AstraZeneca Downgrades Its Efficacy Claims Following Criticism From US Health Agency

AstraZeneca has downgraded its estimates of the efficacy of its Covid vaccine by 3% following recent criticism from a US health agency that results from a trial used “outdated information”. The pharmaceutical company hopes that this small revision will enable its vaccine to receive US approval in the coming weeks. The Mail has the story.

AstraZeneca today claimed its Covid vaccine blocked 76% of symptomatic infections in a major US trial, after downgrading its estimate slightly in the face of unprecedented public criticism.

The Anglo-Swedish pharmaceutical giant was accused of cherry-picking data by US watchdogs, who were “concerned” that the firm provided an “incomplete view” of the jab’s efficacy by releasing early results of the study.

But the recalculated figure was only marginally lower than the original 79% it bragged about on Monday. The data was based on the final results of the exact same 32,000-person trial.  

AstraZeneca’s Mene Pangalos, Executive Vice President of Biopharmaceutical Research and Development, said the results were “consistent” with the interim results that sparked controversy.

He added the data “confirms our Covid vaccine is highly effective in adults, including those aged 65 years and over”.

The US National Institute of Allergy and Infectious Diseases (NIAID) expressed concerns over the use of “outdated information” in trial results in a statement earlier this week. The Mail reported:

The Data Safety Monitoring Board (DSMB), an independent committee overseeing the trial, has “expressed concern that AstraZeneca may have included outdated information from that trial, which may have provided an incomplete view of the efficacy data”, the US NIAID said in a statement.

“We urge the company to work with the DSMB to review the efficacy data and ensure the most accurate, up-to-date efficacy data be made public as quickly as possible,” it said, adding that the DSMB had informed AstraZeneca of its concerns.

AZ scientists have commented that this statement was highly “unusual” given that such discussions are usually held behind closed doors, but have also expressed hope about the vaccine receiving US approval in due course.

The small revision to the efficacy rate will go a long way to putting the vaccine back on track for US approval, with the firm hoping it will be given the green light in the coming weeks. Britain’s regulators gave it the sign off in December.

The Mail’s report on this downgrading is worth reading in full.

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