Brussels resists push for Covid vaccine deliveries before regulatory approval

Brussels is resisting a push by some EU member states for the Oxford/AstraZeneca Covid-19 vaccine to be delivered before it receives authorisation from the bloc’s medical regulator, as officials raise questions about the legal implications. 

Four countries — Austria, the Czech Republic, Denmark and Greece — wrote to the European Council president Charles Michel this week to float the idea of “pre-authorisation distribution”, allowing them to start immunising people the moment approval is received.

However, the European Commission has raised doubts about such a move, arguing that pharmaceutical companies are likely to be unwilling to shoulder the legal responsibility of releasing doses before the formal authorisation of the vaccine. 

The disagreement highlights growing anxiety around EU member states over the slow rollout of vaccines compared with some other rich countries, notably the US and UK, and the unorthodox measures some capitals are proposing to accelerate the process.

The concerns have been amplified this week as EU countries tighten travel rules in response to fears over the spread of highly transmissible coronavirus variants identified in the UK and elsewhere.

Earlier this month EU governments criticised Pfizer’s decision to temporarily cut supplies of the vaccine it developed with BioNTech to European countries, although the company insists the supply will be made up later and the move will help it increase production later in the year.

Tensions over the pace of the EU immunisation rollout boiled over in the leaders’ video summit on Thursday night, given the growing transmission of the new UK-identified strain of the virus in EU countries. 

The proposal for early pre-authorisation delivery of the Oxford/AstraZeneca jab would mean that countries would be ready to begin immunisation on the day the European Medicines Agency and the commission announce the approval of the new vaccine, which could be on January 29.

Danish prime minister Mette Frederiksen pressed the case for early distribution during Thursday night’s talks, said people briefed on the call.

Member states would undertake full responsibility for safe storage and any unintended use of the drug if this happened before it was authorised, according to the proposal. 

But this suggestion was met with scepticism elsewhere. Sandra Gallina, lead negotiator for the EU’s vaccine procurement scheme, told member states this week it was unlikely to be possible given tight rules surrounding vaccines that have not yet been authorised, diplomats said. She also predicted companies would not go along with such a move, they added.

Ursula von der Leyen, commission president, echoed those doubts on the leaders’ call, according to people briefed on the discussion.

The commission said on Friday that requests for pre-emptive delivery should be handled “with caution” because of the various regulatory restrictions on delivering medicines before they had received regulatory authorisation.

“We are very much aware of, and understand, the need to have a fast delivery,” the commission said. “Member states need to see what it is they can do, as well, to facilitate this . . . taking into account all the legal constraints.” 

AstraZeneca, which is producing the vaccine developed with the University of Oxford, had no immediate comment. The jab is already being used in countries including the UK, where it won regulatory approval late last month. 

Brussels is working on other possible measures to speed up the process, such as arranging for regulatory protocols needed prior to the release of batches from factories to be done before the jab is authorised, officials said. The commission has also suggested it might be possible to save time by avoiding the need to translate the instruction booklet with the jabs into all EU languages.

The focus on the Oxford/AstraZeneca vaccine highlights its importance to the EU, given that the bloc did its deal to buy the BioNTech/Pfizer vaccine months later than the US and UK and so is likely to be receiving proportionally fewer early deliveries. The Oxford/AstraZeneca vaccine was the first pre-ordered by the European bloc and the 400m doses of the two-shot course would cover almost half the region’s 446m population. 

Some EU member states are also increasingly agitated by the bloc’s slower approvals for the new Covid-19 drugs, particularly compared with the UK and US. Both those countries have sped up the process by issuing emergency use authorisations, which shift liability for any problems from drugmakers to authorities. Hungary broke ranks this week and became the first EU country to issue a national emergency use authorisation for a coronavirus vaccine, in this case, Russia’s state-developed Sputnik V jab.

Concerns about the pandemic dominated the EU leaders’ call on Thursday. Mr Michel said after the call that leaders were “aware of just how serious the situation is”, and that member states may need to impose fresh restrictions on non-essential travel even as they avoid strict border closures. 

French president Emmanuel Macron is planning to introduce new coronavirus rules for travellers from the EU from Sunday morning, with Paris set to require visitors from inside and outside the bloc to have a negative Covid-19 test performed less than three days before they enter the country.

Additional reporting by Anna Gross in London

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