The European Union is having a hard time speaking with one voice during the Covid-19 pandemic. Despite the reassuring approach of the European Medicines Agency (EMA), to date, a small number of countries - including France, Germany and Italy on Monday 15 March - have halted inoculation of the vaccine produced by AstraZeneca and Oxford University. There are also conflicting views on the lessons to be learned from this crisis.
“Mistakes were made”
“It is true that mistakes have been made when ordering vaccines, both in Brussels and in the Member States”, said European Commission Vice-President Frans Timmermans, calling for lessons to be learned from the pandemic.
But this approach is not shared by all his colleagues: while the institution’s spokesman, Eric Mamer, did acknowledge errors in the implementation of advance purchase agreements with manufacturers, in particular with AstraZeneca, he did not question these agreements.
“This joint purchasing strategy was not only essential, but also very welcome. And it is clearly a success”, said Eric Mamer. “Where we all agree that there is certainly room for improvement, and where we have been partly surprised by developments, is in the ability of the pharmaceutical companies to then organise their production lines in such a way that they can deliver the vaccines according to the timetables we have set”, he continued.
AstraZeneca back in the spotlight
The AstraZeneca vaccine is experiencing delays and is increasingly suspected of causing side effects.
Last week, the Anglo-Swedish company hinted that it would attempt to deliver 30 million doses to the EU by the end of March, notwithstanding a contractual obligation of 90 million and a commitment last month to deliver 40 million doses.
In addition to these delays, Austria, Denmark, Ireland, Italy, Bulgaria, the Netherlands, France, Spain and Germany have decided to partially or fully suspend the administration of AstraZeneca’s vaccine after reports of possible, but so far unrelated, side effects.
The European Medicines Agency, which had already issued a preliminary opinion on 10 March, continues to maintain that the benefits of AstraZeneca’s vaccine outweigh the risks, as Marco Cavaleri reminded the Parliament’s Public Health Committee on Monday 15 March. In a subsequent press release, the agency nevertheless indicated that it would reassess the available information on 16 March and take a decision on 18 March at an extraordinary meeting.
MEPs concerned about new variants
MEPs have expressed serious concerns about the mutation of the virus, the poor sequencing capacity of Member States and the effectiveness of current vaccines in combating these new forms.
The European Commission is currently working on a delegated act to speed up the adaptation of vaccines to variants. “Manufacturers will not have to restart a file from scratch. It will be a variation of the original file, which will save valuable time”, said Marco Cavaleri, on behalf of the EMA, stressing that this legal basis was inspired by what was done for seasonal flu. In his view, in the future, a marketing authorisation could be valid for different variants.
For her part, Katherine O'Brien, representing the World Health Organisation (WHO), stressed the “urgent need for a coordinated approach to surveillance and assessment of variants and their potential impact on vaccine response to countermeasures”. (Original version in French by Sophie Petitjean)