von der Leyen admits to COVID-19 vaccine failures
Authors: Rob Hyde
Journal: The Lancet (2021)

EU Commission President Ursula von der Leyen's comments come after much scrutiny of the EU vaccination programme. Rob Hyde reports. EU Commission President Ursula von der Leyen made a startling speech last week in relation to widespread criticism of how Europe has so far handled the COVID-19 vaccine roll-out. “We were late in granting authorisation. We were too optimistic about mass production. And maybe we also took for granted that the doses ordered would actually arrive on time”, she said. Views differ widely, however, on whether the EU did anything wrong in how it went about securing vaccines for its citizens. The EU aims to both secure vaccine supplies, and also provide support for the development of further vaccines in the union. Its approach is centralised. The Commission acts on behalf of all 27 member states by negotiating advance purchase agreements with vaccine manufacturers. Approval is then made by the European Medical Agency (EMA). The benefit of this approach is that, in theory, the EU can secure lower prices. As a huge bloc, the EU should have significant bargaining power in negotiations. Another advantage is that vaccines are ordered on behalf of all EU countries. This stops wealthier states such as Germany, France, and the Netherlands buying up all available vaccines, leaving nothing for economically weaker states such as Romania and Bulgaria. According to the EU's website, its vaccine strategy is funded via “a significant part” of the €2·7 billion emergency support instrument. This money is used as a down payment on the vaccines that EU member states will then purchase. Other funds are also being used to boost production capacity. The aim is to make millions, or even billions, of doses of a vaccine. It normally takes around 10 years to develop a vaccine. The Commission's strategy, however, is an accelerated programme that is designed to develop the vaccine and make it available within 12–18 months. But just how accelerated is this programme? So far, the EU has concluded contracts for COVID-19 vaccines with Moderna (160 million doses), Sanofi-GSK (300 million doses), AstraZeneca (400 million doses), Johnson & Johnson (400 million doses), CureVac (405 million doses), and Pfizer–BioNTech (600 million doses). It has also had exploratory talks with the pharmaceutical companies Novavax and Valneva. However, the EMA has so far granted conditional market authorisation only to the AstraZeneca, Moderna, and Pfizer–BioNTech vaccines. Further questions have been asked about the speed at which people are being vaccinated, particularly in comparison with the UK. The UK was the first country to approve the Pfizer–BioNTech COVID-19 vaccine, on Dec 2, 2020, and later rolled out the AstraZeneca–Oxford and Moderna vaccines. The EU, however, did not approve the Pfizer-BioNTech vaccine until Dec 20. As of Feb 15, more than 15 million people in the UK had received at least one dose of the vaccine; around 23% of the population. In the EU, however, only 4·4 people per 100 000 have. A key explanation for the gap between the EU and UK vaccine roll-outs is down to the British–Swedish company, AstraZeneca, and the controversial vaccine procurement contacts. In summary, the UK got there first, placing an order in May, 2020, for 100 million doses. It also made sure the contracts had clear delivery dates. The EU signed a deal for 300 million doses of the vaccine, but not until August, 2020. Furthermore, according to reports in the German newspaper Bild, procurement expert Gerd Kerkhoff concluded the contract was “a complete disaster”. The contract had 18 “best reasonable efforts clauses”, which legally allowed the company not to deliver on agreed dates, if it said it was not able to. On Jan 29, 2021, the EU began trying to gain greater control over access to the vaccine. It announced that EU-based manufacturing plants, such as the Pfizer production plant in Puurs, Belgium, would now have to request authorisation to be able to export the vaccine. The EU even threatened to stop the flow of vaccine from Ireland to Northern Ireland, although this proposal was swiftly withdrawn after provoking outrage not just in London and Belfast, but also in Dublin. European media quickly slammed the Commission for threatening the Northern Ireland peace process. Fierce criticism of von der Leyen has also come from the usually pro-EU media in Germany—the very country which von der Leyen once served as defence minister. Die Zeit newspaper's Alan Posener said that “if the British were still EU citizens, they would be like us: instead of having vaccinations, simply waiting for Godot”. Der Spiegel said that the EU had attempted to secure the vaccines in a “hare-brained manner, as if it were a summer sale, a bargain hunt on a whim.” Peter Tiede of the daily Bild newspaper claimed that von der Leyen had “disgraced Europe”. Not everyone, however, shares these views. Ellen 't Hoen, is a lawyer and public health advocate at research group Medicines, Laws and Policy, and is former policy director for Médecins sans Frontières’ Campaign for Access to Essential Medicines. Speaking to The Lancet, she said people should be cautious before envying the UK's approach. “What is the UK going to gain if other countries in Europe don’t have the vaccine? It only works if you say ‘everyone for themselves’ and you build a big wall around yourself.” The EMA assesses all vaccines using the same standards as for all medicines. This means that the COVID-19 vaccines’ effects must first be tested in a laboratory, first on animals, then on human volunteers. Because COVID-19 is a public emergency, the EMA has accelerated the process by using an expert task force and what the organisation describes as “rapid review procedures”. On Oct 30, the UK's Medicines and Healthcare products Regulatory Agency (MHRA) also started a rolling review. But it's approval of the vaccine in early December prompted criticisms, including claims that the UK was not using all available data before making its decision to authorise the vaccine. On Dec 2, former EMA head Guido Rasi, declared the UK Government had not delivered a “robust review of all available data”. On Dec 8, German MEP Peter Liese went a step further, saying a “few weeks of thorough examination by the EMA is better than a hasty emergency marketing authorisation of a vaccine”. MHRA chief executive June Raine released a statement defending the MHRA's approach, saying: “We have carried out a rigorous scientific assessment of all the available evidence of quality, safety and effectiveness. The public's safety has always been at the forefront of our minds—safety is our watchword.” On Feb 14, the EU made further announcements on its approvals for vaccines adapted to combat new variants of SARS-CoV-2. In an interview with Augsburger Allgemeine, European Commissioner for Health, Stella Kyriakides said: “We have now decided that a vaccine that has been upgraded by the manufacturer based on the previous vaccine to combat new mutations will not have to go through the whole approval process.” Speaking to The Lancet from Heidelberg, Germany, Ole Olesen, executive director of the non-profit European Vaccine Initiative, said criticisms can certainly be made, but the Commission should be viewed more as inexperienced than incompetent. “The Commission was unrealistically optimistic that it would roll out the vaccines without obstacles. But I think it is learning fast”, he said. “I hope now that someone will now look at streamlining approvals within the EMA. Giving it the ability to take swift action in emergency decisions, perhaps via a special standing committee, would mean the EMA can then keep the power and stability of a tanker but also have the dynamic agility of a speed boat.” Epidemiologist Ricardo Mexia, president of the National Association of Public Health Doctors in Portugal, is reluctant to criticise the Commission. “We are all learning as we go here”, he said. “The EU is doing its best in a difficult situation. If you rush approval and then it turns out that there are problems with the vaccine, then this would ruin vaccine confidence not just for COVID-19, but for other diseases such as measles”, he added.