european commission
Katalin Cseh a Hungarian MEP associated with the  Renew Europe Group.
EP Plenary session – Preparation of the European Council meeting of 25 and 26 March 2021 and Digital Green Certificate

European Parliament members (MEPs) expressed overwhelming support for a coronavirus-related “Digital Green Certificate” to ease travel within the European Union, voting by a more than two-thirds majority to accelerate approval by the summer.  

But parliamentarians also warned that all efforts to recover from COVID-19 will be void unless Europeans are vaccinated more quickly. 

“We need to speed up vaccination – that is the only light at the end of the tunnel,” said Katalin Cseh a Hungarian MEP associated with the  Renew Europe Group, on the opening day of a two-day debate at the European Union Summit  happening today and tomorrow on the “Digital Green Certificate”.

“We need to increase production capacities to set up more ambitious targets for deliveries to work together with manufacturers, and also to ramp up production,” said Cseh. 

“Only vaccines can offer us a way out of the crisis; we need to do our utmost to help boost vaccine production and ensure more transparency, predictability, and supply of the vaccines, so that we can speed up the vaccination campaigns across the EU,” said Ana Paula Zacarias of Portugal. 

The majority of the MEPs who took the floor said the Digital Green Certificate proposed by the European Commission on 17 March, would support the much-needed recovery of the travel and tourism sector. 

With 468 votes in favor, 203 against, and 16 abstentions, MEPs took advantage of an urgency procedure (Rule 163), which allows for faster parliamentary scrutiny of the Commission’s proposals. The MEPs will next mandate negotiations over the proposal, to be considered during the parliament’s next plenary session (26 – 29 April). 

Certificate To Offer Proof of COVID Vaccination, Recovery Or Negative Test Result
digital green certificate
The stages of the Digital Green Certificate System in practice.

The certificate would be free of charge, in digital or paper format, with a QR code to help ensure security and authenticity.  It would offer proof that a person has either been vaccinated, received a negative test result, or recovered from COVID-19, and has antibodies. 

Other key provisions are that the certificate will be recognized in every EU member state, and it will pave the way for the establishment, or re-establishment, of  full freedom of movement inside the EU during the COVID-19 pandemic. 

“The Commission will build a gateway to ensure all certificates can be verified across the European Union, and will support member states in the technical implementation of certificates,” said Commission Vice-President Maroš Šefčovič. Šefčovič said the Commission aims to have the system in place by June. 

MEPs Call For Legal Action Over AstraZeneca Vaccine Delays & Unreported  Doses 
AstraZeneca vaccine

In terms of speeding up Europe’s vaccine rollout, the MEPs focused most of their fire on the recent AstraZeneca delays in vaccine deliveries. 

Concerns over the failure of the company to meet its EU commitments have been compounded by the  recent discovery of almost 30 million undelivered AstraZeneca doses stashed  in an Italian factory. 

During the debate,  several MEPs speakers called for legal action against the manufacturer.  

Iratxe Garcia Perez, Group of the Progressive Alliance of Socialists and Democrats in the European Parliament, Spain, called the reports about AstraZeneca’s undelivered doses “the straw that broke the camel’s back.” 

“We’re not talking about the fact that they are not complying with their commitments and the contracts. Basically, they’re laughing at us in our faces,” she said. 

The AstraZeneca vaccines were discovered by Italian police in a raid of a factory in Anagni, a town near Rome.  Italian government officials were reportedly unaware of the vaccine stash until the EU’s internal market commissioner, Thierry Breton, launched an investigation, and then tipped off Italian police, according to the Italian newspaper La Stampa. 

Some EU sources said that the jabs had initially been bound for the UK – before being  blocked by Italy after the country introduced new rules on vaccine exports, EU sources told the paper. 

However, in a statement on Wednesday, AstraZeneca said that 16 million of the vaccine doses were simply awaiting quality control to be disbursed to EU countries.  

Another 13 million doses were manufactured outside of the EU, and then brought to the plant for the “fill and finish” process of putting the vaccine into vials, the company said. These doses are awaiting shipment to low and middle-income countries, in the framework of the WHO co-sponsored COVAX global vaccine rollout initiative, which is supported by the EU. 

“It is incorrect to describe this as a stockpile. The process of manufacturing vaccines is very complex and time consuming. In particular, vaccine doses must wait for quality control clearance after the filling of vials is completed,”  the company said.  

Garcia Perez and other MEPs, however, blamed  AstraZeneca for still moving too slowly on the EU vaccine deliveries. 

“[We] have to act firmly and take actions against a pharmaceutical company because they are undermining the prestige of other companies that are meeting their obligations. So I would urge the Commission to get down to work and do something about this flagrant attack against the commitments that the company undertook, “ said Garcia Perez. 

Independence From Pharma, Though Not Through Export Ban 
Martin Schirdewan, of The Left Group in the European Parliament, Germany.

Although several MEPs called for legal action against AstraZeneca to restrain it from exporting vaccines to the UK and elsewhere in the world, others warned that an export ban could result in further delays in Europe’s vaccine rollout. 

“Export bans can lead to retaliatory measures and that could lead to lower production of vaccines in the EU. We could end up in the worst possible situation where nobody benefits,” said Martin Schirdewan, of The Left Group in the European Parliament, Germany.

Schirdewan, however, called on the European Commission to “give up all contracts with the pharmaceutical companies and release the patents to produce the vaccines.” 

“We have made ourselves dependent on the pharmaceutical companies. We have made ourselves dependent on a market that regulates nothing, shown clearly by AstraZeneca stockpiling 29 million doses in Italy that have just been accidentally discovered.” 

“Let’s create a joint European strategy that we can use to combat the virus. Let’s coordinate healthcare, let’s deal with the social and economic consequences of this pandemic for our populations.” 

 

Image Credits: Jan Van De Vel, European Commission, gencat cat/Flickr, Alexis Haulot.

rapid antigen test
A new study suggests that administration to travelers of a rapid antigen test upon arrival at their destination, may be just as effective as quarantine requirements, to stop imports of COVID-19 cases.

A new study published by a consortium of UK-based airline industry interests suggested that administration to travelers of a rapid antigen test upon arrival at their destination, may be just as effective as quarantine requirements, to stop imports of COVID-19 cases.

The study, which reviewed case studies of airport testing procedures elsewhere, claims that a single on-arrival antigen test is as effective as a ten-day-self isolation period in reducing imported cases of COVID-19, while testing after five-seven days of quarantine may catch as many as 90% of cases. Specifically, it found that: 

  • Air passenger testing after five days of quarantine in Iceland is between 83% and 90% effective. 
  • Testing after seven days in Toronto and Paris is between 84% and 90% effective. ​
  • Single tests on arrival in Canada (Toronto-Pearson Airport), France (Paris-Charles de Gaulle Airport), Jersey and Iceland detected between 54% and 76% of infected travellers.

“Real world evidence supports a significant reduction in current UK 14-day quarantine policy,” claimed the studies authors who also disputed a previously published Public Health England (PHE) paper that  had concluded  airport testing would identify only ‘7%’ of virus cases.

The study was prepared for a consortium of British airlines interests, including Virgin Atlantic, Heathrow Airport, and the International Airlines Transportation Association. 

“We believe that international travel can safely restart at scale, using a risk-based, phased easing of testing requirements and border restrictions, that follows the scientific evidence,” Virgin Atlantic’s chief executive Shai Weiss said, upon publication of the review.

Britain has currently banned all foreign travel, except for essential work, education, or health reasons. The ban, along with the current quarantine requirement, was supported by the PHE paper. The new study finds that this significantly underestimates the effectiveness of passenger testing.  

The study has been submitted to Britain’s Global Taskforce, which is set to review how and when travel should restart on 12 April. 

Image Credits: Wikimedia Commons: Nemo.

 

African health officials appeal for more COVID vaccines after current supplies run out in some countries

About 10 African countries have yet to receive any doses of a COVID vaccine, while at least one country, Rwanda, has already run out of the doses that it received through the WHO co-sponsored COVAX facility, said WHO’s African Regional Office on Thursday, citing this as evidence of the vaccine inequalities that continue to mark the battle against the pandemic.  

“It is unfair. I believe that some high income countries are looking to vaccinate their entire populations while others, including most countries in our region, are struggling to reach a significant proportion of at-risk populations,” said Dr Richard Mihigo, Immunization and Vaccines Development Program Coordinator at WHO’s African Regional Office, speaking at a WHO/AFRO press briefing on Thursday.

Under the COVAX initiative, countries are supposed to receive some 20% of their COVID-19 vaccine needs, with the shipment of the doses officially beginning in Accra, Ghana, just weeks ago.  So far, some 7.7 million doses have been administered in 32 African countries through COVAX or national initiatives, the WHO African region officials said.  And some 44 countries have received vaccines through COVAX or other channels.  

At the same time, however, some 10 countries have not received any vaccines at all, and have no idea when the next shipments will be, while other countries are already running out of the doses that they received. 

Rwanda Already Used Its COVAX Vaccine Supplies

Rwanda, for instance,  received about 240,000 doses of the Oxford/AstraZeneca COVID-19 vaccine through the WHO co-sponsored COVAX Facility on March 3. It received a further 103,000 doses of the Pfizer vaccine, as the first African country to administer the vaccine that requires ultracold storage. 

But only 20 days after it commenced vaccination, Rwanda has already administered all of its doses. Rwandan government officials said they did not know when the next shipment will be received, especially since the new guidelines that prioritise India and Europe over the rest of the world, delay vaccine deliveries to Africa. Rwanda has a population of about 13 million and needs to vaccinate 7.8 million people to achieve herd immunity.

“When the COVID vaccine was made available, we already had a programme that was built from the community to national level, so we just plugged into the existing system, and that made it easier and faster to make it happen,” said Dr Sabin NSanzimana, director of the Rwanda Biomedical Centre, at the WHO briefing, describing the country’s experience. “And the thing is that, deploying a vaccine rapidly, without waiting is the best way you can actually stop the progression of this virus.”

However, that success has now been tinged with anxiety as Rwanda awaits more vaccine doses to arrive.

And while countries like Rwanda are rapidly and impressively vaccinating their people against COVID-19 with the very limited doses available, they are largely helpless regarding getting additional doses, said Dr John Nkenkasong, Director of the Africa Centres for Disease Control and Prevention. 

Speaking at a back-to-back Africa CDC briefing, Nkenkasong urged global leaders to pursue equitable access to vaccines, saying:  “There is absolutely no need, absolutely no need for us as a world, as humanity, to go into a vaccine war to fight this pandemic. We’ll all be losers. 

John Nkenkasong, Director of the Africa Centres for Disease Control has appealed for equitable distribution of COVID-19 vaccines, saying there was no need for a vaccine war.

“I remain hopeful that the power of humanity will prevail,”  Nkenkasong added, “I strongly believe that we should continue to be our neighbour’s keeper and the only way we do that is to exercise that strong sense of solidarity and coordination and with common wisdom. I remain hopeful that wisdom will prevail over time.”

Worries That Serum Institute Doses Will Be Kept In India or Diverted To  European Union   

Officials also are worried about the news that AstraZeneca vaccine doses produced by the Serum Institute of India, Africa’s main vaccine supplier either directly and through COVAX, may be kept in India or diverted to the European Union. 

The Oxford/AstraZeneca vaccine is the main vaccine that African countries are receiving through the COVAX  initiative – as well as through bilateral deals. And most of those doses are produced by the Serum Institute. 

In February, however, Adar Poonawalla, CEO of vaccine producer, Serum Institute of India (SII), announced his company had been directed to prioritise the needs of India, currently undergoing a surge in COVID cases. 

“SII has been directed to prioritise the huge needs of India and along with that balance the needs of the rest of the world. We are trying our best,” Poonawalla said on Twitter.   

That was confirmed by a GAVI announcement Thursday, which stated that some 90 million doses due to be supplied to COVAX in March and April may not be delivered – as a result of the Indian government’s decision to divert doses domestically.  

In addition, Africa CDC officials fear that Africa COVID-19 vaccines produced in Europe could also be threatened by new guidelines issued by the European Commission that limit the export of coronavirus vaccines to countries outside the bloc. The guidelines stipulate that the EU countries may curb the exportation of vaccines for six weeks to destinations with fewer COVID cases or higher vaccination rates – although the restrictions explicitly exclude exports to low-income countries that are participating in COVAX. 

Ursula von der Leyen, president of the European Commission, justified the guidelines and said the world is in the crisis of the century and the commission is not ruling anything out. 

“I’m not ruling out anything for now, because we have to make sure that Europeans are vaccinated as soon as possible. Human lives, civil liberties and also the prosperity of our economy are dependent on that, on the speed of vaccination, on moving forward,” Leyen said.

Threats to Africa’s vaccine plans

Also speaking at today’s briefing, Anthony Costello, Professor of Global Health and Sustainable Development, University College London, supported the call for speedier delivery of vaccines to Africa and said the continent’s plan to vaccinate 60% of its citizens by mid-2022 can only be achieved if there is quick access to doses of the vaccines. 

While expecting access to improve before the end of 2021, Costello said the continent needs to vaccinate about 35% of its citizens before the end of the year and this would require about 800 million doses of COVID-19 vaccines.

“If you’re going to reach a 60% target of vaccinating the continent by the middle of next year, which I think is the aim, then, in this year, if you want to reach 35% of the African population, you’re going to need 800 million doses. Let’s say the population of Africa is 1.2 billion, you’re probably going to need to vaccinate 727.5 million people by the middle of next year, that’s going to mean you’ll need almost 1.5 billion doses (of Oxford/AstraZeneca COVID-19 vaccine), so that’s a huge challenge,” Costello said.

Costello expressed confidence that Africa’s health infrastructure  was adequate to ensure a speedy roll-out if the doses became available. “I’m pretty confident that Africa can get there because I think the immunisation infrastructure in Africa is generally not bad. The figures have come up dramatically over the past 10 or 15 years. I think Africa’s public health structure is often better than Europe, to be honest,” he said.

Earlier this month, Africa CDC also announced plans to hold a major conference in April to discuss the local production of vaccines, as one avenue to address the continent’s vaccine shortages. 

Speaking at the time, William Kwabena Ampofo, Chairperson of African Vaccine Manufacturing Initiative, called for a “roadmap” to increase vaccine production that will facilitate immunization of childhood diseases and enable Africa to control outbreaks of highly infectious pathogens

 

Image Credits: Johnson & Johnson, WHO African Region .

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.