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With vaccines lagging, treatments offer key to stemming India’s COVID death toll

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A report by the Washington-based Center for Global Development has revealed that, while official figures set India’s Covid-19 death toll at just over 420,000, the real figure could be up to ten times greater. According to the Center, that would make India the country with the highest coronavirus death toll in the world, far surpassing the United States and Brazil, and would also make the pandemic “arguably India's worst human tragedy since partition and independence", writes Colin Stevens.

Covid-19 deaths have likely been underestimated in Europe as well, with the World Health Organization (WHO) reporting deaths worldwide are likely to be “two to three” times higher than official figures. But in India, four in five deaths were not medically investigated even before the pandemic; now, due to a lack of hospital beds and oxygen, an unknown number of coronavirus sufferers are dying untested and unregistered at home. Widespread social stigma surrounding COVID-19 has compounded this phenomenon, with families often declaring a different cause of death.

While India’s coronavirus infections and deaths have sharply decreased from the peak of the second wave in May, the country has still lost over 16,000 people to Covid since the start of July. Public health experts warn India should brace for a third devastating wave by October, adding urgency to the hunt for tools to help patients who contract severe cases of Covid.

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India’s vaccine drive misses targets

Vaccines are the main preventative tool to keep severe infections at bay, and India has already distributed some 430 million doses—more than any other nation after China. Even so, only 6.9% of the Indian population has been fully vaccinated so far, out of a population of 1.4 billion citizens. Since the emergence of the highly contagious Delta variant in October 2020, India’s immunisation drive has been plagued with vaccine shortages, broken supply chains, and vaccine hesitancy.

This month, the WHO announced India will receive 7.5 million doses of the Moderna vaccine via the COVAX facility, but India’s domestic vaccine rollout continues to hit stumbling blocks. Bharat Biotech – who produce the country’s only approved homegrown vaccine, Covaxin – this week projected further delays, making it impossible for India to meet its target of distributing 516 million shots by the end of July.

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International disagreement on treatments

With herd immunity still far out of reach, India’s medical services still desperately need effective treatment solutions to help hospitalised patients. Fortunately, life-saving therapeutic options now being tried and tested in Europe could soon offer powerful weapons against the most dangerous infections.

While the number of Covid treatments available are growing as drugs complete clinical trials, global public health bodies are still divided as to which ones are most effective. The only treatment to receive the European Union’s greenlight is Gilead's remdesivir, but the WHO actively advises against that particular antiviral treatment, recommending instead two ‘interleukin-6 receptor blockers’ known as tocilizumab and sarilumab. Tocilizumab has also been proven effective by the wide-ranging RECOVERY trial in the UK, reducing time in hospital and the need for mechanically-assisted breathing.

Despite being a global hub for drug manufacturing, India is not always as quick to approve them. US pharmaceutical company Merck boosted India's manufacturing capacity for the antiviral medicine molnupiravir to help fight the second wave this past April, but local drug trials will not be completed until September at the earliest. In the interim, Indian authorities have awarded emergency approval to a different treatment for Covid-19, 2-DG, despite a lack of published trial data for the molecule.

New treatments like Leukine in the pipeline

This limited set of extant Covid-19 drugs will soon be bolstered by other promising therapies. One such treatment, Partner Therapeutics’ sargramostim – known commercially as Leukine – is currently undergoing testing in both Europe and the United States with a view towards rapid approval. In February, trials led by University Hospital Ghent and bringing together five Belgian hospitals found that Leukine “can significantly improve oxygenation in COVID-19 patients with acute hypoxic respiratory failure,” increasing oxygenation in the majority of patients by at least a third from baseline levels.

After noting Leukine’s potential, the US Department of Defence signed a $35 million contract to fund two Phase 2 clinical trials in order to supplement preliminary data. This past June, the results of the second randomized US trials of inhaled Leukine once again showed positive improvements in the lung functions of patients with the acute hypoxemia caused by severe Covid, confirming the Belgian findings that oxygen levels in patients who had received Leukine were higher than those who did not.

Effective Covid treatments would reduce pressure on Indian healthcare providers not only by improving chances of survival, but also by accelerating recovery times and freeing up hospital beds for other patients, including those dealing with other ailments. Faster treatments would also reduce the dangers posed to patients by contagious conditions such as black fungus, which has already been implicated in the deaths of over 4,300 hospitalised Covid patients in India. Greater clarity and accessibility surrounding treatments would also curb the worrying uptick in Indian families turning to the black market to purchase medical supplies of unknown provenance at hugely inflated prices.

Treatments that improve recovery rates and prevent fatal cases of Covid will remain crucial for as long as most Indians remain unvaccinated. Provided new drugs are approved in a timely manner, improved medical understanding of the virus means new Covid patients should have a better prognosis than ever.

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US-EU agenda for beating the global pandemic: Vaccinating the world, saving lives now, and building back better health security

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Vaccination is the most effective response to the COVID pandemic. The United States and the EU are technological leaders in advanced vaccine platforms, given decades of investments in research and development.

It is vital that we aggressively pursue an agenda to vaccinate the world. Co-ordinated US and EU leadership will help expand supply, deliver in a more coordinated and efficient manner, and manage constraints to supply chains. This will showcase the force of a Transatlantic partnership in facilitating global vaccination while enabling more progress by multilateral and regional initiatives.

Building on the outcome of the May 2021 G20 Global Health Summit, the G7 and US-EU Summits in June, and on the upcoming G20 Summit, the US and the EU will expand cooperation for global action toward vaccinating the world, saving lives now, and building better health security.  

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Pillar I: A Joint EU/US Vaccine Sharing Commitment: the United States and the EU will share doses globally to enhance vaccination rates, with a priority on sharing through COVAX and improving vaccination rates urgently in low and lower-middle income countries. The United States is donating over 1.1 billion doses, and the EU will donate over 500 million doses. This is in addition to the doses we have financed through COVAX.

We call for nations that are able to vaccinate their populations to double their dose-sharing commitments or to make meaningful contributions to vaccine readiness. They will place a premium on predictable and effective dose-sharing to maximize sustainability and minimize waste.

Pillar II: A Joint EU/US Commitment to Vaccine Readiness: the United States and the EU will both support and coordinate with relevant organisations for vaccine delivery, cold chain, logistics, and immunization programs to translate doses in vials into shots in arms. They will share lessons learned from dose sharing, including delivery via COVAX, and promote equitable distribution of vaccines.

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Pillar III: A Joint EU/US partnership on bolstering global vaccine supply and therapeutics: the EU and the United States will leverage their newly launched Joint COVID-19 Manufacturing and Supply Chain Taskforce to support vaccine and therapeutic manufacturing and distribution and overcome supply chain challenges. Collaborative efforts, outlined below, will include monitoring global supply chains, assessing global demand against the supply of ingredients and production materials, and identifying and addressing in real time bottlenecks and other disruptive factors for global vaccine and therapeutics production, as well as coordinating potential solutions and initiatives to boost global production of vaccines, critical inputs, and ancillary supplies.

Pillar IV: A Joint EU/US Proposal to achieve Global Health Security. The United States and the EU will support the establishment of a Financial Intermediary Fund (FIF) by the end of 2021 and will support its sustainable capitalization.  The EU and United States will also support global pandemic surveillance, including the concept of a global pandemic radar. The EU and the United States, through HERA and the Department of Health and Human Services Biomedical Advanced Research and Development Authority, respectively, will cooperate in line with our G7 commitment to expedite the development of new vaccines and make recommendations on enhancing the world's capacity to deliver these vaccines in real time. 

We call on partners to join in establishing and financing the FIF to support to prepare countries for COVID-19 and future biological threats.

Pillar V: A Joint EU/US/Partners Roadmap for regional vaccine production. The EU and the United States will coordinate investments in regional manufacturing capacity with low and lower-middle income countries, as well as targeted efforts to enhance capacity for medical countermeasures under the Build Back and Better World infrastructure and the newly established Global Gateway partnership. The EU and the United States will align efforts to bolster local vaccine manufacturing capacity in Africa and forge ahead on discussions on expanding the production of COVID-19 vaccines and treatments and ensure their equitable access.

We call on partners to join in supporting coordinated investments to expand global and regional manufacturing, including for mRNA, viral vector, and/or protein subunit COVID-19 vaccines.

More information

Joint statement on the launch of the joint COVID-19 Manufacturing and Supply Chain Taskforce

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Coronavirus: 200th EU disinfection robot delivered to European hospital, a further 100 confirmed

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On 21 September, the Commission delivered the 200th disinfection robot – to Consorci Corporació Sanitària Parc Taulí hospital in Barcelona. The robots, donated by the Commission, help sanitize COVID-19 patient rooms and are part of the Commission's action to supply hospitals across the EU to help them cope with the effects of the coronavirus pandemic. Further to these initial 200 robots announced in November last year, the Commission secured the purchase an additional 100, bringing the total donations to 300.

A Europe fit for the Digital Age Executive Vice President for Margrethe Vestager, said: “Assisting member states overcome the challenges of the pandemic continues to be a number one priority and these donations – a very tangible form of support – are a prime example of what can be achieved. This is European solidarity in action and I am pleased to see the Commission can go the extra mile in donating an additional 100 disinfection robots to hospitals in need.”

Twenty-five disinfection robots have already been working night and day across Spain since February to help tackle the spread of the coronavirus. Nearly every EU Member State has now received at least one disinfection robot, which disinfects a standard patient room in under 15 minutes, alleviating hospital staff and offering them and their patients greater protection against potential infection. This action is made possible through the Emergency Support Instrument and the devices are supplied by Danish company UVD robots, which won an emergency procurement tender.

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Coronavirus: Commission signs contract for the supply of a monoclonal antibody treatment

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The Commission has signed a joint procurement framework contract with the pharmaceutical company Eli Lilly for the supply of a monoclonal antibody treatment for coronavirus patients. This marks the latest development in this first portfolio of five promising therapeutics announced by the Commission under the EU COVID-19 Therapeutics Strategy in June 2021. The medicine is currently under rolling review by the European Medicines Agency. 18 member states have signed up to the joint procurement for the purchase of up to 220,000 treatments.

Health and Food Safety Commissioner Stella Kyriakides said: “Over 73% of the EU adult population is now fully vaccinated, and this rate will still increase. But vaccines cannot be our only response to COVID-19. People still continue to be infected and fall ill. We need to continue our work to prevent illness with vaccines and at the same time ensure that we can treat it with therapeutics. With today's signature, we conclude our third procurement and deliver on our commitment under the EU Therapeutics Strategy to facilitate access to state-of-the-art medicines for COVID-19 patients.”

While vaccination remains the strongest asset both against the virus and its variants, therapeutics play a critical role in the COVID-19 response. They help to save lives, speed up recovery time, reduce the length of hospitalisation and ultimately ease the burden of health care systems.

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The product from Eli Lilly is a combination of two monoclonal antibodies (bamlanivimab and etesevimab) for the treatment of coronavirus patients who do not require oxygen but are at high risk of severe COVID-19. Monoclonal antibodies are proteins conceived in the laboratory that mimic the immune system's ability to fight the coronavirus. They fuse to the spike protein and thus block the virus's attachment to the human cells.

Under the EU Joint Procurement Agreement, the European Commission has concluded until now nearly 200 contracts for different medical countermeasures with a cumulative value of over €12 billion. Under the joint procurement framework contract concluded with Eli Lilly, member states can purchase the combination product bamlanivimab and etesevimab if and when needed, once it has received either a conditional marketing authorisation at EU level from the European Medicines Agency or an emergency use authorisation in the member state concerned.

Background

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Today's joint procurement contract follows the contract signed with Roche for the product REGN-COV2, a combination of Casirivimab and Imdevimab, on 31 March 2021 and the contract with Glaxo Smith Kline on 27 July 2021 for the supply of sotrovimab (VIR-7831), developed in collaboration with VIR biotechnology.

The EU Strategy on COVID-19 Therapeutics, adopted on 6 May 2021, aims to build a broad portfolio of COVID-19 therapeutics with the goal of having three new therapeutics available by October 2021 and possibly two more by the end of the year. It covers the full lifecycle of medicines from research, development, selection of promising candidates, fast regulatory approval, manufacturing and deployment to final use. It will also coordinate, scale-up and ensure that the EU acts together in ensuring access to therapeutics via joint procurements.

The Strategy forms part of a strong European Health Union, using a coordinated EU approach to better protect the health of our citizens, equip the EU and its Member States to better prevent and address future pandemics, and improve resilience of Europe's health systems. Focusing on the treatment of patients with COVID-19, the Strategy works alongside the successful EU Vaccines Strategy, through which safe and effective vaccines against COVID-19 have been authorised for use in the EU to prevent and reduce transmission of cases, as well as hospitalisation rates and deaths caused by the disease.

On 29 June 2021, the strategy delivered its first outcome, with the announcement of five candidate therapeutics that could soon be available to treat patients across the EU. The five products are in an advanced stage of development and have a high potential to be among the three new COVID-19 therapeutics to receive authorization by October 2021, the target set under the strategy, provided the final data demonstrate their safety, quality and efficacy.

Global co-operation on therapeutics is crucial and a key component of our strategy. The Commission is committed to working together with international partners on COVID-19 therapeutics and make them available globally. The Commission is also exploring how to support the enabling environment for manufacturing health products, while strengthening research capacity in partner countries around the globe.

More information

EU Therapeutics Strategy

Coronavirus response

Safe COVID-19 vaccines for Europeans

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