European Medicines Agency to hold a public update on COVID-19 vaccines on 11 December

EMA will organise a public meeting on 11 December 2020 to inform European citizens about the EU regulatory processes for the approval of COVID-19 vaccines and the Agency’s role in their development, evaluation, approval and safety monitoring.

The COVID-19 pandemic is an unprecedented global crisis, with devastating health, social and economic impact. Safe and effective vaccines for COVID-19 are urgently needed to respond to this crisis and reduce its effects.

Together with the European medicines regulatory network, EMA is supporting the development of COVID-19 vaccines and has taken steps to speed up the evaluation processes for these vaccines. The Agency and its partners are doing so while ensuring that the same high regulatory standards for quality, safety and efficacy are being applied to COVID-19 vaccines.

The public meeting will inform citizens about EMA’s role in the pandemic and of EU regulatory procedures. It will also give the opportunity to the public and stakeholder groups to speak and share their needs, expectations and any concerns, that will be considered by EMA and the European medicines regulatory network in the decision-making process.

The EMA will publish the list of speakers who will make an intervention in advance of the event.

The public meeting will be broadcast live and will be open to all citizens. In addition to the selected list of speakers, during the meeting there will be a mailbox open via EMA’s website for the public to make comments.

The agenda and all information related to the event are available on the EMA website event page.

Please check EMA’s dedicated webpage on COVID-19 for the latest updates.

Updates from the European Medicines Agency: from vaccines to repurposing medicines and pharmacovigilance

24th-25th September
The European  Medicines Agency has hosted its first meetings in Amsterdam  for its Healthcare Professional Working Party and Patient and Consumers Working Party since the move of the Agency from its former Canary Wharf headquarters in London. The sessions coincided with the launch of a further three year work programme agreed between the EMA and its working parties.

Papers from the meetings will be available on the EMA website. 

Key themes in the new work programme will include secure supply of medicines, digital media for health, public health strategy on antibiotic resistance, addressing vaccine hesitancy, early access to medicines, pharmacovigilance, and encouraging patient engagement.

Central Amsterdam

Major topics discussed during the current Amsterdam meetings included initiatives to address vaccine hesitancy, updates on pharmacovigilance and initiatives on repurposing of medicines. In addition, the EMA provided updates from its major standing committees, including the Committee for Orphan Medicinal Products (COMP), Pharmacovigilance Risk Assessment Committee (PRAC), Committee for Advanced Therapies (CAT), Committee for Medicinal Products for Human Use (CHMP), Paediatric Committee (PDCO) and Committee on Herbal Medicinal Products (HMPC).

Isabel de la Mata, Principal Advisor on Public Health and Crisis Management at the European Commission discussed current initiatives to address vaccine hesitancy, an early priority of EU President-elect Ursula van der Leyer.

De la Mata noted that vaccine coverage is below 95% in many EU member states. A 2019 Eurobarometer on vaccine confidence had highlighted several key points of misinformation, for example with 48% of respondents thinking that vaccines often produce serious side effects, 38% that vaccines can cause the disease they prevent and 55% considering that vaccines overload and weaken the immune system.

A Global Vaccination Summit had been held on 12^th September with around 400 delegates political, technical, patients and other - and with WHO collaboration. This led to a 10 point document including new focus on reliable access to vaccines, safety and transparent, clear, independent information.

Actions by member states are to include developing national and regional plans, better access to vaccines, increased public health communications, more training of health professionals, accurate digital information on vaccination status and increased support for vaccine research and innovation.

European level actions are to include a new European Vaccination portal coordinated by ECDC (European Centre for Disease Control) with support from the EMA (EVIS - European Vaccine Information Sharing). Other work will consider dissemination of vaccine schedules, focus on the supply chain, including mitigating shortages and identifying and overcoming barriers to access.

A new coalition of healthcare workers for vaccination, launched on 5^th March in Brussels, aims to address and reverse reasons for outbreaks of measles and other vaccine-preventable infections in health workers as recently as 2017 and 2018, with transmission in the healthcare setting even in countries with high vaccination coverage.

John Kinsman, Expert in Social and Behavioural Change Communication at the ECDC, outlined Development of the European Vaccination information Portal. This is due to be piloted in December 2019 and launched in April 2020 during European Immunisation week.

The portal has a legal basis, arising from a 2016 European Commission call for the ECDC to work with EMA to develop the portal.  Issues include the reality that the majority of the public do not have a scientific background and making sure through content, language and accessibility that the portal is as widely available as possible.

The EMA is seeing an exponential increase in reporting by patients of suspected adverse drug reactions.  A pressing aim of the EMA is how best to learn from patient reporting of possible ADR. This will benefit from previous experience of patient reporting to national competent authorities  (e.g. US FDA and UK MHRA [patient reporting since September 2005]) and international agencies (e.g. the WHO Uppsala Monitoring Centre).

Plans for future meetings include proposals for further discussion of initiatives on vaccine uptake.

Communicating risk to health professionals and patients

The 12th biennial Congress of the European Association for Clinical Pharmacology and Therapeutics (http://eacpt.eu) is underway in Madrid from 27th to 30th June 2015. Over 500 abstracts have been accepted from 66 countries and form all 5 continents for presentation as e-posters and oral presentations. the 54 oral presentations are eligible for an award for the best talk. 
 
During one of the main panel discussions at the EACPT Congress in Madrid,  communicating risk to health professionals and patients was discussed by Barbara Rath (Germany), Almath Spooner (Ireland), Frederic Bouder (The Netherlands), Cristina Cabrita (Portugal) and Dolores Montero (Spain).

Listen to the panel discussing challenges when communicating risk, current initiatives in risk communication, risk perception and related issues.

More on the speaker panel

Almath Spooner is the Pharmacovigilance and Risk Management Lead at the Health Products Regulatory Authority (HPRA), Dublin, Ireland, where she has held a number of assessment and management roles since first joining the National Competent Authority (formerly the IMB).  Dr. Spooner has been the Vice Chair of the European Medicines Agency’s Pharmacovigilance Risk Assessment Committee since its establishment in 2012. She is also the PRAC Member for Ireland. She was formerly a member of the CHMP’s Pharmacovigilance Working Party.
Dr. Spooner is a member of the Heads of Medicines Agencies’ European Risk Management Strategy Facilitation Group, a core member of the EMA’s Incident Review Network and has represented the EU at the International Conference on Harmonisation. Dr. Spooner is a pharmacist by training with a PhD in pharmacy and additional postgraduate qualifications in statistics and pharmaceutical medicine. Before joining the IMB, she had experience in clinical and academic pharmacy.
Link to the HPRA website:   http://www.hpra.ie 

Cristina Cabrita is a Senior Project officer with DECO Proteste, a Non-Governmental Organization interested in consumer defence, health and public health. She trained as a pharmacist at the Instituto Superior de Ciências da Saúde-Sul in Portugal. She also has a Masters in Public Health from the National School of Public health in Lisbon. She Since 2009, she has been a member of the expert panel of the EMA-European Medicine Agency, for reviews of information on medicinal products. She has also been an observer on the EMA’s Pharmacovigilance Working Group.Since  February  2014 she has been a member of the expert health  team for BEUC (Bureau Européen des Unions de Consommateurs: the European Bureau for Consumer Unions).