TAMPA, Fla. — Pfizer announced Wednesday it started a Phase 2/3 study of its COVID pill treatment in children. Local public health experts explain what the potential treatment could mean for families.
The study will look at the safety and effectiveness of its drug Paxlovid in non-hospitalized, symptomatic children with a confirmed COVID diagnosis who are at-risk of severe disease.
“This is just another thing in the toolkit,” said Dr. Jill Roberts, an associate professor at USF Health.
The study will look at kids who are 6 to 17 years old. Currently, the drug is authorized under FDA Emergency Use Authorization in both high-risk adults and high-risk children 12 and up weighing at least 88 pounds.
Pfizer explains while other trials didn’t include people under 18, the FDA authorized the drug for emergency use in pediatric patients 12 years of age and older weighing at least 88 pounds.
“The drug has been proven to be incredibly successful at preventing hospitalization and deaths in high-risk individuals,” said Roberts.
The company shared that data from high-risk adults with COVID showed the drug reduced the risk of hospitalization or death by 89 percent within three days and 88 percent within five days of when symptoms start.
Dr. Roberts says the drug has been a game-changer.
“It is only recommended for those individuals who are at high risk of severe cases, hospitalizations, and death, and so this isn’t something we would want to give to just everyone. It is not an alternative to the vaccine,” said Roberts.
Roberts also explained what access to treatment like this could mean for families.
“To be able to tell someone, you know what, you can just stay home, you can take this pill. Not necessarily mean the pills are widely available. Of course, you need to talk to your physician. You need to talk about those kinds of things,” said Dr. Roberts. “This is significant savings and a significant difference in access to care.”