The European Medicines Agency (EMA) recommended on Friday 29 January the authorisation in the European Union and the European Economic Area (EEA) of AstraZeneca’s Covid-19 vaccine, as the EU tries to guard against announced delays in the delivery of the vaccine.
“With this third positive opinion, we have further expanded the arsenal of vaccines available to EU and EEA Member States to combat the pandemic and protect their citizens”, Emer Cooke, Director General of the EMA, welcomed in a statement.
Based on clinical trials conducted in the UK, Brazil, and South Africa on 24,000 people, this recommendation covers people over the age of 18. There was some doubt about the possible introduction of a maximum age limit, as the German authorities considered that there was insufficient clinical data to prove that the vaccine was safe for people over 65 years of age. The EMA Scientific Committee acknowledged a lack of available data, but considered that the immune response observed in this age group was sufficient to consider AstraZeneca’s vaccine safe for seniors.
Immediately afterward, the European Commission granted a conditional market authorisation for AstraZeneca’s vaccine.
The advantages of AstraZeneca’s vaccine are that it costs much less than Pfizer/BioNTech’s, is easily transportable, can be stored in simple refrigerators, and can be administered by pharmacists. Hence the strong demand from Member States for this vaccine, whose protection rate is estimated at 60%.
At the end of August 2020, the Commission reached an agreement on the early purchase of 300 million doses of AstraZeneca’s vaccine, with an option for a further 100 million doses (see EUROPE 12547/7).
The EMA has already given the go-ahead for the approval of the vaccines from Pfizer/BioNTech (see EUROPE 12627/3) and Moderna (see EUROPE 12630/1).
More info at: http://bit.ly/2NEgqAy
Partial publication of the contract with AstraZeneca
This authorisation concludes a week-long wrestling match between the European Commission and the Anglo-Swedish pharmaceutical giant over the contractual obligations relating to the supply of the vaccine.
Even before the authorisation of its vaccine, AstraZeneca admitted that it was unable to meet the quantities of doses contractually agreed with the EU due to manufacturing problems in Belgium and that it was unable to use UK production sites to supply the European market.
The European Commission recognises that the unprecedented and changing context of the pandemic makes it difficult to meet the commitments made, particularly with regard to the large-scale production of doses of a vaccine even before it is licenced. This uncertainty is reflected in the contract that the EU institution has signed with AstraZeneca, some of which was made public on Friday. But the Commission believes that the investment made to help the laboratory produce doses in advance gives it the right to be supplied quickly.
According to the contract, the Anglo-Swedish company should make ‘best reasonable efforts’ to produce the first doses in the EU-27 until the first quarter of 2021 (article 5.1). But another clause stipulates that it must do the same to produce the doses in the EU, this time including the United Kingdom (article 5.4).
This contract contains “both” an obligation to achieve a result and an obligation concerning the laboratory’s conduct, according to a European source. According to a second source, this is a “contractual obligation”: “UK plants are part of the network of plants responsible for supplying doses”.
However, at this stage, the Commission is not threatening to take legal action. “Going to court will not get us doses”, said the first source.
There are still grey areas regarding the pace and timing of the supply of the doses that both parties have not disclosed. A partially redacted version of the contract shows that the overall value of the contract is €870 million, that the participating States will have to pay the costs of storage, distribution, and disposal, and that the Commission will have the right to audit production costs for up to 5 years after the end of the contract.
This irritated some MEPs, including Kim van Sparrentak (Greens/EFA, Netherlands) and Nathalie Colin-Oesterlé (Renew Europe, France), for whom reading the document raises more questions than it answers, particularly about delivery planning.
Despite the contract’s grey areas, Pieter Liese (EPP, Germany) said he was convinced that “the Commission’s statement that AstraZeneca has committed to supplying 80 million doses of vaccine in the first quarter is correct”. AstraZeneca seems to be able to provide only half of the total over this period.
See the contract with AstraZeneca: https://bit.ly/2KZwYC7
Other companies, such as Pfizer and Moderna, are also having difficulty meeting deadlines. In particular, Moderna announced lower than expected deliveries to Italy and a readjustment of its delivery schedule for France, while maintaining its commitment to deliver 10 million doses to the EU in the first quarter of 2021. In Portugal, Spain, and France, these malfunctions have resulted in delays in vaccinating the population.
The Commission continues to stress that the strategy of negotiating as the EU-27 was the right one, while Hungary is going it alone by urgently approving Russian and Chinese vaccines on its territory. “If we hadn’t negotiated together, there would be Member States that would have no vaccine. (...) We have to stick together to succeed”, said Eric Mamer, spokesman for the Commission, while acknowledging that improvements are possible.
Vaccine export licensing mechanism
On Friday, the Commission unveiled the export licensing mechanism for Covid-19 vaccines that it wants to set up to shed light on vaccines produced in the EU that would be exported outside the EU (see EUROPE 12644/2).
The aim is to ensure that the EU-27, which have taken the risk of investing millions of euros in vaccine production before the vaccines have been approved by the EMA (that is, €336 million for AstraZeneca), have sufficient doses for their population as soon as approval is granted.
“The situation we face leaves us no other choice”, said Commission Vice-President Valdis Dombrovskis. “We paid these (pharmaceutical) companies a lot of money, and now we expect them to meet their commitments”, he added.
Applicable one day after its publication in the Official Journal, the Implementing Regulation will be applicable until the end of March (6+2 weeks) and will be notified to the World Trade Organization. It will require companies to inform national authorities about their exports of vaccines covered by advance purchase agreements. Within 48 hours, Member States will issue an authorisation “on the basis of a binding opinion” from the Commission, Dombrovskis said.
According to a third source, the Member State and the Commission will in fact have to find common ground, and a Member State’s decision to refuse export will be very strictly controlled. “This is not an export ban”, the source said of the Regulation.
In contrast to the UK, almost 100 countries will be exempted from the scope of the Regulation, including EFTA countries such as Switzerland, the EU neighbourhood countries, the Western Balkans, and developing countries benefiting from the COVAX facility.
“This is an insurance policy. Promises are to be kept, and contracts are binding”, stressed Health Commissioner Stella Kyriakides, while stressing that “the race is not against any country” - including the UK - but against the virus. She cited three reasons why the European institution took the initiative: - to be able to work on the basis of evidence; - to enforce advance joint purchases of vaccines; - to protect the integrity of substantial investments made in advance.
More information on the implementing regulation: http://bit.ly/36k95gb
Finally, on Sunday 31 January, Commission President Ursula von der Leyen will hold talks with several pharmaceutical company executives on the objectives and modalities of a biological defence programme, which she announced at the virtual Davos summit (see EUROPE 12644/1).
The aim is to mobilise the future EU Health Emergency Preparedness and Response Authority (HERA) and the private sector to analyse and respond to biological threats, including large-scale production of vaccines, said Mr Mamer. (Original version in French by Mathieu Bion)