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AZ confirms the UK's MHRA has started rolling review of its COVID-19 vaccine

Regulatory agency will review data as and when it becomes available

AstraZeneca (AZ) has confirmed that the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has started a rolling review of its COVID-19 vaccine candidate.

AZ is evaluating the vaccine, AZD1222, in partnership with Oxford University, that originally developed the potential vaccine.

The two partners reached a development and distribution agreement for the vaccine in April, giving AZ responsibility for continuing the development and manufacturing of the vaccine as it advances through late-stage testing.

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

The MHRA will review the vaccine candidate on a rolling basis, meaning that the agency will begin an independent assessment of the vaccine using information submitted by AZ.

It will then accept and consider new evidence as and when it becomes available, until the application is sufficient to warrant regulatory authorisation of the shot.

Last week, the Financial Times reported that AZD1222 triggers protective antibodies and T cell responses in both older and younger adults.

In addition to the promising immune response in older adults, AZ also said that adverse responses were lower among the elderly, according to Reuters.

“It is encouraging to see immunogenicity responses were similar between older and younger adults and that reactogenicity was lower in older adults, where the COVID-19 disease severity is higher,” said an AZ spokesman.

AZ recently received clearance from the US Food and Drug Administration (FDA) to restart a phase 3 trial of its vaccine in the country after the global programme was paused in September.

The study pause was triggered when a participant in AZ’s UK-based study developed a serious adverse event. All phase 3 trials have now resumed, including in the US, UK, Brazil, South Africa and Japan.

Moderna also revealed last week that the MHRA has begun a rolling review of its mRNA-based COVID-19 vaccine mRNA-1273.

The company also recently completed enrolment of its late-stage phase 3 trial, which is testing mRNA-1273 in 30,000 participants.

Bloomberg also reported that the MHRA has started a rolling review of Pfizer’s BioNTech-partnered vaccine, although the pharma company declined to comment on the matter.

Article by
Lucy Parsons

3rd November 2020

From: Regulatory

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