Story at a glance
- U.S. regulatory agency DSMB alleges AstraZeneca’s clinical vaccine trials featured outdated information, which potentially nullified results.
- This follows safety concerns of blood clotting.
Late Monday evening, a U.S. public health agency expressed concern regarding the newly released clinical trial results from the pharmaceutical company AstraZeneca’s COVID-19 vaccine candidate.
Following the release of promising data showing high levels of efficacy in preventing a COVID-19 infection and severe outcomes, AstraZeneca officials confirmed they would be seeking the U.S. Food and Drug Administration’s (FDA) emergency use authorization.
This could be derailed as a public health oversight committee, the Data and Safety Monitoring Board (DSMB) said the clinical trials could have used outdated information in the trials, potentially skewing the results.
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“The DSMB expressed concern that AstraZeneca may have included outdated information from that trial, which may have provided an incomplete view of the efficacy data,” the National Institute of Allergies and Infectious Diseases said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.”
As an oversight committee, the DSMB helps regulate and evaluate clinical trials of new medicines to ensure accuracy and adherence to protocols.
Over the past months, clinical trial data from AstraZeneca’s COVID-19 vaccine has been encouraging, most recently showing a 79 percent efficacy rate in a study of more than 32,000 volunteers.
Prior to the latest data, the vaccine showed comparable efficacy data with a single dose against the U.K. COVID-19 variant — widely regarded to be more transmissible.
Other concerns surrounding the drug were raised last week when several European countries halted the usage of AstraZeneca’s vaccine due to reports of blood clots in some vaccine recipients.
Further analysis dispelled safety concerns, reporting that any blood clot occurrences were not above national averages. Agencies like the World Health Organizations (WHO) encouraged countries to continue vaccinating with AstraZeneca.
“At this time, WHO considers that the benefits of the AstraZeneca vaccine outweigh its risks and recommends that vaccinations continue,” the WHO statement said.
Regardless, AstraZeneca’s COVID-19 vaccine candidate faces an uncertain outcome from the FDA for its emergency use provision.
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Published on Mar 23,2021