Pfizer Inc. announced that the U.S. Food and Drug Administration has authorized the emergency use of PAXLOVID™ for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death.laboratories, which was specifically designed to block the activity of the SARS-CoV-2 M^pro, an enzyme that the coronavirus needs to replicate.
The data demonstrated an 89% reduction in the risk of COVID-19-related hospitalization or death from any cause in adults treated with PAXLOVID, compared to placebo, within three days of symptom onset . No deaths occurred in the treatment group compared to nine deaths in the placebo group by Day 28. While PAXLOVID clinical trials did not include patients under the age of 18, the authorized adult dosing regimen is expected to result in comparable blood concentration levels of PAXLOVID in pediatric patients 12 years of age and older weighing at least 40 kg.
With PAXLOVID now authorized for emergency use, Pfizer stands ready to start delivery in the U.S. immediately. In November 2021, Pfizer announced an agreement with the U.S. government to supply 10 million treatment courses of PAXLOVID, with delivery fulfillment expected to be completed in 2022.In addition to the U.S.
Source: Healthcare Press (healthcarepress.net)
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