coronavirus
Commission chief spokesperson reassures vaccine roll-out on track
Published
3 weeks agoon

The European Commission Chief Spokesperson Eric Mamer rebuffed criticism of the slow uptake of vaccines across the EU, since the authorization of the BioNTech vaccine at the end of December. The EU has in fact secured over 2 billion doses of various vaccines and EU countries will be responsible for the deployment.
The EU has in fact invested early in vaccines, setting out its strategy on development, manufacturing and deployment of vaccines last June. The Commission asked each state to draw up their national strategy for deployment. It has also worked with its medicines regulator, the European Medicines Agency (EMA), based in Stockholm, to ascertain conditional market access as swiftly as possible, but with a strong emphasis on patient safety.
By acting collectively, the Commission has been able to make larger and cheaper orders. EU countries will then buy the vaccines that they believe are best suited to their circumstances. For example, the Pfizer BioNTech vaccine requires sub-zero temperatures and is more demanding to roll out andit also requires a first and second dose. This is more demanding for some countries to achieve.
The Commission is the co-ordinator; it is up to member states to decide whether they want to buy a specific vaccine and how many doses of that vaccine they want.
Chief Spokesperson Eric Mamer said that the judgements being made were premature, as the roll-out has just started. This process was always foreseen as a process that would build-up progressively, with big deliveries anticipated for April - but this was always dependent on issues like regulatory approval.
So far, just one vaccine has received conditional market authorization, the Pfizer/BioNTech vaccine. Today (4 January), EMA announced that its committee for human medicines (CHMP) discussion on COVID-19 vaccine Moderna has not concluded today. It will continue on 6 January.
EMA's committee for human medicines (CHMP) discussion on COVID-19 vaccine Moderna has not concluded today. It will continue on Wednesday 6th January 2021. No further communication will be issued today by EMA.
— EU Medicines Agency (@EMA_News) January 4, 2021
The EU has pre-ordered 2 billion doses of vaccines so far. It has invested in a diversified portfolio of vaccines for EU citizens. Contracts have been concluded with AstraZeneca (400 million doses), Sanofi-GSK (300 million doses), Johnson and Johnson (400 million doses ), BioNTech-Pfizer 300 million doses, CureVac (405 million doses) and Moderna (160 million doses). It has concluded exploratory talks with the pharmaceutical company Novavax with a view to purchasing up to 200 million doses.

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coronavirus
Kyriakides says newly proposed schedule of AstraZeneca ‘not acceptable’
Published
2 hours agoon
January 25, 2021
Following AstraZeneca's statement (22 January) that it would not be able to meet its delivery schedule agreed with the EU for its COVID-19 vaccine, Health Commissioner Stella Kyriakides said that the European Union has pre-financed the development of the vaccine and the production and wants to see the return. She said the new schedule is not acceptable to the European Union.
It is anticipated that the European Medicines Agency (EMA) will grant approval to the AstraZeneca vaccine by the end of the week, currently scheduled for a meeting on 29 January. Though there are some questions of the vaccine’s efficacy with those over 50, it is logistically less challenging than the other vaccines as it does not require storage at very low temperatures.
AstraZeneca informed the Commission last Friday (22 January) that it intends to supply considerably fewer doses than planned in the coming weeks than agreed and announced.
The European Union has pre-financed the development of the vaccine. The European Union wants to know exactly which doses have been produced by AstraZeneca and where exactly so far and if, or to whom, they have been delivered.
The EU wants to know exactly which doses have been produced where by @AstraZeneca so far, and if, or to whom, they have been delivered.
The answers of the company during the Steering Board discussion have not been satisfactory so far. A second meeting is scheduled for tonight.
— Stella Kyriakides (@SKyriakidesEU) January 25, 2021
The joint steering board of the Commission and the 27 member states discussed this with AstraZeneca today. Kyriakides said that the answers of the company have not been satisfactory so far, and that a second meeting is scheduled for tonight (25 January).
The Commission has today proposed to the 27 Mmember states in the Steering Board that an export transparency mechanism will be put in place as soon as possible.
The European Union has supported the rapid development and production of several vaccines against COVID-19 with a total of €2.7 billion. In future, all companies producing vaccines against COVID-19 in the EU will have to provide early notification whenever they want to export vaccines to third countries. The commissioner added that humanitarian deliveries would not be affected by this.
coronavirus
WHO says Pfizer deal could allow poor countries to start vaccinating in February
Published
13 hours agoon
January 25, 2021By
Reuters
The COVAX scheme, led by the WHO and the GAVI vaccine alliance, signed deals for hundreds of millions of doses to vaccinate people in poor and lower-middle income countries, but vaccinations have yet to start. Pfizer’s vaccine is so far the only one that has WHO emergency approval.
“In this world we are as protected as our neighbour,” said Pfizer’s CEO Albert Bourla, officially announcing the deal which Reuters reported on Thursday.
Bourla said the 40 million doses, a fraction of the company’s total 2021 production estimate of 2 billion, would be sold on a non-profit basis. He described it as an initial agreement, and said more doses could be provided through the COVAX programme in future.
The deal comes amid growing criticism of vaccine inequity from both the WHO and others as wealthy countries inoculate millions of people using shots procured through bilateral deals.
WHO Director-General Tedros Adhanom Ghebreyesus said that the new agreement with Pfizer should allow vaccinations to begin in February for health workers, although details of supply arrangements are still being finalised.
He said he hoped the agreement would also encourage other countries to donate more of their Pfizer shots to support rapid roll-out, like Norway has.
“The commitment of the (United States) to join COVAX, together with this new agreement with Pfizer/BioNTech, mean that we are closer to fulfilling the promise of COVAX,” he said.
U.S. President Joe Biden’s chief medical adviser Anthony Fauci said on Thursday the United States intended to join the facility. Biden’s predecessor Donald Trump had halted funding to the Geneva-based body and announced a withdrawal process.
The WHO said earlier this week it planned to deliver 135 million vaccines in the first quarter of 2021, without giving a breakdown by supplier.
GAVI’s CEO Seth Berkley said in the same briefing that countries would receive dose estimates for the early part of this year in about a week’s time.
coronavirus
COVID-19 vaccinations: More solidarity and transparency needed
Published
4 days agoon
January 22, 2021
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 nationalism" 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 authorisation 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, authorising 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.
Backgound: 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 euro 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.
Under the EU Vaccines Strategy launched in June 2020, the Commission 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 authorisation. So far, six contracts with pharmaceutical companies have been concluded.
After scientific evaluation and positive recommendation by the European Medicines Agency, the European Commission granted conditional market authorisation to the first vaccine against Covid-19, developed by BioNTech and Pfizer, on 21 December 2020. Vaccinations across the EU started shortly afterwards on 27 December. On 6 January 2021, Moderna’s vaccine was given conditional market authorisation. The vaccine developed by AstraZeneca could be authorised by the end of January.

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