Officials of the American federal health recently said the AstraZeneca COVID-19 vaccine information containing results from a United States trial of the jab may have included "outdated information" and could mean the drugmaker provided an incomplete assessment of efficacy data.
According to a report from Snopes.com, a spokesperson from AstraZeneca said that their company was looking into it.
Earlier this week, AstraZeneca reported its COVID-19 vaccine provided strong protection among adults of all ages in what this report described as a long-anticipated US trial. It is a result some experts hoped would contribute to the rebuilding of public confidence in the jab worldwide, and move it one step closer to clearance in the country.
In an investigation of over 30,000 adult volunteers, the company reported that its vaccine was found to have 79-percent efficacy at preventing asymptomatic COVID-19 cases, including those in older adults.
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A vial of AstraZeneca Covid-19 vaccine in Saxony during the coronavirus pandemic on March 15, 2021, in Dippoldiswalde, Germany.
What AstraZeneca's Press Release Said
In its press release issued early this week, AstraZeneca stated there were no severe diseases or hospital confinements among vaccinated volunteers if compared with five such cases in participants who were given dummy injections. This is a small number consistent with results from Britain as well as other countries that the vaccine protects from the worst of COVID-19.
In addition, the company also said that independent safety monitors of the study found no severe side effects, which include no increased risk of unusual blood clots like the ones detected in Europe, a panic that led several countries to temporarily suspend vaccinations last week.
However, just a couple of hours following the encouraging results AstraZeneca released, the US National Institute of Allergy and Infectious Diseases released an unusual statement.
According to the agency, the Data and Safety Monitoring Board expressed its concern that AstraZeneca may have included outdated information from said trial and may have provided an incomplete view of the data's efficacy.
In its statement, the agency also urged AstraZeneca to work with the DSMB to review the data's efficacy and guarantee the most accurate, updated efficacy data be made available to the public as quickly as possible.
Fauci on the Data's Inaccuracy
In a related report, according to Reuters, Dr. Anthony Fauci, US President Joe Biden's COVID-19 medical adviser, and the NIAID director said that if one is to look at the AstraZeneca COVID-19 vaccine data, they are quite good although when put into the press release, "it wasn't completely accurate." Good Morning America has a similar report as shown on its YouTube video below.
As earlier mentioned, Fauci added that the data and safety monitoring board got worried that the data in the public statement of the drugmaker were to some extent, outdated, and might in fact be a bit misleading.
The board, comprising a group of independent medical experts at the National Institutes of Health, with the NIAID included, contacted AstraZeneca with their concerns about how it laid out its data through the press release that came out earlier this week.
The health official also said that the back and forth was unfortunate, calling it an unforced error that only contributes to public doubts about COVID-19 vaccines and could potentially lead to more hesitation among people worldwide.
The US Food and Drug Administration, which will review the data of AstraZeneca when it seeks approval for the COVID-19 vaccine in the US, will independently examine every bit of the data themselves, and not depend on any single interpretation, including the drugmaker's, added Fauci.
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