COVID19 Resource Point
To ensure that you are kept abreast of the most relevant and reliable information regarding the COVID-19 pandemic, we reached out to Prof. Jean-Michel Dogné, Head of the Department of Pharmacy at the University of Namur and expert at the European Medicines Agency (EMA) for advice. Based on his recommendations, as well as input from our members, we will be sharing credible figures, research articles and reports on COVID-19 and its effects on the patient and medical community here and in a weekly e-blast to our subscribers (SIGN UP HERE)
COVID-19 Health System Response Monitor
The Health System Response Monitor (HSRM) has been designed in response to the COVID-19 outbreak to collect and organize up-to-date information on how countries are responding to the crisis. It focuses primarily on the responses of health systems but also captures wider public health initiatives. This is a joint undertaking of the WHO Regional Office for Europe, the European Commission, and the European Observatory on Health Systems and Policies. The HSRM allows you to select your country, access up-to-date information, compare health policy responses and access other references.
"How are countries re-organising non-COVID19 healthcare service delivery" - read more here>>>
COVID-19 Figures from Reliable Sources
Check these sites on a daily basis for up-to-date statistics on COVID-19:
New ECDC micro-learning course on #COVID19 - Learn more about: SARSCoV2 persistence on surfaces, clothes and objects plus cleaning and disinfecting for healthcare, non-healthcare with positive cases and general settings.
Development of Therapeutics and Vaccines
Remdesivir wins conditional EU approval for COVID-19 (03/07/2020)
The European Commission today granted conditional approval for Gilead’s remdesivir to treat COVID-19, as a key MEP warned the EU is prepared to take aggressive measures to access the therapy. Early studies suggest it could help speed recovery time for seriously ill patients without causing unacceptable side effects. However, the drugmaker must submit final reports from clinical trials to the European Medicines Agency by December.
The Commission touted the speed of the decision, delivered less than a month after Gilead submitted a formal application.
However, the decision also comes amid concerns that the California-based drugmaker committed to sell most of its planned stock through September to the United States. Gilead has already donated 1.5 million vials of the drug to Europe and can meet global demand “by October at the latest,” the head of the European Federation of Pharmaceutical Industries and Associations told POLITICO on Thursday.
German MEP Peter Liese, health spokesman for the European People’s Party, said today that Gilead’s relationship with the EU is at stake.
Liese noted that the EPP today adopted a position paper backing member countries’ authority to invoke so-called compulsory licenses, which would allow other manufacturers to produce remdesivir “even against Gilead’s will” if the company doesn’t provide access to European patients.
First COVID-19 treatment recommended for EU authorisation (25/06/2020)
EMA’s human medicines committee (CHMP) has recommended granting a conditional marketing authorisation to Veklury (remdesivir) for the treatment of COVID-19 in adults and adolescents from 12 years of age with pneumonia who require supplemental oxygen. Remdesivir is the first medicine against COVID-19 to be recommended for authorisation in the EU. Data on remdesivir were assessed in an exceptionally short timeframe through a rolling review procedure, an approach used by EMA during public health emergencies to assess data as they become available. Read More>>>
EMA receives application for conditional authorisation of first COVID-19 treatment in the EU (08/06/2020)
EMA has now received an application for conditional marketing authorisation (CMA) of the antiviral medicine remdesivir for the treatment of COVID-19 and has formally started its evaluation. The assessment of the benefits and risks of remdesivir is being performed under a reduced timeline and an opinion could be issued within weeks, depending on the robustness of the data submitted and whether further information is required to support the evaluation. Read More>>>
COVID-19: reminder of the risks of chloroquine and hydroxychloroquine (29/05/2020)
EMA is reminding healthcare professionals to closely monitor patients with COVID-19 who are receiving chloroquine or hydroxychloroquine, given the serious side effects that can result from treatment with these medicines. Both chloroquine and hydroxychloroquine, which are authorised for malaria and certain autoimmune diseases, have been used to treat patients with COVID-19 but their beneficial effects in this patient population are not established. Read More>>>
EMA recommends expanding remdesivir compassionate use to patients not on mechanical ventilation (15/05/2020)
EMA’s human medicines committee (CHMP) has recommended expanding the compassionate use of the medicine remdesivir so that more patients with severe COVID‑19 can be treated. The updated recommendations are based on preliminary results from the NIAID-ACTT study, which suggest a beneficial effect of remdesivir in the treatment of hospitalised patients with severe COVID-19. EMA is currently evaluating these data. Read more>>>
How EMA fast-tracks development support and approval of medicines and vaccines (04/05/2020)
As researchers race to develop vaccines and therapeutics against COVID-19, EMA has published an overview of how the Agency will accelerate its regulatory procedures so that marketing authorisations of safe, effective and high-quality COVID-19 related medicines can be granted as soon as possible. The rapid procedures described in the the inventory can accelerate every step of a medicine’s regulatory pathway and the Agency is fully mobilised to deliver these fast-track assessments in the shortest possible timeframes while ensuring robust scientific opinions are reached. Read more>>>
EMA starts rolling review of remdesivir for COVID-19 (30/04/2020)
EMA’s human medicines committee (CHMP) has started a ‘rolling review’ of data on the use of the investigational antiviral medicine remdesivir for the treatment of coronavirus disease (COVID-19). A rolling review is one of the regulatory tools available to the Agency to speed up the assessment of a promising investigational medicine during a public health emergency, such as the ongoing pandemic. Read Full Article>>>
Guidance on how to manage clinical trials during the COVID-19 pandemic (28/04/2020)
This version contains key changes based also on the feedback from different stakeholders’ groups (patients’ organisations, academia and industry) before and during the drafting process. Read full guidance here>>>
The EMA warns against using unproven cell-based therapies (28/04/2020)
EMA’s Committee for Advanced Therapies (CAT) is advising patients and the general public against using unregulated cell-based therapies which may not be safe or effective. The CAT’s advice is in response to individuals, companies and hospitals promoting unproven cell-based therapies as cures for a broad range of conditions including cancer, cardiovascular diseases, autism, cerebral palsy, muscular dystrophy and vision loss. These treatments can pose serious risks to patients for little or no benefit. Read more here>>> and read more about advanced therapy medicinal products here.
Reporting suspected side effects of medicines in patients with COVID-19 (24/04/2020)
EMA and the national competent authorities are reminding patients with confirmed or suspected coronavirus disease (COVID-19) to report suspected side effects that they experience with any of the medicines they are taking. Patients are reminded that there are currently no medicines authorised to treat COVID-19. Patients and healthcare professionals should report suspected side effects directly to their national authority via the contact details available here>>>
COVID-19: reminder of risk of serious side effects with chloroquine and hydroxychloroquine (23/04/2020)
Chloroquine and hydroxychloroquine are currently authorised for treating malaria and certain autoimmune diseases. In addition to side effects affecting the heart, they are known to potentially cause liver and kidney problems, nerve cell damage that can lead to seizures (fits) and low blood sugar (hypoglycaemia). These medicines are being used in the context of the ongoing pandemic for treating patients with COVID-19 and investigated in clinical trials. However, clinical data are still very limited and inconclusive, and the beneficial effects of these medicines in COVID-19 have not been demonstrated. Read more here>>>
Guidance on regulatory requirements in the context of the COVID-19 pandemic (10/04/2020)
The European Commission, EMA and the European medicines regulatory network have developed a question-and-answer (Q&A) document to provide guidance to stakeholders on adaptations to the regulatory framework to address challenges arising from the COVID-19 pandemic, with a particular focus on crucial medicines for use in COVID-19 patients.
Reducing COVID-19 transmission from potentially asymptomatic or pre-symptomatic people through the use of face masks (08/04/2020)
ECDC provides its opinion on the suitability of face masks and other face covers in the community by individuals who are not ill in order to reduce potential pre-symptomatic or asymptomatic transmission of COVID-19 from the mask wearer to others. Read their report>>>
EMA establishes task force to take quick and coordinated regulatory action related to COVID-19 medicines (09/04/2020)
As part of its health threat plan activated to fight COVID-19, the EMA has finalised and published the composition and objectives of its COVID-19 EMA pandemic Task Force (COVID-ETF), which draws on the expertise of the European medicines regulatory network and ensures a fast and coordinated response to the COVID-19 pandemic. Read their full mandate>>>
EU authorities agree new measures to support availability of medicines used in the COVID-19 pandemic (06/04/2020)
The continued availability of medicines, in particular those used for patients with COVID-19, is ofcritical concern for EMA and its partners in the European medicines regulatory network in light of the medical emergency presented by the pandemic. This discusses the role of EMA in actively supporting prevention and management actions during this crisis. Read full article>>>
EMA recommendations on compassionate use of remdesivir for COVID-19 (03/04/2020)
During an extraordinary virtual meeting held on 2 April 2020, EMA’s human medicines committee (CHMP) gave recommendations on how the investigational antiviral medicine remdesivir should be used for treating coronavirus disease (COVID-19) in compassionate use programmes in the European Union. Read full article>>>
COVID-19: chloroquine and hydroxychloroquine only to be used in clinical trials or emergency use programmes (01/04/2020)
The EMA advised patients and healthcare professionals to only use chloroquine and hydroxychloroquine medicines for their authorised indications or as part of clinical trials or national emergency use programmes for the treatment of COVID-19. This is to ensure patient safety and the best use of available supplies. Read full article>>>
Update on treatments and vaccines against COVID-19 under development (31/03/2020)
EMA’s COVID-19 response team has been in contact with developers of around 40 therapeutic medicines, allowing better understanding of potential treatments. EMA’s response team will continue to interact with developers of potential therapeutics or vaccines against COVID-19. The aim is to provide advice on regulatory requirements so that any promising medicinal product can be made available as rapidly as possible to patients, initially in the clinical trial setting and then, once authorised, on the market. Read Full Article>>>
Preserving Clinical Trial Integrity During the Coronavirus Pandemic (25/03/2020)
Clinical trials typically require years to design, fund, conduct, and complete but are essential for improving health and preventing and managing disease. The real effects of the coronavirus pandemic on randomized trials are as yet unknown but will hopefully be short-lived as they could be damaging to the long-term benefits of these trials to millions of people who will continue to live with devastating medical diseases after the crisis ends. This article discusses that creativity and persistence are required to preserve clinical trial integrity, especially during these unprecedented and uncertain times. Read Full Article>>>
Guidance to sponsors on how to manage clinical trials during the COVID-19 pandemic (27/03/2020)
The impact of the COVID-19 pandemic on European health systems and more broadly on society, will make it necessary for sponsors to adjust how they manage clinical trials and the people who participate in these trials. As a result, The European Commission, the European Medicines Agency (EMA) and national Head of Medicines Agencies (HMA) have published new recommendations for sponsors on how to manage clinical trials in the context of the coronavirus disease (COVID-19) pandemic. Read Full Article>>>
EMA’s Statement: Beware of falsified medicines from unregistered websites (24/03/2020)
EMA is urging the general public not to buy medicines from unauthorised websites and other vendors aiming to exploit fears and concerns during the ongoing pandemic of coronavirus disease (COVID-19). Read their Full Statement>>>
MHRA Advice for Management of Clinical trials in relation to Coronavirus (12/03/2020)
The UK Medicines and Healthcare products Regulatory Agency (MHRA) are aware that there are challenges arising in relation to Coronavirus and the effect this is having on the conduct of clinical trials. As a result, they have taken the time to offer advice for patients and organisations during this difficult time. Read MHRA’s Advice>>>
COVID-19 infection: the perspectives on immune responses (23/03/2020)
SARS-CoV-2 infection can be roughly divided into three (3) stages: stage I, an asymptomatic incubation period with/without detectable virus; stage II, non-severe symptomatic period with the presence of virus; stage III, severe respiratory symptomatic stage with high viral load. This article proposes some approaches to the treatment of COVID-19 patients, believing that a two-phase division is very important. Read Full Article>>>
ESPEN Expert Statements and Practical Guidance for Nutritional Management of Individuals with SARS_CoV-2 (24/03/2020)
In the current document, the European Society for Clinical Nutrition and Metabolism (ESPEN) aims to provide concise guidance for nutritional management of COVID-19 patients by proposing 10 practical recommendations. The practical guidance is aimed at those in an ICU setting or in the presence of older age and polymorbidity, which are independently associated with malnutrition and its negative impact on patient survival. Read Full Article>>>
Research and Perspectives from the Field
Covid. The commitment of patient associations: a national survey and a participation space (05/06/2020)
The role of the associations has proved essential in this emergency and the new governance system of the NHS in the aftermath of Covid-19 cannot leave aside mechanisms of integration and representation capable of giving voice to this subject. Hence the need to gather this experience to build a concrete design of structured participation of patient associations at the national and regional institutional level. Read full article (available in Italian) >>>
The toll beyond the COVID-19 deaths (14/04/2020)
As citizens in most countries follow the emotionally charged Covid-19 media coverage, which may itself be having an adverse effect on public health, the case for solidarity on shielding, social distancing, lockdown, and increased surveillance has largely been accepted. This blogpost assesses the wider health impact of the pandemic. Read Full Article>>>
The views of patients and the public should be included in policy responses to Covid-19 (30/03/2020)
The Covid-19 pandemic is affecting people’s lives around the globe and testing the resilience of health systems and social cohesion. Decision makers are trying to put in place effective control measures in an environment that is changing rapidly. The emphasis on maintaining universal health coverage and leaving no one behind is welcome (WHO). This opinion piece highlights that patients and our communities are a critical partner in or out of crisis and in the quest towards more equitable, sustainable and resilient health systems. Read full article>>>
Disabled People have Unique Perspectives on Solitude (25/03/2020)
Thanks to the coronavirus pandemic, we are all becoming intimately acquainted with solitude. One facet of this has been some interesting discussions with the disability community. Various claims are made for disabled people’s unique attitudes and approaches to the practice and art of being alone. Read full article>>>
Patient Perspectives during the COVID-19 Outbreak
From our unique position at the centre of the European patient community, we asked how patients with chronic conditions have been affected by the COVID-19 outbreak.
We kindly invite you to continue to share your voice during this tumultuous period. Send us your thoughts and experiences: email@example.com