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BRUSSELS – ANSWER. It was a week of developments and tensions on the vaccine front. The European Commission, through its President Ursula von der Leyen, announced on Friday that it had managed to double –300 to 600 million– the number of doses of the Pfizer / BioNTech vaccine that will be made available to European citizens this year, under a new agreement with the two companies.
Ms Von der Leyen added that 75 million of these installments would be delivered in the second quarter of 2021 and the rest in the second half of the year. Pfizer / BioNTechAt the same time, they have committed to deliver the first 200 million vaccines of the original contract to EU member states. Until September. The speed with which production will begin at BioNTech’s new plant in Marburg, Germany, will play a crucial role in the availability of 75 million new doses. The plant, which the company bought from Novartis last year, is estimated to produce 750 million doses of the vaccine a year, including 250 million before the end of the first half.
At a press conference on Wednesday, German Health Minister Jens Spann expressed hope that the plant could start production in February, which will allow a “big increase” in the availability of vaccines in the EU. According to German government sources, the competent authorities (from the state of Hesse and the federal government) have worked closely with BioNTech and Novartis to complete a licensing process that generally takes years to complete in months. The same sources estimate that the plant could start producing at the end of February. Pfizer / BioNTech, at the same time, according to information from “K”, are seeking fast-track approval of two more production units, one in Hamburg and one in Austria.
The representative of the Health Commission, Stephane de Kersmaker, in his briefing last Monday, recalled that the Commission has already exercised the right included in the original contract to purchase additional quotas, both from Pfizer / BioNTech (100 million, reaching 300 million) and Moderna (80 million, reaching 160 million), whose vaccine was approved this Wednesday by the European Medicines Agency (EMA). As von der Leyen said on Friday, with vaccines provided by the Commission from just these two producers, it could provide vaccination coverage to 380 million out of 450 million Europeans. Also on Friday, the EMA announced that each vial of the Pfizer / BioNTech vaccine could receive six instead of five doses, which could increase available doses by 20%. “In a few months we will discuss what to do with the incredible excess supply that we will have at our disposal,” said a senior EU source. “We won’t know what to do.”
According to the representative of the Health Commission, it is also negotiating with Member States how to distribute the additional 100 million quotas included in the original contract with Pfizer / BioNTech, as they may not want all of their share. According to the information of “K”, two Member States, including one of the most numerous, initially declared that they were not interested in these quotas, thus increasing the participation of the rest. Since then, however, they have changed their minds and now the negotiation revolves around whether the other 25 countries are willing to return to the original quota.
The questions
At a press conference on Friday, von der Leyen, in response to a question from K. about allegations of parallel negotiations between member states and pharmaceutical companies, was unusually straightforward: “We negotiate together, we supply together,” he said. noting that the obligation of Member States not to negotiate in parallel is “legally binding”.
The bone of contention throughout the week was the agreement, presented on Monday by the German government itself, under pressure on the domestic front, between Germany and Pfizer / BioNTech on a 30 million dose of the vaccine. According to the German Ministry of Health, the two parties reached this agreement (memorandum of cooperation) last September, at the same time that the Commission concluded preliminary talks with the companies on the pan-European pre-purchase agreement and several weeks before the signing of the relevant convention at European level. Berlin claims that Brussels was aware of the memorandum, something denied by a high-ranking EU source.
In addition to the apparent breach of the terms of the common European strategy (a similar agreement with CureVac has been in place since late summer, also several weeks before the relevant European pre-purchase agreement was signed), the question arises as to whether the German government thus more timely access to vaccines. German government sources deny that this is the case. Community sources go even further, stating that any agreement of this type, if it is reached outside the framework of the common European strategy, is de facto invalid. As they explain, the total quota is established by population criteria, so any amount agreed bilaterally will be deducted from the number to which the country is entitled under the European convention. It is recalled that the Danish Minister of Health has also publicly stated that his country has agreed with Pfizer / BioNTech to provide 2.6 million additional doses.
Criticism of the Commission and hunting of consumables
The confirmation of Germany’s agreement with Pfizer / BioNTech came in the wake of strong national criticism of the delays in vaccination compared to other developed countries. In an interview with Bild last Sunday, Bavarian Prime Minister and possible Chancellor Markus Sender referred to countries such as the United Kingdom, the United States, Canada and Israel having approved the German vaccine developed by Germany. before the EU “It is very difficult to explain why vaccination with a very good vaccine made in Germany goes faster elsewhere,” he said. The leader of the Christian Social Union (CSU), the sister party of the Christian Democracy in Bavaria, also highlighted the economic aspect of the slow progress of the vaccination campaign, saying that the countries that advance faster will recover first, with Europe behind.
BioNTech CEO Ugur Sahin has also criticized the Commission. Sahin, speaking to Der Spiegel, questioned the Commission’s decision to strike deals with many different companies rather than buying large quantities of its own vaccine.
Der Spiegel, citing anonymous sources, claimed in a recent lengthy report that the European Commission had the opportunity, even in November, when it was shown that the Pfizer / BioNTech vaccine would win the race and show surprising efficacy to prevent (95%) – to buy 500 million extra installments, but declined. Critics of the Commission’s strategy note that Pfizer / BioNTech and Moderna’s leadership in the vaccine race has been evident since last July. A new report from Spiegel on Friday claims that member state experts on the Commission’s negotiating team were skeptical about the innovative mRNA technology, on which the BioNTech and Moderna vaccines are based, until October.
Competent Community sources indicate that the diversified portfolio strategy (agreements with many companies) was carried out under conditions of great scientific uncertainty and with the consent of the 27 Member States. They also refute the allegation of Franco-German balances in the pre-purchase contracts, which in any event seems incompatible with the fact that the Commission signed a contract with the German CureVac for a further 405 million installments.
Meanwhile, a major obstacle to the successful operation of national vaccination campaigns is the significant shortage of basic consumables needed to administer vaccines. The European Commission had warned at the end of July of such a shortage and had launched a process, similar to that of vaccines, to jointly supply the necessary products. According to a Commission source, 46 contracts related to syringes, needles and gloves have been completed or are in the process of being finalized. Overall, the EU will buy 760 million pairs of gloves, more than 1.2 billion syringes and 588 million needles on behalf of the Member States. Greece has proceeded with the orders for the amounts due and expects deliveries in one to three months.
The downside for Brussels is the speed of approvals
Apart from the issue of the available doses of the first approved vaccines, which arises as a comparative disadvantage of the EU. is the speed of approvals by audit authorities. Last Wednesday, the EMA ruled in favor of granting a conditional marketing authorization for the Moderna vaccine. However, the vaccine already received marketing authorization from Canada on December 23 and emergency use from the US on December 18, and was approved by Israel before the EU. (January 4).
The Pfizer / BioNTech vaccine, respectively, received a green light from Coreper on December 21, but received an emergency use license from the UK on December 1 and the United States on December 11. Its use before the EU also approved Bahrain (12/4), Canada (12/9), Mexico (the same day as the US), Kuwait (12/13), Singapore (12/14) and Costa Rica and Panama (12/1512), Chile and Ecuador (12/16) and Israel.
An even longer delay is expected for the AstraZeneca vaccine and the University of Oxford, whose much lower price and clearly less demanding transport and storage conditions make it ideal for extending vaccination to the general population. The vaccine was approved by the British MHRA on December 30 and by the respective Authorities of India and Argentina on January 3.
On Friday, the EMA announced that based on the new data it had requested and received from AstraZeneca, it expects the company to apply for a conditional marketing authorization next week and that it is “likely” that the opinion will be issued before finalization. January. It is recalled that at the end of December, the Deputy Executive Director of the Agency had expressed skepticism about the possibility of completing the evaluation process in January.
In a statement issued on December 30, Coreper said that it had requested additional information from the company on the “quality, safety and efficacy” of the vaccine and recalled that the emergency authorization process adopted by the United Kingdom differed from that of the conditional marketing authorization. The most important difference between the two is that the legal responsibility (for example, for any negative side effects) in the second case remains with the companies, while in the first it is the responsibility of the audit authority.
Critics of the Organization speak of a bureaucratic approach that adapts to normal times and not pandemic conditions. The standard answer is that the rigorous EMA procedure and scope of obligations associated with phase 4 (after licensing) are vital to both the substance and the concept of quality assurance and formulation safety.
