Pfizer to launch study of COVID antiviral for pediatric patients


Pfizer Inc. PFE, -1.13% said Wednesday it is starting a Phase 2/3 trial of its COVID-19 antiviral in children below the age of 18 who are at high risk of developing severe illness. The aim of the study is to treat children outside of a hospital setting with the five-day treatment Paxlovid, which has been granted an emergency use authorization by the U.S. Food and Drug Administration for high-risk adults and high-risk pediatric patients aged 12 years and older that weigh at least 40 kg. “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 R&D 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.” The company will enroll about 140 participants in the study, divided into two cohorts. The first will be aged 6 to 17 and weigh at least 40 kg, and the second will include those aged 6 to 17 weighing more than 20 kg and less than 40 kg. The two groups will receive different doses of the antiviral orally twice daily for 5 days. The company plans to add younger participants to the study once data are available. An independent data monitoring committee will review the safety data for each cohort. Pfizer’s PAXLOVID reduced risk of hospitalization or death from any cause by 89% (within three days of symptom onset) in an earlier trial and 88% (within five days of symptom onset) compared to placebo, with no deaths in the treatment group. Pfizer shares were up 0.7% premarket and have gained 78% in the last 12 months, while the S&P 500 SPX, -0.72% has gained 7.6%.

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