ANALYSIS INFORMATION FROM A EUROPEAN PERSPECTIVE

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VACCINE DISASTER



THE LATEST ON VACCINES FROM THE EUROPEAN UNION

 COVID-19: MEPs discuss ways to increase roll-out of vaccines with pharma CEO’s.

 In a hearing on Wednesday, MEPs demanded clarity on vaccine deliveries and insisted that pharmaceutical companies honour their contracts. MEPs quizzed CEOs and representatives of leading pharmaceutical companies, including AstraZeneca, Moderna, CureVac, Novavax, Pfizer and Sanofi, on how to remove obstacles to faster commercialisation, manufacturing and distribution of vaccines.

During the discussion, MEPs asked about global technology transfers, sharing patents, and how industry intends to update the vaccines in order to keep up with emerging variants. They also grilled CEOs on how the European Medicines Agency could speed up market approval at European level. Some MEPs asked whether an EU export ban on vaccines would help Europe compared to other countries that have introduced export bans. In their remarks, industry representatives highlighted the challenge of building production capacity for entirely new and complex products, and the international nature of supply chains.

“This was a world first: CEOs of the main vaccine manufacturers appearing before elected representatives. It’s good for transparency, and it’s good for democracy. It is crucial to regularly check accountability and commitments made. Moreover, the race to produce vaccines is intensifying and we are gearing up to use all available tools to support it. This was the point of this hearing”, said Environment, Public Health and Food Safety Chairman Pascal Canfin (Renew Europe, FR). “The European Parliament will play its role fully to win the vaccine deployment battle. The contact group put in place by the Parliament and Commission will further strengthen our role”, he added.

“Today’s challenge is about how to produce extremely complex products on a scale that is absolutely unprecedented. This is an industrial challenge”, said Industry, Research and Energy Committee Chairman Cristian Bușoi (EPP, RO). “This hearing was an exercise in democratic accountability. We wanted to know where the production bottlenecks are and to have a clear picture about the industry’s commitments and obligations. But we also want to help the industry deliver the doses, because our priority is to get vaccination done”.

Developing and distributing effective and safe vaccines against COVID-19 is the most effective response to the pandemic and is at the heart of the EU's recovery strategy. Given the importance of increasing production and access to vaccines, this hearing aimed to establish the facts and to find solutions to improve the roll-out of COVID-19 vaccines in Europe.

Another objective was to have an open discussion with the CEOs of the pharmaceutical industry, the Commission and other stakeholders on how to overcome impediments to speedier commercialization, manufacturing, distribution and equitable access to the COVID-19 vaccines.

THE EUROPEAN PARLIAMENT

Covid-19 Vaccinations:

more Solidarity and Transparency needed.

After scientific evaluation and positive recommendation by the Euro-pean Medicines Agency, the European Commission  granted condit-ional market authorization to the first vaccine against Covid-19, developed by BioNTech and Pfizer, on 21 December 2020. Vaccin-ations across the EU started shortly afterwards on 27 December. On 6 January 2021, Moderna’s vaccine was given conditional market authorization. The vaccine developed by AstraZeneca could be authorized by the end of January.

Under the EU Vaccines Strategy launched in June 2020, the Com-mission negotiated and concluded advance purchase agreements with vaccines developers on behalf of EU countries; the EU covers part of the costs faced by the producers in return for the right to buy a specified amount of vaccine doses in a given timeframe and at a given price, once they are granted market authorization. So far, six contracts with pharmaceutical companies have been concluded.

Background: The Race for Vaccines

From the very beginning of the coronavirus outbreak, the European Parliament has closely followed the vaccine research and development process. The EU coordinated a joint effort to secure the speedy deployment of vaccines against the disease, through the mobilization of hundreds of million euros for research projects and more flexible procedures. Parliament approved a temporary derogation from certain rules for clinical trials to allow vaccines to be developed faster.



MEPs on the health committee repeatedly highlighted the need for public trust in vaccines and the importance of fighting disinformation and asked for more transparency regarding vaccine contracts, authorization and deployment in the EU.



MEPs supported the EU's common approach to fighting Covid-19 and called for more unity and clarity during a debate on the roll-out of vaccines and the EU's vaccines strategy.

During a plenary debate on 19 January about the EU’s strategy on Covid-19 vaccinations, most MEPs expressed support for the EU's common approach, which ensured the quick development and access to safe vaccines. However, they called for even more solidarity when it comes to vaccinations and transparency regarding contracts with pharmaceutical companies.

Esther de Lange (EPP, Netherlands) said: “Only more transparency can take away the widespread perception – whether this is justified or not – that often, too often, profit is put before people in this (pharmaceutical) industry.” She praised the EU's joint purchase of vaccines, which led to a stronger negotiation position than individual EU countries would have had: “That means more vaccines for a better price and under better conditions. It shows what Europe can do when we stand united. We can help save lives.”

Iratxe García Pérez (S&D, Spain) warned against "health national-ism" that could damage cooperation on vaccines in Europe. According to her, solidarity and unity is the answer: “If we can keep unity and have equitable distribution of vaccines in member states, we have reasons to believe that 380 million European citizens will be vaccinated by the summer. This is a scientific and health feat that cannot be ruined by parallel contracts and direct purchases." She added: "Let us speak with one voice so that the largest vaccination campaign in history will bring hope back to us in 2021.”

“What are we doing exactly to increase the speed of administering vaccines across the EU?” asked Dacian Cioloș (Renew, Romania). “I know this is a race against time, but in this race we cannot forget that we have a responsibility to do things in full transparency, a responsibility to our citizens to gain their trust. That trust is largely what the vaccination campaign depends on."

Joëlle Mélin (ID, France) said the negotiation of the vaccine contracts lacked transparency. “We are now in the distribution phase and we discover that there are shortages and broken promises from the pharmaceutical companies,” she added.

Philippe Lamberts (Greens/EFA) also talked about the need for transparency and the fact that the European Commission kept the contracts with laboratories secret: “This opaqueness is an insult to democracy. In every single contract the buyer has to know what he or she is buying at what conditions and what price.” He also spoke about potential liability issues: “It is crucial to know who will hold the liability if there were to be negative side effects of the vaccination - would it be the public decision makers or would it be the drug makers? We have no idea.”

Joanna Kopcińska (ECR, Poland) said the decision for the common vaccination strategy was right: “We need an overarching strategy and of course scepticism has a lot to do with a fear that the vaccination is moving slowly, the delivery is maybe late and the contracts are not transparent." She called for the systematic update of treatment strategies and appropriate information campaigns that reach out to everyone.

Marc Botenga (The Left, Belgium) called for more transparency of contracts and responsibility from pharmaceutical companies. He criticised uneven access to vaccines globally, noting poorer regions have difficulties obtaining enough vaccines. “No profit needs to be made on this pandemic and we certainly do not want segregation at vaccinations.”

Health Commissioner Stella Kyriakides assured MEPs that their calls for transparency had been heard. She welcomed the fact that the first of the vaccine suppliers had agreed to make the text of their contract available and said the Commission was working to get other producers to do the same.

Kyriakides said she expects to see more applications for the authorization of vaccines in the coming months. She stressed the importance of a global approach: “No country will be safe and no economy will truly recover until the virus is under control in all continents." She also talked about Covax - the global facility to ensure fair and universal access to Covid-19 vaccines that the EU helped to set up - which aims to purchase two billion doses by the end of 2021, including more than 1.3 billion for lower- and middle-income countries.

Ana Paula Zacarias, the Portuguese Secretary of State for European Affairs who was speaking on behalf of the Council, said the common EU approach, which sped up the process of developing, authorizing and securing access to vaccines, must continue to ensure the availability and efficient rollout of vaccines in all member states.

Zacarias said that a number of issues still need to be resolved, including the format and role of the vaccination certificate, a common approach on the use and validation of antigen rapid tests and the mutual recognition of Covid-19 test results.