID spread 

The Philippines has increased its restrictive measures once more following the rise in cases.

While the government had relaxed lockdown conditions last October in an effort to revive the battered economy, the increase in cases has forced the government to tighten its restrictions once more.

Restaurants, parks, churches and beauty salons will operate at lower capacity, while in-person classes and contact sports have been suspended.

Unvaccinated residents have to stay at home unless buying essentials or exercising, and are  barred from using public transportation. These rules have also been applied to individuals who have only a single dose of COVID-19 vaccine.

Some bus stations have imposed a “no vaccine card, no ride policy” and have also barred individuals with only their first dose from entering. These measures can encourage people to get vaccinated, but they do not address the lack of accessibility to vaccines, said James Patrick Cruz, speaking with Health Policy Watch. 

“It’s a nice safety measure and a great way to encourage people to be vaccinated but the inaccessibility of vaccines is something the government should also think about.”

Slowdown in vaccinations

While the surge of COVID-19 cases has impacted the Philippine government’s vaccination drive, many have attributed the slowdown in vaccinations to other reasons, including lack of access, anti-poor proposals, and an overwhelmed healthcare system.

The government’s attempts to ramp up vaccinations have been previously criticised as being anti-poor. In November, the Duterte administration proposed to exclude the unvaccinated poor from the cash assistance program, essentially “disincentivisizing” them for being unvaccinated.

“Easy access” to vaccination sites have also been primarily found in urban regions such as Metro Manila, as opposed to other parts of the country.

In addition, healthcare workers administering the jabs have been recalled to hospitals to handle the influx of COVID admissions.

Regi Pamugas, representative of the group Health Action for Human Rights, said that Duterte’s threats will not convince people to get vaccinated.

“We’re almost two years into the COVID-19 crisis and he did not yet learn,” he told INQUIRER.net, saying Duterte should do more to convince people to take the vaccine.

Image Credits: GMA News/Youtube, Leni Robredo/Twitter, ILO/Minette Rimando.

Tourists enjoy Cape Town’s beaches as COVID-19 restrictions are lifted

CAPE TOWN – Shortly before New Year’s eve, the South African government lifted the country’s curfew and allowed indoor gatherings of up to 1000 people – despite the prevalence of the highly infectious Omicron variant.

The Cabinet-level decision was taken after considering “the trajectory of the pandemic, the levels of vaccination in the country and the available capacity within the health sector”, according to a government statement.

On 23 December, the health department had declared that those who were asymptomatic did not have to quarantine and it dumped contact tracing. However, after a public outcry, the department backtracked a week later, saying that it had “decided to put the implementation of the revised policy changes on hold, while taking all additional comments and inputs received into consideration”.

Nonetheless, the health department explained that its initial decision was based on the fact that  “most people have vaccinated with at least one vaccine dose and developed some level of immunity”, “many people do not show any symptoms, and only a small percentage of them are diagnosed” – and “a number of people including children who are in contact with COVID-19 positive people, lose their income and valuable school time while staying at home without symptoms”.

As South Africa opens up, Europe goes for lockdowns

In contrast, European nations including France, Austria, the Netherlands and Germany introduced tough restrictions on gatherings and all but cancelled Christmas as they faced Omicron.

However, South Africa’s mild disease trajectory – coupled with its dire economic situation – enabled a different response.

A couple of weeks after Omicron was identified, scientists reported that its effects were substantially milder than previous COVID-19 outbreaks.

A study published in the International Journal of Infectious Diseases on 28 December based on statistics from hospitals in Tshwane, the city at the centre of the initial Omicron outbreak, reported Omicron deaths were 4.5% of hospital cases versus 21.3% from the previous three COVID-19 outbreaks, ICU admissions were 1% vs 4.3% and Omicron patients’ length of stay in hospital was 4.0 days – less than half the 8.8 days of the previous outbreaks. 

Meanwhile, the country’s most populous state, Gauteng, passed the peak of COVID-19 Omicron infections about a week ago, recording 15% of the deaths of Delta, and half the number of hospitalisations.

While case numbers are still relatively high in states such as the Western Cape, the disease is substantially milder throughout the country, and even though the variant is more infectious than previous ones, it has not overwhelmed the country’s hospitals.

On 6 January, the country reported 9860 new cases and 151,800 active cases in its population of over 55,4 million people.

One of the key reasons for how quickly Omicron has passed in the country is the substantial community exposure to COVID-19, which has built immunity. 

A sero-survey of over 7000 people in Gauteng between October and December 2021 found that almost three-quarters (72%) had experienced previous COVID-19 infection. Sero-positivity was 79% in unvaccinated people and 93% in vaccinated people over the age of 50, which is the group most at risk.

Over half of all adults are also vaccinated against COVID-19, mostly with Pfizer followed by the Johnson & Johnson vaccine. Furthermore, the average South African is much younger than the average European.

Economic desperation

However, the country is also desperately trying to salvage its economy. The GDP contracted by 1,5% in the third quarter of last year, and South Africa is in the midst of the worst unemployment since it started compiling statistics. Over two million people have lost their jobs during the pandemic and the discovery of Omicron shortly before the Christmas tourism season has cost the hospitality industry millions of dollars.

Shops were noticeably quieter this Christmas as job losses and a weakened currency translated into higher prices for fuel and other imported goods. 

Professor Shabir Madhi, head of  Vaccinology at the University of Witwatersrand, has called for new generation vaccines that target a number of different sites of the virus – much like highly active HIV antiretroviral therapy, which targets three different sites of cell entry to combat the fast mutations of HIV.

“The South African government appears to have come to appreciate that the past practices have had limited success in preventing infections, and fully appreciates the detrimental effects that restrictions have had on the economy and society,” wrote Madhi and others in an article in The Conversation on 7 January.

“In addition, it has run out of road to continue with what has unfortunately not yielded much benefit. Despite all the severe lockdowns South Africa still ranks high with a Covid death rate of 481 per 100,000.”

Madhi and colleagues argue that “the major risk is the unpredictability of new variants that evade all aspects of past infection and vaccine-induced immunity”, but also declare that “with Omicron the epidemic phase of COVID-19 is coming to an end”.

Image Credits: Unsplash/ Ethan Smith.

Women who have been vaccinated against COVID-19 had a slight but not clinically significant change in the length of their menstrual cycles compared to unvaccinated women, according to a new study published by researchers from Oregon Health & Science University in Portland in Obstetrics & Gynecology.

Specifically, vaccinated women experienced a less than one-day (0.71-day) unadjusted increase in the length of their menstrual cycle after their first shot and a less than one-day (0.91-day) after their second shot, the study found. 

The increase in cycle length, however, seemed to be driven by several hundred women in the study who received both shots during a single cycle. This subgroup experienced a two-day unadjusted mean cycle length increase. 

“Statistically significant differences existed between vaccination status groups, but the change in cycle length was less than one day, which is below the reportable difference in the menstrual cycle tracking application and is not clinically significant,” the authors stressed.

Reverted to normal

In all cases, the cycles reverted to their original length after two post-vaccine cycles. 

This is the first peer-reviewed research published on the matter through the US National Institute of Child Health and Human Development (NICH), which awarded five grants totaling $1.67 million in October to agencies to explore the link between COVID-19 vaccination and menstruation changes after tens of thousands of women worldwide reported changes in menstruation after receiving the jab. 

“Concerns about a possible association between coronavirus disease 2019 vaccination and abnormal menstrual cycles may lead to vaccine hesitancy,” the study’s authors wrote in their report. “Unfortunately, clinical trials of the current COVID-19 vaccines did not collect menstrual cycle outcomes post vaccine.”

Other NICH-funded research is still underway by teams from Boston University, Harvard Medical School, Johns Hopkins University and Michigan State University.

The study was a retrospective cohort analysis, leveraging data from the Natural Cycles digital fertility-awareness application between October 2020 and September 2021. Nearly 4,000 women – 2,403 vaccinated and 1,556 unvaccinated – between the ages of 18 and 45 who had regular cycles, were not pregnant or taking hormonal contraception were evaluated as part of the study. 

Participants were inoculated with Pfizer (55%), Moderna (35%) or Johnson and Johnson (7%). 

Six cycles were analysed for each participant – for those who were vaccinated, three cycles before the first shot and three cycles during and after.

Study limitations

Dr Itamar Netzer, a gynaecologist and a sub-district director for Clalit Healthcare Services in Israel, there were some challenges with the study, which were also noted by the research team. These included that it relied completely on Natural Cycles data and application users tend to be mostly white, college-educated and have lower BMIs than the average American woman. 

In addition, he said that because the study relies on self-reported data by women, it is possible that these women did not accurately record their number of bleeding days. 

“Women with underlying gynaecological disorders may experience greater differences,” according to Netzer, who noted that only healthy women were included in the study.

Menstrual cycle timing is regulated by the hypothalamic-pituitary-ovarian axis, the researchers explained, which can be affected by life, environment and health stressors. They hypothesised that because mRNA vaccines create a robust immune response or stressor this could temporarily affect this axis, which could be the cause of the slight shift in cycle length. 

Netzer said that the research shows that the vaccine is “probably safe for everyone” and especially menstruating women. He noted that separate studies have shown that the vaccine is safe for pregnant women and does not impact the rate of stillbirths or premature delivery.

“In contrast, we have seen the hazards of COVID-19 on pregnancy,” Netzer stressed. “A pregnant woman who catches COVID is two to five times more likely to be hooked up to a lung-heart machine than a non-pregnant woman.

“We are quite sure the vaccine is safe in pregnancy,” Netzer continued, “and we know the [COVID-19] disease is dangerous for pregnancy.”

WHO press briefing – first of the new year sounds gloomy notes.

Mass Omicron infection could lead to the formation of new and potentially even more dangerous coronavirus variants, officials from the World Health Organization warned on Thursday.

That is despite the fact that the Omicron variant is proving less lethal than its SARS-CoV2 predecessors, such as Alpha, Beta and Delta – which swept through India and then the world beginning in the spring of 2021. 

“We are giving this virus plenty of opportunities to circulate and the more the virus circulates the more opportunity it has to change,” said Dr. Maria Van Kerkhove, WHO’s COVID-19 technical lead, speaking at the first global press briefing of 2022. 

“I think, unfortunately, this will not be the last variant you hear us address. It will not be the last variant of concern.”

Her comments followed on remarks by a WHO European Region Emergencies official, Catherine Smallwood, earlier in the day, who sounded an even more ominous note:  

”The more Omicron spreads, the more it transmits and the more it replicates, the more likely it is to throw out a new variant,” Smallwood told AFP, “Now Omicron is lethal, it can cause death, maybe a little bit less than Delta, but who’s to say what the next variant might throw out.”

At the WHO global briefing later in the day, Mike Ryan, executive director of WHO’s Health Emergencies Program, also recalled having discussions during the previous Delta wave with top scientists who said that the Delta variant was so adept at infecting and replicating, that they could not imagine it mutating much more.  

“Yet it did,” Ryan stressed, “and we have seen a further variant emerge that is even more transmissible than Delta, which was even more transmissible than its predecessors… We are not doing well enough globally to say with any degree of certainty that we can avoid the emergence of new variants.”

Spreading at an unprecedented rate 

Dr Tedros Adhanom Ghebreyesus, WHO Director General.

Omicron is spreading at an unprecedented pace worldwide. In the United States, it now makes up 95% of cases, the Centers for Disease Control and Prevention said. The United Kingdom has said that one in 15 people are infected with the virus, and Indian health officials said Thursday that the country logged more than 90,000 new COVID cases in a 24-hour period, with a positivity rate of more than 4%. 

Last week also saw record highs in the number of new COVID-19 cases to be reported since the beginning of the pandemic  – “and we know for sure this is an underestimate number of cases,” said WHO Director-General Dr. Tedros Adhanom Ghebreyesus.  He stressed that increased vaccine roll-out in underserved countries 

While Omicron does appear to be less severe compared to Delta, especially in those who are vaccinated, it should not be classified as mild, he warned. 

“Omicron is hospitalizing people and killing people,” Tedros said. “It is overwhelming health systems around the world.”

Moreover, the Delta variant is still dominant in some countries and is mutating too, Van Kerkhove added. 

“Omicron is very efficient, but Delta is evolving as well,” Van Kerkhove said. “There are about 30 sub-lineages of Delta that we are tracking.”

WHO Advice includes more of same: masking, social distancing, vaccination  

While the WHO officials sounded a gloomy prognosis on the massive infection wave underway – and what that could mean for future virus mutations  – there were few new measures that they could suggest. 

And certain thorny questions that countries are struggling with now, such as  whether rapid antigen tests could be a reliable go-to protocol for people that suspect they are infected, or want to be released from quarantine, were not addressed. 

Ryan stressed, however, the need to continue with quarantine policies –  even while in some countries as many as one in 15 people are infected with Omicron. He said that quarantines should remain in place for at least five days, while people are most infectious.   That is generally in line with the revised advice that has been issued by the United States Centers for Disease Control, to respond to the infection surge. 

Ryan added that one of the ways to temper longer periods of isolation is through regular testing.  But he didn’t enter the debate raging now in many countries about reliance on rapid antigen tests, as compared to PCRs, to determine COVID infection status, officially report on COVID cases, and send people to quarantine – or allowing them to exit.  

While positive results of rapid antigen tests, using lateral flow devices, are generally regarded as reliable, negative results are considered far less accurate.

One recent pre-print study found that rapid tests are particularly unreliable at detecting the early stages of infection – leaving many people to walk around infectious for an average of three days after a positive PCR test – before showing a positive antigen test result. See related story:

COVID-19 Could Become Endemic in Africa if 70% Vaccination Coverage is not Achieved by 2022 – Africa CDC

WHO officials reiterated well-worn advice on the value of masking, social distancing and vaccination. Tedros also stressed, once more, the importance of expanding vaccine drives in under-resourced developing countries, where even more variants could otherwise fester. 

“This is about making personal decisions,” Van Kerkhove said, “this is about distancing – keeping your distance from others – wearing a well-fitted, appropriately made mask… Make sure you spend more time in places where there is better ventilation… and stay home if you are unwell.”

Air pollution in Mashhad, Iran

Almost nine out of ten (86%) people living in urban areas across the globe, or 2.5 billion people, are exposed to unhealthy particulate matter levels, leading to the 1.8 million excess deaths in cities globally in 2019, in a study that examined urban air pollution and related mortality trends in over 13,000 cities globally. 

The first of two studies, both published today in The Lancet Planetary Health journal, found that 86% of urban inhabitants lived in areas that exceeded the 2005 World Health Organization (WHO) guidelines for annual PM2.5 exposure of 10 micrograms per cubic meter (μg/m3); in 2021 that safe air quality guideline was tightened even further to 5 μg/m3 of PM2.5.  

“The majority of the world’s urban population still live in areas with unhealthy levels of PM2.5,” said lead author of the study Veronica Southerland, of US-based George Washington University. 

Figure 3Change in population-weighted PM2·5 concentrations and PM2·5-attributable mortality rates between 2000 and 2019 for the top 250 most populated urban areas based on 2019 WorldPop estimates

Exposure to PM2.5 (fine particulate matter with a diameter of 2.5 micrometers or less) is a leading environmental risk factor for disease. 

Inhalation is known to increase the risk of premature death from health conditions such as cardiovascular disease, respiratory disease, lung cancer, and lower respiratory infection. 

Additionally, the second study, focusing on transport-related NO2 (nitrogen dioxide gas) pollution and paediatric asthma incidence, found that nearly two in three urban childhood asthma cases in 2019 were attributable to NO2 pollution, with nearly 2 million asthma cases found among children worldwide.  

Both studies highlight the urgent need to improve air quality in cities and reduce exposure to pollution, particularly among children and the elderly. 

PM2.5 concentration seven times WHO 2021 guidelines in first study 

The first study focused on PM2.5 concentrations and associated mortality trends in over 13,000 cities globally between 2000 – 2019. 

Average population-weighted PM2.5 concentration in 2019 across all urban areas globally was 35 micrograms per cubic meter – equivalent to seven times the new 2021 WHO guideline for annual average PM2.5 of five micrograms per cubic meter. 

Study authors estimate that 61 deaths per 100,000 inhabitants in urban areas were attributable to PM2.5 in 2019. 

A 2021 report by Greenpeace Southeast Asia and IQAir had also found the link between urban air pollution and attributed mortality, with exposure to PM2.5 responsible for the deaths of 160,000 in the world’s five biggest cities.  

Southeast Asia sees largest increase in PM2.5 concentration and attributable deaths 

urban
Pollution in Delhi peaks in late autumn when drifting emissions from crop burning exacerbate the usual urban household, traffic and industrial sources

While global average PM2.5 concentrations remained consistent over the 19-year period, there were large variations by regions.

Urban areas in Southeast Asia (including India) saw the largest regional increases, with a 27% increase in average population-weighted PM2.5 concentration between 2000 – 2019. Southeast Asian cities also saw the largest increase in PM2.5-attributable mortality during this period – 33% – from 63 to 84 deaths annually per 100,000 people. 

Trends in global urban mortality rates and PM2·5 concentrations, 2000 to 2019

However, higher or lower PM2.5 concentrations in some urban areas of Asia, Africa and elsewhere did not always yield correspondingly lower PM2.5-attributable death rates. That is because demographic factors, such as the age of the population, as well as baseline health conditions, also have a strong impact on pollution-related deaths. 

For instance, Guangzhou, China, had a decrease in population-weighted PM2·5 of 14% during the 19 year period, from 37 μg/m3 to 32 μg/m3. Howver, PM2·5-attributable mortality rates increased by 10%. In contrast, Luanda, Angola, saw a 38%  increase in PM2·5 population-weighted concentrations from 13 μg/m3 to 18 μg/m3. But attributable mortality decreased by 16%.

At the same time, decreases in PM2.5 concentrations had a comparatively larger impact on reducing PM2.5 attributable mortality in urban areas where pollution levels were already low, such as the Americas and Europe, the researchers found.

For instance, in European cities, a 20% reduction in contractions, from an average of 20 μg/m3 to 16 μg/m3 over the course of the 19 year period, resulted in a 23% decrease in PM2.5 attributable deaths despite an ageing population, the study found. That is because proportionally speaking, decreases in air pollution at relatively lower levels yield comparatively greater reductions in mortality.   

“Avoiding the large public health burden caused by air pollution will require strategies that not only reduce emissions but also improve overall public health to reduce vulnerability,” stated Sutherland. 

Second study finds two out of three new pediatric asthma cases in cities due to NO2 

The second study analyzed global concentrations of NO2 with population and baseline asthma rates in order to estimate the paediatric asthma incidence attributable to NO2 between 2000 – 2019 in 13,129 cities.

NO2 is an air pollutant mainly emitted by vehicles, power plants, industrial manufacturing, and agriculture.

Previous research has shown transport-related air pollution is associated with both asthma exacerbation and new onset of asthma in children. 

The study revealed that 1.85 million, or 8.5% of all new paediatric asthma cases reported in 2019 were attributed to NO2.  Two out of  three of these new cases occurred in the 13,129 urban areas covered in the study.  

In urban areas, NO2 was responsible for 16% of all new child asthma cases in 2019. 

“Our results demonstrate the important influence of combustion-related air pollution on children’s health in cities globally,” says Susan Anenberg of US-based George Washington University, who is co-first author on the NO2 study and corresponding author of both studies.

Anenberg pointed out that despite the downward trend of NO2 concentrations over several decades – the result of effective air quality management programs, NO2 continues to contribute to child asthma. 

“Current NO2 levels contribute substantially to pediatric asthma incidence, highlighting that mitigating air pollution should be a critical element of children’s public health strategies.”

Image Credits: Mohammad Hossein Taaghi, The Lancet, Planetary Health , Flickr, The Lancet, Planetary Health .

Israeli Prime Minister Naftal Bennett (right) is briefed about Sheba Medical Center's COVID-19 fourth shot trial on Tuesday, January 4, by hospital Director-General Prof. Yitshak Kreiss.
Israeli Prime Minister Naftal Bennett (right) is briefed about Sheba Medical Center’s COVID-19 fourth shot trial on Tuesday, January 4, by hospital Director-General Prof. Yitshak Kreiss.

A fourth shot of the Pfizer coronavirus vaccine administered to individuals who received their third shot nearly five months ago produces a five-fold increase in antibodies, according to preliminary results of a first-in-the-world trial being conducted in Israel.

The news comes on the same day that the country announced it would launch a trial to determine the effectiveness of receiving a fourth shot of the Moderna coronavirus vaccine beginning on Wednesday.

Both trials are being run out of Sheba Medical Center at Tel Hashomer and include around 150 medically personnel who received their third doses by August 2021, with a serology result below 700.

Participants in the Pfizer trial were inoculated a week ago. The hospital announced the preliminary results on Tuesday during a visit to the facility by Israeli Prime Minister Naftali Bennett. The data has not yet been published.

Fourth Pfizer shot increases antibodies five-fold

“I am pleased to announce … that the initial research indicates that within one week of receiving the fourth vaccine, there is a nearly fivefold increase in the number of antibodies in the blood,” Bennett said. “[A fourth booster] will probably provide a much higher level of protection than without the shot – a high level of protection for both infection and severe morbidity. In simple terms, the fourth vaccine is safe, it must be. The fourth vaccine is very likely to work.”

He added that in the two days since Israel opened up fourth doses, more than 100,000 Israelis registered to be vaccinated or have already been vaccinated.

Israel is the first country in the world to offer a fourth shot to all citizens over the age of 60 and medical workers who received their last doses at least four months prior.

Chile also announced last month that it would offer citizens a fourth coronavirus vaccine dose, also starting with those who are at highest risk of infection or developing severe disease, but those shots are not expected to begin until February and they are being given only after six months have passed from the previous jab.

Brazil also has approved a fourth shot, but only for the immunocompromised.

Researchers say fourth dose safety profile is as good as expected

Prof. Gili Regev-Yochay, director of the Infection Prevention and Control Unit at Sheba, is overseeing the trial. She stressed that the safety profile of the fourth shot appears similar to the profile in the previous doses.

“These initial findings join the preliminary results on potential side effects, which were obtained following the administration of the fourth dose, which also indicate the safety of the fourth dose,” said Regev-Yochay. “This study will yield more information in the coming days and weeks.”

The Moderna trial is being run in collaboration with Medison Pharma, a company that markets the Moderna vaccine in Israel. Participants will be medical workers who received three shots of Pfizer and will now receive a dose of Moderna. Researchers will be evaluating the degree of immunity and protection against the Omicron variant with this combination.

Both trials are being run on conjunction with Israel’s Health Ministry and with full approval of the Helsinki Committee.

Image Credits: Sheba Medical Center.

Influenza virus
Influenza virus

The world’s first case of “flurona” – a co-infection with both seasonal influenza and COVID-19 was reported in Israel last week, as the Omicron variant sweeps across the world. Since then, small numbers of people co-infected with both viruses have been identified in other European countries as well, a World Health Organization official in the European Regional Office confirmed.

“Small numbers of co-infections of influenza and SARS-CoV-2 have been seen elsewhere and have been reported internationally during the pandemic to date,” Dr. Dorit Nitzan, WHO European Regional Emergency Director, told Health Policy Watch. “Experience and understanding needs to build further whether there are clinical differences in the presentation, management and outcome of these cases.”

WHO so far has not provided any reports on the numbers.

Coronavirus
Coronavirus

Fears of a widespread flu and COVID twindemic did not materialize last year, as masking and social restrictions apparently kept flu cases unusually low.

There are fears that the European region and other parts of the northern hemisphere could now be vulnerable to a “Flurona” wave – as the highly infectious Omicron variant sweeps through the world. And at the same time, many vulnerable people also didn’t get a seasonal flu jab.

Although WHO’s Geneva Headquarters also said Tuesday that the current Omicron symptoms indeed appear much milder than previous waves, largely affecting the upper respiratory tract.

“We are seeing more and more studies pointing out that Omicron is infecting the upper part of the body. Unlike other ones, the lungs would be causing severe pneumonia,” WHO Incident Manager Abdi Mahamud said in a Geneva press briefing.

Seasonal Flu on rise

Already, the number of flu cases detected in the WHO European region was “above what we would normally expect to find in the population,” Nitzan said.

According to WHO European Region,, in any given year 5% to 15% of the population is affected by influenza – around 3 million to 5 million cases resulting in 650,000 deaths.

“With COVID-19 also in high transmission across our region, there is the risk that this so-called twindemic could put excessive pressure on already overstretched health systems,” the WHO website said.

The impact could be especially acute on the most vulnerable populations, such as the elderly or people with underlying medical conditions, explained Prof. Cyrille Cohen, head of the immunology lab at Bar-Ilan University, as both flu and COVID-19 on their own can be lethal for older people.

“One virus might weaken you and the second one could be the straw that breaks the camel’s back,” he said. “You might end up with the Omicron variant that is not so tough but then get the flu and that gives you a high fever and the combination could put your life at risk.”

First case of flurona reported in Israel

The first case reported by Israel was a young woman in her 38th week of pregnancy. The woman was treated with a drug combination that targets both coronavirus and flu, according to Dr. Arnon Wiznitzer, head of the Women’s Hospital at Beilinson Hospital in Petah Tikva, Israel. She and her baby were in stable condition on Monday.

“We did not have any kind of influenza all year last year,” Wiznitzer said, “but this year is different.”

He said that a significant number of pregnant women are presenting in the delivery room with flu-like symptoms and it is difficult to know whether they have influenza or COVID-19. As such, these women are put into special isolation rooms for labor and delivery, where they are tested for both viruses.

Until now, the majority of cases have turned out to be the flu, but he expects the balance will shift as COVID cases rise in the country. Israel is reporting more than 10,000 new cases per day and is expected to reach up to 50,000 – around the same number per capita as some of the hardest hit European countries, such as Denmark.

‘Flurona’ symptoms

When it comes to the symptoms of flu, COVID or flurona, it can be difficult to tell the difference, according to Dr. Richard Peabody, who leads the High-threat Pathogen team and the Surveillance and Laboratory pillar of the COVID-19 Incident Support Management Team at WHO/Europe.

In a WHO Q&A, he explained that “both viruses are highly infectious respiratory diseases and share many of the same symptoms, such as coughing, fever, shortness of breath, and/or loss of taste and smell. Because of the difficulty in distinguishing the diseases from symptoms alone, if you are symptomatic, you should isolate yourself from other people to reduce the risk of the infection spreading, particularly to vulnerable people, and get tested for COVID-19 as soon as possible.

“While both diseases can cause serious illness, COVID-19 is more likely to lead to health complications, admission to hospital and, in some cases, death – so getting tested is essential,” Peabody said.

Flu vaccines important – and so far vaccine rates in European Region appear lower than usual

It is also important to get vaccinated, Peabody stressed.

In Israel, where there are around 2,000 people hospitalized for flu, vaccination rates against influenza are down, in comparison to past years. And this is likely to be reflective of the broader situation in WHO’s European Region, Nitzan said – although WHO’s regional influenza vaccine uptake rates for the 2020/21 season are not yet available.

Until now, the region is mainly seeing three strains of influenza viruses, including: A(H3N2) viruses and some influenza A(H1N1)pdm09 or influenza B viruses, according to WHO’s European Regional Office.

“People at increased risk of severe disease from [flu] infection include older people, pregnant women, young children, immunocompromised people and people with chronic underlying medical conditions,” WHO said. ”These groups represent a sizable proportion of the population in the WHO European Region. Therefore, WHO/Europe recommends that everyone at risk of severe disease from infection with influenza, as well as health-care workers, be vaccinated.”

Although there is limited evidence about people who have received both the COVID-19 and the influenza vaccines at the same time, WHO said that doing so does not show any increase in adverse effects.

Wiznitzer said that in Israel these high-risk groups, especially pregnant women, are encouraged to get both shots, because flu and COVID can have adverse effects on mom and baby.

“Fighting both flu and COVID can be very dangerous,” he said. “I can ensure that both vaccinations are safe during pregnancy and on the baby.”

Image Credits: Flickr.

A child receives a vaccine through the Maccabi Health Fund in Israel in December 2021.
A child receives a vaccine through the Maccabi Health Fund in Israel in December 2021.

Two new large scale reviews of the effects of the two-dose Pfizer’s mRNA vaccine in children aged 5-11 shows fewer severe effects than in older groups.

Tuesday’s report, by the Israeli Health Fund Maccabi covering more than 20,000 children, comes on the heels of a similar US Centers for Disease Control and Prevention (CDC) study of some 42,504 children that found nearly all side effects have been mild as well.

The findings also coincide with a US Food and Drug Administration announcement that it has expanded its approval of booster vaccines to kids aged 12- to 15-years-old. It also said that it would allow some children aged five to 11 who are immunocompromised to get a third shot, such as those who have undergone organ transplants. A CDC expert group is meeting today to decide on implementation of the FDA authorization.

Children ages 5-11 did not experience any severe or unusual side effects after receiving a second dose of the Pfizer coronavirus vaccine, according to a report released Tuesday by Maccabi Health Services – one of Israel’s four national health funds.

No reports of heart inflammation

In the CDC study, there were 12 serious reports of seizure and 11 reports of myocarditis among the children enrolled in the CDC-FDA Vaccine Adverse Event Reporting System (VAERS) – none fatal. Two deaths reported in 5-year-olds with complicated health histories could not be directly linked to the vaccine.

Notably, in the Israeli study, there have been no reports of myocarditis – a rare heart inflammation condition that was found to affect most young men between the ages of 16 and 30 in previous studies of those age groups.

“There were no unusual side effects,” said Dr. Miri Mizrahi Reuveni, director of the Health Division at Maccabi Healthcare Services in a briefing.

According to the report, 70% of children experienced pain at the site of injection – the same percentage who experienced pain after their first jab.

In addition, a third (33%) of children experienced general side effects, such as fatigue, headaches and general achiness. Only 20% of children experienced similar side effects after the first shot.

“One in four (26%) of 11-year-olds vaccinated with a second coronavirus vaccine dose missed a school day or afternoon activity due to side effects,” Reuveni said.

Fewer side effects the younger the age group

She noted that there are fewer side effects the younger the children are. Only 11% of five-year-olds missed a school day or activity. Also, 18% of 11-year-olds experienced a headache, for example, compared to 8% of five-year-olds.

This is also the case when comparing vaccinated children to adults, the Maccabi data shows.

Israel approved vaccines for children 5-11 shortly in late November, shortly after the United States.

So far, around 9% of Israel’s 5-11-year-olds are fully vaccinated, meaning they have had two shots in the last six months, although much higher percentages of children have had their first dose.

Maccabi has vaccinated 44,300 children and another 34,000 have appointments for shots. Around 50% of children have received their second dose.

About one in five children in the US have gotten their first COVID vaccine, according to data by the CDC.

Image Credits: Maccabi Health Services.

First vaccinations of Israeli health workers and people over age 60 roll out on Monday.

JERUSALEM – Israel once again has placed itself in the middle of the global clinical debate on the medical benefits of a fourth Pfizer shot to slow the Omicron wave, when it became the first country to approve such an injection for all citizens over the age of 60 and healthcare workers.

Israeli Prime Minister Naftali Bennett announced the roll-out of the second booster during a press conference Sunday night, where he said that anyone over the age of 60, as well as  medical staff who had received their first booster four months ago or more, could get inoculated. 

“The decision was made after consulting with various experts,” Bennett said. “The significance is great; we will have a new layer of protection.”

He added that the country’s policy of booster shots has kept citizens healthy with per capita death rates among the world’s lowest – as compared to the United Kingdom, where the mortality rate is 50 times greater, Germany 100 times and in the United States, 130 times higher.

Israel was the first in the world to approve a third jab despite international criticism,  including from the World Health Organization, which has repeatedly  warned rich countries  against hoarding shots – saying that leaves variants to flourish in low-income countries, prolonging the pandemic.  

“We must not be complacent,” the prime minister warned. “Everyone who is entitled to a fourth dose, get vaccinated.”

In his own announcement, the country’s Healthy Ministry Director-General Nachman Ash said the move was made “in light of the increase in morbidity,” as new daily cases on Monday topped 6,500 and the prime minister warned of 50,000 new daily cases in the coming weeks. That would be a per capita rate about equal to Denmark, one of the European countries seeing exceptionally high COVID infection rates. 

Still no evidence of fourth dose preventing infection 

But local and international scientists and doctors were quick to highlight that there is still no evidence of the effectiveness of a fourth dose in preventing infection, serious disease or death. 

“The decision must be accompanied by a scientific evaluation by an independent body,” charged the Israeli Association of Public Health Physicians in a statement. “Resources must be directed first and foremost to [encourage the public] to complete their first, second and third vaccines whose benefit is clear and scientifically proven.”

Despite racing ahead of the world on vaccine roll-out, Israel’s overall vaccination rate for people who have received their first two doses now lags behind many other nations, with only 60% of the country vaccinated with two jabs within the last six months or three shots, and some 700,000 entirely unvaccinated.  

Other countries will be closely eyeing moves

As in other virus waves, Israel’s moves will be closely eyed by other countries that are anxious to blunt the full force of the new Omicron variant – which is far more infectious – even if it is also supposedly less deadly.  

That, in the face of mounting evidence from around the world that the degree of protection offered by mRNA vaccines against SARS-CoV2 in general, and against Omicron in particular, declines sharply four to six months after vaccination. Laboratory tests have, however, suggested that even lower levels of neutralizing antibodies, as well as continued T-cell immunity, may still provide protection against the development of serious disease. 

Chile also announced last month that it would offer citizens a fourth coronavirus vaccine dose, also starting with those who are at highest risk of infection or developing severe disease, those shots are not expected to begin until February and they are being given only after six months have passed from the previous jab.

Brazil also has approved a fourth shot, but only for the immunocompromised. 

Giant experiment on safety and efficacy 

Couple awaits their fourth vaccine at a Jerusalem health fund station.

Now Israel’s new campaign, which will be tracked by its  national digitized system of healthcare records, and research teams, is expected to provide real-time information on the efficacy of yet another booster against Omicron – in what amounts to a large-scale national clinical trial. 

There is also still no evidence as to the safety of a fourth shot – although most health experts believe that the mRNA vaccines will not cause any short- or long-term harm. 

Sheba Medical Center at Tel Hashomer last week launched a fourth shot trial in late December of around 150 healthcare workers to see how much an additional COVID shot raises a person’s antibody levels and if there are any negative effects, but no concrete data has been released yet.

On Sunday night, the hospital said that out of 154 people who received the jab, 80% reported mild reactions at the point of injection – similar to after the third dose. Some 45% of recipients experienced fever, weakness, muscle aches or headaches – symptoms that in most cases passed within 24 hours. 

“From these data, it appears at this stage that the fourth vaccine profile is as safe as the previous vaccine doses,” said Dr. Gili Regev-Yochay, director of the Infectious Disease Epidemiology Unit at the hospital who is running the new study. 

Local experts argued that pre-existing vaccine protection could decline to almost nil within another month 

The decision to move to a fourth jab was taken following a December 21 meeting of Israel’s national Pandemic Response Team, when experts warned that within a month’s time, Israel’s population would be as vulnerable to Omicron as they had been to the initial COVID-19 outbreak prior to any vaccination whatsoever.

Another team of researchers told the committee that a third booster shot was not even enough to halt Omicron as its effectiveness against the variant would decline from 75% to 25% after month four. 

The Ministry of Health team ultimately voted in favor of the fourth shot – just 10 days after it had shot down the move. But it took Ash another week and thousands more Omicron cases to give his final approval. 

Other critics still maintain, however, that the Pfizer vaccine was never intended to ward off infection, but to prevent severe disease and death. And it appears that the second dose, and certainly the third shot, does a decent job of that already – even in the face of Omicron. 

Moreover, the Omicron variant causes less serious disease in general than its Delta predecessor, according to all studies and predictions. 

Finally, the Omicron wave appears to be short-lived. Already this week, South African health officials announced that they believed the country had passed the peak of the wave, with new cases dropping by nearly 30%.

But until Sheba’s fourth dose trial is over or enough Israelis over the age of 60 get the jab, the decision to give a fourth dose is just a shot in the dark. 

“In the coming days, we will report preliminary findings regarding the initial increase in antibodies and immunity within a week of vaccination,” Regev-Yochay said. 

Image Credits: Clalit Health Fund , G. Ginsberg.