AstraZeneca Vaccine May Only Gain EU Approval In Under 70s

Limited Data Creates Conundrum For Regulator

 
• By Andrew McConaghie
  
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AZ and the EU are at loggerheads over supplies of the COVID-19 vaccine. On top of that, its marketing authorization will present dilemmas.

A poster promoting COVID-19 vaccination in Berlin, Germany. Politicians in member states are frustrated at what they see as slow decision-making at the EMA and European Commission.

While the AstraZeneca/University of Oxford COVID-19 vaccine is at the center of a row about whether or not the company has broken a promise on supplies to the European Union, the all-important decision on its approval in the bloc is just days away. (Also see "Coronavirus Update: EU Demands AstraZeneca Meets Its Vaccines Commitments After Supply Warning" - Scrip, 26 January, 2021.)

This is also a matter of controversy, as its pivotal Phase II/III trial data is not clear-cut, making its authorization...

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