Company expected to submit its vaccine to FDA this month
Pfizer is expected to submit its coronavirus vaccine to the Food and Drug Administration for emergency use in children ages 5-11 by the end of this month, paving the way for potential approval by the end of October.
During an interview with CBS News earlier this week, former FDA Commissioner Dr. Scott Gottlieb, who also serves on Pfizer’s board of directors, said the company expects to finish its clinical trials in young children before the end of September. He said the results will be filed “very quickly” with the FDA, with hopes that the vaccine could be approved for children in October.
“In a best-case scenario, given the timeline they’ve just laid out, you could potentially have a vaccine available to children aged 5 to 11 by Halloween,” Dr. Gottlieb told CBS. “If everything goes well, the Pfizer data package is in order, and the FDA ultimately makes a positive determination. I have confidence in Pfizer in terms of the data that they’ve collected. But this is really up to the Food and Drug Administration to make an objective determination.”
The push for FDA approval for this age group comes as the Centers for Disease Control and Prevention is reporting an increase in the number of children being hospitalized for COVID-19.
According to the agency’s COVID Data Tracker Weekly Review published last Friday, hospitalizations were occurring at a rate of 0.9 per 100,000 among 5-to-11-year-olds at the end of August. The agency reported that this marks a three-fold increase over data from the end of June, which showed a hospitalization rate of 0.3 per 100,000 among the 5 to 11 age group.
“These recent rates of COVID-19-associated hospitalization are the highest seen for this age group during the pandemic,” the agency wrote in the report.
The nation’s top infectious disease expert, Dr. Anthony Fauci, was reported to have told staff from the National Institute of Health last Friday that if Pfizer submits data to the FDA by the end of September, the “product will likely be ready” in the first couple of weeks of October.
Dr. Fauci also said the Moderna vaccine will likely take about three weeks longer than Pfizer to collect data on children ages 5-11. And he estimated that the FDA’s decision on the Moderna shot could come in November, according to Reuters.
If the Pfizer and Moderna vaccines receive emergency FDA approval for children ages 5-11 on this timeline, two vaccines could be available for young children by the end of this year.