Astrazeneca Stock – AstraZeneca vaccine ‘progressing’ in EUA submission despite EU blood clot link
AstraZeneca is “progressing” its submission for emergency use authorization of a coronavirus vaccine in the United States as British authorities recommended that the vaccine not be given to adults under 30 due to evidence that the shot may be linked to rare blood clots.
The Wednesday recommendation came as regulators in the United Kingdom and the European Union said that the benefits of receiving the vaccine continue to outweigh the risks for most people, even though the European Medicines Agency said it had found a “possible link” between the shot and the rare clots.
The agency said most of the cases reported were in women under 60, though it was unable to identify specific risk factors based on current data.
AstraZeneca has not yet filed for emergency use authorization in the United States, and a spokeswoman for the company said, “We are currently progressing our EUA submission for AZD1222. No further updates right now.”
Dr. Shira Doron, infectious disease physician and hospital epidemiologist at Tufts Medical Center, said evaluations for vaccines are done differently in the United States as the Food and Drug Administration takes original data and re-analyzes it using its own experts.
More importantly, by the time the vaccine could be authorized, Americans may not even need the additional supply.
Doron said the logistics of delivering and administering three different vaccines in the U.S. has already been tough enough, and if more supply isn’t necessary, “there is no point in distributing it.”
In March, more than a dozen countries, mostly in Europe, had suspended their use of AstraZeneca over the blood clot issue. Most restarted — some with age restrictions.
The suspensions were seen as particularly damaging for AstraZeneca because they came after repeated missteps in how the company reported data on the vaccine’s effectiveness and concerns over how well its shot worked in older people.
In a statement, AstraZeneca said both UK and EU regulators had requested their vaccine labels be updated to warn of these “extremely rare potential side effect(s).”
The AstraZeneca vaccine operates on an adenovirus platform, which is a weakened version of a common cold virus that causes infections in chimpanzees.
Herald wire services contributed to this report.