01.13.21

EMA Receives Conditional Marketing Request for AstraZeneca’s COVID-19 Vaccine

Source: FirstWord

The European Medicines Agency announced Tuesday that it received an application for conditional marketing authorization of AstraZeneca and the University of Oxford’s COVID-19 vaccine AZD1222. The regulator noted that the vaccine will be reviewed under an accelerated timeline with an opinion possible by January 29 during a meeting of the Committee for Medicinal Products for Human Use (CHMP).

The EMA noted that the expedited timeline is possible because it has already assessed some of the data on the vaccine after starting a rolling review last year. The regulator said that it has so far looked at data from laboratory studies, the vaccine’s quality and some evidence on safety and efficacy from a pooled analysis of interim results from four ongoing clinical trials in the UK, Brazil and South Africa.

According to the EMA, which indicated late last month that AstraZeneca had yet to formally seek approval of AZD1222, the agency has now received additional information on issues related to quality, safety and efficacy of the vaccine as requested by the CHMP. If the EMA concludes that the benefits of the vaccine outweigh its risks, the European Commission will then fast-track its decision-making process with a view to granting a conditional marketing authorisation within days.

In August, AstraZeneca reached an agreement with the European Commission to supply up to 400 million doses of AZD1222. That contract built on another deal forged between AstraZeneca and Europe’s Inclusive Vaccines Alliance (IVA), spearheaded by Germany, France, Italy and the Netherlands, to also supply the region with up to 400 million doses of the vaccine.

AZD1222, which uses a replication-deficient chimpanzee viral vector and contains the genetic material of the SARS-CoV-2 virus spike protein, was authorized for emergency supply by the UK last month and has since been cleared in India. Meanwhile, the European Commission has granted a conditional marketing authorisation to Pfizer and BioNTech’s coronavirus vaccine Comirnaty, also known as BNT162b2, as well as Moderna’s mRNA-1273.

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