AstraZeneca resubmits US data for COVID-19 vaccine after criticism | FI SENSE

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Following the criticism from official bodies over the handling of data in the trial, AstraZeneca (AZN.L) has re-submitted data for trials of its COVID-19 vaccine in the US.

Analysis of Phase 3 trial data of the AZD1222 vaccine was “consistent” with numbers released earlier this week, AstraZeneca said it’s on Thursday.

The pharmaceutical giant said its vaccine was 76% effective at preventing symptomatic COVID and 100% effective at preventing hospitalisation with the disease. AZD1222 was 85% effective at preventing symptomatic COVID in patients over 65. The trial covered over 32,000 patients.

This week resubmission of data follows criticism from official bodies in the US.

On Monday, AstraZeneca released interim results of its Phase 3 trial, showing the vaccine was 79% effective at preventing symptomatic cases, 100% effective at preventing hospitalisations, and 80% effective for over 65s.

The National Institute for Allergy and Infectious Diseases then called for AstraZeneca to resubmit its data. A day later the Data and Safety Monitoring Board (DSMB) in the US claimed the results included out-of-date data.

Mene Pangalos, executive vice president of BioPharmaceuticals R&D at AstraZeneca said, “The primary analysis is consistent with our previously released interim analysis, and confirms that our COVID-19 vaccine is highly effective in adults, including those aged 65 years and over.”

“With the caveat that we haven’t seen the full dataset and it is yet to be submitted for peer review (i.e. things can change), the initial primary data analysis is very consistent with the interim data release, said by Dr Adam Barker and Dr Tara Raveendran, healthcare analyst at stockbroker Shore Capital.

“Although the point estimate (76%) is slightly different from that released earlier (79%), this difference is statistically irrelevant i.e. they are indistinguishable.”

Dr Barker and Dr Raveendran said it was “unclear what data has prompted the NIAID’s concerns.”

AstraZeneca has submitted the new data to the Data Safety Monitoring Board and hopes to use it as a basis for authorisation of the vaccine by the US Food and Drug Administration.

Pangalos said, “We look forward to filing our regulatory submission for Emergency Use Authorization in the US and preparing for the rollout of millions of doses across America.”

Shares in AstraZeneca were broadly unchanged in London.

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