AstraZeneca plans to file for US emergency use authorization subsequent month for its COVID-19 vaccine — however the course of might be beneath intense scrutiny with a number of European international locations pausing its use over issues about blood clots.
The British pharmaceutical firm has directed an unbiased evaluate of information from its examine of greater than 32,000 volunteers within the US.
If the outcomes are promising, the vaccine might begin the emergency approval course of with Meals and Drug Administration someday in April.
“The principle factor that’s going to be checked out is the efficacy and security demonstrated within the US scientific trials of the treatment and among the many security options that they’ll have a look at will embrace any episodes of clotting and bleeding,” mentioned Dr. David Hirschwerk, an infectious illness skilled at Hofstra College’s Zucker Faculty of Medication.
“It’s nearly sure that they’ll consider the issues that had been raised in Europe.”
Greater than a dozen international locations halted AstraZeneca photographs pending the outcomes of an investigation into stories in Denmark and Norway of potential unintended effects.
Whereas blood clots and bleeding have been reported amongst individuals who have acquired the vaccine, no proof has prompt there’s a direct hyperlink.
However any proof of significant unintended effects might imply that the drug will face an uphill battle in in search of approval throughout the pond within the US.
“Whether it is discovered that there’s a important threat of clotting or bleeding then I feel it stands to purpose that there’s going to be quite a lot of hesitancy to approve it and, naturally, there’s going to be quite a lot of hesitancy from our communities to simply accept this vaccine,” Hirschwerk mentioned.
The corporate over the weekend insisted it has discovered no proof of a hyperlink.
Nationwide Institute Well being Director Dr. Francis Collins mentioned Monday that he feels “fairly reassured” that the blood clot issues are occurring by probability.
With such massive numbers of individuals receiving the vaccine, some are certain to expertise blood clots, Collins mentioned.
“There could also be a little bit of an overreaction to one thing that’s unrelated to the vaccine itself,” the medical skilled mentioned.
So far as the FDA approval course of, Collins mentioned he believes they’ll get the outcomes of the trial knowledge shortly after which will want about three weeks to investigate it.
“I feel all of us hope that it will likely be a extremely excellent news story. And we’ll have the fourth vaccine so as to add to the checklist to boost our skill to get everybody immunized within the nation as quickly as doable,” Collins mentioned.
With Publish wires