Two of the deceased were older than 55 years
United States.- The US Food and Drug Administration. (FDA) has confirmed, in information documents published this Tuesday, that six people died during the trial of the vaccine against him coronavirus developed by Pfizer Y BioNTechBut none of those deaths have been linked to the antidote, which has been shown to be safe and effective.
According to the health authority, four of the deaths were registered in the placebo group and two in the vaccine group, both of whom died over 55 years of age. One of the two deceased vaccinates experienced cardiac arrest 62 days after receiving the second dose of the vaccine and died three days later, while the other died of arteriosclerosis three days after receiving the first dose of the vaccine.
“All deaths represent events that occur in the general population of the age groups where they occurred, at a similar rate,” reads the document.
“Favorable safety profile”
The FDA estimates that the drug exhibited “a favorable safety profile, with no specific safety concerns” that could preclude its authorization for emergency use.
The document, released ahead of a meeting scheduled for Thursday to discuss emergency use of the vaccine, concludes that the antidote “met the prescribed success criteria” in its clinical study.
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