Novavax’s vaccine candidate had a vaccine efficacy rate of 89.3%, while Johnson & Johnson’s highly anticipated single-dose COVID-19 vaccine is 66% effective in preventing moderate to severe infection.

Novavax has become the first  COVID-19 vaccine to show clinical efficacy against two major new SARS-CoV-2 virus variants now circulating worldwide – although the vaccine’s highest efficacy of 95.6% was against the COVID strain that had been predominant up until the end of 2020.

The results of a UK-based Phase 3 clinical trial, which enrolled over 15,000 participants between 18 and 84 years of age, showed an efficacy rate of 85.6% for the Novavax vaccine against the B.1.1.7 variant first detected in the United Kingdom. Half of the COVID-19 cases in the trial were reportedly caused by the B.1.1.7 variant.

The vaccine had a 60% efficacy rate against the “highly worrisome variant currently circulating in South Africa,” reported the principal investigator of the Novavax trial in South Africa, Professor Shabir Maddi. This left an average vaccine efficacy rate of 89.3% from the all arms of the trial.

“[This] is the first vaccine to demonstrate not only high clinical efficacy against COVID-19 but also significant clinical efficacy against both the rapidly emerging UK and South Africa variants,” said Stanley C. Erck, CEO of Novavax, in a press release.

Stanley C. Erck, President and CEO of Novavax, in an interview with CNBC.

Meanwhile, the United States joined over 30 other countries in reporting infections from the B.1.351 variant (also called 501Y.V2), first identified in South Africa.

Novavax’s results also included an analysis of a small Phase 2b trial in South Africa with 4,400 participants, where most of the cases that occurred were caused by the B.1.351 variant. Approximately a third of participants also were previously infected with SARS-CoV-2, which suggests that prior infection may not provide full immunity against the variant.

Novavax Results Are First Showing Vaccine Efficacy Against Variants In Large Populations

The Novavax results are the first to show vaccine efficacy against the variants in large clinical trials – as compared to lab tests of blood samples. While the vaccine performed less impressively against the variants – the results still are reassuring insofar as they pass the 60% bar that both the World Health Organization and the US Food and Drug Administration had set as a criteria for an effective COVID vaccine.

“This is positive news and, if approved by the medicines regulator, the Novavax vaccine will be a significant boost to our vaccination programme and another weapon in our arsenal to beat this awful virus,” said Matt Hancock, UK Secretary of State for Health and Social Care.

Other COVID-19 vaccines have only been tested on the variants in labs. Moderna announced on Monday that there was a six fold reduction in neutralizing antibodies with the B.1.351 variant, but suspected that the response would be sufficiently protective.

Data from Pfizer’s in vitro studies on certain mutations present in the variants, released on Wednesday, revealed that neutralization against the virus was lower, but “the small differences in viral neutralization observed in these studies are unlikely to lead to a significant reduction in the effectiveness of the vaccine.”

Novavax plans to immediately begin clinical development of a vaccine targeting the B.1.351 variant and expects to select a candidate for a booster or a combination bivalent vaccine in the coming days. Clinical testing on the new vaccines will commence between April and June of this year.

“We can expect to see, if required, new vaccines or bivalent vaccines where two different strains are joined together in one vaccine. That now can be done at pace so that we can keep up with these variants, should they prove to be difficult to prevent with the vaccine that we have at the moment,” said Professor Paul Heath, Chief Investigator of the UK Novavax trial, in an interview with BBC Radio 4.

The Novavax vaccine candidate, unlike the Pfizer/BioNTech and Moderna vaccines, uses fairly traditional vaccine technology to generate antigens derived from the SARS-CoV-2 spike protein, which are then joined with an adjuvant to enhance the immune response. Similar to the Oxford/AstraZeneca vaccine, it can be stored at normal refrigeration temperatures (2-8°C), which simplifies the transport and delivery process.

“NVX-CoV2373 has the potential to play an important role in solving this global public health crisis. We look forward to continue to work…to make the vaccine available as quickly as possible,” said Erck.

Novavax has signed vaccine deals with Canada for 75 million doses, the UK for 60 million doses, Australia for 51 million doses, New Zealand for 10.7 million doses, and the US for 100 million doses, which Operation Warp Speed paid US$1.6 billion to secure and to fund clinical development.

Vaccination doses administered globally, as of 29 January 2021 since 14 December 2020.

In addition, Novavax signed a manufacturing agreement with the Serum Institute of India to produce 1 billion doses of the vaccine in 2021, increasing the global manufacturing capacity to over 2 billion annually.

Johnson & Johnson’s One-Shot Vaccine Shows Efficacy – But At Lower Levels

On a less promising note, Johnson & Johnson’s highly anticipated single-dose COVID-19 vaccine was only 66% effective in preventing moderate to severe infection, according to results of Phase 3 trials released by the company on Friday.

But that falls well behind the 90% or more efficacy ratings that Moderna and Pfizer/BioNTech vaccines have received – as well as the results obtained by Novavax and AstraZeneca in some arms of their trials.

Among its 43,700 participants in the large J&J multi-country ENSEMBLE trial, the level of protection against moderate to severe infection provided by the vaccine varied by country and region, with the US recording an efficacy rate of 72%, Latin America reporting 66%, and South Africa recording the lowest levels of efficacy at 57%.

The lower levels of protection in Latin America and South Africa could be due to the spread of SARS-CoV-2 variants that are more highly transmissible during the trial. Nearly all cases of COVID-19 in the trial in South Africa were linked to the variant, the company said. However it did not provide precisely stratified results against each individual variant.

The company said that the Phase 3 ENSEMBLE clinical trial also showed “protection was generally consistent across race, age groups, including adults over 60 years of age.”

Some 28 days after vaccination, the vaccine candidate was 85% effective in preventing severe disease – which includes admission to an intensive care unit, respiratory failure, organ failure, or death – in all adults over the age of 18 and in all regions studied. And complete protection against COVID-19-related hospitalization and death was provided by the vaccine candidate.

Moderate illness was defined as COVID-19 infection with evidence of pneumonia, abnormal blood oxygen saturation levels, deep vein thrombosis, abnormal respiratory rate, or two or more systemic symptoms of COVID-19.

A doctor administering the Johnson & Johnson COVID-19 vaccine candidate during the phase 3 clinical trials.
J&J Touts Results On Severe Disease – Says It Will Still File For US FDA Authorization In February

The company still plans to file for Emergency Use Authorization with the US Food and Drug Administration (FDA) in early February and expects to begin deploying doses immediately following its authorization.

“These topline results with a single-shot COVID-19 vaccine candidate represent a promising moment,” said Paul Stoffels, Chief Scientific Officer at Johnson & Johnson, in a press release. “Eighty-five percent efficacy in preventing severe COVID-19 disease and prevention of COVID-19-related medical interventions will potentially protect hundreds of millions of people from serious and fatal outcomes of COVID-19. It also offers the hope of helping ease the huge burden placed on healthcare systems and communities.”

The vaccine candidate can be stored for at least three months at temperatures of 2-8°C and can be transported using existing cold chain technologies and standard vaccine distribution channels.

The logistical advantages of the Johnson & Johnson vaccine could prove instrumental in light of the increasing need to reduce transmission and the emergence of additional variants.

“Changing the trajectory of the pandemic will require mass vaccination to create herd immunity, and a single-dose regimen with fast onset of protection and ease of delivery and storage provides a potential solution to reaching as many people as possible,” said Mathai Mammen, Global Head of Research and Development at Janssen Pharmaceuticals. “The ability to avoid hospitalizations and deaths would change the game in combating the pandemic.”

J&J Also Signed Deal With COVAX
Forecast of the vaccine candidate-specific supply of COVID-19 vaccines to the COVAX Facility, as of 20 January.

Johnson & Johnson has also signed an agreement with the COVAX Facility to provide up to 500 million doses for distribution to low- and middle-income countries.

Once the agreement is finalized, Gavi, the Vaccine Alliance, the organization co-leading COVAX, will be able to procure up to 200 million doses in 2021 and 300 million in 2022.

Unfortunately, Johnson & Johnson is reportedly experiencing manufacturing delays and is lagging behind its previously set timeline. According to US federal government officials, the company is estimated to be two months behind schedule.

The pharma company joins several others who have announced issues in vaccine production, a few of which, namely Pfizer, AstraZeneca and most recently Moderna, have delayed the delivery of doses. However, Johnson & Johnson claims to be on track to meet its contractual agreements.

“The Company’s anticipated manufacturing timeline will enable it to meet its 2021 supply commitments, including those signed with governments and global organizations,” said the press release.

AstraZeneca, Facing Clash with EU, Releases Vaccine Deal

Meanwhile, AstraZeneca published its Advanced Purchase Agreement (APA) with the European Commission amid a feud over the delay in the delivery of COVID-19 vaccines to the region. 

The Advanced Purchase Agreement between AstraZeneca and the EU, signed on 27 August 2020.

In the partially redacted contract, signed on 27 August, 2020, AstraZeneca committed to “use its Best Reasonable Efforts…to build capacity to manufacture 300 million doses of the vaccine…for distribution within the EU.” 

‘Best Reasonable Efforts’ is defined as “the activities and degree of effort that a company of similar size with a similarly-sized infrastructure and similar resources as AstraZeneca would undertake or use in the development and manufacture of a vaccine at the relevant stage of development.”

Since the UK holds its own deal directly with AstraZeneca and won’t face the same shortfall of vaccines, EU leaders have called for the delivery of doses produced in the UK to make up for the shortage. 

Pascal Soriot, CEO of AstraZeneca, claims that the products manufactured at the two plants in the UK are reserved for its own citizens under the vaccine deal until a sufficient number of doses have been supplied to the UK.

EU officials, however, dispute this argument under article 5.4 of the contract, which states that AstraZeneca agrees to “use its Best Reasonable Efforts to manufacture the vaccine at manufacturing sites located within the EU…and may manufacture the vaccine in non-EU facilities.”

According to Ursula von der Leyen, President of the European Commission, the pharmaceutical company is legally obligated to use the four manufacturing sites in Europe – two in the UK, one in Belgium, and one in the Netherlands – to fulfil its supply commitments. 

While the dispute remains unresolved, Spain and France have announced the temporary pause in their vaccine campaigns because of the shortage of doses. Madrid suspended inoculations on Wednesday for the next two week and Paris plans to temporarily halt its program beginning on 2 February. 

European Commission Establishes Authorization Mechanism for Vaccine Exports 

In a move to increase transparency surrounding the export of COVID-19 vaccines covered under APAs and to ensure the continuation of vaccination campaigns in the EU, the European Commission has put in place a measure requiring authorization for the export of vaccines produced in the EU.

“We gave upfront funding to companies to build the necessary manufacturing capacity to produce vaccines, so deliveries can start as soon as they are authorised,” said Stella Kyriakides, Commissioner for Health and Food Safety, in a press release. “We now need transparency on where the vaccines we secured are going and ensure that they reach our citizens.”

Stella Kyriakides, European Commissioner for Health and Food Safety, at a press briefing on Friday.

The “time-limited and targeted system” will be in place until the end of March 2021 and will not interfere with the EU’s humanitarian aid commitments, including the delivery of vaccines to low- and middle-income countries through the COVAX Facility, according to Valdis Dombrovskis, Executive Vice-President and Commissioner for Trade of the European Commission. 

The authorization will be granted or denied by the EU member states where the production of COVID-19 vaccines takes place. The aim of the new measure will not be to restrict exports “any more than absolutely necessary,” but instead to ensure the critical shortages in Europe are relieved in a “targeted, transparent, proportionate, [and] temporary” manner, said the trade document published by the European Commission on Friday. 

AstraZeneca Vaccine Receives Approval from EU Regulator 

Hours earlier, the European Medicines Agency (EMA) recommended the Oxford/AstraZeneca vaccine for approval one month after the UK provided it with authorization and began the vaccine rollout.

The European Commission followed suit shortly after and granted conditional marketing authorization to the vaccine on Friday, making it the third COVID-19 vaccine authorized in the EU. 

After much discussion about whether the vaccine rollout should include adults over the age of 55, due to the lack of data in older participants, the EMA decided to recommend the vaccine to individuals aged 18 and older. 

“There are not yet enough results in older participants…to provide a figure for how well the vaccine will work in this group. However, protection is expected, given that an immune response is seen in this age group and based on experience with other vaccines…EMA’s scientific experts considered that the vaccine can be used in older adults,” said the EMA press release. 

Overall, the vaccine demonstrated a 60% efficacy rate in clinical trials. 

“With the AstraZeneca vaccine now authorized, 400 million additional doses will be available in Europe. I expect the company to deliver these doses as agreed, so that Europeans can be vaccinated as soon as possible,” said Ursula von der Leyen, President of the European Commission in a press release. 

Following news of the authorization of the Oxford/AstraZeneca vaccine in the EU, WHO officials expressed their hope to grant the vaccine emergency use listing within two weeks. The Strategic Advisory Group of Experts on Immunisation (SAGE), WHO’s vaccine advisory panel, is scheduled to meet to review the Oxford/AstraZeneca vaccine on 8 February. 

“We should have an emergency use listing, providing, of course, that everything goes to plan and all the data is there. We can then start receiving doses from the manufacturing sites in India and South Korea,” said Soumya Swaminathan, WHO Chief Scientist, at a press conference on Friday. 

The Oxford/AstraZeneca vaccine is considered one with global potential – due to its ability to be stored at refrigerator temperatures, making its storage and transportation more manageable, particularly for countries without access to ultra-cold chain storage, which is required for the Pfizer and Moderna vaccines.

Status of COVID-19 vaccines in the process of receiving WHO “Emergency Use Listing” approval, as of 25 January.

Image Credits: Johnson & Johnson, Johnson & Johnson, CNBC, Our World in Data, Johnson & Johnson, GAVI, European Commission, Twitter – European Commission, WHO.

The COVAX facility was launched to ensure equitable distribution of the COVID-19 vaccine.

Member countries will have an idea of how many COVID vaccine doses they will receive via the World Health Organization’s COVAX Facility and when they will arrive within the next day, WHO special advisor Dr Bruce Alyward has said.

These “indicative allocations” would depend on when the WHO’s regulatory review of the specific vaccines that COVAX plans to distribute is completed, as well as on the volumes the companies can produce, Aylward told reporters Friday at WHO’s bi-weekly media pandemic briefing.

“As you know, some companies are having challenges, so that is going to affect potentially what those volumes actually look like,” said Aylward.

COVAX – WHO’s co-led platform dedicated to equitable vaccine distribution – has made its largest deal with AstraZeneca, but the Organization is yet to issue the vaccine an emergency use license (EUL).

It expects to have completed its review of the company’s research within the next two weeks.

Dr Bruce Aylward, WHO Senior Advisor to the Director General.

COVAX is expecting its supply of AstraZeneca vaccines to be produced by the Serum Institute of India, along with a smaller number of Pfizer vaccines, thanks to a recent deal.

This week, AstraZeneca informed the European Commission that there would be a 60% shortfall in vaccine deliveries to Europe this quarter due to a manufacturing issue at a production plant in Belgium.

But the Commission had its doubts over this given explanation and has said it would establish a new mechanism that grants national regulators the power to refuse exports of vaccines following an investigation into the production facility.

Share Vaccines To Ensure Global Coverage Of Health Workers & Elderly

Tomorrow marks the first anniversary of the WHO’s declaration of SARS-CoV-2 as a “public health emergency of international concern”. At that time, there were only around 100 known cases. That number has now passed 100 million.

At the briefing, Dr Tedros Adhanom Ghebreyesus, WHO Director General, once again appealed for equitable access to vaccines, starting with a global rollout to all health workers and the elderly: “For now, vaccines are a limited resource. We must use them as effectively and as fairly as we can. If we do that, lives will be saved.

“That’s why I have challenged governments and industry leaders to work together to ensure that, in the first 100 days of 2021, the vaccination of health workers and older people is underway in all countries.”

Harriet Nayiga, a midwife from Kenya, and Sana Baloch, a nurse in Pakistan, both addressed the press conference to explain their vulnerability to infection.

“We engage with the patient for more hours than any other health worker, so we need to be prioritised to be vaccinated first,” said Nayiga.

Sana Baloch
Pakistani nurse Sana Baloch appealed for vaccines for all health workers.

Baloch said that around 10,000 Pakistani health workers had been infected by the virus and hundreds had died.

Her hospital had “a huge influx of patients” and the “nurses, doctors and paramedics were in great distress”, she said.

“It is our moral responsibility and our job to take care of those patients. We were the only hope of the patients who were admitted in COVID wards where they were not allowed to meet or to see anybody. We cannot leave them alone. But at the same time, we need protection,” said Baloch.

“I appeal to the leaders of the world: please distribute the vaccine on an equitable basis. If you have enough resources to vaccinate all your elderly and all your health care providers, consider donating or help out less developed countries who do not have enough to even vaccinate their health care providers or elders, before moving to the less vulnerable of your population.”

Dr Tedros said that countries that had secured vaccines should share these with COVAX. “My message to people in countries that are now rolling out vaccines is to use your voice to advocate for your government to share those. If you’re someone at lower risk, please wait your turn. Health care workers have been on the frontlines of the pandemic but are often under-protected and overexposed. They need vaccines now.”

Countries Need To Support Travellers With Quarantine And Testing

Dr Michael Ryan, WHO Executive Director of Health Emergencies, said that the expansion of rapid diagnostic tests was “bringing a new and very useful tool to bear, taking pressure off the existing PCR based testing systems”.

But he appealed for coherent messages around travel and asked governments to respect the human rights and comfort of travelers, particularly as the process of travel itself has been “significantly de-risked” thanks to efforts from the travel industry.

Mike Ryan, Executive Director of WHO Health Emergencies Programme.

“Those countries with very low incidents are very, very afraid about re-importing cases, and may have more stringent testing in place. Other countries are worried about the arrival of potential variants that will further complicated situations and they’re targeting reducing movement from certain countries in order to be able to avoid that,” said Ryan.

“We do need coherent messaging around travel requirements. If you’re going to require that travellers arriving in the country quarantine for a particular period or have to be tested, governments should be supporting that process.

“It is very difficult for a traveller arriving to be able to comply sometimes if they don’t get the support to comply. Governments are continuing to try and increase and ramp up their efforts to break chains of transmission and to manage risks. But we also must do that and invest properly in those mechanisms so that people who are travelling between countries are treated with regard to their comfort and their human rights.”

Image Credits: WHO, CIO Look/Flickr, WHO, Screenshot.

The International AIDS Society urged the Biden administration “to consider legislation preventing the global gag rule from returning in the future”.

The International AIDS Society (IAS) has welcomed US President Joe Biden’s repeal of the Mexico City Policy, known as the global “gag rule”, which prevented non-US organisations from getting US aid if they offered abortion services, referrals or advocacy.

But the IAS urged the US administration “to consider legislation preventing the global gag rule from returning in the future”, according to its president, Adeeba Kamarulzaman.

The gag rule was first introduced by Ronald Reagan to prevent US government aid to foreign family planning organisations offering abortions. The Trump administration expanded it significantly to block any foreign NGO associated with abortion from receiving health development funds from any US source.

The rule affected almost $9 billion of US aid, and had a severe impact on organisations offering HIV services, disrupting HIV testing, counselling, condom provision, antiretroviral  treatment and care.

“As HIV professionals, we saw firsthand the impact of the global gag rule from its first iteration – barring and disrupting access to health care for women around the world,” said IAS Executive Director Birgit Poniatowski.

“In its expanded form, the policy threatened to roll back progress in the global HIV response.”

Echoing the IAS call, Ugandan health activist Dorothy Amuron from the Center for Health, Human Rights and Development called on the Biden administration “to take bold action to stop this deadly cycle of granting or rescinding human rights when the political tides shift”.

“The U.S. has an obligation to safeguard human rights for all. But policies like the global gag rule are an attack on our sovereignty and our humanity,” said Amuron. “We call on the Biden administration to use its power to get rid of them forever.”

Ironically, the gag rule was associated with a 40% increase in the rate of abortion and a 13.5% reduction in the use of contraception, according to research published in the Lancet.

Image Credits: Mike Beaty/Flickr.

Healthcare’s overreliance on single-use products and equipment contributes to its carbon footprint

Failure to align the global recovery from COVID-19 with an equally powerful climate response could threaten the worldwide effort to limit the average global temperature increase, public health experts have said.

In a convention in 2015 now known as the Paris Agreement, the United Nations Framework Convention on Climate Change (UNFCCC) established its aim to pause the increase in global average temperature by “well below 2 degrees Celsius above pre-industrial levels and to pursue efforts to limit the temperature increase even further to 1.5 degrees Celsius”.

To achieve that, a global effort is required to decrease greenhouse gas emissions by 7.6% each year across five years. This number falls further out of reach each year without action.

“The reality is that the next five years are going to be pivotal,” Dr Renee Salas, Harvard T.H. Chan School of Public Health, said during a webinar from the Lancet Countdown last week.

The 2020 Report of the Lancet Countdown on Health and Climate Change was published in December, and addressed the converging crises of the COVID-19 pandemic, healthcare systems and climate change.

“Healthcare has to show us how we can decarbonize and decarbonize our healthcare system,” she said, adding that it “is truly the embodiment that climate action is a prescription for health”.

COVID Has Outlined Healthcare Systems’ Flaws

The COVID-19 pandemic has highlighted healthcare’s overreliance on single-use products and equipment, the panel said. Additionally, as using personal protective equipment (PPE) has become a greater necessity, use of disposable products has been extended.

The health system in England is responsible for an estimated 4-5% of the country’s carbon footprint, for example.

NHS carbon footprint is mostly comprise of procured items from the health supply chain

The United Kingdom’s National Health Service listed crutches as accounting for nearly 70% of the carbon footprint for items it procured in 2020.

Additionally, the traditional model of outpatient care doesn’t strictly align with the nature of chronic illnesses, which requires patients return for unpredictable emergency treatment. 

Unpredictable treatment directly leads to increased road traffic and increased air pollution. NHS traffic accounts for 5% of road traffic in England alone.

Quantified in terms of environmental, financial, and health outcomes, this means that 753 deaths can be attributed to NHS traffic, and £650 million in NHS expenditure are lost a year.

“When [evaluating] the value offered in the delivery of a healthcare service, we need to start capturing data that looks at these consequences, thinking beyond the financial and individual patient outcomes,” said Jennifer Isherwood, a National Medical Director’s Clinical Fellow at the Royal College of Physicians, London.

“It’s becoming clear that COVID is not going to be the last pandemic that we see,” Isherwood added. “It may be … disruptive to start addressing challenges of different pathways to different care, but it’s the right tool to start future-proofing our healthcare systems.”

Hiten Patel, Senior Strategy Advisor for Greener NHS, said: “There’s always something else happening in healthcare systems that’s [considered] a priority. It’s about how we can try to make carbon emissions and climate change more of a priority within healthcare systems.” 

Concluded Dr Jodi Sherman, Yale University and Lancet Countdown author, said: “Everything we do in healthcare is through the lens of patient safety. Protecting public health is a matter of patient safety and needs to be integral to everything that we do.” 

Supply and Services Compose Four-Fifths of Overall Healthcare Carbon Footprint
The health supply chain comprises four-fifths of US healthcare carbon footprint
The health supply chain comprises four-fifths of US healthcare carbon footprint

While the COVID pandemic has flagged some key flaws in the world’s healthcare systems, what is still unclear are the direct and indirect carbon emissions of the healthcare sector, and the implications these emissions have on health.

Direct emissions are established and well understood products of the sector: gas exhausts from ambulance tailpipes to fumes emitted from waste incinerators.

But indirect emissions – offsite power generation, the provision of medical supplies and pharmaceuticals, and even research and testing – make up a larger percentage of emissions associated with the healthcare sector.

The United States alone spends more than US$3 trillion on healthcare a year. As healthcare expenditures increased, so too did the carbon footprint from goods and services. Around 7% is due to direct emissions from healthcare facilities, and another 10% from offsite energy.

But four-fifths of the footprint is the supply chain, composed of key sectors that include food, pharmaceuticals, and chemicals.

Dr Matthew Eckelman, Northeastern University, Boston and Lancet Countdown author, called on the health sector to take accountability for its immense carbon footprint.

“It’s very clear that buying renewable energy is not the only solution. You really have to work on reducing carbon emissions in the supply chain, as well.”

Lower the Infection Risk and Financial Losses by Reducing Health Waste

Speakers also addressed how vital it is not to risk patient safety in trying to reduce or cut expenses.

Healthcare-acquired infection – when a patient becomes infected while in care – affects hundreds of millions of patients globally each year. This leads to significant morbidity and mortality that incurs financial losses for health systems, in addition to excess pollution.

As a result, prevention is essential.

“While we do want to reduce waste and reduce costs, we certainly don’t want that to be at the expense of increasing infections,” said Dr Sherman.

Dr Sherman also acknowledged, however, that infection prevention methods often contribute to the excessive use of single-use disposable devices, like masks and gloves.

Using only disposable laryngoscopes would increase costs for hospitals
Using only disposable laryngoscopes would increase costs for hospitals

In a greenhouse gas emissions and cost analysis study comparing reusable and disposable laryngoscopes, Dr Sherman and Eckelman found that disposables – whether plastic or steel – outweigh the reusable in terms of greenhouse gas emissions. Using purely disposables would increase costs by up to US $700,000 a year, for one hospital department.

Recycling these disposables would only reduce a small portion of emissions, especially since the laryngoscope cannot be recycled entirely. “In other words, we can’t recycle a way out of this problem,” Dr Sherman said. 

“The answer isn’t that we should use disposables. It’s that we should clean up our supply.” There needs to be a balance between the “indirect disease burden from all the materials thrown away and lowering the infection risk curve.” 

The greatest causes of healthcare acquired infections, said Dr Sherman, have to do with staff discipline, such as hand washing, and patient health status, and exposure to infection. But simple hand washing and using more and more disposables is not the solution.

Image Credits: Flickr: Marc A. Hermann / MTA New York City Transit, The Lancet Countdown.

A new report has found that current R&D is primarily geared towards COVID-19, with next to no efforts to address other pathogens with the potential pandemic risks like Zika and Sars.

With ten of the world’s most infectious diseases not catered by drug firms, pharmaceutical giants remain unprepared to tackle future pandemics, a new report has said.

The report, published on Tuesday, found that though current medicine and vaccine research and development is primarily geared towards the COVID-19 pandemic, there are next to no efforts to address other pathogens with the potential pandemic risks: namely Nipah, Zika, and Sars.

The Access to Medicine Index evaluates 20 global pharmaceutical companies – including AstraZeneca and Pfizer – and compares how far each goes in fulfilling the role of developing urgently needed health products and improving equitable access to them. The companies’ performance is ranked every two years.

Pfizer joins top 5, while GSK retains its number one position, yet only slightly ahead of Novartis. Pfizer moves into the top five. Johnson & Johnson complete the top five companies. Eight of the top ten companies, including the leaders, are setting a new best practice of systematic access planning during R&D.

“The state of infectious disease research today is, if I can put it mildly, on thin ice,” said Dr Jayasree Iyer, executive director of The Netherlands-based Access to Medicine Foundation, in an interview with DW.

COVID-19 has emphasized the need for both the private and public sectors to actively engage in emerging infectious disease research well before the next pandemic breaks out.

It has also shown that ending a pandemic requires suitable products to be developed and equitably distributed: much of the responsibility for which lies with pharmaceutical companies.

Without their sustained commitment to pandemic preparedness, the report suggests, the world world will remain vulnerable to pandemics.

Increased R&D for COVID-19, but Other Pandemic Risks Unaddressed
Pharmaceutical companies are not targeting priority pathogens with epidemic potential through R&D. Excluding coronavirus, pathogens with pandemic potential where pharma companies are active in R&D show very small pipelines in 2020. Out of 16 pathogens, 10 have empty pipelines.

Even for pathogens under scrutiny, research activity remains low. With most research focused on coronavirus, there are just 13 R&D projects across five non-COVID-19 diseases (Ebola, Zika, Chukungunya, Marburg, and non-polio enterovirus) and zero for the remaining ten of 16 infectious diseases.

Emerging infectious disease (EID) research is concentrated among a few companies. In 2020, 17 companies targeted coronavirus, while nine companies are targeting other EIDs: Bayer, Eisai, Gilead, Johnson & Johnson, MSD, Merck, Roche, and Takeda.

This figure shows the number of R&D projects and companies identified by WHO and Policy Cures as emerging infectious diseases, and how this has changed since 2018.

What 2020 has highlighted is that large pharmaceutical companies have a critical role to play in preparing for the next pandemic, but that these companies have so far delivered a range of responses: some of them apparently shortsighted.

Small biotech companies and academic groups may be able to pioneer new ideas, but it is the big players that are responsible for rapid development and access to vaccines, therapeutics and diagnostics, with the capacity to scale-up both manufacturing and distribution capabilities.

Poorer Countries Lacking Access to More Than Half Key Products Covered By Pharma Companies

However, the pharmaceutical industry only mobilized against COVID-19 once it became clear that the outbreak affected rich as well as poor countries.

“Even in light of COVID-19, there were very few commitments from the pharmaceutical industry last year,” said Iyer.

Other than projects developed within the Access to COVID-19 Tools (ACT) Accelerator, there was little evidence in the first months of the pandemic response that there structures in place to ensure access and distribution to COVID-19 vaccines in poorer countries.

This has once more shown that the Global South still does not benefit significantly from access strategies implemented by big pharma. Less than half of key products controlled by 20 large companies are being offered in countries classified as either lower-middle income countries (LMICs) or low-income countries (LICs).

Low-income countries are most consistently over-looked by access strategies, particularly for products that need to be administered by healthcare practitioners.

The response is even more profound in LICs, which are consistently overlooked despite being home to almost 700 million people. Currently, only eight of the 60 – or 13% – critical products that need to be administered by healthcare professionals, like injectable treatments for cancer, are covered by access strategies in at least one LICs. Self-administered medicines such as pills have 26%.

The numbers jump slightly in LMICs, and even more so in upper-middle income countries (UMICs), with approximately half of critical products covered by access strategies in UMICs. The greatest number of people also benefited from both healthcare professionals administered medicine and self-administered medicine in UMICs.

Many industry access arrangements do not go far enough, with many of the world’s most vulnerable and marginalized not receiving the life-changing medicines they need.

Solving the access to medicine problem requires the pharmaceutical industry to take large-scale action, reaching more people with more products across a wider range of the world’s poorest countries.

“I believe the past year has demonstrated the pivotal importance of supplying affordable medicines for the many, rather than premium-priced products for the few,” said Iyer.

“By investing in fair access to medicine for the poorest and most vulnerable among us, we are also investing in a fair, peaceful and prosperous global community.”

Eight Pharma Companies Paving Way Towards Equitable Access
Top 6 companies with access planning, with percentage of R&D projects with access plans

There are positives: eight companies have taken the lead to integrating systemic access planning into their development processes. Novartis was noted as the first to begin mainstreaming access in the previous Index, and joining them in 2021 are AstraZeneca, GSK, Johnson & Johnson, Merck, Pfizer, Sanofi, and Takeda.

Though the 20 companies in the Index have 394 projects in late-stage development that target either global health priorities (114) such as coronavirus, malaria, tuberculosis or HIV, or offer benefits to low- and middle-income countries (280), the majority of these are not supported by an access plan.

An access plan can include a wide range of activities – prioritising countries with the highest disease burden to strengthening supply chains to ensure all populations have fair access.

To have maximum impact, the Index advises that access plans have a broad geographic focus, explicitly aiming to reach a majority of people affected by a disease or in need of a vaccine or diagnostic tool.

The 20 companies in scope have 394 R&D projects in late-stage development that either target established global health priorities or offer clear public health benefits for low- and middle-income countries. The majority of these are not yet supported by an access plan.

If this happens, people living in low- and middle-income countries, especially those in resource-limited or remote settings, will no longer be left behind for pharmaceutical innovations.

Concluded Iyer: “The power of science to help humanity – whether through new vaccines for common pathogens or novel drugs for rare diseases – is remarkable. But these breakthroughs will only truly deliver for the world if they reach all those who need them.”

Image Credits: Access to Medicine Foundation , Access to Medicine Foundation .

Meirav Eilon Shahar, Israel’s ambassador to the United Nations in Geneva, speaking to the WHO Executive Board.

For the second time in as many years, WHO member states have voted down a proposal by Israel to remove a standalone item from the agenda of the 74th World Health Assembly – devoted exclusively to a report on health conditions in the Occupied Palestinian territories – and consider it as part of WHO’s overall health emergencies agenda.  

Saying that the agenda item unfairly singles out just one country for criticism, as compared to every other nation in the world, Israel on Tuesday proposed to the WHO Executive Board, which fixes the WHA agenda, that the report be considered as part of the overall discussion on WHO’s work in health emergencies when WHO member states meet in May. 

In a lengthy and unusual voting process on the closing day of the 10-day EB session, the proposal was rejected in a vote of 15 to seven – with 9 abstentions and 3 countries absent. Those supporting Israel’s position included the United Kingdom, Germany and Austria, joined by the United States, Australia and Colombia. EB members that were opposed included Oman, China, Russia, and Tunisia. 

Israel’s delegation said the report was a “political” item that does not reflect reality and will not change the situation on the ground.

“Item 25 is a political item with only one purpose – to attack Israel and to politicize an otherwise professional organization [WHO]. This must be changed…What I’m asking you to do today is to ensure that the World Health Assembly maintains its focus on health and the truth,” said Israel’s ambassador to the United Nations, Meirav Eilon Shahar.

“Regardless of what takes place in Geneva, we, Israel, will continue to work with the Palestinians and with WHO and we’ll continue to work on any problem and assistance intended to improve the health conditions for the Palestinians,” she added. 

The Palestinian representative, Ibrahim Khraishi, Ambassador of the State of Palestine to the UN, which holds observer status in the World Health Assembly, retorted that: “The [health situation in the occupied territories] is catastrophic and dire…Israel is finding it easy to renege on its responsibility, for example, it is not meeting its requirement…when it comes to vaccination.

“When we look at the rate of vaccination for [Israeli] citizens, the figure exceeds two and a half million, whereas not one single Palestinian citizen has had the jab because of Israeli practices,” he said. 

Khraishi cited the WHO report from the 73rd WHA in November 2020, which he said shows that infant mortality of West Bank Palestinians is six times higher, and maternal mortality nine times higher than that of the 600,000 Israeli settlers living side by side with Palestinians in the Occupied West Bank. The report also describes barriers Palestinians from the West Bank and Gaza face in accessing more health services, such as the more specialized services in Jerusalem, which is directly under Israeli rule and to which access is tightly-controlled. 

Ibrahim Khraishi, Ambassador of the State of Palestine to the UN and Palestine’s representative to the Executive Board.

After the vote among member states, Israel disputed the vaccination claims, saying that Palestinian inmates have received vaccinations and the PA has been provided with emergency supplies for 100 essential health workers – but the overall responsibility to vaccinate the roughly 5 million Palestinians living in the West Bank and Gaza lies with the Palestinian Authority (PA), not Israel. 

“We are very happy to extend assistance in facilitation of those vaccines in entrance to Israel,” said Eilon Shahar, referring to the expected arrival of PA-purchased vaccine supplies from Russia. PA health officials have not, in fact, officially requested vaccines from Israel, but rather are awaiting the arrival of Russian Sputnik vaccines within the coming two weeks.  However, human rights groups have underlined that Israel still holds the ultimate responsibility for health under international law insofar as it still occupies the West Bank,

The largely technical issue of where on the WHA agenda the report on Palestinian health conditions should be reviewed, was subject to a lengthy and unusual voting process (most EB decisions are made by consensus).  The United States, Australia, and the United Kingdom explained their support of Israel’s proposal, saying that no other country in the world has been singled out in such a way by the WHO.

“We’re concerned that the World Health Assembly does not consider the many other difficult health situations around the world in the same way,” said the UK’s delegate. “This item remains the only country specific item at the WHA…We fail our duty to serve people around the world who have vitally important health concerns if we allow WHO to become politicized in this way.”

The UK’s delegate to the Executive Board.

Australia went a step further, expressing concerns about the introduction of political issues into the WHA through the existence of the stand alone item – and calling for negotiations to permanently remove the item, not only as a stand-alone item but altogether from the agenda. 

The delegations from Oman and the Syrian Arab Republic countered the arguments made by the UK and US, claiming that the agenda item does not single out Israel.

“This is not a country-specific item. This is an item which [reflects] a specific situation, a situation of people under occupation and addresses the legal obligations of the occupying power,” said Syria’s delegate. “The politicization is coming from attempts to go around these facts.”

The Palestinian representative concluded the discussion at the closing session of the Executive Board meeting on Tuesday by urging member states to encourage Israel to “shoulder her responsibilities and do her duty towards all citizens for which she is responsible, particularly those in the occupied Syrian Golan, the Gaza Strip, and the other occupied territories.”  The Gaza Strip has been under Israeli blockade as a result of repeated Israeli confrontations with the fundamentalist Hamas, which wrested control of the Strip from the PA-supported Fatah in 2007,  two years after Israel unilaterally uprooted its settlements and withdrew from the Strip. Israel captured the Golan Heights from Syria in the 1967 Six Day War, and extended Israeli citizenship to the predominantly Druse residents of the Heights who remained after the war.  

Image Credits: WHO.

Victoire Tomegah Dogbé, Prime Minister of Togo

The World Health Organisation (WHO) Thursday released a new road map for reducing by 90% illnesses related to neglected tropical diseases (NTDs) by the year 2030. The plan proposes ambitious targets and a more integrated and holistic approach to tackle 20 diseases which affect more than a billion people worldwide, mainly poor, and which thrive in areas where access to quality health services, clean water and sanitation is scarce.

The 2030 global targets of the roadmap would firstly reduce by 90% the number of people requiring treatment for NTDs, to enable at least 100 countries to have eliminated at least one NTD, and to eradicate dracunculiasis and Yaws on a global scale. The roadmap also aims to reduce by 75% disability adjusted life years – e.g. healthy life-years lost – as a result of NTDs. 

Speaking at the virtual launch event for the road map, Dr Tedros Adhanom Ghebreyesus, WHO Director-General, said the plan was developed through an extensive consultative process and was approved in November 2020 by the World Health Assembly – as well as being shared with the Executive Board again last week. The WHO DG noted that it sets global targets and milestones for prevalence control, elimination and eradication of 20 NTDs in a more integrated manner. 

“By shifting away from single business programmes to an integrated approach, it aims to improve coordination and collaboration,” Dr Tedros said. 

The road map also aims to see a reduction by more than 75% in the number of deaths from vector-borne NTDs such as dengue, leishmaniasis and others, promote full access to basic water supply, sanitation and hygiene in areas endemic for NTDs and achieve greater improvement in collecting and reporting NTD data disaggregated by gender, including tracking 10 cross-cutting and disease specific targets.

Tedros said the roadmap also promotes cross sectoral action in areas such as health, education, nutrition and One Health. 

“The roadmap also addresses stigma, discrimination and mental health conditions which are often neglected consequences of disability,” he said. 

While noting that tackling NTDs is a challenge for countries, Tedros said it also presents an opportunity to address the health inequalities that undermine economic and development progress. In the end, the roadmap is only a guide, he emphasized. 

“We can only reach the destination with country ownership. That means, national and local governments, working in partnership with communities and youth. Accountability is key. By working together, we can prevent suffering and save lives. This roadmap shows us the way,” Tedros concluded.

According to the WHO, NTDs that affect over 1 billion people globally have imapcts well beyond health – leaving lasting social and economic consequences for individuals and societies: “They prevent children from going to school and adults from going to work, trapping communities in cycles of poverty and inequity. People affected by disabilities and impairments caused by NTDs often experience stigma within their communities, hindering their access to needed care and leading to social isolation,” stated WHO in a press release.

By integrating and mainstreaming approaches and actions within national health systems, and across sectors, the roadmap sets out a more innovative approach to disease control programmes that once were confined to distinct silos, health experts say.

“At its core, this road map aims to put people first. It involves working across sectors in delivering programmes for all the 20 NTDs and promoting equity and country ownership,” said Dr Mwelecele Ntuli Malecela, Director, WHO Department of Control of Neglected Tropical Diseases. “To do so programmes have to be sustainable with measurable outcomes, backed by adequate domestic financing.”

WHO Director General Dr Tedros Adhanom Ghebreyesus
Partners align with the new roadmap

Besides lifelong disability, NTDs also lead to stigma inequality and discrimination with huge mental health implications, said Amina Mohammed, Deputy Secretary-General of the United Nations, in an address at the launch. 

While increasing access to diagnosis and treatment is essential, partnerships wll be key to advancing cross sectoral interventions, she added:  

“The new NTDs roadmap is innovative and offers a powerful contribution to the Sustainable Development Goals, especially universal health coverage, it also addresses vulnerability and by doing so, it promotes inequality. But these ambitious targets cannot be achieved unless we unite and act together with ambition.”

Even though COVID-19 continues to attract more attention in global health than other issues, West African countries have also found creative ways to successfully tackle COVID-19 and NTDs at the same time, providing examples of a way forward, said Victoire Tomegah Dogbé, Prime Minister of Togo. 

“Togo has seen tremendous success in the past few years with the elimination of filariasis and other diseases. Thanks to the technical and financial assistance of our partners, we have been able to help thousands of our citizens to overcome these diseases that have impacted their lives every day. Successes give us more confidence in the future and allow us to remain optimistic as we are confronted with the current pandemic, and we try to conduct our actions despite it,” the Prime Minister said.

NTDs are anchored in poverty
Muhammad Ali Pate, Global Director for Health, Nutrition and Population, World Bank

Speaking on a panel at the launch of the roadmap, Muhammad Ali Pate, Global Director for Health, Nutrition and Population (HNP) at the World Bank said NTDs are anchored in poverty and lock people into a cycle of ill health, poor education and lack of opportunities. 

Positioning NTDs as a key threat for building a country’s human capital and for progressing towards personal health coverage, can help place NTDs at the centre of political plans, along with ending extreme poverty and creating a more inclusive society. 

“NTDs have long term consequences that can cause visual, and physical impairments, leading to disabilities that place an overwhelming financial burden on households, and the loss of productivity, which becomes a burden on national economies. This is an impact, due to the costs of seeking health care, which not only include out-of-pocket spending on consultations, laboratory and medicines, but also transportation costs and informal payments to providers,” Pate said.

Much of the World Bank’s work has been focused on ensuring equity of access to essential health services, building robust health systems and expanding financial protection for the poorest people as the most cost effective strategies. 

“These cannot be any more important than with regards to neglected tropical diseases. NTDs affect the most vulnerable and marginalized and poorest people in our societies. Since 2015, our efforts are concentrated in supporting countries to increase sustainable domestic financing to strengthen their primary health care systems,” Pate added. 

Long road ahead

In the past decade, substantial gains have been made, resulting in 600 million fewer people at risk of NTDs than a decade ago and with 42 countries eliminating at least one NTD, and some countries defeating multiple NTDs. Furthermore, global programmes treated more than 1 billion people annually for 5 consecutive years between 2015 – 2019.

But the WHO warned that significant challenges remain, including climate change, conflict, emerging zoonotic and environmental health threats, as well as continued inequalities in access to healthcare services, adequate housing, safe water and improved sanitation. 

“There are also major gaps in current intervention packages of diagnostics, treatment and service delivery models,” WHO stated.

Travel restrictions aiming to limit the importation of variants should be based upon a systematic testing policy and not geographic or national origins, Africa CDC Director Dr John Nkengasong has said.

IBADAN – Five African countries have now confirmed cases of the SARS-CoV-2 501Y.V2 variant, which first appeared in South Africa, and there is concern that the variant is circulating undetected elsewhere on the continent. The Gambia and Nigeria have seen cases of the variant B.1.1.7, first identified in the United Kingdom, said WHO’s African Regional Director today, Dr. Matshidiso Moeti, at a press briefing.

Meanwhile, Africa CDC Director, Dr John Nkengasong, called for a “common approach” to COVID testing to oil the wings of international air travel – and halt the wave of new travel restrictions that countries have been imposing based on people’s national origin or the origins of flights – including people and flights arriving to Europe and the United States from South Africa.

Researchers now believe the variants may be both more infectious but also more deadly than the COVID virus strains that were prevalent until just recently. Researchers also fear the variants could also elude COVID tests and be more resilient to vaccines just being rolled out now – although many unknowns remain.

The countries where 501Y.V2 is circulating include: Botswana, Ghana, Kenya and Zambia, as well as South Africa. Beyond Africa, the variant has been confirmed in 24 countries globally. And there’s concern, it is circulating undetected in other countries in Africa,” Moeti told the press briefing.

Dr. Matshidiso Moeti, WHO’s African Regional Director.

“We are seeing more and more cases of variants and 501Y.V2, which was first identified in South Africa now, cropping up in other countries,” Moeti said. “The evidence suggests that these variants are more transmissible and emerging evidence indicates that the UK variant may cause more severe illness than other common strains, although more research needs to be done.”

These variants in conjunction with “the aftermath of year-end gatherings”, Moeti said, “risk powering a perfect storm and driving up Africa’s second wave and overwhelming health facilities”.

The continent saw a 50% rise in infections between 29 December 2020 and 25 January 2021, when compared with the previous four weeks, while deaths doubled.  Last week, more than 6,200 deaths were reported across Africa, said the WHO.The past week saw a small dip in cases in South Africa, but 22 other countries continued to see numbers surge.

Existing COVID-19 vaccines remain effective against the variants, Moeti said. But Professor Tulio de Oliveira, of the University of KwaZuku-Natal, South Africa, noted that these or other emerging variants may likely require individuals receiving booster doses of the vaccine.

WHO’s African Region is meanwhile setting up a new surveillance network with Africa CDC to track the spread of the virus mutations and variants across Africa and beyond, Moeti added.

“The variant which was first detected in South Africa has spread quickly beyond Africa and so what’s keeping me awake at night right now is that it’s very likely circulating in a number of African countries,” said Moeti. “Africa is at a crossroads. We must stick to our guns and double down on the tactics we know work so well. That is mask wearing, handwashing and safe social distancing. Countless lives depend on it.”

WHO’s African CDC Calls for Common COVID Testing Approach For International Travel

Dr John Nkengasong issued his call for a rethink of travel policies after several foreign countries, including the United States, are considering or have already banned flights originating from South Africa. Travel restrictions aiming to limit the importation of variants should be based upon a systematic testing policy – and not geographic or national origins, said Nkengasong.

“We should not be banning people because of their geographical origin, but we should be encouraging people to travel with negative tests and facilitate the testing process so that people can travel with a negative test,” Nkengasong said.

“If I were to go to Kenya and I show up at the airport with a valid negative test, I pose no threat to the country of Kenya, and that way so you shouldn’t just ban me because I’m coming from a certain country. They should be looking at that test, is your test valid,” Nkengasong added.

Dr John Nkengasong, Director of the Africa CDC.

Up until now, the World Health Organization has resisted recommending pre-travel COVID testing, ostensibly due to fears that it would put an unnecessary onus on poor countries.

In fact, however, many of the poorest African and Asian countries have been requiring pre-flight COVID tests for all incoming passengers – which are paid for privately. Some counties, such as the Democratic Republic of Congo, also demand arrivals briefly quarantine until a post-flight test is completed as well, paid privately as well.

Paradoxically, it is wealthier European and American countries that first issued a rash of orders banning passengers of certain nationalities or flights from certain destinations as a result of variant scares – although more developed countries, most recently Switzerland on Wednesday, have adopted testing requirements.

Senegal’s Pasteur Institute – At Center Of New Genetic Surveillance Network

At the outset of the pandemic, most countries in Africa lacked adequate testing capacity for COVID-19 but this was gradually surmounted as new testing facilities were added.

Now, however, the identification of new variants of the virus will require more advanced capacities for gene sequencing that several countries in Africa have yet to obtain.

To address this vacuum, the Africa CDC, the WHO and member countries have created a network that enables existing labs with gene sequencing capabilities to collect samples from countries that lack such.

One of the labs in the network is the Dakar-based Institut Pasteur de Dakar in Senegal. Its CEO, Dr Amadou Sall, said in addition to providing gene sequencing services for Senegal, the institute is now supporting other countries, Cameroon and Equatorial Guinea notably. Others include Mali, Burkina Faso Guinea-Bissau, Côte d’Ivoire, Niger, Verde, and of course, Guinea.

“With the partnership we have with Africa CDC and WHO, we have the possibility of sequencing 500 genomes per week. And we’re trying to increase this capacity and to make these capacities available in different countries,” Sall said.

Key to the success of COVID-19 genomic surveillance in Africa, Sall said, will be the willingness and openness of African countries to share information.

“We need to be able to share information data and the Pasteur Institute is at the center of a global platform and we’re able to share information; to exchange information rapidly, if countries are willing to do so,” he said.

Knowing When to Raise the Alarm

While noting that identification of new variants is a significant feat, genomic experts warned that alarm should not be raised every time a new strain is identified.

Professor de Oliveira, who heads the KwaZulu-Natal Research and Innovation Sequencing Platform, said attention is raised when new strains are being confirmed in increasing numbers of cases with the new variant and not when just one case has been confirmed.

Describing the impacts that variants have on the epidemiology of the pandemic in South Africa, Oliveira said in some regions, the new variant has become the prominent type. But beyond this, he said South Africa is also worried about the variants from elsewhere getting into the country and circulating among its populations.

“Today, we just reported the first important case of the B.1.1.7, the variant of concern that is circulating in the UK. And it’s quite common that in addition to our main variant that is dominating, we’re going to still have introductions of new lineages,” Oliveira said.

“And in the case they begin to spread very fast, then we will communicate it and then highlight that could be a variant of concern.”

He said that while no one can know for sure about the possibility of third or fourth waves of the pandemic in Africa, the variants are highlighting the need for the entire world to globally control the transmission of  SARS-CoV-2 as a global community.

“We have to really decrease transmission to avoid the next waves and more worry that emergence of new variants of concern will transmit too fast or evade immune response,” he said.

“The appearance of these variants in the African continent, but also in South America and Europe really means that more than ever, it is the time that we don’t leave any continent behind, especially on vaccination,” Oliveira said.

Silver Lining In Cloud – Variants Also Impetus For Cooperation

But within Africa itself, Sall said the various SARS-CoV-2 variants constitute a new impetus for cooperation between countries, to be able to track and measure the circulation of the virus, and to enhance diagnostic capacities that he said will soon be available across Africa.

“The new variants are the object of a very thorough study, and the path of our countries is very clear: obtain maximum information and adapt the strategy to contain the transmission,” he said.

Moeti enjoined countries and individuals to strive to overcome COVID-19 fatigue and return to the fundamental actions that have been found to be effective against these variants. These measures, she said, need much more emphasis that news that the virus is much more transmissible.

“The vaccine is a tool that’s going to make a huge difference all over the world,” she said.

But she reminded that “having a corner of the world not protected, the way the world’s economies and peoples are connected, will have negative economic impact even in those countries that managed to vaccinate the entire population. We really are all in it together, and we have to work to support each other to overcome this global crisis.”

Image Credits: Paul Adepoju/HealthPolicyWatch, Africa CDC.

The Oxford/AstraZeneca vaccine is 2 months behind schedule due to an issue in manufacturing.

AstraZeneca has joined Pfizer in announcing delays in deliveries of COVID-19 vaccines to countries in Europe, leading furious EU officials to plan for a system of tighter monitoring of vaccine exports. 

The British-Swedish pharma company that developed its COVID-19 vaccine with researchers at Oxford University, informed the European Commission on Friday that there would be a 60% shortfall in vaccine deliveries this quarter due to a manufacturing issue at a production plant in Belgium. 

The company is reportedly two months behind schedule with regard to vaccines destined for European countries. Since vaccine deals with the United States and the United Kingdom were signed earlier on, and are based around manufacturing sites in those countries, the company has had a headstart in resolving “glitches” in those supply chains, pharma officials said.

But the Commission had its doubts over this given explanation.

Following an EU-requested investigation into AstraZeneca’s Belgian-based production facility on Wednesday, the European Commission has said it would establish a new mechanism that grants national regulators the power to refuse exports of vaccines.

The mechanism – the criteria for which is expected to be published on Friday – could throw the security of the UK’s 40m-dose deal with Pfizer/BioNTech.

The investigation, a spokesperson for the Belgian health ministry said, was to “make sure that the delivery delay is indeed due to a production problem on the Belgian site”.

AstraZeneca ‘Scaling Up’ Doses, As EU Leaders Question Pharma Company
Pascal Soriot, CEO of AstraZeneca

“We are scaling up to hundreds of millions, billions of doses of vaccines at a very high speed. A year ago we didn’t have a vaccine. When you do that, you have glitches, you have scale-up problems. Therefore, the yield varies,” said Pascal Soriot, CEO of AstraZeneca, in an interview with la Repubblica, an Italian newspaper, on Tuesday. 

News of the delays was met with frustration by EU officials and leaders, who were expecting to receive 80 million doses by the end of March. 

“This new schedule is not acceptable to the European Union,” said Stella Kyriakides, European Commissioner for Health and Food Safety, in a statement released on Monday. “The European Union wants to know exactly which doses have been produced by AstraZeneca and where exactly so far, and if, or to whom, they have been delivered.”

Stella Kyriakides, European Commissioner for Health and Food Safety, at a press briefing on Wednesday.

Soriot disputed suggestions that the company sold the doses elsewhere for a higher price, claiming that “there is a lot of silly talk going on right now about all sorts of things,” and the response from the European Commission and EU member states is because “there are a lot of emotions running in this process right now.”

“The suggestion [that] we sell to other countries to make more money is not right because we make no profit everywhere…That’s the agreement we have with Oxford University,” said Soriot. 

“Governments are under pressure. Everybody is getting kind of…aggravated or emotional about those things. But I understand because the Commission is managing the process for the whole of Europe,” he added. 

In late August, the EU made an upfront payment of €336 million to the company to secure 300 million doses of the vaccine. EU officials have disputed AstraZeneca’s explanation of production issues, claiming there are no excuses for the delay. 

“The flimsy justification that there are difficulties in the EU supply chain but not anywhere else does not hold water, as it is of course no problem to get the vaccine from the UK to the continent,” said Peter Liese, an EU parliamentarian from Germany’s Christian Democratic Union.

Currently AstraZeneca is producing 17 million doses per month. That number will reach 100 million doses from February onwards, according to Soriot, meaning 1.2 billion doses per year. And Europe will receive 17% of the global production in February for a population that represents 5% of the world’s population. 

The Oxford/AstraZeneca vaccine is in the final stages of the approval process with the European Medicines Agency (EMA) and is expected to receive the recommendation for market authorization on Friday. After being approved, the company plans to deliver three million doses immediately. 

Meetings between EU officials and AstraZeneca have done little to resolve the issue, with Kyriakides announcing on Twitter: “Discussions with @AstraZeneca today resulted in dissatisfaction with the lack of clarity and insufficient explanations. EU Member States are united: vaccine developers have societal and contractual responsibilities they need to uphold.”

The EU Steering Board, the body that oversees vaccine deals, plans to meet with AstraZeneca again on Wednesday at 6:30pm CET and hopes to “resolve this in a spirit of collaboration and responsibility,” according to Kyriakides. 

The Italian government plans to take legal action against Pfizer and AstraZeneca over their delays in deliveries, according to an announcement made by Foreign Minister Luigi Di Maio on Sunday. 

“This is a European contract that Pfizer and AstraZeneca are not respecting and so for this reason we will take legal action,” Di Maio said on RAI state television. “We are activating all channels so that the EU Commission does all it can to make these gentlemen respect their contracts.”

According to Soriot, however, the vaccine deal signed with the EU was not a contractual commitment but a best effort, so there is no feasible basis for legal action. 

EU to Establish a Vaccine Export Transparency Mechanism

The Oxford/AstraZeneca vaccine is also considered one with global potential – due to its ability to be stored at refrigerator temperatures. Amidst some countries’ suspicions that countries outside Europe are receiving priority for vaccines produced at the Belgium plant, the European Commission announced plans to establish an export transparency mechanism for vaccines to ensure clarity on transactions and to protect its investments in the R&D that led to development of vaccines like AstraZeneca’s.

AstraZeneca is also a major supplier of the WHO COVAX global distribution initiative – which has pledged to begin distributing vaccine doses to the 92 lowest-income countries in the world within the next two months. Although most of the COVAX supplies were reportedly to be produced by India’s Serum Institute or in the Republic of Korea, the exact supply lines remain unclear. 

“Europe invested billions to help develop the world’s first COVID-19 vaccines…And now, the companies must deliver,” said Ursula von der Leyen, President of the European Commission, at the World Economic Forum on Tuesday. “They must honor their obligations. This is why we will set up a vaccine export transparency mechanism. Europe is determined to contribute to this global common good. But it also means business.”

Ursula von der Leyen, President of the European Commission, speaking at the World Economic Forum on Tuesday.

“In the future, all companies producing vaccines against COVID-19 in the EU will have to provide early notification whenever they want to export vaccines to third countries,” said Commissioner Kyriakides. 

The aim of the proposed system will be to monitor, but not block, exports, officials said. And humanitarian deliveries would be anyway exempt from this oversight mechanism. 

EMA Yet To Issue Final Approval – Insufficient Data on Vaccine in Older People

Meanwhile, the EMA has yet to issue its final regulatory approval for the two-dose Oxford/AstraZeneca vaccine, and is reportedly considering limiting the age range to people under the age of 65 – due to a lack of data on effectiveness in older people. Unlike mRNA counterparts produced by Moderna and Pfizer, the AstraZeneca/Oxford vaccine uses a disabled, modified version of a chimpanzee adenovirus that can enter human cells but cannot replicate or cause the disease, as a vector to deliver a fragment of SARS-CoV2 spike protein, stimulating COVID-19 immunity. 

According to data shared by the company, only 10% of participants in the vaccine clinical trials were over the age of 65 because it was first waiting for sufficient safety data in the 18 to 55 age group before vaccinating older individuals. 

“We don’t have a huge number of older people who have been vaccinated,” said Soriot. “But we have strong data showing very strong antibody production against the virus in the elderly, similar to what we see in younger people.”

The results of an ongoing, larger Phase 3 clinical trial with 30,000 participants being conducted in the United States are expected to provide insight into the protection the vaccine provides to older individuals and ethnic minorities populations –  groups that were not very well represented in previous trials. 

In addition, scientists are exploring whether a half-dose of the first vaccine would reliably yield a higher efficacy rating of 90% that was seen in initial trials. The other regime, involving two full doses was only 62% effective, according to the results released by the company in late November and reviewed by an independent Data and Safety Monitoring Board. That still meets key global benchmarks for efficacy, but is significantly lower than the 94-95% efficacy results for the Moderna and Pfizer mRNA vaccines.

The AstraZeneca vaccine has, however, already been authorized in the UK, is already being used in British vaccination campaigns, including for people over 70 years old.

Image Credits: AstraZeneca, AstraZeneca, Twitter, Twitter.

Member States and non-state actors alike have expressed dissatisfaction with the current system, albeit for different reasons, according to WHO.

The World Health Organization (WHO) aims to make its engagement with non-state actors (non-state actors) more meaningful and efficient with a new proposal to establish a number of NSA fora that would allow exchange with WHO and member state representatives outside of official meetings.

The new proposal — which will be tested during the 74th World Health Assembly (WHA), 24 May to 1 June — would offer multiple side events in which non-state (NSA) actors could engage more informally with member state representatives as well as a forum for exchange between NSAs and WHO regional and technical staff.

But at the same time, non-state actors will be allotted a more limited number of constituency statements in formal governing body meetings – and like-minded groups of actors will be asked to combine their official statements together.

Non-state actors include civil society groups such as non-governmental organizations, international business and professional associations, and philanthropic foundations. More than 70 non-state actors are recognized as being “in official relations” with WHO, and thus contribute in formal meetings such as the EB and the WHA.

However, EB and WHA members have complained that the civil society interventions have become bogged down by too many lengthy, individual statements – and NSAs acknowledge that the statements often had limited impact in member state debates.

More informal meetings ahead of the formal meeting dates would help engender more meaningful interaction, WHO said in its proposal for the reform, which was reviewed by the WHO Executive Board on Saturday. Informal meetings will also allow non-state actors to organize themselves into constituencies, consolidating their positions into joint statements to be presented at official events.

The new arrangements to be tested in May, will “serve as a trial for potential future virtual informal meetings between non-state actors, Member States and the Secretariat, as a means of enabling more in-depth technical exchanges, as well as discussions on the Health Assembly agenda items,” said the WHO Secretariat, in its presentation to the EB on Saturday.

The COVID-19 pandemic has provided added impetus for reforms that have long been in the making – insofar as the limitations of virtual meetings have also curtailed the interactions between member states and non-state actors.

According to the new proposal, the informal series of meetings with non-state actors will be held just ahead of the WHA, and thus prepare the groundwork for the formal meeting.

Role of Non-State Actors Has Evolved – But Increasing Number of Statements Detracted from Impact

In the discussion over the proposal, WHO officials stressed that the Organization “is and remains a Member State Organisation” — engaging with 77 non-state actors, at global, regional and country levels, who also support the development and implementation of the Organization’s policies and recommendations, technical norms and standards.

But while non-state actors have “served the Organization well for several decades”, the increasing number of non-governmental organizations and other non-state actors participating — often with a greater number of requests to speak — has “not resulted in a more meaningful involvement”.

For example, when civil society representatives speak one-by-one at the end of a discussion, their interventions have little impact on the content or direction of the debate, WHO contends.

Member States and non-state actors alike have expressed dissatisfaction with the current system, albeit for different reasons, says the WHO.

A virtual consultation by WHO further confirmed that non-state actors’ primary interests in attending governing body meetings are to participate in technical exchanges with the Secretariat and the Member States and to attend consultative hearings that feed into decision-making processes.

Meaningful Participation From NGOs Critical, Member States Say

The UK delegate said that it would allow NSAs to exert even more credible influence on member states attitudes and positions. The EB representative from the United States flagged that it is critical to ensure and enhance meaningful participation of non-state actors in WHO governing bodies, while also creating greater efficiency in the governance process.

“Non-State actor participation must be allowed in a transparent and accountable manner with an open door to input from all stakeholders including the private sector,” the delegate noted.

Austria pressed for the Secretariat to provide some more detailed information on the procedure for these meetings.

Other states, like Australia, flagged that the trial is very ambitious given the agenda for the 2021 assembly is already very crowded.

“We suggest that before agreeing to a trial, the number of meetings proposed to be repeated and streamlined,” the representative said.This would “provide reflections to technical areas in advance of the governing body meetings”.

Civil Society Groups Request Clarity and Procedure Details

Bodies like Health Action International asked for details as to how NGOs would participate, and for clarity on the processes governing such meetings.

“It is a remaining concern to those who have witnessed creeping capacity shrinking of NGO space and poor consultation in recent years,” said an HAI statement. The HAI delegate requested that similar procedures be implemented for WHO regional meetings with member states, also asking that  “these informal meetings compliment, but do not replace comprehensive consultations with non-state actors.”

Meanwhile, the European Society for Medical Oncology said the views and expertise of non-state actors should be introduced earlier in the WHO decision-making process; it would be of greater value if delivered at the onset of projects, and when member states are drafting zero draft decisions and resolutions.

“Direct interaction and discussion between member states, WHO offices, and Non-State actors would provide the opportunity for more in-depth exchanges, and partnerships, as the Member States, develop policies and implement actions to fulfill their WHO commitments,” said the ESMO spokesperson.

Silberschmidt stressed that the virtual informal meetings will not replace other channels, but become an additional avenue for interaction – highlighting the fact that Dr Tedros Adhanom Ghebreyesus, WHO Director General, has already established a regular dialogue with civil society groups, to be held every six weeks.

 

Image Credits: WHO / Christopher Black.