US regulator calls on AstraZeneca to recalculate the effectiveness of its vaccine

AstraZeneca may have calculated the efficacy data for its coronavirus vaccine based on incomplete data from clinical trials. They need to be clarified, according to American experts.

The US Independent Data and Safety Monitoring Board (DSMB) is concerned that AstraZeneca may have included outdated information in its vaccine trial report, resulting in limited understanding of the drug's effectiveness. This is stated in a statement by the US National Institute of Allergy and Infectious Diseases (NIAID).

“We urge the company to work with DSMB to review the performance information and release the most accurate and up-to-date data as quickly as possible,” NIAID said. Such concerns call into question plans by the pharmaceutical company to file documents "in the coming weeks" in the United States for certification of the vaccine under the accelerated procedure in emergency circumstances, notes . Reuters

• The day before, March 22, AstraZeneca reported that according to the results of the third stage of clinical trials in America, Chile and Peru, the vaccine was effective in 79% of cases against coronavirus with symptoms and 100% against severe disease.
• On March 23, the company's quotes, which rose 4% on data on the effectiveness of the vaccine, fell 1.4% by the close.
• Chief US epidemiologist Stephen Fauci considers the incident an "honest mistake" and believes that the vaccine is good. “But this contributes to the discrediting of vaccines in general and to a decrease in the desire to be vaccinated,” he notes. The FDA will review the efficacy data independently, he said.

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Countries in Europe have begun massive withdrawals from AstraZeneca and Oxford University vaccines due to cases of post-dose thrombosis. The European Medicines Agency (EMA) at a meeting on March 18 stated that the benefits of the vaccine outweigh the possible risks, and there is no evidence of a link between vaccination and thrombosis.