PCI 7 November 2023, 15:44
Temax_Krautz
Owen Mumford 12 January 2022, 17:40

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MHRA starts rolling review of AZ’s coronavirus vaccine

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has started an accelerated or rolling review of AstraZeneca’s coronavirus vaccine candidate, the British pharma giant confirmed on Sunday.

Regulators will be able to review data in real time under a rolling review process, which is designed to help speed up the approval timeline of potential vaccines for the novel coronavirus, which causes COVID-19.

On Sunday, an AZ spokesman told Reuters: “We confirm the MHRA’s review of our potential COVID-19 vaccine.”

AZ is developing its COVID-19 vaccine, AZD1222, with the University of Oxford, and the shot is currently being studied in a large-scale phase III clinical trial programme.

It uses a replication-deficient chimpanzee viral vector based on a weakened version of an adenovirus (the common cold virus) that contains the genetic material of SARS-CoV-2 virus spike protein, which causes COVID-19.

The MHRA has also started a rolling review of Moderna’s mRNA-based vaccine candidate, while Bloomberg also reported last week that the agency has started an accelerated review of Pfizer and BioNTech’s potential COVID-19 vaccine.

AZ said in a statement earlier this month that results from the phase III trials are expected later this year, depending on the COVID-19 infection rate in the communities where the studies are being conducted.