The National Institute of Allergy and Infectious Diseases (NIAID) released a statement on Tuesday, March 23, which said that the Data and Safety Monitoring Board (DSMB) was concerned about the possibility that AstraZeneca may have provided an incomplete view of the efficacy data.
"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," the statement reads.
AstraZeneca COVID-19 Vaccine Safety
AstraZeneca issued a press release on Monday, March 22, to address concerns that the company's COVID-19 vaccine may have been causing blood clots observed all around Europe.
The statement claims that AstraZeneca's COVID-19 vaccine showed 79% efficacy against symptomatic disease based on 32,449 participants who developed 141 symptomatic of COVID-19 cases.
AstraZeneca continued that the vaccine also showed 100% efficacy against severe disease and hospitalization based on five total cases of severe disease or hospitalization in people who received the placebo.
In a follow-up statement issued on Tuesday, March 23, AstraZeneca clarified that their prior conclusion was based on a pre-specified interim analysis with a data cut-off of February 17.
The British-Swedish biotech company added that they would immediately contact the DSMB to share their primary analysis utilizing the most up-to-date efficacy data.
DSMB's Counter-Statement
The DSMB is an independent group of experts tasked to review, evaluate, and make recommendations such as advising positive findings or halting a trial over safety concerns.
The National Institutes of Health (NIH) appointed a DSMB to monitor COVID-19 vaccine clinical trials that received government funding.
The team formed for the assignment was selecting 10 to 15 people who are experts in their field, such as statistics, vaccine development, and ethics.
In AstraZeneca's case, the DSMB has had their eyes locked on after a study participant developed neurological symptoms during the trial conducted in September 2020.
According to a CNN report in October 2020, the DSMB was also responsible for halting the same AstraZeneca trial in July 2020 for the same reason.
Hours after AstraZeneca's Monday press release, the DSMB wrote to the biotech company and U.S. health leaders to raise their concerns about the data used in the latest study.
On Tuesday, March 23, AP revealed that the DSMB believes AstraZeneca cherry-picked their data instead of using the most recent and complete findings.
Outside experts were baffled by the ongoing professional dispute between the biotech company and the independent group.
NIH director Dr. Anthony Fauci expressed his dismay over the matter.
In an interview on ABC's "Good Morning America" last Tuesday, March 23, Fauci said that the incident "really is what you call an unforced error," and hoping that both AstraZeneca and DSMB will straighten the issue out immediately.
"The data and safety monitoring board picking up this discrepancy was an example of a safeguard," he said during the interview.
Related Article: AstraZeneca Vaccine, Blood Clot Link Unveiled by European Experts - Is Vaccine Still Safe for Those Who Have Blood Clot History?
This article is owned by Tech Times
Written by Lee Mercado
