After a slow start in the global vaccination race, Europe has now built up a small but consistent lead in comparison to the United States and enjoys the world’s highest rate of vaccines administered, with the latest numbers from the European Centre for Disease Prevention and Control (ECDC) showing that 510 million doses have now been administered across the countries of the European Union and the European Economic Area (EEA). 64% of the adult population in the EU/EEA zone are now fully vaccinated, and 74.3% have received at least one dose.
While the ECDC numbers point to the resounding success of the EU-wide vaccination campaign in reducing death rates from Covid-19, they also offer a sobering reminder that the virus is still fatal for many. The EU and EEA saw 1,560 people die of Covid-19 in just the first week of August alone, adding to a heart wrenching total of over 746,000 deaths since the start of the pandemic.
The enduring dangers posed by Covid-19 and its variants, especially the Delta variant now dominant across Europe, are pushing the European Medicines Agency (EMA) to continue its review of potential Covid-19 treatments, an endeavour also underway at the Food and Drug Administration (FDA) in the United States and at the World Health Organisation (WHO) in Geneva. Over the months to come, the therapeutic options approved via these channels could save tens of thousands of lives in Europe and millions around the world.
EMA undertakes tocilizumab review
The EMA has technically only approved one therapeutic – the controversial remdesivir – for Covid-19 in the EU, although the agency has also endorsed the use of options such as dexamethasone on the basis of findings from the UK’s groundbreaking RECOVERY trials.
Since the start of 2021, the EMA’s Committee for Medicinal Products for Human Use (CHMP) has also embarked on evaluations of seven more treatment options, with the most recent announcement concerning another drug whose efficacy in helping Covid-19 patients has also been demonstrated by RECOVERY: tocilizumab, an anti-inflammatory which is typically used to treat patients suffering from rheumatoid arthritis but which UK researchers credit with reducing the risk of death among hospitalised patients, speeding up recovery times, and cutting down the chances of needing to resort to mechanical ventilation.
Rigel’s fostamatinib and the FDA
In addition to informing the authorisation process undertaken by the EMA, Covid-19 therapeutic trials taking place in the UK are also contributing to the FDA’s review of new and promising treatment options. Imperial College London, for example, is currently working with the American pharmaceutical company Rigel and Switzerland’s Novartis on its multi-arm trial of inflammatory signal inhibitors for Covid-19 (MATIS), in order to determine whether Rigel’s fostamatinib and Novartis’ ruxolitinib can improve outcomes for hospitalised patients alongside a standard regimen of care.
Fostamatinib, which is marketed in Europe as Tavlesse and in the United States as Tavalisse, is already approved by the EMA and the FDA for use in treating chronic immune thrombocytopenia, a condition in which the body’s immune system destroys healthy blood platelets; Phase II trials conducted in partnership with the National Institutes of Health (NIH) in the US have already indicated fostamatinib can reduce death rates and hospitalisation times for Covid-19 patients as well.
While the FDA recently informed Rigel it would require more data from Covid-19 trials before it could grant fostamatinib an emergency use authorisation (EUA), forthcoming findings regarding the drug’s efficacy will come from the Imperial College study as well as multiple Phase III trials, including one carried out by the NIH’s National Heart, Lung, and Blood Institute (NHLBI) and another currently moving forward with the financial backing of the US Department of Defence (DOD).
WHO launches Solidarity PLUS
While the EMA and the FDA focus on reviewing trial data provided to them by research institutions, the World Health Organisation has recently marked a new milestone in its worldwide exploration of potential Covid-19 treatments, announcing on August 11th that it was launching a new phase of its Solidarity trials. The WHO’s Solidarity PLUS initiative will put the drugs artesunate, imatinib, and infliximab to the test across 52 countries, in an effort that will bring together over 600 hospitals.
Artesunate, produced by Mumbai-based Ipca in India, is an antimalarial drug that has already been in use for over three decades, with an established reputation for safety. Imatinib, another Novartis candidate, is a cancer treatment which has already undergone clinical trials among hospitalised Covid-19 patients in the Netherlands. Infliximab, from the American pharmaceutical giant and vaccine maker Johnson and Johnson, is branded as Remicade and has been approved in the EU for patients suffering from Crohn disease, psoriasis, and several other autoimmune conditions since 1999.
Taken together, these processes are designed to ensure doctors and hospitals have proven treatment options to save the lives of Covid-19 patients worldwide. With ongoing outbreaks outside of Europe feeding misinformation about the efficacy of different treatments and black markets for questionable cures, these efforts remain as important now as they were before the start of the global vaccine rollout.