AstraZeneca aims for FDA authorization despite previous setbacks
The pharmaceutical company AstraZeneca is planning to submit data to the Food and Drug Administration in the coming weeks with the hopes of getting emergency authorization to begin administering its COVID-19 vaccine in the United States.
Before then, the company has encountered many setbacks concerning their vaccine’s efficiency.
On March 22, AstraZeneca released the initial results of their Phase III trial, which showed a higher efficiency rate at preventing the coronavirus than their current results.
At request by the Food and Drug Administration, the company conducted a larger trial to get clearer data. In the results of their earlier trials, which included six hundred participants in the U.K. and Brazil, some participants received two full doses while others received a half dose followed by a full dose, according to The New Yorker.
Additionally, early trials did not include enough people older than 65.
The data alarmed members of the National Institute of Allergy and Infectious Diseases’ Data and Safety Monitoring Board.
It then resulted in NIAID officials releasing a statement on March 23, calling into question the validity of the results and suggesting the company used outdated findings to reach their vaccine efficiency rate.
“AstraZeneca may have included outdated information from that trial, which may have provided an incomplete view of the efficacy data,” the report stated. “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 was unusual, as monitoring boards usually keep their correspondence with companies private.
In response, AstraZeneca released a revised report with updated data, revealing the vaccine to have a lower efficiency rate of 76 percent compared to its initial 79 percent.
Since their issues with the NIAID, AstraZeneca is facing skepticism with its vaccines.
The pharmaceutical company also faced problems in Europe, where a small portion of people experienced blood clots after taking the shot. More than 20 countries stopped distribution until further investigations revealed there is no definite link between the blood clots and the vaccine.
Since then, most of the countries resumed distributing the vaccine despite growing public concern.
If approved by the FDA, AstraZeneca will be the fourth vaccine in the U.S.
However, it might not have a huge role in vaccinating people as Pfizer, Moderna and Johnson & Johnson have already promised to provide enough doses.
Data retrieved from the Centers for Disease Control and Prevention shows the progress made by the current vaccines.
As of March 31, 29.4 percent of the U.S. population has received at least one dose of the coronavirus vaccine and 16.4 percent is fully vaccinated.
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