AstraZeneca misrepresented COVID-19 vaccine data, oversight panel says

An independent panel of medical experts sent a two-page letter to AstraZeneca and federal health authorities March 22 accusing the drugmaker of cherry-picking data on its COVID-19 vaccine that was "most favorable for the study as opposed to the most recent and most complete," The New York Times reported March 23. 

The independent data safety and monitoring board said in its letter that AstraZeneca's vaccine may have been between 69 percent and 74 percent effective, according to the Times. AstraZeneca released a statement March 22 saying its vaccine was 79 percent effective at preventing symptomatic COVID-19 and 100 percent effective at preventing severe disease and hospitalization in a U.S. phase 3 trial.  

The letter from the board reprimanded AstraZeneca for giving a misleading representation of the trial data, the Times reported. 

"Decisions like this are what erode public trust in the scientific process," the board wrote in the letter. 

People familiar with the matter told the Times that the board had twice asked AstraZeneca to take a more rigorous approach to determining whether clinical trial participants had possible or actual cases of COVID-19. But the drugmaker released the results without the full analysis the board requested, according to the Times

"Any type of thing like this could unfortunately contribute to a lack of confidence in the process," Anthony Fauci, MD, director of the National Institute of Allergies and Infectious Diseases and the White House's chief medical advisor, told Good Morning America

AstraZeneca released a statement March 23 saying the results it released the previous day appeared to be "consistent" with more recent data collected and that it would "immediately" share its most up-to-date data with the independent data safety monitoring board. It will also reissue fuller results within 48 hours, the company said. 

More than two dozen European companies recently stopped distributing AstraZeneca's vaccine after multiple reports of patients developing blood clots after receiving the vaccine. No link has been proven between the vaccine and blood clots, and some countries that halted the rollout have resumed using AstraZeneca's vaccine. Scientists in Germany and Norway said March 19 they identified a potential link between AstraZeneca's vaccine and reports of blood clots and that the blood clots could be treated. 

More articles on pharmacy:
Pfizer to develop more mRNA vaccines
US worried J&J may not be able to deliver 20M vaccines this month, Biden officials say
Regeneron says its COVID-19 antibody cocktail reduces hospitalization, death risk by 70%

 

Copyright © 2024 Becker's Healthcare. All Rights Reserved. Privacy Policy. Cookie Policy. Linking and Reprinting Policy.

 

Featured Whitepapers

Featured Webinars