“We are proud to expand studies of our novel Covid-19 treatment to include pediatric participants to further evaluate the safety and efficacy of this treatment in this important population,” Mikael Dolsten, the company’s chief scientific officer and president of worldwide research, development and medical at Pfizer, said in a statement.
The upcoming trials will include roughly 140 children aged 6 to 17 in two branches. The first will include participants weighing at least 88 pounds, who will receive the dosage of Paxlovid currently authorized for those 12 and up. The second will include participants who weigh between 44 and less than 88 pounds, who will receive a smaller dose of the drug. Both groups will receive one pill twice a day for five days, for a total of 10 doses.
Why it matters: Children make up nearly 18 percent of Covid-19 cases, and have no options for outpatient treatments. More than 100,000 kids have been hospitalized from the disease.
Children also have fewer options for vaccines: Pfizer-BioNTech have the only vaccine cleared for 5- to 17-year-olds. Though the vaccine offers significant protection from Covid-19, a recent study from the Centers for Disease Control and Prevention found that the vaccine was less effective at preventing urgent care visits and hospitalizations for kids 5 to 11 years old as it did for teenagers up to five months after a second dose.
Background: FDA first authorized Paxlovid in December. Before FDA cleared the pill for emergency use, the Biden administration purchased 10 million courses of the antiviral through this year.
What’s next: As data from these trials rolls in, Pfizer plans to develop a Paxlovid dosage for children younger than 6 years old. Eventually, the company will enroll children in this age group in the ongoing trial in three different study groups.