3D print of a spike protein on the surface of SARS-CoV-2, enabling the virus to enter and infect human cells.

NEW DELHI – Scientists have sequenced a new “double variant” of the coronavirus first identified  in India – along with a handful of other variants of concern that are appearing during the second biggest wave of the virus since the pandemic began.

The new double variant, bearing two significant mutations in the coronavirus spike protein, dubbed E484Q+L452R, could be associated with higher infectivity and with a capacity to evade antibodies, government experts have warned. Alone or together, the mutations E484Q and L452R “have been found in about 15-20% of samples and do not match any previously catalogued VOCs”,said the Ministry of Health and Family Welfare in a press release, 

The two variants both appear to “confer immune escape and increased infectivity”, the Ministry said; immune escape refers to the ability of a variant to evade immunity conferred by a prior infection. 

The government also said that there is not yet sufficient evidence to establish a link between the new mutation and the surge of COVID-19 cases occurring now in some states of India. India reported 53,476 new cases in the last 24 hours, of which 31,855 are from Maharashtra.  “The variants of concern and a new double mutant variant..have not been detected in numbers sufficient to either establish a direct relationship or explain the rapid increase in cases in some states,” the press statement issued by India’s Ministry of Health and Family Welfare.

The double mutation has been found mostly in the Western state of Maharashtra which is seeing a massive surge in COVID-19 cases. Several cities in Maharashtra including Mumbai and Pune had massive number of cases in the first wave of the pandemic last year. However, since mid-February, the state has seen a massive spike of cases yet again. 

“We have seen this double mutant E484Q+L452R in 206 samples in Maharashtra and a varied number in Delhi. In Nagpur, we found a substantial number of samples with this mutation- about 20%. But, the data so far does not show that the surge is related to this mutant,” said Dr Sujeet Kumar Singh, Director of India’s National Centre for Disease Control, speaking at a press conference on Wednesday.

Nagpur is one of the cities in Maharashtra which saw the beginning of the surge of  Covid-19 cases in India from mid-February. 

Variant of ‘Interest’, Not Yet ‘Concern’ According to WHO Criteria

Speaking at the press briefing, however, Singh also downplayed the significance of the double mutation at this point. 

He said that according to WHO criteria, the double mutation could be called a “variant of interest”, but it has not yet been  established as a “variant of concern” in the same way as the variants first identified in the United Kingdom, Brazilian and South Africa – also circulating in India. 

The WHO has established three classifications for the identification of SARS-CoV2 mutations, including variants under investigation, variants of interest and variants of concern. 

Singh said that further investigations of the Indian mutations are underway. “Only when the variant has public health impact, increases severity of the disease does it become cause of concern,” explained  Singh of the classifications. 

In an interview with Health Policy Watch, Dr Shahid Jameel, chair of the scientific advisory committee of the Indian SARS-CoV-2 Consortium on Genomics (INSACOG), echoed that message. The consortium is a group of 10 laboratories that carry out genomic sequencing and analysis of circulating COVID-19 viruses. The consortium tests international travellers, their contacts, and   community samples. It has so far tested more than 10,000 cases.

“We do not need to worry about the double mutation, but we have to be concerned,” Jameel said. “Both these mutations allow the virus to infect better and evade antibodies. But we do not know how much it will affect the surge on the ground.” 

Variants of greatest concern are typically associated with a higher viral load,  increased transmissibility and  also “immune escape” – referring to variants that can evade immunity conferred by a prior infection. 

The Genomic Consortium is primarily concerned with variants that carry mutations in the characteristic spike protein of the coronavirus, which eases the virus’s way into cells, allowing it to infect individuals with COVID-19. On that spike protein, one region of greatest interest is the “receptor binding domain”, said Jameel.  

In the cases of mutations that facilitate “immune escape”  changes occur in that receptor binding domain, Jameel explained: “In the [spike protein’s] receptor binding domain, there is a path called the ‘receptor binding motif’. It contacts the cell, and from there the virus is able to enter the cell. However, antibodies [built from previous infection or immunization] can prevent its binding to the cell. 

“If the virus changes the process slightly, so that it is not recognised by antibodies it is able to enter cells more effectively,” said Jameel.

Another variant associated with “immune escape” -N44OK- also has been found in the country’s southern states of Kerala and Telangana. This variant, however, has also been reported in 16 other countries including the United Kingdom, Denmark, Singapore, Japan and Australia. 

Sequencing Is Simple – Linkage to Community Spread Is More Difficult

“While sequencing is simple, linking the sequences to community spread depends on various reports and the kinds of samples taken,” said Jameel. “To link it epidemiologically is time consuming and difficult. The mutant strain will be figured out in time, but the important thing is to stop the spread of the virus,” said Jameel.

Even in Nagpur, the cases are spreading in areas of the city that were relatively unaffected in the first wave last year, and that the population in these areas were susceptible to the virus.

A nation-wide survey showed only one out of 5 people have been exposed to the virus. But in cities such as Mumbai, Pune, Delhi the sero-surveillance shows high levels of high levels of sero-positive cases, of more than 50%.

“The most important thing to remember is that viruses will not mutate if they are not allowed to replicate. Therefore, we have to only suppress the chain of transmission to stop mutations of the virus. Testing, quarantine, and containment will limit the spread of the virus,” said Dr Vinod Paul, chairperson of India’s Covid-19 task force.

Mutations Will Not Affect India’s Vaccination Drive

These variants should  not, however, impact India’s vaccination drive, other government officials have said . “It is well established by research studies in literature and published literature, that both the vaccines that are available in our country are effective against both the UK and Brazil variants. The research regarding the South African variant is ongoing at the moment,” Balram Bhargava, director general of Indian Council of Medical Research (ICMR), said.

More than 50 million people have been vaccinated with one dose so far in the country. Much has been said about the slow pace of vaccination in the country covering only about 3% of the population. 

In the first drive of vaccination which started in January, the government only allowed healthcare workers to take the vaccine. In March, the government started the vaccination drive for people above 60 years old and people above 50 years old with co-morbidities. It has now announced that those who are 45-years and more are eligible for the vaccine.

Covid-19’s Second Wave in India

Since mid-February COVID-19 cases have been steadily rising in India. From an average of about 12,000 cases a day at the time, more than 40,000 are getting reported in the last few days.

Just six states in India – the western states of Maharashtra and Gujarat, the central state of Chhattisgarh, the northern state of Punjab and the southern states of Kerala and Karnataka –  have accounted for some 80.63% of the new cases reported in the last 24 hours, said India’s Health Ministry.

Along with any locally emerging variant, another major concern is the high number of samples identified with the UK variation (B.1.1.7) in the northern state of Punjab. The Punjab government said that 81% of the samples examined between January and early March have been found to be from that coronavirus lineage. The explanation for that is likely to be international travel – insofar as the UK is home to a large Punjabi diaspora. 

In the press conference, Singh attributed the rise in cases to the large number of people that were not infected in the first wave, and have not been vaccinated either, and so they are still  susceptible to COVID-19. With a year of the pandemic, pandemic fatigue has set in and people are perhaps lax about COVID appropriate behaviour, he said. 

Image Credits: Flickr – NIAID.

The Wellcome trust is pledging up to US $100 million (£70m/€80m) to accelerate Covid-19 research and development to ensure science keeps pace with the virus.

The funding will help advance treatments and vaccines and SARS-CoV-2 tracking research in low and middle income countries.

Announcing the funding on Wednesday, the trust said the rise and spread of COVID-19 meant new vaccines and treatments were needed along with better global systems to identify and track changes in the virus.

Jeremy Farrar, Director of Wellcome, announced massive funding on Wednesday to accelerate Covid-19 research and development.

Jeremy Farrar, Director of Wellcome, said: “More funding is vital to develop the range of treatments and vaccines the world needs – and to make sure these, and those we already have, are fairly and equally available in all countries. The job for science is a long way from done – either to exit this crisis or ensure the world can keep Covid-19 in check long-term”.

The trust said international funding was not keeping pace with global research needs. The ACT-Accelerator faces a $22.1billion global funding gap. 

Divya Shah, Wellcome’s Epidemics Research Lead, said: “Virus mutations threaten the effectiveness of the Covid-19 tools we have worked so hard to develop. We need to build capacity for genomic sequencing globally to identify new variants and map their spread to inform public health measures and further research”.

The US $100 milion package follows $80m (£60m/€70m) Wellcome pledged in 2020 for treatments, research and capacity building in low- and middle-income countries. The US $80 million included up to $50m in seed funding for the Covid-19 Therapeutics Accelerator.

 

Image Credits: Wellcome Trust.

Anthony Fauci, director of the US National Institute for Allergies and Infectious Diseases.

British-Swedish pharma company AstraZeneca may have included outdated information from their COVID-19 vaccine trial, the US National Institute of Allergy and Infectious Diseases (NIAID) said in a statement released Tuesday. 

The NIAID, part of the National Institutes of Health, urged AstraZeneca to work with the US  Data Safety and Monitoring Board (DSMB) to review the efficacy data to ensure up-to-date efficacy data can be made public as quickly as possible. 

The AstraZeneca US Phase III trial results published on Monday showed a 79% vaccine efficacy of preventing symptomatic COVID-19, and 100% efficacy at preventing severe disease and hospitalization. 

However, US health officials felt that the information was “outdated” and may have provided an incomplete view of the efficacy data. 

NIAID Director Anthony Fauci also discussed the issue during an appearance Tuesday morning on Good Morning America. 

“Because the fact is, this is likely a very good vaccine,” said Fauci. “It [just] wasn’t completely accurate.” 

Unforced Error

Fauci calls AstraZeneca’s “unforced error” something that will cause some people to doubt the vaccines and contribute to the ongoing vaccine hesitancy. 

“We essentially have to keep trying as hard as we can to get people to understand that there are safeguards in place,” he added, calling the DSMB’s ability to pick up on the discrepancy one example of a safeguard. 

While Fauci oversees the DSMB that assessed the trial results for AstraZeneca and other vaccine makers, he is not directly involved in its assessments. The final decision will be made by the US Food and Drug Administration (FDA), which will conduct their own review following the independent advisory committees. AstraZeneca plans to file with the FDA by mid-April, though their timeline relies on the DSMB clearing its trial results.  

AstraZeneca responded to the NIAID’s claims, saying in a statement that the numbers published on Monday were consistent and said it will “immediately engage with the DSMB to share our primary analysis with the most up to date efficacy data.” The company intends to issue results of the analysis within the next 48 hours.  

‘Stunned’ Health Experts Question AstraZeneca’s Credibility 

The national institute’s statement stunned experts, leaving them to question the pharma company’s credibility.  Dr Eric Topol, a clinical trials expert at Scripps Research in San Diego, called AstraZeneca’s response to the DSMB’s statement “unacceptable”. 

“They know exactly what is going on with respect to the time cutoff for primary analysis, which appears to be at odds with the independent Data and Safety Monitoring Board. It should not take 48 hours to sort out,” Topol tweeted on Tuesday.  

“Let’s see all the data, AstraZeneca,” Topol added, calling out the company. “Let’s be clear. This is not about the vaccine. It is about AstraZeneca, their own worst enemy, with an apparent breach on data dissemination. And where is the University of Oxford on this, their partner?” 

Topol had called the DSMB’s statement, which is supported by the National Institutes of Health, to be “unprecedented” in the history of large scale clinical trials. 

“I am rarely speechless. This turn of events has rendered me speechless. What a debacle,” said Helen Branswell, senior writer at Stat News.  

Branswell quoted the Washington Post, which said that the “AstraZeneca results were the equivalent of “telling your mother you got an A in a course, when you got an A in the first quiz but a C in the overall course.” 

Branswell added that, after this “extraordinary public rebuke of AstraZeneca by the DSMB”, the company team will “face tough, tough questioning.” 

Laurie Garrett, a former senior fellow at the Council on Foreign Relations, tweeted that the Board should “fire the entire AstraZeneca management team. “[The team] has made so many major blunders in launching the company’s COVID-19 vaccine that it will be a textbook study for decades in business schools and Communication departments.” 

The renewed skepticism for the pharma company in the US may counter the European Medicines Agency’s statement last week, which declared that the vaccine was safe, in spite of rare blood clotting events seen in Europe. 

 

Image Credits: Flickr, National Institutes of Health.

Globally, 785 million people lack a basic drinking-water service and over half of the world’s population could be water-stressed by 2025.

COVID has highlighted deep-seated weaknesses in urban water and sanitation systems that are vital to health – but the pandemic has also underlined how improvements can hit back at the SARS-CoV2 virus – as well as reducing other traditional waterborne diseases. 

That was a key message at a seminar Monday on “Water and Sanitation in the City” – sponsored by the Geneva Cities Hub, UN Habitat, and Geneva Water Hub, on the occasion of World Water Day. It was the first in a series of ‘Geneva Urban Debates.’ 

“COVID in some ways has given us a huge opportunity in the water sector, because it has acted as an x-ray,” said Graham Alabaster, Chief of the Geneva Office of UN Habitat. 

He pointed to evidence that showed in cities where hygiene standards were improved so as to combat the spread of the SARS-CoV2 virus, the incidence of waterborne diseases has dropped significantly. “So we know that the ideas around hygiene and providing people with water and sanitation work,” Alabaster added.

On the right, Graham Alabaster, Chief of the Geneva Office of UN Habitat, and on the left, Kamelia Kemileva, Executive Manager of Geneva Cities Hub.

Water also is a a critical “engine for economic growth” and a precondition for development, said Sami Kanaan, Mayor of Geneva and the President of the Geneva Cities Hub. It is an issue that converges with health, poverty, climate change, education, and livelihoods. 

“Increasing access to safe drinking water and basic sanitation is a crucial step in eradicating growing poverty and reducing inequality in cities,” said Kanaan. 

The importance of accessing water and sanitation has been highlighted by the COVID pandemic, whereby one of the key infection prevention measures promoted from the beginning by WHO was effective handwashing and other good hygiene measures.

And yet, in many low- and middle-income cities, low-income households and neighbourhoods are often left without reliable access to clean water and must buy it from private vendors, paying up to five times as much as that paid by middle class residents. That makes uptake of hygiene messages for disease prevention all the more challenging.  

Over Half of World’s Population May Be Water-Stressed by 2025

By 2025, over half of the world’s population will be living in water-stressed areas. And some 68% of the global population is projected to be living in cities by 2050, making urban challenges around the universal provision of safe water and sanitation all the more daunting. 

At the same time, some cities have found innovative ways to meet growing demands, and sharing urban experiences across continents can help improve cities’ performance, the panelists underlined.  

The panelists highlighted the need to move beyond an approach to water and sanitation focused merely on service provision; instead attention also needs to be paid to broader assessments of water resources, the effective distribution of water, and sustainable financing for infrastructure. 

“We need an effective multi stakeholder framework, it must be an institutional will and institutional intention at the city level, with the support of the upper institutional levels,” said Kanaan. “Water management needs cooperation of all levels.”

Sami Kanaan, Mayor of Geneva and President of the Geneva Cities Hub, at the ‘Water & Sanitation in Cities’ event on Monday.

“Sustainable management of fresh water is a vital issue of this century at the center of health security, food security, energy security, and in short human security,” said François Münger, General Director of the Geneva Water Hub. 

Conference Featured Stories from Kenya, Tanzania, Nepal & Mauritania 

The conference featured good practices from cities in in Mauritania, Tanzania, Nepal and Kenya highlighting how public and public-private partnerships involved in managing urban water and sanitation had brought about change, in some of the following ways: 

Informal settlements in Dar-es-Salam, Tanzania.

Dar-es-Salaam in Tanzania – Only 10% of the city’s 7 million people have sewer connections or safe onsite septic tanks.  New approaches have revolved around “simplified sewerage” hookups, that involve laying small diameter pipes at a fairly flat gradient/slope to sewer ponds. The municipal water and sewerage utility provide technical support and finance, while households in the community provide space and labour to lay the pipes. A more recent pilot has connected households to a community-based waste water treatment plant (DEWAT) that produces biogas from the methane extracted from the sewage. The biogas then provides a clean and climate friendly fuel source for household cooking.

Nairobi, Kenya – Chronic water shortages affecting some 60% of the population have been traced to the conversion of wetlands and forests that form the watershed for the Tana River – into agriculture land. The unsustainable agricultural development has increased volumes of sedimentation that enter the river with rainfall, reducing the flow of the river and its watershed which supply 95% of the water for Nairobi’s population and causing blockages in water treatment facilities.

Several public and private partners joined to provide training and tools to over 25,000 farmers upstream on river and soil conservation and to restore forest land. These efforts have benefited farmers, by increasing agricultural yields by over US$3 million per year, and city residents, with 27 million more litres of water available every day for the city’s water needs.

The steps involved in the Upper Tana Nairobi Water Fund project in Kenya.

Dhulikhe, Nepal –  A national sanitation and hygiene campaign was launched in 2010, leading to the prioritisation of investment in sanitation facilities and increasing access to sanitation for the majority of households. In the country’s Dhulikhel municipality, the local government passed a ‘’one house, one tap’’ policy with the goal of providing safe drinking water to every household in the city. The plan arranged for every resident to get 65 liters of water per day. 

Dhulikhel also joined Banepa and Panauti, all in the Kavre district, to collaborate and manage drinking water in an integrated manner. The project identified and mapped existing drinking water sources and established Water Supply User Committees to represent and engage local communities in governmental water supply schemes and improve investment in the needs of communities.

Health Impacts of Poor Access to Clean Water and Sanitation 

Long before COVID, diarrhoea was estimated to kill some 829,000 people a year, as a result of unsafe drinking water and poor sanitation, according to the World Health Organization. Contaminated drinking water – which may be due to the encroachment of sewage or industrial pollutants into drinking water resources – is estimated to cause 485, 000 diarrhoeal deaths each year.

Many neglected tropical diseases (NTDs), which infect millions of people worldwide, are water or hygiene-related and are most often found in places with unsafe drinking water, poor sanitation, and insufficient hygiene practices.

Some of the biggest challenges occur in fast-growing cities, where sprawling informal settlements often develop on the periphery, without adequate water and sanitation infrastructure planning – leaving only ad hoc approaches. 

Poor sanitation in informal settlements disproportionately impacts women and girls, with an estimated 335 million girls attending schools without access to safe latrines, not to mention water and soap for hygiene. Deprived of adequate sanitation and hygiene facilities, adolescent girls may just avoid school on days when they are menstruating.  

Improved water, sanitation and hygiene has the potential to prevent at least 9.1% of the global disease burden and 6.3% of all deaths, according to the US Centers for Disease Control and Prevention.

Image Credits: UNHCR, Geneva Cities Hub, Geneva Cities Hub.

The Oxford/AstraZeneca COVID-19 vaccine during the vaccine development process.

In news that should be reassuring for skeptics, the Oxford/AstraZeneca COVID-19 vaccine was found to be 79% effective in preventing symptomatic COVID-19 and 100% effective against severe disease and hospitalization in results of a late-stage clinical trial, published today by the pharma company.

What’s more, analysis of safety results by an independent board found no increased risk of blood-clotting (thrombosis) among the trial participants, the company said in it’s statement – reinforcing findings of the European Medicines Agency (EMA) last week that the vaccine is safe – despite some rare blood clotting events seen in Europe, particularly among young women, that warrant further investigation.

Among trial participants over the age of 65, the vaccine efficacy rate reached 80%. This news is also reassuring, given the limited data on the vaccine efficacy in older individuals that had been seen to date, and which had led many EU countries to set age restrictions on the AstraZeneca vaccine in the first phases of rollout. 

The results of the large-scale trial, with many participants in the United States, also are expected to pave the way for approval of the vaccine by the United States Food and Drug Administration (FDA).

EMA Executive Director Emer Cooke reports the results of the body’s safety committee report  on the AstraZeneca vaccine last week.
New AZ Trial Results – United States, Peru & Chile

The new trial was conducted in the US, Peru and Chile, with 32,449 participants. Efficacy was consistent across age and ethnicity, although 79% of the participants were white, 22% were hispanic, and only 8% were black, 4% asian, and 4% native American. 

In the initial set of Phase 3 trials, which had taken place largely in the United Kingdom and Brazil, only 12% of participants were older than 55. In contrast, the newly reported US trial arm had one fifth of the participants over 65 and approximately 60% had co-morbidities – which would normally increase their risk of developing severe illness, including diabetes, severe obesity, and cardiac disease.

“These findings reconfirm previous results observed in AZD1222 trials across all adult populations, but it’s exciting to see similar efficacy results in people over 65 for the first time,” said Ann Falsey, co-lead Principal Investigator for the US trial, in a press release issued by the pharma company. 

“This analysis validates the AstraZeneca COVID-19 vaccine as a much-needed additional vaccination option, offering confidence that adults of all ages can benefit from protection against the virus,” she added. 

AstraZeneca said that it now plans to submit these findings to the FDA in the coming weeks to receive emergency use authorization. The primary analysis of the data, once it is completed, will also be submitted for peer-reviewed publication.

Planned Delivery of Doses

Meanwhile, AstraZeneca announced on Monday in a press conference that it would deliver 30 million doses of the vaccine to the United States in the first half of April after receiving approval and another 20 million later on in the same month. Subsequently, 15 to 20 million doses will be delivered. 

US health officials have predicted that the country will have enough doses to vaccinate every adult by May using the three vaccines currently approved – Pfizer/BioNTech, Moderna, and Johnson & Johnson.

It is unclear how big of a role the AstraZeneca vaccine will play in the US’ vaccination campaign and whether the government will donate excess doses to countries lacking in vaccines.

At a press conference on Monday, Ruud Dobber, President of AstraZeneca’s Biopharmaceuticals Business Unit, said he would be “very surprised” if the doses were not used to vaccinate Americans. 

Blood Clots and Vaccine Hesitancy
From Europe, concerns have spread worldwide. (on right) Paul Kelly, Australia’s Chief Medical Officer addresses blood clot concerns over AstraZeneca vaccine.

In addition to the trial results, an independent data safety monitoring board (DSMB) conducted a specific review of thrombotic events, including cerebral venous sinus thrombosis (CVST) – a rare disorder of clots in vessels draining from the brain – seen in association with the vaccine’s administration in a number of cases in Europe.

The board found no increased risk of thrombosis among the trial participants, echoing the message from the EMA last week, which stated that the vaccine is safe and effective. 

“We hope this will lead to even more widespread use of the vaccine in the global attempts to bring the pandemic to an end,” said Sarah Gilbert, Professor of vaccinology at Oxford University and co-designer of the vaccine.

According to the latest EMA data, of an estimated 20 million people in the United Kingdom and Europe that had received the vaccine as of March 16, the EMA had identified 18 cases of CVST (cerebral events), occurring shortly after vaccine administration, as well as seven other cases of disseminated intravascular coagulation, DIC.

Although no causal connection has been found between the vaccine and the blood clotting, and several countries have now resumed the rollout of the vaccine, trust in AstraZeneca’s vaccine has taken a hit, particularly in Spain, Germany, France and Italy. 

In a poll conducted by YouGov in March, which included 8,000 participants in seven European countries, respondents were more likely to view the AstraZeneca vaccine as unsafe than safe. 

Some 61% of French, 55% of Germans, 52% of Spaniards, and 43% of Italians said it was unsafe. Confidence in the vaccine has fallen since a poll conducted in February.

“After concerns about its protection and potency were raised by leaders across Europe, the Oxford/AstraZeneca vaccine has undoubtedly suffered damage to its reputation for safety on the Continent,” said Matt Smith, lead data journalist at YouGov, in a statement.

“Not only have we seen considerable rises in those who consider it unsafe in the last two weeks in Europe, the AstraZeneca vaccine continues to be seen as substantially less safe than its Pfizer and Moderna counterparts,” Smith added.

The same decline in public confidence was not seen in the UK, where 77% of participants considered the jab safe. 

According to William Schaffner, Professor of Medicine in Infectious Diseases at the Vanderbilt University School of Medicine, “there will be spillover to the United States, where…there is a substantial group of vaccine hesitant and skeptical people whom we have yet to win over. And all of this discussion, I’m sure, gives them further pause,” he said in an interview with CNBC.

The vaccine has been granted authorization in over 70 countries and received Emergency Use Listing from WHO, leading the way for its use in the COVAX facility to supply low- and middle-income countries with vaccines. 

Serum Institute of India Announces Delays in Supply of AZ Vaccine to several countries.

In other AstraZeneca vaccine news, the Serum Institute of India, a pharma company producing the Oxford/AstraZeneca vaccine for many low-  and middle-income countries, informed Brazil, Morocco and Saudi Arabia that there will be a delay in delivering vaccines they ordered due to a fire in one of the production buildings.

This has “caused obstacles to the expansion of our monthly manufacturing output,” said the Serum Institute in a statement delivered to the Fiocruz Institute in Brazil. 

The statement contradicted one that was provided immediately after the fire took place in which SII said that it would have no effect on vaccine production.

On a brighter side, the company said a production factory in the Netherlands could soon be approved by the EMA. This would expand the doses available to the EU, which has been plagued by vaccine shortages and a slow rollout across the 27-member bloc. 

The announcement came after several months of dispute between AstraZeneca and the European Union over manufacturing hiccups and vaccine supply constraints.   

At the same time, AstraZeneca is the major vaccine supplier of the WHO co-supported COVAX initiative  – and even as production in Europe and the United States moves into higher gear, it may be expected that countries in those regions will come under increased scrutiny for holding onto precious vaccine doses – while LMICs continue to wait.    

“AstraZeneca continues to engage with governments, multilateral organizations and collaborators around the world to ensure broad and equitable access to the vaccine at no profit for the duration of the pandemic,” said AstraZeneca’s statement. 

Image Credits: gencat cat/Flickr, University of Oxford, Sophie Scott/ABC.

Dr Tereza Kasaeva, Director of WHO’s Global TB Programme.

An estimated 1.4 million fewer people received care for tuberculosis (TB) in 2020 than in 2019 – a drop of 21% – according to preliminary data compiled by the World Health Organization (WHO) from over 80 countries.

Countries worst affected are Indonesia (42%), South Africa (41%), Philippines (37%) and India (25%), and the WHO fears that over half a million more people may have died from TB ilast year simply because they were unable to obtain a diagnosis.

“The effects of COVID-19 go far beyond the death and disease caused by the virus itself. The disruption to essential services for people with TB is just one tragic example of the ways the pandemic is disproportionately affecting some of the world’s poorest people, who were already at higher risk for TB,” said Dr Tedros Adhanom Ghebreyesus, WHO Director-General. 

“These sobering data point to the need for countries to make universal health coverage a key priority as they respond to and recover from the pandemic, to ensure access to essential services for TB and all diseases.”

The WHO report follows a report released last week by the Stop TB Partnership which showed that the drop in people diagnosed and treated for TB in nine high-burden countries had dropped to 2008 levels – a setback of 12 years.

New TB Screening Guidelines

“Twelve years of impressive gains in the fight against TB, including in reducing the number of people who were missing from TB care, have been tragically reversed by another virulent respiratory infection,” said Dr. Lucica Ditiu, Executive Director of the Stop TB Partnership.

“In the process, we put the lives and livelihoods of millions of people in jeopardy. I hope that in 2021 we buckle up and we smartly address, at the same time, TB and COVID-19 as two airborne diseases with similar symptoms.”

To mitigate the impact of COVID-19 on service delivery, the WHO has developed new screening guidance, including the use of rapid diagnostic tests, computer-aided detection to interpret chest radiography and the use of a wider range of approaches for screening people living with HIV for TB. 

The WHO recommends that the contacts of TB patients, people living with HIV, people exposed to silica, prisoners and other key populations should be prioritized for TB screening. 

People With TB Most Marginalised

“For centuries, people with TB have been among the most marginalized and vulnerable. COVID-19 has intensified the disparities in living conditions and ability to access services both within and between countries,” says Dr Tereza Kasaeva, Director of WHO’s Global TB Programme.

“We must now make a renewed effort to work together to ensure that TB programmes are strong enough to deliver during any future emergency – and look for innovative ways to do this.”

The new guidance also recommends different tools for screening, namely symptom screening, chest radiography, computer-aided detection software, molecular WHO-approved rapid diagnostic tests, and C-reactive protein. 

As the popularity of tobacco products wanes, tobacco companies are developing new products to expand their markets.

NAIROBI – The Kenyan government issued a directive in mid-February this year requiring the tobacco industry to register all nicotine products as tobacco products – but the industry has yet to comply. 

This follows the decision by the Cabinet Secretary in the Ministry of Health, Mutahi Kagwe, to declare “nicotine pouches” illegal, thus overturning a decision last year by the Pharmacy and Poisons Board (PPB) to license the manufacture and sale of nicotine products in the country.

 The criteria used to issue the license was not clearly defined, according to the Ministry of Health, hence the unprecedented move by the Cabinet Secretary.

The government’s directive comes in the wake of a nicotine production plant by the British American Tobacco (BAT) company being planned in Kenya. The plant will not only serve the east African region with nicotine products but will cater for the entire African market, making Kenya the gateway for nicotine products into the continent.

 Marketing Hub for Harmful Product

“Kenya is a manufacturing hub of this harmful tobacco product. It is unfortunate that they [BAT Kenya] are putting up another plant specifically to produce Lyft,” said Samuel Ochieng, CEO of the Consumer Information Network at a press briefing called by the Kenya Tobacco Control Alliance towards the end of February.

Lyft is the brand name for the “nicotine pouches” being manufactured by BAT. These pouches are small bags of powder containing either tobacco-derived nicotine or synthetic nicotine, but no tobacco leaf, dust, or stem. People place them under the lip to get nicotine. 

All this comes a year after the Cabinet Secretary in the Ministry of Health, Mutahi Kagwe overturned an earlier decision by the Pharmacy and Poisons Board (PPB) to license the manufacture and sale of nicotine products in the country.

The criteria used to issue the license was not clearly defined, according to the Ministry of Health, hence the unprecedented move by the Cabinet Secretary.

When asked about the government’s position on why Kenya was singled out by the tobacco multinational company, Kepha Ombacho, the Chief Public Health Officer in the Ministry of Health, told Health Policy Watch: “We cannot say for sure that they are targeting Kenya.”

Trying to Diversity Product Line

The tobacco industry is trying to diversify its product line after years of well-documented health risks associated with smoking has had an impact on consumers and industry profits. 

In the past week, the WHO published a new report calling for the strengthening of the tobacco control measures to protect the health of children.

The study, Tobacco Control To Improve Child Health and Development  found that of the 1.2 million deaths every year caused by second-hand tobacco smoke exhaled by smokers, 65,000 occur among children under 15 years.

However, the third edition of the WHO global report on the trends in prevalence of tobacco use 2000-2025 published in 2019 shows a decline in tobacco use among people of both sexes in the world.

According to the report, about a third of the global population aged 15 years and above used of some form of tobacco in 2000. This rate declined by nearly 10% to about a quarter by 2015.

If current tobacco control efforts are maintained, the rate is projected to decline to around a fifth of the (20.9%) by the year 2025, says the report.

Use of Social Media Influencers

The furore generated by the Lyft nicotine pouches in Kenya was well captured by The Guardian in February, which detailed how the brand was using social media influencers to promote Lyft. 

The influencer in the article is a young beauty blogger with an Instagram following of more than 250,000 and a Youtube channel following of well over 55,000 subscribers. She appears to have deactivated her account and removed the Lyft tweets since the expose.

Meanwhile, a PR agent working for BAT even offered a Kenyan journalist a bribe to leak details about an investigation by Bureau for Investigative Journalism into how tobacco companies were targeting young people. BAT has since suspended the agency.

It is clear from these reports that tobacco companies have been using influencers that are popular among the youth to push their nicotine products.

This is made more serious because Kenya is a signatory to the WHO’s Framework Convention of Tobacco Control (FCTC). Article 13 of the Convention clearly talks about banning all forms of tobacco advertising, promotion and sponsorship.

 The Ministry of Head’s Ombacho says that Lyft and any products that contain nicotine are not alternative products to tobacco and should be accompanied by clear labeling stating as much.

 Significant Health Risks

According to the Tobacco Act of 2007, tobacco companies are required to set aside 2% of their revenue to go into the Tobacco Fund to assist people suffering from the health effects associated with smoking.

Only BAT has started to make contributions to the fund although there are at least three active tobacco companies in Kenya, and Ombacho said that “they will just have to comply”.

Nicotine pouches appear to have been developed in Scandinavia. They have significant health risks. Issuing a health warning about them last November, Health Canada warned that they had not been authorised in the country and should not be used “by anyone”

“Nicotine is a highly toxic and addictive substance. Excessive amounts of nicotine can cause acute poisoning, resulting in respiratory failure and death,” according to Health Canada.

Image Credits: By Bystroushaak/ CC BY-SA 4.0, Chris Vaughan.

Vaccination rollout in Accra, Ghana

Mayors from three capital cities in the global south have appealed for speedy “technology transfer” to enable them to produce their own COVID-19 vaccines at Friday’s World Health Organization (WHO) bi-weekly COVID-19 media briefing.

The mayors’ appeal comes on the eve of a meeting next week between WHO Director General Dr Tedros Adhanom Ghebreyesus and World Trade Organization (WTO) Director General Dr Ngozi Okonjo-Iweala to discuss “how to overcome the barriers to boost production vaccine equity”, said Tedros.

Adjei Sowah, mayor of Accra in Ghana, said that his city had almost used up all 300,000 vaccine doses it had received recently via COVAX – yet it has a population of five million including a two-million strong transient population which could be spreading the virus to rural areas.

To achieve vaccine equity, Sowah proposed that rich countries “share their surplus doses” and the “acceleration of technology transfer” to enable manufacturing in Ghana and other countries in order to “reach herd immunity as quickly as possible”. 

‘Finish and Fit’ Possible in Bogota

Mayor Claudia Lopez from Bogota in Colombia, with a population of 11 million, said that her city would need to vaccinate six million people to achieve herd immunity – but it lacked the doses to do so.

Bogota had been able to produce vaccines until 2001 but “because we did not have the sufficient investment in research and biotechnology, we lost that capacity”, said Lopez.

She appealed to the WHO to assist her city to get investment to enable vaccine production – starting with “finish and fit”, the assembly of vaccine products once the biological component had been made elsewhere.

“We do face the real risk of a third wave and it is vital that, before May we have vaccinated, everybody over the age of 60 and all healthcare professionals. So that means that we need 2.6 million doses in the next couple of months,” said Lopez.

Mayor Yvonne Aki-Sawyerr of Freetown Sierra Leone

Mayor Yvonne Aki-Sawyerr, representing Freetown in Sierra Leone and one of the poorest countries in the world, said her city’s vaccine rollout had started with week with 296,000 doses of AstraZeneca (two doses needed per person).

At a meeting over the past week with mayors from the C40, a network of 97 of the world’s biggest capital cities’, Aki-Sawyerr said it was “really fascinating” to hear from cities such as Los Angeles “who are able to talk about a mass vaccination rollout, in contrast to some of us”.

While Freetown had only recorded 2,222 COVID-19 cases and 80 deaths ”you’d almost think that COVID had passed us by, but it hasn’t because the economic impact has been significant”, said Aki-Sawyerr of her city of slightly over a million people.

“What we face, and what other countries and cities in emerging economies that don’t have the access to the vaccine in the same way as countries who are ordering five times what they require and holding on to these, is economic exclusion and greater inequality,” said Aki-Sawyerr.

“We face a risk of being in a situation where vaccine passes are needed for travel, and that could certainly have an impact on tourism,” she said. “We are very concerned about how this will move from a disparity in a vaccine rollout to reinforcing inequalities, reinforcing economic exclusion and thereby putting everyone at risk.”

 

Independent Panel Still Seeking Views Ahead of Submission Date

 

If the world’s pandemic preparedness, alert and response system had been working properly, the COVID-19 pandemic would not have had such “catastrophic consequences”, according to Helen Clark, co-chair of the Independent Panel for Pandemic Preparedness and Response.

So far,  the pandemic has cost 2.6 million lives, had a substantial impact on the education of  millions of children and is projected to have cost economies $22 trillion by 2025, according to a media release from the panel on Friday following a two-day meeting.

“If the existing system, from the global to the national levels was good enough, the worst would not have happened,” said Helen Clark, former Prime Minister of New Zealand, co-chair of the panel, at the opening of the meeting. “The status quo isn’t just not good enough; it has actually had catastrophic consequences,” she said. 

The panel is considering a range of recommendations aimed at “resetting the international pandemic preparedness and alert system” as it prepares its final report to be presented to the World Health Organization (WHO) in May.

These include solving the problems of speed and transparency in alert and response; country preparedness; the authority of and support for the WHO and equitable access to diagnostics, therapeutics, and vaccines. It is also still taking submissions to its website.

Eleven Million Girls Have Dropped Out of School

The 13-person panel reflected on the International Monetary Fund’s projection that COVID-19 will cost $22 trillion in projected cumulative output loss over 2020-2025 relative to pre-pandemic projections.  

It also noted the World Bank report that, as a result of the pandemic and school closures, 72 million more primary school-aged children may not be able to read or understand a simple text by the age of 10. Some 11 million girls are estimated to have dropped out of school.

Co-Chair Ellen Johnson Sirleaf, former president of Liberia, stressed that behind those enormous numbers are millions of people who have suffered incalculable setbacks, from which recovery will be difficult.  

“People who are poor, people who are marginalized, and those who have faced structural injustices have been at a great disadvantage during the pandemic. This must not continue through the recovery. We must keep their lives and their voices at the heart of our conclusions and recommendations.” 

The Independent Panel was established by the WHO’s Director-General to review experience gained and lessons learned from the WHO-coordinated international response to COVID-19.    

 

 

Image Credits: Gavi/2021/Jeffrey Atsuson.

Dentists are confronting the fallout from a year of disrupted dental care and treatment.

One of the unquantified side effects (or health impacts) of the pandemic has been in a place few people cared to look very deeply – that is our mouths.

For significant parts of the past year, dentists’ chairs in many offices around the world sat empty – as COVID-19 disrupted routine dental treatments. During the early days of the first lockdowns a year ago, we were able to accept patients for emergency dental treatments only.

Patients’ fear of leaving their homes resulted in delays and cancellations of regular check–ups, while others simply delayed pending treatment. And most of the patients we saw during this period were suffering from severe tooth pain resulting from unfinished or delayed treatment, ultimately culminating in either an extraction or a permanent restoration of the tooth.

On top of that, the dental profession had been called out (falsely) as being one of the most unsafe in terms of pandemic risks.

COVID-19 and Dental Safety

Most dental practices have now been able to re-open (both in and out of lockdowns), by reinforcing our already stringent infection prevention and control protocols as necessary and according to regulations.

We also have updated data showing that the profession has experienced significantly lower infection rates of SARS-CoV-2 than other healthcare professions in the USA, in Europe and beyond.

Preliminary data on the COVID-19 infection rate among dentists and other healthcare workers, suggest that COVID-19 infection in dental practice may be less likely than in other healthcare settings.

Dental practices are proven to be safe. Despite this, an underlying fear in the general public of contracting COVID-19 persists and has resulted in many of our patients delaying regular check-ups and only booking an appointment once they are already in pain or with infections that require complicated treatment. We encourage our higher-risk patients to have a dental check-up every three to six months – many have quite clearly put off a visit for nearly a year, which has led to extractions that could have been avoided.

This is serious cause for alarm, as these initial oral health issues can transform into broader health concerns. High-risk patients – tobacco users, pregnant women, people with diabetes – who are more susceptible to gum disease and tooth decay can also be more vulnerable to other diseases. Poor oral health has been linked to a host of other health conditions including heart disease and stroke, cancers, and respiratory disorders.

If the call for investing in health systems as part of universal health coverage has largely fallen on deaf ears until now, COVID-19 has certainly forced the issue. This pandemic has severely exacerbated health inequities across the spectrum.

Increasing Burden of Oral Disease

It has never been more apparent that overall health and oral health are absolutely intertwined and cannot exist independently. This World Oral Health Day we need to acknowledge the reality that precedes COVID-19: a picture of an increasing burden of oral disease across the board, matched by inadequate population-level prevention strategies and ineffective care for those in need. We must advocate for oral health professionals (and our profession more broadly) to be actively involved in all efforts to improve health for all and leave no one behind.

Optimal oral health for all is certainly an aspirational goal, but what does it actually stand for? How can we make this goal truly meaningful to oral health professionals, patients and people alike?

Universal Coverage for Oral Health

Any genuine move towards oral health for all first needs to embrace the idea of universal coverage for oral health. This starts with driving better oral health awareness campaigns for public benefit, guaranteeing that by 2030 essential oral health services are integrated into primary healthcare in every country. This shift requires focusing on prevention and early detection of diseases, making oral healthcare available and accessible in both urban and rural areas, and ensuring the affordability of appropriate oral healthcare for all.

It will also be essential to integrate oral health into the general health and development agenda by 2030. This means addressing the shared social, moral, and commercial determinants of health and recognising that untreated oral disease is the most common health condition globally—accounting for a considerable fraction of the overall noncommunicable disease burden.

A Resilient Oral Health Workforce

Finally, by 2030, we need to build a resilient oral health workforce by tackling both the plethora and scarcity of oral health professionals and auxiliaries. This model of an oral health workforce would focus on the prevention of oral diseases; screen for and monitor systemic health conditions; integrate environmentally friendly, innovative, and appropriate technologies to benefit patients; and implement oral health resource and workforce planning in cooperation with governments, educators, and oral health professionals.

Let’s not overlook the obvious: as dentists, we are highly skilled health professionals allied with our medical colleagues. Just look to the role many dentists are playing in delivering the COVID-19 vaccine around the world today. This pandemic has also confirmed that we are veterans in adopting those measures considered to protect against the novel coronavirus: protective gear like masks, gloves, and goggles as well as well as established sterilization and disinfection procedures. Our value should not be underestimated, today and in the future.

Dentists have played an important role in testing for COVID-19 and delivering vaccines around the world.

Oral Health for All

Oral health for all will not happen overnight – it will require ongoing education and awareness around the broader health issues linked with noncommunicable diseases that help to change the narrative and reinforce oral health as an essential health priority. We must focus on evidence-based dentistry and critical thinking, educate and train oral healthcare professionals to advocate for oral health, empower our patients to take responsibility for their own health and well-being, and engage with industry partners around emerging technologies.

The goal of oral heath for all will also require the collective vision and engagement of many stakeholders across the spectrum: industry partners, academics, educators, and researchers.

And let’s not forget policy makers. Governments at all levels must commit to leading the conversation around oral health in their countries and allocate sufficient resources to tackle the oral disease burden.

Perhaps most critically, we need the buy-in of the population at large, who are potentially the most powerful advocates of all to lead the world to optimal oral health.

Dr Gerhard Konrad Seeberger, president of FDI World Dental Federation.

Dr Gerhard Konrad Seeberger is president of FDI World Dental Federation and a private practitioner based in Cagliari, Italy. He is a member of numerous scientific societies (implant dentistry, periodontology). and a regular contributor to Italian and international journals. He was awarded a doctor honoris causa in medicine from Yerevan State University in Armenia and is an honorary member of several national dental associations (Bulgarian Dental Association, Chicago Dental Society, Mexican Dental Association, Romanian Association of Private Practitioners).

Image Credits: FDI World Dental Federation, FDI World Dental Federation, Flickr – Navy Medicine, FDI World Dental Federation.

African countries will be hosting a conference in April to discuss the local production of vaccines.

IBADAN – African countries are hosting a large conference in April to discuss the local production of vaccines, as key players in Africa’s public health sector try to address the continent’s vaccine shortages.

Circumstances surrounding the COVID-19 vaccine production and distribution had necessitated this conversation, William Kwabena Ampofo, Chairperson of African Vaccine Manufacturing Initiative, said during a press conference on Thursday. The conference will take place on 12 and 13 April.

Currently, many African countries are getting most of their COVID-19 vaccines through the global distribution platform, COVAX.

“The current COVID-19 pandemic presents a great opportunity to harness the various conversations and proposals into an action-oriented roadmap led by the African Union and the World Health Organization (WHO) in Africa. And this will lead to increased vaccine production that will facilitate immunization of childhood diseases and enable us to control outbreaks of highly infectious pathogens,” he said. 

William Kwabena Ampofo, Chairperson of African Vaccine Manufacturing Initiative.

However, he admitted that Africa only has about 10 vaccine manufacturers based in 5 countries – South Africa, Morocco, Tunisia, Egypt and Senegal – and most were only doing packaging, labelling and filling, rather than the actual production of the vaccine. But Africa has about 80 companies with pharmaceutical production capacity and the manufacturing of sterile injectables, which provided a great opportunity, added Ampofo.

“In Africa, we usually use a primary dosage form, so there is the opportunity to really consider vaccine manufacturing as a major activity that will provide substantial financial returns to the various countries in the different economic blocs if the vaccine supply and chain is well structured,” Ampofo said.

African Health Leaders and Scientist Advocating for Local Production of COVID Vaccines

Even though the COVAX Facility has promised African countries and other beneficiaries 20% of their respective COVID-19 vaccine needs, many more doses are required to achieve herd immunity. 

In addition, Africa CDC Director John Nkengasong said citizens may need booster shots if the protection offered by the vaccine wears off. These are among the reasons why Africa’s public health leaders and scientists are advocating for the continent to be able to produce the COVID-19 vaccines. Beyond COVID-19, Africa heavily relies on UNICEF and the global alliance, Gavi, for its yellow fever and other vaccines. But there are problems ahead. The biggest, Ampofo said, is the way the market is structured. Addressing this will require active involvement of organisational blocs such as the AU.

“We need the regional economic blocs to take care of a very strategic view of how the countries are interdependent. So that production would be geared towards supplying not just a country but meeting regional needs and establishing a system which sustains vaccine production on the continent,” he said.

Covering Ground

Matshidiso Moeti, WHO Regional Director for Africa.

While the local vaccination plans and discussions are continuing, Dr Matshidiso Moeti, the WHO Regional Director for Africa said the continent is rapidly gaining back lost grounds due to the late arrival of doses of the vaccines. 

“Compared with countries in other regions that accessed vaccines much earlier, the initial rollout phase in some African countries has reached a far higher number of people,” Moeti said.

She attributed the development to Africa’s vast experience in mass vaccination campaigns and the determination of its leaders and people to effectively curb COVID-19.

According to the WHO, two weeks after receiving COVAX-funded AstraZeneca vaccines, Ghana has administered more than 420,000 doses and covered over 60% of the targeted population in the first phase in the Greater Accra region – the hardest hit by the pandemic. In the first nine days, it is estimated the country delivered doses to around 90% of health workers. 

In Morocco, WHO said more than 5.6 million vaccinations have taken place in the past seven weeks, while in Angola, vaccines have reached over 49 000 people, including more than 28 000 health workers in the past week. 

“While the rollout is going well, there is an urgent need for more doses as Ghana, Rwanda and other countries are on the brink of running dry,” Moeti said.

Image Credits: Johnson & Johnson, African Vaccine Manufacturing Initiative, Paul Adepoju.