“I AM IMMENSELY PROUD OF THE POSITIVE VACCINES RECOMMENDATIONS EMA HAS GIVEN WITHIN MY MANDATE”
In January 2020, just before the pandemic broke out, the European Medicines Agency (EMA) settled in Zuidas. It became apparent why we need EMA’s expertise in the review and approval of new medicines. Emer Cooke, Executive Director of EMA, had just moved to Amsterdam and found herself grappling with a myriad of challenges in this turbulent period. She talked to us about her past half year at EMA and sheds more light on the concerns surrounding the COVID-19 vaccines.
EMA recently relocated to Zuidas. So, first of all, welcome! What led EMA to choose Zuidas, and what can EMA offer this district?
Thank you so much for your warm welcome. EMA moved to this exciting part of Amsterdam in January 2020, and we are very grateful to the Dutch government for not only creating a stunning new building that’s a great workplace, but also for choosing this spot. Zuidas is very well connected. This makes it easy for staff who live all over North and South Holland to come to work. The vicinity to the airport will also be an asset when it is safe to travel again, and our experts start to come back to do their work face-to-face.
Have you also moved to Amsterdam, or The Netherlands? If so, how do you like it, and what are some of the up- and downsides of this country and Amsterdam?
Yes, indeed, I moved to Amsterdam in November 2020 from Geneva. Of course, it has been a rather strange introduction as the city has been in lockdown most of the time, but I have enjoyed cycling around the city, discovering the parks and the Amsterdamse Bos and was thrilled by the ice skating in February. This year, summer and even spring seem to have been quite late in coming, but I have been heartened by the sun finally coming out at the end of May. I am impressed by how easy it is to move from the city to the countryside and the sea. The only thing I miss here are the mountains and of course my family and friends, who I have not yet been able to visit.
You worked at WHO before this, and now you’re EMA’s executive director in rather turbulent times. What has this past year been like for you?
The past year has been both exciting and challenging. Prior to moving to EMA, I had spent most of 2020 working on pandemic-related issues at WHO, where my role involved preparing for the global rollout of possible new vaccines and therapeutics. From a scientific point of view, I was well prepared for taking over the helm at EMA. I started at EMA just after the announcement of positive clinical trial results on two of the mRNA vaccines, which meant that we needed to review the applications as quickly as possible. I am immensely proud that EMA has already given positive recommendations on four vaccines since the start of my mandate. They were approved within a little over a year of the declaration of a pandemic, which shows unprecedented agility at a European level. It has both been highly motivating, but also very stressful on a personal level.
COVID-19 is the big issue right now. Is EMA wholly focused on COVID at the moment?
Supporting the development, authorization and supervision of safe and effective COVID-19 vaccines and treatments is our number one priority, but that does not mean we are dropping our other responsibilities. Patients in the EU have medical needs that go beyond the pandemic and we need to play a part in helping to address them. I’m pleased that, in 2020, we recommended 97 new human medicines for approval, the highest number in ten years. Many of these were for new cancer treatments, but there were also treatments for rare genetic disorders, for which previously there were no therapeutic options for patients. The positive trend continues; in the first five months of this year, we have already recommended 42 new medicines for approval. On the veterinary side, we are currently reshaping the regulation of medicines for animals, as we are implementing new rules for the EU. We are also continuing our fight against antimicrobial resistance.
There has been lots of speculation about virus mutations and suspicions that existing COVID vaccines may not be effective in the long run. Is this something EMA is working on? What can you say about this?
Mutations of the virus and their impact on the effectiveness of the COVID-19 vaccines is something we are monitoring very carefully. Right now, it seems the vaccines we have authorized protect against all the strains that are dominant in the EU. However, we have to be vigilant and prepare ourselves for new mutations against which the current vaccines may not work as well. Even if, or rather when, this happens, we won’t have to develop a new vaccine from scratch, but we are confident that the existing vaccines can be modified so that they also protect against the mutated virus strains. To be ready for this, we are already discussing with the vaccine manufacturers what steps are needed to update vaccines quickly with new or additional virus strains.
It was EMA that discovered the link between AstraZeneca and blood clotting/thrombosis. Could you say more about this?
EMA was indeed the first regulatory authority to pick up this very rare blood clotting condition that some people developed after receiving the AstraZeneca vaccine. Following initial reports coming from a small number of EU countries, we immediately started to investigate. Our review was carried out in record time. We analysed all case reports in our adverse drug reaction database in detail, looked at the clinical studies again, sought input from experts with experience in blood-clotting disorders and concluded there was a possible link between the vaccine and those rare blood clots. We have now added blood clots with a low blood platelet count to the list of side effects.
Can you see why that made some people hesitant to get this vaccine?
The side effect is extremely rare – affecting 1 in 100,000 people, but it is very important that healthcare professionals and patients are aware of it, so it can be spotted, diagnosed and treated with specialist care as quickly as possible. With these risk mitigation measures in place, the AstraZeneca vaccine continues to be a safe and effective vaccine that plays an important role in vaccination campaigns in the EU and worldwide.
Would you do anything differently, knowing how the review affected vaccine confidence?
Keeping silent about a vaccine reaction, even an extremely rare one, was never an option. This case demonstrates the challenges of large-scale vaccination campaigns. When millions of people receive a vaccine, very rare side effects can occur that didn’t show in the clinical trials which form the basis of the authorization. But it also shows that our safety monitoring system works; these very rare side effects were picked up early, identified, analysed and we have given clear advice to healthcare professionals to allow the safe and effective use of the vaccine. We are now seeing the impact of this advice in terms of reduction in fatalities.
Is there anything else you would like to say to the readers of Hello Zuidas?
I’m very pleased that the Agency has been located in Zuidas. There is a sense of dynamism here and I look forward to experiencing it in full, once we have conquered this pandemic.