(WXYZ) — Pfizer started late-stage trials of Paxlovid in children ages 6 to 17. The COVID-19 antiviral pill will be evaluated for the safety and efficacy of treatment in kids considered to be at risk for severe disease. Paxlovid is already authorized for people aged 12 and up, and who weigh at least 88 pounds.
The FDA did grant emergency use authorization for Paxlovid. However, the approval was based on trials that only included adults 18 and up. There were no children. So that’s why Pfizer’s Phase 2 and 3 trials will only include kids aged 6 to 17.
Now the participants will be split into two groups based on weight. The first group will weigh at least 88 pounds and be given the authorized dose of Paxlovid. The second group will consist of kids that weigh between 44 and 88 pounds. They’ll be given a smaller dose of Paxlovid. Both of these groups will take three pills twice a day for a total of 5 days.
Children are less likely to be hospitalized or die from COVID-19. But unfortunately, it does happen. And the kids who are immunocompromised are most at risk. So, children who have cancer, HIV, or an organ transplant - they’re the ones whose immune systems may not develop a strong immune response after getting vaccinated. This is why only those who are most at risk will be included in these trials.
I’m really hopeful that data from Pfizer’s study with kids will be similar to the results seen in adult trials. In the adult trials, Paxlovid was found to cut the risk of hospitalization or death by 88% if taken within five days of symptoms, which is pretty significant.