Battling COVID on the Policy Front in Europe

As COVID cases continue to mount alarmingly in Europe, at least some good news comes in from time to time on the vaccine front. Following the European Union conditional marketing authorization issued just a week ago for the Moderna vaccine, the European Medicines Agency announced this morning that it had received an application from AstraZeneca and Oxford University for conditional marketing authorization for the vaccine they have developed, which it has promised to process "under an accelerated timeline." This is the product that the UK health authorities gave an emergency clearance to just over a week ago.

The arrival of this submission means, said EMA, that its opinion could be issued by January 29^th, "provided that the data submitted on the quality, safety and efficacy of the vaccine are sufficiently robust and complete and that any additional information required to complete the assessment is promptly submitted." The European Commission's director general for health, Sandra Gallina, said later that this could mean the vaccine being delivered from as soon as mid-February.

That would bring to three the number of vaccines authorized for use in Europe. And the number of doses to be made available is now being augmented by a doubling of the EU's initial order of 300 million from BioNTech/Pfizer for Comirnaty, under an agreement announced on January 8^th.

In addition, the European Commission announced this morning that it had concluded exploratory talks with Valneva with a view to purchasing 30 million doses of its potential COVID vaccine, with an option for 30 million more. Valneva is a European biotechnology company developing an inactivated virus vaccine using traditional vaccine technology, currently the only such candidate in clinical trials against COVID in Europe. The decision, says the Commission, "based on a sound scientific assessment, the technology used, the company's experience in vaccine development and its production capacity."

Further developments are expected from the other contracts the EU has signed with Sanofi-GSK, Janssen Pharmaceutica NV, and CureVac- and the Commission has also confirmed it has now concluded exploratory talks concluded with Novavax. Already the EU has reserved vaccines sufficient to treat 380 million Europeans more than 80% of the European population.

Which is all just as well, because today the European Parliament's health committee grilled Gallina on the arrangements she has supervised for procuring vaccines for the EU. The health official was able to make reassuring noises about progress and prospects, and to rebut any suggestions of foot-dragging or bureaucratic delay. MEPs insisted on greater clarity and transparency regarding vaccine contracts, as well as the decision-making process at EU level, and questioned how coherent the EU's joint procurement strategy was, in light of reports of fighting over allocations and freelance attempts by some countries to secure more supplies for themselves. Gallina said she was not aware of any additional national or bilateral contracts, and the allocation of vaccines was agreed on the basis of population. And she revealed that Curevac had agreed to make its contract available (in redacted form) for MEPs to scrutinize under close conditions of confidentiality.

And the activity continues apace. Next week the EU's financial watchdog, the European Court of Auditors, is to publish the report it has been compiling on the EU’s initial response to the COVID health crisis, which will give a view on—among other things—the actions of the European Commission and other EU agencies "to support the provision of medical supplies and the research and development of tests, treatments and vaccines." That could make some grim reading, given the confusion that surrounded the early weeks and months of the pandemic.