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# AstraZeneca Scrutinized on Covid Vaccine Data
- URL: https://www.fdaweb.com/astrazeneca-scrutinized-on-covid-vaccine-data/
- Published: 2021-03-23T12:00:00.000Z
- Updated: 2026-09-14T16:51:55.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5148936

AstraZeneca is being scrutinized over data it presented in a press release about its Covid-19 vaccine. In the release, the company touted data showing efficacy of 79% at preventing symptomatic Covid-19 and 100% efficacy at preventing severe disease and hospitalization ([see story](https://www.fdaweb.com/astrazeneca-covid-vaccine-has-79-efficacy/)). Late 3/21, the study’s data and safety monitoring board raised concern that AstraZeneca may have included outdated information from its trial, which may have provided an incomplete view of the efficacy data. The National Institute of Allergy and Infectious Diseases (NIAID) urged the company to work with the data board to review the efficacy data and ensure the most accurate, up-to-date efficacy data are made public as soon as possible.

In response, AstraZeneca said its data contained in the press release were based on a pre-specified interim analysis with a data cut-off of 2/17\. “We have reviewed the preliminary assessment of the primary analysis and the results were consistent with the interim analysis,” it said. “We are now completing the validation of the statistical analysis. We will immediately engage with the independent data safety monitoring board (DSMB) to share our primary analysis with the most up to date efficacy data. We intend to issue results of the primary analysis within 48 hours.”

NIAID director **Anthony Fauci** told [*Good Morning America*](https://www.goodmorningamerica.com/news/video/fauci-discusses-concerns-oxfordastrazeneca-vaccine-data-76626319?ref=fdaweb.com)that the data dispute was an “unforced error” by AstraZeneca. “If you look at it, the data really are quite good, but when they put it into the press release, it wasn't completely accurate,” Fauci said. “We have to keep essentially trying as hard as we can to get people to understand there are safeguards in place.”

FDA will likely receive an emergency use authorization request by mid-April from the company, and its reviewers will reconcile the data and make a summary available before the request is discussed by an advisory committee meeting in May.