AstraZeneca plans to file for the US Emergency Use Authority for its COVID-19 vaccine next month – but the process remains under intense scrutiny in several European countries with concerns about blood clots preventing its use Can.
The British pharmaceutical company has directed an independent review of data from its study of more than 32,000 volunteers in the US.
If the results are promising, the vaccine may begin an emergency approval process with the Food and Drug Administration sometime in April.
Dr. David Hirschk, an infectious disease specialist at Hofstra University’s Zucker School of Medicine.
“It is almost certain that they will take into account the concerns that were raised in Europe.”
More than a dozen countries intercepted AstraZeneca shots and pending the result of investigations into reports about possible side effects in Denmark and Norway.
While blood clots and bleeding have been reported in people receiving the vaccine, no evidence has been provided that there is a direct link.
But any evidence of serious side effects could mean the drug would face a tough battle in the US seeking approval across the pond.
“If it is found that there is a significant risk of clotting or bleeding, I think it is for this reason that it is going to be very hesitant to approve and naturally, there is a lot of hesitation from our communities. Accept this vaccine.
Over the weekend, the company insisted that it had not found any evidence of the link.
National Institute of Health Director Drs. Francis Collins said on Monday that he felt “very confident” that the blood clotting problem was occurring coincidentally.
Collins said that with the large number of people getting the vaccine, some people are bound to experience blood clots.
The medical expert said, “There is nothing related to the vaccine, which is related to the vaccine.”
As far as the FDA approval process, Collins said he believed they would get the results of the test data soon and then would need about three weeks to analyze it.
“I think we all hope that this will be really good news. We will have a fourth vaccine to add to the list to increase the ability to vaccinate everyone in the country as soon as possible.
With post wires
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