On 16 November, the European Medicines Agency (EMA) hosted a meeting with its Patients and Consumers Working Party (PCWP) and Healthcare Professionals Working Party (HCPWP) on the COVID-19 pandemic. The PCWP and HCPWP are composed of representatives from patient, consumer and healthcare professional associations, including Alzheimer Europe alongside organisations such as the European Patients’ Forum and the European Respiratory Society.
Noel Wathion, Deputy Executive Director of the EMA, kicked off the meeting by providing an update on the Agency’s responses to the COVID-19 pandemic. These include the implementation of exceptional measures to maximize the transparency of its activities and the provision of rapid scientific advice for therapeutics and vaccines in advanced stages of development. Noel Wathion also emphasized the importance of addressing vaccine hesitancy head-on, calling for all organisations, regulatory authorities and governments to work together to increase public trust in vaccines.
Next, Marco Cavaleri (EMA Head of Biological Health Threats and Vaccines Strategy) presented an update on therapeutics and vaccines currently being developed for COVID-19. During his presentation, Marco discussed the development and testing of therapeutics such as Remdesivir and dexamethasone, highlighting the fact that very few investigational therapeutics for COVID-19 have been uniformly successful in clinical trials. However, he emphasized that there are promising treatments which have been shown to reduce disease duration when used to target viral replication during the early stages of COVID-19, as well as corticosteroid therapies that can alleviate symptoms through immunosuppression in more advanced and severe disease. Over a hundred therapeutics and over 30 vaccines are currently under discussion at the EMA, with results imminently expected from large vaccine trials.
In the latter half of the meeting, representatives from EMA, the PCWP and HCPWP outlined how patients and healthcare professionals are involved in the EMA COVID-19 taskforce, providing input on discussions around therapeutics, vaccines and outreach strategies. EMA representatives outlined the pharmacovigilance and risk management plans for COVID-19 vaccines, including the timely publication of public vaccine safety updates. Following a discussion on the vaccine outreach strategy being developed by the EMA, Juan Garcia-Burgos drew the meeting to a close by addressing some of the questions raised, and by inviting all attendees to an upcoming public stakeholder meeting on the EU regulatory processes for approval of COVID-19 vaccines.
