 Good morning, everybody. I'm Terence O'Rourke, a member of the Board of IEA, and I'm very delighted to work with you this morning for our first IEA webinar of 2021. And we're delighted and privileged to be joined today by the Executive Director of the European Medicines Agency, Imer Cooke, who has been generous enough to include her in her busy schedule. And as Executive Director of the European Medicines Agency, Imer will speak to us for about 20 minutes, and then we will go on to the questions and answer session with our audience this morning. As usual, you'll be able to join the discussion using the Q&A function on Zoom, which you'd see on your screen. And as you know, please feel free to send in your questions throughout the session. We'll be using your name and your affiliation, and maybe it will be helpful for us to just include the affiliation in your question. But send your questions that occur to you, and we'll come to them once Imer has finished her presentation. A reminder to everybody that today's public presentation and Q&A are both on the record. And as ever, we also encourage you to join the discussion on Twitter using the handle at IEA. Before asking Imer to address us, I'll just give you a little bit of a background. Imer Cooke was appointed as the new Executive Director of the European Medicines Agency on the 16th of November 2020. As an Irish national, she also holds the chair of the International Coalition of Medicines and Regulatory Authorities for a term of two years. Imer Cooke served as the director of all medical product related regulatory activities at the World Health Organization from 2016 to 2020, where she led the whose global work on the regulation of health technologies. So I'm delighted this morning to introduce you to Imer Cooke. Thank you, Chair. It's a real pleasure for me to talk with the Institute of International and European Affairs. I have to confess that I didn't actually know of this institute before I was invited to speak, but once I started to look into it, I was really intrigued about the activities and how much it fits with my own personal background. In international and European affairs. And of course, being part of the Irish diaspora, I quickly realized that I already met some of your board members, Catherine Degue when I lived in Brussels and Marie Cross when I was living in Prague. Throughout myself, I grew up in Dublin. I love Ireland. I'm extremely proud to be Irish, but I'm also proud to be European and have had to have had the opportunity and the privilege to work in an international context. I lived in Ireland 28 years ago this month, and since then I've lived and worked in five European cities I've worked for three European organizations, and one global organization the WHO, and I have to say that I have had many interesting enriching and very exciting roles. And so I have to say also that taking over the helm of the European Medicines Agency just two months ago on the 16th of November, could not have happened at a more challenging nor exciting time. It's very possible that many of you had not heard about the European Medicines Agency until very recently and had little or no knowledge or awareness of medicines regulation. I would say that this lack of awareness is by no means exclusive to Irish citizens. I've lived in five European countries. I've never met anybody who knew what I did. But today, I can strike up a conversation with any taxi or Uber driver and you can guarantee that they will have a view on the agency I work for the vaccines that we are evaluating either too slowly or too quickly and what we should do. The European Medicines Regulation has never been more visible. The European Medicines Agency has never been more visible. In a way, we feel like everyone as far as to be a medicines regulator, or at least has an opinion on what we should do. And today I'd like to give you a little bit more insight behind the newspaper headlines and the taxi conversations to tell you what we really do and why it is important. So let's take a look at some of the disclaimers. We actually have a very, we have a very focused role. Our role is to evaluate the safety quality and efficacy of the medicines and vaccines that are used on a day to day basis. But in this context, the medicines and vaccines that will be used to manage this pandemic. Without enough vaccines, we don't decide who are the priority groups to get the first doses. We don't buy the vaccines, we don't distribute them. We don't even decide which vaccines a country will decide to use. And in contrast to many medical product regulators, including the Irish regulator, the Health Products Regulatory Authority, we don't regulate medical devices. What we do is provide advice on which vaccines or medicines and medicines are safe, effective and meet consistent quality standards. So what is the EMA and what is our role for public health? Well, EMA started operating in 1995. And last year, like many individuals and many organizations, we did try to celebrate our 25th anniversary. We're hoping we'll be able to properly celebrate it this year. Ironically, the European legislation that established the European Medicines Agency in 1993 was one of the reasons that I moved to Brussels in 1992. I had been working for the Irish regulator, then called the National Drugs Advisory Board as a pharmaceutical assessor, and I was involved at that time in some of the European procedures. And I was looking at the legislation that was on the on the books, and I was worried that with the establishment of a European agency, Ireland would no longer be involved in evaluating the more innovative products on the horizon at the time. So EMA's main role is the scientific evaluation of medicines, including vaccines to allow marketing author authorisation in the EU through a centralized procedure, and then the safety monitoring of these vaccines once they're on the market. We act as a networking agency, facilitating the work of our scientific committees which are made up of experts from the competent authorities in the now 27 member states. EMA is an example of a real EU success story because it demonstrates the value of us working together and relying on each other's expertise. It was set up because at the time in the context of new biotechnological solutions, there really wasn't enough individual national expertise and it was thought that bringing everybody together, this would be make sure that we could benefit from a large pool of experts from across the EU who could then share the evaluation work and carve out the different activities. In Ireland, the health products regulatory authority is a very important member of our network and a strong contributor to our scientific work. And yes, I was wrong. They continue to be very actively involved in the evaluation of innovative medical products. Sharing expertise across the EU leads to a very efficient use of resources and a built in peer review system which guarantees that in the end, our opinions can be guided solely by science. Our scientific assessment is independent and is driven by patient and public health needs. We have patients on many of our scientific committees who tell us what's needed from the patient perspective. It's based on the strength of the scientific evidence on a vaccine or a medicine on its safety quality and efficacy and nothing else. The EMA evaluation leads to the granting of a marketing authorization and this authorization is valid in all EU member states at the same time, but also in the European Economic Area countries Iceland, Liechtenstein and Norway. And in this way, we leave no European country behind. Now, moving to the current crisis, I think it's fair to say that we were not really set up to deal with crisis we were set up to deal with innovation but we have over the years had to do a lot of crisis management. In the context of COVID-19, we've had to adapt quickly together with the EU regulatory network and we quickly made the response to the pandemic our priority. We also recognize that staying within the boundaries of our mandate, it was not enough to take on the many tasks that we needed to protect EU citizens during the pandemic. And just to take an example, we don't have a, at the moment, we don't have a mandate to deal with shortages, but one of the issues that came out very early on in the pandemic was that there were shortages of much needed ICU medicines across the EU and there was a need to adapt quickly and mitigate these shortages. We also set up a very agile infrastructure, including a pandemic task force, the COVID emergency task force which brings together all the best expertise to facilitate fast decision making by our scientific committees. These committees are mainly two in this context, the Human Medicines Committee, the committee for the CHMP, whose task is to recommend medicines and vaccines for authorization, but also the Pharmacovigilance and Risk Assessment Committee, the PRAC. Now, we based a lot of what we did in the context of COVID and what we had learned from our work during the H1N1 pandemic because at that time, we put together a public health emergency plan. And this enabled us to promptly adapt our processes and to be as efficient as possible for the review of new medicines and vaccines against COVID-19. One of the measures we put in place was the concept of a rolling review mechanism. So this allowed us to start evaluating data as it became available, rather than waiting as we normally would do for a company need to collect everything together. And then we start the review when all the information is available and all the studies have been done. So putting in place this rolling review allowed us to significantly shorten the time needed once the formal marketing application is received because this means most of the data will have been reviewed on this rolling basis before that. I would say, I take no credit for these new adapted procedures. As I said, I've only here two months, so these were set up under my predecessor, Professor Guido Razzi, and I thank him for all the foresight and work that went into making this happen. I would like to say, though, that my four years experience in charge of medical products regulation at the World Health Organization from 2016 to November last year have really helped prepare me to take over this, this, this role. Almost exactly one year ago, I remember sitting at a meeting where we were talking where experts were discussing about a new disease in Wuhan and debating over whether there was human to human transmission. And I think the rest is history. I spent the best part of the next 10 months setting up and preparing for a global approach to the regulation and monitoring of diagnostics treatments and vaccines. Back to the EMA. Where are we now? To date, we've two COVID-19 vaccines authorized in the EU, the Pfizer-BioNTech vaccine, Comernati, which was authorized on the 21st of December, and the Moderna vaccine, which was authorized on the 6th of January. Our scientific assessment has led to the granting of conditional marketing authorizations for these vaccines, and these, this conditional marketing authorization comes with corresponding safeguards, controls, and obligations. Both of these vaccines use similar messenger RNA technology, and they have similar and very impressive safety profiles. Although hundreds of experts have worked around the clock to perform this evaluation work in what we see as record time, we constantly hear criticism about perceived delays in the EU, particularly in view of the emergency use authorizations which were granted in the UK and the US. Now I have to say that there is no European provision for such emergency approvals, but I don't think that's what's important. What's important is that the European Member States told us that the conditional marketing authorization was the most appropriate regulatory mechanism for use in Europe in the current pandemic emergency. I want to stress that we have applied the same robust evaluation standards as we would for any vaccine. So a little bit about what a conditional marketing authorization is. A conditional marketing authorization results in one authorization which is valid throughout Europe, allowing all member states, big or small to benefit from the joint work performed at European level. But before it ensures that no EU member state is left behind and it provides them with a firm scientific foundation for the rollout of their vaccination programs, but also and very importantly a continuing framework for control and supervision of the vaccines. It's supported by extensive data which has been submitted by companies to demonstrate the quality of the vaccine, how well it works, its safety, and it provides a controlled and robust framework for both pharmacovigilance which is what we call the post marketing monitoring for adverse events and for manufacturing controls and other post approval obligations. So effectively there are legally binding obligations to ensure continuous monitoring and updates and this helps to provide the basis for a high level of protection to citizens during the course of a mass vaccination campaign as we're seeing being rolled out at the moment. Now, in addition to the two vaccines that we've already authorized there are two further vaccines in the pipeline, one from AstraZeneca and one from Janssen and these are both viral vector based vaccines and they're currently under active review. We've just received a conditional marketing authorization application for the AstraZeneca vaccine this week. I think it was Tuesday and we're hoping that we can conclude the evaluation by the end of January. The Janssen vaccine is a little bit further behind and it's under the rolling review process. I can also tell you that more than 45 other vaccine developers have been in contact with us and that many other many therapeutics are also in the pipeline and some of these are likely to come to EMA for authorization later during the year. Well, we have taken every step to expedite our evaluation processes. I want to repeat that we have applied the same robust evaluation standards as for any vaccine and ensuring vaccine safety has been our number one priority. We're keenly aware of the huge responsibility we have to get these recommendations right to protect European citizens. Our work doesn't stop at authorization of the vaccine or medicine. We continue to collect and analyze data to ensure that the use of the vaccine is always based on the most up to date evidence. The authorization provides for an agreed plan that includes specific and legally binding obligations on the companies to ensure that additional data continues to be generated and submitted after approval and in accordance with predefined deadlines. The safety and effectiveness of these vaccines will continue to be very closely monitored through the EU pharmacovigilance system as vaccines are rolled out across the member states and also globally. And in addition to the normal requirements that any vaccine or medicine would have to ensure that all side effects are reported to our pharmacovigilance system eudovigilance and to continue continually monitor on a national regional and global basis companies exceptionally have to provide EMA with additional monthly safety updates and conduct specific studies to monitor safety and effectiveness. We're now at the start of vaccination campaigns that will see millions of EU citizens immunized in a very short time, and we're leveraging all data sources to achieve nearly real time safety monitoring of the vaccines. We're taking steps to ensure that we can leverage real world data from clinical practice to monitor the safety and effectiveness. And what's also new is that in addition to the requirements that we put on the companies independent European studies on safety and effectiveness will be conducted under the supervision of the European Medicines Agency and also the European Center for Disease Controls. Back in May 2020, we already set up a project to establish harmonized tools to conduct specific pharmacoeppy studies on COVID-19 vaccines. And at the very end of last year, we commissioned the first safety monitoring study in population groups prioritized for vaccination in at least five member states. And this will run between February and December 2021. Later in the year we're planning to launch a much larger prospective safety study, which will be building on the outputs of the previous project and will span over two years in many more member states with a focus on healthcare personnel and risk groups that have not yet been included in the pre authorization trials. We're also closely collaborating with the ECDC who is leading on coordinating studies to monitor effectiveness. We're constantly reviewing our recommendations to ensure that the vaccines are used according to the most up to date scientific information. One example I can give you is that on the basis of additional studies, we recommended updating the product information for common commonality to clarify that six doses of the vaccine can be safely extracted from each file, provided that appropriate syringes and needles are used. This will help to increase the number of citizens who can be vaccinated by the available stocks in member states. We're also working with the companies and national authorities to help increase production capacity in new manufacturing sites and to facilitate scale up. Throughout this crisis, we medicines regulators have reinforced our bonds with our sister agencies in other regions of the world. As Terence mentioned, I currently chair the international coalition of medicines regulatory authorities, and under this umbrella we have led global efforts to streamline regulatory requirements for vaccine development, helping to facilitate both the development and approval processes. We've been working closely with other European partners, including the European Commission, the Health Security Committee and the European Center for Disease Control, and with international partners such as the WHO and with many regulators from across the world. The COVID-19 pandemic has prompted us not only to rethink how we work in a crisis, but to ensure that we are relevant, our voice is heard, and more importantly that our voice is understood. It's brought medicines regulation into the spotlight. As I said at the beginning, many EU citizens did not know that EMA even existed. It's typically medicines regulation, it's typically an activity that happens in the shadows. There's a public expectation that the medicines we use are safe, efficacious and of high quality, but most people have very little knowledge about what happens in practice to make sure that this is the case. In the context of this public health crisis, we've suddenly become mainstream and we've moved to the center of intense public debates with some calling for speedier approvals while others are concerned that development was going too fast to ensure safety. Now, this situation certainly presented us with challenges, but it was also an opportunity to make better known the contribution that we play and the contribution that we bring to public health and the important regulatory role that we have to take decisions that are based on evidence, and facts, and science. We keenly recognize that vaccines will only help in the fight against COVID-19 if citizens have enough confidence in our authorizations to get vaccinated. No citizens transparency so they can make up our minds about the vaccines based on the evidence that we communicate so we've had to step up our communication activities. This has been a great experience for us. We've organized two stakeholder meetings, public stakeholder meetings open to everybody across the world to explain how we are evaluating and monitoring the COVID-19 vaccines and to respond directly to questions and concerns from European citizens. Our most recent public meeting was held on the 8th of January and we use this to explain the basis for the EU approval of the two vaccines and how the safety would be monitored long term. And both of our, both the events, the event in December and the event in January were followed live by several thousand participants. These meetings have been a great opportunity for us to listen to the needs of concern and concerns of citizens, but also to help us support public competence in these vaccines and in EMA's assessments. I was brought up in Ireland in the 1960s. I was vaccinated against polio, typhoid, smallpox, diphtheria, TB, measles, months, rubella. These vaccines were game changers. Smallpox has been eradicated. Global disease incidence of the other killer infections is extremely small. Most of our citizens take this for granted, but it didn't happen by magic. It's the result of effective vaccines and vaccination strategies. Vaccines that prevent COVID-19 are also game changers. But to enable changing the current game, we needed to mobilize hundreds of experts across EMA and the national authorities. We needed to ensure that they could work tirelessly in many activities that would help us to support the development and assessment of the evidence that was generated. I'm very proud of EMA's achievements, but it remains critical that we explain our decisions well and also manage public expectations. We're not yet at a turning point in this pandemic. We will need more vaccines to cover the needs not only of Europeans, but also of all global citizens who are suffering as a result of this pandemic. EMA will continue to play our part in working hard to fulfill these needs, working closely with the member states and the European Commission. I focus my talk on vaccines because this is on everybody's mind at the moment, but there's still an urgent need to have new and better treatments for patients who have COVID-19. As is the case for vaccines, there are many new and old therapeutics being studied to see if they can alleviate symptoms, they can manage hospitalization and prevent deaths. But so far, we have only provided a conditional marketing authorization for one product, Remdesivir, and we have additionally authorized the endorse the use of dexamethasone for some patients. There's a lot of interest around the use of monoclonal antibodies, the use and potential of monoclonal antibodies, and working with a lot of developers in the scientific advice stage, but the trials as yet have not shown definitive efficacy. It's going to take a while, it's going to take time to roll out the vaccines to sufficiently large numbers of people to enable all our citizens to be protected and the occurrence of infection to be suppressed to the greatest extent that we can imagine. The authorization of vaccines is a very positive step in the right direction, but vaccines alone are not the silver bullet that will allow us to return to normal life immediately. We are very aware that the pandemic has caused and continues to cause hardship for many and that patients is running low, but we still need to speak out for science and ask everyone to contribute in preventing the spread of the disease. We need to follow the advice of our health authorities, wear masks, wash hands, maintain distance. This is still going to go on for some time. Europeans have worked together to achieve authorization and roll out of vaccines in record time frames, and we need to continue to work together in 2021 to beat this pandemic. Now, as I come to the end of my talk, I want to leave you with what I think that we at EMA will take away once we have this pandemic under control. I think we very, we understand very, very keenly that medicines regulators cannot work in isolation. We need to be connected to the healthcare systems, patients, public and all relevant stakeholders. We need to be agile and reactive and ready to step up in crisis situations. The new legislative proposal for the European Health Union recognizes this need and gives the agency more roles in crisis situations. Diseases know no borders, and while it is legitimate to make national decisions, it's almost impossible that these decisions will not affect other countries, and therefore we need to be aware of what's going on and connected internationally. I am extremely proud of what Europe has delivered to date, but let's remember that this is a disease that only just has its first birthday. We knew very little about it then. We know a lot more about it now, but we are still learning and there's a lot we have to learn. As I sat in that meeting room one year ago, I couldn't have imagined the scale this disease would reach, but equally I couldn't have imagined that we would have such effective vaccines being developed in such a short time that we could reduce our normal authorization times from about a year to less than a month, and that there would be a joint approach to European procurement. As I said, there's a lot that we still don't know. The virus is mutating, as all viruses do, and we need to evaluate the impact of these mutations on current and future vaccines. Personally, I think that COVID-19 is helping us to think about the different questions we need to ask as medicines regulators, and really what matters in real life. This will help us to be better prepared and more reactive. I also firmly believe that in the public sector, we have to constantly challenge ourselves to think outside our comfort zones and to understand all stakeholder perspectives so that we continue to be relevant, proactive and connected. As Europeans, we are stronger together. At the end of my five-year mandate as Executive Director of the European Medicines Agency, I want people to know the European Medicines Agency. I want them to know what we do, what we have done, but not just because there is a crisis, hopefully because there is no longer one. And in the words of my great friend and previous boss, Marie Angela at WHO, who used to tell us every day what we needed to do, he used to say, when all is said and done, let there be more done than said. Thank you very much for your attention. Thank you very much, that was fantastic. I think that's everybody wanted to hear that. We now know about the EMA now and you've told us a lot more about what went on and I think answered lots of people's questions, but there are still some questions coming in, lots of questions coming in, so maybe I might start off with those. Maybe I'll start with a topical one from Francis Jacobs, who's an IEA member. Francis asks, the UK and other countries appear to support the idea of delay between the first and second dose of the Pfizer vaccine to accelerate vaccination of the population in the UK's case for a long period of the 12 weeks. I just might join that Aiden O'Connor, who's with the EU Commission, he said, is there a risk in the UK approach in not giving a second dose in line with approval. And Francis's question concludes, how far advanced is the EMA's review of this idea. So this idea of the time gap between the first and second vaccination. So yeah, of course, this is a very topical question. It's been discussed very widely across European and international circles. We have to, the authorisation that we give is based on the evidence in the file and the evidence in the file allows us to recommend the Pfizer vaccine for an interval of the first dose is the second dose is 21 days after the first dose and in the case of the Moderna vaccine is 28 days. Now there is a bit of leeway around that that we've seen in the clinical trials, but how much leeway has not been studied. There's a lot of work to do to really be to be able to say definitively whether this will work or not, and we can only go on the basis of the of the trials that have been done, and the evidence in those trials. Okay. Thank you. Question from Naomi Leary in the Irish Times. What political pressure did the EMA commander in December to speed up the approval process of the vaccine of the Pfizer vaccine. Yeah. So, this is of course not the first time that I've been asked this question either. We are under intense pressure. It's not political pressure. It's pressure to serve the European citizens. So we're constantly thinking about how we can do better how we can be more reactive how we can speed up our processes. Since the start of this pandemic, and I can speak from the start of my tenure at EMA, we have been looking at ways to take out the more bureaucratic aspects of our processes to try and make sure that we have a robust scientific process at the same time as eliminating things that might be unnecessary so I can, I can firmly. I can firmly confirm that we have the pressure that we have been under is pressure, our responsibility towards European citizens and not political pressure. Move on to a question from Steven Murphy who's with the, I think the Department of Health, our Department of Health. First of all, he says congratulations on retaining your accent. We've been away in many years, but we know where you're from. His question is, do you anticipate a re-engagement, or am I going to say an increase engagement with local medicine agencies by the USA under the new administration. Yeah, but that's again that's very interesting question. I know I'll speak from my point, the point of view of being at WHO when under the previous administration where I think many of you will be aware that the the US stopped, withdrew its support for WHO and we were worried about the impact that we'll have on medicines regulation. I have to say that that we have behind the scenes we've continued to have very good scientific collaboration with the US FDA and because I think everybody's concerned about about the same things. I do hope that the visibility, the international visibility and the need for international collaboration will be a feature of the new administration. Okay, good. Question from Bobby McDonald who's the former Irish diplomat. And I guess he's just going back to one of the issues you're raising your speech about the difference maybe between emergency approval and conditional marketing approval. Is there any suggestion that there were some corners might have been caused a little bit in emergency approval. Would you like to distinguish between those two in any way. So, I think what I don't think it's a question of cutting corners. The emergency use provisions are different provisions and they have they result in different legal obligations, and particularly in the context of the European system. They would have, they would have resulted in different European European approaches. I am strongly, I believe that all my fellow regulators across the world have a strong commitment to ensure the safety effectiveness and quality. So having emergency use or temporary use provisions allow them to do things slightly differently to have a slightly different data package which can help them to to work quicker. But I don't believe that corners have been cut in the evaluation. Thank you. And the questions are continuing to come in. And I might remind our audience just to add your affiliation we do like to emerge to understand what the questions coming from. And I'm going to give you a question now and I don't know where the person's from Michelle Hennessy asked the question. She says we've heard from Pfizer that if a new strain of the virus shows resistance of vaccines. It can make a vaccine work in six weeks we know what the new variants. Could the company have to go through the entire three phase process or is there an expedited expedited process to this situation. So, very good question. We're working with Pfizer and with Madonna, precisely on how their vaccines would work in the to in the context of the new strains. We're asking them to to to study but it we hope we'll be able to do a very adapted a process they wouldn't have to go back to the full package we'd be able to use a lot of what we had already. Okay, thank you. And I should say that Michelle is of course I should have known this is from the journal.ie so that was the question there. Another question from CJ waltz and again I don't know the affiliation but the EMAs role reactions in the event of use of unauthorized Chinese or Russian vaccines in the U it's what what happens in those circumstances people want to use the Chinese or the Russian vaccines in the U of the EMA role in that. So, let me let me just first start by saying that we will evaluate any vaccine, regardless of its origin. But at the moment we haven't yet had applications for the Russian and for the Russian and Chinese vaccines I can say that were the Russian vaccine. We're in discussions with the Russian vaccine developer. So, we can only, we can only elaborate on something that we've actually seen, and we haven't seen these, these dossiers to date. We're very open to discussing and looking at the dossiers and hopefully evaluate if they have a role in this pandemic. We want them to play that role. Another question now again from Michelle Hennessy and again acknowledging that she's with the journal that I and I guess coming from the point of view that there and we know there are people out there nervous about vaccines. And Michelle asks the monitoring of these vaccines is obviously going to be a big part the process going forward. Many of our readers have asked questions about a serious or rare side effects to be monitored that that is obviously a concern to people. Yeah. So, part of the process for when you're looking at the dossier for for any vaccine or medicines you, you look at all the the rare, the serious and non serious events that came up in the clinical trials. But there's, but these trials, the ones for the existing vaccines were in 30,000 patients, more or less. And that's, even though that's a very good safety cohort by, by vaccine standards, it's still not enough to be able to detect very rare side events. So we ensure that the patients who were involved those in those trials are followed up for a period of two years afterwards. And that again, make sure that we are monitoring for any new or unexpected side effects over a longer period of time. And we also have our pharmacovigilant system where we have the potential to react to any new signal that comes in from anywhere in the world to see whether in fact that could be related to the, to the vaccine. You'll understand that that that, especially when vaccines are given to elderly populations or populations with comorbidities, that there is, there are underlying conditions irrespective that that that will cause problems irrespective of the vaccine so it's always, we always look at, at how, whether this might be related to the vaccine or not. If it is we will take the measures to mitigate it, but in many cases, the, what's been reported might not be related to the vaccine administration. And now to a question from Liz Canavan, who's with the Department of Physiology, she asks, do we have a sense yet of how long the vaccine lasts, and is there a risk that we will therefore be going into a requirement for a rolling vaccine program for years. Let me come back to one of the points I made during my, my talk about how much we know and how much we'd like to know. And this is something that we don't know yet. It's part of the studies that are ongoing. So how long the vaccine, we know that the vaccine prevents disease. We don't know how long it prevents disease for. It could be if we had, if we had thought about designing the trials and this wouldn't have been us of course but but now if we were looking at designing trials or contributing to that we might have added some parameters that would help us know this quicker but it's part of the part of the studies being done as part of the rollout of the vaccination strategy. Okay. So I'm going to go from Donald O'Brien who's an IEA member. I'm just asking about the extent of whether the capacity of EMA that the move from from absolute from to Amsterdam from London which happened in 2019. We have a lot of history of UK people doing lots of medical science research, Fleming and all the rest DNA and everything that will happen in London, and now EMA is based in Amsterdam so to what extent is the capacity of EMA being affected by that move. Again, a question that we often, we often get asked, we, I was not involved in the, in the, in the moves because I basically the, the whole move to Amsterdam took place while I was still at WHO. But actually the administration here did a lot of work to make sure that we would not be adversely affected by the move to Amsterdam that we would maintain our staffing and in fact we've, we've, we've, we've, we've kept very much. I think it's what 80% of, of, of the staff who were in London before we came have, have, have gone with us. Another issue is the role of the UK in the whole process because it's true that the UK authority was a very strong member of our network and provided very good input in a lot of our systems. We've been preparing for this for three years, and building capacity, building capability, making, identifying where there were potential gaps and working together with the national authorities to make sure that we were prepared. This was, as a result of Brexit, but it served us in the context of COVID as well. Thank you. And it's a slight variation of my question probably asked earlier this is from Kiran O'Driscoll who is a policy research officer with European movement and he asks. How do you think the challenge around COVID-19 disinformation should be addressed to ensure it does not undermine the uptake of vaccines by European citizens. There was a lot of gossip and social media. So, really, it's the, all the, the info, info demic, I think is what they call it. It's really put a lot of challenges on our system because we were dealing with myths and rumors as opposed to facts and science and we're used to dealing with facts and science. So we've had to, again, as I said, step up our communication activities. We want to, to be a source of science fact based information for European citizens. We want people to know that if they want to know what the real the truth and the facts that it's to EMA that they need to come. We've also, we're also monitoring social media, we're trying to make sure that, that, that we, we understand the type of, of issues that are being discussed so that we, we can counter them if they, if it is misinformation, or reinforce them if it's, if it's true. So we, we've, we've had to step up our communication activities to work more with social media outlets to understand the environment better and to try and be the source of the true factual evidence. Thanks, Simra. I'd move on now to question from Fergal O'Brien from RTE News, Fergal is the medical correspondent RTE. He says, how confident with EMA be at the stage based on the current data you've received that the Oxford AstraZeneca vaccine we got approval as you on the Commission meeting on the 29th of January. Well, I'll take out my crystal ball now. So, we have, we started the official review on Tuesday, we put a tentative timetable in for the end of January. There is some, we're receiving new information all the time. There are, there are two big trials ongoing. One of them we won't be, we won't have all that information by the end of, by the end of January. But we need, we, we, we do hope that we have sufficient to be able to come to a scientific conclusion by then, by then. I have to say, and being at the same time, pragmatic but quite conservative, things can go wrong. And these dates depend on everything going right. And, and us all reacting and working together to make this happen. It's, yeah, it's, it's, it's challenging, but I'm hopeful. I'm delighted to hear that. Another question and it goes back to somebody we touched on briefly there but the UK from Germans or leery who's the chief economist with a good restart brokers he asks, how much interaction or coordination is there now with UK medicines regulator how do you expect that relationship to happen going forward. Yeah. We have, I mentioned that I'm chair of the international coalition of medicines regulatory authorities, mh array is one of the authorities involved in these in the this coalition. And so we would have in the context of these multilateral frameworks we would have certainly weekly, if not, and daily interaction with with mh array I can say that because they rolled out the biotech vaccine and there was the case of the faxes we have an immediate contact with mh array to look at the facts and what could be done to mitigate the consequences also to feed into our evaluation so on a scientific level where we continue to continue to have excellent contact. Good, good to hear a question now from the health editor of the Irish Times Paul Colin. Paul asks a question I've heard asked before. And what did you citizens gain from the additional time that he may spend assessing the Pfizer vaccine when the outcome seemed to have been the same. Yeah. What to citizens gain. I think they gain the assurance that they have that we have looked at it collectively from a European perspective that all European member states have been involved it's been peer reviewed at a European level. We have a robust and legally binding framework to monitor and oblige the company to do things afterwards. That doesn't happen with the European. That doesn't happen with an emergency use authorization. Okay. Thanks. A question from Gina Williamson who's SSU regulatory manager as in senior health. Particularly COVID but but relations. Is the email experiencing any delay and the review and advice on trials and compounds not related to COVID as per because of the handling of the academic. And if you have any plans to keep measures adapted to handle and monitor trials remotely, not just during COVID but afterwards as well. Yeah. Again, another very, very good question. So, no, we're not we're managing our workload effectively. The way we're organized is we have a group working on infectious diseases we have our task force working, particularly on vaccines and then other parts of the population would focus on oncology, diabetes, different, different therapeutics area so this allows us to continue our mainstream activities in addition to the additional workloads of COVID but we have had to divert additional resources to our COVID activities, but so far I can say it has not been at the expense of delays in the authorization system. In terms of what we will keep. What we will keep when all this is over. I think there are there are many aspects of how we've learned to adapt to the current pandemic remote working. Our committees now are all working remotely. We haven't had a face to face meeting since the 13th of March, and we have been able to maintain our, and our timelines and engagement. It's harder work in a lot of ways because the level of concentration and, you know, sitting at a screen for four days in a row as opposed to being able to get up and move you know these things make a difference. In terms of remote inspections, we haven't been able to do some onsite inspections since about the same time. What we have done is worked closely with regulators across the world to get information from them if they were able to do those inspections. And we have a project now looking at how we can use digital tools to enable this to be continued in the future so we will take aspects of what we've learned. It won't become the new norm because there are advantages of the old system as well, but a combination of what we've learned and what we've learned we can do and what we've done before is likely to be the basis of where how we go forward. We're coming up to our last five minutes with the questions are still flowing in so I'll try and get to them as quickly as we can. George Lee from Ortee News asks, that's two questions, I can ask both of them together. One, the vaccines today have been approved for use by people over the age of 18. Is there any sign of approval for using vaccines and younger people, especially our school going population? And secondly, then a second question, why would the UK regulatory authorities able to do the vaccine approval work on AstraZeneca vaccine apparently so much faster than EMA? So, yeah, just to say that part of the one of the obligations of the approval of the authorizations is to is to study in different population groups including what we call pediatric populations but in fact this will be it will progressively go from older children to younger children. And just to come back to the conditional marketing authorization as being the most appropriate tool for a European wide approach. Yes, it does take a bit, a bit longer, but it does benefit from a very robust peer review system. And it means then we have collective acceptance across the EU, which is very important in terms of movement and communication and effectively travel in the long term. So I'm asking another question from the Department of T-shirt where it's kind of an again asks, are we anticipating that some vaccines might be more suitable or more effective for some cohorts than others? It's certainly it's it's very possible. And so for the two vaccines that we've looked at so far, we've seen consistent efficacy across the age group studied. So from 16 in the case of the Pfizer-BioNTech and from 18 in the case of the Moderna right up to older age groups. It's very consistent efficacy, but it would not be uncommon to see different populations group react differently to vaccination and that's something that is always part of either the initial studies or continuing studies post authorization. Okay, thank you. This is from a particular kind of vaccine. This is from Patrick Halpin in Reuters. He asks, do you expect Johnson and Johnson to seek approval for its vaccine in February? This was recently suggested by a senior member in the European Parliament in this week. I expect for Johnson to seek approval for his vaccine when they're ready to seek approval. And I have enough experience in working in regulation to be very wary about putting fixed dates until we're actually sure that all the information is ready to go. So yes, we hope it to come in February, but whether I could confirm that that's the case I'm afraid I'm not in a position to do so. I'm not in a position to confirm that. And this is from Nora Ohm, who's IEA member and former justice minister. Nora asks, it's not clear yet that even after receiving a vaccine, a person might still carry COVID infect others without getting infected themselves. Is there a danger that the last groups get the vaccine could become heavily infected as those vaccinated groups begin to unlock their activities and get out the bush. Well, I'm, I have to apologize, but this is beyond the my scientific expertise at the moment. I don't think we've studied it. Maybe it's something we need to look at maybe our experts are looking at it, but I have to say I'm not in, in, in a position to comment on this at this time. Okay. But I take it, I'll take it back. Please. Please be assured. Okay, good. I'm delighted to hear that. The question. I'm one of the last questions here from Fergal Laney, a digital editor of the Irish Daily Mirror. It's another crystal ball question. He was wondering if you could get the latest EMI timeline and more crucially a potential end date for when the six vaccines ordered by the commission or projected have passed through the evaluation phase, and could be approved for market authorization. So the other indicative dates we have the remaining the pharma companies when submitting their cases. All I can say at this stage with respect to the, the back scenes is that we're in discussions with all of them. We have as I said there are the four, the two authorized to enrolling review and we're expecting additional information that will allow us to start a rolling review on the others. Have we got that on our websites. I think we have some indicative times. But it really depends on when the trials are finished complete and ready, ready to go. And that's variable and also depending on, you know, the emerging epidemiology where the studies are being done. It's very, it's very difficult to give a clear time frame and it's not because I'm trying to avoid it. It just is very difficult. Okay, and it's going to be a final question because we're now up against time and I'm going to be another one from further Brian naughty news. And again, journalists last questions. There's been criticism of the pace of rollout of vaccines in Europe. What would you say to those who believe the entire process has been too slow. Sorry, that's not been your last question was probably very topical question is going to imagine. This is something I mean, as I said at the beginning, EMA is not responsible for the rollout. And if you think about it, this has been an incredible process. It's required us to work together as European member states it's required individual countries to get organized. The first vaccine we often we authorize is a difficult vaccine to roll out. I mean, with storage temperatures of a minus 70 it's not your common. Well, I don't think there is any common or garden vaccine but it's not an easy one to do so. So, I think we could always have expected some challenges, I think we will get better. I am personally. I think Europe has done an amazing job, really, in terms of the joint procurement process, the evaluation process and the rollout and there will always be criticisms and we could always have done it better. But could, could we have imagined that we would have been able to do this together. One year ago, I don't think so. Thank you very much, you know, I should just say to all the people have been asking questions apologies that we have been able to deal with them all. And you will forgive me also if I buy us a little bit towards the journalists questions because I guess they will have a reproductive impact and the, the ripple waves will make the extent a bit further with the, the, the journalists who have, I buy some of my, my selection to them, apologies for that, but I could not get to it everybody, but even I think it's a tribute to what you are doing and your team are doing the incredible interest that has been in this morning session. You've been brilliant in your, in your exposition of the thing and you've been fantastic in answering the question so on behalf of everybody this morning, just like to thank you very much, and wish you and your team every continuing success and what you're doing. Thank you. Thank you very much. It's been a real pleasure.