Is AstraZeneca Playing Hardball with the American Regulatory Agencies?
The AstraZeneca vaccine has been on the headlines for quite a while. Ironically, this has been for both good and bad reasons. Speaking of the negatives, there were reports from certain European countries at some point that this vaccine caused blood clotting. This has been debunked by the pertinent regulatory authorities. However, it seems AstraZeneca’s woes are not over in light of reports from the United States.
What the United States Drug Regulatory Agencies Are Saying
Pertinent regulatory agencies in the United States are refusing to give the green light on the Use of the AstraZeneca vaccine. This is even though the pharmaceutical company has released the required data required for clinical evaluation by the authorities.
As reported by major healthcare players such as Dr. Fauci, AstraZeneca has provided very valid data reports on the safety and efficacy of their vaccine to the authorities. However, there is still a problem as certain data expected were left out.
This means that the data submitted by the pharmaceutical manufacturers are outdated in some regards. This is a major cause for concern and the regulatory bodies will not validate the use of the vaccine on American soil until this is sorted out.
What AstraZeneca Is Saying About the Situation
AstraZeneca has been swift to issue statements addressing the issue in a press release. For the record, this is not the first time the company will have to address publicly known issues in recent times. For instance, it did this when it debunked claims that the vaccines were responsible for blood clotting in several parts of Europe.
In the same vein, the vaccine manufacturers admitted to the fact that some parts of the required data were left out. However, the tone suggested that the company had no intention of keeping away sensitive information and that the needed data that were not submitted will be given to the authorities in no more than 48 hours.