In an unusual statement issued on Tuesday, Mar. 23, the United States health officials said that the data released by AstraZeneca on its COVID-19 vaccine might have outdated information.
The announcement came from the National Institute of Allergy and Infectious Diseases or NIAID. It came less than a day after the pharmaceutical company said that its vaccine was very effective in the US trial.
The NIAID stated that the board of experts reviewed the details from the trial, and it immediately raised concerns about the publicly released information and that it may have given an incomplete view of the efficacy data.
According to Dr. Anthony Fauci, the director of the NIAID, the announcement may contribute to some of the unnecessary hesitancy around the AstraZeneca vaccine during his interview on Good Morning America.
Dr. Fauci said that this is called an unforced error because AstraZeneca is a really good vaccine. If the data is reviewed, the vaccine is good, but it was not completely accurate when it is put into the press release.
AstraZeneca said in a statement that the information that it released was based on data that was collected until Feb. 17. The pharmaceutical company stated that it is now analyzing the most recent data, and they will share it with the public within 48 hours.
Eric Topol, a clinical trials expert, and director of the Scripps Research Translational Institute in California, told The New York Times that usually, disagreements between companies and the independent boards overseeing their trials do not happen in public.
Topol stated that he has never seen anything like this.
The announcement is the latest in a long line of issues with the AstraZeneca vaccine. The company has not been as transparent with regulators as it should and gave some clinical trial participants in the United Kingdom the wrong dose of its vaccine.
European doctors raised safety concerns after some people had unusual clotting disorders after getting the anti-COVID-19 shot from the pharmaceutical company.
Experts hoped that the announcement, which included data from the massive and tightly controlled US clinical trial, would help clarify lingering questions about the vaccine and restore some confidence in the shot.
If and when AstraZeneca applies for authorization in the United States, it will have to send all of the data from the US clinical trial to the US Food and Drug Administration or FDA.
Agency scientists will publicly publish their independent analysis, which will give the experts the chance to review it.
The AstraZeneca COVID-19 vaccine is already being used in numerous countries around the world.
AstraZeneca's COVID-19 vaccine showed 79% efficacy against symptomatic disease and 100% efficacy against severe disease and hospitalization in a new clinical trial done in the United States.
The findings from the new trial, which included more than 32,000 participants, may boost confidence in the vaccine, which was originally developed by the University of Oxford.
The trial showed that the COVID-19 vaccine was well-tolerated and is safe. An independent committee found no risk of thrombosis or events that are characterized by thrombosis among the 21,583 participants who got one dose of the vaccine.
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Written by Sieeka Khan