Don’t quote, don’t trust, verify here, my comments in brackets.
Von der Leyen, henceforth VDL: [missed a little at the start] Discussion an action plan to build synergies with space industries. Communication on trade. New direction for assertive trade policy. Adopted joint communication with High Rep on EU’s contribution to rules-based multilateralism. HRVP Borrell also briefed College on the int’l arena. EC approved 2nd contract with Moderna for 300m additional doses of vaccine. We will and shall vaccines in the weekly and months to come. More Covid cases linked to new variants. Vaccines approved in Europe appear to be effective against these new variants, but there could be more variants, and could be more resistance. Why today we are presenting the HERA incubator. Public-private cooperation. Use combined strength to get area of new variants. We know where there were delays and bottlenecks the first time around. Five priorities: sequencing of virus (and variants), adapt existing vaccines, need evidence-based data fast, fast-track reg approval of vaccines and manu’f sites, upscale mass production of new and existing vaccines. EU-wide genetic sequencing must be speeded up. Also, 2nd building stone, need to support undertakings when vaccines adapted to new variants. Allocating 150m euro to research projects for this. Third, clinic studies. Must be coordinated better throughout Europe. Today, EU-wide clinical study launched today. Also, market approval for new vaccines must be streamlined. Like flu-jabs every year. Also must have sufficient manu’f capacity here in Europe. When need to ramp up production, must be able to do it immediately. Why we’re proposing HERA incubator now.
Stella Kyriakides, EU commissioner for health and food safety. Authorised vaccines still the first line of defence. Effective against the variants. By nature, they mutate, our defences need to evolve. HERA incubator: what needs to be done in terms of new variants. All MS need capacity to have a sequencing of about 5% of positive results. Figure now 1%. We need a network across MS. 2nd element of HERA: advance purchase agreements. Our approach to ‘de-risk’ vaccine candidates has shown its worth. Need to build on it. 3rd, regulatory process. Need a new vaccines to be approved through streamlined procedures. No compromises will be made on safety. Also need to look at how we use regulatory procedures. Also early involvement of regulatory authorities. Can propose emergency approval with shared liability. HERA incubator, we knew that this was missing from our structures, now acting upon that today.
Thierry Breton, internal market commissioner. Our European strategy against variants. Need to anticipate. Third wave. The scientific element, sequencing, adaptation to new variants, and after all that, industrial side of things. So it’s not easy. Not a piece of cake. We’re in a race. The scientists have done amazing things. Ten months after WHO announcements, we have four, five vaccines that work. Most that work were selected from 100s of candidates. Most developed in Europe with European funds. We should be proud of this, that Europe through its financing was able to participate in this global effort. Delivered 178 million doses [globally?]. It’s not enough. US, 50 m delivered. China, about 40 m delivered, here in Europe, 33 million doses. We started a bit later. Factories. Not easy to produce vaccines. Takes 4-5 years, not a timescale we can accept. Need to use existing industrial basis. Amongst approved vaccines, RNA vaccines. Nobody’s done this before. To scale up factories, we need 18-24 months. Can’t accept. We need a war footing here, some people use that phrase. We’re asking them to boost production in 4-5 months, when usually they need 1.5-2 years. 16 sites in Europe producing the vaccine. Not all of them mobilised for selected vaccines, some for vaccines that will hopefully be approved. We need to help these companies to follow the time-frame, why president asked me to help set up industrial task-force, it has been set up. It’s going well. To produce vaccines, you need organic components, chemical components, mechanical. Need to ensure the supply chain works. Need a global, general view. In this global race, need to ensure that companies not supplying vaccines today but have infrastructure, need to ensure they can make this available, can help boost capacity and we can play a coordinating role. Our objective not just to be ready now, but if need be, to come back in, re-intervene, b/c maybe a variant requires a booster shot that we need to produce industrially. Final objective, need to ensure that our continent can be fully autonomous when it comes to vaccine production. Need to supply other countries, other continents, particularly Africa.
Q&A [where’s where the fun begins]
13:26, Mathijs: will you try to re-negotiate current contracts? New emergency authorisation system, how long will it take? A couple of days?
VDL: we need of course a new contract [to fight a new variant]. Good experience with our contractors, the nature way to continue. Re advance purchase agreements, on the one hand, prior investment important to boost production capacity, for companies, important that they have guaranteed doses that we will be talking. For us, roundabout investment about 3 billion, plus 1 billion for investment. [other figures – overall cost something like 30 billion]. [So advance contracts important.] Emergency authorisation in place until March.
Marco: some regions in Italy in contact with brokers for approved vaccines. Has Germany bilaterally purchased 30 million doses from Pfizer?
VDL: very clear in contracts we have with MS, MS are not supposed to have bilateral negotiations with pharmaceutical companies, if they did, they would have to notify, I have no knowledge about any side contracts. We’ve agreed as EU 27, with out purchasing power, 2.3 billion doses negotiated, today 300 million more. Re fraud, I’ve heard that doses have been offered. In a crisis, you’ll always have people who seek to profit from problems of others. See a growing number of fraud attempts. OLAF is investigating. Our goal is to bring them to justice. On general topic, speaking about Pfizer ‘being offered’, no guarantee that the vaccine is really in the vial. Extremely risky. You have no clue [where it’s been]. If you buy it on the black market, you take the risk. A good reason why we have these detailed tracking systems and logistical chains.
13:33, Jullian Deutsch: Commission to mobilise all necessary funding. How much? Where will it come from? Also, state of play re AstraZeneca. Only one facility for substance to produce in the EU. Would get doses from India. Any news?
VDL: For companies, more important that we guarantee that we take doses than the upfront payments. EC has done the payments. But the doses are being bought by the respective MS at a later stage. This guarantee that we’ll take doses is important for their investment decisions.
Thierry: we’re seen a slow run-up by AstraZeneca. Visited their factory last week here in Belgium. Capacity to produce doses is drastically increasing from what it was before I came. Improvement of 50 per cent. Another factory in Italy. We are confident that they will catch up. And you can count on me, I am behind the [on top of them] on a daily basis.
Athanasios: if we had the means to go faster, why didn’t we go faster before?
VDL: making a vaccine normally take 5-10 years, with 6 months approval. So reduction of process to 3-4 weeks right now is a big step forward. These were completely new vaccines. In the interest of people being vaccinated that the vaccine be effective and safe. We’re gonna look into how to better synchronise steps. Might change the regulatory process to allow HERA to do that. Re variants, now a bottom-line knowledge, just need to look at incremental improvement or change. Can reduce procedure on top.
Stella: we were dealing with totally new vaccines, needed to go through safety regulatory framework. HERA incubator, looking at vaccines that might need to be adapted for variants, can [collaborate] with industry [more easily].
VDL: [These folks know how to talk] It’s so good that we have today the start of a clinical trial network in Europe, a standardised approach.
Thierry: The incubator is important b/c everybody will pool their efforts. In many cases, clinical trials started in the summer when Europe was in lockdown, and numbers of infections went down, so took a bit more time to gain access to all the testing capacities, one of the things that slowed the process down. In all 3 types of technologies, the first one, messenger RNA, proposing b/c if genetic mutations, only a number of elements will have to be changed [but without changing everything]. Nanoparticles won’t have to be interfered with. So new vaccines for variants [won’t take so long].
MARCUS: 2.3 billion doses already, why order more doses? Because of concerns about other vaccines’ quality? Why supply chain steps not taken sooner?
VDL: 2.3 billion already, behind it two things, at the start we had no clue which of six vaccines would make it. At the start, had 160 different applicants, narrowed it down to 30, chose 6, negotiating with 2 more. Five will for sure within this year. So very successful, and at the start we had no clue. Second dimension, from the start counted more doses b/c we wanted to supply also to our neighbourhood. Two tracks: either by doses in kind, COVACs, in COVACS, we do funding with money. Team Europe, the largest funding partner, counting on the US to join COVACS. Additional doses important for us and our neighbourhood. If we negotiate further contracts, inevitably the thought of variants. New contracts [keep new variants in mind]. We will always have to be vigilant to be able to fight mutations with new vaccines and over time to vaccinate vulnerable groups.
Thierry: we had six candidates. We didn’t know which one would be ready first. Before it was impossible to identifies bottlenecks in supply chains. Past six weeks, we’ve been on the ground. But everything has to be done step-by-step.
VDL: why not earlier? We invested heavily in advance purchase agreement, 2.9 billion euro, to have them boost their capacities and get their supply chain in order. Whole world asking for raw materials now. If we had not done that, deliveries would be way lower low.
Christian: authorisations. You spoke about confidence. Now, today, you think it is advisable to accelerate authorisations, but AstraZeneca doesn’t inspire confidence, but discouraged for over-55s, so if you’re going to speed things up, won’t you just speed up public mistrust? Also, do we know anything about the Sputnik vaccine? Also, going to be a long-term pandemic, going to need to vaccinate every year. Will we have the capacity to vaccinate every year?
VDL: Not one-size-fits-all vaccination. If we have an incremental change in the vaccine, then of course you can reduce the time. But being thorough with safety is important. Sputnik? But Sputnik hasn’t applied with EMA. They haven’t applied for conditional market authorisation. If they do, they have to submit all their data and go through the whole process. So, not producing in Europe, needs to be an inspection on the inspection side. We still wonder why Russia is offering millions and millions of doses while they are not sufficiently vaccinating their own people.
Thierry: we need to be humble. The problem for us today is not vaccine, it’s the availability. We have strict rules for safety. We’re at advanced discussions with vaccine producers. I know that there’s a lot in the pipeline, it’s not easy. We’re not going to start from zero. When it comes to types of vaccines, we’re boosting the production capacity. Our objectives can be met. Our ambition is to look to the future. Not sure if we’ll have to vaccinate every year. But we need to have health sovereignty in the EU. Need to be able to react quickly. One of the objectives of HERA is to work with industry so we have the whole panoply of technologies. Once again, this is the case for us and for the countries around us.
[?]: Why do you think about Hungarian approach to approving Chinese and Russian vaccines?
Stella: Sputnik V has not applied for market authorisation. Advance purchase agreements [APA] for authorised vaccines. If MS purchase other vaccines, that’s their responsibility. When we’re talking about accelerating the regulatory framework, we’re talking about authorised vaccines. The process allows for phrama co-vigilance. When going through authorisation [process], [all sides] follow up all cases in cases of difficulties or side effects. Any MS that goes outside the framework, no co-vigilance.
[?didn’t catch name]: why did the companies say of problems after the contracts were signed? A contradiction to sign the contracts, and then say, by the end of the summer we’ll have vaccinated 70 per cent of the population?
VDL: [wasn’t easy for companies either]. Science overtook industry. A reason why BioNTech and Pfizer had to reduce expectations on deliveries. Science incredible, industry very very good, but all sorts of bottlenecks and delays. A learning element that feed deep into HERA incubator. [They’re selling it like someone at McDo trying to push a side order of fries]
Thierry: companies made investments in advance. They bought huge containers that were left empty. So we financed this period upstream, when they time came, they started the manufacturing process. Some cases, could start producing right away, sometimes not. [Look, shite happens.]
Mayer: question for VDL. Much criticism from some MS that EC failed at the start. But at the same time, we’re also seeing implementation of jointly agreed strategy not working well. Border closures, what have you. What proposal would you have to enable cooperation between MS and the EC? Plain for everyone to see that we have problems, but not just in Brussels, in and amongst the MS. Maybe we need a better way of working together.
VDL: In July the Council has been meeting on a monthly basis to discuss the pandemic, in VTC. This is, of course, a huge challenge for everyone. The EC does not have a huge area of competence here, a good sign of cooperation that we’ve made the process that we’ve made. Imagined if MS had gone it alone. Some empty handed, would have been the end of the EU, would have destroyed the single market, if one MS vaccinated all its people while virus still running wild in other MS, [wouldn’t have been good]. I think [our progress] is something to be proud of. I understand that people are impatient. It’s really frustrating. But we stuck together and we continue to stick together. We’re set up a next-generation Europe initiative. Economic crisis severe even before the pandemic, but we have a comprehensive, joint response. Something the MS have done together, going to invest all this money in the MS. Hasn’t been an easy path. When we work together, we have success.
14:14, Louise: press release talks about EU… project. How do you envision capacity? EU build and own its own factories?
Thierry: we focus our effort on helping companies scale up their production. You can understand that. Our understand by my body language that we will do it. But in the future, maybe a new pandemic. We don’t know what kind of technology will be needed. So discussion, that we had before this year already, talking of how companies can prepare themselves, put in place a network of all industries that exist together in continental Europe, if everything goes well and everything will go well [good to know], we’ll be one of the first continents in terms of manufacturing vaccines. But need to keep it up and running if something happens. So need the right governance structure.
Diego: numbers allocate to the COVACS programme, or will you think of COVACs after [?]. Also Hungary?
VDL: COVACS, we had two pledging sessions in May, 16 billion euro pledged, by now COVACS covering 92 lower and middle-income countries. Most important principle is to fund COVACS. It’s negotiating with pharmaceutical companies. Distributing vaccines. COVACS itself spent 2 billion so far, need 7 billion. For EU, important to share if possible doses with COVACS and the neighbourhood. We’ve started work on a sharing mechanism among the MS. But still struggling to get started. One more point re HERA, we have to think in parallel, working not only on capacities in Europe, but where in Africa are potential capacities that could be boosted, for example in Senegal. A form of licensing is proposed in the communication. Licensing possible. Best practice that under ownership of producer, licensing in Africa. The ideal approach.
Fleming: AstraZeneca, usefulness with South Africa variant. Does contract require additional [fixing]? Advice to MS considering Sputnik to wait for authorisation? Is it risky for them to go ahead?
Stella: EMA following up about AstraZeneca and South African variant. We need to take into account vaccine efficacy towards variants, manufacturers looking into this. In terms of Sputnik, no submission for conditional market authorisation, can only assess vaccine after going through EMA scientific assessment.
Matina: re-introduction of border checks. Germany and Belgium. EC urging proportionality, communication, scientific backing. But not really been the cases for most recent checkpoints. How much are you concerned about this and whether you’re worried this is affecting the internal, common market. New EC recommendations but it seems they’re already out the window.
VDL: 17 MS last spring re-introduced border measures, didn’t stop the virus but did cause enormous [economic] problems. In December, down to 4 states with border measures, now we’re back to 9 MS with border measures. So of course we always have to balance health and full movement. More important to look at regions with the same epidemiological situation. That’s what we’ve told the MS. The virus taught us that closing borders does not stop it. In our own interest to stick to the recommendations we agreed together.