COVID-19 Oral Treatment Being Evaluated by Adolescents and Children

New York-based Pfizer Inc. recently announced today that it had initiated a Phase 2/3 study, EPIC-PEDS, to evaluate the safety, pharmacokinetics, and efficacy of PAXLOVID™ in non-hospitalized, symptomatic, pediatric participants with a confirmed diagnosis of COVID-19 who are at risk of progression to severe disease.

The Phase 2/3 trial is an open-label, multi-center, single-arm study in approximately 140 participants under 18 years of age.

• Cohort 1 includes participants aged 6 to 17 weighing at least 40 kg, and,
• Cohort 2 includes those aged 6 to 17 weighing more than 20 kg and less than 40 kg.

"Since the beginning of the pandemic, more than 11 million children under the age of 18 in the U.S. alone have tested positive for COVID-19, representing nearly 18% of reported cases and leading to more than 100,000 hospital admissions," commented Mikael Dolsten, Chief Scientific Officer and President, Worldwide Research, Development and Medical, Pfizer, in a press release issued on March 9, 2022.

"There is a significant unmet need for outpatient treatments that can be taken by children and adolescents to help prevent progression to severe illness, including hospitalization or death."

"PAXLOVID is already authorized or approved in many countries worldwide, with more than 1.5 million treatment courses delivered thus far and 30 million expected by July (2022) to help combat this devastating disease."

This clinical trial is essential as the SARS-CoV-2 virus variant known as BA.2 continues to spread in the U.S.

The U.S. HHS/ASPR confirmed on March 25, 2022, that based on in vitro assay data, these products (Paxlovid) are likely to retain activity against the BA.2 variant.

Additional COVID-19 oral treatment news is posted at PrecisionVaccinations.com/antivirals.

Note: This news article integrated and edited information for clarity and was manually curated for mobile readers.