EDQM and COVID-19 – Rising to the challenge of a global crisis

Description

The SARS-CoV-2 virus, which causes COVID-19, triggered a global pandemic on a staggering scale in 2020. In the course of just a few months, it brought entire societies to a near standstill with trade, travel, transportation and countless other vital sectors deeply impacted. Public health systems worldwide bore an enormous burden and were stretched to the limit. The pharmaceutical industry scrambled to develop treatments like antivirals and vaccines to avert worst-case scenarios and prevent the spread of the virus. The pandemic highlighted just how important the EDQM’s mission is to ensure high standards in public health protection. Due to the resourcefulness of its staff and its extensive networks of experts, partners and stakeholders, the EDQM played a crucial role in the fight against COVID-19. In the episode, Catherine Milne, Gwenaël Cirefice and Pierre Leveau from the EDQM explain how.

Hosted on Ausha. See ausha.co/privacy-policy for more information.

Transcription

Speaker #0
Welcome to EDQM On Air, a podcast on public health brought to you by the European Directorate for the Quality of Medicines and Healthcare of the Council of Europe. We hope you enjoy this episode and we invite you to stay tuned to learn how the EDQM and its stakeholders work together for better health for all. Around the beginning of 2020, the world started hearing about a new viral disease spreading across the globe. The culprit for this disease was a coronavirus with flu-like symptoms, with severe clinical outcomes leading to high rates of hospitalization and a rampant mortality rate. The virus in question, of course, was SARS-CoV-2, the coronavirus that causes COVID-19, and what was ahead of us was a global pandemic. of a staggering scale. It only took a few more months before most of the world had declared near total lockdowns, ordering people to stay home in order to protect the population and halt the spread of the virus. This had an enormously disruptive effect on the majority of our systems. Trade, travel, transportation, countless more key sectors were either heavily burdened by the pandemic or in the worst cases, immobilized completely. The healthcare sector especially had to bear an enormous burden, which pushed it to its limits. Hospital staff in states of extreme exhaustion, ICUs filled to the brim, and shortages of medical supplies are just a few examples of the pressure that the pandemic put on public health systems worldwide. The pharmaceutical industry also had its own challenges to deal with. As the world spiraled into chaos due to a disease without a cure, the ones with the capacity to find it had to give it everything they had. Along with regulatory authorities, the pharma world scrambled to develop therapeutics like antivirals for treatment, and most importantly, vaccines, to protect individuals and populations from the worst-case scenarios and prevent the spread of the virus. Not only that, but there was also the need to address problems like shortages of masks, testing kits and oxygen supply. In this new and sudden environment of global crisis, the EDQM needed to adapt as well. Our job is to maintain a high standard of public health, and under the context of a pandemic, this mission became more important than ever. Thankfully, due to our resourcefulness and the help of our extensive network of partners and stakeholders, we were able to successfully keep doing what we do and contribute to the collective fight against COVID-19. Let's take a look at how we did it. Joining me for this episode are Catherine Milne, Gwenaëlle Sirefis, and Pierre Léveau from the EDQM. Now, the EDQM plays a significant role in the regulatory ecosystem of public health, and so keeping its core activities functional is essential. Also, given the context of COVID and the need to develop and roll out vaccines as efficiently as possible, maintaining functionality was obviously more important than ever during that period. So in early 2020, the EDQM established a business continuity plan to anticipate and mitigate any risks of disruption caused by the pandemic. Could you walk me through it a little bit?
Speaker #1
Yeah, for instance, for the reference standard. So perhaps just to explain what is a reference standard. So it's just a small vial containing a chemical or biological substance that allows the implementation of a monograph. So it's a physical item that you need to... test medicines. So you are totally right saying that we established a continuity plan but in fact it was not the covid that triggered this plan it was the Fukushima crisis. So after the Fukushima we saw disruptions everywhere in the supply chain and so we elaborated a first business continuity plan. Among other measures we initiated the building of a contingency stock of reference standards and we built a second building. not far away from Strasbourg in order to secure our stock of reference standards. Of course, the COVID crisis was highly disruptive in all areas, including those that we didn't imagine before. For instance, we had trucks block at the borders containing packaging material, so that prevented us to ship temperature-controlled reference standards. We had also local authorities not allowing the dispatch because all travels were forbidden. So we had to convince those authorities that it was very important because even if it's not a medicinal product, you need the reference standards in order to release the final medicine product. So you can imagine that at the time of crisis, we received many phone calls from hospitals, from pharmaceutical companies and intensive care units saying, where is my reference standards? I need it to release my batch. And we have patients waiting for a final product. So. We needed to be very creative and we completely reshuffled the supply chain. We built stock, something that we didn't imagine to do before. We have identified new suppliers and hopefully we built a more resilient supply chain. I also took the opportunity to congratulate the staff. As mentioned before, the staff was on site even at the beginning of the crisis with no masks, no gloves, nothing in order to to continue working and supplying the reference standards to our final users. So a big thank you to all of them. Of course, reference standards was not the only topic affected by this crisis. There was also the certification of suitability to the nomograph of the European Pharmacopeia. As I mentioned before, no travels. So how can you conduct inspection, meaning GMP and certification inspection, to countries where it was banned to travel? So once again, we were very creative and we initiated a remote inspection called Airtemis. So it was a purely virtual system of auditing sites from abroad. So this was established during the crisis and still remains for some very specific case. So once again, creativity was the keyword.
Speaker #0
Thank you. So Catherine, the EDQM had an important role to play in the fight against COVID-19, especially as related to the availability and deployment of a vaccine. So what was our contribution like?
Speaker #2
Well, one of the big contributions to the crisis was related to the official control authority batch release, or what we call OCABR activity. This is an activity of the OMCL network for which EDQM is the secretariat. OCABR is foreseen in the EU legislation for vaccines and human blood derived medicinal products. so member states may require an independent control of every single batch. It consists of a review of the manufacturer's test results, presented in a protocol, and the performance of selected tests by the OMCLs. The tests are agreed by all member states for their added value to the independent analysis. The OMCL confirms that the batch complies with the approved quality defined in the marketing authorization dossier, and when the batch is compliant, an EU OCABR certificate is issued. By law, The certificate is recognized throughout the EU EEA. So this work-sharing approach means that there's rapid access to quality medicines for all citizens. Early on in the COVID crisis, it was clear that the member states and the EU Commission wanted OCABR for the COVID vaccines. This meant the network had to get ready in record time.
Speaker #0
All right, so how long does it normally take to develop a vaccine and to prepare for OCABR?
Speaker #2
Well, the development of a vaccine by a manufacturer can take years and depends on many factors. Normally, an OMCL prepares for OCABR once the manufacturer has their control strategies in place and that they're sure they'll market the vaccines or have already submitted the marketing authorization application to the European Medicines Agency, the EMA, who are responsible for the central marketing authorizations like for COVID vaccines. There's a defined time schedule for the marketing authorization assessment, and this typically takes 10 to 18 months. But the EMA used an accelerated process called rolling review for the COVID-19 vaccines. This means that they assess the data packages as they were generated with rapid back and forth between the assessors and the manufacturers. And this significantly reduced the time frame to a couple of months. The whole process from development to approval was reduced from several years to a few months.
Speaker #0
All right. So what exactly did you have to do then to get ready in time?
Speaker #2
Well, there were a lot of challenges. At the beginning, there were hundreds of vaccine candidates. We didn't know which ones would arrive first and which ones would be successful. There were several different vaccine platforms, some traditional, like inactivated vaccines, others newer, like the mRNA and viral-vectored vaccines. There was a learning curve for all of us. We were also all working in lockdown conditions, which we shouldn't forget. We began collecting information and putting in place strategies already from March 2020 to help the network and the manufacturers work together smoothly. And communication was a big key to the success. There was communication between the member states and OMCLs, with the manufacturers, with the EMA, the EU Commission, and our global partners like CEPI COVAX and the WHO. The exchange with the manufacturers was to understand their proposed quality control strategies and to identify relevant tests for the OMCLs. But we also had to collect information from the OMCLs on their competencies to identify the right OMCLs for the job. And we needed more than one OMCL per vaccine because of the expected volume. and to assure business continuity in case there were issues related to the pandemic. All of this activity resulted in several guidance documents, including recommendations to manufacturers on method transfer and product-specific guidelines. The latter were published in the EDQM website in an accelerated manner to ensure that the information was available for transparency to the public and to other countries outside the EU so they could understand the basis of OCABR and rely on the certificates. The first product-specific guideline was already available in September 2020, and in the end we had four. We also put in place a rapid... reporting and recognition strategy to help the vaccines get to the population faster. And of course, the OMCLs had to implement and validate the use of the relevant methods.
Speaker #0
Okay. Wow, that sounds like so much stuff to take care of, and especially under the context of a global crisis. I wonder if you managed to actually get everything in place.
Speaker #2
Well, yes, we did. The OMCLs were ready for each vaccine as they received their conditional marketing authorization. And for each batch, OCABR certificates were issued within a day or two of receiving the manufacturer's protocol. This was possible because the OMCLs tested the samples at the same time as the company were doing their own quality control testing. This parallel testing is always possible but it was really heavily employed during the crisis to great advantage. So between the first batch of vaccine that was released in December 2020 to April 2023 at the end of the emergency, the OMCLs had evaluated more than 3,500 lots of COVID vaccines. which represents multiple billions of doses. The OMCLs provided certificates that were used by all the member states through mutual recognition for the benefit of all recipients, which meant rapid access without delay and no duplication of work. It was also instrumental in supplying vaccines globally, since the EU certificates were used by reliance in many non-EU countries as an independent verification of quality, so they could also access the vaccines more rapidly. It's important to remember in this whole story that the OMCLs also managed to continue their regular OCABRA for other vaccines and blood-derived medicinal products, which are also essential for public health, and there was no reduction in that activity. All of this was possible thanks to the incredible dedication and hard work of many, and I would like to recognize them, in particular those at the OMCLs who are on the front line, my colleagues at EDQM, as well as the manufacturers, assessors, and all our partners in this crisis management.
Speaker #0
All right. Thank you.
Speaker #3
Okay, so before talking about the work done by the European Pharmacopoeia, so let me remind what the European Pharmacopoeia is. So the European Pharmacopoeia is a single reference work for the quality controls of medicines in 39 member states. So in Europe, that's the EU plus 12 European countries. It contains official standards for the quality of medicines and their components. And these standards, they give... tests that are to be performed on medicines, raw materials used in production and intermediates of production. And I think what is important to keep in mind is that the producers of medicines, of vaccines, they must comply with the standards of the European Pharmacopoeia in order to market their product in Europe. So at the level of the European Pharmacopoeia, we had several initiatives to support the developers of COVID vaccines. In the context where these developers, they were small and medium-sized companies, they were universities, research centers, and many of them were not familiar at all with regulatory requirements for medicines in Europe. So a first initiative was to publish a package of European pharmacopoeia quality standards for vaccines and make that available in free access. And the aim was really to... openly share knowledge and offer free access to the relevant guidance, to the relevant standards for vaccines. What we wanted to do was to support vaccine developers. So in particular, those small and medium-sized enterprises in designing appropriate analytical strategies for their candidate vaccines and ultimately help ensure the quality and safety of their products. There was one initiative. A second was to publish training materials on the European Pharmacopoeia. So we compiled training materials on the Pharmacopoeia and on the text of the Pharmacopoeias that are related to vaccines. And the aim was really to fast-track the understanding of the European Pharmacopoeia for the vaccine developers, and again, in particular, those small biotechs.
Speaker #0
small research labs to bring everyone up to speed as quickly as possible basically precisely okay
Speaker #3
And another important project we had was to elaborate guidance documents on the control of vowel-vectored vaccines. And you heard before, in the pandemic, there was a broad range of technologies that were being explored in the development of COVID vaccines. So we had the traditional, conventional platforms, but then there was also the more recent technologies like mRNA vaccines or like vowel-vectored vaccines. And at the time, there was rather limited guidance available to cover the quality of these new platforms. The World Health Organization was coordinating an international effort to draft new guidance on mRNA vaccines. So in this context, EDQM embarked into drafting a guidance document to cover the control of viral vector vaccines. So the other class that was also being developed. So to support developers that... that were working on candidate vaccines that were based on viral vectors. And this is a work that was accomplished in collaboration with the European Pharmacopoeia group of experts on human vaccines. And there was a group made of representatives from licensing authorities, from national control labs, from academia industry, from Europe, but also beyond. So we had also representatives from the US FDA or from Health Canada, for example. And this provided options, I think we could call that, for analytical strategy for the development of viral vector vaccines. And it really was aimed at filling a gap in the guidance that was available on quality for these new technologies. And a fourth initiative was also... collaboration with the European Medicines Agency to gather, to compile the relevant standards and requirements on the pharmaceutical quality. So that means on the one hand, European Pharmacopeia standards, on the other hand, EMA guidelines, and put that all in on a single web page to really facilitate access to guidelines, resources, pharmacopoeia texts for developers of... COVID vaccines, COVID therapies.
Speaker #2
I mean, I think this all shows that through the work of the Pharmacopoeia and through the work of the OMCL network, that we were really focused on making sure that despite the rapidity and the speed of the situation we were finding ourselves in, there was still quality being built into the products that were going to reach the patients in the end.
Speaker #3
Yeah. So during the pandemic and besides the new vaccine, there was also some major efforts being made towards the development of therapies. And in that, I'm thinking of the antivirals or the neutralizing monoclonal antibodies. So in the same spirit as for the vaccine and at the level of the pharmacopoeia, there was also initiatives, again, to share knowledge as much as possible. So I'm thinking of a joint initiative that the European Pharmacopoeia had with the British Pharmacopoeia to share for free supportive pharmacopoeial texts for antiviral vaccines. And the logic was the same as for vaccines. It was to support those developing, manufacturing or testing relevant antiviral medicines.
Speaker #0
All right.
Speaker #3
So overall for the European Pharmacopoeia, as you heard, there were a number of initiatives to support the developers of medicines or vaccines, always by trying to openly share the knowledge we had. So either by giving access to the relevant standards, training resources, providing guidance. And there was what you heard also for Caber, there was always this collaboration and continuous dialogue with the partners for the Pharmacopoeia, the network of experts of the Open Pharmacopoeia, the National Pharmacopoeia Authorities, the Open Medicines Agency, the World Health Organization. And that was really key also for coordinated and timely response.
Speaker #2
And I think we can't underestimate the contribution of the experts from our networks, whether it was the Pharmacopoeia side or the OMCL network side. for everything that I put into making this crisis turn out in a way that was much better than was feared at the very beginning.
Speaker #0
All right. So, yeah, I mean, we went over a lot of the things that we did, a lot of the EDQM's actions. We touched on the importance of collaboration and a main theme was the importance of flexibility, as we said before, and really trying to figure out innovative solutions really in the heat of the moment, which is what really made the difference. So again, as we said, very unprecedented crisis with a lot of new challenges that we needed to face. And from this period, obviously, there should have been some lessons learned that we could potentially apply for future similar situations. So what were these lessons and how did the EDQM's approach to pandemic preparedness evolve after the COVID crisis?
Speaker #1
Well, perhaps as I mentioned before, we have now established a very solid business continuity plan, including building stocks. And that was something that we didn't imagine before. We have also improved a lot the way we work internally. For instance, we have, of course, developed Visio and teleconference. That's something that was not really very popular before the crisis. On the other hand, it allowed us to reach new experts around the globe, allowing us to work with countries not located in Europe. And it's also very good for environmental sustainability. So if we may say, at least it was something quite positive.
Speaker #2
I think that's an important point, Pierre. And I think it's important to recognize as well that the competence and experience of the world is very important. experience that already existed in the network and was already being coordinated at some level by EDQM was vital for the rapid reactivity to the crisis situation. Indeed, for the OCABRA network, it was successful thanks to the fact that there's a maintenance of a qualified and competent network of experts and laboratories who can quickly react based on their existing programs and adapt to the specific purpose.
Speaker #3
And in the same way, for the pharmacopoeia, we could rely also on this experience that was accrued over the years with the elaboration of quality standards for vaccines. And that really allowed to fast track the development of guidance to support the developers. And I think from my perspective, it also showed that it was possible to speed up the elaboration process in an urgent situation like we had during the pandemic. And to me, it also showed the importance of maintaining up-to-date quality standards for medicines and vaccines.
Speaker #1
Perhaps we can also say that we have also improved our communication with our colleagues. key stakeholders, including in time of crisis where you need to be very agile, very reactive. I think, as it was mentioned before, we are quite reactive and we can work with very qualified experts and very committed people. So that also improved in the time of crisis, this communication aspect.
Speaker #0
Okay. Speaking of this communication, the way I have it in my head, the way this kind of worked is that there was a whole network. of institutions that kind of form this public health regulatory ecosystem. And in the time of crisis, it's kind of like all the neurons kind of fire up to connect, you know, really come up with things. So in this aspect of communication, would you say that the COVID crisis really kind of opened up new avenues of interacting and cooperating and communicating that before were not really there or thought of?
Speaker #1
Probably it speeded. the communication amongst the stakeholders. I think we also explored new way of working together. And I think it's a positive aspect of this crisis.
Speaker #2
Okay. Yeah. I mean, we learned the importance of the global community. I think we saw in all the activities in exchange at a global level, the key stakeholders were rapidly identified. And for example, in the OCABR, the interaction with the manufacturers, while OMCLs are independent, it was still important to have an open dialogue with them early so that we could get the right information and they could have the information back from us. I think the working together and everybody communicating, putting their part in and bringing their expertise was what helped us to get through this.
Speaker #3
And that also avoided any duplication at a time where you really want to progress and also to work in a coordinated fashion.
Speaker #2
I mean, that was particularly evident with the OCABR system, where these certificates were available primarily in concept for the EU, but they were used really around the world for reliance, which meant that these vaccines were available all over in a rapid way to really fight the pandemic.
Speaker #0
The pandemic challenged us in ways we never imagined. Through the chaos, the EDQM stood resilient. adapting to new realities with resourcefulness and the vital help of its extensive network. In this episode, we delved into the pivotal role played by the EDQM during the unprecedented challenges of the COVID-19 pandemic. We explored how the EDQM swiftly implemented a comprehensive business continuity plan in early 2020, ensuring the uninterrupted functioning of critical activities across various domains, such as pharmacopoeia and quality standards, reference standards, certification of suitability, and the OMCL network. The EDQM's adaptive measures included virtual and hybrid meetings, remote inspections through the Artemis system, and close collaboration with experts from the OMCL network, the European Pharmacopoeia and national pharmacopoeia authorities. Additionally, we discussed the EDQM's substantial contribution to the global fight against COVID-19, how it offered guidance for the development of vaccines and antiviral medicines, and how it facilitated the independent testing of vaccines used in Europe and around the world via the OCABR system. Finally, we touched upon the EDQM's commitment to pandemic preparedness and potential lessons learned from this challenging period. emphasizing the organization's dedication to maintaining public health standards and contributing to global efforts in times of crisis. We hope this episode has made you more aware of the dedication of the EDQM to protect public health, your health, even in the most unfavorable circumstances. Thanks for tuning in, and see you in the next episode.

Description

Hosted on Ausha. See ausha.co/privacy-policy for more information.

Transcription

Speaker #0
Welcome to EDQM On Air, a podcast on public health brought to you by the European Directorate for the Quality of Medicines and Healthcare of the Council of Europe. We hope you enjoy this episode and we invite you to stay tuned to learn how the EDQM and its stakeholders work together for better health for all. Around the beginning of 2020, the world started hearing about a new viral disease spreading across the globe. The culprit for this disease was a coronavirus with flu-like symptoms, with severe clinical outcomes leading to high rates of hospitalization and a rampant mortality rate. The virus in question, of course, was SARS-CoV-2, the coronavirus that causes COVID-19, and what was ahead of us was a global pandemic. of a staggering scale. It only took a few more months before most of the world had declared near total lockdowns, ordering people to stay home in order to protect the population and halt the spread of the virus. This had an enormously disruptive effect on the majority of our systems. Trade, travel, transportation, countless more key sectors were either heavily burdened by the pandemic or in the worst cases, immobilized completely. The healthcare sector especially had to bear an enormous burden, which pushed it to its limits. Hospital staff in states of extreme exhaustion, ICUs filled to the brim, and shortages of medical supplies are just a few examples of the pressure that the pandemic put on public health systems worldwide. The pharmaceutical industry also had its own challenges to deal with. As the world spiraled into chaos due to a disease without a cure, the ones with the capacity to find it had to give it everything they had. Along with regulatory authorities, the pharma world scrambled to develop therapeutics like antivirals for treatment, and most importantly, vaccines, to protect individuals and populations from the worst-case scenarios and prevent the spread of the virus. Not only that, but there was also the need to address problems like shortages of masks, testing kits and oxygen supply. In this new and sudden environment of global crisis, the EDQM needed to adapt as well. Our job is to maintain a high standard of public health, and under the context of a pandemic, this mission became more important than ever. Thankfully, due to our resourcefulness and the help of our extensive network of partners and stakeholders, we were able to successfully keep doing what we do and contribute to the collective fight against COVID-19. Let's take a look at how we did it. Joining me for this episode are Catherine Milne, Gwenaëlle Sirefis, and Pierre Léveau from the EDQM. Now, the EDQM plays a significant role in the regulatory ecosystem of public health, and so keeping its core activities functional is essential. Also, given the context of COVID and the need to develop and roll out vaccines as efficiently as possible, maintaining functionality was obviously more important than ever during that period. So in early 2020, the EDQM established a business continuity plan to anticipate and mitigate any risks of disruption caused by the pandemic. Could you walk me through it a little bit?
Speaker #1
Yeah, for instance, for the reference standard. So perhaps just to explain what is a reference standard. So it's just a small vial containing a chemical or biological substance that allows the implementation of a monograph. So it's a physical item that you need to... test medicines. So you are totally right saying that we established a continuity plan but in fact it was not the covid that triggered this plan it was the Fukushima crisis. So after the Fukushima we saw disruptions everywhere in the supply chain and so we elaborated a first business continuity plan. Among other measures we initiated the building of a contingency stock of reference standards and we built a second building. not far away from Strasbourg in order to secure our stock of reference standards. Of course, the COVID crisis was highly disruptive in all areas, including those that we didn't imagine before. For instance, we had trucks block at the borders containing packaging material, so that prevented us to ship temperature-controlled reference standards. We had also local authorities not allowing the dispatch because all travels were forbidden. So we had to convince those authorities that it was very important because even if it's not a medicinal product, you need the reference standards in order to release the final medicine product. So you can imagine that at the time of crisis, we received many phone calls from hospitals, from pharmaceutical companies and intensive care units saying, where is my reference standards? I need it to release my batch. And we have patients waiting for a final product. So. We needed to be very creative and we completely reshuffled the supply chain. We built stock, something that we didn't imagine to do before. We have identified new suppliers and hopefully we built a more resilient supply chain. I also took the opportunity to congratulate the staff. As mentioned before, the staff was on site even at the beginning of the crisis with no masks, no gloves, nothing in order to to continue working and supplying the reference standards to our final users. So a big thank you to all of them. Of course, reference standards was not the only topic affected by this crisis. There was also the certification of suitability to the nomograph of the European Pharmacopeia. As I mentioned before, no travels. So how can you conduct inspection, meaning GMP and certification inspection, to countries where it was banned to travel? So once again, we were very creative and we initiated a remote inspection called Airtemis. So it was a purely virtual system of auditing sites from abroad. So this was established during the crisis and still remains for some very specific case. So once again, creativity was the keyword.
Speaker #0
Thank you. So Catherine, the EDQM had an important role to play in the fight against COVID-19, especially as related to the availability and deployment of a vaccine. So what was our contribution like?
Speaker #2
Well, one of the big contributions to the crisis was related to the official control authority batch release, or what we call OCABR activity. This is an activity of the OMCL network for which EDQM is the secretariat. OCABR is foreseen in the EU legislation for vaccines and human blood derived medicinal products. so member states may require an independent control of every single batch. It consists of a review of the manufacturer's test results, presented in a protocol, and the performance of selected tests by the OMCLs. The tests are agreed by all member states for their added value to the independent analysis. The OMCL confirms that the batch complies with the approved quality defined in the marketing authorization dossier, and when the batch is compliant, an EU OCABR certificate is issued. By law, The certificate is recognized throughout the EU EEA. So this work-sharing approach means that there's rapid access to quality medicines for all citizens. Early on in the COVID crisis, it was clear that the member states and the EU Commission wanted OCABR for the COVID vaccines. This meant the network had to get ready in record time.
Speaker #0
All right, so how long does it normally take to develop a vaccine and to prepare for OCABR?
Speaker #2
Well, the development of a vaccine by a manufacturer can take years and depends on many factors. Normally, an OMCL prepares for OCABR once the manufacturer has their control strategies in place and that they're sure they'll market the vaccines or have already submitted the marketing authorization application to the European Medicines Agency, the EMA, who are responsible for the central marketing authorizations like for COVID vaccines. There's a defined time schedule for the marketing authorization assessment, and this typically takes 10 to 18 months. But the EMA used an accelerated process called rolling review for the COVID-19 vaccines. This means that they assess the data packages as they were generated with rapid back and forth between the assessors and the manufacturers. And this significantly reduced the time frame to a couple of months. The whole process from development to approval was reduced from several years to a few months.
Speaker #0
All right. So what exactly did you have to do then to get ready in time?
Speaker #2
Well, there were a lot of challenges. At the beginning, there were hundreds of vaccine candidates. We didn't know which ones would arrive first and which ones would be successful. There were several different vaccine platforms, some traditional, like inactivated vaccines, others newer, like the mRNA and viral-vectored vaccines. There was a learning curve for all of us. We were also all working in lockdown conditions, which we shouldn't forget. We began collecting information and putting in place strategies already from March 2020 to help the network and the manufacturers work together smoothly. And communication was a big key to the success. There was communication between the member states and OMCLs, with the manufacturers, with the EMA, the EU Commission, and our global partners like CEPI COVAX and the WHO. The exchange with the manufacturers was to understand their proposed quality control strategies and to identify relevant tests for the OMCLs. But we also had to collect information from the OMCLs on their competencies to identify the right OMCLs for the job. And we needed more than one OMCL per vaccine because of the expected volume. and to assure business continuity in case there were issues related to the pandemic. All of this activity resulted in several guidance documents, including recommendations to manufacturers on method transfer and product-specific guidelines. The latter were published in the EDQM website in an accelerated manner to ensure that the information was available for transparency to the public and to other countries outside the EU so they could understand the basis of OCABR and rely on the certificates. The first product-specific guideline was already available in September 2020, and in the end we had four. We also put in place a rapid... reporting and recognition strategy to help the vaccines get to the population faster. And of course, the OMCLs had to implement and validate the use of the relevant methods.
Speaker #0
Okay. Wow, that sounds like so much stuff to take care of, and especially under the context of a global crisis. I wonder if you managed to actually get everything in place.
Speaker #2
Well, yes, we did. The OMCLs were ready for each vaccine as they received their conditional marketing authorization. And for each batch, OCABR certificates were issued within a day or two of receiving the manufacturer's protocol. This was possible because the OMCLs tested the samples at the same time as the company were doing their own quality control testing. This parallel testing is always possible but it was really heavily employed during the crisis to great advantage. So between the first batch of vaccine that was released in December 2020 to April 2023 at the end of the emergency, the OMCLs had evaluated more than 3,500 lots of COVID vaccines. which represents multiple billions of doses. The OMCLs provided certificates that were used by all the member states through mutual recognition for the benefit of all recipients, which meant rapid access without delay and no duplication of work. It was also instrumental in supplying vaccines globally, since the EU certificates were used by reliance in many non-EU countries as an independent verification of quality, so they could also access the vaccines more rapidly. It's important to remember in this whole story that the OMCLs also managed to continue their regular OCABRA for other vaccines and blood-derived medicinal products, which are also essential for public health, and there was no reduction in that activity. All of this was possible thanks to the incredible dedication and hard work of many, and I would like to recognize them, in particular those at the OMCLs who are on the front line, my colleagues at EDQM, as well as the manufacturers, assessors, and all our partners in this crisis management.
Speaker #0
All right. Thank you.
Speaker #3
Okay, so before talking about the work done by the European Pharmacopoeia, so let me remind what the European Pharmacopoeia is. So the European Pharmacopoeia is a single reference work for the quality controls of medicines in 39 member states. So in Europe, that's the EU plus 12 European countries. It contains official standards for the quality of medicines and their components. And these standards, they give... tests that are to be performed on medicines, raw materials used in production and intermediates of production. And I think what is important to keep in mind is that the producers of medicines, of vaccines, they must comply with the standards of the European Pharmacopoeia in order to market their product in Europe. So at the level of the European Pharmacopoeia, we had several initiatives to support the developers of COVID vaccines. In the context where these developers, they were small and medium-sized companies, they were universities, research centers, and many of them were not familiar at all with regulatory requirements for medicines in Europe. So a first initiative was to publish a package of European pharmacopoeia quality standards for vaccines and make that available in free access. And the aim was really to... openly share knowledge and offer free access to the relevant guidance, to the relevant standards for vaccines. What we wanted to do was to support vaccine developers. So in particular, those small and medium-sized enterprises in designing appropriate analytical strategies for their candidate vaccines and ultimately help ensure the quality and safety of their products. There was one initiative. A second was to publish training materials on the European Pharmacopoeia. So we compiled training materials on the Pharmacopoeia and on the text of the Pharmacopoeias that are related to vaccines. And the aim was really to fast-track the understanding of the European Pharmacopoeia for the vaccine developers, and again, in particular, those small biotechs.
Speaker #0
small research labs to bring everyone up to speed as quickly as possible basically precisely okay
Speaker #3
And another important project we had was to elaborate guidance documents on the control of vowel-vectored vaccines. And you heard before, in the pandemic, there was a broad range of technologies that were being explored in the development of COVID vaccines. So we had the traditional, conventional platforms, but then there was also the more recent technologies like mRNA vaccines or like vowel-vectored vaccines. And at the time, there was rather limited guidance available to cover the quality of these new platforms. The World Health Organization was coordinating an international effort to draft new guidance on mRNA vaccines. So in this context, EDQM embarked into drafting a guidance document to cover the control of viral vector vaccines. So the other class that was also being developed. So to support developers that... that were working on candidate vaccines that were based on viral vectors. And this is a work that was accomplished in collaboration with the European Pharmacopoeia group of experts on human vaccines. And there was a group made of representatives from licensing authorities, from national control labs, from academia industry, from Europe, but also beyond. So we had also representatives from the US FDA or from Health Canada, for example. And this provided options, I think we could call that, for analytical strategy for the development of viral vector vaccines. And it really was aimed at filling a gap in the guidance that was available on quality for these new technologies. And a fourth initiative was also... collaboration with the European Medicines Agency to gather, to compile the relevant standards and requirements on the pharmaceutical quality. So that means on the one hand, European Pharmacopeia standards, on the other hand, EMA guidelines, and put that all in on a single web page to really facilitate access to guidelines, resources, pharmacopoeia texts for developers of... COVID vaccines, COVID therapies.
Speaker #2
I mean, I think this all shows that through the work of the Pharmacopoeia and through the work of the OMCL network, that we were really focused on making sure that despite the rapidity and the speed of the situation we were finding ourselves in, there was still quality being built into the products that were going to reach the patients in the end.
Speaker #3
Yeah. So during the pandemic and besides the new vaccine, there was also some major efforts being made towards the development of therapies. And in that, I'm thinking of the antivirals or the neutralizing monoclonal antibodies. So in the same spirit as for the vaccine and at the level of the pharmacopoeia, there was also initiatives, again, to share knowledge as much as possible. So I'm thinking of a joint initiative that the European Pharmacopoeia had with the British Pharmacopoeia to share for free supportive pharmacopoeial texts for antiviral vaccines. And the logic was the same as for vaccines. It was to support those developing, manufacturing or testing relevant antiviral medicines.
Speaker #0
All right.
Speaker #3
So overall for the European Pharmacopoeia, as you heard, there were a number of initiatives to support the developers of medicines or vaccines, always by trying to openly share the knowledge we had. So either by giving access to the relevant standards, training resources, providing guidance. And there was what you heard also for Caber, there was always this collaboration and continuous dialogue with the partners for the Pharmacopoeia, the network of experts of the Open Pharmacopoeia, the National Pharmacopoeia Authorities, the Open Medicines Agency, the World Health Organization. And that was really key also for coordinated and timely response.
Speaker #2
And I think we can't underestimate the contribution of the experts from our networks, whether it was the Pharmacopoeia side or the OMCL network side. for everything that I put into making this crisis turn out in a way that was much better than was feared at the very beginning.
Speaker #0
All right. So, yeah, I mean, we went over a lot of the things that we did, a lot of the EDQM's actions. We touched on the importance of collaboration and a main theme was the importance of flexibility, as we said before, and really trying to figure out innovative solutions really in the heat of the moment, which is what really made the difference. So again, as we said, very unprecedented crisis with a lot of new challenges that we needed to face. And from this period, obviously, there should have been some lessons learned that we could potentially apply for future similar situations. So what were these lessons and how did the EDQM's approach to pandemic preparedness evolve after the COVID crisis?
Speaker #1
Well, perhaps as I mentioned before, we have now established a very solid business continuity plan, including building stocks. And that was something that we didn't imagine before. We have also improved a lot the way we work internally. For instance, we have, of course, developed Visio and teleconference. That's something that was not really very popular before the crisis. On the other hand, it allowed us to reach new experts around the globe, allowing us to work with countries not located in Europe. And it's also very good for environmental sustainability. So if we may say, at least it was something quite positive.
Speaker #2
I think that's an important point, Pierre. And I think it's important to recognize as well that the competence and experience of the world is very important. experience that already existed in the network and was already being coordinated at some level by EDQM was vital for the rapid reactivity to the crisis situation. Indeed, for the OCABRA network, it was successful thanks to the fact that there's a maintenance of a qualified and competent network of experts and laboratories who can quickly react based on their existing programs and adapt to the specific purpose.
Speaker #3
And in the same way, for the pharmacopoeia, we could rely also on this experience that was accrued over the years with the elaboration of quality standards for vaccines. And that really allowed to fast track the development of guidance to support the developers. And I think from my perspective, it also showed that it was possible to speed up the elaboration process in an urgent situation like we had during the pandemic. And to me, it also showed the importance of maintaining up-to-date quality standards for medicines and vaccines.
Speaker #1
Perhaps we can also say that we have also improved our communication with our colleagues. key stakeholders, including in time of crisis where you need to be very agile, very reactive. I think, as it was mentioned before, we are quite reactive and we can work with very qualified experts and very committed people. So that also improved in the time of crisis, this communication aspect.
Speaker #0
Okay. Speaking of this communication, the way I have it in my head, the way this kind of worked is that there was a whole network. of institutions that kind of form this public health regulatory ecosystem. And in the time of crisis, it's kind of like all the neurons kind of fire up to connect, you know, really come up with things. So in this aspect of communication, would you say that the COVID crisis really kind of opened up new avenues of interacting and cooperating and communicating that before were not really there or thought of?
Speaker #1
Probably it speeded. the communication amongst the stakeholders. I think we also explored new way of working together. And I think it's a positive aspect of this crisis.
Speaker #2
Okay. Yeah. I mean, we learned the importance of the global community. I think we saw in all the activities in exchange at a global level, the key stakeholders were rapidly identified. And for example, in the OCABR, the interaction with the manufacturers, while OMCLs are independent, it was still important to have an open dialogue with them early so that we could get the right information and they could have the information back from us. I think the working together and everybody communicating, putting their part in and bringing their expertise was what helped us to get through this.
Speaker #3
And that also avoided any duplication at a time where you really want to progress and also to work in a coordinated fashion.
Speaker #2
I mean, that was particularly evident with the OCABR system, where these certificates were available primarily in concept for the EU, but they were used really around the world for reliance, which meant that these vaccines were available all over in a rapid way to really fight the pandemic.
Speaker #0
The pandemic challenged us in ways we never imagined. Through the chaos, the EDQM stood resilient. adapting to new realities with resourcefulness and the vital help of its extensive network. In this episode, we delved into the pivotal role played by the EDQM during the unprecedented challenges of the COVID-19 pandemic. We explored how the EDQM swiftly implemented a comprehensive business continuity plan in early 2020, ensuring the uninterrupted functioning of critical activities across various domains, such as pharmacopoeia and quality standards, reference standards, certification of suitability, and the OMCL network. The EDQM's adaptive measures included virtual and hybrid meetings, remote inspections through the Artemis system, and close collaboration with experts from the OMCL network, the European Pharmacopoeia and national pharmacopoeia authorities. Additionally, we discussed the EDQM's substantial contribution to the global fight against COVID-19, how it offered guidance for the development of vaccines and antiviral medicines, and how it facilitated the independent testing of vaccines used in Europe and around the world via the OCABR system. Finally, we touched upon the EDQM's commitment to pandemic preparedness and potential lessons learned from this challenging period. emphasizing the organization's dedication to maintaining public health standards and contributing to global efforts in times of crisis. We hope this episode has made you more aware of the dedication of the EDQM to protect public health, your health, even in the most unfavorable circumstances. Thanks for tuning in, and see you in the next episode.

Embed