AstraZeneca Seeks EU Approval of its COVID-19 Vaccine
AstraZeneca (AZ) has filed for EU approval of its COVID-19 vaccine and a conditional marketing authorization is expected in late January following a Jan. 29 meeting of the European Medicines Agency’s (EMA) expert panel on human medicines.
If the panel is satisfied with the vaccine’s safety and efficacy, authorization by the European Commission (EC) would occur “within 24 hours,” a commission spokesperson told FDAnews.
The commission, which negotiates supply deals with vaccine developers on behalf of all 27 EU member states, inked an advance purchase order with AZ last August for 300 million doses with an option for 100 million more (DID, Aug. 28, 2020). The cost of the order was not disclosed.
The AZ/Oxford University vaccine offers several advantages over the two messenger RNA-based products from Pfizer/BioNTech and Moderna because the adenovirus-based vaccine is easier to manufacture and can be stored using normal refrigeration, avoiding the ultra-cold shipping and storage requirements for the Pfizer/BioNTech vaccine.
In a rolling review of the AZ/Oxford vaccine that started in October, the EMA is assessing interim data from four ongoing clinical trials in the UK, Brazil and South Africa. Calculated by averaging data from two-dose and one-and-half-dose regimens, the analysis indicated an efficacy of 70.4 percent (DID, Dec. 9, 2020).
The UK and India have already approved the vaccine as a full, double-dose regimen (DID, Jan. 4) and the EU is expected to do likewise.
The EMA requested additional information from AZ/Oxford last month and is awaiting further data from late-stage trials. Separate data from an ongoing phase 3 U.S. trial led by AZ is also expected early this year. AZ has not yet filed for Emergency Use Authorization in the U.S. but is expected to do so shortly after the release of the U.S. phase 3 trial data.
Authorization of the AZ/Oxford vaccine, in addition to the two currently available products and several others on the way, will put the EU within reach of its goal of securing vaccine doses for its entire population of 448 million. ― Jason Scott