Pfizer Starts Next Phases Of COVID-19 Antiviral Trial In Kids
Pfizer is now clinically testing Paxlovid, an oral COVID-19 treatment, in children ages 6 to 17.
On Wednesday, the company announced that it began both a phase 2 and phase 3 clinical trial of its antiviral treatment, Paxlovid, in kids ages 6 to 17. Paxlovid is an oral pill used to treat mild to moderate COVID-19 illness.
The latest phases — which were shared via a news release, according to CNN — will study both the safety and efficacy of this antiviral treatment for kids ages 6 to 17 who fall into the following categories:
- Those who have are symptomatic and test positive for COVID-19
- Those who are considered high risk for developing “severe disease” but aren’t hospitalized
“Since the beginning of the pandemic, more than 11 million children under the age of 18 in the United States alone have tested positive for COVID-19, representing nearly 18% of reported cases and leading to more than 100,000 hospital admissions,” said Mikael Dolsten, Pfizer’s chief scientific officer and president of worldwide research, development and medical. “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.”
This news comes after the drugmaker faced a recent setback with parents after deciding to delay requesting approval for its COVID-19 vaccine for kids under 5 years old. However, this latest announcement shows progress toward a potential pediatric “COVID pill,” and is promising for moms and dads.
In December 2021, the U.S. Food and Drug Administration authorized emergency use of Paxlovid for high-risk individuals ages 12 and older (who weigh at least 88 pounds). But according to CNN, that approval was made with data from clinical trials that had no participants younger than 18.
The hope now is that new results will find Paxlovid, which is a combination of antiviral drugs nirmatrelvir and ritonavir, drastically decreases the chances of death for high-risk patients across age groups, even kids. This is based on the adult trial results, which Pfizer says showed that taking these pills reduced the risk of being hospitalized or dying by 89% — if patients took it within the first few days of developing symptoms. And for those who took it a bit later, within the first five days of becoming symptomatic, they also had impressive results: risk of death and hospitalizations were slashed by 88%.
There will be around 140 participants in the latest trial, and they’ll be broken up into two groups in order to study the pill’s effectiveness based on certain factors. The results “will provide further support for the dose recommendations in this population, as well as potentially expand the indication to younger age groups and lower weights,” Pfizer said in the release.
Although it might be hard right now for parents to envision going back to a world where they don’t have to worry about their kids getting COVID-19, Pfizer is working on making this a reality. Both with its series of pediatric vaccines and boosters, as well as possible access to a simple pill regime that treats symptoms in sick children.