Yesterday (24 March), the Commission adopted decisions on harmonized standards which will allow manufacturers to place on the market high performing devices to protect patients, health-care professionals and citizens in general. The standards will facilitate a faster and less expensive conformity assessment procedure. The revised harmonized standards play a pivotal role in the current coronavirus pandemic because they relate to critical devices such as medical face masks, surgical drapes, gowns and suits, washer-disinfectors, sterilization.
Health Commissioner Stella Kyriakides said: “We must not waste a second in our fight against the coronavirus. With the measures we adopt today, we speed up the entry of safe, essential medical equipment and devices such as masks, gowns and suits in the EU market. This equipment is fundamental for our health professionals – the brave and resilient women and men at the front line - to keep saving lives.”
Once implemented, the use of these standards will allow manufacturers of medical devices and other concerned economic operators, to comply with the health and safety requirements of the EU legislation, taking into account the most updated technical solutions. These standards, once referenced in the Official Journal of the European Union, grant conformity of devices with the requirements of the three Directives on medical devices.
More information is available online in a press release.
Coronavirus: Commission signs contract to procure monoclonal anti-body treatment
Yesterday (27 July), the Commission signed a joint procurement framework contract with the pharmaceutical company Glaxo Smith Kline for the supply of sotrovimab (VIR-7831), an investigational monoclonal antibody therapy, developed in collaboration with VIR biotechnology. It is part of the first portfolio of five promising therapeutics announced by the Commission in June 2021, and is currently under rolling review by the European Medicines Agency. 16 EU member states are participating in the procurement for the purchase of up to 220,000 treatments. Sotrovimab can be used for the treatment of coronavirus patients with mild symptoms who do not require supplemental oxygen, but who are at high risk for severe COVID-19. Ongoing studies suggest that early treatment can reduce the number of patients that progress to more severe forms and require hospitalisation or admission to the intensive care units.
Health and Food Safety Commissioner Stella Kyriakides said: “We committed in our COVID-19 Therapeutics Strategy to have at least three new therapeutics authorised by October. We are now delivering a second framework contract that brings monoclonal antibodies treatments to patients. Alongside vaccines, safe and effective therapeutics will play a pivotal role in Europe's return to a new normal.”
Monoclonal antibodies are proteins conceived in the laboratory that mimic the immune system's ability to fight the coronavirus. They attach to the spike protein and thus block the virus' attachment to the human cells. The European Commission concluded nearly 200 contracts for different medical countermeasures worth over €12 billion.
Under the current framework contract with Glaxo Smith Kline, member states can purchase sotrovimab (VIR-7831) if and when needed, once it has received either emergency use authorisation in the member state concerned or a (conditional) marketing authorisation at EU level from the European Medicines Agency. Further information can be found here.
With vaccines lagging, treatments offer key to stemming India’s COVID death toll
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.
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.
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.
COVID-19 vaccines: Launch of the interactive map on vaccine production capacities in the EU
The Commission has published an interactive map showcasing COVID-19 vaccine production capacities in the EU, along the entire supply chain. The mapping tool is based on data gained through the work of the Task Force for Industrial Scale-up of COVID-19 vaccine production, on data collected during the matchmaking event organised by the Commission in March, as well as publicly available information and information shared by member states. This data will be complemented and updated as further information becomes available.
Commissioner Breton, responsible for the Internal Market and head of the Task Force, said: “With more than one billion vaccine doses produced, our industry has helped the EU become the world's most vaccinated continent and the world's leading exporter of COVID-19 vaccines. This interactive map, featuring hundreds of EU-based manufacturers, suppliers and distributors, shows the breadth of the industrial ecosystem, as well as the potential for new industrial partnerships to further boost our health emergency preparedness.”
The Task Force categorized the companies based on their main area of activity, thus companies may have more capacities than those reflected in the map. The Task Force for Industrial Scale-up of COVID-19 vaccine production was set up by the Commission in February 2021 to ramp up production capacity for COVID-19 vaccines in the EU, acting as a one-stop-shop for manufacturers seeking support, and to identify and address bottlenecks in terms of production capacity and supply chain. The interactive map is available here.
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