The European Centre for Disease Prevention and Control’s prediction that the Delta variant will account for 90% of European coronavirus cases by the end of August makes plain the fact that many thousands of EU citizens are still vulnerable to Covid-19. The ECDC’s modelling of this variant – first observed in India and estimated to be 60% more infectious than the original SARS-CoV-2 virus – suggests a summer of lax Covid restrictions and a plateauing of vaccination rates “could lead to…an increase in hospitalisations, and deaths, potentially reaching the same levels of the autumn of 2020.”
While a fully vaccinated population is the EU’s primary exit strategy for the pandemic, vaccine supplies are already beginning to outweigh demand even in sizable countries like Romania, as a substantial minority of vaccine sceptics refuse inoculations and the EU’s goal of vaccinating 70% of its adult population this summer becomes steadily more unrealistic. To make matters worse, uncoordinated genome sequencing of positive Covid tests means the EU has only an approximate idea of the extent of the Delta variant’s reach, although there is no denying the extent of the variant’s spread after an uptick of detections in Lisbon triggered a weekend lockdown in the Portuguese capital.
The throngs of Europeans that remain unvaccinated has the WHO calling for “#SummerSense” as low case-numbers encourage lawmakers from Spain to Sweden to relax mask mandates and social distancing rules. Instead of succumbing to pandemic fatigue, Brussels must dedicate greater attention and funds not just to the bloc-wide vaccine rollout, but also towards potentially life-saving treatments for those who will invariably contract severe cases of Covid in the months to come.
Europe’s knee-jerk reactions to the pandemic must stop
While hospital admissions have been dropping in recent weeks, the EU risks abandoning current and future patients in ICU wards by eschewing treatment research and funding in favour of a single-track focus on prevention. At present, Europe still lacks both adequate strategic reserves of Covid-19 treatments and a coherent procurement strategy for anything other than vaccines, despite the fact scientists in the UK found patients with the Delta variant have an 85% higher risk of hospitalisation. With the Delta variant now accounting for the majority of positive tests in the UK, Britain has seen a 41% rise in patients on ventilation beds in recent weeks.
The EU has demonstrated a track record of penny-pinching and unpreparedness from the pandemic’s outset, as evidenced by the decisions to establish a first “rescEU” stockpile of medical supplies and a flurry of last-minute orders of ventilators, masks, and protective equipment only after Italy had already entered a nationwide lockdown last year. That is to say nothing of the disastrous decision to construct the European inoculation campaign around cheap doses of AstraZeneca.
Even though the Commission now promises at least three Covid therapeutics will be authorised for mass production in Europe by October, the bloc has allocated just €90 million for clinical trials and €40 million to expand production lines. On the other side of the Atlantic, the US government has allocated $3.2 billion (€2.68 billion) for the development of antiviral pills for use against Covid-19.
This disconnect between Europe’s need for a robust medical stockpile and its inadequate procurement strategy for therapeutics could come to be seen as yet another unforced error in the EU pandemic response – particularly in light of the rude awakening expected to come this winter. As the spread of the new Delta variant continues, the EU clearly requires greatly expanded investment and research into effective treatments, and European lawmakers could do worse than look to the extensive trials already underway in the US and UK for examples.
Trials explore new and existing drug candidates, including Tavlesse
The British Recovery trial was responsible for the discovery of the low-dose steroid dexamethasone, widely used since June 2020, and has also now discovered that the intravenous antibody infusion known as Regeneron could save six lives for every hundred patients treated. In America, the Biden administration seeks to build on the success of the $18.5 billion Washington invested in vaccines under “Operation Warp Speed” last year with a new focus on Covid-19 treatments. So far, the US Food and Drug Administration (FDA) has approved just one Covid-19 drug – remdesivir – but the $3.2 billion investment in a new Antiviral Program for Pandemics will support research into a further slate of promising antiviral treatments.
As in the UK, American researchers and the US government are closely examining the efficacy of existing drugs for patients dealing with severe cases of Covid-19. The most promising candidates include a drug named Tavalisse (marketed in Europe as Tavlesse), which has already been approved by the FDA and by the European Medicines Agency as a treatment for the blood disease chronic immune thrombocytopenia (ITP).
Tavlesse, produced by the American pharmaceutical company Rigel Pharmaceuticals, is an oral spleen tyrosine kinase (SYK) inhibitor which contains the active substance fostamatinib. The drug is now entering Phase III clinical trials in both the US and the UK, after extremely promising Phase II trials conducted in collaboration with the National Institutes of Health (NIH)’s National Heart, Lung, and Blood Institute (NHLBI) found that fostamatinib reduced the prevalence of “serious adverse events” in hospitalised Covid-19 patients by half.
According to Rigel, “the results of this trial suggest fostamatinib may be a useful addition to improve the outcome of severe and critically ill COVID-19 patients who are at the highest risk of death despite treatment with the best conventional therapies under the current standard of care (including remdesivir and steroids).” Patients who were given fostamatinib demonstrated a more rapid decline in “a number of inflammatory biomarkers that have previously been shown to be associated with the course of COVID-19 disease” versus those who were given the placebo.
Encouraged by the drug’s success in trials thus far, the US Department of Defense awarded Rigel $16.5 million in funding to conduct the Phase III trials that will help regulators better understand the ability of Tavlesse to help Covid-19 patients in the US.
Ultimately, even with vaccines now widely available, the EU’s willingness to follow the British and American lead in researching and procuring Covid-19 treatments will play a major role in determining how the next winter will look in Europe’s hospitals. The unpredictability of Covid variants and the ECDC’s worrying estimates mean Brussels must begin preparing for the possibility of future, vaccine-resistant waves of Covid-19 starting now.
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