The grace of the system agreed by the 27 was that there was not a fight between the 27. That there were no hunger games with vaccines. But the fight is already raging in the face of AstraZeneca’s problems, the seriousness of the economic and health crisis and the difficulties in vaccinating at the rate of countries such as the United Kingdom or the United States. And, precisely, those who are unleashing the fight are those who at the time skipped the key element of collective purchasing by the European Commission and the Member States: equity through the apportionment of doses based on the population of each country.
Because there were those, like Austria who, when there were not even vaccines and it was not known which would arrive sooner or would be better distributed, disdained part of what they had to do with Pfizer-BioNTech because it seemed expensive and logistically complicated, and focused on others, like AstraZeneca, which was cheaper and less complex technology, or Janssen, which only required a puncture. But the first is being a fiasco due to its distribution problems within the EU and the second is not expected to arrive until late April.RELATED
Sandra Gallina, chief negotiator for vaccines at the European Commission and director of the disease center (ECDC), explained this Tuesday to the Committee on Budgetary Control of the European Parliament that “255 million doses will be needed to guarantee that 70% of the 18 years and older are vaccinated by the summer, “a figure that is” achievable, but requires vigilance, given AstraZeneca’s performance to date. ” In fact, the calculations of the president of the European Commission, Ursula von der Leyen, would fit the objectives if everything were as expected on paper. Thus, the EU expects 360 million vaccines for the second quarter of 2021: Pfizer, 200 million; Janssen, 55 million; AstraZeneca, 70 million (instead of the 180 agreed); Modern, 35 million.
Gallina recalled that AstraZeneca had to deliver 400 million doses in total, with 300 million between the first and second quarters of 2021 and starting from December. However, it has claimed that the EMA authorization was delayed until the end of January because the manufacturer “either did not provide the data in time, or did not provide sufficient amounts of data.”
According to the ECDC director, Brussels will use “all the tools” at its disposal in the negotiation with the laboratory: “We have a formal notification to the company, the objective agreed with the Member States is to get more doses of AstraZeneca”. At the moment, there are 30 million doses confirmed for the first quarter and 70 for the second. A third of what was expected.
“Last year, the European Commission closed advance purchase agreements with six pharmaceutical companies to buy doses of vaccines that did not yet exist,” Gallina explained: “To close the contract, the pharmaceutical companies needed a commitment of a certain amount of doses, that is, an incentive to research and produce about 300 million doses, for example. However, as a negotiator, the European Commission needed to make sure that the Member States bought the doses. ”
Gallina recalled that Member States had to decide whether to stay in or out of the program, if they could stay solely on the basis of a prorated distribution. Did they have to keep all the doses based on the population? Or could they stay on the program and get fewer doses than prorated? Gallina has said that the trend last year among member states was “to have fewer doses than prorated because they were committing money for vaccines that did not yet exist.”
Finally, what was agreed is that other Member States could take over the extra doses from those who were keeping less doses than allocated in the apportionment: that is, some Member States committed to pay more to collect additional doses of vaccines. that they did not yet exist and that other states, like Austria, disdained.
As Gallina recalled, without some countries that paid for more doses, some contracts with pharmaceutical companies could not have been closed. “It was not easy to place these doses, because these vaccines did not exist,” said Gallina. “It was not easy for some states to buy doses that did not exist. But we are very grateful to the countries that bought those doses because they allowed the contracts to be closed.” That has allowed four vaccines to be approved in the EU: AstraZeneca, Moderna, Pfizer and Janssen.
Of course, no state that bought more is making money from reselling: when a country renounces a percentage of the assigned doses and delivers them to another, it transfers the payment obligation. France, Germany, the Netherlands and Denmark confirmed the New York Times have purchased doses in excess of their assigned prorated fees through this system. But that does not mean that there has been nothing that the Austrian Chancellor, Sebastian Kurz, denounces in relation to corruption or opacity.
The list of countries that have renounced doses has not been made public, but, from what Gallina has said, it is long, and may include countries that are pressing with Austria to change the distribution system and request more doses than anticipated. by Pfizer from the second half of the year to the first: Bulgaria, Croatia, Latvia, Czech Republic and Slovenia.
But the European Commission agreed with Pfizer to advance the supply of 10 million doses from the third to the second quarter for “areas in difficulty”, while Austria and other countries ask for another type of redistribution with the threat of a veto if they are excluded from the distribution of extra Pfizer doses.
Regarding the mechanism that will be discussed this Thursday and Friday by the Heads of State and Government to extend export controls proposed by the European Commission, Gallina has stated that “the monitoring of exports is made up of two parts: the Member States they make a decision on a suspension or not, and the European Commission supports or rejects the decision, that is, it is not only up to the Commission. ” Indeed, when the shipment of 250,000 doses to Australia was blocked, it was the Italian Government that took the initiative, ratified by Brussels.
“The epidemiological situation is getting worse,” the president of the European Commission, Ursula von der Leyen, recently recognized at the presentation of the vaccination certificate proposal this Wednesday in Brussels. And vaccination targets depend on AstraZeneca data, which in turn is up in the air for several factors. One is that the scientific evaluations on the cases of thrombi are passed, which will be presented this Thursday by the European Medicines Agency. And the other, the restrictions on exports of vaccines from AstraZeneca from the UK and the US.
“Since the beginning of February, we have received hundreds of export applications, all but one of which have been authorized. [la partida de 250.000 dosis de Italia a Australia]. In that time, 41 million doses have been exported to 33 countries, including the United Kingdom. But the roads have two directions. That is why we must ensure reciprocity and proportionality. If this situation does not change, we will reflect on exports to vaccine-producing countries, “said Von der Leyen.
That is, the president of the European Commission has launched the threat of banning the export of vaccines to producing countries that have bans or a higher vaccination rate, such as the United Kingdom.
The United States also produces and does not let out the doses of AstraZeneca, which is also the target of Brussels, although in another way: “With the US, reciprocity occurs because there are no exports of vaccines from the US to the EU, but neither the other way around. And there is a continuous flow of products and raw materials. “
The US regulator has not yet approved the use of AstraZeneca, which is about to apply for emergency authorization after having conducted a specific clinical trial in the United States. But the Biden Administration now has its own dispute with the Anglo-Swedish pharmaceutical company. This Monday AstraZeneca announced that, according to the data of the trial, its vaccine had an average of 79% efficacy against COVID-19, but hours later the national institute of allergies and infectious diseases directed by Anthony Fauci complained in a public letter from that the efficacy data were “incomplete” and “outdated”. AstraZeneca got engaged this Tuesday to publish an update in a maximum of 48 hours. In the letter, the panel of experts of the US public institute points out that the latest data for February and March showed an efficiency between 69 and 74%.
In the British case, AstraZeneca alleges that there is an “England first” clause in the contracts, so that in fact there would not be a ban on exports as Downing Street advocates.
The tension is growing in the last hours, but also the negotiations to find a way out, while, according to community sources, the Netherlands could also block shipments if the United Kingdom does not agree to share vaccines from a plant that is about to starting with the AstraZeneca vaccine. “The British insist that the Halix plant in the Netherlands must deliver what is produced there”, an EU official told Reuters. The Leiden-based plant, run by subcontractor Halix, is listed as a vaccine supplier in both the contracts AstraZeneca has signed with the UK and the European Union.
German Chancellor Angela Merkel spoke about the conflict on Tuesday: “I support the president of the Commission, Ursula von der Leyen. We have a problem with AstraZeneca.” Brussels has accused London of applying a de facto ban on exports. The UK, in turn, has voiced alarm at the EU’s threat to block AstraZeneca supplies leaving the continent. Merkel has said that both she and French President Emmanuel Macron had spoken with Johnson about an issue that will be addressed by EU leaders at the summit by video conference on Thursday and Friday.
The director of the European Medicines Agency (EMA), Emer Cooke, appeared on Tuesday before the Health Committee of the European Parliament while Gallina was in Budgetary Control. Cooke, in this case, has given some new information about the Russian vaccine: “We are analyzing the Sputnik V vaccine, we have been in talks with the company, the representatives of the fund that has developed the vaccine, we have accepted a continuous review of the Sputnik and we are in the process of evaluating and launching the inspections. We hope that it will be a valuable vaccine to add to the vaccines that are available in the EU and that it will obtain an authorization in Europe with the same safety, quality and efficacy standards that we apply for each vaccine “.
“We work as fast as we can,” Cooke said, “but we have to ensure that we base our conclusions on scientific evidence. We constantly collaborate with companies to collect additional data. We now have three: Sputnik V, Novavax and Curevac. The fact The fact that they are still under review means that we are not yet in a position to define specific dates and we do not have a timetable for approval. In some cases trials have not been completed and in other cases production information is not yet available. “.